cloud-based medical analysis for linking local trends with resource capture behaviors of larger data

专利摘要:
The present invention relates to a cloud-based medical analytical system comprising a processor, a memory, an input / output interface for accessing data from central medical controller communication devices, each coupled to a surgical instrument, and a bank to store data. The processor aggregates patient outcome data from central medical controllers. The patient outcome data comprises data related to the steps performed and the corresponding execution times of each step in procedures with the patient, related to a result of each procedure performed and related to medical resources used in the patient's procedures. Patient outcome data comprises location data that indicates the medical facilities to which the medical resource has been allocated and data that indicates the outcome as a success or failure. The processor aggregates medical resource capture data from medical central controllers, determines the correlation between positive results and resource capture data, generates medical recommendations based on the correlation, and causes medical recommendations to be displayed on medical central controllers located in different medical facilities .
公开号:BR112020012809A2
申请号:R112020012809-0
申请日:2018-07-31
公开日:2020-11-24
发明作者:Frederick E. Shelton Iv；Jason L. Harris；David C. Yates；Gregory J. Bakos；Jeffrey S. Swayze；Michael A. Chirumbolo
申请人:Ethicon Llc；
IPC主号:

专利说明:

[001] [001] This application claims priority under 35 USC 119 (e) to US Provisional Patent Application Serial No. 62 / 649,333, entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER, filed March 28, 2018, whose description is hereby incorporated by reference, in its entirety.
[002] [002] This application claims priority under 35 USC 119 (e) to US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, of US Provisional Patent Application n Serial No. 62 / 611,340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed on December 28, 2017, and US Provisional Patent Application No. Serial No. 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017 , the description of each of which is incorporated herein by way of reference, in its entirety. BACKGROUND OF THE INVENTION
[003] [003] The present description refers to several surgical systems. In the digital and information age, medical facilities and systems are often slower to implement systems or procedures that use new and improved technologies due to patient safety and a general desire to maintain traditional practices. However, medical facilities and systems can therefore, consequently, lack communication and knowledge shared with other neighboring or similar facilities. To improve patient practices, it would be desirable to find ways to help improve the interconnection of medical facilities and systems. SUMMARY OF THE INVENTION
[004] [004] In general, a cloud-based medical analytical system is provided. The cloud-based medical analytical system comprises at least one processor; at least one memory coupled in communication with at least one processor; an input / output interface configured to access data from a plurality of medical central controller type communication devices, each communicatively coupled to at least one surgical instrument; and a database that resides in at least one memory and is configured to store the data; At least one memory stores executable instructions for at least one processor to: aggregate patient outcome data from the plurality of central medical controllers. The patient outcome data comprises: data related to the steps performed and the corresponding times of execution of each step in procedures with the patient; data related to a result of each patient procedure performed; and data related to medical resources used in patient procedures. The patient outcome data also includes, for each item of data related to the medical resource, location data describing the medical facilities to which the medical resource was allocated; and, for each item of data related to the outcome of the patient's procedure, data indicating the success or failure of the procedure. At least one memory additionally stores instructions executable by at least one processor to: aggregate data capture medical resources from central medical controllers; determine a correlation between positive results from patient outcome data and fundraising data; generate a medical recommendation to change a medical resource capture practice based on the correlation; and cause the medical recommendation to be displayed on a plurality of central medical controllers located in different medical facilities.
[005] [005] In another general aspect, computer-readable media is provided. Computer-readable media is non-transitory and stores instructions executable by at least one processor in a cloud-based analysis system to aggregate patient outcome data from a plurality of central medical controllers. The patient outcome data comprises: data related to the steps performed and the corresponding times of execution of each step in procedures with the patient; data related to a result of each patient procedure performed; data related to medical resources used in patient procedures; and, for each item of data related to the medical resource: location data describing the medical facilities to which the said medical resource was allocated; and, for each item of data related to the outcome of the patient's procedure, data indicating the success or failure of the procedure. Executable instructions also do the following: aggregate medical resource capture data from central medical controllers; determine a correlation between positive results from patient outcome data and fundraising data; generate a medical recommendation to change a medical resource capture practice based on the correlation; and cause the medical recommendation to be displayed on a plurality of central medical controllers located in different medical facilities.
[006] [006] In yet another general aspect, a cloud-based medical analytical system is provided. The cloud-based medical analytical system comprises at least one processor; at least one memory coupled in communication with at least one processor; an input / output interface configured to access data from a plurality of medical central controller type communication devices, each communicatively coupled to at least one surgical instrument; and a database that resides in at least one memory and is configured to store the data; At least one memory stores executable instructions for at least one processor to: aggregate data from medical instruments from the plurality of central medical controllers.
[007] [007] The features of various aspects are presented with particularity in the attached claims. The various aspects, however, with regard to both the organization and the methods of operation, together with additional objects and advantages of the same, can be better understood in reference to the description presented below, considered together with the attached drawings, as follows.
[008] [008] Figure 1 is a block diagram of an interactive surgical system implemented by computer, according to at least one aspect of the present description.
[009] [009] Figure 2 is a surgical system being used to perform a surgical procedure in an operating room, in accordance with at least one aspect of the present description.
[0010] [0010] Figure 3 is a central surgical controller paired with a visualization system, a robotic system, and an intelligent instrument, according to at least one aspect of the present description.
[0011] [0011] Figure 4 is a partial perspective view of a central surgical controller compartment, and of a generator module in combination received slidingly in a central surgical controller compartment, in accordance with at least one aspect of the present description.
[0012] [0012] Figure 5 is a perspective view of a generator module in combination with bipolar, ultrasonic and monopolar contacts and a smoke evacuation component, in accordance with at least one aspect of the present description.
[0013] [0013] Figure 6 illustrates different power bus connectors for a plurality of side coupling ports of a side modular cabinet configured to receive a plurality of modules, in accordance with at least one aspect of the present description.
[0014] [0014] Figure 7 illustrates a vertical modular cabinet configured to receive a plurality of modules, in accordance with at least one aspect of the present description.
[0015] [0015] Figure 8 illustrates a surgical data network comprising a modular communication center configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a utility facility especially equipped for surgical operations, to the cloud, in accordance with at least one aspect of the present description.
[0016] [0016] Figure 9 illustrates an interactive surgical system implemented by computer, in accordance with at least one aspect of the present description.
[0017] [0017] Figure 10 illustrates a central surgical controller that comprises a plurality of modules coupled to the modular control tower, according to at least one aspect of the present description.
[0018] [0018] Figure 11 illustrates an aspect of a universal serial bus (USB) central controller device, in accordance with at least one aspect of the present description.
[0019] [0019] Figure 12 illustrates a logical diagram of a control system for an instrument or surgical tool, according to at least one aspect of the present description.
[0020] [0020] Figure 13 illustrates a control circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present description.
[0021] [0021] Figure 14 illustrates a combinational logic circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present description.
[0022] [0022] Figure 15 illustrates a sequential logic circuit configured to control aspects of the instrument or surgical tool, according to at least one aspect of the present description.
[0023] [0023] Figure 16 illustrates an instrument or surgical tool that comprises a plurality of motors that can be activated to perform various functions, according to at least one aspect of the present description.
[0024] [0024] Figure 17 is a schematic diagram of a robotic surgical instrument configured to operate a surgical tool described therein, in accordance with at least one aspect of the present description.
[0025] [0025] Figure 18 illustrates a block diagram of a surgical instrument programmed to control the distal translation of the displacement member, according to an aspect of the present description.
[0026] [0026] Figure 19 is a schematic diagram of a surgical instrument configured to control various functions, in accordance with at least one aspect of the present description.
[0027] [0027] Figure 20 is a simplified block diagram of a generator configured to provide tuning without an inductor, among other benefits, according to at least one aspect of the present description.
[0028] [0028] Figure 21 illustrates an example of a generator, which is a form of the generator of Figure 20, according to at least one aspect of the present description.
[0029] [0029] Figure 22 is a block diagram of the interactive surgical system implemented by computer, according to at least one aspect of the present description.
[0030] [0030] Figure 23 is a block diagram that illustrates the functional architecture of the interactive surgical system implemented by computer, according to at least one aspect of the present description.
[0031] [0031] Figure 24 is an illustrative illustration of an organization of several resources correlated to specific types of surgical categories, according to at least one aspect of the present description.
[0032] [0032] Figure 25 provides an exemplary Illustration of how data is analyzed by the cloud-based system to provide a comparison between multiple facilities to compare resource usage, in accordance with at least one aspect of this description.
[0033] [0033] Figure 26 illustrates an example of how the cloud-based system can determine trends in the effectiveness of an aggregated set of data across entire regions, in accordance with at least one aspect of the present description.
[0034] [0034] Figure 27 provides an exemplary illustration of some types of analysis that the cloud-based system can be configured to perform to provide forecasting modeling, in accordance with at least one aspect of the present description.
[0035] [0035] Figure 28 provides a graphic illustration of a type of exemplary analysis that the cloud-based system can perform to provide these recommendations, in accordance with at least one aspect of the present description.
[0036] [0036] Figure 29 provides an illustration of how the cloud-based system can perform analyzes to identify a statistical correlation for a local issue that is linked to how a device is used in the localized configuration, in accordance with at least one aspect of this description.
[0037] [0037] Figure 30 provides a graphic illustration of an example of how some devices can satisfy an equivalent use compared to an intended device, and that the cloud-based system can determine such an equivalent use, according to at least one aspect of the this description.
[0038] [0038] Figure 31 provides several examples of how some data can be used as variables in deciding how a post-operative decision tree can branch, according to at least one aspect of the present description.
[0039] [0039] Figure 32 is a timeline that represents the situational recognition of a central surgical controller, according to at least one aspect of the present description. DESCRIPTION
[0040] [0040] The applicant for this application holds the following provisional US patent applications, filed on March 28, 2018, each of which is incorporated herein by reference in its entirety:  US Provisional Patent Application Serial No. 62 / 649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;  US Provisional Patent Application Serial No. 62 / 649,294, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;  US Provisional Patent Application Serial No. 62 / 649,300, entitled SURGICAL HUB SITUATIONAL AWARENESS;  US Provisional Patent Application Serial No. 62 / 649,309, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;  US Provisional Patent Application Serial No. 62 / 649,310, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;  US Provisional Patent Application Serial No. 62 / 649,291, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;
[0041] [0041] The applicant for this application holds the following US patent applications, filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:  US Patent Application Serial No., entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED
[0042] [0042] The applicant for this application holds the following US patent applications, filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:  US Patent Application Serial No. , entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES; proxy document number END8506USNP / 170773;  US Patent Application Serial No. , entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS; proxy document number END8506USNP1 / 170773-1;  US Patent Application Serial No. , entitled CLOUD-
[0043] [0043] The applicant for this application holds the following US patent applications, filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:  US Patent Application Serial No., entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; proxy document number END8511USNP / 170778;  US Patent Application Serial No., entitled COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; proxy document number END8511USNP1 / 170778-1;
[0044] [0044] Before explaining in detail the various aspects of surgical instruments and generators, it should be noted that the illustrative examples are not limited, in terms of application or use, to the details of construction and arrangement of parts illustrated in the drawings and description attached. Illustrative examples can be implemented or incorporated into other aspects, variations and modifications, and can be practiced or performed in a variety of ways. Furthermore, except where otherwise indicated, the terms and expressions used in the present invention were chosen for the purpose of describing illustrative examples for the convenience of the reader and not for the purpose of limiting it. In addition, it should be understood that one or more of the aspects, expressions of aspects and / or examples described below can be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.
[0045] [0045] Referring to Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (for example, cloud 104 which may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one central surgical controller 106 in communication with the cloud 104 which can include a remote server 113. In one example, as illustrated in Figure 1, surgical system 102 includes a visualization system 108, a robotic system 110, a smart handheld surgical instrument 112, which are configured to communicate with each other and / or the central controller 106. In some respects, a surgical system 102 may include an M number of central controllers 106, an N number of visualization systems 108, an O number of robotic systems 110, and a P number of smart, hand-held surgical instruments 112, where M, N, O, and P are whole numbers greater than or equal to one.
