sensor monitoring system for permanent catheter based treatments

专利摘要:
The present invention relates to a patient monitoring system that can be used with catheters to monitor the infusion and drainage of any solution to the human body. The system can be used, for example, with permanent catheters for peritoneal dialysis in patients with end-stage renal disease (ESRD), urinary tract catheters, insulin pumps in diabetic patients, feeding tubes and central venous line catheters. The patient monitoring system includes one or more fluid pathways to infuse and / or drain solutions out of the catheter and one or more sensors to monitor the fluid. The patient monitoring system transmits patient monitoring data to a database, allowing data storage, processing and access through graphical user interfaces for patients and providers through device applications or web-based portals. in browser.
公开号:BR112020011772A2
申请号:R112020011772-2
申请日:2018-12-14
公开日:2020-11-17
发明作者:Aly R. ELBADRY；Eric Hsiang Yu；Ahmad Naim Saleh；Michael Austin Snyder
申请人:Gastroklenz Inc.；
IPC主号:

专利说明:

[0001] [0001] This request claims priority to Serial Provisional Order No. 62 / 599,619, filed on December 15, 2017, and to Serial Provisional Order No. 62 / 731,339, filed on September 14, 2018, whose content each is incorporated herein by reference in its entirety. Background
[0002] [0002] Several chronic diseases depend on the patient's self-administration or the administration of home treatment in outpatient settings, including infusion and / or drainage of body fluids through catheters or tubes. Examples of such treatments include, but are not limited to, permanent catheters for peritoneal dialysis in patients with end-stage kidney disease, urinary catheters, catheters used with insulin pumps in diabetic patients, permanent or temporary feeding tubes, ascites drainage catheters, catheters for ascites hydrocephalus drainage, and a wide variety of central venous lines offered treatment applications. For treatments that have an alternative treatment modality at the center, such as hemodialysis for peritoneal dialysis, the recent change from a fee-for-service model to the structure of CMS value-based payment systems has led providers to financially encouraged to the largest possible number of patients be treated through outpatient modalities to avoid the high burden associated with treatment at the center. In these outpatient treatment environments, there are high indirect costs transferred to providers, as a guarantee of compliance and hospitalizations related to infections. With peritoneal dialysis (PD), for example, dialysis providers pay more than $ 200 million annually in wages for outpatient PD nurses and more than $ 1 billion annually in infections-related hospitalizations. Currently, patients visit dialysis clinics 1 to 3 times a month, on average, with the main purpose of the visits being a visual inspection of originated infections, ensuring compliance through data manually recorded by the patient or cards computer memory with data records collected by the night cycler for continuous cycling dialysis patients and monitoring the effectiveness of treatment via blood collection. Therefore, additional devices, systems and methods for monitoring patient complications, such as infection, catheter block and failure to ultrafiltration, may be desirable. summary
[0003] [0003] A sensor monitoring system is provided that can be used with existing catheters to monitor the infusion and drainage of any solution in the human body. The system can be used, for example, with permanent catheters for peritoneum dialysis in patients with end-stage renal disease (ESRD), urinary catheters, hydrocephalus leads, ascites drainage catheters, insulin pumps in diabetic patients, feeding tubes , central venous line catheters, and the like. The sensor monitoring system includes one or more fluid pathways to infuse and / or drain solutions out of the catheter and one or more sensors to monitor the fluid and / or the patient (for example, in an area adjacent to the exit site catheter). The sensor monitoring system transmits the patient's monitoring data to a database, which can, for example, allow storage, processing and / or access to data through graphical user interfaces for patients and suppliers via through browser-based device applications or web access portals.
[0004] [0004] A variation of the system includes devices and methods for monitoring dialysis therapy in relation to) patient adherence to the prescribed dialysis therapy, b) effectiveness of ultrafiltration (UF) of the dialysate solution and / or c) complications related to dialysis, such as infection and / or catheter blocks. The system provides a variety of sensors with a multitude of detection mechanisms contained in a housing and fluidly connected to the dialysate solution. One or more parameters or signals from the patient are monitored and, in some variations, a combination of different signals and / or signals over time are generated from the sensor matrix and reported or analyzed to determine the patient's condition.
[0005] [0005] As described in more detail below, the system can be used in an outpatient or home environment as a first line of defense so that professionals continuously monitor the first signs of complications, including, among others, infections, leakage of catheters and blocking catheters. The patient's adherence to the prescribed treatment can be tracked and communicated to the patient and / or providers, and the adequacy / efficacy of the treatment can also be assessed to indicate whether the organism is responding to the treatment. These systems can allow an increase in the number of patients to which each health professional is assigned and can reduce the number of visits to the clinic, which can provide substantial cost-saving value proposals for reducing indirect management costs. outpatient. In addition, the early detection of infections can allow the capture of infections originating at a stage where it is treatable by a course of antibiotics, instead of being referred to a hospital. Once antibiotic therapy is started, the effectiveness of antibiotic treatment can also be monitored with the system.
[0006] [0006] The one or more of the patient's parameters can be transmitted wirelessly through secure protocols to a database that stores and processes the data. A patient user interface allows you to retrieve information from the database and additional patient entries that are stored in the database. A user interface for the provider allows remote monitoring of one or more patients through a visual interface that displays the monitored data and an alert system, which can provide updates or indicate deviations in the monitored patient data ( for example, reduced levels of analyte, decreased patient physical activity, decreased pH value, increased central body temperature) and / or diagnosis of clinical results (eg, patient infection, catheter leakage, catheter, patient non-adherence to therapy, decreased treatment efficacy, etc.), for example. A provider's user interface can also allow input of patient vital sign measurements, test results and clinical events, such as an acute infection, to track patient care history and provide data for analysis regression, such as correlation of sensor-based data and infection complications.
[0007] [0007] In one variation, the system monitors patients with end-stage renal disease prescribed for peritoneal dialysis. In this variation, a patient monitoring device comprises flow sensors connected to the patient's dialysis catheter. The flow sensor can be used to measure the filling volume (FV) of the dialysate solution infused through the catheter and / or the drainage volume (DV) of the residual dialysate solution exiting the catheter to determine the PV / DV ratio. Only with the measurement of DV measured from the sensors, the prescribed value of FV can be entered by the patient or supplier and, therefore, the FV / DV ratio also
[0008] [0008] In another example for patients on peritoneal dialysis, in which the patient monitoring device is connected to the dialysis catheter, a combination of one or more of temperature, optical fluid dispersion / absorption, conductivity, flow and pH sensors can be used to detect infection in patients. The multitude of sensors can detect the various biological expressions of the infection. Several sensor measurements can be used to trigger alerts to the supplier about potential infection. For example, alerts can be triggered by an elevated temperature of the drain dialysate solution in addition to a standard biological range, greater dispersion / optical absorption of the drain dialysate solution (with or without normalization of the drain volume or data the flow sensor dwell time) of the baseline values, increase in the pH variation of the drainage dialysate solution from the baseline values and / or changes in the conductivity of the drainage dialysate solution and / or changes in the PV / DV ratio. The provider may, in some variations, log in to the browser-based web portal to review recent data in the context of historical data, initiate infection treatment and monitor treatment adequacy.
[0009] [0009] For patients on peritoneal dialysis, the system can use a multitude of sensors, including, among others, flow, temperature, optical dispersion / absorption, pressure, pH, conductivity, accelerometer and gyroscopes to provide remote monitoring of a) related dialysis - no complications (for example, peritonitis, catheter obstruction, catheter leakage, hernia incidence), b) patient adherence to the prescribed dialysis therapy and c) adequacy of dialysis therapy ultrafiltration. Remote monitoring offers professionals and patients a more economical and convenient dialysis treatment.
[0010] [0010] Another potential benefit of the monitoring system is to allow caregivers to monitor patients more frequently than can be practical through face-to-face clinical visits. Frequent monitoring of patients allows professionals to resolve complications and / or poor treatment efficacy immediately before problems exacerbate. For example, infections, when detected early, can be treated with an antibiotic regimen that, at the beginning of the onset of infection, is much more effective and, therefore, can prevent the patient's hospitalization when detected late. The resolution of the infection can be monitored after starting antibiotic treatment. In another example, when treatment efficacy is low, the prescribed medical therapy (eg, medication, dosage, frequency) can be updated immediately.
[0011] [0011] Another potential advantage of the monitoring system is to provide additional data for the provider to use in the diagnosis of complications and to determine the best treatment options. The
[0012] [0012] It should be considered that systems and methods can be used in a variety of different dialysis therapies to treat kidney failure. Dialysis therapy can include and cover any form of therapy that uses fluids (eg, patient's blood, dialysate) to remove waste, toxins and excess water from the patient. Such therapies include, for example, hemodialysis, hemofiltration, hemodiafiltration and peritoneal dialysis, including automated peritoneal dialysis, continuous ambulatory peritoneal dialysis and continuous flow peritoneal dialysis. Such therapies may also include, where applicable, intermittent therapies and continuous therapies used for continuous renal replacement therapy. Patients treated with dialysis therapies may include patients with chronic renal failure, as well as those with acute renal failure, resulting from renal or non-renal disease.
[0013] [0013] In one variation, a method for detecting infection from a patient includes the steps of receiving fluid from the patient through a fluid conduit, measuring an optical characteristic of the patient's fluid in two or more wavelength ranges, estimate a leukocyte concentration based, at least partially, on the measurement of optical characteristic in two or more wavelength ranges, and detect a patient's infection status based, at least partially, on the leukocyte concentration estimated.
[0014] [0014] In some variations, an optical characteristic comprises one or more among optical dispersion and absorption. In some variations, the optical characteristic can be measured in a first wavelength range corresponding to a total particle concentration of the patient's fluid and the optical characteristic can be measured in a second wavelength range corresponding to a concentration of leukocytes from the patient's fluid. The first wavelength range may be different from the second wavelength range. In some variations, the first wavelength range is between approximately 700 nm and approximately 1 mm and the second wavelength range is between approximately 260 nm and approximately 550 nm.
[0015] [0015] In some variations, measuring the optical characteristic in a first wavelength range corresponds to a total particle concentration of the patient's fluid and measuring the optical characteristic in a second corresponding wavelength range to a concentration of non-leukocyte particles in the patient's fluid. The first wavelength range may be different from the second wavelength range. In some variations, the patient's fluid homogeneity can be measured using the sensor. A set of measures of optical characteristic can be excluded from the estimate of leukocyte concentration based, at least partially, on the measure of homogeneity.
[0016] [0016] In some variations, dialysate fluid can be received through the fluid conduit. The optical characteristic of the dialysate fluid can be measured using the sensor. Dialysate fluid can be infused into the patient and the patient's fluid can be drained from the patient. The estimated leukocyte concentration can be based, at least partially, on the measure of the optical characteristic of the dialysate fluid. In some variations, a differential of the optimal characteristic
[0017] [0017] In some variations, one or more of a flow and volume of the patient's total fluid flow can be measured using a flow sensor coupled to the fluid conduit. The optical characteristic measurement can be normalized based on one or more of the flow and the total flow volume measurement. In some of these variations, one or more of an obstruction and flow direction can be detected based, at least partially, on the flow rate. In some of these variations, one or more of an infusion volume, drainage volume, infusion time, drainage time, and residence time can be estimated based, at least partially, on the flow rate. One or more of a dialysis efficacy and dialysis adequacy can be estimated based, at least partially, on the estimated infusion volume, drainage volume, and length of stay. In some variations, one or more of an infusion state, permanence state, and drainage status of the patient's fluid can be detected without user input.
[0018] [0018] In some variations, the method may comprise one or more of the steps of measuring pH of the patient's fluid using a pH sensor, in which the detected infection state is based, at least partially, on the pH measurement, measure a lactate concentration of the patient's fluid using a lactate sensor, where the detected infection state is based, at least partially, on the lactate concentration measure, counting patient's fluid cells using a cell counter , where the detected infection status is based, at least partially, on the cell count, measure leukocyte esterase of the patient's fluid using a test strip, on which the detected infection status is based, at least partially , in the measure of leukocyte esterase, measure a chemiluminescence of the patient's fluid using a chemiluminescence sensor, in which the detected state of infection is based, at least partially, on the measure of chemiluminescence, less than go a patient's skin color using an image sensor, where the detected infection status is based, at least partially, on the color measurement, measure a patient's fluid conductivity using a conductivity sensor , estimate a solute concentration of the patient's fluid based, at least partially, on the conductivity measure, measure urea of the patient's fluid using an electromechanical sensor, estimate the patient's fluid urea concentration based, at least partially, urea measurement and at least one of the conductivity and a flow measurement, measure the patient's fluid creatinine using an electromechanical sensor, estimate a creatinine concentration in the patient's fluid based, at least partially, on the measurement of creatinine and a measure of flow volume, measure glucose from the patient's fluid using a glucose sensor, and estimate the glucose concentration of the patient's fluid based, at least partially, on the measure of gl icosis and at least one of the conductivity and flow volume measurement.
[0019] [0019] In some variations, at least an alert can be issued comprising one or more of the patient's infection status, patient complying with the prescribed therapy, therapy effectiveness, sensor calibration, fluid conduit maintenance, and sensor data. In some of these variations, an alert sensitivity can be modified based on one or more of a set of clinical patient events and a patient profile.
[0020] [0020] In some variations, a request may be issued to enter patient data in response to the detection of a positive infection status of the patient. The patient's input data can be received. The detected infection status can be classified as a false positive based, at least partially, on the patient's input data. In some variations, an alert corresponding to the obstruction of the fluid conduit may be issued based, at least partially, on a pressure measurement and an acceleration measurement. In some variations, the patient's infection status can be passed on to a health care provider. A prescription for a therapeutic agent can be received from the health care provider. The therapeutic agent can be dispensed without user input.
[0021] [0021] In some variations, a sample of the patient's fluid may be collected in a sample container releasably attached to the fluid conduit based, at least partially, on the patient's detected infection state. The sample container can be disengaged from the fluid conduit. In some variations, an alert sample container may be issued to one or more of the patient, a health care provider, and a carrier based, at least partially, on the state of infection and a location of the container for the patient. sample. In some variations, the sensor can be coupled between a drain line and a drain vessel or the sensor can be coupled between an infusion line and an infusion dialysate container.
[0022] [0022] In some variations, a patient monitoring device may comprise an optical sensor arrangement comprising at least one emitter and at least one detector. The emitter can be configured to transmit light to one or more wavelength bands through a patient's fluid flowing through a fluid conduit. At least one detector can be configured to receive the light transmitted through the patient's fluid and generate signal data based on the received light. A controller can be configured to estimate total particle concentration and leukocyte concentration using the signal data. In some variations, the device may comprise a housing involving the arrangement of the optical sensor. The fluid conduit can be configured to release reliably to the housing. In some of these variations, the housing can be configured to move between an open configuration with an exposed interior cavity and a closed configuration with a closed interior cavity.
[0023] [0023] In some variations, at least one sensor without fluid contact comprises one or more of a pressure sensor, image sensor, accelerometer, gyroscope, temperature sensor, and magnetic field transducer. In some variations, the fluid conduit comprises at least one transparent portion that is substantially transparent to at least one of ultraviolet light, visible light, and infrared radiation. In some variations, the fluid path comprises an inlet configured to couple at least one of a permanent catheter and a drainage line for peritoneal dialysis, and an outlet configured to open towards a drainage vessel.
[0024] [0024] In some variations, one or more portions of the fluid conduit may be composed of one or more of cyclic olefin, acrylic, polycarbonate (COC) copolymers, polystyrene, acrylonitrile butadiene styrene (ABS), polyethylene glycol coated silicone, polyurethane coated with zwitterionic, polyvinyl chloride coated with polyethylene oxide, and polyphenyl silicon. In some of these variations, the fluid conduit is a first fluid conduit, and a second closed-end fluid conduit branches off the first fluid conduit. A flow sensor can also be configured to measure a fluid level from the second fluid conduit. And bad-
[0025] [0025] In some variations, the housing may comprise a therapeutic agent container configured to store a therapeutic agent. The controller can be configured to receive a prescription from a healthcare provider and release the therapeutic agent based on the prescription received. The release of the therapeutic agent may comprise one or more of unlocking the therapeutic agent container and dispensing the therapeutic agent to the fluid conduit. In some variations, the controller can be configured to open a valve to fill a sample container with the patient's fluid when detecting a positive infection status of the patient. In some variations, a support may comprise an adhesive layer comprising one or more of a silicone adhesive and an acrylate adhesive. In some variations, one or more of a temperature sensor and skin color sensor can be located on a mounting surface.
[0026] [0026] In some variations, a patient monitoring device may comprise a housing configured to releasably engage a fluid conduit. At least one sensor can be configured to measure at least one fluid flow characteristic through the fluid conduit. A controller can be configured to generate patient data comprising a patient's infection status based, at least partially, on a characteristic. In some of these variations, the characteristic may comprise one or more among optical dispersion, absorption, color, flow, conductivity, temperature, pH, lactate concentration, cell count, leukocyte esterase concentration, chemiluminescence, concentration glucose, urea concentration, and creatinine concentration.
[0027] [0027] In some variations, the housing may comprise a joint and the housing is configured to surround at least a portion of the fluid conduit. In some variations, the fluid conduit may comprise the rigid curved end configured to reliably secure the fluid conduit to a drainage vessel so that the housing is separate from the drainage vessel. In some variations, at least one sensor is configured to tighten a portion of the transparent fluid conduit to at least one of ultraviolet light, visible light, and infrared radiation. In some variations, at least one sensor is a fluid contact sensor. In some variations, the device may comprise a limited-use sensor configured to releasably engage one or more of the fluid conduit and housing. In some of these variations, the controller can be configured to detect an expiration of the limited use sensor based, at least partially, on the flow measurement.
[0028] [0028] In some variations, the fluid conduit can be attached to one or more of a permanent catheter for peritoneal dialysis, a urinary catheter, hydrocephalus bypass, percutaneous abscess drainage catheter, ascites drainage catheter , insulin pump, feeding tube, central venous line catheter, tunneled catheter, and implanted access port. In some variations, a docking station may comprise at least one fluid chamber, a pump coupled to at least one fluid chamber, a fluid port coupled to at least one fluid chamber, a connectable coupling with a patient monitoring device, a coupling sensor configured to generate a sensor signal when the coupling facility is joined with the patient monitoring device, and a controller configured to circulate a fluid through the patient monitoring device patient monitoring using the fluid pump based, at least partially, on the sensor signal.
[0029] [0029] In some variations, the fluid is circulated at one or more among predetermined flow, conductivity, optical dispersion, absorption, and temperature, and the controller is configured to calibrate at least one sensor of the patient monitoring device using the circulated fluid. In some variations, at least one fluid chamber comprises a first chamber and a second chamber, the first chamber fluidly separated from a second chamber. In some variations, the docking station comprises a UV light source configured to optically connect to a fluid conduit of the patient monitoring device. The controller can be configured to emit UV light to the fluid conduit using the UV light source. In some variations, the coupling feature may comprise a fluid connector and an electrical connector. The fluid connector can be configured to connect with a fluid conduit from the patient monitoring device. The electrical connector can be configured to connect with one or more of an electronic communication device and a power supply for the patient monitoring device.
[0030] [0030] In some variations, at least one sensor can compose
[0031] [0031] In some variations, a method of monitoring a patient's infection may include the steps of measuring at least one characteristic of a patient's fluid over a first period and a second period after the first period. At least one feature can comprise one or more of optical dispersion, optical absorption, flow rate, conductivity, temperature, pH, lactate concentration, cell count, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration , and creatinine concentration. Patient data comprising a reference range, of at least one characteristic, can be generated over the first period. A patient's status based at least partially on the reference range and the measured characteristic can be monitored over the second period.
[0032] [0032] In some variations, a set of clinical patient events can be measured during the first period and the second period after the first period. A relationship can be estimated between the set of clinical patient events and at least one characteristic about the first period. A patient's condition based, at least partially, on the estimated relationship and the measured characteristic can be monitored over the second period. In some variations, an alert to a predetermined contact can be issued when the characteristic measured over the second period deviates from the reference range.
[0033] [0033] In some variations, an alert sensitivity can be modified based on one or more of a number of deviations from the reference range and a number of clinical patient events. In some variations, the patient's condition may comprise one or more of a patient's infection status, patient complying with a prescribed therapy, therapy effectiveness, device maintenance, sensor calibration, and sensor data. In some variations, a communication channel can be established between the patient and a healthcare professional in response to the corresponding alert to the patient being in a high risk condition. Brief description of the figures
[0034] [0034] Figure 1A schematically illustrates an exemplary variation of a monitoring system.
[0035] [0035] Figure 1B schematically illustrates another exemplary variation of a monitoring system.
[0036] [0036] Figure 2 schematically illustrates an exemplary variation of a patient monitoring device, describing a layout of the patient monitoring device, and connections to a permanent catheter and dialysate fluid.
[0037] [0037] Figure 3 illustrates a top and side view of an exemplary variation of a patient monitoring device for accommodation and components.
[0038] [0038] Figure 4 illustrates a top cross-sectional view of another exemplary variation of a monitoring device for patient housing and components.
[0039] [0039] Figure 5 illustrates an assembly view of an exemplary variation of a patient monitoring device for disposable and permanent components.
[0040] [0040] Figures 6A-6D and 7A-7D illustrate several exemplary patient monitoring devices and configurations of the disposable component. In particular, Figures 6A, 6C, 7A, and 7C are schematic top views and Figures 6B, 6D, 7B, and 7D are schematic cross-views.
[0041] [0041] Figure 8A illustrates a perspective view of an exemplary variation of a disposable component of a patient monitoring device coupled to a fluid conduit. Figures 8B and 8C are schematic top views of the disposable component and fluid conduit shown in Figure 8A.
[0042] [0042] Figures 9A-9D illustrate a schematic perspective view of an exemplary variation of a removable disposable component in different states.
[0043] [0043] Figures 10A-10C illustrate top views of exemplary variations of an optical sensor system. Figure 10A illustrates a top view of a sensor system. Figure 10B illustrates a variant of a sensor system including a fluid conduit. Figure 10C illustrates a variation of an optical reader attached to a fluid conduit.
[0044] [0044] Figures 11A and 11B illustrate respective perspective and side views of an exemplary variation of a patient monitoring device configured to attach to a fluid conduit.
[0045] [0045] Figure 12 illustrates an exemplary variation of a patient monitoring system including a patient monitoring device coupled to a drainage vessel.
[0046] [0046] Figure 13 illustrates an exemplary variation of a patient monitoring system including a patient monitoring device coupled to a permanent catheter and connector tubing.
[0047] [0047] Figure 14 illustrates an exemplary variation of a patient monitoring system including a set of patient monitoring devices coupled to the connector tubing and, respectively, to a solution vessel and a drain vessel.
[0048] [0048] Figure 15 illustrates an exemplary variation of a patient monitoring system including a patient monitoring device coupled to the connector tubing and a drainage vessel.
[0049] [0049] Figure 16A illustrates a plan view of an exemplary variation of a fluid conduit. Figure 16B is a plan view of an exemplary variation of a PCB interface. Figure 16C is a plan view of an exemplary variation of the fluid conduit and PCB interface shown in Figures 16A and 16B. Figure 16D is a top view of an exemplary variation of a fluid conduit and patient monitoring device. Figure 16E is a side cross-sectional view of an exemplary variation of the fluid conduit and patient monitoring device depicted in Figure 16D.
[0050] [0050] Figure 17 illustrates a perspective view of an exemplary variation of a fluid conduit.
[0051] [0051] Figure 18 illustrates an exemplary variation of an input and output of a patient monitoring device.
[0052] [0052] Figure 19 illustrates an exemplary variation of a patient monitoring system including a patient monitoring device coupled to a permanent catheter.
[0053] [0053] Figures 20A and 20B illustrate respective perspective and side views of an exemplary variation of a patient monitoring device configured to attach to a fluid conduit such as a connector tube.
[0054] [0054] Figures 21A, 21B, and 21C illustrate respective perspective and side views of another exemplary variation of a patient monitoring device configured to attach to a connector tube.
[0055] [0055] Figure 22 illustrates a side view of an exemplary variation of a patient monitoring device.
[0056] [0056] Figures 23A and 23B illustrate a schematic perspective view of an exemplary variation of a patient monitoring device having an assembly feature.
[0057] [0057] Figures 24A and 24B illustrate perspective views of an exemplary variation of a patient monitoring device attached to a toilet.
[0058] [0058] Figures 25A and 25B illustrate perspective views of exemplary variations of a pipe connector assembly.
[0059] [0059] Figure 26 illustrates a schematic diagram of an exemplary variant of a patient monitoring device comprising a set of fluid conduit and a set of one-way valves.
[0060] [0060] Figures 27, 28, 29, 30, 31, and 32 illustrate schematic diagrams of exemplary variations of a patient monitoring device comprising fluid conduit and sensors.
[0061] [0061] Figure 33 illustrates a schematic circuit diagram of an exemplary variation of a thermistor.
[0062] [0062] Figure 34 illustrates a schematic circuit diagram of an exemplary variation of an infrared dispersion and / or optical absorption sensor.
[0063] [0063] Figure 35 illustrates an exemplary variation in an absorption spectrum of effluent components.
[0064] [0064] Figure 36 illustrates an exemplary variation of a graph of cell concentration and voltage emitted from a dispersion and / or optical absorption sensor.
[0065] [0065] Figure 37 illustrates an exemplary graph of proportion of cellular concentration and signal.
[0066] [0066] Figures 38A and 38B illustrate an exemplary graph of cell concentration and signal emitted from a two-stage system of dispersion and / or optical absorption where the second stage uses a differentiation wavelength range.
[0067] [0067] Figures 39A and 39B illustrate other exemplary graphs of cell concentration and signal emitted from a two-stage system of dispersion and / or optical absorption where the first and second stages use the differentiation wavelength bands.
[0068] [0068] Figure 40A illustrates an exemplary graph of homogeneous optical dispersion / absorption. Figure 40B is an image of a homogeneous mixture of particles in a solution.
[0069] [0069] Figure 41A illustrates an exemplary graph of non-homogeneous optical dispersion / absorption. Figure 41B is an image of non-homogeneous particles suspended in a solution.
[0070] [0070] Figure 42A illustrates an exemplary graph of large particle flow over time. Figure 42B is an image of a stringer (for example, fibrin) in a fluid conduit.
[0071] [0071] Figure 43 illustrates a schematic cross-sectional view of an exemplary variation of an optical dispersion and / or absorption sensor.
[0072] [0072] Figure 44 illustrates a schematic diagram of an exemplary variant of an optical advancement system.
[0073] [0073] Figure 45 illustrates a schematic circuit diagram of an exemplary variation of a pressure sensor mechanism.
[0074] [0074] Figure 46 illustrates a schematic circuit diagram of an exemplary variation of a conductivity sensor.
[0075] [0075] Figure 47A illustrates a perspective view of an exemplary variant of a docking station.
[0076] [0076] Figure 47B illustrates a perspective view of an exemplary variation of a patient monitoring device
[0077] [0077] Figure 48A illustrates a schematic diagram of an exemplary variation of the docking station. Figure 48B illustrates a perspective view of the docking station shown in Figure 48A. Figures 48C and 48D illustrate perspective views of exemplary connectors of the docking station shown in Figure 48B.
[0078] [0078] Figure 49 illustrates an exemplary calibration process using flow monitoring.
[0079] [0079] Figure 50 illustrates an exemplary method for determining alternate flow states of solution.
[0080] [0080] Figure 51 illustrates an exemplary method for generating a warning for changing the effectiveness of ultrafiltration.
[0081] [0081] Figure 52 illustrates an exemplary method for generating a warning based on pressure data.
[0082] [0082] Figure 53 illustrates an exemplary method for generating an alert for detecting infection.
[0083] [0083] Figures 54A and 54B illustrate schematic cross-sectional views of an exemplary variation of a sample container coupled to a fluid conduit.
[0084] [0084] Figures 55A, 55B, and 55C illustrate schematic cross-sectional views of another exemplary variation of a sample container coupled to a fluid conduit.
[0085] [0085] Figure 56 illustrates an exemplary method for generating alerts to a set of shareholders.
[0086] [0086] Figures 57A, 57B, 57C, 58A, 58B, and 58C illustrate exemplary methods for storing and accessing a therapeutic agent.
[0087] [0087] Figure 59 illustrates an exemplary method for controlling sensitivity at the alert level based on one or more vital measures of the patient.
[0088] [0088] Figure 60 illustrates an exemplary graphical user interface for monitoring the patient by a provider. Figure 61 illustrates an exemplary graphical user interface for patient monitoring by a patient.
[0089] [0089] Figure 62 illustrates an exemplary variation of a patient monitoring system including a patient monitoring device attached to a urinary tract catheter.
[0090] [0090] Figures 63A, 63B, and 63C illustrate several views of exemplary variations of a subcutaneous sensor variation device.
[0091] [0091] Figure 64A is a perspective view of an exemplary variation of a patient monitoring device. Figure 64B is a perspective view of the patient monitoring device shown in Figure 64A attached to a toilet.
[0092] [0092] Figure 65 is a perspective view of an exemplary variation of a durable component of a patient monitoring device.
[0093] [0093] Figures 66A and 66B are seen in perspective of an exemplary variation of a disposable component of a patient monitoring device. Figure 66C is a perspective view of an exemplary variation of a disposable fluid conduit for a patient monitoring device. Figure 66D is a perspective view of the disposable component and disposable fluid conduit shown in Figures 66A-66C. Figure 66E is an enlarged perspective view of the patient monitoring device. Figure 66F is an assembled perspective view of a patient monitoring device.
[0094] [0094] Figures 67A and 67B are seen in perspective of an exemplary variation of a patient monitoring device attached to a toilet.
[0095] [0095] Figures 68A, 68B, 68C, and 68D are seen in perspective of an exemplary variation of a patient monitoring device.
[0096] [0096] Figures 69A, 69B, 69C, and 69D are seen in perspective of an exemplary variation of a durable component of a patient monitoring device.
[0097] [0097] Figures 70A and 70B are seen in perspective of an exemplary variation of a fluid conduit from a patient monitoring device.
[0098] [0098] Figure 71A is a perspective view of an exemplary variation of a patient monitoring device. Figure 71B is a perspective view of an exemplary variation of an assembly feature. Figures 71C and 71D are seen in perspective of the patient monitoring device and mounting feature shown in Figures 71A and 71B.
