systems and methods for automatically removing fluid from multiple regions of a respiratory tract

专利摘要:
These are systems and devices to monitor, detect and remove fluid buildup found in various regions along an intubated patient's tracheal tube. The fluid management system includes pressure and flow sensors to detect if there is fluid in the various regions along the tracheal tube, and a means to extract the fluid into collection jars. The system also includes flushing features that are capable of flushing out different varied regions along a tracheal tube. Also disclosed are breathing inserts that attach to tracheal tubes or incorporate tracheal tubing, wherein the breathing insert body has channels and ports that contact various regions along the tracheal tube. The combination of the fluid management system and breathing inserters effectively monitors and removes fluid at multiple locations along an intubated patient's tracheal tube.
公开号:BR112017002798B1
申请号:R112017002798-4
申请日:2015-08-13
公开日:2021-07-06
发明作者:Jagdish Chaturvedi；Nitesh Kumar Jangir；Nachiket Deval；Ramakrishna Pappu；Raghuveer Rao；Mohammed Sajid Ali；Vimal Kishore Kakani
申请人:Coeo Labs Private Limited；
IPC主号:

专利说明:

CROSS REFERENCE TO RELATED ORDERS
[001] This patent application claims priority to Indian Provisional Application No. 3988/CHE/2014 filed on August 14, 2014, entitled "DEVICE AND METHOD FOR REMOVAL OF SECRETIONS TO PREVENT VENTILATOR ASSOCIATED PNEUMONIA", whose description of which is incorporated by reference. INCORPORATION BY REFERENCE
[002] All publications and patent applications mentioned in this specification are hereby incorporated by reference in their entirety to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. FIELD
[003] The present invention generally relates to fluid management apparatus including or for use with tracheal tubes and related devices. More particularly, the present invention relates to fluid management systems that are capable of removing secretions and monitoring blockages from crucial points along an endotracheal tube either continuously or at predefined intervals. When a blockage is detected, the system is then able to clear the blockage. Fluids and mucous membranes can then be collected for analysis. The devices are breathing inserters that monitor and remove fluid in different regions along a tracheal tube. FOUNDATION
[004] Tracheal tubes are inserted into the airway of patients in medical situations where the patient is unable to breathe on their own due to obstructions or lack of sensitization/awareness on the part of the patient. Tracheal tubes aid in mechanical ventilation of patients until patients can breathe on their own. Most tracheal tubes currently in use include an inflatable cuff or balloon between the tracheal tube and the walls of the patient's trachea. The balloon or cuff obstructs the airway passage and establishes a closed system where gas pressure to the patient's lungs can be more easily regulated and the cuff or balloon helps prevent the passage of fluid and debris to the patient's trachea . FIGURES 1A-B show typical locations in the respiratory tract where fluid can travel in an intubated patient. While FIG. 1A shows that primary fluid buildup typically occurs above an inflatable cuff of a tracheal tube; FIG. 1B shows that other regions along the trachea of an intubated patient may also be susceptible to fluid accumulation.
[005] A major complication associated with intubation and the use of tracheal tubes is ventilator-associated pneumonia (VAP). VAP is a type of lung infection that occurs in patients who are placed on ventilators. VAP typically affects those who are already weak, such as patients in an intensive care unit (ICU) and/or with compromised immune systems. The development of VAP can increase the time a patient is in the ICU and hospital. VAP also increases the probability of death by 2030%.
[006] VAP usually occurs because the tracheal tube allows the passage of bacteria to the lower portions of the lung in an intubated patient. These patients may already have underlying problems that lower their resistance to bacteria. Bacteria can thrive in fluid that accumulates around the tracheal tube, especially where there are bends in the tracheal tube that allow fluid to accumulate. Thus, the initial curvature in the tracheal tube between the posterior part of the oral cavity and just after the pharynx, as well as the area above the cuff or inflatable balloon, can be especially prone to accumulation of fluids and mucous membranes. When patients remain on a ventilator for long periods, the risk of bacterial infection increases. Furthermore, bacteria can also be pulled down towards the lungs during breathing. In addition, the bacteria that cause VAP can be differentiated from the bacteria that cause the more common community-acquired pneumonia (CAP). Several bacteria associated with VAP are resistant to commonly used antibiotics. Thus, it would be desirable to minimize the amount of fluid collection along the tracheal tube which can provide a hospitable environment for bacteria to grow.
[007] The existing mechanism to address fluid accumulation around a tracheal tube is not adequate. In most systems currently available and described, the device is only designed to draw fluid away from the tracheal tube in one location or if there is the potential for more than one suction site along the tracheal tube, the additional area is limited to the region immediately above of the cuff or inflated balloon. In some variations, ports are arranged along a tracheal tube at two locations, but these locations are not associated with specific anatomic locations in a patient. For example, U.S. Patent 8,434,488 ('488) describes a tracheal tube with multiple ports that are integrated with the groove of the main tracheal tube. The '488 tracheal tube only includes a suction lumen, where suction occurs slightly distal to the cuff. The ‘488 tracheal tube also includes a line to inflate the cuff and maintain a certain amount of pressure within the cuff. FIGURES 1C and D illustrate traditional fluid management systems where suction only occurs in the region directly above the inflatable cuff. In addition, traditional fluid management systems require the caregiver to manually suppress any fluid present over the time a patient is intubated, which requires more staff time in an already understaffed healthcare system.
[008] Thus, there is a need for fluid management apparatus for use with ventilation that can monitor for fluid accumulation along different regions of a respiratory insert (eg, tracheal) and automatically and periodically remove fluid. SUMMARY OF DESCRIPTION
[009] The present invention relates to apparatus (including systems and devices) and methods for periodically (and automatically) eliminating fluid buildup in three or more regions along a breath insertion device (e.g., tube) which are more likely to collect fluid, so any accumulated fluid can be removed. These devices can also be configured to level fluid ducts and/or provide a flush to the patient.
[010] Certain regions (corresponding to the patient's anatomy) along a breathing insertion device (such as endotracheal tube, tracheostomy tubes, etc., which may be referred to for convenience herein as a "tracheal tube") are more likely to collect fluid when inserted into a patient in a 30 degree tilted/horizontal position. Three regions identified include the subglottic region directly above the inflatable balloon or cuff, an oropharyngeal cavity located after the oral cavity, and the oral cavity. Being able to remove fluid buildup in these three regions will significantly reduce the likelihood of VAP in an intubated patient.
[011] The fluid management apparatus described herein can automatically remove fluid from multiple regions of a patient's respiratory tract. In some variations, the fluid management apparatus (eg system) can be manually adjusted to remove fluid from different regions along a tracheal tube. Also discussed here are breathing inserters that can connect to the fluid management system, although the fluid management devices described herein can also be configured to operate with commercially existing breathing inserters (e.g., endotracheal tubes and tracheostomy tubes).
[012] A fluid management system may include an input (e.g., button, touch screen, display, switch, etc.) that is capable of receiving user-selected control information, such as wash release frequency, wash duration, wash pressure, frequency of suction application, and suction pressure. In some variations, the user can set the pressure threshold to determine if there is a blockage within a fluid duct connected to a breathing insertion device. Thresholds can also be preset. For example, default values can be set by the manufacturer. Threshold values for pressure can be the same for each of the separate ducts, but different pressure values for different ducts can be selected in some variations.
[013] The fluid management apparatus described herein may also have other control and detection components. This can include suction valves that are in fluid communication with sensors and suction mechanism. Valves can control fluid flow within fluid ducts. These devices can also include flow and pressure sensors that detect one or both of the presence of fluid in a given duct and/or blockage within the fluid ducts, as well as monitor when all fluid has been removed from a particular region. . The system can also include filters before and/or after valves and sensors connected or connected to one or more fluid ducts. Filters can minimize contamination reaching valves and sensors.
[014] The devices described here can automatically remove fluid from multiple regions along a respiratory tract. The system can also be configured to flush a portion of the oral cavity of the respiratory tract. In some variations, the system includes controller circuitry, a display, and one or more valves configured to couple to a source of air pressure. The system may also include first, second and third fluid ducts, wherein the first, second and third fluid ducts mate with one or more valves of the controller, and wherein the controller is configured to apply, independently, positive or negative pressure through each of the first, second, or third fluid ducts. The first fluid duct can couple to a first flow sensor and a first pressure sensor, the second fluid duct can couple to a second flow sensor and a second pressure sensor, and the third fluid duct can couple to a third flow sensor and a third pressure sensor. Flow sensors may be outside their respective fluid ducts. In some variations there are 4 fluid ducts, with an additional fluid duct as well as the three ducts (oral, oropharynx and subglottic) mentioned above. The additional fluid duct can remove secretions from the interior of the breathing inserter (eg, endotracheal tube) either using a closed suction catheter or using a modified breathing inserter with an additional lumen on the inwardly facing distal end. to remove secretions from the interior of the breathing inserter (eg, endotracheal tube).
[015] Fluid management system controller circuit sets can be configured to periodically, automatically and independently apply negative pressure to each of the first, second, and third fluid ducts (and, in some variations, fluid ducts additional fluid, such as a fourth or tracheal fluid duct), and stop applying negative pressure in the first, second or third fluid ducts when fluid flows in the first, second or third fluid ducts is below a first flow threshold and when the pressure in that fluid duct is above a first pressure threshold. The controller circuit assembly may also apply positive pressure to the first, second or third fluid ducts when the fluid flow is below the first flow threshold, when negative pressure is applied and the pressure is below a second threshold of pressure in the first, second, or third fluid ducts. Finally, the controller circuitry may be configured to display for one or more of the first, second and third fluid duct data comprising one or more of the flow rate of a secretion within the fluid duct, secretion thickness within the fluid duct, volume of secretion within the fluid duct, or color of secretion within the fluid duct.