[0046] [0046] Figure 3 represents an example of a surgical system 102 being used to perform a surgical procedure on a patient who is lying on an operating table 114 in a surgical operating room 116. A robotic system 110 is used in the surgical procedure as a part of surgical system 102. Robotic system 110 includes a surgeon console 118, a patient car 120 (surgical robot), and a robotic central surgical controller
[0047] [0047] Other types of robotic systems can readily be adapted for use with the surgical system 102. Various examples of robotic systems and surgical instruments that are suitable for use with the present description are described in Provisional Patent Application No. 62 / 611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, whose description is hereby incorporated by reference in its entirety.
[0048] [0048] Various examples of cloud-based analysis that are performed by the cloud 104, and are suitable for use with the present description, are described in US Provisional Patent Application Serial No. 62 / 611.340, entitled CLOUD-BASED MEDICAL ANALYTICS , filed on December 28, 2017, the description of which is incorporated herein by reference, in its entirety.
[0049] [0049] In several aspects, the imaging device 124 includes at least one Image sensor and one or more optical components. Suitable image sensors include, but are not limited to, load-coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.
[0050] [0050] The optical components of the imaging device 124 may include one or more light sources and / or one or more lenses. One or more light sources can be directed to illuminate portions of the surgical field. The one or more image sensors can receive reflected or refracted light from the surgical field, including reflected or refracted light from tissue and / or surgical instruments.
[0051] [0051] The one or more light sources can be configured to radiate electromagnetic energy in the visible spectrum, as well as in the invisible spectrum. The visible spectrum, sometimes called the optical spectrum or light spectrum, is that portion of the electromagnetic spectrum that is visible to (that is, can be detected by) the human eye and can be called visible light or simply light. A typical human eye will respond to wavelengths in the air that are from about 380 nm to about 750 nm.
[0052] [0052] The invisible spectrum (that is, the non-luminous spectrum) is that portion of the electromagnetic spectrum located below and above the visible spectrum (that is, wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the visible red spectrum, and they become invisible infrared (IR), microwaves, radio and electromagnetic radiation. Wavelengths shorter than about 380 nm are shorter than the ultraviolet spectrum, and they become invisible ultraviolet, x-ray, and electromagnetic gamma-ray radiation.
[0053] [0053] In several respects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use with the present description include, but are not limited to, an arthroscope, angioscope, bronchoscope, choledocoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagus-duodenoscope
[0054] [0054] In one aspect, the imaging device employs multiple spectrum monitoring to discriminate topography and underlying structures. A multispectral image is one that captures image data within wavelength bands across the electromagnetic spectrum. Wavelengths can be separated by filters or using instruments that are sensitive to specific wavelengths, including light from frequencies beyond the visible light range, for example, IR and ultraviolet light. Spectral images can allow the extraction of additional information that the human eye cannot capture with its receivers for the colors red, green, and blue. The use of multispectral imaging is described in more detail under the heading "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the description of which is here incorporated as a reference in its entirety. Multispectral monitoring can be a useful tool for relocating a surgical field after a surgical task is completed to perform one or more of the tests previously described on the treated tissue.
[0055] [0055] It is axiomatic that strict sterilization of the operating room and surgical equipment is necessary during any surgery. The strict hygiene and sterilization conditions required in an "operating room", that is, an operating or treatment room, justify the highest possible sterilization of all medical devices and equipment. Part of this sterilization process is the need to sterilize anything that comes into contact with the patient or enters the sterile field, including imaging device 124 and its connectors and components. It will be understood that the sterile field can be considered a specified area, such as inside a tray or on a sterile towel, which is considered free of microorganisms, or the sterile field can be considered an area, immediately around a patient, who was prepared to perform a surgical procedure. The sterile field may include members of the brushing team, who are properly dressed, and all furniture and accessories in the area.
[0056] [0056] In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays and one or more screens that are strategically arranged in relation to the sterile field, as shown in Figure 2. In one aspect, the display system 108 includes an interface for HL7, PACS and EMR. Various components of the visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the description of which is incorporated herein as a reference in its entirety.
[0057] [0057] As shown in Figure 2, a primary screen 119 is positioned in the sterile field to be visible to the operator on the operating table 114. In addition, a viewing tower 111 is positioned outside the sterile field. The display tower 111 includes a first non-sterile screen 107 and a second non-sterile screen 109, which are opposite each other. The visualization system 108, guided by the central controller 106, is configured to use screens 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the central controller 106 can have the visualization system 108 display a snapshot of a surgical site, as recorded by an imaging device 124, on a non-sterile screen 107 or 109, while maintaining a live transmission of the surgical site on the main screen 119. The snapshot on the non-sterile screen 107 or 109 can allow a non-sterile operator to perform, for example, a diagnostic step relevant to the surgical procedure.
[0058] [0058] In one aspect, central controller 106 is also configured to route a diagnostic input or feedback by a non-sterile operator in the display tower 111 to the primary screen 119 within the sterile field, where it can be seen by a sterile operator on the operating table. In one example, the entry may be in the form of a modification of the snapshot displayed on the non-sterile screen 107 or 109, which can be routed to main screen 119 by central controller 106.
[0059] [0059] With reference to Figure 2, a 112 surgical instrument is being used in the surgical procedure as part of the surgical system
[0060] [0060] Now with reference to Figure 3, a central controller 106 is shown in communication with a visualization system 108, a robotic system 110 and a smart handheld surgical instrument 112. The central controller 106 includes a central controller screen 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132 and a storage assembly 134. In certain respects, as shown in Figure 3, central controller 106 additionally includes a smoke evacuation module 126 and / or a suction / irrigation module 128.
[0061] [0061] During a surgical procedure, the application of energy to the tissue, for sealing and / or cutting, is generally associated with the evacuation of smoke, suction of excess fluid and / or irrigation of the tissue. Fluid, power, and / or data lines from different sources are often intertwined during the surgical procedure. Valuable time can be wasted in addressing this issue during a surgical procedure. To untangle the lines, it may be necessary to disconnect the lines from their respective modules, which may require a restart of the modules. The central compartment of the central controller 136 offers a unified environment for managing power, data and fluid lines, which reduces the frequency of entanglement between such lines.
[0062] [0062] Aspects of the present description feature a central surgical controller for use in a surgical procedure that involves applying energy to tissue at a surgical site. The central surgical controller includes a central controller compartment and a combination generator module received slidingly at a central controller compartment docking station. The docking station includes data and power contacts. The combined generator module includes two or more of an ultrasonic energy generating component, a bipolar RF energy generating component, and a monopolar RF energy generating component which are housed in a single unit. In one aspect, the combined generator module also includes a smoke evacuation component, at least one power application cable to connect the combined generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid , and / or particulates generated by applying therapeutic energy to the tissue, and a fluid line that extends from the remote surgical site to the smoke evacuation component.
[0063] [0063] In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to a suction and irrigation module received slidingly in the central controller compartment. In one aspect, the central controller compartment comprises a fluid interface.
[0064] [0064] Certain surgical procedures may require the application of more than one type of energy to the tissue. One type of energy may be more beneficial for cutting the fabric, while another type of energy may be more beneficial for sealing the fabric. For example, a bipolar generator can be used to seal the tissue while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present description present a solution in which a modular compartment of the central controller 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the modular compartment of the central controller 136 is that it allows the quick removal and / or replacement of several modules.
[0065] [0065] Aspects of the present description feature a modular surgical compartment for use in a surgical procedure that involves applying energy to the tissue. The modular surgical compartment includes a first energy generator module, configured to generate a first energy for application to the tissue, and a first docking station that comprises a first docking port that includes first data and power contacts, the first being The power generator module is slidingly movable in an electrical coupling with the data and power contacts and the first power generator module is slidingly movable out of the electric coupling with the first data and power contacts.
[0066] [0066] In addition to the above, the modular surgical compartment also includes a second energy generator module configured to generate a second energy, different from the first energy, for application to the tissue, and a second docking station comprising a second docking port which includes second data and power contacts and the second power generator module is slidingly movable in an electrical coupling with the data and power contacts, and the second power generator module is slidingly mobile to out of the electrical coupling with the second data and power contacts.
[0067] [0067] In addition, the modular surgical compartment also includes a communication bus between the first coupling port and the second coupling port, configured to facilitate communication between the first energy generating module and the second energy generating module.
[0068] [0068] With reference to Figures 3 to 7, aspects of the present description are presented for a modular compartment of the central controller 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation 128. The modular compartment of the central controller
[0069] [0069] In one aspect, the modular compartment of the central controller 136 comprises a modular power and a back communication board 149 with external and wireless communication heads to allow the removable fixing of modules 140, 126, 128 and interactive communication between the themselves.
[0070] [0070] In one aspect, the modular compartment of the central controller 136 includes docking stations, or drawers, 151, here also called drawers, which are configured to receive modules 140, 126, 128 in a sliding manner. Figure 4 illustrates a partial perspective view of a central surgical controller compartment 136, and a combined generator module 145 received slidably at a docking station 151 of the central surgical controller housing 136. An anchor port 152 with data and power contacts on a rear side of the combined generator module 145 it is configured to engage a corresponding docking port 150 with data and power contacts of a corresponding docking station 151 of the central controller modular compartment 136 as the combined generator module 145 is slid into the position in the corresponding docking station 151 of the central controller module compartment 136. In one aspect, the millstone combined generator module 145 includes a bipolar, ultrasonic and monopolar module and a smoke evacuation module integrated into a single cabinet unit 139, as shown in Figure 5.
[0071] [0071] In several respects, the smoke evacuation module 126 includes a fluid line 154 that carries captured / collected fluid smoke away from a surgical site and to, for example, the smoke evacuation module 126. Suction a vacuum that originates from the smoke evacuation module 126 can pull the smoke into an opening of a utility conduit at the surgical site. The utility conduit, coupled to the fluid line, can be in the form of a flexible tube that ends in the smoke evacuation module 126. The utility conduit and the fluid line define a fluid path that extends towards the smoke evacuation module 126 which is received in the central controller compartment
[0072] [0072] In several aspects, the suction / irrigation module 128 is coupled to a surgical tool comprising a fluid suction line and a fluid suction line. In one example, the suction and suction fluid lines are in the form of flexible tubes that extend from the surgical site towards the suction / irrigation module 128. One or more drive systems can be configured to cause irrigation and aspiration of fluids to and from the surgical site.
[0073] [0073] In one aspect, the surgical tool includes a drive shaft that has an end actuator at a distal end thereof and at least an energy treatment associated with the end actuator, a suction tube, and a suction tube. irrigation. The suction tube can have an inlet port at a distal end of it and the suction tube extends through the drive shaft. Similarly, an irrigation pipe can extend through the drive shaft and may have an entrance port close to the power application implement. The power application implement is configured to deliver ultrasonic and / or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the drive shaft.
[0074] [0074] The irrigation tube can be in fluid communication with a fluid source, and the suction tube can be in fluid communication with a vacuum source. The fluid source and / or the vacuum source can be housed in the suction / irrigation module 128. In one example, the fluid source and / or the vacuum source can be housed in the central controller compartment 136 separately from the control module. suction / irrigation 128. In such an example, a fluid interface can be configured to connect the suction / irrigation module 128 to the fluid source and / or the vacuum source.
[0075] [0075] In one aspect, modules 140, 126, 128 and / or their corresponding docking stations in the modular compartment of central controller 136 may include alignment features that are configured to align the docking ports of the modules in engagement with their counterparts at the docking stations of the central compartment of the central controller 136. For example, as shown in Figure 4, the combined generator module 145 includes side supports 155 which are configured to slide the corresponding supports 156 of the corresponding docking station 151 of the compartment. modular central controller
[0076] [0076] In some respects, the drawers 151 of the modular compartment of the central controller 136 are the same, or substantially the same size, and the modules are adjusted in size to be received in the drawers 151. For example, the side brackets 155 and / or 156 can be larger or smaller depending on the size of the module. In other respects, drawers 151 are different in size and are each designed to accommodate a specific module.
[0077] [0077] In addition, the contacts of a specific module can be switched to engage with the contacts of a specific drawer to avoid inserting a module in a drawer with unpaired contacts.