[0099] [0099] Figures 72 and 73 illustrate exemplary graphical user interfaces for patient monitoring by a patient.
[00100] [00100] Figure 74 is a perspective view of an exemplary variation of a fluid conduit for a patient monitoring device including a ball flow sensor.
[0100] [0100] Figures 75A and 75B are detailed side views of an exemplary variation of a fluid flow ball sphere sensor.
[0101] [0101] Figures 76A and 76B are detailed side views of another exemplary variation of a valve ball in a fluid conduit.
[0102] [0102] Figure 77 is a schematic cross-sectional side view of another exemplary variation of a fluid conduit for a patient monitoring device.
[0103] [0103] Figures 78A, 78B, 78C, and 78D are a schematic cross-sectional side view of an exemplary variation of an optical sensor and fluid conduit configuration of a patient monitoring device.
[0104] [0104] The various examples here refer to a system used to collect, measure, analyze, transmit, and / or store patient data related to infusion and / or drainage solutions to the human body through catheters for monitoring various therapies. The systems described in this document may comprise a patient monitoring device with one or more sensors connected between, on and / or inside a patient's catheter, connecting tube and the infusion solution and / or drainage solution. The patient's monitoring device collects and can process sensor data. The system can include an integrated or separate transmitter to receive and transmit data from the patient's monitoring device to one or more computing devices, such as a mobile device and a database server. The system can include a database server that receives and / or processes the data. The system can include user interfaces that receive data from the database server, summarize the data visually, provide alerts to one or more stakeholders (for example, users, providers, family, partners, caregivers) and / or allow users to enter additional monitoring data.
[0105] [0105] In a method of use, the system monitors the patient's compliance with the prescribed therapy, the patient's complications and / or the effectiveness of the treatment. Initially, the provider can configure the patient in the monitoring system by inserting the information through one or more applications on one or more computer devices, mobile devices, tablets and / or browser-based web access portals. The entry of information can include the identification number of the patient's monitoring device, the identification number of the transmitting device, the patient's name,
[0106] [0106] The patient can connect the patient monitoring device to his catheter or connector tubing. Patients can prepare the patient monitoring device by first assembling a disposable component from the housing to the durable component of the patient monitoring device. The patient could then charge the patient monitoring device by connecting a micro-USB cable to a power source and a micro-USB port on the patient monitoring device. In addition or alternatively, the patient monitoring device can be docked to a docking station that can be configured to charge a battery from the patient monitoring device, upload / download data to a memory of the device. patient monitoring, cleaning and / or sterilizing one or more components of the patient monitoring device (eg contact sensors, fluid conduit), and / or calibrating the patient monitoring device. To activate the system, the patient can hold a switch to turn on the system, indicated by an LED light on the patient monitoring device. The patient can pair the patient monitoring device with a separate computing device (eg tablet, smartphone) via Bluetooth connectivity, keeping the switch on the patient monitoring device until a blue and red LED light flashes. , opening a unique application on the computing device for the system, locating the patient monitoring device in the computing device application and entering a unique code provided (eg PIN, password, identifier). After communication is established and the patient's monitoring device is authenticated, the app confirms the patient with a pop-up message to connect the patient's monitoring device to the catheter.
[0107] [0107] In some variations, the patient monitoring device can be connected to a drainage vessel (for example, drainage bowl, toilet, sink, bathtub, garbage bag, etc.) via a clamp holder, hook, clamp, strap, adhesive or other suitable mounting device and / or device. Alternatively, patients can connect the patient's monitoring device to the abdomen or other skin surface to the side of the catheter (for example, through an adhesive, after removing an adhesive release layer). The patient can wash the tube of the monitoring device with sterile saline by connecting a syringe filled with saline to the port of the inlet tube and injecting the saline until all air is expelled. The patient can connect the fluid connection accessory of the patient's monitoring device to his catheter port or to the connector tube. The patient can remove the syringe from the inlet tubing of the patient monitoring device.
[0108] [0108] During prescribed durations, the patient can connect the accessory opposite the patient monitoring device tube to the prescribed therapy tubing line (for example, the dialysis tube port for patients on peritoneal dialysis, the tube port intravenous for patients with PICC lines treating infection, etc.).
[0109] [0109] While using the device (for example, with a frequency of approximately 2-4 weeks), the patient can receive a push notification on the computing device's tablet or a text message on the mobile device to maintain / repair the patient monitoring device. The service may require that the patient
[0110] [0110] In another variation, the maintenance / service of the patient monitoring device may include the use of a docking system (for example, docking station) to automate the cleaning, sterilization, data transfer, loading processes. - device calibration and / or calibration. The coupling system can be a separate hardware device that includes an inlet and outlet fluid conduit that can be configured to communicate with a patient conduit fluid conduit. At a predetermined interval, a user can disconnect the patient monitoring device from the catheter or tubing connectors and then connect the patient monitoring device to the connections of the anchoring system. Once connected, the anchoring system can charge an energy source and / or pump various fluids to clean and sterilize one or more components of the patient's monitoring device. While connected, the plug-in system can calibrate the sensors with fluid, such as a clear fluid with dispersion / optical absorption characteristics known to calibrate one or more sensors (eg spectroscopy sensor, dispersion sensor / optical absorption) and / or fluid of known temperature to calibrate a temperature sensor and / or fluid pumped at a flow known to calibrate a flow sensor and / or fluid with known conductivity to calibrate a conductivity sensor.
[0111] [0111] The patient monitoring device can communicate sensor data to one or more processing devices (for example, computing devices), such as a tablet, docking station, mobile device and the like, using a wireless protocol (e.g. Bluetooth). The processing devices can receive and process the data and can also transmit the data to a server (for example, database) via a wired or wireless network connection. When using a docking system, additional communication methods can be used, such as a wired Ethernet connection or Wi-Fi. Redundant communication in the docking system can be used to transmit data when communicating using the device's monitoring device. patient fails.
[0112] [0112] In some variations, the patient may have access to data and / or analysis of his sensors through a graphical user interface of a computing device (for example, tablet, cell phone, laptop, PC). The system can also allow the patient to enter additional data into the user interface, such as weight, blood pressure, oxygen saturation, energy / fatigue level, feeling of well-being, fever and pain. Some of these entries may be required at a specified frequency and patients may be asked to enter data at those specified frequencies via push notification and / or text message.
[0113] [0113] In some variations, a provider (eg, healthcare professional, care provider) may have access to patient monitoring data through a graphical user interface on one or more computing devices, as a browser-based web access portal. The provider can, for example, log into the browser-based web access portal via a personal computer. The provider can review all data
[0114] [0114] The system can also provide alerts to the patient and / or provider. A patient alert can be generated as a reminder to start a step in your prescribed therapy or to warn the patient in case of delays in administering prescribed therapy or ignored therapies. In addition, alerts can be generated for the patient and provider when data anomalies occur, such as when a potential complication is likely (for example, a blocked catheter, patient infection event) or when a patient has skipped multiple doses of your therapy. In some variations, one or more alerts may be provided to a predetermined group of predetermined contacts (for example, family, partner, caregiver, healthcare provider) based on predetermined criteria, such as non-compliance or infection detected. The contact group can be selected, for example, by the patient or healthcare professional and can receive alerts or other communications through one or more phone calls, email, text messages, push notifications on a mobile device, web portal and taste. In some variations, data communication can be initiated at predetermined intervals, such as when coupling to a docking station and / or when an infection state is detected. Patient monitoring system settings
[0115] [0115] Figure 1A represents an exemplary variation of a monitoring system for patients undergoing peritoneum dialysis therapy. The patient may have a permanent patient catheter 12 that is connectable to a set of transfer tubing T that allows the introduction and solution of dialysate 27 into and from the patient through the patient catheter 12, as in a dialysate exchange. Generally, a patient monitoring device 00 can be fluidly connected to the permanent patient catheter 12 (for example, by the transfer tubing assembly) to thereby receive dialysate solution (for example, drained dialysate solution). For example, patient monitoring device 00 can be coupled in line with a drainage line D, as for receiving dialysate from the patient and passing it into a drainage vessel (for example, bathroom). The patient monitoring device 00 can include one or more sensors to measure one or more parameters of the dialysate solution. The sensor data can be analyzed, as described here, to monitor one or more patient conditions.
[0116] [0116] Patient monitoring device 00 can include a microcontroller that, via firmware, can control one or more sensors, receive the signal output from the sensors and / or, optionally, analyze the data from the sensors. The patient monitoring device 00 can store the data locally on a memory chip, encrypt the data and send the data to a transmitter module 20 (for example, docking station, mobile patient device). The transmitter module can transmit data via wireless network connectivity to a database server 29 and / or network and other / or devices. In addition, or alternatively, patient monitoring device 00 may include a transmitter module to transmit data directly to database server 2 and / or network and / or other devices.
[0117] [0117] The database server 29 can receive the transmitted data, decrypt the data, analyze the data through a processor and / or store the data on memory chips. The database server 29 can also upload processed data through a secure access system for inter-
[0118] [0118] User interface systems may include one or more browser-based web access portals 41 and / or device applications 31 that can be accessed by an authorized user (eg provider, patient, provider care, partner). The user interface system can communicate user authentication data and data requests to the database server 29 and / or download processed patient data from the database server 29 via a network connection to or wirelessly and display the data in a graphical user interface (GUI). In addition or alternatively, user interface systems can include the patient and provider GUI to enter additional data that is transmitted to the database server 29. The user interface system can also provide alerts to the patient and to the provider, such as push notifications and pop-up message boxes, and through the use of colored highlights of data deviations in the GUI.
[0119] [0119] A patient monitoring device can be fluidly connected to the catheter and fluid infused or drained in a variety of configurations. Like the patient monitoring device 00 described above with reference to Figure 1A, variations of the patient monitoring device 00 can receive dialysate fluid and include one or more sensors to measure one or more dialysate fluid parameters, and the sensor data can be communicated
[0120] [0120] For example, Figure 1B illustrates another variation in which a patient monitoring device 00 is coupled to a patient, such as at or near the catheter 12 patient exit site. For example, the patient monitoring device patient 00 can include an adhesive, belt clip or other device connected to or near the patient.
[0121] [0121] In one variation, where the system is used for patients on peritoneal dialysis, a set of fluid detection sensors can be in fluid communication with fresh dialysate infusing the patient and dialysate residues draining out of the patient. For example, Figure 13 represents the patient monitoring device 00 connected via a connector 53 to the catheter connector 14 and a separate connector 54 connected to the dialysate tubing connector 13 after junction 55 of the blood vessel. infusion dialysate 56 and drainage dialysate vessel 57. In this variation, residual dialysate and fresh dialysate flow through the same set of sensors. In this variation, the flow direction can be determined by using a flow sensor and / or pressure sensor, so that the system can differentiate or recognize when infusion or drainage is occurring. In some variations, flow sensors are configured or selected to detect flow velocity and flow direction. In other examples, a pressure sensor can be used, with or without sensor data from a flow sensor, to detect higher pressure during the infusion cycle and stay in the dialysate and a rapid drop in pressure during the cycle drainage. This system provides compatibility and use with a variety of existing dialysis catheters and dialysate infusion systems, including continuous cycle peritoneal dialysis (CCPD) systems and continuous ambulatory peritoneal dialysis (CAPD) systems. The systems
[0122] [0122] In another variation, illustrated in Figure 14, first the patient monitoring device 00b is connected to tubing 65 for the drain dialysate vessel 57 and a second patient monitoring device 00a is connected to tubing 63 for the infusion dialysate vessel 56 prior to junction 62 of the infusion dialysate vessel 56 and drainage dialysate vessel 57. The first and second patient monitoring devices 00b, 00a can be connected with or without wire. At least one of the first and second patient monitoring devices 00b, 00a may comprise one or more of the hardware, energy, communication and data storage components described above.
[0123] [0123] In another variation illustrated in Figure 15, a set of sensors is connected only to the port of the waste dialysate solution. Figure 15 shows patient monitoring device 00 connected only to the dialysate solution waste tubing connector 57 (for example, pouch) before junction 64 of dialysate infusion container 56 (for example, pouch ) and drain dialysate vessel 57. A drain dialysate bag is not always used, and in such cases, the drain line can be connected to a drain vessel, such as a toilet, bathtub, sink and the like. In this variation, the patient monitoring device monitors only the drainage dialysate solution. Likewise, for patients in CCPD, patient 00 monitoring can be connected to the drain tube of the waste dialysate solution that is normally connected to a toilet, bathtub, drain bucket or similar container for disposal.
[0124] [0124] One or more portions of the fluid conduits described here can be composed of an optically clear material, with high optical transmission over wide wavelength ranges, which can maintain good optical clarity over time, as one or more glass, polyvinyl chloride), silicone, polycarbonate, fluorinated ethylene propylene (FEP), hexafluoroethylene vinylpropene tetrafluoroethylene fluoride (THV), acrylic or cyclic olefin copolymer (COC). Coating materials, such as a hydrophilic coating of Zwitterionic and silicone polyethylene glycol, can also be used to prevent biological fouling of the fluid conduit. The fluid conduit can comprise one or more materials. For example, a segment of glass tube can integrate with a dispersion and / or optical absorption sensor without contact with fluid and connect through a joint or adhesive superimposed on a separate PVC tube that integrates with the sensors of contact with fluid (eg pH temperature, pressure, impedance and conductivity). Patient monitoring device
[0125] [0125] In some variations, the patient monitoring devices described here may comprise two or more separate components that can be coupled together to provide complete functionality. For example, a disposable component (eg, fluid conduit, cartridge, drain line, piping) can be configured to removably engage a durable component (eg, housing, housing, sensor module) of a patient monitoring device. In some variations, a durable component may include at least one sensor and a processor to measure the patient's fluid and detect the patient's infection.
[0126] [0126] The disposable component can include fluid contact components and the durable component can include a set of fluid-free contact components. The disposable component can be replaced at predetermined intervals (for example, daily, weekly) and / or predetermined criteria (for example, patient's infection event). The disposable component can, for example, be useful for short-term use, as bacterial growth in the fluid conduit over time can result in an unacceptable number of false positive and / or false positive patient outlets. negative. The durable component can provide long-term, multi-year functionality, with proper calibration and maintenance (for example, refilling, cleaning).
[0127] [0127] In some variations, fluid characteristics such as optical dispersion, optical absorption and / or fluid flow can be measured non-fluidly using the durable component without separate sensors in the disposable component. As a result, the manufacture of the disposable component can be simplified and supplied at a reduced cost. In addition, the disposable component can be configured to connect to existing sets of drain lines to provide additional functionality to existing peritoneal dialysis systems. In some variations, the disposable component can replace the existing tube set connectors. Figure 67A shows an exemplary variation of a 6700 patient monitoring device coupled to a 6750 drain line (eg, tubing) and connected to a 6760 toilet. The 6700 patient monitoring device includes a durable 6710 component (eg housing, housing) releasably attached to a 6730 mounting feature, such as a hook clamp configured to attach to an edge of the 6760 toilet. For example, the durable 6710 component can be coupled to the 6730 mounting feature by means of magnets, interlocking and / or complementary features, fasteners and / or in any suitable manner. A disposable 6720 component (for example, fluid conduit) can be removably attached within an internal cavity of the durable 6710 component. The durable 6710 component can include at least one lumen configured to allow fluid to flow through it. A proximal end of the 6710 disposable component can be coupled to a distal end of a 6750 drain line using a 6740 connector as described in more detail here. For example, the 6720 fluid conduit inlet may comprise a 6740 tubing connector. A distal end of the 6720 disposable component can be configured to empty the fluid (eg, patient fluid) into a vessel. drain, such as the 6760 toilet. In some variations, a portion of the 6720 disposable component may follow a shape of the 6730 mounting feature (for example, having a similar profile), in order to reduce the overall size and volume of the 6700 device. The 6720 disposable component can comprise one or more parts, such as a rigid distal end configured for connection to the 6740 tubing set connector and a flexible proximal end configured for release release with the mounting feature
[0128] [0128] Figure 67B illustrates patient monitoring device 6700 without attachment to a 6750 drain line and connector
[0129] [0129] Figures 68A and 68B are seen in perspective of a patient monitoring device 6800 in the respective closed and open configurations. A housing 6802 of a durable component may comprise a rotating cap 6814 around a hinge 6812. Housing 6802 may define an internal cavity 6816 configured to retain a disposable component 6830 (e.g., fluid conduit). Fluid conduit 6830 can be configured to releasably engage housing 6802. For example, disposable component 6830 can be fitted into inner cavity 6816 of housing 6802. Housing 6802 is configured to transition between an open configuration (Figure 68B) with an exposed internal cavity 6816 and a closed configuration (Figure 68A) with a closed internal cavity 6816. In the closed configuration shown in Figure 68A, at least a portion of the 6830 fluid conduit it can be protected from external light and sealed from external fluid. A 6840 mounting feature can be removably attached to housing 6802.
[0130] [0130] In some variations, the 6814 cover may be a set of flaps, door, slot, cover, shield, latch, fastener or any other structure that allows a 6830 disposable component to be kept removable in an 6816 internal cavity. For example , a disposable component 6830 can be pushed through an opening between a pair of tabs to engage the disposable component 6830 with an internal cavity 6816 of housing 6802. When a release mechanism is actuated (for example, the 6820 latching feature, the disposable component 6830 can be released and / or pushed out of the inner cavity 6816 through the pair of tabs In some variations, an opening in the inner cavity 6816 may face a drain vessel, which may allow a user to connect first a disposable component to a drain vessel and then allow the patient monitoring device to be pushed over the disposable component and against the drain vessel. enage. To decouple the patient monitoring device from the disposable component, the user can activate the release mechanism and pull the durable component out of the disposable component and the drainage vessel.
[0131] [0131] Housing 6802 may comprise at least one 6822 non-contact fluid sensor configured to measure one or more fluid flow parameters through the disposable component
[0132] [0132] In some variations, the 6800 patient monitoring device may further comprise at least one non-contact sensor including one or more of a pressure sensor, image sensor, flow sensor, accelerometer, gyroscope, temperature sensor - rupture, and magnetic field transducer. The image sensor may comprise one or more of a cell counter and color sensor. For example, some sensors, such as an accelerometer and gyroscope, can be provided in housing 6802 separate from inner cavity 6812 and fluid conduit. A variation of a flow sensor is described in more detail with reference to Figure 69D.
[0133] [0133] Housing 6802 may include a controller comprising a processor and memory (not shown) and which may be coupled to the 6822 optical sensor array. The controller includes hardware and firmware which, with the support of the pro's memory - gram and random access memory, control one or more sensors, receive sensor data, process sensor data, store processed data in memory, communicate with a transmitter or directly to the server database (no shown) through a communication device and manages the power source. The memory can store the processed data until the successful transmission of the data to the database server is confirmed. A power charging port can be controlled by the controller to charge the local power supply.
[0134] [0134] The controller can be configured to receive signal data corresponding to the received light generated by at least one detector. The controller can estimate total particle concentration data and leukocyte concentration data using the signal data as described in more detail here. The patient monitoring device may further comprise an electronic communication device (eg, wireless transmitter, transceiver) and a power source (eg, battery) coupled to the controller.
[0135] [0135] In some variations, the 6800 patient monitoring device may comprise a user interface (for example, Figure 72) (for example, visual indicator) configured to provide a patient monitoring device status, patient status, fluid monitoring status, disposable component status, communication status, combinations of them and the like. For example, a visual indicator may include an LED or LCD configured to display battery life, operation status and the status of the disposable component (for example, attachment status, replacement status). A visual indicator can be configured to notify the patient to contact their doctor or health care professional due to a detected patient's infection event.
[0136] [0136] Figure 68C is an enlarged view of the assembly of the patient monitoring device 6800. The fluid conduit 6830 can be configured to be fixed in the internal cavity 6816 by a friction fitting and / or mechanical adjustment. For example, housing 6802 comprises a 6828 fluid conduit hitch feature (e.g., cradle or other recess) compatible with a corresponding 6834 housing hitch feature in the fluid conduit
[0137] [0137] Fluid conduit 6830 may comprise an inlet 6832 configured to couple at least one between a permanent catheter and a drain line, and an outlet 6834 configured to open towards a drain vessel. The 6830 fluid conduit is described in more detail here with reference to Figures 70A and 70B.
[0138] [0138] Figures 69A-69D are seen in perspective from a 6900 patient monitoring device similar to the 6800 patient monitoring device except that a disposable component and mounting feature are removed for clarification. A housing 6902 of a durable component can comprise a swivel cap 6914 around a hinge 6912. Housing 6902 can define an inner cavity 6916 configured to hold a disposable component (e.g., fluid conduit). Housing 6902 is configured to move between an open configuration (Figure 69B) with an exposed interior cavity 6916 and a closed configuration (Figure 69A) with a closed interior cavity
[0139] [0139] Figure 69C illustrates an open configuration of the patient monitoring device 6900 including a 6924 power supply and cap 6926. Cap 6926 may comprise a fluid seal (eg gasket) to prevent entry of fluid. The housing 6902 comprises a coupling feature of the fluid conduit 6928 connectable with a fluid conduit. Housing 6902 may further comprise an engagement sensor (e.g., switch, optical sensor) configured to generate a sensor signal when the 6928 fluid conduit coupling feature is coupled to a fluid conduit. The housing 6902 may comprise a seal 6918 configured to prevent fluid from entering the inner cavity 6916 of the housing 6902 in the closed configuration. The cover 6914 may comprise a latching feature of the housing 6921 (for example, lock) connectable with a latching feature of the corresponding cover 6920 (for example, release of the spring loaded latch) of the housing 6902.
[0140] [0140] Figure 69D is a detailed perspective view of the interior cavity 6916 of the patient monitoring device.
[0141] [0141] At least one 6919 sensor, such as an optical sensor, comprising a light emitter and a light detector can be configured to measure a fluid level within the 6917 cavity. The 6919 sensor can be configured to generate data signals corresponding to a patient's fluid flow flowing through a disposable component (for example, fluid conduit). Cavity 6917 can extend parallel to a longitudinal axis of the internal cavity
[0142] [0142] Figures 70A and 70B illustrate perspective views of a disposable component as fluid conduit 7000 defined as a lumen 7002 (e.g., fluid flow channel, fluid flow path). Fluid conduit 7000 can comprise an inlet 7020 and an outlet 7030. For example, fluid conduit 7000 can comprise an inlet 7020 configured to couple at least one of a permanent catheter and a drain line, and an outlet 7030 configured to open towards a draining vessel. Fluid conduit 7000 can have a curved shape like L shape, J shape, S shape, U shape, C shape, their combinations, and the like, for example, to conform and couple to an edge of a drain, such as a toilet or sink. The shape and diameter of fluid conduit 7000 can be configured to reduce clogging and obstruction of solid particles in the fluid, such as fibrin.
[0143] [0143] In some variations, input 7020 may comprise a connector which may, for example, have a thread and / or a cone. The inlet may comprise a barbed fitting configured to mate with the drain lines of the standard piping set. Fluid conduit 7000 may comprise one or more coupling features 7040 as tabs configured to align lumen 7002 of fluid conduit 7000 with the inner cavity of the durable component. In some variations, the 6830 fluid conduit may comprise at least one fluid contact sensor comprising one or more of a flow sensor, conductivity sensor, temperature sensor, pH sensor, lactate sensor , test strip, chemo-luminescence sensor, electromechanical sensor, and glucose sensor.
[0144] [0144] In some variations, fluid conduit 7000 comprises at least one optical sensing region configured to allow an optical sensor to optically measure a fluid characteristic of the patient's fluid flow. For example, fluid conduit 7000 comprises at least one transparent portion 7010 disposed along any portion of fluid conduit 7000 between the inlet.
[0145] [0145] The transparent portion is substantially transparent to at least one of ultraviolet light, visible light, and infrared radiation. One or more portions of fluid conduit 7000 can, for example, be composed of one or more of copolymers of cyclic olefin, acrylic, polycarbonate (COC), fluorinated propylene ethylene (FEP), hexafluoropropylene vinylidene (THV), polycarbonate tetrafluoroethylene fluoride , polystyrene, acrylonitrile butadiene styrene (ABS), silicone coated with polyethylene glycol, polyurethane coated with zwitterionic, polyvinyl chloride coated with polyethylene oxide and polyphenyl silicone. For example, the entire fluid conduit 7000 can be transparent or the portion of fluid conduit 7000 held within an internal cavity of a durable component can be transparent. The transparent portion 7010 may be composed of a different material (and have a different transparency) than other portions of the fluid conduit 7000.
[0146] [0146] In some variations, an exterior of fluid conduit 7000 may comprise one or more handling interfaces (eg protrusion, adhesion) configured for manipulation by a patient. This can reduce the patient's contact with sensitive portions of the 7000 fluid conduit (for example, inlet and transparent portions) that can alter sensor measurements. For example, a set of spaced projections can be provided around a circumference of the transparent portion that is not within the line of sight of any of the emitters and detectors. In addition, markings on the fluid conduit 7000 can be provided to indicate the handling interfaces and / or sensitive portions that must remain sterile (for example, free of fingerprints and other contacts).
[0147] [0147] To conserve the system's general energy usage, it is desirable that each sensor operate only as needed. In some variations, the patient's monitoring device can detect the patient's complications only when the fluid flows through the conduit, thus reducing energy consumption and unnecessary data generation. In some applications, such as continuous cyclic peritoneal dialysis (CCPD), a cycle will include stages of infusion, permanence and drainage, where the patient's monitoring device may only need to monitor the drainage stage. The fluid conduit will initially be empty, from which the optical sensor array can measure and determine when the initial drain time begins. However, after completing the first drain cycle, the fluid conduit may have residual fluid that may not allow accurate measurement of the initial drain times for subsequent cycles. Therefore, in subsequent changes, the fluid flow measurement can be used to estimate an initial drain time of a cycle. A fluid flow sensor can be used to determine when fluid is flowing through the fluid conduit. When the fluid flow sensor indicates that fluid is flowing through the fluid conduit, one or more other patient monitoring sensors may start to operate continuously, but otherwise they operate at a relatively low duty cycle during the periods when the fluid flow sensor indicates that there is no fluid flow. Generally, the patient monitoring device can operate in a low power mode during a period without fluid flow (that is, during infusion and steps in the cycle). When fluid flow is detected, sensors can be connected and generate signal data.
[0148] [0148] The measurement of fluid flow can be performed by any suitable mechanism. For example, the patient monitoring system can generate a fluid flow signal using one or more of the optical sensors in the patient monitoring device. As another example, the patient monitoring device may comprise an accelerometer configured to detect vibrations corresponding to the activation of the fluid pump and fluid flow. As another example, the patient monitoring device may comprise an audio device (for example, microphone) configured to detect a standard sound corresponding to one or more of the fluid pump and fluid flow activation. Additionally or alternatively, a fluid flow signal can be received (for example, by wireless communication) from a cycler and / or patient to indicate the beginning or end of the fluid flow (eg, pumping) when a drain cycle begin. The patient monitoring device described here may comprise a non-fluid contact flow sensor configured to determine a fluid flow state within the fluid conduit. Figures 70 and 74-76 are exemplary variations of a fluid conduit comprising a portion configured to be measured by the flow sensor, as described below.
[0149] [0149] In some variations, as shown in Figures 70A and 70B, the first fluid conduit 7000 comprises a second fluid conduit 7050 (which may be closed-ended)
[0150] [0150] A volume of fluid from the second 7050 fluid conduit (for example, when the fluid fills the 7050 housing) can correspond to a patient fluid flow in the fluid conduit
[0151] [0151] In some variations, fluid flow detection, including a start and / or end (end) of the fluid flow, can be used to determine when to start and end the patient's infection detection. Figures 74 to 76 represent other variations of a fluid flow detection mechanism. Figure 74 is a perspective view of a disposable component, such as a fluid conduit 7400, which defines a lumen 7402 (for example, channel, path). The fluid conduit 7400 may comprise a 7430 inlet and an outlet 7440. For example, the 7400 fluid conduit may comprise a 7430 inlet configured to couple at least one of an internal catheter and a drain line, and an outlet. - ia 7440 configured to open towards a drain vessel. The 7400 fluid conduit may comprise one or more 7450 engagement features, such as tabs configured to align the lumen 7002 of the fluid conduit 7000 with the inner cavity of the durable component. In Figures 70A and 70B, fluid conduit 7002 comprises a first transparent portion 7010 configured for measuring patient infection (e.g., dispersion and / or optical absorption) and a second transparent portion 7050 configured for measuring fluid flow. The transparent portions 7010, 7050 are substantially transparent to at least one ultraviolet light, visible light and infrared radiation. The transparent portions 7010, 7050 can be composed of a different material (and have different transparency) than other portions of the fluid conduit 7002.
[0152] [0152] In some variations, as shown in Figure 74, the second transparent portion 7412 comprises a flow sensing portion of sphere 7420 including a sphere 7422 disposed near one or more stops in the fluid lumen 7402. Generally, a height ball 7422 within the flow detection portion 7420 will be translated (for example, increased) in relation to stops in response to increased fluid flow. For example, the 7422 sphere has neutral or slightly negative buoyancy and will rest on the bottom of the 7420 flow detection portion when there is no flow of fluid through the 7400 fluid conduit. An optical sensor can be configured to detect the location of the ball 7422 and generate a fluid flow signal based on the location of the sphere. In some variations, the fluid flow signal can be a binary signal, such as fluid flow ON and fluid flow OFF.