[016] The fluid management system may also include a flushing system (or subsystem). The flushing system (subsystem) can apply positive pressure to release a flushing fluid through one of the fluid ducts (e.g., the duct connected to the region of the breathing inserter within the oral cavity) and to apply negative pressure to one or more other of the fluid ducts to remove the flushing fluid. The pump may be in communication with the controller and flush fluid source and may be signaled to provide positive pressure to the fluid ducts. The system may include a plurality of fluid ducts that directly connect (or may be connected through one or more flush release fluid ducts) to the source of flush liquid fluid. The controller may signal the wash pump to apply positive pressure to one or more wash release fluid ducts to release wash fluid. Any of these apparatus may also include one or more containers to hold the returned wash fluid.
[017] Thus, any of these systems may also include a source of flushing fluid (e.g., antibacterial mouthwash, etc.), wherein the controller is configured to automatically apply positive pressure to release flushing fluid at a frequency of wash release; and a first collection vessel coupled to first fluid ducts for collecting fluid from the first fluid duct, a second collection vessel coupled to the second fluid duct for collecting fluid from the second fluid duct, and a third fluid duct collection coupled to the third fluid duct to collect fluid from the third fluid duct.
[018] As mentioned above, these appliances may also include an input configured to receive control information selected by the user, which may include (or be limited to) control information related to suction and/or washing, including: the frequency wash release time, wash duration, wash pressure, suction application frequency, suction duration, and suction pressure.
[019] In general, any of these apparatus may also include one or more filters, wherein one or more valves is in communication with fluid ducts through one or more filters. The valves can be suction valves, where a first suction valve is between the first fluid duct and the air pressure source, a second suction valve is between the second fluid duct and the air pressure source, and a third suction valve is between third fluid duct and air pressure source.
[020] As mentioned, the apparatus may also include one or more wash release fluid ducts that are connected to the wash liquid source, and wherein the controller is configured to apply positive pressure to one or more wash fluid ducts. flush release to release flushing fluid. The apparatus may also include a pump configured to apply positive pressure, where the pump is in communication with the controller and the source of flushing fluid. In this way, the controller can be configured to apply positive pressure to release the flushing fluid through the first fluid duct and to apply negative pressure to the first, second, and third fluid ducts to remove the flushing fluid. Finally, the apparatus may include a container to collect used flushing fluid.
[021] The fluid management systems described herein may also include an output, such as a display (eg, display, monitor, etc.), where data relative to the first, the second, and in some variations, the third , of four additional fluid ducts are shown. Data can include the flow rate of a secretion within the fluid duct, the thickness of the secretion within the fluid duct, the volume of secretion within the fluid duct, or the color of the secretion within the fluid duct.
[022] Any of these devices may include collection containers. One or more, for example, a first, a second and a third (and in some variations, a fourth) collection containers may be coupled to a first, second and third fluid duct, where each is connected. to a valve of one or more valves and the source of air pressure.
[023] The breathing inserter extends distally along its main axis. The breather inserter includes first and second lumens, where the first and second lumens include first and second grooves in fluid connection with the first and second lumens, respectively. The first and second grooves are located spatially from each other along the tracheal tube such that two regions along the tracheal tube prone to fluid accumulation correspond to the location of the first and second grooves. In some cases, the first and second grooves are at least 0.4 inches apart. In other examples, a third lumen having a corresponding third groove is also disposed along the tracheal tube in a region remote from and not in regions corresponding to the location of the first and second grooves of the first and second lumens.
[024] The first, second and potentially third lumen all include a means to fluidly connect to corresponding fluid ducts at an opposite end from the respective grooves. The fluid ducts are coupled to suction apparatus, such as a pump, which are capable of extracting fluid from regions associated with the first, second and third grooves. There may be separate fluid ducts that connect to the first, second and third lumens, or there may be a fluid duct that serves to remove fluid from the entire lumen present using appropriate connectors.
[025] The fluid management system also includes a controller that is in electrical communication with the sensors, the pump or pumps, valves and other components. The controller will periodically test for fluid or mucosal blockage within the different lumen that correspond to different regions of the tracheal tube. If blockage is detected, the controller will tell the pumps to apply positive pressure and then negative pressure to clear fluid and mucus.
[026] In general, a tracheal tube is a catheter that is inserted into the trachea for the primary purpose of establishing and maintaining an airway patent and ensuring adequate exchange of oxygen and carbon dioxide. Many different types of tracheal tubes are available, suitable for different specific applications, including endotracheal tubes and tracheostomy tubes. For example, an endotracheal tube (ET) is typically a specific type of tracheal tube that is almost always inserted through the mouth (orotracheal) or nose (nasotracheal). A tracheostomy tube is another type of tracheal tube, which can be, for example, a 2-3 inch long curved metal or plastic tube that can be inserted into a tracheostomy stoma (following a tracheostomy) to maintain a lumen of patent. The breathing (or in some variations, endorespiratory) inserters described herein may be tracheal tubes or may be adapted for use with a tracheal tube, as described in greater detail below.
[027] The system may couple to a breathing inserter (which may also be referred to as a breathing inserter), wherein the breathing inserter extends distally on an elongated axis, the breathing device. Breathing insert may include a plurality of lumen extending on the elongated axis and a plurality of grooves, where each lumen is in fluid connection with a groove, and where grooves for different lumen are separated along the elongated axis at length. minus 0.4 inch. In general, each of the lumens in the plurality of lumens is configured to fluidly connect with one of the first, second, or third fluid ducts. As described in detail below, in some variations the systems described herein may include additional fluid ducts and, in particular, a fourth fluid duct that is configured to connect to a lumen in a tracheal device that can be connected to remove fluid. from within the central and/or main lumen of the tracheal tube. This can be referred to as a tracheal line.
[028] As mentioned, the breathing inserters described herein may be tracheal tubes or may attach to an existing tracheal tube. In the first case, where the tracheal tube incorporates fluid management features, the breathing insertion device may have three or more (eg 4) lumens integrated along with the main tracheal tube passage, ie the three lumens for the aforementioned sites and a fourth lumen to remove secretions from the interior of the main tracheal tube. As mentioned above, suction from predetermined regions along the tracheal tube path is through slots along the breathing inserter. In the latter case, where the breathing inserter attaches to an existing endotracheal tube, several examples are described herein. In one example, the breathing inserter can fit into an existing endotracheal tube and be slid down along the length of the tracheal tube. The breathing inserter clip includes separate lumen having corresponding grooves that contact predetermined regions along the tracheal tube. In some variations the breath inserter clip may have a hinge to facilitate placement of the breath inserter.
[029] The respiratory insert body can independently remove fluid from multiple regions of a respiratory tract. The respiratory insert may have an elongated shaft extending proximally and distally with a first lumen disposed along the elongated body having a first lumen proximal end and a first lumen distal end, a second lumen disposed along the length. elongated body having a second proximal lumen end and a second lumen distal end, and a third lumen disposed along the elongated body having a third lumen proximal end and a third lumen distal end. In some variations, the apparatus may include a first, second, and third slot respectively disposed over the first, second, and third lumen distal ends. The first, second, and third grooves can be positioned along the elongated body so that the first, second, and third grooves are separated from each other by at least 0.4 inches along the elongated axis. . The first slot in the respiratory insert can be configured to be positioned in a user's oral cavity, the second slot is configured to be positioned in a user's oropharynx region, and a third slot through the endotracheal insert is configured to be positioned in a user's subglottic region when the endotracheal insertion body is inserted into the user's throat. In some examples, the elongated body comprises a tubular body that has a central tracheal tube lumen groove at a proximal end and a distal end of the endotracheal insert. In other examples, the elongated body comprises a sheath configured to connect over an endotracheal tube. The elongated body can also be a spiral sheath configured to connect over an endotracheal tube. In some cases, a series of clips/attachments that can fit over an endotracheal tube. In general, the first proximal lumen end, the second proximal lumen end, and the third proximal lumen end each comprise a fluid duct coupler configured to connect to a fluid duct. Finally, the first groove is between about 3 cm and 14 cm from the third groove, and further wherein the second groove is between about 2 cm and 10 cm from the third groove.
[030] Some of the breathing inserters described herein are for coupling to tracheostomy tubes or may incorporate a tracheostomy tube. In one case, the inserter has an elongated bifurcated body having a first arm and a second arm, the body having an elongated axis extending proximally and distally. The first arm is configured to extend through a lumen of the tracheal tube and comprises a curved distal end region configured to extend outwardly from a distal end of the tracheostomy tube, surround the distal end of the tracheal tube and extend proximally. through the tracheal tube. The second arm is configured to extend distally along the outside of the tracheal tube. First and second grooves disposed within the first arm of the elongated body. The first groove is disposed proximal to the curved distal end region of the first arm and configured to reside within the lumen of the tracheal tube. The second slot may be disposed distally to the bent distal end region and configured to reside outside a distal end region of the tracheal tube. A third slot may be disposed in a third lumen within the second arm, the third slot disposed near a distal end of the second arm. The proximal end of the first lumen may comprise a first fluid duct coupler configured to connect to a first fluid duct, a proximal end of the second lumen comprises a second fluid duct coupler configured to connect to a second fluid duct and a proximal end of the third lumen comprises a third fluid duct coupler configured to connect to a third fluid duct.