[0078] [0078] As shown in Figure 4, the docking port 150 of one drawer 151 can be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between the modules housed in the modular compartment of the central controller 136. The anchor ports 150 of the modular compartment of the central controller 136 can, alternatively or additionally, facilitate interactive wireless communication between modules housed in the modular compartment of the central controller 136. Any suitable wireless communication can be used, such as Air Titan Bluetooth.
[0079] [0079] Figure 6 illustrates individual power bus connectors for a plurality of side coupling ports of a side modular cabinet 160 configured to receive a plurality of modules from a central surgical controller 206. Side modular cabinet 160 is configured to receive and laterally interconnect modules 161. Modules 161 are slidably inserted into docking stations 162 of side modular cabinet 160, which includes a back plate for interconnecting modules 161. As shown in Figure 6, modules 161 are arranged laterally in the side modular cabinet 160. Alternatively, modules 161 can be arranged vertically in a side modular cabinet.
[0080] [0080] Figure 7 illustrates a vertical modular cabinet 164 configured to receive a plurality of modules 165 from the central surgical controller 106. The modules 165 are slidably inserted into docking stations, or drawers, 167 of the vertical modular cabinet 164, the which includes a rear panel for interconnecting modules 165. Although the drawers 167 of the vertical modular cabinet 164 are arranged vertically, in certain cases, a vertical modular cabinet 164 may include drawers that are arranged laterally. In addition, modules 165 can interact with each other through the docking doors of the vertical modular cabinet
[0081] [0081] In several respects, the imaging module 138 comprises an integrated video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is comprised of a modular cabinet that can be mounted with a light source module and a camera module. The case can be a disposable case. In at least one example, the disposable case is removably coupled to a reusable controller, a light source module, and a camera module. The light source module and / or the camera module can be selected selectively depending on the type of surgical procedure. In one aspect, the camera module comprises a CCD sensor. In another aspect, the camera module comprises a CMOS sensor. In another aspect, the camera module is configured for imaging the scanned beam. Similarly, the light source module can be configured to provide a white light or a different light, depending on the surgical procedure.
[0082] [0082] During a surgical procedure, removing a surgical device from the surgical field and replacing it with another surgical device that includes a different camera or other light source may be inefficient. Temporarily losing sight of the surgical field can lead to undesirable consequences. The imaging device module of the present description is configured to allow the replacement of a light source module or a "midstream" camera module during a surgical procedure, without the need to remove the imaging device from the surgical field.
[0083] [0083] In one aspect, the imaging device comprises a tubular cabinet that includes a plurality of channels. A first channel is configured to receive the Camera module in a sliding way, which can be configured for a snap-fit fit (pressure fit) with the first channel. A second channel is configured to slide the camera module, which can be configured for a snap-fit fit (pressure fit) with the first channel. In another example, the camera module and / or the light source module can be rotated to an end position within their respective channels. A threaded coupling can be used instead of a pressure fitting.
[0084] [0084] In several examples, multiple imaging devices are placed in different positions in the surgical field to provide multiple views. Imaging module 138 can be configured to switch between imaging devices to provide an ideal view. In several respects, imaging module 138 can be configured to integrate images from different imaging devices.
[0085] [0085] Various image processors and imaging devices suitable for use with the present description are described in US Patent No. 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, granted on August 9, 2011 which is incorporated herein by way of reference in its entirety. In addition, US Patent No. 7,982,776, entitled SBI.
[0086] [0086] MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, granted on July 19, 2011, which is hereby incorporated by reference in its entirety, describes several systems for removing motion artifacts from image data. Such systems can be integrated with imaging module 138. In addition to these, US Patent Application Publication No. 2011/0306840, entitled CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS, published on December 15, 2011, and the Application Publication US Patent No. 2014/0243597, entitled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published on August 28, 2014, which are each incorporated herein by reference in their entirety.
[0087] [0087] Figure 8 illustrates a surgical data network 201 comprising a central modular communication controller 203 configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a healthcare facility. audiences specially equipped for surgical operations, to a cloud-based system (for example, cloud 204 which may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communication central controller 203 comprises a central network controller 207 and / or a network key 209 in communication with a network router. The central modular communication controller 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 can be configured as a passive, intelligent, or switching network. A passive surgical data network serves as a conduit for the data, allowing the data to be transmitted from one device (or segment) to another and to cloud computing resources. An intelligent surgical data network includes features to allow traffic to pass through the surgical data network to be monitored and to configure each port on the central network controller 207 or network key 209. An intelligent surgical data network can be called a a central controller or controllable key. A central switching controller reads the destination address of each packet and then forwards the packet to the correct port.
[0088] [0088] Modular devices 1a to 1n located in the operating room can be coupled to the central controller of modular communication 203. The central network controller 207 and / or the network switch 209 can be coupled to a network router 211 to connect devices 1a through 1n to the 204 cloud or the local computer system
[0089] [0089] It will be understood that the surgical data network 201 can be expanded by interconnecting multiple central network controllers 207 and / or multiple network keys 209 with multiple network routers 211. The central communication controller 203 may be contained in a modular control roaster configured to receive multiple devices 1a to 1n / 2a to 2m. The local computer system 210 can also be contained in a modular control tower. The modular communication central controller 203 is connected to a screen 212 to display the images obtained by some of the devices 1a to 1n / 2a to 2m, for example, during surgical procedures. In several respects, devices 1a to 1n / 2a to 2m can include, for example, several modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, an evacuation module smoke 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage assembly 134, a surgical device attached to a screen and / or a non-contact sensor module, among other devices modular modules that can be connected to the central communication controller 203 of the surgical data network 201.
[0090] [0090] In one aspect, the surgical data network 201 may comprise a combination of central network controllers, network switches, and network routers that connect devices 1a to 1n / 2a to 2m to the cloud. Any or all of the devices 1a to 1n / 2a to 2m coupled to the central network controller or network switch can collect data in real time and transfer the data to cloud computers for data processing and manipulation. It will be understood that cloud computing depends on sharing computing resources instead of having local servers or personal devices to handle software applications. The word "cloud" can be used as a metaphor for "the Internet", although the term is not limited as such. Consequently, the term "cloud computing" can be used here to refer to "a type of Internet-based computing", in which different services - such as servers, storage, and applications - are applied to the modular communication central controller 203 and / or the computer system 210 located in the operating room (for example, a fixed, mobile, temporary or operating room or space) and devices connected to the modular central communication controller 203 and / or computer system 210 via Internet. The cloud infrastructure can be maintained by a cloud service provider. In this context, the cloud service provider may be the entity that coordinates the use and control of devices 1a to 1n / 2a to 2m located in one or more operating rooms. Cloud computing services can perform a large number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The central controller hardware allows multiple devices or connections to be connected to a computer that communicates with cloud computing and storage resources.
[0091] [0091] The application of cloud computer data processing techniques to the data collected by devices 1a to 1n / 2a to 2m, the surgical data network provides better surgical results, reduced costs, and better patient satisfaction. At least some of the devices 1a to 1n / 2a to 2m can be used to view tissue status to assess leakage or perfusion of sealed tissue after a tissue sealing and cutting procedure. At least some of the devices 1a to 1n / 2a to 2m can be used to identify the pathology, such as the effects of disease, with the use of cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes confirmation of the location and margin of the tissue and phenotypes. At least some of the devices 1a to 1n / 2a to 2m can be used to identify anatomical structures of the body using a variety of sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. The data collected by devices 1a to 1n / 2a to 2m, including the image data, can be transferred to the cloud 204 or the local computer system 210 or both for data processing and manipulation including image processing and manipulation. The data can be analyzed to improve the results of the surgical procedure by determining whether additional treatment, such as application of endoscopic intervention, emerging technologies, targeted radiation, targeted intervention, accurate robotics at specific tissue sites and conditions, can be followed. This data analysis can additionally use analytical processing of the results, and with the use of standardized approaches they can provide beneficial standardized feedback both to confirm surgical treatments and the surgeon's behavior or to suggest changes to surgical treatments and the surgeon's behavior.
[0092] [0092] In an implementation, devices in the operating room 1a to 1n can be connected to the central modular communication controller 203 via a wired channel or a wireless channel depending on the configuration of devices 1a to 1n on a central controller of network. The central network controller 207 can be implemented, in one aspect, as a local network transmission device that acts on the physical layer of the OSI model ("open system interconnection"). The central network controller provides connectivity to devices 1a to 1n located on the same network as the operating room. The central network controller 207 collects data in the form of packets and sends it to the router in "half-duplex" mode. The central network controller 207 does not store any media / Internet protocol (MAC / IP) access control for transferring data from the device. Only one of the devices 1a to 1n at a time can send data through the central network controller 207. The central network controller 207 has no routing tables or intelligence about where to send information and transmits all network data through each connection and to a remote server 213 (Figure 9) in cloud 204. The central network controller 207 can detect basic network errors, such as collisions, but having all the information transmitted to multiple input ports can be a security risk and cause strangulation.
[0093] [0093] In another implementation, operating room devices 2a to 2m can be connected to a network switch 209 through a wired or wireless channel. The network switch 209 works on the data connection layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operation center to the network. The network key 209 sends data in frame form to the network router 211 and works in full duplex mode. Multiple devices 2a to 2m can send data at the same time via network key 209. Network key 209 stores and uses MAC addresses of devices 2a to 2m to transfer data.
[0094] [0094] The central network controller 207 and / or the network switch 209 are coupled to the network router 211 for connection to the cloud
[0095] [0095] In one example, the central network controller 207 can be implemented as a central USB controller, which allows multiple USB devices to be connected to a host computer. The central USB controller can expand a single USB port on several levels so that more ports are available to connect the devices to the system's host computer. The central network controller 207 can include wired or wireless capabilities to receive information about a wired channel or a wireless channel. In one aspect, a wireless wireless, broadband and short-range wireless USB communication protocol can be used for communication between devices 1a to 1n and devices 2a to 2m located in the operating room.
[0096] [0096] In other examples, devices in the operating room 1a to 1n / 2a to 2m can communicate with the central modular communication controller 203 via standard Bluetooth wireless technology for exchanging data over short distances (with the use of short wavelength UHF radio waves in the ISM band of 2.4 to 2.485 GHz) from fixed and mobile devices and build personal area networks (PANs). In other respects, operating room devices 1a to 1n / 2a to 2m can communicate with the central modular communication controller 203 via a number of wireless and wired communication standards or protocols, including, but not limited to a, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long-term evolution (LTE, "long-term evolution"), and Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM , GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, as well as any other wireless and wired protocols that are designated as 3G, 4G, 5G, and beyond. The computing module can include a plurality of communication modules. For example, a first communication module can be dedicated to short-range wireless communications, such as Wi-Fi and Bluetooth, and a second communication module can be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO and others.
[0097] [0097] The modular communication central controller 203 can serve as a central connection for one or all operating room devices 1a to 1n / 2a to 2m and handles a data type known as frames. The tables carry the data generated by the devices 1a to 1n / 2a to 2m. When a frame is received by the modular central communication controller 203, it is amplified and transmitted to the network router 211, which transfers data to cloud computing resources using a series of wireless communication standards or protocols or wired, as described in the present invention.
[0098] [0098] The modular communication central controller 203 can be used as a standalone device or be connected to compatible central network controllers and network switches to form a larger network. The 203 modular communication central controller is, in general, easy to install, configure and maintain, making it a good option for the network of devices 1a to 1n / 2a to 2m from the operating room.
[0099] [0099] Figure 9 illustrates an interactive surgical system, implemented by computer 200. The interactive surgical system implemented by computer 200 is similar in many ways to the interactive surgical system, implemented by computer 100. For example, the interactive, implemented, surgical system per computer 200 includes one or more surgical systems 202, which are similar in many respects to surgical systems 102. Each surgical system 202 includes at least one central surgical controller 206 in communication with a cloud 204 which may include a remote server
[00100] [00100] Figure 10 illustrates a central surgical controller 206 that comprises a plurality of modules coupled to the modular control tower 236. The modular control tower 236 comprises a central controller for modular communication 203, for example, a network connectivity device , and a computer system 210 for providing local processing, visualization, and imaging, for example. As shown in Figure 10, the modular communication central controller 203 can be connected in a layered configuration to expand the number of modules (for example, devices) that can be connected to the modular communication central controller 203 and transfer data associated with modules to computer system 210, cloud computing resources, or both. As shown in Figure 10, each of the central controllers / network switches in the modular communication central controller 203 includes three downstream ports and one upstream port. The central controller / network switch upstream is connected to a processor to provide a communication connection to the cloud computing resources and a local display 217. Communication with the cloud 204 can be done via a wired communication channel or wireless.