[0153] [0153] Figures 75A and 75B represent a first variation of an optical sensor and a flow detection portion (for example, ball flow sensor). A fluid conduit 7510 comprises a flow sensing portion including a ball 7520 and a first internal radial extension configuration 7520 and / or a second internal radial extension configuration 7522. The first and second configurations 7520, 7522 can be longitudinally or axially spaced in the 7510 fluid conduit. The ball can be arranged between the first and second configurations, so that the first and second configurations are configured to limit the range of motion of the 7520 sphere inside the 7510 fluid conduit (for example, the displacement of the sphere is limited in a proximal direction by one configuration and in a distal direction by the other configuration). For example, the arrangement of an optical sensor comprising a 7540 emitter and a 7542 detector can be configured to transmit and receive light through a transparent portion of the 7510 fluid conduit. For example, the 7530 sphere rests on the first -
[0154] [0154] Figures 76A and 76B represent a second variation of an optical sensor and a flow detection portion. The configuration and operation of the 7610 fluid conduit is similar to that described in Figures 75A and 75B, except that the first one-lumen configuration of the 7610 fluid conduit may comprise a small diameter or neck portion 7620 configured to receive or hold a 7620 ball and provide a fluid seal when there is no fluid flow. This variation acts as a unidirectional valve that obstructs the flow in the downward direction of Figures 76A and 76B. The 7610 fluid conduit further comprises a second adjustment 7622 (for example, a set of one or more pins) configured to limit a range of motion of the ball within the 7610 fluid conduit, but still allows fluid flow in the upward direction of Figures 76A and 76B. An optical sensor array comprising a 7640 emitter and a 7642 detector can be configured to transmit and receive light through a transparent portion of the 7610 fluid conduit. The optical sensor can be located along any portion of the valve so that the obstruction of light by ball 7620 corresponds to the flow of fluid and the transmission of light
[0155] [0155] The fluid conduits described here can be formed in one or more portions. For example, one or more transparent portions (e.g., optical sensing regions) of the fluid conduit can be formed separately from other portions and coupled to form a single piece component by any suitable method, including but not limited to molding, welding, bonding, adhesives, mechanical adjustment and the like.
[0156] [0156] In addition or alternatively, one or more portions of the fluid conduit may be composed of a material susceptible to bacterial incrustations. That is, one or more portions of the fluid conduit can be composed of a material that allows for an improved growth of bacteria on a surface of the inner wall of the fluid conduit compared to a surface that does not comprise the material. In some variations, the fluid conduit may comprise a plurality of parallel channels. In some variations, the fluid conduit may comprise one or more valves, such as a one-way valve. In some variations, the fluid conduit can be configured to be replaced at a predetermined interval (for example, daily, every other day, weekly).
[0157] [0157] Figures 71A-71B illustrate perspective views of a 7130 mounting feature (for example, bracket) of a 7100 patient monitoring device. Figure 71A is a perspective view of a 7100 in patient monitoring device. - including a durable component 7110 and disposable component 7120 such as those described herein. Figure 71B illustrates a support 7130 comprising an engaging feature of housing 7140. In some variations, the engaging feature of housing 7140 may comprise a magnet within an indentation. The 7130 support can be configured
[0158] [0158] In some variations, a method for detecting patient infection using a patient monitoring device such as those illustrated in Figures 67 to 71 and 74 to 76 may include the steps of securing a mounting device (for example, clamp ) to a drainage vessel (eg toilet). A durable component of the patient monitoring device can be attached to the mounting feature. If necessary, a power supply such as a battery can be inserted into the patient monitoring device (Figure 69C). A disposable component (for example, fluid conduit, drain line extension tube) can be connected to a pipe assembly drain line like those manufactured by Baxter and Fresenius. The disposable component can be coupled to the durable component so that a transparent detection portion of a fluid conduit is optically coupled to a sensor of the durable component. The durable component can then be activated and used to monitor the patient's fluid and / or parameters and used to generate data and / or alerts.
[0159] [0159] In another variation, a disposable component can first be coupled to a distal end of a pipe assembly drain line. The disposable component can then be attached to a drainage vessel. A durable component can be releasably attached to the disposable component. For example, a patient monitoring device can be attached to a transparent portion of a disposable component.
[0160] [0160] In some variations, a calibration process can be performed by coupling the disposable component to the durable component. For example, one or more optical sensors can confirm the detection of a fluid conduit after receiving a coupling signal. Alternatively, a switch can be activated when the fluid conduit is inserted. After the fluid conduit is assembled, the optical sensor data can be used to authenticate the fluid conduit and confirm its parameters, such as transparency and / or sterility. For example, the patient's monitoring device can be deactivated and / or an alert transmitted if an incompatible tube is placed inside the internal cavity of the patient's monitoring device. Even if the fluid conduit is authenticated, an error can be generated using the optimal sensors.
[0161] [0161] In some variations, patient fluid can be received through a fluid conduit coupled to or disposed near a sensor. A fluid flow signal can be received and used to initiate one or more fluid characteristic measurements. For example, a patient monitoring device can generate a fluid flow signal using an optical sensor and / or accelerometer array. In addition or alternatively, a cycler can emit a fluid flow signal. In response to the fluid flow signal, a fluid characteristic such as dispersion and / or optical absorption of the patient's fluid can be measured in one or more wavelength bands (strips) using the sensor. A concentration of particles and / or leukocyte concentration in the patient's fluid can be estimated based, at least partially, on the dispersion and / or optical absorption measured in one or more wavelength ranges. A patient's infection status can be detected based, at least partially, on the estimated leukocyte concentration. The patient's fluid is drained from it.
[0162] [0162] In some variations, a measure of optical dispersion and / or absorption in a first wavelength range can be correlated to a total particle concentration of the patient's fluid, and a measure of dispersion and / or absorption optics in a second wavelength range can be correlated to a specific leukocyte concentration in the patient's fluid, where the first wavelength range is different from the second wavelength range. For example, the first wavelength range can be between approximately 700 nm and approximately 1 mm, and the second wavelength range can be between approximately 260 nm and approximately 550 nm. In some variations, the second wavelength range can correspond to a concentration of non-leukocyte particles in the patient's fluid. For example, the second wavelength range can include wavelengths of the specific particle type (for example, red blood cells, fibrin, triglycerides) and exclude wavelengths between approximately 260 nm and approximately 550 nm. The leukocyte concentration can be calculated by subtracting the total particle concentration from the non-leukocyte concentration.
[0163] [0163] In some variations, a first array of the optical sensor can initially measure optical dispersion and / or fluid absorption over a first wavelength range. If the measures exceed a predetermined limit (for example, corresponding to a potential infection). Then, a second array of the optical sensor can measure optical dispersion and / or fluid absorption over a second wavelength range. A ratio of the signals from the first and the second optical sensor array can be calculated.
[0164] [0164] In some variations, the patient monitoring device can be configured to measure the homogeneity of the patient's fluid using the sensor. A set of dispersion and / or optical absorption measures can be excluded from the leukocyte concentration estimate based, at least partially, on the measure of homogeneity. For example, inhomogeneous fluid flow due to large and / or mixed particles (eg, fibrin) can generate sensor measurements that form inaccurate concentration estimates.
[0165] [0165] In some variations, the patient monitoring device can be coupled between a dialysate fluid vessel and a dialysate line to thereby receive dialysate fluid through the fluid conduit where the dialysate fluid is to be infused into the patient. The optical dispersion and / or absorption of the dialysate fluid can be measured using one or more sensors. The estimated leukocyte concentration can be based, at least partially, on the dispersion and / or optical absorption measures of the dialysate fluid. An optical dispersion and / or absorption differential between the patient's fluid and the dialysate fluid can be estimated by the patient monitoring device. The patient's infection status can be updated based, at least partially, on the dispersion differential and / or optical absorption or on the ratio.
[0166] [0166] As described herein, a flow rate, total flow volume, and / or flow direction of the patient's fluid can be measured using a flow sensor coupled to the fluid conduit. The measures of optical dispersion and / or absorption can be standardized based, at least partially, on the measure of the total flow or volume of flow. One or more of the patient's fluid measurements can be normalized based, at least partially, on the total flow or volume flow measurement. One or more of an obstruction and flow direction can be detected based, at least partially, on the flow measurement. One or more of an infusion volume, drainage volume, infusion time, drainage time, and residence time can be estimated based, at least partially, on the flow rate. For example, residence time and drain time can be estimated when a patient monitoring device starts measuring the new fluid flow for cycle machines that measures multiple drain cycles with residence cycles between them. In some variations, fluid flow parameters can be determined using an ultrasonic flow sensor coupled to a fluid conduit, an accelerometer configured to detect the corresponding vibrations for fluid pump activation, and data communication with a cycle machine.
[0167] [0167] One or more of a dialysis efficacy and dialysis adequacy can be estimated based, at least partially, on the estimated infusion volume, drainage volume, and length of stay. One or more of an infusion state and drainage status of the patient's fluid can be detected without user input.
[0168] [0168] In some variations, at least one alert can be issued comprising one or more of the patient's infection status, patient complying with a prescribed therapy, therapy effectiveness, sensor calibration, flow conduit maintenance - do, and sensor data. The alert may include notification of at least one predetermined contact, comprising one or more patients, a healthcare professional, a patient's partner, family member and provider.
[0169] [0169] A communication channel can be established between the patient and a healthcare professional in response to the alert corresponding to the patient being in a high risk condition. At least one alert threshold can be defined, corresponding to turbidity, fluid flow and conductivity based on user input. An alert corresponding to the effectiveness of the therapy can be issued based, at least in part, on a flow measurement and a conductivity measurement. An alert corresponding to the fluid conduit obstruction can be issued based, at least in part, on a pressure measurement and an acceleration measurement. A patient infection alert can be issued based on one or more of the patient's fluid measurements. Additional patient monitoring devices
[0170] [0170] In some variations, a disposable component of a patient monitoring device may include a fluid conduit and one or more sensors that can be, for example, a limited-use sensor that can have a limited life and can be replaced at the same time as the fluid conduit. For example, the disposable component may comprise at least one fluid contact sensor that can be configured to measure at least one fluid characteristic of the patient's fluid in the fluid conduit, such as fluid ion conductivity. Consequently, the number of sensors in a durable component can be reduced, thus allowing the durable component to be reduced in size. The replacement of components that come into contact with the fluid also negates the need to clean and maintain the components that come into contact with the fluid, which are susceptible to bio-fouling and corrosion. In some variations, a set of disposable components compatible with a single durable component can be configured with different sensor arrangements for different measurement applications and requirements. Figure 64A represents an exemplary variation of a 6400 patient monitoring device configured to connect to a drain line (for example, connector piping) and attached to a 6450 toilet. patient 6400 includes a durable 6410 component (eg housing, housing) loosely coupled to a 6430 mounting feature such as a hook clamp configured to attach over a 6450 toilet bowl edge. a disposable 6420 component (eg conduit fluid) can be releasably fixed inside an inner cavity of the durable component
[0171] [0171] Figure 65 illustrates a durable 6500 component of a patient monitoring device. A housing 6510 of the durable component 6500 may comprise a lumen 6520 and cavity 6530 configured to releasably hold and / or engage one or more disposable components 6600, 6660 (see Figures 66A-66D) of the patient monitoring. For example, as shown in Figures 66E and 66F, a first disposable component 6600 can be snapped into cavity 6530 and the second disposable component 6660 can be threaded to the first disposable component 6600 and held in lumen 6520 of the durable component 6500. The 6510 housing can also comprise a 6532 connector configured to provide an electrical connection
[0172] [0172] The durable component 6500 can comprise at least one 6522 non-contact fluid sensor configured to measure one or more fluid flow parameters through disposable components 6600, 6660. Measurement of sensor data using the sensor 6522 can be used to detect the patient's infection. For example, the durable component 6500 can comprise at least one optical sensor 6522 arranged substantially perpendicular to a longitudinal axis of the 6520 lumen of the durable component 6500. The optical sensor 6522 can comprise an emitter and at least one connector as described in detail here. The optical sensor 6522 can match any of the optical sensors described here as in Figures 34, 43, 44, 68, and 69.
[0173] [0173] In some variations, the 6500 patient monitoring device may further comprise at least one non-contact sensor including one or more of a pressure sensor, image sensor, flow sensor, accelerometer, gyroscope, temperature sensor - rupture, and magnetic field transducer. The image sensor may comprise one or more of the cell counter and color sensor.
[0174] [0174] The durable component 6500 may include a controller comprising a processor and memory (not shown) and which may be coupled to the 6522 optical sensor. The controller includes hardware and firmware which, with the support of the program memory and random access memory, control one or more sensors, receive sensor data, process sensor data, store processed data in memory, communicate with a transmitter or directly to the database server system data (not shown) via a communication device and manages the power source. The memory can store the processed data until the successful transmission of the data to the database server is confirmed. A power charging port can be controlled by the controller to charge the local power supply. The controller can be configured to receive signal data corresponding to the received light generated by at least one detector. The controller can estimate total particle concentration data and leukocyte concentration data using the signal data as described in more detail here. The patient monitoring device can also comprise an electronic communication device (eg, wireless transmitter, transceiver) and a power supply (eg, battery) coupled to the controller. In some variations, the durable 6500 component may comprise a user interface (as shown and described with reference to Figure 72) and described in more detail here.
[0175] [0175] The first disposable component 6600 is configured to be fixed in cavity 6530 by a friction fit or mechanical interaction. For example, housing 6510 comprises a feature of engaging the disposable component 6540 (for example, spring loaded pins) connectable with the first disposable component
[0176] [0176] Figures 66A and 66B are seen in perspective of a first disposable component 6600 comprising a housing 6602 defining a first fluid conduit 6610 coupled to an inlet 6620 and an outlet 6630. An outlet 6630 of the first disposable component 6600 can be attached to an end near a drain line that opens towards a drain vessel. For example, outlet 6630 may comprise a splinter fit. An input 6620 of the first disposable component 6600 can be configured to mate with an output of a second disposable component 6660. For example, input 6620 may comprise a female Luer-lock fitting. The first disposable component 6600 may comprise one or more 6640 fluid contact sensors such as a flow sensor, ionic conductivity sensor, and fluid temperature sensor. In some variations, the first disposable component 6600 can be configured to be replaced at predetermined intervals (for example, weekly).
[0177] [0177] Figure 66C is a perspective view of a second disposable component 6660 comprising a housing 6661 defining a second fluid conduit 6662 coupled to an inlet 6668 and an outlet 6666. An inlet 6668 of the second disposable component 6660 can be attached to the end of a drain line. For example, inlet 6668 may comprise a splinter fitting (e.g., double splinter fitting) that can be configured to be difficult to remove after coupling. An outlet 6666 of the second disposable component 6660 can be configured to mate with an input of the first disposable component 6600. For example, outlet 6666 may comprise a Luer male fitting. In some variations, the second disposable component can be configured to be replaced at a predetermined interval (for example, daily, weekly, biweekly). The second disposable component can be replaced at a higher frequency than the first disposable component. For example, the second disposable component 6660 can be replaced daily by the piping set of the cycle machine. The second disposable component 6660 can comprise a coupling feature 6664 configured to assist the user's rotation from the second disposable component 6660 to the first disposable component 6600. When the second disposable component 6660 is completely coupled to the first component disposable 6600, any thread or dividing line of the second disposable 6660 component may be out of sight of a 6522 optical sensor of the durable component
[0178] [0178] Housing 6661 comprises at least one transparent portion 6663 which can be substantially transparent to at least one of ultraviolet light, visible light, and infrared radiation. For example, one or more portions of housing 6661 are comprised of one or more of cyclic, acrylic, polycarbonate (COC) olefin copolymers, polystyrene, acrylonitrile butadiene styrene (ABS), polyethylene glycol coated silicone, zwitterionic coated polyurethane , polyvinyl chloride coated with polyethylene oxide, and polyphenyl silicon. The transparent portion 6663 can be composed of a different material (and have different transparency) than other portions of the housing 6661. The second disposable component 6660 can be formed by injection molding and can be formed as a part single or multi-piece component. The first and second disposable components can be sterile when supplied to the patient.
[0179] [0179] Figure 66D is a perspective view of the first disposable component 6600 coupled to the second disposable component 6660. In some variations, an inlet 6668 of the second disposable component 6660 can be coupled to the end of a drain line. An outlet 6666 of the second disposable component 6660 can be configured to mate with an input 6630 of the first disposable component 6600. An outlet 6620 of the first disposable component 6600 can attach to the tubing configured to open towards a drainage vessel such as the vessel Restroom.
[0180] [0180] Figure 2 represents an exemplary hardware configuration for the electrical layout of the hardware patient monitoring device. The various detection technologies inside the housing or housing 26, connections to other electrical components, and fluid conduit 15 are illustrated.
[0181] [0181] Figure 3 represents a configuration of a patient monitoring device. The housing or housing 26 contains the component patient monitoring device. A first half of the wrapper 26a can be fitted with a second disposable half of the wrapper 26b, which is glued to an adhesive layer 30 which can be temporarily glued to the patient's skin. In other examples, the housing can be hot welded or glued, or it can comprise a housing with a side opening and a side cover, or it can comprise a set attached with fasteners such as screws, or it can comprise a lock release with spring on one side or a connection with one side threaded internally and the other side threaded externally. Piping connectors (for example, standard Luer connectors) can include a connection port 13 connected to the dialysate solution and a connection port 14 connected to the internal catheter. The connection port for the catheter 14 can be contained within the housing 26. Among the connectors 13, 14, there is a fluid conduit 34 (for example, tube) that enters through a network of sensors that can comprise an infinity of sensors without contact with fluid 43 (for example, optical sensors of dispersion / absorption), sensors of contact with fluids without moving parts 11 (for example, sensors of conductivity, impedance and pressure) and sensors of contact with fluids with moving parts 1 (eg Hall sensor flow effect). A motion sensor
[0182] [0182] Figure 4 represents an alternative configuration of the patient monitoring device. The housing or housing 26 contains at least a portion of the component patient monitoring device. The connectors include a first connector 13 connected to the dialysate solution and a second connector 14 connected to the catheter. The second connector can be closed within housing 26. Between connectors 13, 14, a fluid conduit 34 can couple with one or more non-fluid contact sensors 43 (for example, optical dispersion / absorption sensors and optical counter cell) and fluid contact sensors without moving parts 11 (for example, conductivity, impedance, pressure, pH, temperature sensors). A gyro / accelerometer motion sensor 23 can also be provided, separate from fluid conduit 34. A 24-point color sensor
[0183] [0183] In the variations shown in Figures 3 and 4, the sensor network is combined with the rest of the hardware system and incorporated into the PCB containing the battery 32, control device 18, loading port 33, connectors 13, 14 and compartment 26. In another variation, shown in Figure 5, a set of permanent or semi-permanent sensors 1, 43 are connected to the first half of housing 26a26a. Another set of disposable sensors 11 (for example, enzyme-based electrochemical sensors, test indicator strips) can be connected to the second half of case 26b which also contains adhesive layer 30 in contact with the patient. In this variation, the second half of the housing 26b and the components attached to it can be referred to as a cartridge. The adhesive layer replacement cycle can coincide with the sensor replacement cycle, so that the cartridge can be replaced together. The two halves of the assembly 26a, 26b can be removably coupled, such as by means of pressure fittings and / or an electrical connector. Different cartridges may comprise different configurations, such as different sensor packages. In some variations, a cartridge may comprise a closed housing, so that the components in contact with the fluid are sterile until the cartridge is loaded correctly into the durable interface of the component (e.g., first half 26a26a).
[0184] [0184] In each variation described in Figures 3, 4, and 5, one or more components of the patient monitoring device (for example, battery, memory, sensors, fluid conduit) can be removable for ease of one or more more among replacement, cleaning, data transfer, and loading. In some variations, redundant components may be provided as a redundant battery of equal or different capacity used as a backup power source in case the primary battery has run out.
[0185] [0185] In some variations, the patient monitoring device can be two or more separate components that can be attached together to provide full functionality. For example, a cartridge-based device may comprise a disposable cartridge configured to removably connect to a durable component interface (eg, permanent compartment / compartment) of the patient monitoring device. The cartridge can comprise a set of fluid contact components (for example, fluid conduit, fluid contact sensors) and the durable component interface can comprise a set of fluid-free contact components (for example, fluid sensors). contact without fluid, control device, battery, transmitter). In some of these variations, fluid contact components can be removed and replaced as needed. For example, fluid contact components of the patient monitoring device may require replacement due to one or more regulatory requirements, bio-encrustation, wear, tear, degradation and other changes over time. In addition, if a patient requires the device only for a short period of time, replacing the fluid contact components allows the device to be used safely for multiple patients by changing the fluid contact components. In some variations, the disposable cartridge may comprise two or more portions that can be removably attached to form the disposable component.
[0186] [0186] In addition or alternately, one or more durable components and cartridges of the patient monitoring device can be cleaned and sterilized using devices, fluids and / or media such as ethylene oxide (EtO), an autoclave, solvent immersion, immersion in cleaning agent, and the like at predetermined intervals. For example, the cartridge can be configured to be cleaned, sterilized and reused at predetermined intervals, instead of being discarded. For example, the cartridge can be replaced or sterilized using an autoclave whenever an infection is detected or once every 28 days. In addition, between these replacement or sterilization steps, the cartridge can be cleaned daily or weekly with a fluid (for example, acid, rinse with alcohol). In some variations, the durable component may comprise a con-
[0187] [0187] Figures 16A to 16C illustrate a variation of a fluid conduit coupled to a printed circuit board that can comprise a set of sensors configured to determine one or more characteristics of the fluid flowing through a fluid conduit. - gone. Figure 16A represents a fluid conduit 34 (for example, formed using molded PVC) defining one or more holes 70 covered by one or more respective sealing elements 49 (for example, silicone sealing rings, adhesive, glue) . Figure 16B illustrates a printed circuit board (PCB) interface 1600 comprising a surface mount device (SMD) sensor 2a and a printed circuit board (PCB) 2b connector. In Figure 16C, a set of fluid contact sensors 44 is disposed within a corresponding set of holes 70. The SMD 2a sensor can be sealed within a hole 70 by means of gasket 49 and compression connection with screws 45 A sensor terminal 2c can be connected to the connector mounted on the printed circuit board 2b. The SMD 2a sensor can be, for example, a non-contact sensor.
[0188] [0188] Figure 16D illustrates an upper cross-sectional view and Figure 16E represents a side cross-sectional view of a patient monitoring device such as a 1610 optical dispersion / absorption measurement system. The 1610 system may include a sensor spectroscopy system consisting of a set of light emitters 71 and light sensors 73. The set of light emitters 71 can be configured to transmit light to a fluid conduit 34. In some variations, a lens or filter 72a can be arranged between the lighter emitters 71 and the fluid conduit 34. The light sensor set 73b, 73a can be oriented in the respective predetermined light absorption angles and dispersion angles in relation to the light emitter set 71. In some variations, a lens or filter 72b may be arranged between the light sensor set 73b, 73a and the fluid conduit 34. As described here below, the spectroscopy sensor does not need to take into account with the fluid flowing through the fluid conduit 34, but, instead, the fluid conduit 34 can be substantially optically transparent (or close, with a high total transmittance of the wavelengths used in the measurement), such that the spectroscopy sensor can measure the contents of the fluid conduit 34. In some variations, the fluid conduit 34 can define a set of holes configured to hold a corresponding set of fluid contact sensors while maintaining a seal of fluid (for example, with gaskets 40.
[0189] [0189] In some variations, the fluid conduit may have a circular cross-sectional shape. The fluid conduit can define a lumen (for example, having a circular or square cross section) within a rigid or semi-rigid material. In other variations, the fluid conduit can have any suitable shape. For example, Figure 17 illustrates a square 15 cross-section fluid conduit in a structure 71 (for example, housing) with holes configured to hold a set of fluid contact sensors 44 and a hole for optical dispersion / emitter of the absorption / 2b sensor and a hole for an optical detector of the dispersion / absorption sensor 2a. Emitter 2b and detector 2a are shown oriented 90 degrees from each other around the fluid conduit. Additionally or alternatively, the sensors can be molded directly into the frame 71 to ensure a fluid tight seal. In some variations, sensor assembly 2, 44 can be held in the holes using an adhesive to ensure a fluid tight seal. In some variations, a transparent layer can be provided between the sensor and the lumen. For example, a glass interface can be arranged between a sensor 2, 44 and the fluid in the fluid conduit 15. In some variations, the structure 71 can be formed by, for example, one or more injection molding techniques , machining, ultrasound welding and 3D printing.
[0190] [0190] In the systems and devices described in this document comprising a plurality of sensors, upstream sensors can be configured to change the properties of the particles in the fluid conduit and, therefore, affect the measurements made by the downstream sensors. For example, chemical resistance sensors can react chemically to particles, which can alter, for example, the optical dispersion / absorption of fluid in the fluid conduit. In another example, an optical sensor may include light emitters that emit light in the ultraviolet wavelength range, which can kill cells and / or pathogens, thereby affecting the optical measurement downstream of cells and / or pathogens. Conductivity measurements that apply electrical current through the fluid can also damage cells or pathogens, thus affecting the optical measurement downstream of cells and / or pathogens. In addition, conductivity measurements can also heat up the fluid, which can alter the downstream temperature measurement. As such, the order of the sensors can be important in a sensor system with a plurality of sensors. In particular, sensors that can react with the fluid and / or particles within the fluid conduit should generally be placed downstream, so that their effects do not affect the measurements made by the sensors in the system.
[0191] [0191] In some variations, as in the example of Figures 26, 29 and 30, in which the fluid flow conduit is unidirectional through the patient monitoring device, one or more unidirectional valves 61 can be used to ensure that the flow fluid flow is limited in the intended direction. One-way valves, such as part Qosina nº 80107 (Ronkonkoma, NY), automatically seal when the flow goes in the opposite direction to the intended direction. The check valve can be permanently connected to the patient monitoring device or used as a separate accessory. The check valve can be used in addition to the Luer-activated valve.
[0192] [0192] The sensor network can be configured to measure the fluid flowing into or out of the catheter. There are various configurations of sensors and fluid conduits. In a variation, as shown in Figures 2 and 3, there are one or more sensors in a single fluid conduit.
[0193] [0193] In another variation, shown in Figure 26, the fluid conduit forks between a sensor fluid conduit and an infused fluid conduit. When fluid is infused from the tubing assembly, a one-way valve 61a at junction 62 for the tubing assembly prevents fluid from entering the fluid conduit of sensor 65. All infusion fluid passes through the flow conduit - infusion set 63 and then through the junction of catheter 64, into the catheter. When fluid is drained from the catheter, a one-way valve 61b at junction 64 of the catheter prevents the drained fluid from entering the infusion fluid conduit 63. The drain fluid passes through the drain fluid conduit 65 and then through from the junction of the pipe assembly 62 to the drain line. By isolating the infused fluid conduit, there is a lower risk of trapped pathogens that can be infused into the patient.
[0194] [0194] In another variation, shown in Figures 27 and 28, there is a plurality of parallel fluid conduits, where different sensors 1, 2 reside in different fluid conduits. With several optical sensors, for example, it may be desirable to isolate sensors so that interference between the sensors can be minimized. Between each fluid conduit, there may be electrical and / or light protection materials to isolate the sensors. Each of the fluid conduits can also have unique cross-sectional areas. In the case of sensors based on chemical resistance mechanisms, in which a long fluid residence time is desirable, the cross-sectional area of the measuring channel can be relatively small (for example, approximately 100 to approximately 500 µm in diameter) ) to reduce flow velocity by increasing the back pressure of the lumen reduction. Figures 27 and 28 represent a fluid conduit 15 which is divided into three fluid conduits 66, 67, 68, with sensors 1, 2 monitoring each fluid conduit. After passing through the three fluid conduits, the fluid converges again to a fluid conduit 69 connected to the catheter. Figure 27 represents the direction of fluid flow with arrows showing when the fluid is being infused into the catheter and Figure 28 represents the direction of fluid flow with arrows showing when the fluid is coming out of the catheter.
[0195] [0195] In another variation, shown in Figures 29 and 30, a one-way valve 61 can be used so that the only infusion or outlet solution is measured by the sensors in one or more fluid conduits. Figures 29 and 30 represent a fluid conduit 15 which is divided into three fluid conduits 66, 67, 68 with sensors 1, 2 monitoring each fluid conduit. The fluid conduits converge again to a fluid conduit (69) connected to the catheter. Between the fluid conduit 15 and the fluid conduit 69, there is a one-way valve 61. Figure 29 represents the direction of the fluid flow with arrows showing when the fluid is being infused into the catheter and Figure 30 represents the direction of the fluid flow. fluid with arrows showing when fluid is coming out of the catheter. During the infusion state, the unidirectional valve 61 prevents the fluid from flowing to the fluid conduit 68, but when the fluid is exiting the catheter, the unidirectional valve allows the fluid to flow into the fluid conduit 68. An example of this mode of operation is when using an active sensor that can react with the fluid, such as enzyme-based electrochemical sensors, which produce by-products of the enzymatic reaction that the system can prevent from entering the patient and it will only be activated when the fluid is leaving the patient.
[0196] [0196] In another variation, the device interfaces only with the drain fluid. Figure 31 shows this in the most basic configuration. The drain line is connected to the primary conduit 15 which passes through the patient monitoring sensors 1, 2 and exits to the waste receptacle.
[0197] [0197] In another variation of a device connected to the drain line, Figure 32 represents the fluid conduit. The drain line is connected to the primary drain conduit 15 and a valve 72 deflects the flow to one or more detection channels 73 while the rest of the fluid flow continues through the waste channel.
[0198] [0198] Figures 6 and 7 illustrate examples of a patient monitoring device comprising cartridge loading mechanisms. Figures 6A and 6B represent a top and front view of the durable component of a patient monitoring device without a loaded cartridge. There is a recess (for example, mat) 37 configured to attach to the cartridge (not shown). In some variations, a switch 38 can be arranged inside or adjacent to the recess 37.
[0199] [0199] Figures 6C and 6D illustrate a top and side view of the patient monitoring device with the disposable cartridge 40 loaded. Loading the cartridge 40 into the recess 37 can activate a switch 38 configured to transmit an installation signal. A locking mechanism, such as a set of spring flanges 39, can be configured to advance towards cartridge 40 and hold it in place, as shown in Figure 6D. Additionally or alternatively, a set of fluid contact sensors 44 can be advanced towards cartridge 44 after loading, allowing sensors 44 to come in contact with the fluid flowing through a fluid conduit from cartridge 40, as shown in Figure 6C. In some variations, a visual indicator 41 may be provided to indicate a cartridge status. For example, indicator 41 may turn red when the cartridge is not loaded (for example, turn off) or loaded incorrectly and may turn green when it is loaded correctly (for example, turn on).
[0200] [0200] As another example, Figure 7A represents a top and front view of the patient monitoring device without the cartridge 40 loaded. A durable component defining a recess (for example, strip) 37 may comprise an electrical connector 42 configured to engage with cartridge 40. In some variations, cartridge 40 may comprise a printed circuit board and a connector 45 configured to connect with electrical connector 42 of the durable component. Fluid-free contact sensors 43 remain on the reusable module, and fluid-contact sensors 44 remain on the reusable module.