[031] In another example, a breathing insertion device includes an integrated tracheostomy tube. Here, the inserter may have an elongated body, the body having an elongated axis extending proximally and distally, an inflation clamp near a distal end of the elongated body, a central lumen within the elongated body, a first a lumen extending proximally and distally along an elongated body that has a first groove facing inwardly toward the central lumen/passage (between the first lumen and a central lumen that serves as a tracheal tube), a second lumen that extends proximally and distally along the elongate body having a second groove in the second lumen at an exterior of the elongate body distal to the inflation clamp, and a third lumen extending proximally and distally along the elongate body having a third groove into the third lumen on an exterior of the elongated body proximal to the inflation arm. Similar to the examples above, a proximal end of the first lumen may comprise a first fluid duct coupler configured to connect to a first fluid duct, a proximal end of the second lumen may comprise a second fluid duct coupler configured to connect to a second fluid duct and a proximal end of the third lumen may comprise a third fluid duct coupler configured to connect to a third fluid duct. BRIEF DESCRIPTION OF THE DRAWINGS
[032] FIG. 1A shows a traditional endotracheal tube (tracheal tube) that has been inserted into a patient where the arrow shows a fluid accumulation bag.
[033] FIG. 1B shows a trachea and a region of the bronchi, showing different regions where fluid can collect.
[034] FIG. 1C shows a traditional fluid removal set that only aspirates a subglottic region of the patient.
[035] FIG. 1D shows a traditional tracheal tube system that requires manual suction and drainage of subglottic secretions.
[036] FIG. 2 shows an example of a fluid management system, together with a breathing insertion device, that automatically and periodically monitors and removes fluid from multiple regions along a tracheal tube.
[037] FIG. 3 shows an example of a breath insertion device of an automatic fluid removal system inserted through a subject's mouth (shown in cross section) and the groove created within a patient's trachea.
[038] FIG. 4 shows a generic fluid management system as described herein.
[039] FIG. 5 shows one embodiment of a fluid management system that can be used in combination with various embodiments of a breath insertion device (three are shown on the right).
[040] FIG. 6 shows two aspects of a fluid management system, including detection and control components.
[041] FIG. 7 is a block diagram of a fluid management system embodiment showing a controller in connection with various components (including tracheal tube, a flow sensor, a pressure sensor, a pressure control mechanism, control valve, vacuum, washing, a display and an energy source).
[042] FIG. 8 is a block diagram of an alternative embodiment of the tracheal tube fluid management system for three regions of the trachea having an external suction.
[043] FIG. 9 is a block diagram of an alternative embodiment of the tracheal tube fluid management system for three regions of the trachea having an incorporated suction.
[044] FIG. 10 is a circuit diagram of a variation of a fluid management system.
[045] FIG. 11 is a block diagram of an embodiment of a fluid management system having secretion collection vessel detection units and a pressure sensor, and having six independent ducts including three aspiration ducts and three wash ducts.
[046] FIG. 12 is a block diagram of another variation of a fluid management system having non-return valves along each independent suction tube.
[047] FIG. 13 shows an alternative embodiment of a fluid management system having secretion collection containers behind aspiration values and controls.
[048] FIG. 14 shows an alternative embodiment of a fluid management system having a collection vessel behind suction ducts, valves and flush valves using 3-way valves.
[049] FIG. 15 shows an alternative embodiment of a fluid management system having four independent ducts with corresponding sensors.
[050] FIG. 16A is an image of the closed controller, fluid ducts, and secretion collection vessel.
[051] FIG. 16B is a meticulous image of the controller showing microcontroller, valves, pumps, and circuitry.
[052] FIG. 16C is yet another meticulous image showing controls, controller with suction valves, pressure controller, vacuum, and fluid ducts.
[053] FIG. 17 shows another representative block diagram of the fluid management system having three independent suction ducts.
[054] FIG. 18 shows various combinations of traditional tracheal tubes and systems with the fluid management system described and an insertion body.
[055] FIG. 19A shows a variation of a breath insertion device.
[056] FIG. 19B shows a spiral embodiment of a breath insertion device.
[057] FIG. 19C shows a spiral-shaped breathing insert for use with a tracheal tube.
[058] FIG. 19D shows a meticulous image of regions of the breathing inserter of FIG. 19A.
[059] FIG. 20 shows a hinged embodiment of the breath inserter.
[060] FIG. 21 shows a stent-type embodiment of the breathing inserter.
[061] FIG. 22A shows a ring-like embodiment of a breathing inserter with suction lumen.
[062] FIG. 22B is an alternative perspective view of the ring-like embodiment of the breathing inserter with the suction lumen of FIG. 22A.
[063] FIG. 22C is an enlarged drawing of a portion of the ring-type modality breathing inserter with suction lumen.
[064] FIG. 23A shows a front view of an alternative embodiment of a clip breathing inserter.
[065] FIG. 23B shows a side view of the alternative embodiment of the clip breathing inserter of FIG. 23A.
[066] FIG. 24A is a disadvantageous view of yet another embodiment for the clip breathing inserter comprising two materials.
[067] FIG. 24B is a side view of another embodiment for the clip breathing inserter comprising C-shaped supports.
[068] FIG. 25A is a front perspective view of an embodiment of a breather inserter with five channels for flushing and removing secretions.
[069] FIG. 25B is a side view of an embodiment of the breath inserter with five channels for flushing and removing secretions.
[070] FIG. 25C is a perspective view of an embodiment of the breath inserter with five channels for flushing and removing secretions.
[071] FIG. 26A is a front perspective view of one embodiment of a stacked lumen clip breathing inserter.
[072] FIG. 26B is a side view of the free clip breathing inserter of FIG. 26A with stacked lumen.
[073] FIG. 26C is a side view of a stacked lumen clip breathing inserter engaged with a tracheal tube.
[074] FIG. 27A is a side view of an oropharyngeal airway insert. FIG. 27D shows a sectional view through the proximal end of the insert of FIG. 27A.
[075] FIG. 27B is another view of the oropharyngeal airway insert.
[076] FIG. 27C is a third view of the oropharyngeal airway insertion body showing suction ports.
[077] FIG. 28A is a side view of an integrated breath inserter showing a first suction region.
[078] FIG. 28B is a side view of the integrated breather inserter of FIG. 28A showing a second suction region.
[079] FIG. 28C is a side view of the integrated breather inserter of FIG. 28A showing a third suction region.
[080] FIG. 28D is a representation of a section through the proximal end of the integrated breathing inserter of FIG. 28A.
[081] FIG. 28E shows a distal end of the integrated breath inserter of FIG. 28A.
[082] FIG. 28F shows another view of the respiratory insert having three ports along its main body.
[083] FIG. 28G shows a cross-section of the respiratory insert of FIGURES 28A-F, where an internal port for aspiration from the interior of the endotracheal tube is shown.
[084] FIG. 29A is a drawing of a first embodiment of a breathing inserter for use with a tracheostomy tube.
[085] FIG. 29B shows the breathing inserter of FIG. 29A coupled with a tracheostomy tube.
[086] FIG. 30 is an example of a breathing inserter integrated with the tracheostomy tube. DETAILED DESCRIPTION
[087] Here are described systems and devices for managing unwanted fluid collection along a tracheal tube. In general, the fluid management system may include a controller, a plurality of fluid ducts, a plurality of flow sensors, a plurality of pressure sensors, a flush subsystem, and at least one secretion collection vessel. . In some embodiments, the fluid management system may also contain a display to show pressure values or keep a user informed of where within the cycle the system is during operation. The system can also be adapted to display a secretion analysis. Breath inserters can couple to any of the fluid management systems described. The breathing inserters that will be described below can generally work to remove fluid buildup along certain regions of a tracheal tube. Breathing inserters can be used in conjunction with an existing tracheal tube or can perform the function of the tracheal tube including the tracheostomy tube, in addition to working to manage fluid collection along the respiratory tract. In general, the system can include a controller, power source, pumps, valves, suction devices, sensors, fluid ducts, display, and switches.
[088] The system described here can automatically remove fluid from multiple regions along a respiratory tract. The term can automatically refer to any act or function that is capable of functioning independently (for example, without continuous input from a user). In some variations, the term can automatically indicate that some action is taken without manual intervention. This does not mean that no manual intervention is required, because in the present case, human intervention can be used to trigger or define the process that, in all other respects, may be automatic. In particular, a user can configure the system to run at set intervals or when certain conditions are met.
[089] Fluid can refer to a substance that is capable of flowing and deforming continuously under applied shear stress. Fluids can include liquids, gases, plasma, and some solids. As applicable herein, the term fluid can be used synonymously with liquid, a substance that has a defined volume but not a fixed form. Thus, fluids can refer to biological fluids secreted from a person's respiratory and oral system, mainly saliva, mucosa, gastric contents, and lavage fluid.
[090] Next, the system may include fluid ducts that connect the breathing insertion device with the fluid management system. Fluid ducts can be any hollow body that can transport fluids, liquids, or gases from one location to another (eg, tubes, channels, etc.). Fluid ducts can be formed from metals, glass, rubber, and other synthetic or naturally occurring materials. Fluid ducts can be flexible and formed of fluid impermeable hollow cylindrical bodies that join the respiratory insert body to the fluid management system.
[091] The respiratory tract can refer to regions associated with breathing in a mammal, specifically, a human. In general, the "respiratory tract" can refer to the upper respiratory tract and/or the lower respiratory tract. The upper respiratory tract may refer to parts of the respiratory system above the glottis (vocal cords), while the lower respiratory tract consists of the trachea, bronchi, bronchioles, and lungs. The respiratory tract can refer to the oral cavity, the glottis, the trachea, and the region directly above the bronchi.