[00101] [00101] The central surgical controller 206 employs a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using non-contact measuring devices of the laser or ultrasonic type. An ultrasound-based non-contact sensor module scans the operating room by transmitting an ultrasound explosion and receiving echo when it bounces outside the perimeter of the walls of an operating room, as described under the heading "Surgical Hub Spatial
[00102] [00102] Computer system 210 comprises a processor 244 and a network interface 245. Processor 244 is coupled to a communication module 247, storage 248, memory 249, non-volatile memory 250 and input / output interface 251 via a system bus. The system bus can be any of several types of bus structures, including the memory bus or memory controller, a peripheral bus or external bus and / or a local bus that uses any variety of available bus architectures including, but not limited to, limited to, 9-bit bus, Industrial Standard Architecture (ISA), Micro-Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI) , USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association (PCMCIA) bus, Small Computer Systems Interface (SCSI) or any other proprietary bus.
[00103] [00103] Processor 244 can be any single-core or multi-core processor, such as those known under the trade name of ARM Cortex available from Texas Instruments. In one respect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz , a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with StellarisWare® software, a memory only 2 KB electrically erasable programmable readout (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder (QEI) analog inputs, one or more "analog to digital" converters 12-bit (ADC) with 12 channels of analog input, details of which are available for the product data sheet.
[00104] [00104] In one aspect, processor 244 may comprise a safety controller comprising two controller-based families, such as TMS570 and RM4x, known under the tradename Hercules ARM Cortex R4, also by Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[00105] [00105] System memory includes volatile and non-volatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within the computer system, such as during startup, is stored in non-volatile memory. For example, non-volatile memory can include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM),
[00106] [00106] Computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card or memory stick (pen drive). drive). In addition, the storage disc may include storage media separately or in combination with other storage media including, but not limited to, an optical disc drive such as a compact disc ROM (CD-ROM) device recordable (CD-R Drive), rewritable compact disc drive (CD-RW drive), or a versatile digital ROM drive (DVD-ROM). To facilitate the connection of disk storage devices to the system bus, a removable or non-removable interface can be used.
[00107] [00107] It is to be understood that computer system 210 includes software that acts as an intermediary between users and the basic resources of the computer described in a suitable operating environment. Such software includes an operating system. The operating system, which can be stored on disk storage, acts to control and allocate computer system resources. System applications benefit from the management capabilities of the operating system through program modules and program data stored in system memory or on the storage disk. It is to be understood that the various components described in the present invention can be implemented with various operating systems or combinations of operating systems.
[00108] [00108] A user enters commands or information into the computer system 210 through the input device (s) coupled to the I / O interface 251. Input devices include, but are not limited to, a device pointer such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, game pad, satellite card, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices connect to the processor via the system bus via the interface port (s). The interface ports include, for example, a serial port, a parallel port, a game port and a USB. Output devices use some of the same types of ports as input devices. In this way, for example, a USB port can be used to provide input to the computer system and to provide information from the computer system to an output device. An output adapter is provided to illustrate that there are some output devices such as monitors, screens, speakers, and printers, among other output devices, that need special adapters. Output adapters include, by way of illustration and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and / or device systems, such as remote computers, provide input and output capabilities.
[00109] [00109] Computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computers, or local computers.
[00110] [00110] In several respects, computer system 210 of Figure 10, imaging module 238 and / or display system 208, and / or processor module 232 of Figures 9 to 10, may comprise an image processor, image processing engine, media processor or any specialized digital signal processor (DSP) used for processing digital images. The image processor can employ parallel computing with single multi-data instruction (SIMD) or multiple multi-data instruction (MIMD) technologies to increase speed and efficiency. The digital image processing engine can perform a number of tasks.
[00111] [00111] Communication connections refer to the hardware / software used to connect the network interface to the bus. Although the communication connection is shown for illustrative clarity within the computer system, it can also be external to computer system 210. The hardware / software required for connection to the network interface includes, for illustrative purposes only, internal and external technologies such as modems, including regular telephone serial modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.
[00112] [00112] Figure 11 illustrates a functional block diagram of an aspect of a USB 300 central network controller device, in accordance with at least one aspect of the present description. In the illustrated aspect, the USB 300 network central controller device uses a TUSB2036 integrated circuit central controller available from Texas Instruments. The central network controller USB 300 is a CMOS device that provides a USB transceiver port 302 and up to three USB transceiver ports downstream 304, 306, 308 in accordance with the USB 2.0 specification. Upstream USB transceiver port 302 is a differential data root port comprising a "minus" (DM0) differential data input paired with a "plus" (DP0) differential data input. The three ports of the downstream USB transceiver 304, 306, 308 are differential data ports, with each port including "more" differential data outputs (DP1-DP3) paired with "less" differential data outputs (DM1-DM3) .
[00113] [00113] The USB 300 central network controller device is implemented with a digital state machine instead of a microcontroller, and no firmware programming is required.
[00114] [00114] The USB 300 network central controller device includes a 310 series interface engine (SIE). The SIE 310 is the hardware front end of the USB 300 central network controller and handles most of the protocol described in chapter 8 of the USB specification. SIE 310 typically comprises signaling down to the transaction level. The functions it handles could include: packet recognition, transaction sequencing, SOP, EOP, RESET, and RESUME signal detection / generation, clock / data separation, data encoding / decoding non-inverted zero (NRZI) , generation and verification of CRC (token and data), generation and verification / decoding of packet ID (PID), and / or series-parallel / parallel-series conversion. The 310 receives a clock input 314 and is coupled with a suspend / resume logic circuit and frame timer 316 and a central controller repeat circuit 318 to control communication between the upstream USB transceiver port 302 and the USB transceiver ports downstream 304, 306, 308 through the logic circuits of ports 320, 322, 324. The SIE 310 is coupled to a command decoder 326 through the logic interface to control the commands of a serial EEPROM via an EEPROM interface in 330 series.
[00115] [00115] In several aspects, the USB 300 central network controller can connect 127 functions configured in up to six logical layers (levels) to a single computer. In addition, the USB 300 central network controller can connect all peripherals using a standardized four-wire cable that provides both communication and power distribution. The power settings are bus-powered and self-powered modes. The USB 300 central network controller can be configured to support four power management modes: a bus-powered central controller with individual port power management or grouped port power management, and the self-powered central controller with power management. individual port power or grouped port power management. In one aspect, using a USB cable, the central USB network controller 300, the upstream USB transceiver port 302 is connected to a USB host controller, and the downstream USB transceiver ports 304, 306, 308 are exposed to connect USB-compatible devices, and so on. Surgical instrument hardware
[00116] [00116] Figure 12 illustrates a logic diagram of a module of a 470 control system of a surgical instrument or tool, according to one or more aspects of the present description. The 470 system comprises a control circuit. The control circuit includes a microcontroller 461 comprising a processor 462 and a memory 468. One or more of the sensors 472, 474, 476, for example, provide real-time feedback to processor 462. A motor 482, driven by a driver of motor 492, operationally couples a longitudinally movable displacement member to drive the beam element with I-shaped beam. A tracking system 480 is configured to determine the position of the longitudinally movable displacement member. Position information is provided to the 462 processor, which can be programmed or configured to determine the position of the longitudinally movable drive member, as well as the position of a firing member, firing bar and an I-beam beam cutting element. Additional motors can be provided at the instrument driver interface to control the firing of the I-profile beam, the displacement of the closing tube, the rotation of the drive shaft and the articulation. A 473 screen displays a variety of instrument operating conditions and can include touchscreen functionality for data entry. The information displayed on screen 473 can be overlaid with images captured using endoscopic imaging modules.
[00117] [00117] In one aspect, the 461 microcontroller can be any single-core or multi-core processor, such as those known under the ARM Cortex trade name available from Texas Instruments. In one respect, the main microcontroller 461 can be an LM4F230H5QR ARM Cortex-M4F processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single cycle flash memory, or other non-volatile memory, up to 40 MHz, a prefetch buffer to optimize performance above 40 MHz, a 32 KB single cycle SRAM memory, an internal ROM loaded with StellarisWare® software, a 2 KB EEPROM memory, one or more PWM modules , one or more analog QEI and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available for the product data sheet.
[00118] [00118] In one aspect, the 461 microcontroller may comprise a safety controller that comprises two families based on controllers, such as TMS570 and RM4x known under the trade name Hercules ARM Cortex R4, also available from Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[00119] [00119] The 461 microcontroller can be programmed to perform various functions, such as precise control of the speed and position of the joint and knife systems. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 can be a brushed direct current (DC) motor with a gearbox and mechanical connections with an articulation or scalpel system. In one aspect, a motor drive 492 can be an A3941 available from Allegro Microsystems, Inc. Other motor drives can be readily replaced for use in tracking system 480 which comprises an absolute positioning system. A detailed description of an absolute positioning system is given in US patent application publication 2017/0296213, entitled SYSTEMS AND METHODS FOR
[00120] [00120] The 461 microcontroller can be programmed to provide precise control of the speed and position of the displacement members and articulation systems. The 461 microcontroller can be configured to compute a response in the 461 microcontroller software. The computed response is compared to a measured response from the real system to obtain an "observed" response, which is used for actual feedback-based decisions. The observed response is a favorable and adjusted value,
[00121] [00121] In one aspect, motor 482 can be controlled by motor driver 492 and can be used by the instrument's trigger system or surgical tool. In many ways, the 482 motor can be a brushed direct current (DC) motor with a maximum rotational speed of approximately
[00122] [00122] The 492 motor driver can be an A3941, available from Allegro Microsystems, Inc. The 492 A3941 driver is an entire bridge controller for use with external power semiconductor metal oxide field (MOSFET) transistors. , of N channel, specifically designed for inductive loads, such as brushed DC motors. The 492 actuator comprises a single charge pump regulator that provides full port drive (> 10 V) for batteries with voltage up to 7 V and allows the A3941 to operate with a reduced door drive, up to 5.5 V. A capacitor A bootstrap can be used to supply the battery supply voltage required above for N-channel MOSFETs. An internal charge pump for driving the high side allows operation in direct current (100% duty cycle). The entire bridge can be triggered in fast or slow drop modes using diodes or synchronized rectification. In the slow drop mode, the current can be recirculated by means of FET from the top or from the bottom. The energy FETs are protected from the shoot-through effect through resistors with programmable dead time. Integrated diagnostics provide indication of undervoltage, overtemperature and faults in the power bridge, and can be configured to protect power MOSFETs in most short-circuit conditions. Other motor drives can be readily replaced for use in the tracking system 480 comprising an absolute positioning system.
[00123] [00123] Tracking system 480 comprises a controlled motor drive circuit arrangement comprising a position sensor 472 in accordance with an aspect of the present description. The position sensor 472 for an absolute positioning system provides a unique position signal that corresponds to the location of a displacement member. In one aspect, the displacement member represents a longitudinally movable drive member comprising a rack of drive teeth for engagement with a corresponding drive gear of a gear reduction assembly. In other respects, the displacement member represents the firing member, which can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents the firing bar or the I-shaped beam, each of which can be adapted and configured to include a rack of driving teeth.
[00124] [00124] The 482 electric motor may include a rotary drive shaft, which interfaces operationally with a gear set, which is mounted on a coupling coupling with a set or rack of drive teeth on the drive member. A sensor element can be operationally coupled to a gear assembly so that a single revolution of the position sensor element 472 corresponds to some linear longitudinal translation of the displacement member. An array of gears and sensors can be connected to the linear actuator by means of a rack and pinion arrangement, or by a rotary actuator, by means of a sprocket or other connection. A power source supplies power to the absolute positioning system and an output indicator can display the output from the absolute positioning system. The drive member represents the longitudinally movable drive member comprising a rack of drive teeth formed thereon for engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents the longitudinally movable firing member, the firing bar, the I-beam or combinations thereof.