[0201] [0201] The components can be assembled together through various mechanisms. For example, components can be held together through a set of locks, a set of magnets and magnetic counterparts, screws with threaded holes, a nut that holds the parts together under pressure, combinations of the same and similar. Additionally or alternatively, one or more components can twist and seal like that of a Luer lock or lock through an axle lock, frame lock, latch lock or locking mechanism that can be released by pressing the lock part, a separate button or other accessory. The interfaces listed above are examples that are inclusive and other interfaces can be used to repair components together for use.
[0202] [0202] The components can be released from each other by pressing a button on the locking feature, but can alternatively employ other mechanical and / or electrical means. One method for releasing the disposable from the durable component is through a user interface on the patient's monitoring device or a separate user interface for mobile, tablet or browser. The patient can choose to change the disposable cartridge due to an automated prompt, prompt from the provider or through their own agency. The cartridge would be released or unlocked and able to be removed from the durable component of the device after the action. Alternatively, an employee of the device manufacturer, provider, or third party service may be asked to change the disposable component. The employee may have a special key, which can be physical or electronic, to unlock the device and also release the durable component. Through this method, the patient would not need
[0203] [0203] In some variations, one or more of the cartridge components and the durable component can be deactivated under predetermined conditions. For example, if one or more sensors lose calibration due to bacterial buildup, low battery or predetermined time interval, loss of calibration, a signal can be received by one or more cartridges and durable components to disable monitoring of the patient. Sterility
[0204] [0204] Any of the cartridges described here can be configured to maintain the sterility of their fluid channels between the factory and the installation. In some variations, the ends of a fluid channel in the cartridge can be sealed using a thin membrane to maintain the sterility of the fluid channel. The membrane can be composed of silicon, hydrogel, polyvinyl alcohol (PVA), combinations thereof and the like. In some of these variations, the fluid conduit can be inserted into a lumen of a connection port (for example, pipe connector), where the connection port is configured to fluidly attach to a dialysate solution or permanent catheter. In these variations, the membranes can remain intact until the fluid flows through the connection port to make contact. For example, the fluid flow through the connection port can come in contact and then dissolve the membranes (for example, PVA membrane), thus fluidly coupling the fluid conduit to the connection port. In addition or alternatively, the membrane seals can be broken by applying sufficient external force to the ends of the fluid conduit (for example, by tightening the fluid channel). In other variations, one end of the connection port can be inserted into a fluid channel lumen sealed by a set of membranes, thus puncturing the membrane seals and fluidly connecting the fluid conduit to the connection port.
[0205] [0205] In some variations of the disposable cartridge, the fluid channel material can be composed of materials with known fouling properties that are factored into the sensor readings affected by the clarity of the fluid channel, to calibrate the sensor readings. The manufacturer's calibration can form an initial calibration and then use a trial period to see how the inlay progresses over time with a specific individual. After that, the typical fouling dynamics can be known and explained. The device can record metrics such as the total time the fluid contact material was in the device and the total fluid it was in contact to refine the fouling corrections and also to determine how often to change the component. - cardable.
[0206] [0206] In a variation, materials with high anti-fouling properties, such as silicone coated with polyethylene glycol (PEG) with hydrogel-coated silicon, polyurethane coated with zwitterionic (phosphorylcholine, sulfobetaine), polyvinyl chloride (PVC) coated with oxide made of polyethylene and polyamiphilic silicone, can be used to maintain consistent optical clarity during use. The materials
[0207] [0207] All parts connected fluidly to the catheter are designed to prevent or reduce the possible transmission of infection. For example, the sensor surfaces that interface with the infused fluid and any accessories or connectors can be configured or selected to minimize the space or surface area on which bacteria or biofilm can accumulate. Flow sensors, for example, can be configured or selected to use ultrasound or optical measurement that have no moving parts, as opposed to Hall effect sensors that have a rotating sensor element or another moving element in contact with the infused fluid. However, a Hall effect sensor, which contains antimicrobial surface treatment, such as silver coating, and with all fluid flow cavities that have no static fluid can be used. The Hall effect sensor can also be used in cases where the fluid only drains from the catheters and never enters the patients.
[0208] [0208] The materials of the sensor can be selected so that the contact surfaces are resistant to corrosion and biocompatible. In one example, borosilicate glass can be the interface between dialysate fluid and infrared sensors. The hardware system comprises materials that can be sterilized by means of
[0209] [0209] In other variations, a fluid conduit may be composed of a material susceptible to bacteria and / or other biofuels to exacerbate the reduction in light received by the optical dispersion / absorption sensor. This can promote one or more cleaning, sterilization and replacement of the fluid conduit at predetermined intervals. In some of these variations, one or more portions of the patient's monitoring device composed of material susceptible to biofuels can be replaced after the patient's infection is detected. This can allow the system to “restart” and monitor the progress of the patient's infection or detect a new infection. The fouling materials include high surface energy materials, polycarbonate, nylon, polyethylene terephthalate (PET).
[0210] [0210] Materials can also be designed for frequent cleaning. Materials with high hardness and resistance to solvents, such as quartz, borosilicate or sapphire glass, can be used for abrasive and / or solvent cleaning. Other materials with high lubrication and resistance to solvents, such as fluoropolymers (FEP, PTFE), can be used for cleaning by washing with solvents and / or light abrasion. Patient monitoring device housing and support
[0211] [0211] The patient monitoring device described here may comprise a housing (for example, housing) that may vary based on the application and the patient's needs. For example, the housing of a patient monitoring device can be flexible, rigid or both, and comprises components with different flexibility and / or rigidity. For example, the casing of a patient monitoring device used by the patient may include one or more pieces of a flexible nature to accommodate movement of the contact skin area, improve patient comfort and reduce stress on the adhesive. Housing parts can be manufactured (for example, injection molded, machined, printed in 3D) from flexible materials such as silicone, thermoplastic polyurethane (TPU) and the like. The casing may also include a rigid base material, such as polycarbonate and acrylonitrile-butadiene-styrene (ABS), with one or more flexible molded materials in excess. The housing may comprise an assembly feature configured to attach to a structure such as a drainage vessel or a patient.
[0212] [0212] In some variations, the compartments described here can be coupled to the patient in several ways. In one example, the wrapper is attached to the patient's skin using an adhesive. A double-sided adhesive layer may comprise a specific adhesive in interface with the wrapper and a separate adhesive in interface with the patient's skin. In one example, the wrapper may comprise silicone walls or include an outer layer of silicone. The adhesive can be a silicone adhesive, such as Dow Corning's Silastic medical adhesive (Midland, MI). Various patches can be used on the surface side of the skin, including hydrocolloid patches, which can sufficiently seal the skin surface for 2 to 4 weeks. The adhesive can be replaceable and can be made in a period corresponding to the battery charge maintenance cycle, cartridge replacement, cleaning / sterilization cycle, patient infection detection, combinations of the same and similar.
[0213] [0213] The housing, as described above and illustrated in Figure 3, may contain one or more components and openings. To promote
[0214] [0214] In the variations shown in Figures 3, 4 and 5, the enclosure can include port 14 (for example, connector) connected to the catheter, in addition to the catheter exit site from the patient's skin, which can provide protection against infection at the catheter exit site. Typically, port 14 can be connected to the enclosure via piping, but in other examples, port 14 can be integrated into the enclosure wall. The patient monitoring device may alternatively have both ends of the doors exiting the enclosure, as in the variation shown in Figure 18. Figure 18 shows an alternative variation of the form factor of the patient monitoring device in which the enclosure has two exposed ports for the fluid conduit external to the housing body. One port 58 connects to the catheter (not shown) and another port 60 connects to the infusion / drain fluid tubing port (not shown).
[0215] [0215] In another variation, depicted in Figure 14, patient monitoring devices are arranged in place of conventional transfer sets used for quick connection of tube sets for peritoneal dialysis therapy. Thus, the devices
[0216] [0216] In another variation, the patient monitoring devices described here can be arranged in place of the conventional drain lines used for the flow of drain fluid into a disposal container. In some of these variations, the patient monitoring device may include a length of tube connected to a CCPD or CAPD. The piping can be used for one or more drain cycles. Thus, the patient monitoring devices described herein can be referred to here as an "intelligent" drain line.
[0217] [0217] In another variation, shown in Figure 20A, a patient monitoring device 301 can be attached over a sensor portion of a fluid conduit 34 (for example, tubing set, connector tubes). In some variations, one or more portions of the fluid conduit 34 may comprise a sensor portion 302 and piping connections 34. In particular, the patient monitoring device 301 may be configured to tighten the sensor portion 302 to measure one or more more fluid properties without direct fluid contact. For example, the patient monitoring device 301 may comprise one or more sensors configured to measure one or more parameters such as dispersion fluid / optical absorption, fluid temperature (by infrared detection), and fluid pressure (by distending the material from the detection region). In some variations, the sensor portion 302 may consist of an optical grade silicone (Nusil MED-6033) with a thin wall (i.e., 0.020 inches) that can be molded with the fluid conduit 34.
[0218] [0218] In some variations, a patient monitoring device can be fastened to a convenient tubing set
[0219] [0219] In some variations, two of the 304 projection sensors may comprise electrodes configured to measure fluid conductivity, and a third sensor may comprise a pressure sensor. In other variations, one or more of the 304 sensors may comprise a temperature sensor. In some variations, the sensor portion 302 may not include a set of classified drilled holes. In some variations, the set of projection sensors 304 may include a set of protrusions configured to penetrate a wall of the sensor portion 302. For example, the set of protrusions may comprise a set of sharp needle-like ends. In some variations, the sensor portion 302 may be formed of rigid material such as PVC or nylon that can be easily drilled using a protrusion.
[0220] [0220] In another variation, the patient monitoring device
[0221] [0221] In another variation, represented in the cross-sectional perspective views of Figures 23A and 23B, a patient monitoring device 2300 may comprise a housing 400 having a mounting clip 401 designed to attach to a drainage vessel, such as a toilet, drain pan, waste bucket, waste bag, bathtub, and the like. A drain line from the 402 pipe set can be connected to an inlet connector
[0222] [0222] Figures 24A and 24B represent a variation of a 2300 patient monitoring device attached to the side of a 2400 toilet. Standard Luer type connectors (normal size or large diameter) can be used as a line interface. flow from the patient monitoring device to the Luer connector on most catheters and the Luer connector on the connecting tube for most pharmaceutical products infused solutions or drainage bags. In another example, a barb accessory can be used. In other examples, however, a different or proprietary connector interface can be used.
[0223] [0223] In one variation, a threaded connector as shown in Figures 25A and 25B can be used as a universal connector to connect to the drain line of various manufacturers. For example, a first connector 407 may comprise a thread 409 configured to connect with the inside diameter of one end of the drain line 408 of a second connector 410 by twisting the pipe of the drain line to a joint. - so free of leaks. The first connector 407 can be sized to a predetermined internal pipe diameter size, as shown in Figure 25A or a plurality of pipe sizes by a cone design illustrated in Figure 25B. These first 407 connectors can be coupled to an input / output connector on the patient monitoring device.
[0224] [0224] In some variations, one or more fluid connector conduits from a patient monitoring device may include a Luer-activated valve. The valve can open to allow fluid flow when a permanent catheter or connector tubing is connected and closed to seal the liquid and air when the permanent catheter or connector tubing is disconnected. Luer-activated valves, such as Qosina part # 80114 (Ronkonkoma, NY) are bi-directional self-sealing when not connected, and activate when the stem of the Luer male lock connection to allow fluid flow in any direction. The valve can be permanently attached to the patient monitoring device, or used as a separate accessory, which allows separation during system sterilization, and easy replacement during maintenance cycles. Test indicator strips
[0225] [0225] In some variations, a disposable cartridge for a patient monitoring device may include a set of test indicator strips. The test indicator strips can be single use or have a limited number of uses, where the system monitors the number of uses before indicating or signaling replacement. In some variations of the test strips that provide a positive reaction only, the test strips can be used until a positive reaction is obtained or until a non-specific binding of particles to the receptors reaches a predetermined non-specific binding threshold. (for example, 30% of receivers). For example, a non-specific binding limit may correspond to a predetermined volume of fluid drained that flows over the test strip set. Assuming a positive reaction does not occur, the test strip set can be used continuously until the predetermined volume of fluid drained has been detected by, for example, a fluid flow sensor. In some variations, a control device (eg, processor) in the system can analyze the fluid flow generated by a fluid flow sensor to generate a signal indicating that the test strip set should be replaced. As described in more detail here, an optical reader can be used to read the set of test strips.
[00101] [00101] In some variations, the test indicator strips can detect specific solutes that would indicate complications (for example
[00102] [00102] Figures 8A and 8C represent variations of the device in which disposable test strips are used to assess the presence and / or concentration of specific solutes. In some variations, a set of test strips housed in a removable sensor can be removably attached to a disposable cartridge comprising a fluid conduit. Strips 46 are attached to a cartridge 47 and are in direct contact with the fluid being analyzed. For example, a cartridge 47 can be removably attached to a cartridge having a fluid conduit 48. For clarity, only the fluid conduit 48 of the disposable cartridge is illustrated in Figure 8A. As shown in Figure 8A, cartridge 47 can be inserted through gaskets 49 disposed on a wall of fluid conduit 48, which allows cartridge 47 to be replaced at a different frequency than fluid conduit 48 and corresponding disposable cartridge. Figure 8B illustrates a durable component coupled to a fluid conduit 48 of a disposable component. When cartridge 47 is not attached to fluid conduit 48, as shown in Figure 8B, an indicator light 134 may indicate a hold status of cartridge 47 (for example, red corresponds to an unattached cartridge state and green corresponds to to a fixed cartridge state). The recess 135 can be configured to receive test strip module 47. When attaching cartridge 47 to fluid conduit 48, as shown in Figure 8C, indicator light 134 may indicate a fixed cartridge state (for example, green light ) where the test strip set 46 is inserted through the gaskets 49 and the fluid conduit 48.
[00103] [00103] In another variation, the 6830 disposable fluid conduit shown in Figures 68A-D can integrate the test strips into the lumen. The test strips would then be part of the disposable set, which could facilitate replacement.
[00104] [00104] Some test indicator strips have specific exposure times and, in some variations, a set of test strips can be exposed to only part of the volume of the test fluid and analyzed at a specific time after fluid exposure. For example, the Siemens Multistix 10 SG Reagent Strip works optimally when glucose and bilirubin tests are read approximately 30 seconds after exposure, the ketone test is read approximately 40 seconds after exposure, the test specific gravity test is read approximately 45 seconds after exposure, the pH test, protein test, urobilinogen test, blood test and nitrite test are read approximately 60 seconds after exposure and the leukocyte test is read approximately 2 minutes after exposure. Exposure, incubation and reading steps can be performed by the device, a user or a combination of both. For example, an audible alert (for example, beep, voice) can be issued to a user when one or more test strips are ready for visual analysis.
[00105] [00105] The light emission or color change are two of the possible readings for the test strips, they can be measured by the user or by means of an optical instrument such as the Siemens Clinitek Status + Analyzer. Alternatively, a test strip optical reader can be integrated into the patient monitoring device (eg, durable component, disposable cartridge) or as a separate removable optical sensor.
[00106] [00106] The display and reading of test strips using the systems and devices described in this document can provide systematic monitoring, in addition to more sensitive and consistent analyzes (for example, optical reading and non-optical readings (for example, chemicals)) of a test strip than that provided by a patient. The test indicator strips cannot be used for all fluid tests, but only when a complication indicated by another sensor is suspected. For example, if optical dispersion / absorption data indicates an increase in optical dispersion / absorption levels, one or more test indicator ranges can be used to detect the presence of leukocytes or blood to determine the source specific dispersion / optical absorption. Exposure can occur automatically using the patient's monitoring device or by the patient himself, inserting the strips into the solution when it leaves the drain line, for example.
[00107] [00107] A set of test strips can be supplied in a cartridge (for example, test strip module) that can be removably connected to one or more patient monitoring devices and / or disposable components. In some variations, the cartridge can be removably attached to a disposable component (eg, cartridge) and the disposable component can be removably attached to a durable component of the patient monitoring device. In some variations, the device can automatically change the strips on the loaded cartridge, reducing the need for the patient to be responsible for replacing and intervening with the patient monitoring device. Figures 9A-9D illustrate a variation of a cartridge 900 comprising a set of test strips 46. In Figure 9A, a first subset of test strips can be arranged in a first position 902, where the test strips are stored and ready to be exposed to the fluid flow. A second subset of test strips can be arranged in a second position 904, where one or more test strips can be advanced in and out of cartridge 900. The cartridge 900 can define one or more openings (for example, slots in the test strip) configured for advancing the second test strip subset out of cartridge 900. For example, similar to that shown in Figures 8A and 8C, test strips 46 may advance out of cartridge 900 and through one or more joints in the wall of a fluid conduit (not shown) and subsequently contact fluid that flows into the fluid conduit. In some variations, the test strip set 46 in the second position 904 may be exposed to half or less the width of the fluid conduit in order to reduce the effect of the laminar flow of the test strip set 46 on the test conduit. fluid.
[00108] [00108] After the set of strips in second position 902 is used, the set of test strips 46 in second position 902 can be retracted into cartridge 900, as shown in Figure 9B. The entire set of test strips 46 can then be advanced (FIG. 9C) towards the third position (906) (FIG. 9D) thereby aligning a set of unused strips 46 to the second position
[00109] [00109] In some variations, a test strip reader, whether a durable or disposable component, can be located adjacent to the fluid conduit to read the test strips held in the second position 904. In some variations, the test strip reader Test strips can be arranged between an outer surface of the fluid conduit and a surface of the 900 cartridge, so that the test strip reader can read test strips 46 as they are retracted in the 900 cartridge. In other variations, a test strip reader can be arranged inside the cartridge 900 and configured to read the retracted test strips 46 at the third position 906 inside the cartridge 900.
[00110] [00110] In some variations, one or more test strips can be integrated directly into the disposable fluid line or into the drainage vessel. For example, one or more test strips can be arranged along an inner wall of a connector tube (for example, fluid line, drain line) and drain vessel. Peritoneal dialysis can include disposable lines and drainage vessels that can be replaced at predetermined intervals (for example, after each change cycle, daily). A test strip reader can be attached (for example, attached) to the connector tube and / or drain vessel and configured to read the test strips. The fluid flowing through the connector tube and / or drain vessel can come in contact with the test indicator strips and be read by a test strip reader. The connector tube and / or the drainage vessel can be discarded after use, after the test strip reader is removed. The connector tube and / or the drainage vessel can be composed of a material with high optical clarity that can be molded or modeled, such as silicone, PVC, polyurethane and nylon. In some variations, the test strips can be attached to an inner wall of a connector tube and / or drainage vessel using one or more adhesive, an injection molding process, an ultrasonic connection, laser connection and similar. In some other variations, a set of test strips may be arranged in a separate conduit (for example, fluid conduit and / or container) connected to a connector tube and / or drain vessel. The conduit can be attached to one or more patient monitoring devices, connector tube and drainage vessel. The fluid flow can be controlled in the conduit. For example, the conduit can be coupled with one or more valves, permeable membranes and dissolvable obstructions (for example, polyvinyl alcohol). The valve can be controlled by a user and / or the patient's monitoring device.
[00111] [00111] In a variation, Figure 12 illustrates an optical reader 52 coupled to an internal wall of a drain vessel 57. In this configuration, the container 57 and the reader 52 can be discarded together. In some variations, the optical reader 52 can be attached to the inner wall of the vessel 57 or tubing in the same way as the test strips (eg adhesive, injection molding, ultrasonic bonding, laser bonding). In some variations, optical reader 52 may comprise a battery, processor, memory and wireless transmitter and may process and transmit sensor data in a manner similar to the patient monitoring devices described herein. Optical reader 52 can form a wired connection to a patient monitoring device (not shown) for communication and / or data control.
[00112] [00112] In other variations, one or more test strips can be arranged in a separate test strip module connected to an input and / or output of the patient monitoring device and / or the disposable tube. The independent test strip module allows the test strips to be flexibly connected in different locations to a variety of tube sets from different manufacturers. The patient monitoring device can also be replaced at a different frequency than the other components of the system. Figure 10A shows a variation in which a set of test strips 46 is attached to an internal fluid flow conduit of a test strip module 1000. Inlet connector 50 or outlet connector 51 can match tubes connector 1010. Connectors 50, 51 can be one or more of a barbed type, standard quick disconnect, universal Luer type connectors and custom connector types. The system is shown mounted on the tubing in Figure 10B and together with the fixation strip reader 52 in Figure 10C.
[00113] [00113] Another variation of the fixing test strip reader with the test strips is shown in Figures 11A and 11B. Figure 11B is a perspective view of a patient monitoring device 301 (e.g., test strip reader) that can comprise one or more sensors configured to read a set of test strips 302 attached to each other. Figure 11A illustrates a portion of the sensor 302 of a fluid conduit 34 (e.g., drain pipe). For example, the sensor portion 302 may comprise a set of test strips aligned to an optically transparent window for a fixing optical reader 301 for measuring the set of test strips. The patient monitoring device 301 can be configured to attach the sensor part 302 to read the color of the test strip set 302. Sensors for infection detection
[00114] [00114] Catheters of permanent patients are susceptible to complications of infection. In the case of patients on peritoneal dialysis, a catheter is used to infuse and drain the dialysate solution, and peritonitis is a common complication. In the example of patients on peritoneal dialysis, infection detection can be monitored with at least one patient infection detector, such as one or more sensors configured to measure a suitable parameter, including, but not limited to, the patient's core body temperature, patient's skin, pH drainage dialysate, optical dispersion / absorption of the drainage dialysate, white blood cell count or activity in the drainage dialysate, lactate content of the drainage dialysate and skin discoloration at the catheter exit site (for example, example, due to rash), etc.
[00115] [00115] Clinically, one of the signs of infection is fever. Body temperature usually varies between 36.1 and 37.2 ° C. Body temperature that exceeds this range is indicative of fever. For temperature monitoring, an infrared, thermocouple or thermometer sensor can be used to monitor the skin surface or, in the case of patients on peritoneal dialysis, the sensor can directly measure the drainage dialysate solution immediately after exit from the body.
[00116] [00116] Thermistors are generally two-terminal semiconductor devices made of semiconductor materials that have an electrical resistance that varies non-linearly with temperature. Figure 33 shows a circuit design for a thermistor, in which energy 74 is supplied by the microcontroller to sensor 75, which is placed so that the sensing surface is in direct contact with the fluid conduit 15 to optimize heating transfer and the sensor sends a voltage 76 to the microcontroller. In the thermistors, the temperature variation results in resistance changes, causing a variation in the voltage output.
[00117] [00117] When using the thermistor for patients on peritoneal dialysis, the thermistor sensor can be positioned to measure the flow conduit of the dialysate drainage fluid that immediately leaves the catheter / body, which would allow readings of the dialysate solution drainage system exiting directly from the body. The temperature of the draining dialysate should be equal to the body temperature after the long time in the abdomen. However, depending on the distance from the thermistor and body position, which is driven mainly by the length of the internal catheter extending outside the body, a temperature shift may be necessary to compensate for heat loss or gain . For example, a separate room temperature sensor and a fluid flow meter can be used in combination with the fluid temperature sensor. By measuring flow and ambient temperature, heat loss can be estimated with a reasonable degree of accuracy. As an alternative to compensating the thermistor values based on the thermal loss in the pipeline and using the temperature value in absolute terms, temperature changes relative to the measured temperature of the drainage dialysate, measured over time, can be used. .
[00118] [00118] In another method, thermistors can also be placed directly against the skin to measure the temperature of the skin surface to monitor patients using various types of catheters.
[00119] [00119] The optical measurement of dispersion / absorption of the fluid leaving the catheter can also be used for the detection of infections. In the case of patients on peritoneal dialysis, fresh dialysate delivered to the patient is a clear solution prior to introduction into the body. After draining the dialysate solution, the cloudy dialysate solution may be indicative of infection, specifically peritonitis. The white blood cells, also called leukocytes, are concentrated in the areas of infection and are mixed with the dialysate solution during the peritoneal dialysis session, thus producing a cloudy dialysate solution. The system can use a spectroscopy sensor (for example, optical dispersion / absorption sensor) to analyze the infusion and drainage dialysate solution as a method to detect the patient's infection.
[00120] [00120] An optical dispersion / absorption sensor is used to quantitatively measure particles suspended in a fluid. This is done by measuring light scattering and / or light absorption imposed by solids suspended in a fluid. Notably, optical dispersion / absorption measurement can be used to determine the composition of particles within a fluid. As used herein, optical dispersion / absorption can mean the absorption or dispersion of light at particular wavelengths or bands that can provide
[00121] [00121] Figure 34 represents an example of an optical infrared dispersion / absorption sensor. A microcontroller supplies power 74 to a light emitter 86 and a detector 84. Emitter 86 transmits light through the fluid interface surface 92 and the fluid conduit 15. Detector 84 detects the dispersion of the light transmitted through and emits a corresponding voltage 80 based on the amount of light detected for the microcontroller. As shown in Figure 34, the emitter and detector are oriented 180 degrees apart around the circumference of the fluid conduit 15, although the emitter and detector can also be oriented at other forward dispersion angles ( > 90 degrees), side scatter angle (90 degrees) or reverse scatter angles (< 90 degrees). To add specificity to the detected particles, additional patterns of absorption and scattering of light can be used at different wavelengths and / or scattering angles with various emitter / detector systems based on unique patterns of absorption and dispersion of different types. particles (both cellular and non-cellular).
[00122] [00122] The fluid conduit, the light emitter and the detector can have several configurations. Figures 77A-77D represent variations of orientations in which at least one detector (for example, photo sensor) 7802 is oriented along a longitudinal axis of the fluid conduit 7803. A light emitter 7801 can be oriented closer to the distal end 7805 of fluid conduit 7803 (Figure 78B) or closer to the proximal end (7804) of fluid conduit 7803 (Figure 78A). One or more detectors 7802 can be oriented radially around the fluid conduit 7803. To align the light emitter 7801 longitudinally with the fluid conduit 7803, a 90 degree curve in the fluid conduit 7803 is plotted,
[00123] [00123] In some variations, the accuracy of the measurements of the optical signal can be improved by reducing the presence of bubbles (of medium and larger size) that stick to the surface of a fluid conduit during the measurement. Some variations in the fluid conduit may comprise one or more hydrophilic materials configured to prevent bubbles from adhering to a conduit surface and a filter may be placed upstream of an optical sensor array. For example, the filter can be an air filter, such as the Hydrophilic Filter (Qosina, P / N 28216).
[00124] [00124] In addition or alternatively, a pressure differential within the fluid conduit can reduce the presence of bubbles. In some variations, the fluid conduit may have a non-uniform profile, in which a transparent portion (for example, optical detection region) has a reduced cross-sectional area that generates a pressure differential configured to evacuate bubbles the transparent portion. For example, Figure 77 represents a cross-sectional view of a 7700 fluid conduit having a transparent portion 7702 with a reduced cross-sectional area in relation to other portions of the 7700 fluid conduit. In the reduced cross-sectional area, the speed of the fluid flow increases abruptly, which facilitates the release of bubbles that attach to the surface of the fluid conduit 7700 in the transparent portion 7702. A variety of
[00125] [00125] In some variations, the accuracy of optical signal measurements can be improved by reducing and / or compensating for external light noise (such as from ambient light sources) using one or more of the mechanisms described in detail in this document. For example, a transparent region (for example, optical detection region) of a fluid conduit can be protected from external light using an enclosure (for example, opaque housing, cover, cover, flaps, door) during measurement. In some variations, a collimator located in front of a detector can be configured to reduce the detection of external light noise (for example, scattered light). In addition or alternatively, the fluid conduit may comprise one or more light-absorbing portions (e.g., opaque portions, rings) proximal and / or distal to the transparent portion. The light-absorbing portions are configured to reduce light conduction from light sources external to the patient monitoring device. In some variations, an optical sensor array can be configured to measure a quantity of external light, so that measurements and / or calculations of optical characteristics can be modified to compensate for the measured external light. For example, an emitter of an optical sensor array can be configured to generate light in a pulsed manner. The optical characteristics can be measured by at least one detector when the emitter pulses light and an amount of external light can be measured by at least one detector when the emitter does not emit light and is "in the dark".
[00126] [00126] Figure 43 represents a cross-sectional view of a stage of an optical dispersion / absorption system. Fluid flows through fluid conduit 15 with particles 81. Light source 82, flat-convex lenses 83, light detectors 84 and fluid conduit are mounted on an electrical device 85. Light source 82 emits light and a lens convex plane 83 collimates light waves. One of the detectors 84 oriented at 180 degrees in relation to the emitter 86 receives the rest of the light after passing through conduit 15. Another flat convex lens 83 oriented at 90 degrees in relation to the emitter receives the light scattered laterally. This convex-flat lens collimates the light received before reaching the light detector 84 oriented at 90 degrees.
[00127] [00127] Additional lens types (equi-convex, bi-convex, converging meniscus, positive meniscus) can be used to focus the light source of the light source or the scattered light to the detector. The wavelengths of light can be transmitted in phase or out of phase. From the relatively wide range of a light source, filters can be used for discrete wavelength transmission.
[00128] [00128] In some variations, a scintillator can be used to improve the signal strength of the light detector 84. In some variations, a light detector 84 may have a larger surface area to capture more light. Light detectors 84, as shown in Figure 43, are oriented perpendicular to the radial direction of the fluid conduit 15. Additionally or alternatively, light detectors 84 can be supplied at an angle (<90 degrees or> 90 degrees) with respect to the radial direction of the fluid conduit 15 to effectively increase the surface area in the light path to receive additional light and / or to prevent the light from reflecting back into the fluid conduit 15.
[00129] [00129] As an alternative, or complement to the optical dispersion / absorption system described, a spectroscopy system can be integrated for a broadband wavelength absorbance analysis to determine specific constituents within the fluid. A forward optical system is shown in Figure 44. A white light source 82 transmits a wide range of wavelengths to a monochromator 87. Discrete wavelengths are transmitted through fluid channel 15 and the constituents within fluid 81 absorb different wavelengths in the light spectrum, with the resulting light measured by detector 84. A reverse optical system can also be integrated.
[00130] [00130] When using the dispersion / absorption optical sensor within the system, the material of the fluid interface surface can comprise material with high optical clarity, such as one or more acrylic cyclic olefin copolymers and a material that combines high temperature conductivity, such as Pyrex glass or glass-filled nylon, or a material with high anti-fouling properties, such as silicone coated with polyethylene glycol (PEG), hydrogel-coated silicone, zwitterionic-coated polyurethane (phosphorylcholine, sulfobetaine), oxide polyethylene coated polyvinyl chloride (PVC) and polyphilic silicone, to maintain consistent optical clarity during use.