[092] As discussed above, a tracheal tube can refer to a hollow tube that can be inserted into a patient's trachea, primarily to establish and maintain the patient's airway and to ensure adequate breathing. In general, tracheal tubes can include endotracheal tubes and tracheostomy tubes.
[093] A controller can generally refer to a device that can interact with peripheral components and manage how the peripheral components interact and work in liaison with each other. The controller may include circuitry (eg, chips, motherboard integrated circuit, cards, and the like) to send commands to the components present with the fluid management device. The controller can contain logic gates, routine/subroutines, and data storage components to run the monitoring and suction programs. The controller can also include external user interfaces such as displays, buttons and switches.
[094] Sensors generally refer to a component that can detect a certain resource of the environment in which it is found. In particular, described here are flow and pressure sensors. Flow sensors can be configured to detect the presence or absence of fluid. Flow sensors can be differential pressure flow meters, velocity flow meters, positive displacement flow meters, mass flow meter, or open channel flow meter, IR-based sensors, capacitive sensors, and sensors UV. Pressure sensors can sense pressure and can include, but are not limited to, absolute pressure sensors, gauge pressure sensors, vacuum pressure sensors, differential pressure sensors, and sealed pressure sensors. Some pressure sensors are force-type sensors that collect a force value to measure voltage when pressure is applied to the area and include piezo-resistant, capacitive, electromagnetic, piezoelectric, optical, and potentiometric voltage meters. Other non-forced collection pressure sensors may include resonant, thermal, and ionization type pressure sensors. As with any type of sensor, calibration will help to accurately determine the value associated with the detected condition. Finally, flow and pressure sensors can be either internal or external to the fluid management system. One possible position is where the flow and pressure sensors are placed in the system's fluid ducts in relation to the proximity of where the system attaches to the breath insertion device. Other potential locations for the flow and pressure sensors may be inside the controller unit body.
[095] Washing can refer to rinsing a body cavity with water or a medicated solution either to remove unwanted materials or for diagnostic purposes. As described herein, lavage can occur in various predetermined regions along the breath inserter. For example, the devices described herein can apply lavage to the oral cavity and oropharyngeal region in a patient. Fluid Management Systems
[096] In general, a fluid management system may include fluid ducts, sensors, a controller and circuitry for the controller, and flushing components. The controller is typically the portion of the fluid management system that oversees the operation of the components of the fluid management system. The controller may contain circuits and microcontrols to regulate fluid removal, in the case of fluid suction away from a region along the tracheal tube, or fluid release in the case of washing a certain region of the oral cavity or respiratory tract, where the tracheal tube was inserted. The controller may contain valves that connect and maintain the fluid ducts that connect the breathing inserter to the sensing, suction, and pumping components of the fluid management system. In use, the controller may also include microcontrols that contain circuitry to coordinate the sensing, suction, and pumping cycles. The controller periodically, automatically, and independently applies pressure, suction, or sensing to each fluid duct.
[097] The fluid management system also contains fluid ducts that connect the breathing insertion device with the sensing, pumping, and suction components of the fluid management system. Fluid ducts can be arranged in multiple configurations. In some examples, separate fluid ducts connect to each of the ports contained in the breath insertion device. In other examples, more than one port on the breath insertion device can be connected to a fluid duct through a multiport component. Fluid ducts must be flexible, such as surgical tubes, pressure tubes, or the like. Although no preference for fluid duct materials is noted here, it would be useful for fluid ducts to be able to withstand suction without the walls of collapsing pressure or tube resistance without having the line break from the applied pressure.
[098] The fluid management system also typically contains sensors that allow the system to determine the presence (eg, by flow) of secretions in the fluid duct (presumably removed from predetermined regions along the tracheal tube), and/ or regulate the amount of pressure or suction being applied. Flow and suction sensors can be present to detect the presence/absence of secretions that flow past the sensors. Sensors can be configured to provide analog/digital signals to the controller. The fluid management system can then compare the detected signals with pre-programmed values entered by a user or manufacturer to keep the system running until it detects the presence of secretions.
[099] The controller may incorporate a power source that powers the fluid management system components. In the case where the power source is integrated into the controller body, buttons and switches can be found on the fluid management system body which allows the user to control the fluid management system. In other examples, the power source is maintained externally and is linked to the fluid management system when in use. The fluid management system may also contain pumping and suction mechanisms maintained internally or externally.
[0100] Thereafter, the fluid management system may include a flushing mechanism to rinse an empty region associated with the tracheal tube. Washing an area that is in contact with a tracheal tube and where fluid or moisture can help lessen the amount of harmful microbes that can accumulate. Although washing a patient's oral cavity is more common, it is also possible to wash other regions along a tracheal tube, such as the oropharyngeal region or the subglottic region. The fluid management system includes fluid ducts that connect to the breathing inserter to release and subsequently suction flushing fluid from the void region. Fluid for flushing may be sterile water, saline, chlorhexidine, or other suitable solution.
[0101] The fluid management system may also contain analytical components that can test fluid drawn from different regions along a patient's tracheal tube. The fluid management system may contain pre-programmed subroutines that can periodically test the withdrawn fluid for certain types of harmful microbes. If detected, the fluid management system may include a way to notify the physician or caregiver of the potential for infection based on testing positive for harmful microbes or analyzing the viscosity, volume and/or color of the extracted fluid.
[0102] Fluid management systems may also include one or more secretion collection containers (eg, containers, chambers, cups, etc.). The secretion collection containers can be placed in different locations from the other components of the fluid management system as will be discussed in more detail below. In addition, there may be a single secretion collection container that collects all of the fluid from the different regions along the breath insertion device, or there may be separate individual fluid collection containers that correspond to the collection of fluid from the different regions. There may also be a separate fluid collection container for receiving flushing fluid. The fluid obtained can be discarded or sampled to test for the presence of microbes. In some examples, collection containers may also include a fluid level sensor to detect when the liquid has reached a certain level and provide user alerts to empty the collection container or containers.
[0103] In use, the system starts with suctioning the sample at a predefined time period (which is adjustable and can be adjusted by the clinician based on clinical judgment and the patient's condition). During sample aspiration, the control unit turns ON the suction valves and suction starts for a minimum period of time (predefined by the physician or manufacturer). During this sample suction phase, the secretion fluids (saliva, mucosa, gastric reflux or any other bodily fluid) are aspirated into the detection unit that is close to the patient's head. The sensing unit senses the flow/presence of fluid and holds the suction ON until it senses that the flow/presence of fluid/secretions has decreased to a preset value. This fluid is collected in the collection container.
[0104] When there are no more fluids/secretions in the patient's oral/oropharynx/subglottic cavity (above the cuff) and/or within the main lumen of the tracheal tube, the sensor unit can detect the absence of secretions in the tube and check if there is door lock by use of pressure sensor. Upon detection of port blockage, a flushing liquid is injected from the liquid container into the blocked duct for use by the pump and valve groove. This fluid injected in the opposite direction to the suction direction unlocks the port. The injected fluid is immediately aspirated by using suction from two other ducts or through the same duct.
[0105] In case none of the doors are blocked, the pressure sensor does not detect the door blocking and the system concludes that there is no more secretion. Then it turns off until the next sample suction cycle.
[0106] The sheath/sleeve will have additional ports or, using the ports in the oral cavity, the lavage fluid is passed through the oral cavity at regular intervals previously defined by the physician (or in some modalities, the manufacturer) to perform an oral rinse for maintain oral hygiene. Washing liquid is sucked in immediately through the same port/other ports. The device effectively reduces the nurse/caregiver's contact with the patient's trachea and thus reduces the chances of cross-infection.
[0107] The device incorporated software to calculate and analyze the volume, flow rate and viscosity of secretions and graph the patient's secretion pattern and detect and predict the onset of infection or detect early signs of infection. It is also possible to detect pathogen agents, where the device has the added capability of detecting the particular strain of bacteria/pathogens causing the infection using microfluid based technology.
[0108] The device can share data via USB, Internet, Wi-Fi, Bluetooth, Ethernet, memory card or any other data transfer technologies and has a small printer attachment to print hard copies of the patient's infection chart .
[0109] Returning to FIGURES 2 and 4, a general embodiment of the fluid management system 200 and a breath insertion device 270 are shown. In this particular example, there are three fluid ducts 220 that couple to the breath inserter 270. A further discussion of the various modalities of the breath inserter and how it connects to the fluid management system as well as the tubes. existing tracheal tubes will be discussed in greater detail below. The fluid management system shown in this example has an integrated controller 201 that includes flow sensors 230 and pressure sensors 240 (not shown). Also included, but not shown here, are the 242 pressure controls and the 232 suction/aspiration controls for detecting and removing fluid buildup in predefined regions along the tracheal tube. A single secretion collection container 260 is also shown. As mentioned earlier, while the fluid management system is capable of separately collecting fluid withdrawn from predefined regions along the tracheal tube, a user can easily combine fluid through separate fluid ducts 220 into the fluid collection container. fluid 260. FIG. 3 provides a better view of a breathing inserter 370 in a patient intubated with an existing tracheal tube. The image shows a cross-section of a patient's oral, oropharyngeal, and subglottic regions with and regions along the patient's tracheal tube and respiratory tract that correspond to fluid accumulation and where the breath insertion body can monitor and remove the fluid.
[0110] FIG. 4 shows a general schematic of a fluid management system 400 and its main components. The location and connections between the components shown are illustrative and are intended to indicate to the reader the general location of these components. Components can be arranged and coupled in a variety of ways that are suitable for managing fluid accumulation in an intubated patient and will be discussed in more detail below.