[00125] [00125] A single revolution of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement of d1 of the displacement member, where d1 represents the longitudinal linear distance by which the displacement member moves from point "a" to point "b" after a single revolution of the sensor element coupled to the displacement member. The sensor arrangement can be connected by means of a gear reduction which results in the position sensor 472 completing one or more revolutions for the complete travel of the displacement member. The 472 position sensor can complete multiple revolutions for the full travel of the displacement member.
[00126] [00126] A series of keys, where n is an integer greater than one, can be used alone or in combination with a gear reduction to provide a single position signal for more than one revolution of the position sensor 472. The state of the switches is transmitted back to microcontroller 461 which applies logic to determine a single position signal corresponding to the longitudinal linear displacement d1 + d2 +… dn of the displacement member. The output of the position sensor 472 is supplied to the microcontroller 461. In several embodiments, the position sensor 472 of the sensor arrangement may comprise a magnetic sensor, an analog rotary sensor, such as a potentiometer, or a series of analog Hall effect elements. , which emit a unique combination of signals or position values.
[00127] [00127] The position sensor 472 can comprise any number of magnetic detection elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector components of the magnetic field. The techniques used to produce both types of magnetic sensors cover many aspects of physics and electronics. Technologies used for magnetic field detection include flow meter, saturated flow, optical pumping, nuclear precession, SQUID, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric compounds, magnetodiode, magnetic transistor, fiber optics, magneto-optics and magnetic sensors based on microelectromechanical systems, among others.
[00128] [00128] In one aspect, the position sensor 472 for the tracking system 480 which comprises an absolute positioning system comprises a magnetic rotating absolute positioning system. The 472 position sensor can be implemented as an AS5055EQFT single-circuit magnetic rotary position sensor, available from Austria Microsystems, AG. The position sensor 472 interfaces with the 461 microcontroller to provide an absolute positioning system. The 472 position sensor is a low voltage, low power component and includes four effect elements in an area of the 472 position sensor located above a magnet. A high-resolution ADC and an intelligent power management controller are also provided on the integrated circuit. A CORDIC (digital computer for coordinate rotation) processor, also known as the digit-for-digit method and Volder algorithm, is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions that require only addition, subtraction, displacement operations bits and lookup table. The angle position, alarm bits and magnetic field information are transmitted via a standard serial communication interface, such as a serial peripheral interface (SPI), to the 461 microcontroller. The 472 position sensor provides 12 or 14 bits of resolution. The position sensor 472 can be an AS5055 integrated circuit supplied in a small 16-pin QFN package of 4 x 4 x 0.85 mm.
[00129] [00129] The tracking system 480 comprising an absolute positioning system can comprise and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power source converts the signal from the feedback controller to a physical input to the system, in this case the voltage. Other examples include a voltage, current and force PWM. Other sensors can be provided to measure the parameters of the physical system in addition to the position measured by the position sensor 472. In some respects, the other sensors may include sensor arrangements as described in US Patent No. 9,345,481 entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, granted on May 24, 2016, which is incorporated by reference in its entirety in this document; US Patent Application Serial No. 2014/0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, published on September 18, 2014, is incorporated by reference in its entirety into this document; and US Patent Application Serial No. 15 / 628,175, entitled TECHNIQUES FOR ADAPTIVE
[00130] [00130] The absolute positioning system provides an absolute positioning of the displaced member on the activation of the instrument without having to retract or advance the longitudinally movable driving member to the restart position (zero or initial), as may be required by the encoders conventional rotating machines that merely count the number of progressive or regressive steps that the 482 motor has traveled to infer the position of a device actuator, actuation bar, scalpel, and the like.
[00131] [00131] A 474 sensor, such as a strain gauge or a micro strain gauge, is configured to measure one or more parameters of the end actuator, such as, for example, the amplitude of the strain exerted on the anvil during a gripping operation, which may be indicative of tissue compression. The measured effort is converted into a digital signal and fed to the 462 processor. Alternatively, or in addition to the 474 sensor, a 476 sensor, such as a load sensor, can measure the closing force applied by the drive system. anvil closure. The 476 sensor, such as a load sensor, can measure the firing force applied to a beam with an I-profile in a firing stroke of the tool or surgical instrument. The i-profile beam is configured to engage a wedge slider, which is configured to move the clamp actuators upward to force the clamps to deform in contact with an anvil. The i-profile beam includes a sharp cutting edge that can be used to separate fabric, as the i-profile beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure the current drained by the 482 motor. The force required to fire the displacement member may correspond to the current drained by the 482 motor,
[00132] [00132] In one form, a 474 strain gauge sensor can be used to measure the force applied to the tissue by the end actuator. A strain gauge can be attached to the end actuator to measure the force applied to the tissue being treated by the end actuator. A system for measuring forces applied to the tissue attached by the end actuator comprises a 474 strain gauge sensor, such as, for example, a microstrain gauge, which is configured to measure one or more parameters of the end actuator, for example. In one aspect, the 474 strain gauge sensor can measure the amplitude or magnitude of the mechanical stress exerted on a claw member of an end actuator during a gripping operation, which can be indicative of tissue compression. The measured effort is converted into a digital signal and fed to the 462 processor of a microcontroller
[00133] [00133] Measurements of tissue compression, tissue thickness and / or force required to close the end actuator on the tissue, as measured by sensors 474, 476, can be used by microcontroller 461 to characterize the selected position of the trigger member and / or the corresponding trigger member speed value. In one case, a 468 memory can store a technique, an equation and / or a look-up table that can be used by the 461 microcontroller in the evaluation.
[00134] [00134] The control system 470 of the instrument or surgical tool can also comprise wired or wireless communication circuits for communication with the central modular communication controller shown in Figures 8 to 11.
[00135] [00135] Figure 13 illustrates a control circuit 500 configured to control aspects of the instrument or surgical tool according to an aspect of the present description. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 may comprise a microcontroller comprising one or more processors 502 (for example, microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores instructions executable on a machine which, when executed by the processor 502, cause the 502 processor to execute machine instructions to implement several of the processes described here. The 502 processor can be any one of a number of single-core or multi-core processors known in the art. The memory circuit 504 may comprise volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present description.
[00136] [00136] Figure 14 illustrates a combinational logic circuit 510 configured to control aspects of the instrument or surgical tool according to an aspect of the present description. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 may comprise a finite state machine comprising a combinational logic 512 configured to receive data associated with the surgical tool or instrument at an input 514, process the data by combinational logic 512 and provide an output 516.
[00137] [00137] Figure 15 illustrates a sequential logic circuit 520 configured to control aspects of the instrument or surgical tool according to an aspect of the present description. Sequential logic circuit 520 or combinational logic 522 can be configured to implement the process described herein. Sequential logic circuit 520 may comprise a finite state machine. Sequential logic circuit 520 may comprise, for example, combinational logic 522, at least one memory circuit 524 and a clock 529. The at least one memory circuit 524 can store a current state of the finite state machine. In certain cases, the sequential logic circuit 520 may be synchronous or asynchronous. Combinational logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data by combinational logic 522, and provide an output 528. In other respects, the circuit may comprise a combination of a processor (for example , processor 502, Figure 13) and a finite state machine for implementing various processes of the present invention. In other respects, the finite state machine may comprise a combination of a combinational logic circuit (for example, a combinational logic circuit 510, Figure 14) and the sequential logic circuit 520.
[00138] [00138] Figure 16 illustrates an instrument or surgical tool that comprises a plurality of motors that can be activated to perform various functions. In certain cases, a first engine can be activated to perform a first function, a second engine can be activated to perform a second function, a third engine can be activated to perform a third function, a fourth engine can be activated to perform a fourth function, and so on. In certain cases, the plurality of motors of the robotic surgical instrument 600 can be individually activated to cause firing, closing and / or articulation movements in the end actuator. The firing, closing and / or articulation movements can be transmitted to the end actuator through a drive shaft assembly, for example.
[00139] [00139] In certain cases, the tool or surgical instrument system may include a 602 firing motor. The 602 firing motor can be operationally coupled to a 604 firing motor drive assembly, which can be configured to transmit movements triggering elements generated by the 602 motor to the end actuator, particularly to move the beam element with an I-profile. In certain cases, the triggering movements generated by the triggering motor 602 can cause the clamps to be positioned from the cartridge staples in the fabric captured by the end actuator and / or the cutting edge of the I-beam beam element to be advanced in order to cut the captured fabric, for example. The I-beam member can be retracted by reversing the direction of the 602 motor.
[00140] [00140] In certain cases, the surgical instrument or tool may include a closing motor 603. The closing motor 603 can be operationally coupled to a drive assembly of the closing motor 605 that can be configured to transmit closing movements generated by the motor 603 to the end actuator, particularly to move a closing tube to close the anvil and compress the fabric between the anvil and the staple cartridge. Closing movements can cause the end actuator to transition from an open configuration to an approximate configuration to capture tissue, for example. The end actuator can be moved to an open position by reversing the direction of the 603 motor.
[00141] [00141] In certain cases, the surgical instrument or tool may include one or more articulation motors 606a, 606b, for example. The motors 606a, 606b can be operationally coupled to the drive assemblies of the articulation motor 608a, 608b, which can be configured to transmit articulation movements generated by the motors 606a, 606b to the end actuator. In certain cases, the articulation movements can cause the end actuator to be articulated in relation to the drive shaft assembly, for example.
[00142] [00142] As described above, the surgical instrument or tool can include a plurality of motors that can be configured to perform various independent functions. In certain cases, the plurality of motors of the instrument or surgical tool can be activated individually or separately to perform one or more functions, while other motors remain inactive. For example, the articulation motors 606a, 606b can be activated to cause the end actuator to be articulated, while the firing motor 602 remains inactive. Alternatively, the firing motor 602 can be activated to fire the plurality of clamps, and / or advance the cutting edge, while the hinge motor 606 remains inactive. In addition, the closing motor 603 can be activated simultaneously with the firing motor 602 to cause the closing tube and the I-beam beam element to move distally, as described in more detail later in this document.
[00143] [00143] In certain cases, the instrument or surgical tool may include a common control module 610 that can be used with a plurality of motors of the instrument or surgical tool. In certain cases, the common control module 610 can accommodate one of the plurality of motors at a time. For example, the common control module 610 can be coupled to and separable from the plurality of motors of the robotic surgical instrument individually. In certain cases, a plurality of surgical instrument or tool motors may share one or more common control modules, such as the common control module 610. In certain cases, a plurality of surgical instrument or tool motors may be individually and selectively engaged to the common control module 610. In certain cases, the common control module 610 can be selectively switched between interfacing with one of a plurality of instrument motors or surgical tool to interface with another among the plurality of instrument motors or surgical tool.
[00144] [00144] In at least one example, the common control module 610 can be selectively switched between the operational coupling with the articulation motors 606a, 606b, and the operational coupling with the firing motor 602 or the closing motor 603. In at least one example, as shown in Figure 16, a key 614 can be moved or transitioned between a plurality of positions and / or states. In the first position 616, the switch 614 can electrically couple the common control module 610 to the trip motor 602; in a second position 617, the switch 614 can electrically couple the control module 610 to the closing motor 603; in a third position 618a, the switch 614 can electrically couple the common control module 610 to the first articulation motor 606a; and in a fourth position 618b, the switch 614 can electrically couple the common control module 610 to the second articulation motor 606b, for example. In certain cases, separate common control modules 610 can be electrically coupled to the trip motor 602,
[00145] [00145] Each of the motors 602, 603, 606a, 606b can comprise a torque sensor to measure the output torque on the motor drive shaft. The force on an end actuator can be detected in any conventional manner, such as by means of force sensors on the outer sides of the jaws or by a motor torque sensor that drives the jaws.