[00131] [00131] Materials susceptible to bacterial incrustations can also be used to amplify changes in the level of optical dispersion / absorption. At light absorption angles (180 degrees), the increase in optical dispersion / absorption related to infection generally reduces the light received by the detector. The bacterial encrustation of the piping material can further reduce the amount of light received by the detector, amplifying the signal. Alternatively, any bio-encrustation of the material that results in a reduction in the light received by the detector of the dispersion / absorption optical system can be used to signal one or more of the replacement, cleaning and maintenance of the fluid channel.
[00132] [00132] The identification of particles indicative of a specific complication is challenging in complex fluids, such as blood, urine, ascites and drainage of peritoneal dialysis. As shown in Figure 35, different types of particles (red blood cells, chylomicrons, triglycerides, white blood cells) can have unique and distinguishable optical absorbance spectra. In some variations, a sensor can be sensitive to a wide range of wavelengths and configured to measure the entire absorbance spectrum to identify the unique signatures of the optical absorbance spectrum of the present particles, but these systems can be relatively bulky and expensive in some contexts. Measurements in certain selected wavelength ranges (for example, the infrared range), may allow minimal differentiation of different types of particles based on their optical absorbance behavior, making it difficult to distinguish between different types of particles ( for example, red blood cells, chylomicrons, triglycerides, white blood cells) when measuring optical characteristics in the infrared range. Therefore, in some variations, optical measurements of a fluid in a specific wavelength range or range can indicate the presence of any one or more of a plurality of particle types in the fluid, which can lead to ambiguity as to what types of particles) are present in the fluid based on a given sensor signal. For example, optical measurements for a wavelength range may correspond to a cell concentration of red blood cells or white blood cells or a combination of both.
[00133] [00133] In some variations, measurements on a set of different wavelengths (for example, discrete) or wavelength bands can be performed by at least one sensor to differentiate the particles present in the fluid and their characteristics -
[00134] [00134] The sensor data of the various stages can, in some variations, be analyzed to identify the types of particles based, at least in part, on one or more correlation graphs for possible types of particles.
[00135] [00135] Additionally or alternatively, based on correlation graphs, such as those described above, one or more proportions of sensor data associated with the different stages (for example, measurements in different wavelength ranges) can be calculated and plotted according to the concentration of the particle type to derive additional correlation plots. For example, Figure 37 is a correlation graph of sensor data measured from the first and second stage sensor systems (for example, voltage from a first stage sensor system described above, in relation to (for example, example, divided by) second-stage stress described above) for variations in white blood cell concentrations. A similar correlation graph using sensor data measured from the first and second stage sensor systems can be created for the red blood cells. Due to the unique absorbance characteristics of the types of particles WBC and RBC in the wavelength band of the second stage, the proportions can be different for each type of particle.
[00136] [00136] The correlation graph data generated at different stages (for example, discrete wavelength bands or bands) can allow types of particles within a fluid to be differentiated (for example, identified). This can be useful in situations in which optical measurements of a fluid in a specific wavelength range or range can indicate the presence of any one or more of a plurality of particle types in the fluid, which can lead to ambiguity in what type of particle (s) are
[00137] [00137] Generally, an optical sensor can be configured to measure fluid in two or more wavelength ranges. Measurements in different wavelength ranges can be plotted separately for different types of particles in relation to known concentration ratios. A set of possible concentrations of the particle type can be estimated from these plots. The estimated concentrations can then be compared with each other to find substantially corresponding values. When the estimated concentration values for a particle type coincide with the different graphs, the particle type can be estimated. For example, the concentration of the unknown dominant particle type can be identified in a set of one or more known (or predetermined) correlation plots (for example, concentration curves). The set of correlation graphs can, for example, include a specific particle correlation graph (for example, similar in concept to the correlation graph shown in Figure 36, which relates (i) signal at a wavelength to ( ii) a specific particle type, such as white blood cells) and one or more ratio-based correlation graphs (for example, similar in concept to the correlation graph shown in Figure 37, which relates (i) a data ratio of signal for multiple wavelengths a (ii) a specific particle type, such as white blood cells). Generally, sensor signals and a proportion of sensor signals for measurements at different wavelengths can be corrected
[00138] [00138] Example 1: A first optical stage sensor (for example, without particle differentiation) can be configured to measure fluid between approximately 850 nm and approximately 870 nm wavelength and a second optical stage sensor (for example , particle differentiation) can be configured to measure fluid between approximately 400 nm and approximately 420 nm wavelength. The optical sensor of the first stage measures an output voltage of 0.95 V. The optical sensor of the second stage measures an output voltage of approximately 0.15 V.
[00139] [00139] Figures 38A and 38B represent the application of correlation graphs to identify the type of particle and the concentration of these two signals emitted by the optical sensors of the first and the second stage. Figure 38A is a predetermined correlation plot of the sensor signal (for example, optical wavelength measurement within a first or wavelength range, such as infrared) versus white blood cell concentration, overlaid with a predetermined correlation plot of the sensor signal versus red blood cell concentration (the curve is substantially the same for white and blood cell concentrations). Specifically, the sensor signal was derived from a first-stage optical sensor configured to measure fluid between approximately 850 nm and approximately 870 nm. In this example, the first stage optical sensor provided a signal output of approximately 0.95 V, which (based on the correlation of this value with the concentration of cells in Figure 38A) suggests that the measured fluid has a concentration of approximately 23 cells / µL of an unknown particle type concentration (white blood cells or red blood cells). To help determine whether the fluid has a concentration of 23 white blood cells / µL or 23 red blood cells / µL, a second step of analysis using one or more ratio-based correlation plots, as shown in Figure 38B, can to be fulfilled.
[00140] [00140] Figure 38B is an overlay of ratio-based correlation plots for white blood cells (WBC) and red blood cells (RBC). Specifically, the WBC and RBC curves in Figure 38B correspond to known concentration ratios of a ratio of the measured sensor outputs in the first wavelength range ("Wavelength A") divided by a second wavelength range (" Wavelength B ") (measurements in the first stage compared to measurements in the second stage). In this example, the ratio of the first stage to the second stage (λ A / λ B) is calculated as 0.95 / 0.15 = 6.33. The measured ratio of 6.33 crosses the leukocyte curve at 23 cells / µL and does not intersect the leukocyte curve. Therefore, the ratio-based correlation graph in Figure 38B indicates that the measured cell concentration of 23 cells / µL is white blood cells. In other words, since the estimated leukocyte concentration values coincide with different correlation plots, the optical dispersion / absorption measured by the first and second stage optical sensors is largely due to the leukocyte particles and minimally of the leukocyte particles. The measured leukocyte concentration values can then be used to determine the patient's infection, as described in more detail here.
[00141] [00141] Example 2: In this example, the two stages of optical dispersion / absorption can be at wavelengths that have different absorption characteristics for different types of particles. A first optical stage sensor (for example, without particle differentiation) can be configured to measure fluid at a wavelength of approximately 260 nm (wavelength C) and a second stage optical sensor (for example, particle differentiation) can be configured to measure fluid at another specific cell wavelength (D wave length). The first stage optical sensor measures a sensor output voltage of approximately 0.950 V. The first stage optical sensor measures an output voltage of approximately 0.194 V.
[00142] [00142] Similar to Example 1, correlation plots, as shown in Figures 39A and 39B, for different types of particles, can be used to analyze sensor data from the first and second stages. Specifically, Figure 39A includes an overlay of a predetermined correlation graph for the sensor signal output measured at C versus WBC wavelength, and the sensor signal output measured at C versus RBC wavelength. In this example, the first stage optical sensor provided a signal output of approximately 0.950 V, which (based on the correlation of this value with the concentration of cells in Figure 38A) suggests that the measured fluid has a concentration of approximately 44 cells / µL of WBC or approximately 23 cell concentration / µL of RBC. However, it is not clear only in Figure 39A whether the signal from the first stage sensor should be correlated with this leukocyte concentration or with this red blood cell concentration. Therefore, a second analysis step using one or more ratio-based correlation plots, like the one shown in Figure 39B, can be performed.
[00143] [00143] As in Figure 38B, Figure 39B is an overlay of ratio-based correlation plots for white blood cells
[00144] [00144] In another method to distinguish types of particles, non-homogeneous and homogeneously mixed particles can be distinguished. The optical dispersion / absorption sensor can sample at a frequency high enough (for example, 50 Hz) to detect particles as they flow through the sensors. The homogeneous fluid will exhibit a relatively low variation with each measurement, as shown in Figure 40A.
[00145] [00145] In the case where several discrete particles are passing, the optical absorption / dispersion sensor captures peaks in the measurement output as the particle passes, and a correspondingly high variation in the data can result, as shown in Figure 41A.
[00146] [00146] The sensors described here can also detect single cables (for example, fibrin stringers). As the stringer (see Figure 42B) passes through the dispersion / absorption optical sensor, a large change in the measured value of the dispersion will be generated
[00147] [00147] The integration of the optical scatter / absorption light emitter and detector inside the compartment must include protection against light through an opaque enclosure around the emitter and scatter / absorption sensor optical detectors, in order to exclude ambient light noise and optimize the performance of the dispersion / absorption optical sensor.
[00148] [00148] The optical values of the output voltage of the dispersion / absorption sensor can be converted into Formazina turbidity units (FTU) to be used directly or as a differential. The optical dispersion / absorption of the fresh infused dialysate solution before entering the body can be measured by the sensor and compared to the optical dispersion / absorption of the drainage dialysate solution exiting the body in order to determine a differential or pro - dispersion / optical absorption portion. For example, the levels of dispersion / optical absorption of drained dialysate (usually in the range of 5-100 FTU) can be monitored alone or a proportion without unit can be calculated from the dispersion / optical absorption of drained dialysate for dispersion / optical absorption. of infused dialysate. Alternatively, as the optical dispersion / absorption is usually associated with the high concentration of white blood cells from an infection event, the optical dispersion / absorption values can be converted.
[00149] [00149] Optical dispersion / absorption measurements can also be used in conjunction with other data inputs. In one example, the optical dispersion / absorption system is used in conjunction with a flow sensor. The flow sensor determines the overall volume of the drain fluid. In the case of peritoneal dialysis, the flow sensor can also determine the dialysis residence time. The particle concentration can vary based on the fluid drain volume and / or the waiting cycle time. Therefore, it may be important to normalize the measurements of the optical dispersion / absorption value with the drainage volume and / or the waiting cycle time.
[00150] [00150] The pH of the fluid coming out of the catheters can vary due to the appearance of the patient's acidosis, which is a symptom of the patient related to infections. In one use case, pH sensors can monitor acidosis in patients on peritoneal dialysis. Many dialysate solutions used for peritoneal dialysis have a neutral pH of 7.0. A known bodily response to infection, such as peritonitis, is acidosis, indicated by a pH less than 7.0. The system can use a pH sensor as a method to detect infection. A pH sensor measures the acidity or alkalinity of a solution, measuring the difference in electrical potential. Examples of pH sensors that can be used include, but are not limited to, Analog Devices EVAL-CN0326-PMDZ-ND (Norwood, MA) and Vernier Software and Technology PH-BTA (Beaverton, OR). A pH sensor fluidly connected to the dialysate fluid flow conduit would monitor the pH of the dialysate for the fresh dialysate and the drain dialysate. The calibration of the pH sensor can be carried out with a known pH of the fresh infused dialysate. The values of the sensor's analog output can be converted directly into a pH value or, alternatively, the relative difference between the pH sensor outputs of the fresh dialysate and the drain dialysate can be used. For example, the measurement of the drainage dialysate produces a 3.2V output from a pH sensor and, based on the linear calibration curve, can correspond to a pH of 6.5, which can trigger an alert due to acidity of the drainage dialysate solution. Alternatively, the infused dialysate produces a 3.5V output and the drain dialysate produces a 3.0V output. Based on the design of the sensor in which the output voltage directly correlates with the pH values, it would be deduced that the drainage dialysate is more acidic than the infused dialysate and an alert would be triggered.
[00151] [00151] For patients on peritoneal dialysis, an ascites lactate level above 25 mg / dL may be indicative of active peritonitis. Monitoring lactate using an amperometric sensor, such as the Zimmer and Peacock A-AD-GG-106-L model (Royston, UK), allows for another early diagnosis method for peritonitis. A lactate sensor works by producing a current when a potential is applied between three electrodes. The analysis of the potential and the current produced determines the presence of lactate in the ascites solution. In the system, the lactate sensor electrodes can be immersed or in direct fluid communication within a section of the dialysate fluid flow conduit, as configurations shown in Figures
[00152] [00152] The presence of a high concentration of white blood cells in the liquid coming out of the catheters can be indicative of infections. Higher concentrations of white blood cells can generally be correlated with higher degrees of infection. A portion of these white blood cells diffuse into the dialysate fluid and concentrations greater than approximately 100 cells / ml are highly indicative of peritonitis. The fresh dialysate solution is a dextrose solution with some substrates and, before entering the body, it has no cells. Peritonitis patients will accumulate white blood cells in the peritoneum to fight infection, and the body's dialysate drainage solution will have several of these leukocytes. Therefore, peritonitis can be detected with cell counter sensors that can distinguish between one or more types of leukocyte cells. Commercially available cell counters include Millipore Sigma PHCC40050 (Burlington, MA). The use of a combined flow detection and cell count approach can yield data in the diagnosis of peritonitis, as well as other infections. In the system, a leukocyte cell counting microscope can be connected fluidly to the fluid flow conduit of the dialysis drain fluid, so that the detection surface area is continuously in contact with the drainage dialysate solution. The cell counter sensors contain a micro-fabricated cell detection zone that allows discrimination by cell size and volume to specify the cell type. Leukocyte cells can be counted by the sensor. In combination, the flow sensor can provide data on the volume of fluid measured by the cell counter, in order to normalize the concentration of cells per unit volume of fluid.
[00153] [00153] In another method, cells can be counted by means of optical image and analysis of image data to determine the cell count of leukocytes and / or other cells. A microcamera, such as the Lumenier CP-520 Pico - 520TVL Nano Camera 1460 (Sarasota, FL), available on the market, can be aligned to an optically clear length of the dialysate fluid flow conduit and capture high-resolution images magnification and high resolution. In the system, the camera can be combined with an optical zoom lens next to a clear length of the dialysate fluid conduit, include a light source and have light protected from external light in the camera section, which would affect the captured image . The images would be sent to the database server system and analyzed by a microprocessor. Leukocytes are different in size from other cell types and can be distinguished by means of image analysis with the microprocessor, in order to count the total number in any given image.
[00154] [00154] In addition, the increased presence or activity of white blood cells due to infections can be determined using a proxy known to be associated with white blood cells. An example is leukocyte esterase, which can be determined using a test strip such as Siemens Multistix 10 SG. This test is based on polymorphonuclear leukocyte esterase activity. The high activity of esterase is suggestive of infection through the high activity or concentration of polymorphonuclear leukocytes. Another proxy-based test to determine the onset of infection involves chemiluminescence, which explores phagocytosis. Chemiluminescence binds the luminous signal to the phagocytic activity of cells, which indicates a high concentration of certain types of white blood cells or phagocytic activity. Thus, a high chemiluminescent signal may indicate an increase in the activity or concentration of certain white blood cells.
[00155] [00155] Patients with infections can develop cuff rashes
[00156] [00156] The detection of pressure of permanent catheters can provide valuable information about possible displacements, leaks or blockages of the catheter during the administration of therapies when a fluid is infused or leaves the catheter. For example, pressure measurement during a period when the solution is infused via a pumping system can detect sudden drops in pressure indicative of leakage or a sudden increase in pressure indicative of a blockage in the fluid conduit.
[00157] [00157] When therapies are not being administered, the detection of pressure from the catheter can also provide valuable information for monitoring the patient's vital system. For the central venous lines, for example, the catheters are positioned inside the patient's venous vein, where the extremities are close to the right atrium of the heart. When the system is connected to central venous catheters, pressure measurement can provide vital information to the patient, including central venous pressure, heart rate and respiratory rate.
[00158] [00158] Pressure sensors have a variety of operating mechanisms, including, but not limited to, piezoresistive, capacitive,
[00159] [00159] Figure 45 shows the use of a pressure sensor. Voltage 76 is supplied and grounded by the microcontroller, and sensor 75 has the sensor surface connected fluidly to the fluid conduit 15. The signal outputs from sensor 80 are measured by the microcontroller.
[00160] [00160] In the system, the pressure sensor can be connected fluidly to the catheter, through the patient monitoring device, as in the configuration shown in Figures 16A-16C, in which the pressure sensor can be placed as a of sensors 44 in the conduit fluid. During cycles of infusion and / or drainage of the dialysate solution, changes in pressure may indicate possible complications. For example, high pressure during infusion or drainage suggests possible catheter clogging. During the infusion, if there are sudden drops in pressure, the system can detect a leak in the catheter or connection or herniation of the patient's abdominal cavity.
[00161] [00161] In the case of patients on peritoneal dialysis, in which the catheter is implanted in the peritoneal cavity, the system can monitor the intra-peritoneal pressure. There is a relationship between intraperitoneal pressure (PIP) and some known complications associated with peritoneal dialysis, including hydrothorax, abdominal wall hernias and gastroesophageal reflux. In addition, pressure changes during dialysate infusion cycles can indicate blockages, dislocations or leaks of the catheter that remains. Pressure sensors can be used to detect these complications.
[00162] [00162] During the waiting cycles, or after the completion of a dialysis cycle, the dialysate tube can be disconnected; In this case, the sensor system still remains connected to the diaphragm catheter.
[00163] [00163] The patient's physical movement and position are important indicators of the patient's well-being. The patient's general well-being can be used alone or in conjunction with other patient monitoring data. Accelerometers and / or gyroscopes with one or more axes can measure the patient's movement and position through the force generated from a mass inside the sensor that is displaced by gravity during linear or rotational acceleration. Any type of accelerometer, for example, the NXP p / n MMA8453QT (Eindhoven, Netherlands) and gyroscopes, for example, the InvenSense ITG-3200 (San Jose, CA) can be used. In the system, the accelerometer and / or gyroscope can be incorporated anywhere on the monitoring device
[00164] [00164] The gyroscope data can be used to monitor the patient's position. Gyroscope data can be used to quantify the length of time a patient is lying down. The total daily duration in which the patient is not lying down can be monitored as a metric for the patient's activity. Any significant deviations for the duration can trigger an alert.
[00165] [00165] In another use case, the combination of the gyroscope and the accelerometer can be used to detect a patient's fall event. Falls from patients, whether related to dialysis or not, can trigger an alert. Flow differential sensors
[00166] [00166] A flow sensor can track the flow and direction of a fluid or gas along a channel. In the system, a flow sensor can be connected fluidly to the catheter, where the cross-sectional area of the conduit is constant over the length in which the flow sensor is contained. The speed at which the fluid is infused and exits is tracked by the flow meter. Given the cross-sectional area of the fixed channel, volumetric data can also be derived.
[00167] [00167] In the case of using flow sensors to monitor patients on peritoneal dialysis, the flow meter would operate for the entire duration of the infusion and drainage cycle. The total flow volume of the infusion solution and drainage solution can be quantified. The volume of dialysate infusion (Vi) and the volume of dialysate residues (Vw) can be used to determine a Vw / Vi ratio. The Vw / Vi ratios are indicative of the peritoneum permeability to water mainly, but also of other dialysis solutes from ultrafiltration. The Vw / Vi ratio normally stabilizes in the first 6 weeks of a patient's peritoneal dialysis treatment. Therefore, the Vw / Vi ratio can be used as a metric to determine the effectiveness of dialysis.
[00168] [00168] The flow sensor can also be used to monitor the patient's compliance guarantee. When coupled fluidly to the catheter, the flow sensor can use flow directionality data to determine whether the flow is infusing the drain. In the system, the flow meter can be coupled with the time data. When the flow sensor detects flow velocity other than zero and flow directionality in the infusion direction, the microprocessor can register an infusion start time. When the flow sensor detects that the flow speed is zero after the initial infusion, the microprocessor can register a waiting start time. When the flow sensor detects a flow velocity other than zero and the flow directionality is in the direction of the drain, the microprocessor can register a time for the drain to start. In this way, all times of infusion, permanence and drainage can be recorded for each cycle of various therapies to determine the patient's compliance with the prescribed therapy.
[00169] [00169] The flow sensor (s) can (can) also be used to detect obstructions in the catheter. When using the system with peritoneal dialysis, for CAPD and even some stages of the CCPD cycles, the flow is infused or drained by means of hydrostatic fluid pressure differentials. During the dialysate infusion, a support keeps the dialysate fluid at an elevation above the patient, which creates a relatively constant positive pressure gradient and the dialysate fluid flows to the patient. During the dialysate drainage, the drainage tube is positioned close to or on the ground at an elevation below the patient, which creates a relatively negative pressure gradient and the dialysate fluid flows out of the patient. Since pressure gradients during each of these cycles are reasonably consistent (depending on the patient's position), average fluid flow rates must be reasonably consistent cycle by cycle. However, decreasing fluid flow between cycles would suggest an obstruction somewhere in the fluid flow line. Increased fluid flow would suggest possible leakage from the system. To determine any condition, the average flow can be measured and recorded for each cycle, or simply the total duration of each cycle can be measured and recorded.
[00170] [00170] There are several flow sensor mechanisms, including, but not limited to, mechanical flow meters, pressure based meters, Doppler flow meters, optical flow meters, open channel flow meters, ultrasonic flow meters and electromagnetic flow meters. For example, a compact ultrasonic flow meter, such as Parker CFM1 flow meter (Parker Hannifin; Cleveland, OH), can be used. In another example, the flow sensor is a microfluidic chip with a microsensor. This sensor allows the measurement of liquid flow within an economical flat glass substrate. The digital microsensor chip provides complete signal processing functionality for a fully calibrated, temperature compensated and linearized digital output. In addition, this sensor provides real-time detection of faults such as clogging, air bubbles or leaks. This can provide data on catheter leakage, line clogging or even a possible diagnosis of hernia in the patient. Sensors for solute measurement
[00171] [00171] In the case of dialysis patients, the analyte measurements of the solutions indicate the effectiveness of the dialysis treatment. For example,
[00172] [00172] Urea is a colorless crystalline compound that is the main product of nitrogen degradation of protein metabolism in mammals and is excreted in the urine. As the kidneys help human beings to decompose the main toxins and nutrients in our body, patients with acute to chronic renal failure need dialysis. The success or adequacy of dialysis treatment can be quantified by tracking urine clearance. The urea concentrations should decrease in the patient and increase the dialysate solution. Common techniques for measuring small solute clearance include urea clearance normalized by total body water. A urea sensor measures the concentration of urea in a fluid sample. Using an electrochemical sensor, urea levels can be tracked with relatively high specificity and resolution. A urea sensor is usually constructed by coupling a hydrophilic polymeric membrane containing immobilized urease to a commercial ammonia electrode, which in turn consists of a pH glass electrode covered by an internal electrolyte and a gas-permeable hydrophobic membrane. Allowing this sensor to detect the dialysate solution entering urea, in which it should not exist, and comparing it with the drained dialysate solution exiting the peritoneum, creates a strong metric to determine the effectiveness of dialysis. In order to better use this sensor, the high specificity would require that a small reserve of dialysate solution be slowed by a reserve conduit to obtain the best readings from the urea concentration sensors. In the system, the measuring surface of the urea sensor would be fluidly connected to the infusion dialysate solution and the drainage dialysate solution.
[00173] [00173] Another technique used to evaluate the effectiveness of dialysis is the clearance of peritoneal creatinine (CCr). Creatinine clearance is used to estimate the general clearance of small solutes during dialysis. The enzyme-catalyzed polymer transformation with electrochemical detection of AC impedance is used for the measurement of creatinine in serum samples. Similar to the design of a urea sensor, urease is replaced by creatinine deiminase. The poly (methyl vinyl ether) / maleic anhydride is printed on canvas on carbon electrodes printed on interdigitated canvas and the electrodes are coated with absorbent pads containing the relevant enzyme. The application of serum samples with creatinine results in rapid polymer transformation and changes resulting in the capacitance of electrodes coated with polymer that depend on the concentration of the analyte. As a result, a creatinine sensor is created. The same system can be used for the detection of urea or other serum. This sensor depends on a change in pH, catalyzing the reaction and, therefore, can be used for a pH measurement and also for the detection of infections. In the system, the measuring surface of the creatine sensor would be fluidly connected to the infused dialysate solution and the drainage dialysate solution.
[00174] [00174] The effectiveness of dialysis can also be monitored via the concentration of glucose in the dialysate solution. Dextrose in dialysate solution is equivalent to the D, D-glucose isomer. Common dextrose concentrations in the dialysate include levels of 1.5%, 2.5% and 4.5%. During PD cycles, the peritoneum permeability allows for some diffusion of dextrose in the patient. Therefore, the measurement of glucose concentration can correlate with the peritoneal permeability, which also represents the permeability of other solutes. In the system, the measuring surface of the glucose sensor would reside in a fluid conduit connected to the infusion dialysate solution and to the
[00175] [00175] In addition to monitoring the peritoneum's permeability to solutes, glucose measurements can also help prevent hyper or hypoglycemia during dialysis treatment. During dialysis, a portion of dextrose is also absorbed in the tissue of the abdominal cavity and a large number of dialysis patients are also diabetic. Therefore, it would be desirable to monitor the reduction in the dextrose content in the post-treatment with dialysate.
[00176] [00176] There are numerous glucose monitoring technologies commonly used to control diabetes. Examples of glucose measurement sensors that can be used include the Zimmer & Peacock ZP Glucose sensor (Napa, CA). In another type of sensor, the combination of micro-dialysis with infrared spectrometry provides an assay without calibration for accurate continuous glucose monitoring, since the reference spectra of the dialysate components can be allocated a priori. This sensor directly measures glucose concentrations by amperometric detection of hydrogen peroxide.
[00177] [00177] In another variation, the solute measurement sensor (s) can also be used to determine if the correct dialysate solution is being infused, as a method of monitoring patient compliance. Dialysate solutions typically differ in the concentration of dextrose. To monitor the concentration of dialysate,
[00178] [00178] In some variations, a coupling system can be used in conjunction with the patient monitoring device. The docking system (for example, docking station) can perform several functions, including cleaning, calibration, loading, data processing and periodic data transmission. The docking system itself can be connected to an outlet power source (for example, wall outlet, power supplied via a USB connection, etc.) and / or may have an internal battery that can be charged and used without thread. In some variations, the plug-in system may have a safety interlock feature, so that it is electronically functional only when connected to a valid power source (for example, connected to a power source in a wall outlet) work, have a sufficiently charged battery, etc.) In a variation, the patient monitoring device is used in conjunction with a docking system to periodically clean, load, sterilize and calibrate the device. Figures 47A represent docking station 94 and Figure 47B represents docking station 94 mounted with a patient monitoring device 4710. Dock 94 may include, for example, two fluid port connectors 95, 96 that connect to the fluid conduit inlet and outlet of the patient monitoring device, respectively. Electrodes 97 at docking station 94 can be configured to match the electrical connectors on the 4710 patient monitoring device for charging and / or data transmission. The cleaning and calibration liquid can fill a set of fluid chambers through a fluid port 99.
[00179] [00179] Figures 48A-48D illustrate another variation of a station
[00180] [00180] In some variations, the circulating fluid can be pumped through the fluid conduit of the anchorage 98, the entrance port (95), the patient monitoring device, the exit port (96) and in a separate compartment (eg, waste chamber) (not shown) within the docking station to prevent mixing with the new fluid (eg, cleaning fluid) stored in the fluid chambers. Additionally or alternatively, the circulating fluid can pass through a set of filters before
[00181] [00181] The calibration fluid may contain a fluid with predetermined optical dispersion / absorption characteristics, temperature and conductivity. In addition, the calibration fluid can be pumped through a patient monitoring device at a predetermined flow rate. For example, an isotonic fluid, such as a phosphate buffer solution, can be heated to approximately 37.0 ° C in a calibration fluid chamber 102 and then pumped through a patient monitoring device at a constant flow rate. 200 ml / min through the third pump 106c. A phosphate buffered solution is optically clear and has a known conductivity value of approximately 13,000 µS / cm. The patient monitoring device can calibrate its sensors based on the known characteristics of the calibration fluid. Thus, the patient monitoring device, in this example, can calibrate its set of optical sensors for dispersion / absorption, temperature, conductivity and flow when coupled to the docking station. In some variations, the calibration fluid, once pumped by the patient monitoring device, can be pumped back into a separate compartment (eg, waste chamber) to avoid mixing with the new calibration fluid and not pumped. In another variation, the calibration fluid can be pumped through a filter and mixed with the rest of the calibration fluid in the calibration fluid chamber 102.
[00182] [00182] In some variations, the cleaning and calibration fluid can be recirculated in a closed circuit system. In the anchorage system shown in Figures 47A and 47B, the inlet port 95 and the outlet port 96 allow the fluid to recirculate continuously for a predetermined period. In some variations, the fluid can be inlet and outlet from only one of the inlet 95 and outlet 96 ports in one or more cycles, thus allowing a predetermined volume of fluid to wash a fluid conduit from a monitoring device. patient treatment in an alternate way for a predetermined period. In some of these variations, the fluid can be recirculated. In some variations, a cleaning cycle may include a predetermined immersion time.
[00183] [00183] In some variations, a cleaning fluid may comprise chemicals configured to remove sources of scale. For example, one or more of nitric acid and hydrochloric acid can be used as a cleaning fluid to remove proteins. In addition or alternatively, alkaline cleaning solutions (eg Hellmanex® III, Mullheim, Germany) can be used to effectively remove fats and proteins. Subsequent cleaning with alcohols (eg, ethanol, isopropanol) or acetone can be used to remove oils and water-based contaminants. Deionized water can also effectively remove contaminants from the water base. A valve can be configured to allow air to flush and dry the docking station when fluid circulation is complete.
[00184] [00184] In some variations, the coupling system may also comprise a set of sensors configured to monitor the fluid flow and confirm the cleaning. For example, a set of optical sensors located in the fluid chambers 100, 101, 102 can measure an amount of fluid in the respective fluid chambers 100, 101, 102 and be used to indicate when the fluid needs to be replaced. A set of sensors from the docking station can also measure one or more of optical dispersion / absorption, temperature, conductivity and / or fluid flow driven by a pump 106a, 106b, 106c.