[0111] Finally, any fluid management system can incorporate lavage as an adjunct to remove fluid secretions around the tracheal tube. The lavage can be applied to the oral cavity, oropharynx or subglottic region of the patient to moisten areas where saliva would normally bathe but not in the case of an unconscious and intubated patient. Washing can be used to periodically wash the aforementioned regions to clean debris and microbes that can cause infection. Fluid and suction ducts for lavage can be in addition to what is already present to detect and remove fluid from the oral, oropharynx and subglottic regions and have separate pumping and suction components inside or outside the controller. In some cases, wash ducts may touch and share existing fluid ducts.
[0112] FIGURES 5 and 6 show the fluid management system unit, as conceived and reduced to practice. In FIG. 5, a representative number of breath inserters is shown to indicate that the fluid management system can be used with any of the breath inserters that will be described below. The overall goal of the fluid management system is to detect and control the amount of fluid secretions from an intubated patient that accumulates along the tracheal tube.
[0113] The sensing aspect of the fluid management system can contain two types of sensors. Flow sensors can be used to determine the flow at a particular time in the pipe, while pressure sensors can be used to determine port blocking after the flow sensors have detected an absence of secretions. Simultaneously, the pressure sensors can record pressure values associated with any of the fluid ducts that connect to the breath insertion device and communicate the values back to the controller. A routine can be initiated within the controller to compare the detected pressure with preset values, such that if the detected pressure is less than the preset value, blockage or fluid collection is indicated in a particular region along the device. of breath insertion. Sensors can be placed in any suitable region, including in the breathing insert port slots or along fluid ducts to detect if there is fluid present in these locations. As mentioned, the sensors can be non-contact, for example, configured outside the fluid duct so that they do not contact fluid inside the fluid tubes. If fluid flow (and therefore fluid) is detected and reported back to the controller, the controller can initiate a set of instructions to clear the fluid. In this configuration, the pressure sensor can detect blockage only in the case that the flow sensors first detect that there is no secretion.
[0114] The control aspect of the fluid management system regulates the mechanical flow and pressure within the system. As FIG. 6 shows, solenoid valves in connection with at least one pump are used to control fluid flow within the fluid management system and the breath insertion device. Also maintained within the fluid management system module are electronics to collect and retain information associated with the monitoring frequency for lockout. There may also be internal tests that detect the presence of potentially harmful microbes inside any of the fluid ducts. Fluid management system status information can be displayed on an integrated monitor or can be shown on a separate monitor.
[0115] A first modality of the fluid management system is shown in FIG. 7. A 701 controller connects all other components present. A breathing inserter 770 can be an integrated tracheal tube, a sheath, or one of the other arrangements that will be discussed below. The breathing inserter can be arranged as the primary tracheal tube or a connection to an existing tracheal tube within a patient. Breathing inserter 770 can include at least two lumens for sucking two different regions along a tracheal tube. The breath inserter 770 is fluidly connected to the remaining fluid management system components 700 through fluid ducts 720. Adjacent to the breath inserter 770 are flow sensors 730. The flow sensors detect the flow /presence of secretions at an instant in the particular place and help to switch off the device, if they notice the absence of secretions. The cycle starts at a predetermined time interval and continues to run until there is no more flow. Flow sensors 730 are associated with each duct present within breath inserter 770. Flow sensors 730 can detect if there is still fluid present within the corresponding duct within breath inserter 770. Flow sensors 730 they can automatically and continuously (within a given cycle) detect flow within their corresponding ducts as part of a step-by-step routine. Alternatively, a user can manually determine the flow at any or all by selecting certain options provided within the controller 701. In this present embodiment, the flow sensors 730 are shown as being in duct with other components of the fluid management system. 700, but in other examples, the flow sensors may be associated with a separate lumen within the breath delivery device. Flow sensors can be any suitable sensor that can detect and report flow and/or the presence of secretions within a pipeline. Examples of such sensors can include IR sensors, UV sensors, resistive sensors, capacitive sensors, ultrasound sensors, and Hall Effect sensors.
[0116] Remaining with the modality shown in FIG. 7, fluid management system 700 also includes pressure sensors 740 and pressure controls 742. Pressure sensors 740 are capable of sensing pressure within a corresponding fluid duct that connects to a particular lumen of the inserter. 770. The 701 controller may include routines that test the pressure within the fluid ducts automatically and periodically or manually at the user's request. The 742 pressure controls can either create negative pressure within a duct to assess the amount of blockage within a particular duct or create positive pressure to help unblock a particular duct. There may also be a pressure relief/relief 747 within the fluid management system in situations where the pressure sensed within a pipeline is above a defined threshold value. The Pressure/Relief 747 release can prevent excessive pressure from being exerted on the patient's respiratory tract or within the fluid connections of the breathing inserter or fluid management system.
[0117] The modality shown in FIG. 7 also includes a collection container 760. Although the box diagram does not indicate the possible number of collection containers, there may be a central collection where all extracted fluid or more than one collection container can be held. In the case where there is only one collection vessel, corresponding multi-port valves will be used to connect the fluid ducts to the collection vessel. A multiple collection container set may be more useful in revealing where the source of an infection is and providing caregivers with a clearer idea of which region along the patient's respiratory tract to target treatment in the event of an infection. It may also be useful to include a volume sensor within all collection containers present, such that when the fluid with the containers reaches a certain level, a fluid level sensor can signal the controller to issue an alarm to notify the user that one or all of the collection containers need to be emptied.
[0118] A washing system 750 is also present in the embodiment shown in FIG. 7. Flush system 750 includes a flush pump 751 and flush pressure control valve 752. While not specifically shown herein, flush system 750 can release flush fluid to at least one region around the along breath inserter 770. Controller 701 regulates flush pump 751 and flush pressure control valve 752 to release flush fluid at a desirable flow rate and pressure to the region or regions of interest. When the rinse portion of the rinse cycle is complete, the rinse pump 751 can exert negative pressure to aspirate rinse fluid. Although not specifically shown, an additional fluid duct in connection with a collection vessel can receive the post-wash fluid. Alternatively, the additional fluid duct can connect to any of the fluid collection containers already present within the fluid management system. FIGURES 8 and 9 show two possible arrangements of the suction features in the fluid management system modality discussed above. In FIG. 8, a suction feature is not included in the 800 fluid management system. In this arrangement, the suction or aspiration feature is provided to the outside. FIG. 9 shows the case where suction/aspiration is included within the fluid management system. While there are advantages and disadvantages to both arrangements, they neither greatly affect the overall functionality of the fluid management system. Finally, in both variations shown, the collection vessels are located after the suction and pressure valves. The advantage of having the suction and pressure valves in closer proximity to the breath inserter is more accurate control of suction and pressure within the breath inserter. The disadvantage of having the pressure and suction valves situated between the breath insertion device and the collection container is that, during suction, these valves can more easily become contaminated by the fluid that passes. Placing the collection container between the breath inserter and the pressure and suction valves would minimize contamination of the valves, but would also provide less accurate control of the pressure and suction occurring at the distal end of the breath inserter.
[0119] FIG. 10 shows a more detailed diagram of a fluid management system modality. Although the system in FIG. 10 is similar to that shown in FIGURES 7-9, the diagram in FIG. 10 indicates more than a general fluid management system concept and describes, in great detail, the components used to reduce the fluid management system to practice.
[0120] FIGURES 11-15 show an additional variation in the arrangement of collection containers and the various valves present within the fluid management system. In the fluid management system 1100 shown in FIG. 11, the collection containers are placed before the suction and pressure valves. In system 1100, three separate ducts emanate from breather insertion device 1170. Collection vessel 1160 is associated with each duct 1120. Collection vessel 1160 may be a single container or multiple containers, e.g. collection corresponding to each pipeline. As mentioned earlier, one of the main advantages of having collection containers in front of at least some of the valves is that less contaminants reach these valves during suction, and require less frequent cleaning or replacement of these valves. There are also sensing units 1130, 1140 which sense pressure and flow and are associated with each fluid duct. In many of the embodiments, filters are placed before the various modules to minimize contamination of these modules. System 1100 also includes flush 1150 having three separate flush ducts 1153 that connect to the breath inserter (not shown). The three wash ducts 1153 are controlled by a central wash control valve 1152 and a wash pump 1151. Also included are wash jars 1158 which contain wash liquid where wash liquid can be pumped through each of the wash ducts 1153 for rinsing the different regions along the breath inserter. It should be mentioned that the wash control valve can only allow the wash liquid to pass into one or two wash ducts 1153 for rinsing. Control of the wash ducts receiving the rinse fluid can be controlled by the operator or it can be based on a sensed value or condition set by the controller which then automatically signals the wash system to activate. Although not shown, the wash system 1150 may include a separate duct to remove the wash liquid once the wash is complete or it may use fluid ducts 1120 to collect the used wash liquid, here the wash liquid is returned to collection container 1160.
[0121] FIG. 12 shows an alternative embodiment of fluid management system configuration. Similar to the 1100 system configuration, the 1200 system has 1260 collection vessels that are situated before the 1245 suction valves. A notable difference in the 1200 system is the 1253 flush ducts that feed the 1220 fluid ducts and not directly to the device. of breath insertion. As shown, each flush duct 1253 touches a corresponding fluid duct 1220. To prevent flush fluid 1259 from traveling to suction valves 1245 rather than to the breath inserter during flushing, system 1200 includes a series of 1248 non-return valves. When, 1248 non-return valves force flushing fluid into the breath insertion device. For example, a non-return valve may have an on/off feature and may be operated to close the suction duct only after there is pressure due to the flushing liquid; other times the suction ducts remain open.