[00146] [00146] In several cases, as shown in Figure 16, the common control module 610 may comprise a motor starter 626 which may comprise one or more H-Bridge FETs. The motor driver 626 can modulate the energy transmitted from a power source 628 to a motor coupled to the common control module 610, based, for example, on an input from a microcontroller 620 (the "controller"). In certain cases, the microcontroller 620 can be used to determine the current drawn by the motor, for example, while the motor is coupled to the common control module 610, as described above.
[00147] [00147] In certain examples, the microcontroller 620 may include a microprocessor 622 (the "processor") and one or more non-transitory computer-readable media or 624 memory units (the "memory"). In certain cases, memory 624 can store various program instructions which, when executed, can cause processor 622 to perform a plurality of functions and / or calculations described herein. In certain cases, one or more of the memory units 624 can be coupled, for example, to the processor 622.
[00148] [00148] In certain cases, the power source 628 can be used to supply power to the microcontroller 620, for example. In certain cases, the 628 power source may comprise a battery (or "battery pack" or "power source"), such as a Li ion battery, for example. In certain cases, the battery pack can be configured to be releasably mounted to the handle to supply power to the surgical instrument 600. Several battery cells connected in series can be used as the 628 power source. In certain cases, the power source 628 power supply can be replaceable and / or rechargeable, for example.
[00149] [00149] In several cases, the 622 processor can control the motor drive 626 to control the position, direction of rotation and / or speed of a motor that is coupled to the common control module 610. In certain cases, the processor 622 can signal the motor driver 626 to stop and / or disable a motor that is coupled to the common control module 610. It should be understood that the term "processor", as used here, includes any microprocessor, microcontroller or other control device. adequate basic computing that incorporates the functions of a central computer processing unit (CPU) in an integrated circuit or, at most, some integrated circuits. The processor is a programmable multipurpose device that accepts digital data as input, processes it according to instructions stored in its memory, and provides results as output. This is an example of sequential digital logic, as it has internal memory. Processors operate on numbers and symbols represented in the binary numeral system.
[00150] [00150] In one example, the 622 processor can be any single-core or multi-core processor, such as those known by the Texas Instruments ARM Cortex trade name. In certain cases, the 620 microcontroller may be an LM 4F230H5QR, available from Texas Instruments, for example. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that comprises a 256 KB single cycle flash integrated memory, or other non-volatile memory, up to 40 MHz, an early seek buffer for optimize performance above 40 MHz, a 32 KB single cycle SRAM, an internal ROM loaded with StellarisWare® software, 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, one or more ADCs 12-bit with 12 channels of analog input, among other features that are readily available for the product data sheet. Other microcontrollers can be readily replaced for use with the 4410 module. Consequently, the present description should not be limited in this context.
[00151] [00151] In certain cases, memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are attachable to common control module 610. For example, memory 624 may include program instructions for controlling the motor trigger 602, closing motor 603 and hinge motors 606a, 606b. Such program instructions can cause the 622 processor to control the trigger, close, and link functions according to inputs from the instrument or surgical tool control algorithms or programs.
[00152] [00152] In certain cases, one or more mechanisms and / or sensors, such as 630 sensors, can be used to alert the 622 processor about the program instructions that need to be used in a specific configuration. For example, sensors 630 can alert the 622 processor to use the program instructions associated with triggering, closing, and pivoting the end actuator. In certain cases, sensors 630 may comprise position sensors that can be used, for example, to detect the position of switch 614. Consequently, processor 622 can use the program instructions associated with firing the beam with I-profile of the actuator end by detecting, through sensors 630, for example, that key 614 is in first position 616; the processor 622 can use the program instructions associated with closing the anvil upon detection through sensors 630, for example, that switch 614 is in second position 617; and processor 622 can use the program instructions associated with the articulation of the end actuator upon detection through sensors 630, for example, that switch 614 is in the third or fourth position 618a, 618b.
[00153] [00153] Figure 17 is a schematic diagram of a robotic surgical instrument 700 configured to operate a surgical tool described in this document, in accordance with an aspect of that description. The robotic surgical instrument 700 can be programmed or configured to control the distal / proximal translation of a displacement member, the distal / proximal displacement of a closing tube, the rotation of the drive shaft, and articulation, either with a single type or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to individually control a firing member, a closing member, a driving shaft member and / or one or more hinge members. The surgical instrument 700 comprises a control circuit 710 configured to control motor-driven firing members, closing members, driving shaft members and / or one or more hinge members.
[00154] [00154] In one aspect, the robotic surgical instrument 700 comprises a control circuit 710 configured to control an anvil 716 and a beam portion with I-shaped profile 714 (including a sharp cutting edge) of an end actuator 702, a cartridge of removable clamps 718, a drive shaft 740 and one or more hinge members 742a, 742b through a plurality of motors 704a to 704e. A position sensor 734 can be configured to provide feedback on the I-profile beam 714 to control circuit 710. Other sensors 738 can be configured to provide feedback to control circuit 710. A timer / counter 731 provides timing information and control circuit 710. A power source 712 can be provided to operate motors 704a to 704e and a current sensor 736 provides motor current feedback to control circuit 710. Motors 704a to 704e can be operated individually by the control circuit 710 in an open loop or closed loop feedback control.
[00155] [00155] In one aspect, the control circuit 710 may comprise one or more microcontrollers, microprocessors or other processors suitable for executing instructions that cause the processor or processors to perform one or more tasks. In one aspect, a timer / counter 731 provides an output signal, such as elapsed time or a digital count, to control circuit 710 to correlate beam position with i 714 profile, as determined by position sensor 734, with the timer / counter output 731 so that the control circuit 710 can determine the position of the i-profile beam 714 at a specific time (t) in relation to an initial position or time (t) when the profile-beam i 714 is in a specific position in relation to an initial position. The timer / counter 731 can be configured to measure elapsed time, count external events or measure external events.
[00156] [00156] In one aspect, control circuit 710 can be programmed to control functions of end actuator 702 based on one or more tissue conditions. Control circuit 710 can be programmed to directly or indirectly detect tissue conditions, such as thickness, as described here. Control circuit 710 can be programmed to select a trigger control program or closing control program based on tissue conditions. A trigger control program can describe the distal movement of the displacement member. Different trigger control programs can be selected to better treat different tissue conditions. For example, when thicker tissue is present, control circuit 710 can be programmed to translate the displacement member at a lower speed and / or with a lower power. When a thinner tissue is present, the control circuit 710 can be programmed to move the displacement member at a higher speed and / or with greater power. A closing control program can control the closing force applied to the tissue by the anvil 716. Other control programs control the rotation of the drive shaft 740 and the hinge members 742a, 742b.
[00157] [00157] In one aspect, the motor control circuit 710 can generate motor setpoint signals. Motor setpoint signals can be provided for various motor controllers 708a through 708e. Motor controllers 708a to 708e can comprise one or more circuits configured to provide motor drive signals for motors 704a to 704e in order to drive motors 704a to 704e, as described here. In some instances, motors 704a to 704e may be brushed DC motors. For example, the speed of motors 704a to 704e can be proportional to the respective motor start signals. In some examples, motors 704a to 704e may be brushless DC electric motors, and the respective motor drive signals may comprise a PWM signal provided for one or more stator windings of motors 704a to 704e. In addition, in some instances, motor controllers 708a through 708e can be omitted and control circuit 710 can directly generate motor drive signals.
[00158] [00158] In one aspect, the control circuit 710 can initially operate each of the motors 704a to 704e in an open circuit configuration for a first open circuit portion of the travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open circuit portion of the stroke, control circuit 710 can select a trigger control program in a closed circuit configuration. The response of the instrument may include a travel distance from the displacement member during the open circuit portion, a time elapsed during the open circuit portion, the energy supplied to one of the 704a to 704e motors during the open circuit portion, a sum pulse widths of a motor start signal, etc. After the open circuit portion, control circuit 710 can implement the selected trigger control program for a second portion of the travel member travel. For example, during a portion of the closed loop course, control circuit 710 can modulate one of the motors 704a to 704e based on the translation of data describing a position of the closed displacement member to translate the displacement member to a constant speed.
[00159] [00159] In one aspect, motors 704a to 704e can receive power from a 712 power source. Power source 712 can be a DC power source powered by an alternating main power source, a battery, a supercapacitor , or any other suitable energy source.
[00160] [00160] In one aspect, control circuit 710 is configured to drive a firing member as the portion of the I-profile beam 714 of end actuator 702. Control circuit 710 provides a motor setpoint for a motor control 708a, which provides a drive signal for motor 704a.
[00161] [00161] In one aspect, control circuit 710 is configured to drive a closing member, such as anvil portion 716 of end actuator 702. Control circuit 710 provides a motor setpoint for motor control 708b, which provides a drive signal for motor 704b. The output shaft of the 704b motor is coupled to a 744b torque sensor. The torque sensor 744b is coupled to a transmission 706b which is coupled to the anvil 716. The transmission 706b comprises moving mechanical elements, such as rotating elements and a closing member, to control the movement of the anvil 716 between the open and closed positions. In one aspect, the 704b motor is coupled to a closing gear assembly, which includes a closing reduction gear assembly that is supported in gear engaged with the closing sprocket. The torque sensor 744b provides a closing force feedback signal for control circuit 710. The closing force feedback signal represents the closing force applied to the anvil 716. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal for control circuit 710. Additional sensors 738 on end actuator 702 can provide the feedback signal for closing force for control circuit 710. A pivoting anvil 716 is positioned on the side opposite staple cartridge 718. When ready for use, control circuit 710 can provide a closing signal to motor control 708b. In response to the closing signal, the motor
[00162] [00162] In one aspect, control circuit 710 is configured to rotate a drive shaft member, such as drive shaft 740, to rotate end actuator 702. Control circuit 710 provides a motor setpoint for a 708c engine control, which provides a drive signal for the 704c engine. The output shaft of the 704c motor is coupled to a 744c torque sensor. The torque sensor 744c is coupled to a transmission 706c which is coupled to the shaft 740. The transmission 706c comprises moving mechanical elements, such as rotary elements, to control the rotation of the drive shaft 740 clockwise or counterclockwise until and above 360 °. In one aspect, the 704c engine is coupled to the rotary drive assembly, which includes a pipe gear segment that is formed over (or attached to) the proximal end of the proximal closing tube for operable engagement by a rotational gear assembly that is supported operationally on the tool mounting plate. The torque sensor 744c provides a rotation force feedback signal for control circuit 710. The rotation force feedback signal represents the rotation force applied to the drive shaft 740. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal to the control circuit 710. Additional sensors 738, such as a drive shaft encoder, can provide the rotational position of the drive shaft 740 to the control circuit 710.
[00163] [00163] In one aspect, control circuit 710 is configured to pivot end actuator 702. Control circuit 710 provides a motor setpoint for a 708d motor control, which provides a drive signal for the motor 704d. The output shaft of the 704d motor is coupled to a 744d torque sensor. The torque sensor 744d is coupled to a transmission 706d which is coupled to a pivot member 742a. The 706d transmission comprises moving mechanical elements, such as pivoting elements, to control the articulation of the 702 ± 65 ° end actuator. In one aspect, the 704d motor is coupled to a pivot nut, which is rotatably seated on the proximal end portion of the distal column portion and is pivotally driven thereon by a pivot gear assembly. The torque sensor 744d provides a hinge force feedback signal to control circuit 710. The hinge force feedback signal represents the hinge force applied to the end actuator 702. The 738 sensors, as a hinge encoder , can provide the pivoting position of end actuator 702 for control circuit 710.
[00164] [00164] In another aspect, the articulation function of the robotic surgical system 700 may comprise two articulation members, or connections, 742a, 742b. These hinge members 742a, 742b are driven by separate disks on the robotic interface (the rack), which are driven by the two motors 708d, 708e. When the separate firing motor 704a is provided, each hinge link 742a, 742b can be antagonistically driven with respect to the other link to provide a resistive holding movement and a load to the head when it is not moving and to provide a movement of articulation when the head is articulated. The hinge members 742a, 742b attach to the head in a fixed radius when the head is rotated. Consequently, the mechanical advantage of the push and pull connection changes when the head is turned. This change in mechanical advantage can be more pronounced with other drive systems for the articulation connection.