[00185] [00185] For device calibration, a single program can perform a calibration of all sensors on the device or exclusive programs can be used for calibration of individual sensors or sets of sensors. Calibration can be performed by user selection or remote selection by the healthcare professional or the device manufacturer. Calibration can also be performed automatically every time the device is docked, based on a defined frequency or when performance tests determine the need to calibrate. During calibration, the device can be mechanically locked at the station until the calibration process is completed. The calibration results can be sent to the healthcare professional or device manufacturer for quality control and monitoring of device performance.
[00186] [00186] The interfaces between the device and the station may vary and may include a magnetic fixation, using locks (for example, axle lock, chassis lock, liner lock, rear lock, Luer lock), plugs, screws or nuts that hold the device on the dock. The release feature can involve pressing an electrical device into the device, such as a button or locking mechanism, but it can also involve many other physical or electronic variations.
[00187] [00187] The cleaning of the fluid channel can increase the longevity of the components, reducing or eliminating the presence of biofilms and other fouling mechanisms. In addition, cleaning can be used to remove residual fluid from samples that have been collected. The properties of the fluid channel materials can dictate the dock cleaning mechanism. For example, materials with high hardness and resistance to solvents, such as quartz, borosilicate or sapphire glass, can be used for abrasive and / or solvent cleaning. Other materials with high lubrication and resistance to solvents, such as fluoropolymers (FEP, PTFE), can be used for cleaning by washing with solvents and / or light abrasion. Alternatively, or in conjunction with other cleaning agents, a UV light can be used to sterilize the device's fluid channel.
[00188] [00188] In some variations, a docking station can attach to a patient monitoring device without attaching to the docking station. For example, a docking station entrance door can be flexibly extended to connect to a patient monitoring device without removing or disconnecting the patient monitoring device from its own connections (for example, example, hooked onto a toilet seat). Figure 48B illustrates the docking station 94 comprising a flexible tube 108 configured to transmit fluid and electric current. Figure 48C illustrates a detailed perspective view of one end of flexible tube 108. The end of flexible tube 108 may comprise a set of electrical connectors 109a, 109b (e.g., electrical contact points) and a fluid lumen
[00189] [00189] To charge the patient monitoring device, the patient monitoring device can be placed on the station and the electrodes exposed on the docking station with exposed connectors 45 on the patient monitoring device. Alternatively, wireless charging can be used. Charge cycles, including fast charging or full charging, can be implemented. In some variations, the docking station may comprise a battery charging port configured to charge a battery from the patient monitoring device. For example, a removable battery from the patient monitoring device can be attached to a battery charging port to charge the battery while another battery is used in the patient monitoring device.
[00190] [00190] The docking station can also transmit data from the patient's monitoring device. Data transmission can be the singular method of data transmission to the system, or a redundant method of data transmission with the transmission of data from the patient's monitoring device in the event of communication failure in one or the other systems . Thus, the transmission of data to the database can be performed by the sensor device and / or by the dock. The sensor device can transmit data through a wireless cellular LTE module, for example, but connectivity can sometimes be limited. Alternatively, the dock can transmit data from a wired or wireless Ethernet connection via a modem, which can be used when the LTE signal is limited to the patient's monitoring device.
[00191] [00191] The anchoring sensor can also store sensor data for each patient continuously. Data can be stored in addition to or in place of data storage in the cloud. The data can be stored locally on an SD card or other memory device, for example, and patients can transport the SD card to the provider during frequent visits to monitor the data. In some variations, the coupling system can authenticate the patient monitoring device attached to it before performing one or more functions, such as cleaning, calibration, data transfer and the like. Sampling collection
[00192] [00192] Additional actions can also be requested by the system when certain limit action limits are detected. In one example, there may be a sterile collection container loaded at all times in the fluid sample collection device that can be sent to a laboratory for analysis. Upon detecting a potential complication, a sample of the patient's fluid can be collected in the container. An example of the mechanism for collecting the sample is to have a sterile needle connected hydraulically to the sample container, through the pipe into which the fluid is flowing to collect the sample. The needle can also be oriented in the opposite way, so that the needle goes through the lid of the collection container, allowing the fluid to be collected while maintaining a lid in the collection container. Alternatively, a pressure-based valve can apply positive or negative pressure to a fluid channel connected to the main pipeline and the collection vessel to open the channel until sufficient sample fluid has been collected. In a variation, shown in Figure 54, the channel for the sample collection container 110 remains closed due to the fact that the two channel walls are in contact with each other and prevent flow to the collection container. The walls can be made of a malleable material, such as silicone, which can have a negative pressure (for example, suction) applied to it in vacuoles 107 next to the channel, which open the channel for collecting fluid 108 until the pressure is no longer applied. As a last example, there may be a manually or automatically controlled valve that can divert the flow to the sample collection container.
[00193] [00193] Figure 55 illustrates a method of collecting fluid sample. When fluid 108 is detected by the sensors to have a complication and require sampling, a valve 109 in the fluid channel can open from a closed state, as in 55a, to an open state, as in 55b, which allows the fluid to flow to the sample collection container 110. When a sufficient amount of sample is collected, shown at 55c, the valve closes. By automatically collecting fluid, the system can determine when the sample collection container is full by weighing the container or using an optical device to determine when the liquid has reached a limit level in the container.
[00194] [00194] The container can always be sealed, as in the case where a needle pierces the lid of the container to collect the sample. Otherwise, the container can be sealed by methods, including, but not limited to, a screw cap that is screwed automatically after sampling, a cap that fits in the locking position or a snap fit. a lid on the container. In addition, the container can be sealed with a tamper-proof seal to ensure sample fidelity before further testing and labeling.
[00195] [00195] In another example, the device stores and delivers therapeutic agents. When an action limit is detected for a potential complication, such as infection or catheter block, the device infuses the appropriate therapeutic agent, such as an antibiotic to treat the infection or a thrombolytic to resolve the catheter block. Figures 57A-57C illustrate an example configuration of a therapeutic agent that is stored within the device. Initially, shown in Figure 57A, therapeutic agent 117 is blocked in the device. When the sensors indicate a complication that requires the therapeutic agent, a fluid sample is collected in a laboratory test container and a notification 111 is made when the collection is complete, unlocking compartment 118 holding the therapeutic agent, as shown in Figure 57B. Next, Figure 57C shows the patient able to access the agent for immediate use after detecting the corresponding complication. Methods of detecting patient infection
[00196] [00196] In a variation of the devices described above, the system can be used to monitor the patient's infection by the drainage fluid exiting the catheter during each drainage therapy cycle. The patient first assembles the disposable and reusable halves of the patient monitoring device, releases the fluid conduit in the patient monitoring device with sterile saline, connects the patient monitoring device connector to the catheter and applies the patch to the skin. The patient starts the patient monitoring device by turning on the patient's monitoring device, then turns on the tablet device, opens the user interface application on the tablet device, checks LTE connectivity, logs in to the patient interface application user on the tablet device to establish communication with the database server system and establish the Bluetooth connection between the user interface application on the tablet device and the patient's monitoring device by entering a unique identification code for the device monitoring system in the user interface. The database server system authenticates the patient's login credentials and the identification code of the patient's monitoring device and sends the authentication confirmation to the user interface system, along with an encryption key. for use in communication requests. When turned on, the microprocessor of the patient monitoring device initializes the operating system and firmware and runs through the readings of each of the sensors - inline fluid thermistor, optical absorption / dispersion sensor, flow sensor, sensor pressure sensor and pH sensor, skin surface color sensor and accelerometer / gyroscope position sensor mounted on PCB. The patient monitoring device confirms the output signals from the sensor and transmits confirmation of sensor operation through the user interface system to the database server. After the system is booted, the system enters the calibration mode and notifies you that the user calibration mode is being initiated by the user interface system.
[00197] [00197] During operation in the drain infection detection system calibration mode, the system first determines the baseline readings of the flow sensors, pressure sensor and skin surface color. The patient monitoring device records readings from each of these sensors for a static duration of 30 seconds at a sample rate of 5 to 100 Hz that is encrypted, temporarily stored in the memory chip of the patient monitoring device and then transmitted by the user interface system to the server system database.
[00198] [00198] During the use of the monitoring system, users can use the docking station for loading, cleaning, sterilization and calibration. At predetermined intervals, such as daily after the completion of your nightly peritoneal dialysis cycle, a user (eg, patient) can connect the patient monitoring device to the docking station. In some variations, the docking station can be placed at a fixed location, connected to an electrical outlet and / or operate on battery power. A user can place the patient monitoring device in a cradle of the docking station, as shown in Figure 47B. In some variations, the user can connect the two fluid conduit ends of the patient monitoring device to the corresponding inlet and outlet ports on the docking station. Once packed, the docking station can detect electrical contact with the patient monitoring device and begin charging the patient monitoring device and cleaning the fluid conduit using fluid stored within the docking station. In some variations, once a cleaning fluid is pumped through the patient monitoring device, the patient monitoring device can be recalibrated by the docking station. For example, the calibration fluid can be pumped through the patient monitoring device.
[00199] [00199] The patient monitoring device can also communicate data to the docking station through, for example, electrical contacts. In some variations, the docking system can be connected to a home wireless network to transfer data that the patient monitoring device cannot transmit due to, for example, low LTE wireless connectivity. A set of indicator lights arranged on an external surface of the system and / or coupling device can indicate when the loading, cleaning, sterilization, calibration and data cycles are complete.
[00200] [00200] During the monitoring operation of the drain infection detection system, when there is no fluid drainage through the conduit, the flow sensor is sampled at a frequency of 1 Hz in a continuous cycle, the gyroscope sample and the accelerometer at a frequency of 5 Hz in a continuous duty cycle, the pressure sensor samples at a frequency of 20 Hz for a period of 30 seconds once every four hours, the color sensor of the surface of the skin collects samples at a frequency of 5 Hz for a period of 10 seconds once every four hours and the microprocessor operates in a low power consumption mode, while no other sensor measures data. During this period of low power operation, data is temporarily stored on the memory chip of the patient monitoring device and is not transmitted. The data is transmitted in its entirety when the system enters active measurement mode.
[00201] [00201] During the monitoring operation of the drain infection detection system, when the fluid drain starts, the flow sensors detect the fluid flow and the microprocessor activates the system in the active measurement mode . The microcontroller controls all sensors to record measurements during the active measurement mode, with varying duty cycles. The flow sensors measure the fluid flow in a continuous duty cycle and increase to a sampling rate of 10 Hz. The thermistor measures the fluid temperature at a frequency of 5 Hz for a period of 10 seconds at the beginning of the drain and for 2 seconds at the end of the drain, when the fluid flow drops to zero. The dispersion / optical absorption sensor measures the dispersion / optical absorption of the fluid at a frequency of 5 Hz for 30 seconds at the beginning of the drain and for 10 seconds at the end of the drain when the fluid flow drops to zero. The pH sensor measures the pH level of the fluid at a frequency of 5 Hz for 5 seconds at the beginning of the drain and for 30 seconds at the end of the drain when the fluid flow drops to zero. During the active measurement mode, at the frequency of once every 5 minutes, and also at the conclusion of the drain cycle when the fluid flow drops to zero, the data is encrypted, temporarily stored on the memory chip of the device. monitoring of the patient
[00202] [00202] In the variations in which the test strips are used with the systems and devices described here, actions initiated by the patient, automated or a combination of the two can occur. For example, test strips can be positioned in a standard inactive position (for example, embedded in the test strip cartridge). However, after draining the patient's fluid, the patient can place the test strips in an active position in the fluid channel (for example, pressing a button to advance the test strips from the inactive state and back to the state internal active) of the fluid conduit) to start the measurement. In some of these variations, when the test strips are used in conjunction with other sensors, one or more sensors (for example, pressure sensor) can monitor one or more characteristics of the fluid in the fluid channel. After the recognition of the fluid in the channel, the test strips can be automatically advanced from an inactive position (for example, embedded in the test strip cartridge) to an active position to measure the characteristics of the fluid. After fluid recognition, a notification can be sent to a patient's mobile device, which can ask the patient to confirm that fluid is flowing through the device before pushing the test strip into the fluid conduit, limiting thus the potential for false measurements, such as when the fluid has not reached a steady state or desired state for the measurement.
[00203] [00203] During the monitoring operation of the drainage infection detection system, the patient receives push notifications from the user interface system for additional data entry. At the end of each day, the user interface asks the patient to enter their general feeling of well-being rated as 1-5 (5 = very good, 4 = well, 3 = medium, 2 = unwell, 1 = very bad) and pain level around the catheter exit site classified as 0-3 (0 = no pain, 2 = mild pain, 3 = moderate pain, 4 = severe pain). After data is entered, it is transmitted to the database server system, which processes the data to monitor patient infection by calculating average patient ratings over time and identifying deviations from average patient values or when any single score for well-being is 1, or when any individual score for pain is 3 or 4.
[00204] [00204] During the monitoring operation of the drain infection detection system, pressure data is processed through the database server processor to monitor vital patient information (for example, respiratory rate, heart rate). The data from the accelerometer / gyroscope position sensor are processed by the database server processor to monitor the patient's activity, determine metrics for the total number of steps the patient performs daily and the total number of minutes per day in that the patient is lying down. The data from the skin surface color sensor, positioned next to the catheter outlet site, are processed by the database server processor to monitor the onset of the rash by the differential skin level of redness. baseline measurements. Fluid flow sensor data is processed via the database server processor to monitor the patient's fluid drain volumes daily or per cycle,
[00205] [00205] During the monitoring operation of the drainage infection detection system, the provider inserts patient data into the user interface system. The professional informs the laboratory results of the patient's blood tests, urine tests and vital system measurements taken during visits to the clinic. The supplier also inserts notes of observations of visits to the clinic, yes, it inserts in a checkbox when an infection is diagnosed, together with the name of the pathogen and the date of diagnosis, but in a checkbox. for other complications, along with the name of the complication and the date of diagnosis. After the data is entered, it is transmitted to the database server system. The laboratory test, vital test data and observation notes are analyzed and stored. When infection or complication data is recorded as "yes", the database server system performs a regression analysis on all patient data 4 weeks before the date of diagnosis and 1 week after diagnosis . The bank server system
[00206] [00206] During the monitoring operation of the drainage infection detection system, the processed data are presented in the patient and provider's user interface system. The user logs in to the user interface system using login credentials or biometric input, which is communicated to the database server system. The database server system authenticates the patient's login credentials or biometric entry and sends confirmation of authentication to the user interface system, along with an encryption key for use in communication requests. A graphical user interface presents the data processed in the form of data graphs over time, highlighted data points that differ from the average historical values (that is, greater than two standard deviations from the mean), highlighted data points that diverge from accepted physiological norms (that is, at temperatures above 99 ° F) or the diagnosis of the system of infections or complications. For the professional
[00207] [00207] During the monitoring operation of the drainage infection detection system, the database server system generates infection alerts directly, or through third party services, to the patient and provider in the form of messages text, push notifications and / or automated phone calls. The database server system determines alert levels based on several factors. For the patient's sense of well-being and pain at the catheter exit site, the database system calculates a moving average and standard deviation and generates an alert when any individual well-being rating falls by two standard deviations from the mean value , any pain classification at the catheter exit site exceeds two standard deviations from the mean value, or when any single classification for well-being is 1 or when any single classification for pain is 4. For temperature readings, the The database system calculates a moving average and a standard deviation and generates alerts based on any temperature readings that exceed the average by a standard deviation. For the patient's activity level, the database system calculates the moving average and standard deviation and generates alerts based on step counts or vertical standing time falling below 2 standard deviations from the mean for 2 straight days. The patient's activity level and vital pressure sensor-based patient data are also used to calculate a patient's daily wellness score based on a scale of 1 or 2. When any level of patient activity or data patient's vitals based on pressure sensor drops beyond a standard deviation from the patient's average, a wellness score of 1 is assigned to the patient. Otherwise, the patient will receive a score of 2. For the differential values of dispersion / optical absorption of pH, pH and redness of the skin surface color, the database server system calculates the moving average and the standard deviation. When the patient's wellness score is 1, alerts are generated when any optical fluid dispersion / absorption value exceeds a standard deviation from the mean or any pH value falls below a standard deviation from the mean or any value differs - redness ratio of the skin surface color exceeds a standard deviation from the mean. When the patient's wellness score is 2, alerts are generated when any optical fluid dispersion / absorption value exceeds two standard deviations from the mean or any pH value falls below two standard deviations from the mean or any differential value of redness of the skin surface color exceeds two standard deviations from the mean. In addition, the system generates alerts based on diagnoses detected by the system through algorithms based on the regression analysis of results.
[00208] [00208] In another variation, the system monitors the infection in catheter systems in which the liquid is only infused. In this case, the system monitors the patient with a thermistor mounted on the skin surface, the color sensor of the skin surface and the accelerometer / gyroscope position sensor mounted on PCB.
[00209] [00209] In another variation in which a device is used to monitor peritoneal dialysis, the system monitors the infection in patients on peritoneal dialysis, where dialysate fluid is infused and drained from the patient. In this case, the system comprises the same sensors previously described for drainage catheters, such as inline fluid thermistor, optical dispersion / absorption sensor, flow sensor, pressure sensor and pH sensor, color sensor of the surface of the skin and accelerometer mounted on PCB / gyroscope position sensor. However, instead of calibrating the optical dispersion / absorption sensor and the pH sensor, the system measures the optical dispersion / absorption and the pH of the fresh dialysate fluid during infusion cycles, in addition to the measures taken in the dialysate solution waste in drainage cycles. By measuring the optical dispersion / absorption and pH of fresh dialysate and residual dialysate, an optical dispersion / absorption differential and pH differential can be calculated for each cycle. The use of differentials is desirable in conditions where the sensor values fluctuate over time due to the degradation of the performance of the sensor mechanism or the optical quality of the interface between the sensor and the fluid. In addition, the system can use flow volume measurements to monitor the patient's compliance with prescribed therapy and monitor volume differentials calculated as a proportion of the volume of fluid flow drained divided by the volume volume of infused fluid for each cycle, which can be used to assess the effectiveness of dialysis. Sensor calibration methods
[00210] [00210] Several types of sensors require calibration. Optical sensors, in particular, are sensitive to changes in the optical quality of materials between the sensor and the test medium, including the optical sensor housing. Therefore, it is important to have the means to frequently calibrate the sensors to obtain optimal accuracy. In the variation represented in Figure 13, in which the fresh infused solution and the drain solution pass through the same fluid flow conduit and sensor network, there is an opportunity for the sensors to calibrate with each cycle of the fresh infused solution, assuming that the fresh infused solution is optically constant.
[00211] [00211] Figure 49 represents a process for calibrating an optical sensor. The flow sensor first provides the flow direction reading to the microprocessor, indicating whether a new solution or drain solution is passing through the sensor network. When a new solution is infused, the microprocessor enters the calibration mode in which the sensor output is reset to a constant, known value for the infused solution. When the residual dialysate solution is draining, the microprocessor enters the measurement mode of the sensor and records the output reading. A similar process can be used to calibrate the pH sensor when the pH value of the fresh infused solution is known.
[00212] [00212] In some variations, the calibration of an optical sensor can be performed at one or more predetermined intervals, such as replacing a fluid conduit, engaging a fluid conduit with a durable component, at device startup, detecting a clinical event and the like. For example, the 6830 fluid conduit can be disposable and replaced frequently. Disposable components can generally have dimensionally variable tolerances, as well as variations in material, surface finish, cleanliness and other manufacturing variations. Thus, recalibrating a 6830 fluid conduit at one or more predetermined intervals can improve the accuracy of optical sensor measurements. In some variations, a switch can be triggered when fluid conduit 6830 is engaged in housing 6802 to signal recalibration due to, for example, replacement of fluid conduit 6830. Additional or alternatively, fluid conduit 6830 it can comprise an identifier such as an RFID tag or unique identification chip used to identify the 6830 fluid conduit as a replacement disposable component. In some variations, after checking and / or authenticating a new 6830 fluid conduit, the patient monitoring device can perform one or more optical measurements to establish a baseline for calibration.
[00213] [00213] In some variations, calibration can be performed for a patient monitoring device connected only to the fluid drainage conduit. The device, during maintenance periods (that is, docking at a station for refilling, cleaning and calibration), can have a calibration fluid with a predetermined set (for example, known) of parameters passed in which optical sensors and / or pH sensors, and / or conductivity sensors can be calibrated.
[00214] [00214] In other variations, the calibration can also be performed with the active participation of the patient through the patient's user interface. In one example, the accelerometer and gyroscope are calibrated when the hardware sensor system is connected to the patient. The application's user interface system on the patient's tablet can request the patient to lie down, sit down and get up. As the patient is repositioned in each state, the sensors are calibrated accordingly.
[00215] [00215] Various sensor data can also be used simultaneously to accurately determine the monitoring metrics. For example, pH and conductivity measurements can be affected by temperature. When using a calibration function indicating the relationship of the conductivity and pH value to the temperature, the temperature input data can be used to convert the values of the conductivity sensor and the pH sensor into an accurate conductivity output. and the pH of the fluid. Sensor measurement methods
[00216] [00216] The sensors can measure in absolute or relative terms. In the example of temperature sensors, pressure sensors and flow sensors, an absolute measurement may be desirable to accurately determine the patient's temperature and flow volume by infusing or draining. Alternatively, in case the system is measuring optical dispersion / absorption, the conductivity or the pH of the drainage fluid, the values for the fresh infusion fluid may be sufficient.
[00217] [00217] The accuracy of the sensors when measuring in absolute terms can be limited and the design of these sensors can result in excessively complex, large and expensive systems. Thus, it is desirable to have sensors that can measure in relative terms. In the variation described (shown in Figure 50), in which the new solution and the residual solution pass through the same network of conduits and sensors, relative differences between the sensor values can be used. An optical dispersion / absorption sensor, in an example using infrared emitters that detect light scattering by the detector, can compare the light scattering of the fresh TUi dialysate solution with the residual TUw dialysate solution to determine a rate of optical dispersion / absorption = TUw / TUi. The TUw / TUi values can then be monitored over time to establish baseline values and determine deviations from the baseline that can be indicative of patient infection.
[00218] [00218] In another example, the conductivity of the dialysate solution can be measured by a pair of spaced electrodes, passing a constant current between the electrodes and measuring an output voltage. The difference between the tension of the fresh dialysate solution Vi and the residual dialysate solution Vw can be measured as Vw-Vi and monitored over time to establish baseline values and determine deviations from the baseline. basis that can be indicative of the patient's infection. Integrated sensor network
[00219] [00219] The sensors can accumulate data individually for the indicated monitoring purposes, and the sensors can also work in combination with other sensors. In the example shown in Figure 50, the firmware algorithms in the microcontroller determine the directional information provided by the flow sensor, which work in combination with any of the other sensors to provide contextual information about whether the test fluid is a solution. new inlet or drain solution. In addition, flow information from the flow sensor can be used in combination with the cell counter sensors to normalize the cell count data.
[00220] [00220] In another example, the sensors can work together to limit energy consumption. For example, the flow sensor can work in continuous operation to determine if there is any flow entering or leaving the system. When the flow is interrupted, the process can keep some or all of the other sensors in the off or off mode or with a reduced power state. When the flow is started, the sensors can be turned on, depending on the state of the flow.
[00221] [00221] In another example, the sensors can work together to determine alternative states. A procedure for managing the catheter includes washing a small volume of heparin or another thrombolytic solution through the catheter between infusion cycles to prevent catheter clogging. The injection of heparin through the sensor network can be interpreted as a dialysis solution infused in the absence of steps to detect this state. Figure 50 shows an exemplary process that uses the flow sensor and the conductivity sensor to detect this state. Heparin has a high conductivity value that is usually higher than the fresh infusion solution. When the flow sensor detects that the fluid is infusing, conductivity can be measured. If the conductivity values are higher than the infused therapeutic solution, a step of detecting an alternative solution being infused can be performed and the volume of the measured flow can be excluded or signaled to exclude the flow metrics. When the conductivity values correspond to the infused therapeutic solution, the microprocessor can start recording the flow volumes.
[00222] [00222] Different sensors can also have some redundancy and correlation. The urea content, for example, which can be measured as part of the effectiveness of ultrafiltration, is correlated to pH, which can be measured as part of detecting complications from infection. Due to the potential use of pH sensors to monitor infection, it is important that the system includes redundant detection mechanisms for effective ultrafiltration and infection detection and steps to identify interactions. For example, if the patient's ultrafiltration effectiveness changes, the urea sensor would include a higher content of detected urea. The pH sensor, during this period, would show a decrease in pH levels, even if the patient does not have an infection. During this period, the firmware algorithm can delete the pH data for infection monitoring. In another example, flow and pressure will have a high correlation in the case of a blocked catheter.
[00223] [00223] The sensor hardware can also be used for various purposes. For example, the conductors used for measuring the thermocouple temperature can also be used in combination with a separate conductor for conductivity or impedance measurements. When the system is measuring the temperature, current flows only between the thermocouple terminals. When the system is measuring conductivity, current flows between the thermocouple wires and the separate conductivity electrode.
[00224] [00224] Likewise, optical sensors can use image analysis to detect optical dispersion / absorption and cell counting. In this example, optical dispersion / absorption can be measured from an optical image, which is analyzed by the microprocessor on the patient's monitoring device or by a microprocessor on the database server system. The image can be analyzed for general optical dispersion / absorption via color gradient, gray scale gradient or alternative methods. The same image can also be analyzed for counting individual cells.
[00225] [00225] The sensor data can also be used together to provide contextual data. For example, the flow volume can be determined from measurements using the flow sensor. Flow sensor data and timestamp data can be used to determine the total residence time of the fluid exchanged by patients on peritoneal dialysis. The flow volume and waiting time can be used to normalize the data generated by conductivity, urea, glucose and / or other sensors for the concentration of the analyte. Likewise, the flow volume and waiting time can be used to normalize the data generated by the optical fluid dispersion / absorption sensor or cell counters. Sensor sample rate
[00226] [00226] Each sensor can operate at different sampling frequencies and service cycles. In order to conserve the system's general energy use, it is desirable that each sensor operate only as needed. A primary sensor such as the flow sensor can operate in continuous operation, but operates at a relatively low duty cycle during periods when there is no fluid flow. The flow sensor would then operate in a relatively high duty cycle configuration during periods when there is fluid flow. The sample rate would be optimized for sensor performance, as needed. When there is no flow, the sampling frequency of the flow sensor can operate at just 1 Hz and increase to 10 Hz when the flow is started again.
[00227] [00227] Secondary sensors such as a conductivity or pH sensor can only measure the fluid for a few seconds during the beginning and end of the dialysis infusion and drain cycles, as the solutions generally have a homogeneous pH and conductivity, so that a part of the volume of drainage or infusion solution is representative of the total volume of the fluid.
[00228] [00228] The sampling rate of the sensors can also be used to identify non-homogeneous constituents. For example, with optical fluid dispersion / absorption, a high sampling rate can be used to capture non-homogeneously mixed particles (eg, fibrin) that have unusual signal peaks when compared to homogeneously mixed particles. (i.e., white blood cells) that have a constant signal. Data processing and alert generation
[00229] [00229] All sensor-based data, patient input data and provider input data will henceforth be classified as "patient data". The database server system receives, stores and processes patient data, and then allows the patient and the supplier software to retrieve information using secure protocols. In a variation, the database server determines the metrics of the patient's specific historical baseline over a specified period. As patient data is retrieved continuously, the database identifies data points that differ from baseline metrics and signals alerts to the provider and / or patient.
[00230] [00230] In an example of this variation for patients undergoing peritoneal dialysis therapy, the conductivity of the drier dialysate solution
[00231] [00231] In another example, the database alerts the provider and / or patient when patient data changes abruptly during a specific monitoring period. For patients on peritoneal dialysis therapy, intraperitoneal pressure can be measured during periods when flow is interrupted during a period of stay in the dialysate or between dialysis cycles. Temporary changes in pressure events can be measured, for example, by calculating a moving average during the monitoring period, and any reading outside of three standard deviations (or another suitable predetermined threshold) can be detected and trigger an alert.
[00232] [00232] In another example, the database alerts the provider and / or the patient when the patient's data falls outside an absolute predetermined range. In an example of this variation, the skin surface temperature of patients with a PICC line is monitored. Any temperature values outside the standard physiological range [97.7–99.5 ° F] (or other suitable range) can trigger an alert to the provider and / or patient.
[00233] [00233] In another example, the therapy prescribed for the patient is inserted by the provider in the software system of the user interface and the data are transmitted and stored by the database server. The sensor network monitors the patient's therapy, starting the infusion time, the infusion volume and, in some cases, the initial drainage time. Alerts are sent to the provider and / or patient when the total number of daily infusion / drain cycles, infusion volume, infusion start time, length of stay and other prescribed parameters are outside the prescribed therapy.
[00234] [00234] One or more data inputs can be used to determine statistical alert limits in order to monitor a) patient compliance with prescribed therapy, b) therapy effectiveness, c) detection of complications, d) calibrating the sensor, e) cleaning the device and / or f) replacing components (for example, replacing cartridges). In one example, for patients on peritoneal dialysis, the effectiveness of dialysate ultrafiltration is monitored by the dialysate infusion for the Vi / Vw drainage flow volume ratio and the conductivity differential of the dialysate drainage solution from the conductivity of the dialysate solution. fresh dialysate Ci - Cw. Alerts can be triggered when either of the two parameters that monitor the effectiveness of dialysate ultrafiltration exceeds the statistical alert limits or when both parameters exceed the statistical alert limits. When the two parameters are used, each parameter can be weighted differently. For example, the alert limits for the flow volume ratio are based on a standard deviation from the mean value of the baseline, while the conductivity differential is based on three standard deviations from the mean value of the line base.
[00235] [00235] In addition to the statistical limits of the data values, the alert sensitivity can be controlled by the number of instances in which the data values deviate from the statistical limits. For example, a highly sensitive alert would require only a single data value that deviates from the statistical limits to trigger the alert. A low sensitivity system may require several data values other than statistical limits to trigger the alert.