[0122] FIG. 13 shows yet another embodiment of fluid management system configuration. Similar to system 1200, flush 1350 from system 1300 is routed to corresponding fluid ducts 1320 before reaching the patient's trachea tube. In system 1300, a collection vessel 1360 is placed behind suction valves 1345 and pressure valves 1344 are situated between collection vessel 1360 and the breath insertion device. As mentioned earlier, a disadvantage of having fluid ducts 1320 contacting suction valves 1345 and pressure valves 1344, is the greater chance of contamination. In order to minimize this effect, the valves will be constructed with non-clogged components that will allow fluids of different density and viscosity to pass through. In some instances, the interior of the valves may be coated with non-stick material making it more difficult for microbes to attach. The valves can also be non-contact valves (eg pinch valves) and thus solve the contamination problem since the valve body will never come into contact with the fluids and the valves will only compress the fluid ducts 720 to close them.
[0123] FIG. 14 shows a final fluid management system configuration with three fluid ducts. In system 1400, container 1460 is situated close to the suction source and away from suction valves 1445 and the breath inserter. The 1445 suction valves are three way valves that allow different fluid management system functions to share some of the same ducts that can decrease the space required within the fluid management system. System 1400 includes flush ducts (not shown in FIG. 14) that connect to the rest of the fluid ducts from fluid management components 1420 between suction valves 1445 and canister 1460. System 1400 also includes sensor units 1430 and 1440 to monitor pressure and flow. System 1400 also includes additional suction control valves 1457 that can control the removal and flow rate of used wash liquid 1459 from the patient breath insertion device.
[0124] FIG. 15 shows an embodiment of a fluid management system having four independent fluid ducts. The rest of the fluid management system remains the same. In this embodiment, the extra fluid duct can be used to remove fluid from a fourth location along the tracheal tube. Also, the additional fluid duct can be used to remove fluid within the current tracheal tube as well.
[0125] FIGURES 16A-C show images of a reduced-to-practice fluid management system configuration. FIG. 16A shows the controller in connection with several fluid ducts. FIGURES 16B and C show controller images that include valves, pump, motor, and microcontrols. Breath Insertion Devices
[0126] As mentioned, the fluid management systems described above can be coupled to a breath insertion device. FIGURES 1730 depict the breath inserter connected to the fluid management system, as well as the different modalities of the intended breath inserter.
[0127] In some variations, a breathing insertion device will fit over any endotracheal tube and can be slid down into the proper position. For example, the sheath/sleeve can be placed in the oral cavity of an intubated patient with the dorsal end reaching up to the vocal cords. The sheath/sleeve may have two or more (e.g. three) parallel independent channels running with multiple slots/ports in different locations corresponding to the subglottic region, oropharyngeal region and oral cavity. In some variations, the sheath only includes two lumens (channels), since the tracheal tube over which it is attached already has a lumen that can be used to remove fluid from a region around (and/or inside) the tracheal tube. The ends of these channels have connectors for coupling with a suction duct tube.
[0128] The breathing insertion device can be constructed of any suitable materials. Such materials include but are not limited to: polyurethane, polyvinyl chloride (PVC), polyethylene terephthalate (PETP), low density polyethylene (LDPE), polypropylene, silicone, neoprene, polytetrafluoroethylene (PTFE), or polyisoprene or any other elastomer, relevant plastic, or rubber or any other biocompatible material.
[0129] The breathing inserter can be connected to a connecting tube, and the sensing units can be placed for optimal detection. The detection unit contains fluid detection sensors and sends their values to a control and processing unit that has a microcontroller and a set of valves, namely, suction on/off valve, wash on/off valve, suction pressure control valve, flushing pressure control valve. It also houses the variable outlet pump, collection vessel and display. The collection container has a provision for connecting a sample collection system that includes, but is not limited to the small container, for the collection of small amounts of secretions to be sent to the microbiology/pathology laboratory.
[0130] The control and processing unit is powered by an external or internal power source. It performs suction from an external negative pressure source, such as any suction creation apparatus (wall mounted suction duct, portable suction system, independent suction system) and is connected to the control unit.
[0131] FIG. 17 shows the overall tracheal management system which includes a fluid management system 1700 and a breath inserter 1770. In general, the breath inserter 1770 includes a sheath 1773 having a proximal end 1771 and a distal end 1772. The 1771 proximal end is located adjacent to the 1700 fluid management system. The 1772 distal end corresponds to the subglottic region of an intubated patient. Breathing inserter 1770 generally includes at least two lumens and typically comprises a third. In FIG. 17, three lumens 1774, 1776 and 1775 are shown. The proximal and distal ends of each of lumens 1774, 1776, and 1775 extend longitudinally along the length of sheath 1773. Each of the proximal ends of lumens 1774, 1776, and 1775 may mate with corresponding fluid ducts (not -shown) of the 1600 fluid management system. The distal ends of lumens 1774, 1776, and 1775 correspond to different regions along a tracheal tube. In particular, the oral cavity, oropharynx, and subglottic regions, in an intubated patient, are of interest. The distal end of lumens 1774, 1776, and 1775 each includes oral aspiration ports 1777, 1778, and 1779 for detecting and removing fluid from these regions in direct contact with the ports. Still shown in FIG. 17 are the 1730 flow sensors and 1740 liquid/pressure sensors. The 1730 flow sensors can detect the rate of fluid flow with the fluid ducts and assist in regulating the flow within the fluid ducts. The 1740 pressure sensors can detect the amount of resistance when negative pressure is applied through the fluid ducts and relay to the controller if the amount of resistance exceeds a threshold value, indicating that there is blockage in the duct. Although the 1740 pressure sensors shown in FIG. 17 are located in lumens 1774, 1776 and 1775, pressure sensors can be placed over the fluid duct and external to the breath insertion device.
[0132] Different combinations of the breath insertion device can be coupled to the various fluid management system configurations discussed above. FIG. 18 shows a subset of possible combinations of breathing inserter and fluid management system. First, the fluid management system can be used with a traditional tracheal tube, more specifically, an endotracheal tube or a tracheostomy tube. This may not be ideal because the traditional tracheal tube does not have the necessary lumen and corresponding ports that would allow monitoring and fluid evacuation. FIG. 18 also shows that the fluid management system can be used with a modified tracheal tube having a lumen that attaches to an existing tracheal tube. FIG. 18 also shows a continuous subglottic secretion tube aspiration (CASS) which allows for suction along subglottic regions, as well as use with innovative integrated tracheal tube configurations which will also be discussed in more detail in the following paragraphs. And finally, the diagram indicates that the fluid management system can also work with an integrated endotracheal tube where the lumen is integrated into the device body.
[0133] FIGURES 19A-D show a first embodiment of a 1970 breath insert. The 1970 breath insert has a 1971 proximal end that is near the intubated patient's mouth and a 1972 distal end that corresponds to the end from the patient's trachea and to the top of the bronchi region. The 1970 breathing inserter has a spiral configuration where a 1973 device body wraps around an existing 1990 tracheal tube. The 1970 device is prevented from passing a secure region of the patient's respiratory tract since the distal end of device 1970 abuts a clamp 1991 of the tracheal tube and placement of the appropriate device 1970 along the existing tracheal tube is achieved when the distal end of the device 1970 rests against the clamp 1991 and the end of the proximal device 1970 adjacent to the proximal end of the tube existing tracheal tube. Device 1970 includes at least one device 1980 fluid duct for suction. The 1980 device fluid duct may include a 1981 coupler for connecting to the fluid ducts of the fluid management system. The small circles along the tracheal tube show where fluid is most likely to accumulate. As previous references have indicated, an area of fluid accumulation corresponds to the patient's subglottic region, especially around the cuff. Two other regions not specifically mentioned and targeted by earlier tracheal tube fluid management devices are the oral cavity and the oropharyngeal regions adjacent to the tracheal tube. An unconscious intubated patient cannot say that saliva is a build-up in their mouth and has no automatic reflex to rid their mouth of fluid especially with the presence of the tracheal tube. The oropharyngeal region is also susceptible to fluid accumulation due to the arcuate curvature in the tracheal tube as it passes through the oral cavity into the trachea in combination with the typical horizontal position of an intubated patient. FIG. 19A shows a breath inserter similar to that of FIG. 17; FIGURES 19B, 19C and 19D show enlarged views of parts of this device. Suction ports are disposed in various regions on the 1973 device body. An exploded view corresponding to the oropharyngeal region along the tracheal tube shows a plurality of ports 1978. Circles and arrows show moving fluid and other debris towards 1978 doors to be vacuumed out. Although not specifically shown, ports are also disposed on the breathing inserter body that corresponds to the oral cavity and subglottic region of the intubated patient. In addition, the spacing of ports corresponding to different regions of the tracheal tube must be at least 0.4 inch from each other (eg, ports at the distal ends of the lumen). At the proximal ends of the lumen, which can connect to fluid ducts, ports into the lumen can be immediately adjacent to each other or can extend like tubes from the device. This requirement does not apply to ports associated with the same region, which is shown in the enlarged views in FIGURES 19B, 19C and 19D.
[0134] FIG. 20 shows aspects of a breather inserter 2070 for removing fluid from two or more regions along a tracheal tube in accordance with some embodiments. Device 2070 includes a sheath 2073. Sheath 2073 having a hinge 2084 and a slot 2085. Disposed along the perimeter of the sheath 2073 are a plurality of lumens. In FIG. 20, two lumens 2074 and 2075 are shown. Lumens 2074 and 2075, when connected to fluid ducts of the fluid management system, are capable of drawing two different locations of an existing tracheal tube through adjacently disposed (not shown) ports (not shown) to the distal end 2072 of device 2070. In use, hinge 2084 of sheath 2073 can open and increase the circumference of slot 2085. A user can then more easily slide device 2070 over an existing tracheal tube or before placing the tracheal tube in a patient or after placement of the tracheal tube. 2081 couplers are also present for connection to the fluid management system. In variations of this modality, more than two lumens are disposed along the perimeter of the sheath of the device.