[00165] [00165] In one aspect, the one or more motors 704a to 704e may comprise a brushed DC motor with a gearbox and mechanical connections to a firing member, closing member or articulation member. Another example includes electric motors 704a to 704e that operate the moving mechanical elements such as the displacement member, the articulation connections, the closing tube and the drive shaft. An external influence is an excessive and unpredictable influence on things like tissue, surrounding bodies, and friction in the physical system. This external influence can be called drag, which acts in opposition to one of the electric motors 704a to 704e. External influence, such as drag, can cause the functioning of the physical system to deviate from a desired operation of the physical system.
[00166] [00166] In one aspect, the position sensor 734 can be implemented as an absolute positioning system. In one aspect, the 734 position sensor can comprise an absolute rotary magnetic positioning system implemented as a single integrated circuit rotary magnetic position sensor, AS5055EQFT, available from Austria Microsystems, AG. The position sensor 734 can interface with the control circuit 710 to provide an absolute positioning system. The position can include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit by digit method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions which only require addition, subtraction, bit shift and lookup table operations.
[00167] [00167] In one aspect, the control circuit 710 can be in communication with one or more sensors 738. The sensors 738 can be positioned on the end actuator 702 and adapted to work with the robotic surgical instrument 700 to measure various derived parameters such as span distance in relation to time, compression of the tissue in relation to time, and deformation of the anvil in relation to time. The 738 sensors can comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor and / or any other sensor suitable for measuring one or more parameters of end actuator 702. Sensors 738 may include one or more sensors. Sensors 738 may be located on the staple cartridge platform 718 to determine the location of the tissue using segmented electrodes. The torque sensors 744a to 744e can be configured to detect force such as firing force, closing force and / or articulation force, among others. Consequently, control circuit 710 can detect (1) the closing load experienced by the distal closing tube and its position, (2) the trigger member on the rack and its position, (3) which portion of the staple cartridge 718 has tissue in it, and (4) the load and position on both articulation rods.
[00168] [00168] In one aspect, the one or more sensors 738 may comprise a stress meter such as, for example, a microstrain meter, configured to measure the magnitude of the stress on the anvil 716 during a grip condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. Sensors 738 can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. Sensors 738 can be configured to detect the impedance of a section of tissue located between the anvil 716 and the staple cartridge 718 which is indicative of the thickness and / or completeness of the fabric located between them.
[00169] [00169] In one aspect, the 738 sensors can be implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magneto-resistive devices (MR) giant magneto-resistive devices (GMR), magnetometers, among others. In other implementations, the 738 sensors can be implemented as solid state switches that operate under the influence of light, such as optical sensors, infrared sensors, ultraviolet sensors, among others. In addition, the switches can be solid state devices such as transistors (for example, FET, junction FET, MOSFET, bipolar, and the like). In other implementations, the 738 sensors can include driverless electric switches, ultrasonic switches, accelerometers and inertia sensors, among others.
[00170] [00170] In one aspect, sensors 738 can be configured to measure the forces exerted on the anvil 716 by the closing drive system. For example, one or more sensors 738 may be at a point of interaction between the closing tube and the anvil 716 to detect the closing forces applied by the closing tube on the anvil 716. The forces exerted on the anvil 716 may be representative of the tissue compression experienced by the tissue section captured between the anvil 716 and the staple cartridge 718. The one or more sensors 738 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied to the anvil 716 by the closing drive system. The one or more sensors 738 can be sampled in real time during a gripping operation by the processor of the control circuit 710. The control circuit 710 receives sample measurements in real time to provide and analyze information based on time and evaluate, in real time the closing forces applied to the anvil 716.
[00171] [00171] In one aspect, a current sensor 736 can be used to measure the current drained by each of the 704a to 704e motors. The force required to advance any of the moving mechanical elements such as the I-beam profile 714 corresponds to the current drained by one of the motors 704a to 704e. The force is converted into a digital signal and supplied to control circuit 710. Control circuit 710 can be configured to simulate the response of the instrument's actual system in the controller software. A displacement member can be actuated to move an I-beam beam 714 on end actuator 702 at or near a target speed. The robotic surgical instrument 700 may include a feedback controller, which can be one or any of the feedback feedback controllers, including, but not limited to, a PID controller, state feedback, linear quadratic (LQR) and / or, for example , an adaptable controller. The robotic surgical instrument 700 can include a power source to convert the signal from the feedback controller to a physical input such as case voltage, PWM voltage, frequency modulated voltage, current, torque and / or force, for example. Additional details are disclosed in US patent application serial number 15 / 636,829, entitled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, filed on June 29, 2017, which is hereby incorporated by reference in its entirety.
[00172] [00172] Figure 18 illustrates a block diagram of a surgical instrument 750 programmed to control the distal translation of a displacement member according to an aspect of the present description. In one aspect, the 750 surgical instrument is programmed to control the distal translation of a displacement limb,
[00173] [00173] The position, movement, displacement, and / or translation of a linear displacement member, such as the beam with I-764 profile, can be measured by an absolute positioning system, sensor arrangement, and a position sensor 784. Since the I-beam beam 764 is coupled to a longitudinally movable drive member, the position of the I-beam beam 764 can be determined by measuring the position of the longitudinally mobile drive member employing the 784 position sensor Consequently, in the following description, the position, displacement and / or translation of the I-profile beam 764 can be obtained by the position sensor 784, as described in the present invention. A control circuit 760 can be programmed to control the translation of the displacement member, such as the I-profile beam 764. The control circuit 760, in some examples, may comprise one or more microcontrollers, microprocessors or other suitable processors the instructions that cause the processor or processors to control the displacement member, for example, the I 764 profile beam, as described. In one aspect, a timer / counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate beam position with I-shaped profile 764 as determined by position sensor 784 with output of the timer / counter 781 so that the control circuit 760 can determine the position of the I-profile beam 764 at a specific time (t) in relation to an initial position. The timer / counter
[00174] [00174] Control circuit 760 can generate a setpoint signal for motor 772. The setpoint signal for motor 772 can be supplied to a 758 motor controller. The 758 motor controller can comprise one or more circuits configured to provide a motor 774 drive signal to motor 754 to drive motor 754, as described in the present invention. In some instances, the 754 motor may be a DC motor with a brushed DC electric motor. For example, the speed of motor 754 can be proportional to the drive signal of motor 774. In some instances, motor 754 can be a brushless DC electric motor and the motor drive signal 774 can comprise a PWM signal provided for a or more motor stator windings 754. In addition, in some examples, motor controller 758 may be omitted, and control circuit 760 can generate motor drive signal 774 directly.
[00175] [00175] The 754 motor can receive power from a power source
[00176] [00176] The control circuit 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end actuator 752 and adapted to work with the surgical instrument 750 to measure the various derived parameters, such as span distance in relation to time, compression of the tissue in relation to time and tension of the anvil in relation to time. The 788 sensors can comprise a magnetic sensor, a magnetic field sensor, a stress meter, a pressure sensor, a force sensor, an inductive sensor such as a eddy current sensor, a resistive sensor, a capacitive sensor, a sensor optical and / or any other sensors suitable for measuring one or more parameters of the 752 end actuator. The 788 sensors may include one or more sensors.
[00177] [00177] The one or more sensors 788 may comprise an effort meter, such as a microstrain meter, configured to measure the magnitude of the strain on the anvil 766 during a grip condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. The 788 sensors can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The 788 sensors can be configured to detect the impedance of a section of tissue located between the anvil 766 and the staple cartridge 768 which is indicative of the thickness and / or completeness of the fabric located between them.
[00178] [00178] The 788 sensors can be configured to measure the forces exerted on the anvil 766 by a closing drive system. For example, one or more sensors 788 can be at a point of interaction between a closing tube and anvil 766 to detect the closing forces applied by a closing tube to anvil 766. The forces exerted on anvil 766 can be representative of the tissue compression experienced by the tissue section captured between the anvil 766 and the staple cartridge 768. The one or more sensors 788 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied anvil 766 by the closing drive system. The one or more 788 sensors can be sampled in real time during a gripping operation by a processor of the control circuit 760. The control circuit 760 receives sample measurements in real time to provide and analyze information based on time and evaluate, in real time, the closing forces applied to the anvil 766.
[00179] [00179] A current sensor 786 can be used to measure the current drained by the 754 motor. The force required to advance the beam with I-shaped profile 764 corresponds to the current drained by the motor
[00180] [00180] The control circuit 760 can be configured to simulate the real system response of the instrument in the controller software.
[00181] [00181] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member or beam with I-764 profile, by a brushed DC motor with gearbox and mechanical connections to a joint and / or knife system. Another example is the 754 electric motor that operates the displacement member and the articulation drive, for example, from an interchangeable drive shaft assembly. An external influence is an excessive and unpredictable influence of things like tissue, surrounding bodies and friction in the physical system. This external influence can be called drag, which acts in opposition to the 754 electric motor. External influence, like drag, can cause the functioning of the physical system to deviate from a desired operation of the physical system.
[00182] [00182] Several exemplifying aspects are directed to a surgical instrument 750 that comprises an end actuator 752 with surgical implements of stapling and cutting driven by motor. For example, a motor 754 can drive a displacement member distally and proximally along a longitudinal axis of the end actuator 752. The end actuator
[00183] [00183] In several examples, the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of the displacement member, such as the beam with I-shaped profile 764, for example, based on one or more tissue conditions . The control circuit 760 can be programmed to directly or indirectly detect tissue conditions, such as thickness, as described here. Control circuit 760 can be programmed to select a control program based on tissue conditions. A trigger control program can describe the distal movement of the displacement member. Different trigger control programs can be selected to better treat different tissue conditions. For example, when a thicker tissue is present, control circuit 760 can be programmed to translate the displacement member at a lower speed and / or with a lower power. When a thinner tissue is present, the control circuit 760 can be programmed to move the displacement member at a higher speed and / or with greater power.
[00184] [00184] In some examples, control circuit 760 may initially operate motor 754 in an open circuit configuration for a first open circuit portion of a travel member travel. Based on an instrument response 750 during the open circuit portion of the course, control circuit 760 can select a trip control program. The response of the instrument may include a travel distance of the displacement member during the open circuit portion, a time elapsed during the open circuit portion, the power supplied to the motor 754 during the open circuit portion, a sum of pulse widths a motor start signal, etc. After the open circuit portion, control circuit 760 can implement the selected trigger control program for a second portion of the travel member travel. For example, during the closed loop portion of the stroke, control circuit 760 can modulate motor 754 based on translation data that describes a position of the displacement member in a closed circuit manner to translate the displacement member into a constant speed. Additional details are disclosed in US Patent Application Serial No. 15 / 720,852, entitled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT, filed on September 29, 2017, which is hereby incorporated by reference in its entirety.
[00185] [00185] Figure 19 is a schematic diagram of a 790 surgical instrument configured to control various functions in accordance with an aspect of the present description. In one aspect, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as the I-profile beam 764. The surgical instrument 790 comprises an end actuator 792 that can comprise an anvil 766, a beam with I-profile 764 and a removable staple cartridge 768 that can be interchanged with an RF cartridge 796 (shown in dashed line).
[00186] [00186] In one aspect, the 788 sensors can be implemented as a limit switch, electromechanical device, solid state switches, Hall effect devices, MRI devices, GMR devices, magnetometers, among others. In other implementations, 638 sensors can be solid state switches that operate under the influence of light, such as optical sensors, infrared sensors, ultraviolet sensors, among others. In addition, the switches can be solid state devices such as transistors (for example, FET, junction FET, MOSFET, bipolar, and the like). In other implementations, 788 sensors can include driverless electric switches, ultrasonic switches, accelerometers, inertia sensors, and more.
[00187] [00187] In one aspect, the position sensor 784 can be implemented as an absolute positioning system, which comprises a rotary magnetic absolute positioning system implemented as a single integrated circuit rotary magnetic position sensor, AS5055EQFT, available from Austria Microsystems, AG. The position sensor 784 can interface with the control circuit 760 to provide an absolute positioning system. The position can include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit by digit method and Volder's algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions which only require addition, subtraction, bit shift and table lookup operations.