[00236] [00236] The sensitivity of the alert can be based on predetermined or customized values by the provider. For example, the provider can customize the sensitivity of the alert based on the patient's condition. In the case of a dialysis patient with minimal renal function (high flow differential) and general health problems, the provider can set the statistical limit conservatively for a standard deviation and a single instance of data that deviate from the specific limit. to trigger the alert. In another case of a patient on dialysis with moderate kidney disease (the flow differential is low) and in good general health, the provider can set the statistical limit for three standard deviations and four instances of data that deviate from the statistical limit for trigger the alert.
[00237] [00237] In an alternative variation, the database server system can analyze patient information to determine the patient's general health as a patient profile and adapt the alert's sensitivity accordingly. The sensitivity of the patient's alert may remain constant or change over time. For example, data for the patient's flow volume differential may be low and there are no occurrences recorded in a patient's complication profile, so the database server adjusts the sensitivity level for alerts for low settings . After some time, the data for the patient's flow volume differential increases to a high level, and the patient has two instances of infection recorded in his patient profile. The database server consequently adjusts the sensitivity level so that alerts are high. Alert types
[00238] [00238] When alerts are triggered, alerts can only present data and / or an assessment of the patient's condition. For example, the temperature anomaly can be displayed in an alert such as "Patient X's temperature is 101.1 ° F" or, alternatively, "Patient X may have a fever".
[00239] [00239] Various data can be combined in an alert to monitor a) patient adherence to the prescribed therapy, b) effectiveness of dialysate ultrafiltration and c) detection of complications. For example, the patient's infection can be expressed by the patient with an elevated core temperature, as well as a drop in the pH value of the dialysate. The alert, in this example, can summarize the two entries as "The patient is at high risk of infection".
[00240] [00240] The alerts can also indicate the severity levels through the use of different audio, vibration or visual cues, such as pop-up windows with color markings in the software GUI. Severity is determined by the monitoring category, as well as the magnitude of the statistical deviation. For example, deviations in patient compliance, such as when a patient undergoes dialysis after prescribing, would justify a low severity alert. Successive missed dialysis sessions can guarantee a higher severity alert. A high temperature above 105 ° F and a drop of four standard deviations in the pH value would justify an extreme severity alert.
[00241] [00241] In another variation, the device's server and / or processor can be configured to determine critical emergency scenarios for the patient's condition and trigger additional actions.
[00242] [00242] Alerts can be communicated in the user interface or by phone, text message, e-mail or separate alert hardware installed in the dialysis clinic. Depending on the severity of the alert, one or more communication methods may be used. In addition, alert communication preferences can be customized by the provider and / or the patient.
[00243] [00243] In some variations, the functionality of the patient monitoring device may be limited by the database server if a user does not respond to a critical alert (for example, critical alert to replace a disposable cartridge / component). Avoidance of negative / false-positive alert
[00244] [00244] Normally, certified nursing professionals are the main provider and monitor approximately 15 to 20 patients on peritoneal dialysis at any time. Due to the high time constraint, it is desirable for the system to limit false positive alerts that waste the time of the patient and the supplier. One of the main factors of false positives is the particles of non-white blood cells that increase the turbidity of the effluent for a reason unrelated to the infection. For example, red blood cells, proteins, triglycerides and fibrin are common false positive drivers related to turbidity. However, as described here, the types of particles can be differentiated based on optical measurements made on different wavelength ranges and proportions calculated from them, in order to improve the measurement of the concentration of globules.
[00245] [00245] The frequency of false positive states can still be avoided or reduced with one or more redundant sensors. In the case of monitoring the effectiveness of dialysate ultrafiltration, a conductivity sensor can be used in addition to a flow sensor that determines flow volume differentials. While the flow volume differential mainly measures water diffusion during ultrafiltration, conductivity mainly measures salt diffusion during ultrafiltration. In cases where there is a change in ultrafiltration due to changes in peritoneum permeability, the concentrations of solutes - water and salt must be affected. Therefore, the process can take into account the change in the differential and conductivity of the flow volume before triggering an alert. Figure 51 shows the logical flow of using the flow volume differential and the change in conductivity, in which the two sensor systems need to demonstrate changes before an alert is triggered.
[00246] [00246] False positives can also be avoided or reduced with exclusive sensors that monitor false positive conditions. For example, monitoring the pressure for the patient's hernia or complications in catheter block can be complemented by the use of an accelerometer. A patient's hernia can result, for example, in a rapid change in pressure. However, the patient's cough may likewise show rapid changes in pressure. In this use case, an accelerometer integrated into the patient's monitoring device can be used to detect cough, which usually results in sudden movements in the abdomen and diaphragm. Thus, the accelerometer can filter the pressure sensor data to avoid false positives. Figure 52 shows the logical flow of pressure sensor data and the accelerometer cough detection to filter the data or trigger alerts.
[00247] [00247] Another false positive scenario can occur when a patient is exercising. During exercise, intraperitoneal pressure may increase and the frequency of the breathing cycle increases, and pressure sensor data may indicate a patient complication. Accelerometers and / or gyroscopes can be used in combination with the pressure sensor to detect when patients are exercising due to the constant movement detected and to filter pressure data during the exercise period.
[00248] [00248] In addition, the system can be configured to increase sensitivity to detect certain states, to avoid or reduce the risk of lost infections for patients, for example, it can result in long hospital stays or in the patient's morbidity. False negative states can also be avoided or reduced with redundant sensors. Systems designed to avoid false negatives are particularly useful in the event that detectability is low. Different pathogens, different types of infections and different physiologies of patients result in the expression of the infection in different ways. Therefore, several sensors can be used to detect infections. In one example, pH sensors can be used in combination with optical dispersion / absorption sensors and temperature sensors. During an infection, a patient may not express the infection through the three parameters, so a change in any of the sensors can trigger an alert. Figure 53 shows an example of an optical dispersion / absorption process, temperature and pH sensors, in which any of the sensors can trigger an alert. Figure 73 shows a variation of a GUI configured to define a sensitivity of the alert levels based on one or more parameters, such as turbidity 7316, fluid flow 7318, ultrafiltration conductivity 7320, volume of ultrafiltration flow 7322 and like it. For example, a provider can manipulate a 7312 slider over a predetermined 7310 scale to adjust a sensitivity level 7314 for an alert.
[00249] [00249] Furthermore, after detecting specific complications, the user (for example, patient, healthcare professional) may be asked to answer several questions through a graphical user interface to reduce false positive claims. For example, optical sensors can detect abnormal signals due to a nascent infection, but also due to the patient's unnatural dietary action. The patient may be asked through a user interface or other means of communication if there was any abnormal behavior (for example, eating a large meat meal when a vegetarian diet is usually followed) that may have caused the signal to change. The patient's subsequent alert and responses can be recorded in the historical data, but potentially an alert is given to the provider only when there is no aberrant behavior, as stated by the patient.
[00250] [00250] In addition, the data can be resolved in time to track false positives. For example, if there is an infection, it would lead to a high concentration of leukocytes that would likely be maintained or increased over time. For each patient, false positive alerts may appear after an abnormal signal reading, but this metric may drop to a normal level at the next reading. For each patient, the behavior of the signal resolved in time for false positives can be learned. The increase in ultrafiltration is also associated with the incidence of peritonitis. An increase in ionic conductivity in parallel to the high dispersion / optical absorption readings is an additional parameter indicative of the source of the infection. Sample collection methods
[00251] [00251] Additional actions can also be requested by the system when certain limit action limits are detected. In one example, there may be a sterile collection container loaded at all times in the fluid sample collection device that can be sent to a laboratory for analysis. Upon detecting a potential complication, a sample of the patient's fluid can be collected in the container. The container can also be labeled with a shipping label and ejected from the device or removed by the patient. The samples can then be discarded directly into a mailbox for delivery to an analysis facility or automate mail collection from the patient's home.
[00252] [00252] As part of the sample collection, a separate sample can be collected for testing on the device with test strips or another test modality for common pathogen identification. The test results can be delivered to the healthcare professional or the analysis laboratory to streamline the analysis process, providing initial data on the identity of the pathogen causing the complication. Thus, the initial sample screen can be completed before arriving at the analysis site. In some variations, an optical sensor can measure one or more optical characteristics (for example, image, color) of a test indicator strip with the sensor signal automatically transmitted to one or more of memory, network, database and service provider.
[00253] [00253] In another example, the alert can notify the device manufacturer, the healthcare professional, the analysis laboratory, the courier service or a third party service to collect a sample. Someone can be dispatched to go to the patient and collect a sample directly during the drainage process or the previous drainage. In addition or alternatively, the test strips can be stored in the device that the dispatched individual can use to test common pathogens, or the results of the test strips used automatically can be read.
[00254] [00254] After sampling, a warning generation cascade can be triggered. A notification (for example, text, email, app notification) can be sent to the healthcare provider and analysis center to alert you to the patient's status and the impending arrival of a test sample. In one example, an alert can be sent to a courier service to collect the sample, so that the patient does not have to place the sample in the mailbox. Alternatively, the patient can place the sample in the mailbox or in another external container so that the courier can collect the sample without the need to coordinate with the patient and decrease the total transit time of the sample. Subsequent notifications can be triggered when the sample arrives at the test facilities, the results are known and the main reference parameters are reached for the treatment of the complication in the patient.
[00255] [00255] The carrier can have exclusive access to the sample container to guarantee the fidelity of the test and the safety of the patient. The device may contain a locked compartment, which houses the sample and can be opened by an authorized delivery service. The courier can then replace the sample with a new sample collection container on the device.
[00256] [00256] Figure 56 illustrates a possible series of notifications. When the sample collection container 110 is filled and sealed for transport, a notification 111 is sent to the post office 112 to collect the sample, to the health professional 113 to keep them informed and to the analysis laboratory 114 to inform them. imminent tests. An additional notification is sent to the healthcare provider and the analysis center when the post collects the sample. Then, the health professional is notified when the mail is sent.
[00257] [00257] As part of the cascade of automatic response, a treatment regimen can be started immediately after the collection of samples. For example, for an infection, it can be a broad-spectrum antibiotic and, for a catheter block, it can be a thrombolytic agent. In either case, treatment can be delivered automatically to the patient's infusion fluid line, or it can be in a locked receptacle accessible to the patient, which is unlocked remotely or automatically, or via an access code sent to the patient. For treatments not injected directly into the inlet fluid (for example, when there is only one drainage tube), the treatment can be administered orally. through the catheter, through a syringe, through a transdermal patch, etc. Figures 57A-C and 58A-C represent the treatment regimen that begins after sample collection, but not as part of the automatic response cascade.
[00258] [00258] In another example, when an action limit is detected for a potential complication, such as infection or catheter block, the system can alert a pharmacy to administer an antibiotic to treat the infection or a thrombolytic to resolve the problem. catheter block. The provider can be notified of the alert and can send a remote prescription to the patient through the device's application or the user interface for broad-spectrum antibiotics initially and more specific antibiotics later, when they get results sample analysis or observe low or no treatment efficacy. Remote prescriptions can work in conjunction with test strips or another test modality on the device for common pathogens to increase the information the provider should use when prescribing a treatment. Therapeutic agent methods
[00259] [00259] Figures 58A-58C represent a variation of a method in which a therapeutic agent is injected directly into the fluid that enters the patient. Similar to Figure 57A, the injectable therapeutic agent 119 is protected from exposure to the patient initially, as shown in Figure 58A. After the sample is collected and notification 111 is made, a needle 120 is pushed forward and punctures the fluid channel wall, as shown in Figure 58B. Then, Figure 58C shows the injectable therapeutic agent being dispensed into the fluid in the device channel, which starts the treatment process immediately after detecting complications and collecting samples. Additional data entries
[00260] [00260] In addition to the sensor data, the metrics can be entered by the supplier and the patient through the software system. This data can be transmitted to the database server, which receives, processes and stores the data. When processed, the data can be used independently to trigger alerts or can be used in combination with other monitoring data.
[00261] [00261] In one example, the patient on peritoneal dialysis therapy manually enters weight data from a separate scale before, during and after a dialysis exchange cycle. Changes in weight between each stage of the dialysis cycle indicate changes in fluid volume. When the patient's weight after the dialysis infusion cycle is entered and the patient's weight after the dialysis drain is entered, the differential weight (Md) and the net fluid weight (Ms) of the infusion dialysis solution calculated can be calculated (based on the volume of the flow and the density of the dialysate infusion) in a differential mass ratio, Rm = Md / Ms. The proportion generally correlates directly with the proportion of the volume of residual fluid drained (Vw) and the volume of fluid infused (Vi), Rv = Vw / Vi. The mass data can be used as an alternative or supplement to the flow sensor data, in order to calculate the volume differentials between the infused and drained dialysate fluid. If the data is used to complement the flow sensor data, false positives or false negatives can be avoided. In some variations, a weight scale can be configured to automatically transmit weight (for example, wirelessly via Bluetooth or Wi-Fi) weight data and time stamp to the patient.
[00262] [00262] In this example, the user interface software system can also ask the patient for weight measurements during different periods in the dialysis cycle. Specific weighing points may be required via the software interface, allowing only readings made at specific points to be transmitted to the database or not allowing the next step of the exchange cycle to be started until the patient's weight is recorded.
[00263] [00263] Weight data can also be used to help calculate the total volume of body water. The total value of the body water volume "V" is an important component of the adequacy test of the standard dialysis KT / V, where K is the urea clearance in the dialysator and T is the dialysis time.
[00264] [00264] In another example, the patient's blood pressure, heart rate and / or oxygen level are manually entered into the user interface software system by the patient or provider. Vital measurements and sensor data can be used together to determine the effectiveness of treatment and to detect possible complications. Figure 59 shows a use of vital data to alter the sensitivity of sensors for treatment effectiveness and detection of complications. In one scenario, the patient's blood pressure increases above a standard deviation from the mean value of the baseline, increasing the sensitivity of infection detection warning systems and treatment efficacy. The dispersion / absorption optical sensor, pH and conductivity data alert levels can drop from two standard deviations from the baseline mean to a standard deviation from the baseline mean.
[00265] [00265] In some variations, one or more diagnostic devices (eg, blood pressure monitor, pulse oximetry device, vital signs monitor, heart rate monitor, temperature monitor) configured to automatically transmit (for example, wirelessly via Bluetooth or Wi-Fi) diagnostic data and date and time data to one or more memory, network, database, and service provider.
[00266] [00266] In another example, the patient's physical activity can be monitored using an accelerometer, or similar means, in order to determine the patient's level of physical activity. The patient's level of activity can be correlated with the efficacy and complications of dialysis treatment. The low efficacy and infection of dialysis treatment can cause fatigue and lethargy, which translates into less patient activity. In one scenario, the patient's accelerometer data indicates that the patient reduced the total number of steps, a standard deviation from the mean value of the baseline and maintained a lying position for the total duration of daily time greater than one standard deviation from the mean value of the baseline. The sensitivity of the alert system for detecting infection and the effectiveness of the dialysate may increase and the alert threshold drops from two standard deviations to a standard deviation from the mean values of the sensors baseline.
[00267] [00267] In another example, the patient provides daily contributions on various questions to determine his feeling of well-being and pain based on a numerical scale (ie 1-5) or graphical representation (smiley, sad faces) through the GUI of the user interface software system. The patient's feeling of well-being and pain can be correlated with the effectiveness and complications of dialysis. Poor well-being, which varies from loss of appetite, lethargy and shortness of breath, may be related to the low effectiveness of dialysis. Abdominal pain can correlate with hernias or infection. In a use case, the patient enters wellness data for energy, appetite and pain based on a scale of 1 to 5 (1 = very poor, 2 = poor, 3 = average, 4 = good, 5 = excellent ). The patient's pain level decreases two standard deviations from the mean value from the baseline on successive days and an alert is triggered for a possible patient complication. In another scenario, the value of the patient's energy rating falls 2 standard deviations below the mean value of the baseline on successive days. The threshold for the alert system for detecting infection and the effectiveness of the dialysate falls from two standard deviations to a standard deviation of the mean values of the baseline of the sensors.
[00268] [00268] In addition, the user interface software system can allow dialysis providers to enter monthly clinic test data to be entered and continuously monitored in a manner similar to the other metrics mentioned above, with alerts generated for changes in long term that may indicate deterioration of the patient's condition. These tests include, but are not limited to, blood tests, analysis of urine samples and vital monitoring (eg blood pressure, weight, temperature). For patients on peritoneal dialysis, additional data may include dialysate drainage analysis and pro-card data from CCPD night cycling machines.
[00269] [00269] The user interface software system may have
[00270] [00270] In some variations, changes in the patient interface (as a color indicator) due to a possible complication (for example, infection, catheter block) can be defined to be resolved only when a health professional (for example , physician) or authorized user reviewed and updated the patient's status. For example, a healthcare provider may be asked to review patient data, including culture results, cell counts generated in the laboratory, types of antibiotics administered, combinations of them and the like.
[00271] [00271] Unlike direct patient or provider entry into the user interface software system, external hardware can also communicate directly with the sensor hardware system and / or the transmitter and / or the software system of the user interface and / or directly with the database. In one example, a watch connected to the Internet or another wearable, that is, Fitbit, the App Watch monitors physical activity through a proprietary app or an existing health app, and data is sent wirelessly via LTE or another wireless connection directly to the database. In another example, a blood pressure cuff enabled
[00272] [00272] In another variation, the server analyzes the data stored in the database to evaluate or determine a diagnosis or a clinical condition. The database can use regression analysis between clinical events (for example, infection, catheter obstruction and / or loss treatment efficacy) and sensor-based data or patient input data to generate metrics or lines. patient or population mites to generate alerts. This analysis can be a retrospective statistical regression analysis based on one or more patient data. Regression analysis can be used to determine the relationship of the monitored parameters and the patient's clinical events. After regressions are established, when a patient's monitored data indicates a high probability of a clinical event, the server database can alert the provider of a specific patient diagnosis. In one example, the glucose levels in the drainage dialysate increase two standard deviations from the baseline levels in combination with the conductivity of the drainage dialysate dropping 1 standard deviation from the baseline level. Based on previous data analysis, the database diagnoses with a high probability that there is a change in the permeate permeability and that the prescribed dialysate solution has lost clinical efficacy.
[00273] [00273] The patient provider's user interface software system additionally includes entries in the patient's actual diagnosed events that are transmitted to the database server related to a) treatment effectiveness and b) treatment complications. These "output data" are analyzed in combination with the "input data" for regression analysis, in order to determine the algorithms for the automated diagnosis of events based on system inputs. In one example, the provider records the incidence of a patient's hernia (outgoing data point) at a specific time in the GUI of the user interface software system. The patient's hernia and time data are transmitted to the database server, which receives and stores the output data point. The database server performs a regression analysis of the pressure sensor data (input data point) before, during and after the hernia event time. The regression analysis determines that the acute change in dP pressure exceeded, for example, 2.5 standard deviations σ on the day immediately before the hernia event (or other suitable threshold). Thus, a predictive diagnostic algorithm for detecting the patient's hernia can be developed as dP> 2.5σ.
[00274] [00274] In another example, the professional diagnoses a failure in the effectiveness of dialysis for the patient on peritoneal dialysis, as the patient develops fatigue, nausea and vomiting. The provider records the efficiency failure (output data point) and the time point of the event in the GUI of the user interface software system. The dialysis failure time and effectiveness data are transmitted to the database server, which receives and stores the output data point. The database server performs a regression analysis of differential volume data and conductivity data (input data points) before, during and after the time of the dialysis failure event. Regression analysis shows that the dialysate volume ratio data infused with
[00275] [00275] In another example, the provider diagnoses an extraluminal infection. The provider records the extraluminal infection (outgoing data point) and the time point of the event in the GUI of the user interface software system. Extraluminal infection and time data are transmitted to the database server, which receives and stores the outgoing data point. The database server performs regression analysis of the dispersion / optical absorption data of the drainage dialysate pH, pH and temperature of the drainage dialysate (input data points) before, during and after the time of the extraluminal infection event. The regression analysis shows that there is no correlation between the patient's optical dispersion / absorption and pH with the event of extraluminal infection. However, there is a correlation with the temperature of the patient's drainage dialysate, T greater than 38.4 ° C. Thus, a predictive diagnostic algorithm for extraluminal infection can be developed as T> 38.4 ° C.
[00276] [00276] Predictive diagnostic algorithms can be developed with additional data from the same patient and / or from multiple patients. In another variation, regression analysis and artificial intelligence can be implemented so that the algorithms can be developed exclusively for each patient. Data transmission
[00277] [00277] In the patient monitoring device, the data is processed by the microcontroller and the processed data is stored
[00278] [00278] In another variation, all processed data is stored on a removable storage card, including, without limitation, an SD card, and sent to an exclusive module dedicated to the monitoring system, mobile device, smartphone device , smartphone, phablet, tablet, PDA, personal computer or similar form of hardware with data network capability to send data to the database system.
[00279] [00279] In another variation, the patient monitoring device contains a cellular data transmission module (for example, 3G, 4G, LTE) and sends the data directly to the database server via the cellular network. Emission of data
[00280] [00280] The user interface software system can be recovered by any accessible computing device (for example, Android, iOS), web browser accessing a secure website and / or cloud computing solution. Patients and providers can register an account through the app and log in to access the functionality. Through wired or wireless network communication, the user interface software system transmits the user's login information and requests system data from the database server. The database server system receives the requested data and login data, determines the user's access level from the login information (for example, administrator, patient, provider), authenticates the login data and sends the requested data. The user interface software system receives the requested data from the database server system and analyzes the user interface data. The user interface software system can communicate with the database server system through an application program interface (API).
[00281] [00281] The patient and provider can use a graphical user interface (GUI) to review patient data and alerts. The GUI can include multiple page layouts, such as displaying a list of multiple patients and viewing details for a single patient. The user can interact and navigate the GUI through various input devices, such as a mouse, keyboard and / or touchscreen. During user interaction with the GUI, requests for additional data can be sent and communicated to the database server. The graphical user interface can be displayed in one or more customizable formats. In addition or alternatively, the presentation of data and / or alerts may include push notifications, text messages, calls and / or emails.
[00282] [00282] In Figure 60, the provider's GUI displays information for several patients 121 and includes the display of various monitored dialysis parameters 122. Alert boxes 123 highlight patients with parameters outside the standard ranges and specific parameters outside the range 124) are highlighted. The user interface software system can include data from the server database system and from alternative sources, such as the laboratory database system.
[00283] [00283] In Figure 61, the patient's GUI includes a display of historical reference data 125 and the most recent data 126 for various monitored dialysis parameters. An example of alert 127 for parameters outside the baseline range is shown. In addition, the contact buttons 128 facilitate communication with the provider.
[00284] [00284] In some variations, a GUI can be displayed by a patient monitoring device, such as those represented in Figures 64-71 or described here. In some variations, the status of the patient and / or patient monitoring device can be communicated to the patient using one or more exit methods. Figure 72 is a GUI 7200 that can be displayed on the outside of a durable component of the patient monitoring device. For example, a system status can be communicated to the operator using a set of light patterns emitted by one or more optical waveguides (for example, a light tube). One or more optical waveguides can receive light from a light source (eg, LED) using a predetermined combination of light output parameters (eg, wavelength, frequency, intensity, pattern, duration) for provide the patient with a predetermined visual indicator. Optical waveguides can be integrally formed to accommodate a patient monitoring device to simplify manufacturing and allow for a compact design and minimal energy use.
[00285] [00285] An optical waveguide can refer to a physical structure that guides electromagnetic waves, such as visible waves in the light spectrum, to passively propagate and distribute the received electromagnetic waves.
[00286] [00286] In some variations, the patient's monitoring device may emit one or more colors as a visual indicator, for example, of the patient's status. The GUI 7200 can be issued by an LED or LCD and display one or more status of the patient monitoring device, patient status, fluid monitoring status, disposable component status, communication status, combinations thereof and the like . For example, the GUI 7200 can display the 7220 battery life, the 7210 patient status, the 7230 communication status, and the 7240 disposable component status (for example, accessory status, replacement status). The GUI 7200 can be configured to notify the patient to contact their doctor or healthcare professional due to an infection event of the detected patient. For example, an external part of the patient monitoring device may glow green when an infection has not been detected and may glow orange when patient intervention is required (for example, contact your service provider. , the health professional).
[00287] [00287] The light patterns described here may, for example, comprise one or more flashing, hidden, isophasic lights, etc. and / or light of any suitable light / dark pattern. For example, flashing light can correspond to rhythmic light in which the total duration of light in each period is less than the total duration of darkness and in which the flashes of light have the same duration. Hidden light can correspond to rhythmic light, in which the duration of light in each period is greater than the total duration of darkness. Isophasic light can correspond to light that has dark and light periods of equal length. Pulse light patterns can include one or more colors (for example, different color output per pulse), light intensities and frequencies.
[00288] [00288] In some variations, one or more visual, auditory
[00289] [00289] The user interface software system for the patient can be used additionally to send reminders to the patient to initiate dialysis therapy, drainage or other prescribed maintenance. Alerts can indicate when additional patient information is missing (ie weight, blood pressure, pain condition). Reminders and alerts can also be sent to patients to maintain the sensor system, such as replacing / charging the battery and failing to transmit data that requires maintenance of any equipment. Reminders for supplier appointments can also be sent via the user interface.
[00290] [00290] The user interface software system for the provider may additionally include reminders for patient consultations, patient data review times or patient reports that require input.
[00291] [00291] The user interface software system may also contain communication channels, such as video calls, private messages or phone calls between the patient, the provider and / or the emergency team. Alternating applications for permanent catheters
[00292] [00292] Alternative variations of continuous monitoring of permanent catheters include central venous lines, catheters in tunnels, implanted access doors, insulin pumps for type 1 diabetics, long-term feeding tubes, drainage bypass.
[00293] [00293] For all listed applications that do not include fluid drainage as a main component of treatment, detection can be limited to fluid flow measurements, pressure detection, skin surface detection and / or detection technologies the wound site. The system can be configured to use data correlation features to correlate the sensor data with various occurrences of complications. Correlation data will support the development of comprehensive diagnostic tools. Urinary tract catheters
[00294] [00294] Urinary tract catheters can be used in hospitals, nursing homes or patients' homes and can be used in a short or long term context. In a variation used for urinary tract catheters, the patient monitoring device can be attached to the catheter tube, as shown in Figures 10 and
[00295] [00295] Figure 62 illustrates another variation of a patient monitoring device 00 used as a connector between the collection vessel 129 and the pipe 130. The device can connect to the pipe and the drain vessel 129 via Luer-lock interface, pressure adjustment or other water-protected design. In another example, the device can be used only when emptying the drain pan. The patient monitoring device can be configured to monitor the patient and detect some of the complications that occur with the use of urinary tract catheters, including infection, blockage and genitourinary trauma.
[00296] [00296] To detect infections and also monitor the progression of recovery after the implementation of the treatment, the device can observe several parameters. The device can measure the flow of fluid in the catheter, which can decrease in the case of an infection due to obstruction of the catheter due to the development of biofilm, blood clots, mineral content or other sources in the catheter lumen. The presence of bacteria will cause an upward change in the pH that the device can measure. In addition, the fluid temperature and the patient's body can be measured, which can be raised in the case of an infection. An infection would lead to an increase in the concentration of leukocytes, causing the solution to become cloudy, which can be detected by the optical absorption / dispersion sensor in the system. For urinary tract infections, 40 leukocytes / µL have been shown to have high sensitivity and specificity with positive culture for infections, which suggests the use of 40 leukocytes / µL as a general limit for this use case, in instead of 100 leukocytes / µL as peritoneal. dialysis. Finally, more specific biomarkers for urinary tract catheter infections can be detected using the device's sensors, such as nitrite levels, a known biomarker for urinary tract infections, leukocyte esterase, a common infection marker, protein binding to heparin, or interleukin-6 (IL-6). For infection detection, aberrations of baseline data or the behavior of the individual patient or patient population with respect to the parameters mentioned above can be detected at the beginning of the infection cycle with an alert sent to the healthcare professional or the patient. After an infected patient has undergone treatment, regression of the characteristics of the infection (for example, leukocyte concentration below approximately 40 leukocytes / µL) can be monitored by the device to allow healthcare professionals or patients to see the effectiveness of the treatment.
[00297] [00297] Trauma can also be detected by the device using optical sensors. Specifically, the device can detect hematuria by observing a high optical signal in active areas for hemoglobin. Optical signals at approximately 410 nm and approximately 550 nm are two examples of signals that can be monitored in an optical dispersion / absorption system to capture the presence of blood in the urine that is suggestive of genitourinary trauma or trauma unrelated to catheter, such as acute kidney injury (AKI). Lesions unrelated to the catheter can also be detected with other biomarkers that the device can detect, for example, serum creatinine concentration (sCR) in the case of AKI. An increase in the sCR of approximately ≥ 0.3 mg / dL in 48 hours or an increase of approximately 50% in the patient's baseline sCR in one week are typical indicators of AKI.
[00298] [00298] A reduction in fluid flow in the urinary tract catheter can be seen through the flow sensor and pressure sensor. Notably, a reduction in flow and an increase in fluid pressure
[00299] [00299] Central venous line catheterization is used in several therapeutic procedures, including, among others, medication administration. Examples include long-term intravenous antibiotics, long-term parenteral nutrition, especially in people with chronic illnesses, long-term painkillers, administration of drugs likely to cause phlebitis in the peripheral (caustic) veins, such as calcium chloride, chemotherapy, solution hypertonic saline, potassium hydrochloride (KCl) amiodarone, vasopressors (eg, epinephrine, dopamine) and plasmapheresis (collections of peripheral blood stem cells).
[00300] [00300] For such applications in which the fluid is infused into the patient and no fluid is drained, the flow meters, skin surface temperature and luminal pressure sensing components of the system can be used to detect complications. Some of the common complications include, among others, infections by patients, which would result in fever detectable by the temperature sensor. Complications also include catheter block, torsions and changes in position from the expected placement position that cause variation in the blood flow contact areas, which are detectable through the pressure sensor. The pressure sensor can also be used to monitor the patient's vital system, such as blood pressure, heart rate and respiratory function. Vital system data can be used to detect relatively common cardiac complications that can progress to arrhythmia or cardiac arrest and pulmonary complications. In addition, a pressure sensor can detect the back pressure exerted at the outlet site, which may be indicative of a fibrin sheath formation in the line or bleeding close to the site due to line malposition.