[0135] FIG. 21 shows aspects of a breather insert 2170 for removing fluid from two or more regions along a tracheal tube in accordance with some embodiments. Device 2170 includes one or more sleeve 2173. Sleeve 2173 functions much like a stent, in that sleeve 2173 expands laterally when a force is applied longitudinally, and thus device 2170 can be inserted segmentally over a existing tracheal tube. Device 2170 may include lumens along the perimeter of the upper sleeve that extend along the longitudinal axis of the upper sleeve. The upper sleeve may include a lumen that terminates in an upper sleeve port groove for suctioning a first region along the existing tracheal tube. The first region may correspond to the oral cavity of the intubated patient. Lumens 2174, 2175 and 2176 are shown entering sleeve 2173 at a ring 2182. The upper sleeve may align and mate with lower sleeves with corresponding lumen ending in port grooves along the length of the lower sleeve. A first port slot 2177 may correspond to a patient's oral cavity. Other port slots 2178 and 2179 may correspond to second and third regions along the existing tracheal tube, such as the oropharynx and subglottic regions. Although the lumen of FIG. 21 is all shown to insert largely one point on the sleeve, it is also possible for the different lumen to insert at different points on the ring and having corresponding channels in the lower sleeves. Additionally, each lumen includes 2181 couplers for connection to fluid management system or similar. It should be noted that when positioning this modality of device, ventilation may have to be interrupted for a short period to allow mounting of the cuff over the existing tracheal tube.
[0136] FIGURES 22A-C illustrate aspects of a breathing inserter 2270 for removing fluid from two or more regions along a tracheal tube in accordance with some embodiments. Device 2270 is designed to fit over an existing tracheal tube and includes a series of stacked rings 2282 held together by a series of support structures 2273. Stacked rings 2282 may include at least one set of longitudinally aligned ring ports . Device 2270 further includes an integrated lumen 2281 that is capable of reaching multiple points along the length of the existing tracheal tube. The distal end of the integrated lumen 2281 includes a series of tentacle-like lumen that pass through at least one of the longitudinally aligned ring ports 2288. The tentacle-like lumen at the distal end is capable of reaching farther along the Existing tracheal tube can thread through two or more of the longitudinally aligned ring ports 2288. The tentacle-like lumens 2274, 2275 and 2276 terminate with corresponding suction ports 2277, 2278 and 2279 which are capable of removing fluid from corresponding regions along the existing tracheal tube. Finally, the lumen joins at the proximal end of the 2281 integrated lumen and connects to a 2281 connector that connects the lumen to the fluid management system.
[0137] FIGURES 23A-B illustrate aspects of a breathing inserter 2370 for removing fluid from two or more regions along a tracheal tube in accordance with some embodiments. Device 2370 can attach to an existing tracheal tube. Device 2370 includes device body 2373 along one side and a series of clips 2383 that allow device 2370 to attach to the existing tracheal tube. The 2383 series of clips each include a 2385 slot that allows a user to slightly increase the diameter of the 2383 series of clips to fit the 2370 device over the existing tracheal tube. Device 2370 includes a cavity 2386 running essentially the entire length of device 2370. Although not shown, the catheter or tube may be inserted through cavity 2386 to terminate at various points along device 2370 for suction at different regions along the device. of the tracheal tube.
[0138] An alternative embodiment to device 2370 is device 2470 as shown in FIGURES 24A-B. One difference between devices 2470 and 2370 is that device 2470 is composed of two different materials. Most of the 2470 device is composed of a softer elastomer that is flexible along the longitudinal axis of the device. Device 2470 includes regions having "C" shaped supports 2487 comprising harder material. C-shaped supports 2487 are located along the longitudinal axis of device 2470 which provide overall rigidity in the transverse plane of device 2470. Device 2470 includes a channel 2486 that runs along and follows the curve of the body of the device. Channel 2486 can retain at least one catheter or tube body to aspirate at least one area along the existing tracheal tube. When there is more than one catheter or tube body held within channel 2486, the distal ends of the catheter or tube body terminate at different points along the existing tracheal tube.
[0139] Next, FIGURES 25A-C illustrate aspects of a breathing inserter 2570 for removing fluid from two or more regions along a tracheal tube according to some modalities. Device 2570 is a variation on the clip format. Device 2570 has a proximal end 2571, a distal end 2572, and a device body 2573. The proximal end 2571 is located near a patient's mouth, while the distal end 2572 is located between a patient's lower trachea and bronchi. . FIG. 25A shows an image of the proximal end 2571 that includes a series of channels 2586 that follow the length of the device body 2573 and terminate at various points along an existing tracheal tube. In some instances, channels 2586 correspond to the oral, oropharynx, and subglottic regions in a patient. FIGURES 25B and C show that some of the channels 2586 terminate in three ports 2574, 2575 and 2576 for suction from different regions along the existing tracheal tube. Depending on how the fluid ducts are connected, some of the channels can be used to flush out various regions of the patient's oral, oropharynx, and subglottic cavities. Finally, device 2570 includes a slot 2585 that allows for easier placement of device 2570 over a tracheal tube.
[0140] FIGURES 26A-C show a variation of the device shown in FIGURES 25A-C. Similarly, device 2670 has an image format that allows it to be connected to an existing tracheal tube. Device 2670 includes a device body 2673, a proximal end 2671, and a distal end 2672. Device 2670 also has a C-shaped cross section having a slot 2685, wherein the slot distance is greater than that of the device. 2570. End 2671 of device 2670 includes two couplers 2681 that allow device 2670 to attach to a suction system, such as the fluid management system described above. Couplers 2681 connect to channels 2674 and 2675 which run the length of device 2670 and terminate in different zones along device 2670. At the end of channels 2674 and 2675 are ports 2674 and 2675 for suctioning different regions to the device. along an existing tracheal tube.
[0141] FIGURES 27A-27D illustrate aspects of a breathing inserter 2770 for removing fluid from two or more regions along a tracheal tube in accordance with some embodiments. Device 2770 is another version of a clip-on fluid suction device that can be coupled with an existing tracheal tube. Device 2770 has a device body 2773, a proximal end 2771 that is close to a patient's oral cavity when in use, and a distal end 2772 that is between the patient's lower trachea and bronchi when in use. Device 2770 includes a series of clips 2783 for attachment to a tracheal tube. Device 2770 also includes stacked lumens 2774, 2775 and 2776 that run the length of device body 2773 and terminate at different regions along device body 2773. At the end of lumens 2774, 2775 and 2776 are corresponding ports 2777, 2778 and 2779 to work with the fluid management systems described above or other similar systems to detect and aspirate fluid from different regions along the tracheal tube. Although not shown, the proximal end of lumens 2774, 2775, and 2776 can be coupled to fluid ducts from the fluid management system or other similar systems.
[0142] FIGURES 28A-G illustrate aspects of a breathing inserter 2870 for removing fluid from two or more regions along a tracheal tube in accordance with some embodiments. The 2870 device is an integrated tracheal tube with sensing and suction capabilities, as well as an airway passage for connection to an external breathing mechanism. Device 2870 includes a device body 2873, a proximal end 2871, and a distal end 2872. A clamp 2891 is located toward the distal end 2872 of device 2870. Device 2870 further includes a portion of tracheal tube 2890, a duct of cuff inflation 2892, and first, second, and third lumens 2874, 2875, 2876 for suctioning different regions along a patient's respiratory tract. The distal ends of lumens 2874, 2875 and 2876 all terminate with corresponding ports 2877, 2878 and 2879 which aid in detecting and removing fluid from different points along the body of device 2873. FIG. 28G shows a cross section of this particular embodiment of the breather inserter 2870 where the breather inserter 2870 further includes an inner port 2893 for suction in the inner region of the tracheal tube portion of the breather inserter 2870. the channels associated with ports 2877 and 2878 that correspond to the oral cavity and regions of the oropharyngeal cavity.
[0143] Returning to FIGURES 29A-30, devices for use in a tracheostomy setting will be described. FIGURES 29A and B show a first embodiment of a tracheostomy device 2970. Device 2970 includes a proximal end with one or more fluid duct connectors 2971, 2971', 2971'' (e.g. three in this example), a distal end 2972 and a device body 2973. Device body 2973 is bifurcated into first and second lumens 2974 and 2976. In use, first lumen 2974 is located outside the tracheostomy tube, while second lumen 2976 is largely situated within the tracheostomy tube as shown in FIG. 29B. First lumen 2974 includes a first port 2977 at its end that is used to detect and remove fluid from a first outer surface of the tracheostomy tube, primarily above an inflatable clamp 2991 of the tracheostomy tube. The second lumen 2976 is larger than the first lumen 2974 and includes a curve at its end. At the bend, the second lumen 2976 exits the tracheostomy tube and terminates below the clamp 2991. At its end, the second lumen 2976 includes a second port 2979 for detecting and aspirating a lower region of the tracheostomy tube just below the clamp 2991. Second lumen 2976 also includes a third port 2978 that is located within and near the distal end of the tracheostomy tube to detect and remove fluid from the lower portion of the tracheostomy tube. Finally, device 2970 includes a coupler 2981 for connecting to a fluid management system or similar system for detecting and removing fluid from different regions along the tracheostomy tube.