[00301] [00301] For the application of the central venous line, patients would use the device in a form factor fixed to the skin by means of an adhesive similar to the representation of Figures 1 and 13 or in a cylindrical shape that connects the inhabiting component to the similar external fluid source for the representation in Figure 22. The housing would include a skin surface temperature sensor, flow sensor, pressure sensor and an accelerometer to monitor the patient's activity levels.
[00302] [00302] The adhesive would be placed next to the catheter at the installation site. Patients managed the treatment perfectly in outpatient settings, as they normally would, and the invention collected the necessary data and transmitted it to the cloud-based database, visible by the provider for remote monitoring.
[00303] [00303] With each dose administration, the flow sensors would indicate the exact volume inserted and the injection time, providing complete data to guarantee compliance to suppliers. A skin surface temperature sensor would read the skin exposed by the wound site leaving the catheter, reducing the variability in the reading due to the insulating effects of the clothing. The temperature sensor would take readings with each dose administration to identify the temperature differential and identify the fever for the early detection of the infection. The pressure sensor would take a reading of the luminal pressure and compare it with the base value recorded for each patient. Any deviation in pressure values can indicate torsion,
[00304] [00304] Hemodialysis, with particular emphasis on home hemodialysis, is another application of the central venous line that can be monitored by the system. Since the administration of hemodialysis includes the total circulation of the blood stream into and out of the human body, all the aforementioned detection technology for monitoring peritoneal dialysis is applicable to the remote monitoring of patients on hemodialysis. The hemodialysis device can take on a wearable shape similar to Figure 13 or attached to a drainage line, as in Figures 23 and 24.
[00305] [00305] In addition, common complications can be detected through sensors directed to small molecules or specific electrolytes. For example, electrolytes, including potassium, sodium and calcium, can be detected by sensors specific to the electrolytes or by monitoring the conductivity or pH of the blood. It is known that these electrolytes undergo sudden changes during a hemodialysis session and can cause problematic changes in the osmolarity of intra and extracellular concentrations. The resulting problems include hyponatremia (blood sodium levels below approximately 135 milliequivalents / L), which can lead to muscle cramps and a decrease in the effectiveness of dialysis, reduced blood pressure, hypercalcaemia (potassium levels in the blood above 5.5 milliequivalents / L), which can lead to heart abnormalities and bone diseases, which can be seen through a reduced amount of vitamin D (the normal concentration is greater than approximately 20 ng / dL) or an increased amount of calcium (the normal range is 8.5 to 10.5 mg / dL).
[00306] [00306] Other complications can be detected using the sensors mentioned above. Notably, blood pressure, which can be hyper or hypotensive in hemodialysis patients, can be tracked during a session to observe the initial value, the final value and changes throughout the session using the pressure sensor. Anemia, a low concentration of red blood cells in the blood, can be observed using optical sensors that can quantify the optical signal of hemoglobin, which has a unique optical signature and signal peaks around 410 nm and approximately 550 nm. With the use of optical sensors, blood oxygenation can also be monitored. Finally, pericarditis or other infections can be detected by looking at the leukocyte count or leukocyte proxies (for example, leukocyte esterase). Blood drainage
[00307] [00307] In the case of a patient who needs only a single blood drain, the measurements would be compared to the standard population. In certain cases, previous blood samples can be used as a reference point if they are close enough to the time of blood drainage. For patients with multiple or chronic use of blood drainage techniques, a baseline can be established for the metrics of complications.
[00308] [00308] The complications detected include, among others, the detection of infections through an increase in the leukocyte concentration through the quantification of cells or a proxy such as leukocyte stasis, hyper or hypotension through measurements blood pressure, abnormal levels of solute (for example, hyperkalaemia which can result in heart problems). abnormalities and dysfunction), anemia and problems with clotting. These complications and others can be detected by the device and alert health professionals
[00309] [00309] In addition, the total volume drained and the speed of the drain can be monitored to ensure proper handling of the patient by the individual who supervises the blood drain. Alerts can be generated when blood is collected too quickly or too much blood is collected, based on the expected rates for the entire population or the size and weight of the specific patient. Hydrocephalus
[00310] [00310] Hydrocephalus is a condition in which there is excess fluid in the brain's ventricles. The common treatment is to insert a subcutaneous bypass from the brain to another part of the body, such as the abdomen, to remove excess fluid from the brain area. Given the sensitive nature of the brain, detecting and resolving complications as quickly as possible is critical for patients with hydrocephalus.
[00311] [00311] A subcutaneous device that incorporates the full range of features detailed previously can be used to monitor patients remotely. Figures 63A-63C illustrate a variation of a patient 132 subcutaneous monitoring device. The device may comprise a biocompatible sheath 131 around a circumference of the device 132 that allows it to remain subcutaneous. The sheath 131 can be cylindrical and completely surround the device, as shown in Figures 63A and 63B. Sheath 131 can interact with tap 133 through a pressure adjustment that can be applied during manufacturing. The patient's subcutaneous monitoring device 132 may comprise one or more of the sensors described herein. Infections could be detected specifically through the data collected from the optical sensor of
[00312] [00312] In the case of an infection, the shunt can usually be removed from the patient and the patient's excess fluid can be drained externally during the treatment of the infection. In this scenario, an external device can be used to monitor the patient during treatment of the infection. For example, the temperature of the fluid (indicating fever) and the concentration of white blood cells can be used as indicators of the severity of an infection. Thus, a return to the baseline for both values would indicate that the treatment is effective and the patient is or is almost recovered from the infection. The external device can connect two piping components, analogous to Figure 10, or it can exist at the end of the drain line for the external bypass, with an interface as in Figures 23 and 24.
[00313] [00313] Insulin pumps remain continuously in individuals with type 1 diabetes. Complications may occur due to the presence of insulin at the site of the tube that enters the body and releases insulin. A wearable patient monitoring device, like the one shown in Figure 13, can be used to detect common complications, including infection at the exit site, lipohypertrophy and pump cellulitis. Several different sensors can be used to detect an infection, such as pump cellulite or general infection, including a temperature sensor to measure the skin temperature around the exit site or a skin color sensor that can detect this skin color due to pus or other physical manifestations of infections. Lipipohypotrophy can result in discoloration by the development of granulation tissue, and a skin color sensor can be used to detect this aberrant discoloration. Lipohypertrophy can produce an accumulation of adipose tissue, creating a protuberance on the skin. Thus, a light-based sensor can be used to detect abnormal skin contours that suggest a lipothermia-induced swelling. Ascites drainage
[00314] [00314] Ascites drainage involves a permanently fixed device (for example, a peritoneal port or a catheter or a central venous catheter) or temporarily invasive hospital procedures, such as large volume paracentesis. For a permanently attached device, the patient monitoring device can be a patient monitoring device that can be attached to the skin at the patient's exit site (eg, peritoneal port) or cannot be used and attached to the tubing. The non-wearable device can connect two pieces of tubing, having fluid contact between the two sets of tubing, as in Figure 10. Alternatively, the patient monitoring device can be attached to a connector tube (with or without contact with fluid), as in Figures 20 and 21, or attached to a drainage vessel, as in Figures 23 and 24. Leakage or obstruction of the catheter can be detected by the drainage flow or pressure compared to a line base. For patients with frequent ascites drainage (for example, more than once a week), a patient-specific baseline can be developed over approximately 3 months or after the measurement of approximately 25 drainage sessions. For patients with less frequent drainage, such as monthly, the comparison of the drainage characteristics of the patient with the population baseline may be more practical. For individuals drained less frequently, data can still be collected to establish an individualized baseline. However, until a sufficient number of data points are collected (for example, 25 sessions), a set of alerts can be derived from a population baseline. An infection can be detected by measuring the temperature of the patient's skin surface. When the patient monitoring device is connected to the drainage fluid, an infection can be monitored by measuring the temperature of the drainage fluid, conductivity, or optical markers of an infection (for example, optical dispersion / absorption caused by a high count of white blood cells) and comparing this to baseline values for the individual patient or the patient population. Feed tubes
[00315] [00315] Gastroenterological tube feeding plays an important role in the management of patients with low voluntary intake, chronic neurological or mechanical dysphagia or intestinal dysfunction and severely ill patients. This catheter is used to pass nutrients / food to a patient who cannot eat food normally. In principle, tube systems for gastric or jejunal nutrition can be placed by nasal insertion (nasoenteral tubes; NETs), guided percutaneous or surgically applied. Functionality metrics can be tracked using system technology. Various complications can occur with the feeding tubes.
[00316] [00316] Peristemic infections of the wound are the most common complication associated with the PEG procedure, with incidence ranging from approximately 4% to approximately 30%. Approximately three quarters of these are smaller and disappear when treated with antibiotics. Being able to detect the infection early would prevent other complications, hospitalization, etc. Research has identified methicillin-resistant Staphylococcus aureus (MRSA) emerging as an important cause of PEG-related wound infection. The system's temperature, pressure and pH sensor components can provide early infection detection.
[00317] [00317] Clogged feeding tubes are another potential complication. As pH values below 4 have been described to promote protein coagulation, repeated gastric residual aspiration should be avoided or minimized. The tubes should also be washed with 40-50 mL of water before and after the administration of medications or bulking agents (ie, psyllium, resins). The flow, conductivity, temperature and pressure sensors can be used to differentiate inserted fluids and to guarantee compliance with the best treatment practices, capturing infections in the first points of origin.
[00318] [00318] Peristomal leak is another known problem. Several factors that contribute to the risk of peristomal leakage have been identified, including excessive cleaning with hydroperoxide, including
[00319] [00319] Buried Bumper Syndrome: Buried Bumper Syndrome (BBS) is a rare complication, especially in the long term, of PEG, in which the internal support migrates from the gastric lumen and stores in the gastric wall. Common symptoms include immobilization of the PEG tube, feeding difficulties or the need for more pressure when feeding, peritubular leakage, complete occlusion of the tube and occurrence of abdominal pain. Being able to track the pressure needed to feed a patient can help to detect this complication early in the disease. Typically, it has not been found for months, but with the system's monitoring capabilities, detection can be reduced to a matter of days. It is also possible to identify leaks using the same sensor, the pressure or piezoelectric sensor, in the system, to find gradients in the fluid movement or high pressure location, which means that there is an occlusion. Percutaneous Abscess Drainage and Other Drainage Modalities
[00320] [00320] The system is applicable to all treatment modalities not mentioned above, incorporating fluid drainage from the body as a central step in the administration of treatment. The drained fluids are available in the drainage path for a full spectrum analysis using the complete system technology, similar to the treatment of peritoneal dialysis. Flow meters, temperature, optical dispersion / absorption, pressure, conductivity, pH, lactate, glucose, urea and cells are useful to detect patient compliance, origin of complications and efficacy of remote treatment / general monitoring of the well -be.
[00321] [00321] The database server system includes network connectivity and communication, data processing by means of a computer processor and random access memory and storage resources by hard drives or similar hardware. The database server system may include an application program interface (API) to define communication procedures and protocols for interfacing with the hardware patient monitoring device, transmitter module and / or system. user interface software. In addition, the database server system may have an API for communicating with external systems in order to store additional data metrics for monitoring trends, alert generation, diagnostics or alternative proposals. For example, the dialysis center's data system includes entry of laboratory results, such as blood test, urine test and consultation notes with the provider. This data system can upload data directly to the system's database server system. Alternatively, the system's database server system can load data into the dialysis center's data system. With several data sources used to monitor, diagnose and treat dialysis patients, it is desirable to consolidate data in one system.
[00322] [00322] The database server system can be composed of cloud-based storage and / or local servers. Network-based storage can be called remote data storage or cloud data storage. The EMG signal data stored in the cloud data storage (for example, database) can be accessible to the respective users over a network, such as the Internet. The data stored in a database in the cloud can be accessible from any account and / or device that has access granted to that data. In some variations, a patient's computing device may connect to another service / platform containing patient data (for example, valve data, sensor data, dialysis data) to receive that data.
[00323] [00323] In a variation, the database server system communicates with the patient's monitoring device (directly or through a separate transmitting device) for the entire duration of the monitoring period via communication channels wireless or wired network (for example, LTE cell phone, 4G, wired internet or wireless internet). The database server system can send encryption keys to the patient monitoring device, receive data from the patient monitoring device in raw, partially processed or fully processed format and send confirmation from the monitoring device when the data is successfully received. The database server system can decrypt patient monitoring device data, process patient monitoring device data by performing a series of mathematical calculations on received data with or without received historical data, perform a series of image analysis algorithms and store data in memory units. The database server also communicates with user interface systems through wired or wireless network communication channels (for example, LTE, 4G cell phone, wired internet or wireless internet). The database server system can receive logon requests with user information and password from the user interface system, send confirmation of the user interface system login with a temporary access key or deny access. login access, receive data requests from the user interface system along with the access key, send the data requested by the user interface system, receive additional user input data in an encrypted format from the interface system with the user, decrypt and process additional user input data and store additional user input data. The database server also communicates an alert system to the user interface system (eg, push notifications, messages, alerts), directly to cell phones (eg, calls, text messages), via email (for example, email messages), or for emergency personnel communication systems (for example, 911 calls). Processor
[00324] [00324] The processor can be any suitable processing device configured to execute and / or execute a set of instructions or code and can include one or more data processors, image processors, graphics processing units, processing units physical processing, physical processing units, digital signal processors and / or central processing units. The processor can be, for example, a general purpose processor, Field Programmable Port Array (FPGA), an Application Specific Integrated Circuit (ASIC) and / or the like. The processor can be configured to run and / or run application processes and / or other modules, processes and / or functions associated with the system and / or a network associated with it. The underlying device technologies can be supplied in a variety of component types, including, but not limited to, metal oxide semiconductor field effect transistor (MOSFET) technologies as a complementary metal oxide semiconductor (CMOS), bi-polar technologies such as emitter-coupled logic (ECL), polymer technologies (for example, polymer conjugated to silicon and polymer-
[00325] [00325] In some variations, the memory may include a database (not shown) and may be, for example, a random access memory (RAM), a memory buffer, a hard disk, an erasable programmable read-only memory (EPROM), an electrically erasable read-only memory (EEPROM), read-only memory (ROM), Flash memory and the like. As used here, the database refers to a data storage facility. The memory can store instructions to make the processor (execute modules, processes and / or functions associated with the computing device, such as valve control, signal data processing, data analysis, sensor control, communication and / or user settings. variations, storage can be network based and accessible to one or more authorized users. network based storage can be called remote data storage or cloud data storage. EMG signal stored in cloud data storage (eg database) can be accessible to the respective users over a network, such as the Internet. In some variations, the database server may be an FPGA based in the cloud.
[00326] [00326] The systems, devices and / or methods described here can be executed by software (executed in hardware), hardware or a combination of them. The modules can include, for example, a general purpose processor (or microprocessor or microcontroller), a field programmable port arrangement (FPGA) and / or an application specific integrated circuit (ASIC). Software modules (running on hardware) can be expressed in a variety of software languages (for example, computer code), including C, C ++, Java®, Python, Ruby, Visual Basic® and / or other object-oriented, procedural, or other programming language and development tools.
Examples of computer code include, but are not limited to, microcode or micro-instructions, machine instructions as produced by a compiler, code used to produce a Web service, and files that contain top-level instructions executed by a computer using an interpreter.
Additional examples of computer code include, but are not limited to, control signals, encrypted code and compressed code.

权利要求:
Claims (60)
[1]
1. Method for detecting infection in a patient, characterized by the fact that it comprises: receiving fluid from the patient through a fluid conduit; measure an optical characteristic of the patient's fluid in two or more wavelength ranges; estimate a leukocyte concentration based, at least partially, on the measure of optical characteristic in two or more wavelength bands; and detecting a patient's infection status based, at least partially, on the estimated leukocyte concentration.
[2]
2. Method, according to claim 1, characterized by the fact that the optical characteristic comprises one or more within optical dispersion and absorption.
[3]
3. Method, according to claim 1, characterized by the fact that measuring the optical characteristic in a first wavelength range corresponds to a total particle concentration of the patient's fluid and measuring the optical characteristic in a second wavelength wavelength corresponds to a leukocyte concentration in the patient's fluid, where the first wavelength range is different from the second wavelength range.
[4]
4. Method according to claim 1, characterized by the fact that the first wavelength range is between approximately 700 nm and approximately 1 mm and the second wavelength range is between approximately 260 nm and approximately 550 nm.
[5]
5. Method, according to claim 1, characterized by the fact that measuring the optical characteristic in a first wavelength range corresponds to a total particle concentration of the patient's fluid and measuring the optical characteristic in a second wavelength wavelength corresponds to a concentration of non-leukocyte particles in the patient's fluid, in which the first wavelength range is different from the second wavelength range.
[6]
6. Method, according to claim 1, characterized by the fact that it comprises: measuring the homogeneity of the patient's fluid using the sensor; and exclude a set of measures of optical characteristic from the leukocyte concentration estimate based, at least partially, on the measure of homogeneity.
[7]
7. Method, according to claim 1, characterized by the fact that it comprises: receiving dialysate fluid through the fluid conduit; and measure the optical characteristic of the dialysate fluid using the sensor, where the dialysate fluid must be infused into the patient and the patient's fluid is drained from it, and the estimated leukocyte concentration is based, at least partially, in the measure of the optical characteristic of the dialysate fluid.
[8]
8. Method, according to claim 1, characterized by the fact that it comprises: estimating a differential of the optical characteristic between the patient's fluid and the dialysate fluid; and updating the patient's infection status based, at least partially, on the differential of the optical characteristic.
[9]
9. Method according to claim 1, characterized by the fact that it comprises: measuring one or more of a flow and volume of the patient's total fluid flow using a flow sensor coupled to the fluid conduit; and normalize the measurement of optical characteristic based on one or more of the flow and measure of total flow volume.
[10]
10. Method, according to claim 9, characterized by the fact that it comprises: detecting one or more of an obstruction and flow direction based, at least partially, on the flow measurement.
[11]
11. Method according to claim 9, characterized by the fact that it comprises: estimating one or more of an infusion volume, drainage volume, infusion time, drainage time, and residence time based, at least partially , to the extent of flow; and estimate one or more of a dialysis efficacy and dialysis suitability based, at least partially, on the estimated infusion volume, drainage volume, and length of stay.
[12]
12. Method, according to claim 1, characterized by the fact that it comprises: detecting one or more of an infusion state, permanence state, and drainage status of the patient's fluid without user input.
[13]
13. Method according to claim 1, characterized by the fact that it comprises one or more of the steps of: measuring the pH of the patient's fluid using a pH sensor, on which the detected state of infection is based, at least partially, in the pH measurement; measuring a lactate concentration in the patient's fluid using a lactate sensor, where the detected infection state is based, at least partially, on the measurement of lactate concentration;
count cells from the patient's fluid using a cell counter, where the detected infection status is based, at least partially, on the cell count; measuring leukocyte esterase of the patient's fluid using a test strip, in which the detected state of infection is based, at least partially, on the leukocyte esterase measurement; measuring a chemiluminescence of the patient's fluid using a chemiluminescence sensor, in which the detected state of infection is based, at least partially, on the chemiluminescence measurement; measure a patient's skin color using an image sensor, where the detected infection status is based, at least partially, on the color measurement; measure a conductivity of the patient's fluid using a conductivity sensor; estimate a solute concentration of the patient's fluid based, at least partially, on the conductivity measurement; measure the patient's fluid urea using an electromechanical sensor; estimate the urea concentration of the patient's fluid based, at least partially, on the urea measurement and at least one among the conductivity and a flow measurement; measure creatinine from the patient's fluid using an electromechanical sensor; estimate a creatinine concentration in the patient's fluid based, at least partially, on the measure of creatinine and a measure of flow volume; measuring glucose from the patient's fluid using a glucose sensor; and estimate a glucose concentration in the patient's fluid based, at least partially, on the glucose measurement and at least one among the conductivity and the measurement of the flow volume.
[14]
14. Method according to claim 1, characterized by the fact that it comprises: issuing at least one alert comprising one or more of the patient's infection status, patient complying with a prescribed therapy, therapy effectiveness, sensor calibration , fluid conduit maintenance, and sensor data.
[15]
15. Method, according to claim 13, characterized by the fact that it comprises: modifying an alert sensitivity based on one or more of a set of clinical patient events and a patient profile.
[16]
16. Method, according to claim 1, characterized by the fact that it comprises: issuing a request to insert patient data in response to the detection of a positive infection state of the patient; receive the patient's input data; and classifying the detected infection status as a false positive based, at least partially, on the patient's input data.
[17]
17. Method, according to claim 1, characterized by the fact that it comprises: issuing an alert corresponding to the obstruction of the fluid conduit based, at least partially, on a pressure measurement and an acceleration measurement.
[18]
18. Method, according to claim 1, characterized by the fact that it comprises: transmitting the patient's infection status to a health care provider;
receiving a prescription for a therapeutic agent from the health care provider; and dispensing the therapeutic agent without user input.
[19]
19. Method, according to claim 1, characterized by the fact that it comprises: collecting a sample of the patient's fluid in a sample container releasably coupled to the fluid conduit based, at least partially, on the state of infection detected from the patient; and disengage the sample container from the fluid conduit.
[20]
20. Method according to claim 1, characterized by the fact that it comprises: issuing an alert sample container to one or more of the patient, a health care provider, and a carrier based, at least partially, on the infection status and a location of the sample container.
[21]
21. Method according to claim 1, characterized in that it comprises coupling the sensor between a drain line and a drainage container or coupling the sensor between an infusion line and an infusion dialysate container.
[22]
22. Patient monitoring device, characterized by the fact that it comprises: an optical sensor arrangement comprising at least one emitter and at least one detector, the emitter configured to transmit light in one or more wavelength bands through a patient fluid flowing through a fluid conduit, and the at least one detector configured to receive the light transmitted through the patient's fluid and generate signal data based on the received light; and a controller configured to estimate the total particle concentration and leukocyte concentration using the signal data.
[23]
23. Patient monitoring device, according to claim 22, characterized by the fact that it comprises: a housing closing the arrangement of the optical sensor, in which the fluid conduit is configured to releasably engage the housing .
[24]
24. Patient monitoring device according to claim 23, characterized in that the housing is configured to move between an open configuration with an exposed interior cavity and a closed configuration with a closed interior cavity.
[25]
25. Patient monitoring device according to claim 22, characterized by the fact that it comprises at least one non-contact fluid sensor comprising one or more of a pressure sensor, image sensor, accelerometer, gyroscope, temperature sensor , and magnetic field transducer.
[26]
26. Patient monitoring device according to claim 22, characterized in that the fluid conduit comprises at least one transparent portion that is substantially transparent to at least one among ultraviolet light, visible light, and infrared radiation .
[27]
27. Patient monitoring device, according to claim 22, characterized by the fact that the fluid path comprises an entrance configured to couple at least one of a permanent catheter and a drainage line for peritoneal dialysis, and an outlet configured to open towards a drain pan.
[28]
28. Patient monitoring device according to claim 22, characterized by the fact that one or more portions of the fluid conduit are composed of one or more of copolymers of cyclic olefin, acrylic, polycarbonate (COC), polystyrene , acrylonitrile butadiene styrene (ABS), silicone coated with polyethylene glycol, polyurethane coated with zwitterionic, polyvinyl chloride coated with polyethylene oxide, and polyphenyl silicon.
[29]
29. Patient monitoring device according to claim 26, characterized in that the fluid conduit is a first fluid conduit, and a second closed-end fluid conduit branches from the first fluid conduit, and comprises a flow sensor configured to measure a fluid level from the second fluid conduit.
[30]
30. Patient monitoring device according to claim 22, characterized in that the fluid conduit comprises a sphere, and further comprises a flow sensor configured to measure the sphere.
[31]
31. Patient monitoring device according to claim 22, characterized in that the fluid conduit comprises at least one fluid contact sensor comprising one or more of a flow sensor, conductivity sensor , temperature sensor, pH sensor, lactate sensor, test strip, chemiluminescence sensor, electromechanical sensor, and glucose sensor.
[32]
32. Patient monitoring device according to claim 22, characterized by the fact that one or more portions of the fluid conduit are composed of a material susceptible to bacterial incrustations.
[33]
33. Patient monitoring device, according to claim 22, characterized by the fact that it comprises a support configured to reliably fix the housing to a drainage container.
[34]
34. Patient monitoring device according to claim 22, characterized in that the housing comprises a therapeutic agent container configured to store a therapeutic agent, in which the controller is configured to receive a prescription from a provider of healthcare and releasing the therapeutic agent based on the prescription received, where releasing the therapeutic agent comprises one or more of unlocking the container of the therapeutic agent and dispensing the therapeutic agent to the fluid conduit.
[35]
35. Patient monitoring device according to claim 22, characterized in that the controller is configured to open a valve to fill a sample container with the patient's fluid upon detecting a positive infection status of the patient.
[36]
36. Patient monitoring device according to claim 22, characterized in that it comprises a support comprising an adhesive layer comprising one or more of a silicone adhesive and an acrylate adhesive.
[37]
37. Patient monitoring device according to claim 34, characterized by the fact that it comprises one or more of a temperature sensor and a skin color sensor located on a mounting surface.
[38]
38. Patient monitoring device, characterized by the fact that it comprises: a housing configured to releasably engage a fluid conduit; at least one sensor configured to measure at least one characteristic of the fluid flow through the fluid conduit; and a controller configured to generate patient data comprising a patient's infection status based, at least partially, on at least one characteristic.
[39]
39. Patient monitoring device according to claim 38, characterized by the fact that the characteristic comprises one or more among optical dispersion, absorption, color, flow, conductivity, temperature, pH, lactate concentration, count cell count, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration, and creatinine concentration.
[40]
40. Patient monitoring device according to claim 38, characterized in that the housing comprises a joint and the housing is configured to surround at least a portion of the fluid conduit.
[41]
41. Patient monitoring device according to claim 38, characterized in that the fluid conduit comprises a rigid curved end configured to reliably secure the fluid conduit to a drainage container so that the housing is separate from the drain pan.
[42]
42. Patient monitoring device according to claim 38, characterized in that at least one sensor is configured to pinch a portion of the transparent fluid conduit to at least one of ultraviolet light, visible light, and radiation infrared.
[43]
43. Patient monitoring device according to claim 38, characterized by the fact that at least one sensor is a fluid contact sensor.
[44]
44. Patient monitoring device according to claim 38, characterized by the fact that it comprises a limited-use sensor configured to releasably engage one or more of the fluid conduit and the housing.
[45]
45. Patient monitoring device according to claim 44, characterized by the fact that the controller is configured to detect an expiration of the limited use sensor based, at least partially, on the measured flow.
[46]
46. Patient monitoring device according to claim 38, characterized by the fact that the fluid conduit is coupled to one or more of a permanent catheter for peritoneal dialysis, a urinary catheter, hydrocephalus derivation, percutaneous catheter abscess drainage, ascites drainage catheter, insulin pump, feeding tube, central venous line catheter, tunneled catheter, and implanted access port.
[47]
47. Docking station, characterized by the fact that it comprises: at least one fluid chamber; a pump coupled to at least one fluid chamber; a fluid port coupled to at least one fluid chamber; a connectable hitch feature with a patient monitoring device; an engagement sensor configured to generate a sensor signal when the engagement feature is coupled with the patient monitoring device; and a controller configured to circulate a fluid through the patient monitoring device using the fluid pump based, at least partially, on the sensor signal.
[48]
48. Docking station according to claim 47, characterized by the fact that the fluid is circulated in one or more of a predetermined flow, conductivity, optical dispersion, absorption, and temperature, and the controller is configured to calibrate at least a sensor from the patient monitoring device using the circulating fluid.
[49]
49. Docking station according to claim 47, characterized in that at least one fluid chamber comprises a first chamber and a second chamber, the first chamber fluidly separated from a second chamber.
[50]
50. Docking station according to claim 47, characterized by the fact that it comprises a UV light source configured to optically connect to a fluid conduit of the patient monitoring device, in which the controller is configured to emit UV light to the fluid conduit using the UV light source.
[51]
51. Docking station according to claim 47, characterized by the fact that the coupling feature comprises a fluid connector and an electrical connector, in which the fluid connector is configured to connect with a fluid conduit of the device. positive patient monitoring, and the electrical connector is configured to connect with one or more of an electronic communication device and a power source from the patient monitoring device.
[52]
52. Docking station according to claim 47, characterized by the fact that it comprises at least one sensor comprising one or more of a flow sensor, conductivity sensor, image sensor, pressure sensor, accelerometer, and temperature transducer magnetic field.
[53]
53. Docking station according to claim 47, characterized by the fact that the controller is configured to receive, store, and transmit one or more of the sensor data, calibration data, patient data, and device data. patient monitoring device.
[54]
54. Docking station, according to claim
47, characterized by the fact that it comprises a battery charging port configured to supply a battery for the patient monitoring device.
[55]
55. Method of monitoring a patient's infection, characterized by the fact that it comprises: measuring at least one characteristic of a patient's fluid over a first period and a second period after the first period, to at least one characteristic comprising a or more among optical dispersion, optical absorption, flow, conductivity, temperature, pH, lactate concentration, cell count, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration, and creatinine concentration; generate patient data comprising a reference range of at least one characteristic on the first period; and monitoring a patient's status based, at least partially, on the reference range and the characteristic measured over the second period.
[56]
56. Method, according to claim 55, characterized by the fact that it comprises: measuring a set of clinical patient events during the first period and the second period after the first period; estimate a relationship between the set of clinical patient events and at least one characteristic over the first period; monitor a patient's status based, at least partially, on the estimated relationship and the characteristic measured over the second period.
[57]
57. Method, according to claim 55, characterized by the fact that it comprises sending an alert to a predetermined contact when the characteristic measured over the second period deviates from the reference range.
[58]
58. Method, according to claim 55, characterized by the fact that it comprises modifying an alert sensitivity based on one or more of a number of deviations from the reference range and a number of clinical patient events.
[59]
59. Method according to claim 55, characterized by the fact that the patient's condition comprises one or more of a patient's infection status, patient complying with the prescribed therapy, therapy effectiveness, device maintenance, sensor calibration, and sensor data.
[60]
60. Method, according to claim 55, characterized by the fact that it comprises: establishing a communication channel between the patient and a health professional in response to the alert corresponding to the patient being in a high risk condition.

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同族专利:

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EP3723608A1|2020-10-21|

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JP2021507737A|2021-02-25|

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WO2019118929A1|2019-06-20|

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AU2018385767A1|2020-06-11|

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US20190358387A1|2019-11-28|

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法律状态:
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