[0144] A second embodiment of a tracheostomy device 3070 is shown in FIG. 30. The 3070 device is an integrated tracheostomy tube and fluid detection and management device. The 3070 device includes three independent lumens 3074, 3075 and 3076 that are integrated with a 3073 tracheostomy tube. The proximal ends of the 3074, 3075 and 3076 lumens include 3081 couplers for connection to the fluid management system or other similar systems. The end of each lumen 3074, 3075 and 3076 is at different locations along tracheostomy tube 3073. At the end of each lumen 3074, 3075 and 3076 are corresponding ports 3077, 3078 and 3079 for detecting and removing fluid from there. corresponding regions. In some cases, fluid, such as a 3050 flushing fluid, can be introduced into the 3073 tracheostomy tube and the flushing fluid can be removed through ports 3077, 3078, and 3079. Fluid with Breath Insertion Devices
[0145] The following paragraphs describe the method of using the fluid management system and breath insertion device. A user may insert a breathing inserter having a plurality of slots into an individual's respiratory tract so that a first slot is positioned in the oral cavity (e.g., near a base of the individual's tongue), a second slot. is positioned in the individual's oropharynx, and a third groove is positioned in the individual's subglottic region. In one case, the respiratory insert attaches to a preexisting tracheal tube, while in other cases, the respiratory insert incorporating a tracheal tube is newly inserted into a patient's trachea.
[0146] The user then couples the respiratory insert to a controller to couple a first lumen of the respiratory insert that is in communication with the first slot for a first fluid duct, connecting a second lumen of the insert that is in communication with the second slot to a second fluid duct, and connecting a third lumen of the respiratory insert that is in communication with the third slot to a third fluid duct. The operator can then automatically adjust the controller, within a predetermined period of time, apply suction through each of the first, second, and third fluid ducts, and automatically turn off suction in one or the first, in the second or in the third fluid duct when the fluid flow through one of the fluid ducts falls below a flow threshold and when the pressure in that fluid duct is above a pressure threshold. and applying positive pressure in that fluid duct to release a blockage when the fluid flow through that fluid duct falls below the flow threshold and when the pressure is below the pressure threshold. The operator may also choose to connect a flushing fluid to various regions along the tracheal tube.
[0147] When a resource or element is referred to herein as being "linked" to another resource or element, it may be directly on the other resource or element or the intervening resources and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly linked" to another feature or element, there are no intervening features or elements present. It will also be understood that when a resource or element is referred to as being "linked", "attached" or "coupled" to another resource or element, it may be directly linked, attached or coupled to another resource or element or resource or intervening elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to the other feature or element, there are no intervening elements or elements present. Although described or shown in relation to one embodiment, the features and elements so described or shown may apply to other embodiments. It will also be appreciated by the skilled artisan that references to a structure or resource that is disposed "adjacent" to another resource may have portions that overlap or underlie adjacent resources.
[0148] The terminology used herein is intended only to describe particular embodiments and is not intended to be a limitation of the invention. For example, as used herein, the singular forms "a", "a" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising", when used in this descriptive report, specify the presence of indicated resources, steps, operations, elements and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/".
[0149] Spatially relative terms, such as "under", "below", "inferior", "over", "superior", and the like, may be used here for ease of description to describe an element or resource relationship with others elements or features as shown in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, the elements described as "under" or "under" other elements or features would then be oriented "over" to other elements or features. Thus, the exemplary term "under" can encompass either an up or down orientation. The device may be oriented in another way (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted in this way. Likewise, the terms "upward", "downward", "vertical", "horizontal" and the like are used herein for explanation purposes only, unless specifically indicated to the contrary.
[0150] Although the terms "first" and "second" may be used here to describe various features/elements (including steps), these features/elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish a feature/element from another feature/element. Thus, a first feature/element discussed below could be termed as a second feature/element, and similarly, a second feature/element discussed below could be termed as a first feature/element without departing from the teachings of the present invention.
[0151] Throughout this specification and the claims that follow, unless the context otherwise requires, the word "comprises" and variations such as "comprises" and "comprising" mean that various components may be co-used in the methods and articles, eg compositions and apparatus including device and methods). For example, the term "comprising" will be understood to imply the inclusion of any declared elements or steps, but not the exclusion of any other elements or steps.
[0152] Although various illustrative embodiments are described above, any of a number of changes can be made to various embodiments without departing from the scope of the invention as described in the claims. For example, the order in which several described method steps are performed can often be changed in alternative embodiments, and in other alternative embodiments one or more method steps can be omitted altogether. Optional features of various device and system modalities may be included in some modalities and not others. Therefore, the foregoing description is provided primarily for exemplary purposes and is not to be construed to limit the scope of the invention as set out in the claims.
[0153] The examples and illustrations included herein show, by way of illustration and not limitation, specific modalities in which the subject may be practiced. As mentioned, other modalities can be used and derived therefrom, so that structural and logical substitutions and alterations can be made without departing from the scope of this description. Such embodiments of the subject matter of the invention may be referred to herein individually or collectively by the term "invention" only for convenience and not intended to voluntarily limit the scope of this application to any single invention or concept of the invention, if more than one is, in fact, disclosed. Thus, although specific and described embodiments have been shown here, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This description is intended to cover any and all adaptations or variations of various modalities. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to the skilled artisan upon review of the above description.

权利要求:
Claims (14)
[0001]
1. System for automatically removing fluid from multiple regions of a respiratory tract and washing a portion of the oral cavity of the respiratory tract, the system being characterized by the fact that it comprises: a controller (701) comprising a set of circuits of controller and one or more valves configured to mate with a source of air pressure; a plurality of fluid ducts (220), wherein the fluid ducts (220) mate with one or more valves of the controller (701) , and wherein the controller circuitry is configured to control one or more valves to apply positive or negative pressure through each fluid duct among the plurality of fluid ducts (220); a plurality of flow sensors and sensors of pressure, wherein the fluid ducts (220) are each coupled to a flow sensor and a pressure sensor that are configured to report fluid flow and pressure within the fluid duct to control. side (701); a source of washing liquid, wherein the controller (701) is configured to apply positive pressure to release washing liquid; and a plurality of collection containers, each coupled to a fluid duct of a plurality of fluid ducts (220), and configured to collect fluid from the fluid ducts (220), wherein the plurality of collection containers are connected between a controller pressure control (701) and the plurality of flow sensors; wherein the controller circuitry is configured to periodically, automatically and independently apply negative pressure to each of the fluid ducts (220) to continue applying negative pressure until there is no more flow and to stop applying negative pressure in each fluid duct among the plurality of fluid ducts (220) when the fluid flow in that fluid duct indicates an absence of secretions, and to detect a blockage in the fluid duct based on fluid flow and pressure in that fluid duct; wherein, in addition, the controller circuitry is configured to clear a blockage in that fluid duct.
[0002]
2. System according to claim 1, characterized in that it additionally comprises an input configured to receive user-selected control information comprising one or more of: wash release frequency, wash duration, wash pressure. washing, frequency of suction application and suction pressure.
[0003]
3. System according to claim 1, characterized in that the controller (701) additionally comprises a display, and wherein the controller circuitry is configured to display one or more of the first, second, and third fluid duct data (220) comprising one or more of: flow rate of a secretion within the fluid duct, thickness of secretion within the fluid duct, volume of secretion within the fluid duct, or color of secretion within of the fluid duct.
[0004]
4. System according to claim 1, characterized in that the controller (701) is configured to apply positive pressure to release the flushing fluid through one of the fluid ducts (220) and to apply negative pressure to a or more among the other fluid ducts (220) to remove the flushing fluid.
[0005]
5. The system of claim 1, characterized in that the plurality of fluid ducts (220) comprises a first, second and third fluid duct and wherein the controller circuitry is configured to independently apply pressure through each of the first, second, and third fluid ducts.
[0006]
6. System according to claim 1, characterized in that the plurality of fluid ducts (220) comprises a first, second, third and fourth fluid ducts and wherein the controller circuitry is configured to apply independently negative pressure through each of the first, second, third, and fourth fluid ducts.
[0007]
7. System according to claim 1, characterized in that the plurality of fluid ducts (220) comprises one or more wash release fluid ducts that are connected to the source of wash liquid and in which the controller (701) is configured to apply positive pressure to one or more wash release fluid ducts to release wash fluid.
[0008]
8. System according to claim 1, characterized in that it further comprises a pump configured to apply positive pressure, wherein the pump is in communication with the controller (701) and the source of washing fluid.
[0009]
9. System according to claim 1, characterized in that the source of washing liquid comprises a receptacle configured to hold a washing liquid.
[0010]
10. System according to claim 1, characterized in that the one or more valves comprises a plurality of suction valves, wherein each of the fluid ducts (220) is among the plurality of fluid ducts (220) is in communication with a suction valve among the plurality of suction valves.
[0011]
11. System according to claim 1, characterized in that the plurality of flow sensors is outside the plurality of fluid ducts.
[0012]
12. The system of claim 1, wherein the controller circuitry is configured to apply positive pressure to release flushing fluid through one or more of the plurality of fluid ducts (220).
[0013]
13. System according to claim 1, characterized in that the controller circuitry is configured to periodically apply positive pressure to release flushing fluid through one or more of the plurality of fluid ducts (220) at a wash release frequency.
[0014]
14. System according to claim 1, characterized in that the collection containers are connected to fluid ducts (220) between the one or more valves and the source of air pressure.

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法律状态:
2020-05-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2021-04-27| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2021-07-06| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/08/2015, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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IN3988CH2014|2014-08-14|

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IN3988/CHE/2014|2014-08-14|

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PCT/IB2015/001903|WO2016024169A2|2014-08-14|2015-08-13|Systems and methods for automatically removing fluid from multiple regions of a respiratory tract|

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