[00188] [00188] In one aspect, the I-764 beam can be implemented as a knife member comprising a knife body which operationally supports a fabric cutting blade therein and may additionally include anvil hinges or flaps. and channel hitch or base features. In one aspect, the staple cartridge 768 can be implemented as a standard (mechanical) surgical clamp cartridge. In one aspect, the RF cartridge 796 can be implemented as an RF cartridge. These and other sensor provisions are described in Commonly Owned US Patent Application Serial No. 15 / 628,175, entitled TECHNIQUES
[00189] [00189] The position, movement, displacement and / or translation of a linear displacement member, such as the beam with I-764 profile, can be measured by an absolute positioning system, sensor arrangement and position sensor represented as the position sensor 784. Since the I-beam beam 764 is coupled to the longitudinally movable drive member, the position of the I-beam beam 764 can be determined by measuring the position of the longitudinally mobile drive member that employs the position 784. Consequently, in the description below, the position, displacement and / or translation of the I-profile beam 764 can be obtained by the position sensor 784, as described in the present invention. A control circuit 760 can be programmed to control the translation of the displacement member, such as the I-profile beam 764, as described here. The control circuit 760, in some examples, may comprise one or more microcontrollers, microprocessors or other suitable processors to execute the instructions that cause the processor or processors to control the displacement member, for example, the I-shaped beam 764 , as described. In one aspect, a timer / counter 781 provides an output signal, such as elapsed time or a digital count, to control circuit 760 to correlate beam position with I-shaped profile 764 as determined by position sensor 784 with output of the timer / counter 781 so that the control circuit 760 can determine the position of the I-profile beam 764 at a specific time (t) in relation to an initial position. The 781 timer / counter can be configured to measure elapsed time, count external events, or measure timeless events.
[00190] [00190] Control circuit 760 can generate a setpoint signal for motor 772. The setpoint signal for motor 772 can be supplied to a 758 motor controller. The 758 motor controller can comprise one or more circuits configured to provide a motor 774 drive signal to motor 754 to drive motor 754, as described in the present invention. In some instances, the 754 motor may be a brushed DC motor. For example, the speed of motor 754 can be proportional to the drive signal of motor 774. In some instances, motor 754 can be a brushless DC electric motor and the motor drive signal 774 can comprise a PWM signal provided for a or more motor stator windings 754. In addition, in some examples, motor controller 758 may be omitted, and control circuit 760 can generate motor drive signal 774 directly.
[00191] [00191] The 754 motor can receive power from a power source
[00192] [00192] The control circuit 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end actuator 792 and adapted to work with the surgical instrument 790 to measure the various derived parameters, such as span distance in relation to time, compression of the tissue in relation to time and tension of the anvil in relation to time. The 788 sensors can comprise a magnetic sensor, a magnetic field sensor, a stress meter, a pressure sensor, a force sensor, an inductive sensor such as a eddy current sensor, a resistive sensor, a capacitive sensor, a sensor optical and / or any other sensors suitable for measuring one or more parameters of the end actuator 792. The 788 sensors may include one or more sensors.
[00193] [00193] The one or more sensors 788 may comprise an effort meter, such as a microstrain meter, configured to measure the magnitude of the strain on the anvil 766 during a grip condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. The 788 sensors can comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The 788 sensors can be configured to detect the impedance of a section of tissue located between the anvil 766 and the staple cartridge 768 which is indicative of the thickness and / or completeness of the fabric located between them.
[00194] [00194] The 788 sensors can be configured to measure the forces exerted on the anvil 766 by the closing drive system. For example, one or more sensors 788 can be at a point of interaction between a closing tube and anvil 766 to detect the closing forces applied by a closing tube to anvil 766. The forces exerted on anvil 766 can be representative of the tissue compression experienced by the tissue section captured between the anvil 766 and the staple cartridge 768. The one or more sensors 788 can be positioned at various points of interaction throughout the closing drive system to detect the closing forces applied anvil 766 by the closing drive system. The one or more 788 sensors can be sampled in real time during a hold operation by a processor portion of the control circuit 760. The control circuit 760 receives sample measurements in real time to provide and analyze time-based information and evaluate , in real time, the closing forces applied to the anvil
[00195] [00195] A current sensor 786 can be used to measure the current drained by the motor 754. The force required to advance the beam with I-shaped profile 764 corresponds to the current drained by the motor
[00196] [00196] An RF power source 794 is coupled to the end actuator 792 and is applied to the RF 796 cartridge when the RF 796 cartridge is loaded on the end actuator 792 in place of the staple cartridge 768. The control circuit 760 controls the supply of RF energy to the 796 RF cartridge.
[00197] [00197] Additional details are disclosed in US patent application serial number 15 / 636,096, entitled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed on June 28, 2017, which is hereby incorporated as a reference in its entirety. Generator hardware
[00198] [00198] Figure 20 is a simplified block diagram of a generator 800 configured to provide tuning without an inductor, among other benefits. Additional details of generator 800 are described in US Patent No. 9,060,775, entitled "SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES", granted on June 23, 2015, hereby incorporated in its entirety for reference. The generator 800 can comprise a patient isolated stage 802 in communication with a non-isolated stage 804 via a power transformer 806. A secondary winding 808 of the power transformer 806 is contained in the isolated stage 802 and can comprise a bypass configuration. (for example, a central or non-central bypass configuration) to define the trigger signal outputs 810a, 810b and 810c, in order to provide trigger signals to different surgical instruments, such as an ultrasonic surgical device, an electrosurgical instrument RF and a multifunctional surgical instrument that includes ultrasonic and RF energy modes that can be delivered alone or simultaneously. In particular, trigger signal emissions 810a and 810c can provide an ultrasonic trigger signal (for example, a 420 V mean square value (RMS) trigger signal) to an ultrasonic surgical instrument, and signal emissions from drive 810b and 810c can provide an RF electrosurgical drive signal (for example, a 100 V RMS drive signal) to an RF electrosurgical instrument, with output 810b corresponding to the center tap of the 806 power transformer.
[00199] [00199] In certain forms, ultrasonic and electrosurgical trigger signals can be supplied simultaneously to different surgical instruments and / or to a single surgical instrument, such as the multifunctional surgical instrument, with the ability to supply both ultrasonic and electrosurgical energy to the tissue. It will be noted that the electrosurgical signal provided by both the dedicated electrosurgical instrument and the multifunctional electrosurgical / ultrasonic combined instrument can be both a therapeutic and subtherapeutic signal, where the subtherapeutic signal can be used, for example, to monitor tissue or condition of the instruments and provide feedback to the generator. For example, RF and ultrasonic signals can be provided separately or simultaneously from a generator with a single output port in order to provide the desired output signal to the surgical instrument, as will be discussed in more detail below. Consequently, the generator can combine the RF and ultrasonic electrosurgical energies and supply the combined energies to the multifunctional electrosurgical / ultrasonic instrument. Bipolar electrodes can be placed on one or both claws of the end actuator. A claw can be triggered by ultrasonic energy in addition to RF electrosurgical energy, working simultaneously. Ultrasonic energy can be used to perform tissue dissection while RF electrosurgical energy can be used to cauterize vessels.
[00200] [00200] The non-isolated stage 804 may comprise a power amplifier 812 that has an output connected to a primary winding 814 of the power transformer 806. In certain forms the power amplifier 812 may comprise a push-pull amplifier. For example, the non-isolated stage 804 may additionally contain a logic device 816 to provide a digital output to a digital-to-analog converter (DAC) circuit 818 which, in turn, provides a signal analog corresponding to a power amplifier 812 input. In certain ways, logic device 816 may comprise a programmable gate array (PGA), an FPGA (field-programmable gate array FPGA) , a programmable logic device (PLD, for "programmable logic device"), among other logic circuits, for example. The logic device 816, by controlling the input of the power amplifier 812 through the DAC 818, can therefore control any of several parameters (for example, frequency, waveform, amplitude of the waveform) of drive signals appearing at the trigger signal outputs 810a, 810b and 810c. In certain ways and as discussed below, logic device 816, in conjunction with a processor (for example, a DSP discussed below), can implement a number of control algorithms based on
[00201] [00201] Power can be supplied to a power rail of the power amplifier 812 by a key mode regulator 820, such as, for example, a power converter. In certain forms, the key mode regulator 820 may comprise, for example, an adjustable buck regulator. The non-isolated stage 804 can further comprise a first processor 822 which, in one form, can comprise a PSD processor as an analog device ADSP-21469 SHARC PSD, available from Analog Devices, Norwood, MA, USA, for example , although in various forms, any suitable processor can be used. In certain ways, the DSP processor 822 can control the operation of the key mode regulator 820 responsive to voltage feedback data from the power amplifier 812 by the DSP processor 822 via an ADC 824 circuit. For example, the DSP processor 822 can receive input via the ADC 824 circuit, and the waveform envelope of a signal (for example, an RF signal) is amplified by the power amplifier 812. The processor PSD 822 can then control the key mode regulator 820 (for example, via a PWM output so that the rail voltage supplied to the power amplifier 812 follows the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the 812 power amplifier based on the waveform envelope, the efficiency of the 812 power amplifier can be significantly improved over fixed rail voltage amplifier schemes.
[00202] [00202] In certain forms, the logic device 816, in conjunction with the PSD 822 processor, can implement a digital synthesis circuit as a control scheme with direct digital synthesizer to control the waveform, frequency and / or amplitude of the trigger signals emitted by the generator 800. In one way, for example, the logic device 816 can implement a DDS control algorithm by retrieving waveform samples stored in a lookup table (LUT, "look" -up table ") updated dynamically, as a LUT RAM that can be integrated into an FPGA.
[00203] [00203] The non-isolated stage 804 may additionally comprise a first ADC 826 circuit and a second ADC 828 circuit coupled to the output of the power transformer 806 by means of the respective isolation transformers, 830 and 832, to respectively sample the voltage and current of trigger signals emitted by generator 800. In certain forms, ADC circuits 826 and 828 can be configured for high speed sampling (eg, 80 mega samples per second (MSPS)) to allow over-sampling of the trigger signals. In one way, for example, the sampling speed of the ADC 826 and 828 circuits can allow an oversampling of approximately 200x (depending on the frequency) of the drive signals. In certain ways, the sampling operations of the ADC 826 and 828 circuits can be performed by a single ADC circuit receiving voltage and current input signals via a bidirectional multiplexer. The use of high-speed sampling in the forms of generator 800 can allow, among other things, the calculation of the complex current flowing through the branch of motion (which can be used in certain ways to implement DDS-based waveform control described above), accurate digital filtering of the sampled signals and the calculation of actual energy consumption with a high degree of accuracy. The feedback data about voltage and current emitted by the ADC 826 and 828 circuits can be received and processed (for example,
[00204] [00204] In certain forms, feedback data about voltage and current can be used to control the frequency and / or amplitude (for example, current amplitude) of the trigger signals. In one way, for example, feedback data about voltage and current can be used to determine the impedance phase. The frequency of the trigger signal can then be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (eg 0 °), thereby minimizing or reducing the effects of harmonic distortion. and, correspondingly, improving the accuracy of the impedance phase measurement. The determination of phase impedance and a frequency control signal can be implemented in the PSD 822 processor, for example, with the frequency control signal being supplied as input to a DDS control algorithm implemented by the programmable logic device.
[00205] [00205] In another form, for example, the current feedback data can be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude set point can be specified directly or indirectly determined based on the specified set points for voltage and power amplitude. In certain ways, current amplitude control can be implemented by the control algorithm, such as a proportional-integral-derived control (PID) algorithm, in the DSP processor
[00206] [00206] The non-isolated stage 804 may additionally comprise a second processor 836 to provide, among other things, the functionality of the user interface (UI). In one form, the 836 processor can comprise an Atmel AT91SAM9263 processor with an ARM 926EJ-S core, available from Atmel Corporation, of San Jose, California, USA, for example. Examples of UI functionality supported by the UI 836 processor may include audible and visual feedback from the user, communication with peripheral devices (eg via a USB interface), communication with the foot switch, communication with a data entry device (for example, a touchscreen) and communication with an output device (for example, a speaker
[00207] [00207] In certain ways, both the PSD 822 processor and the UI 836 processor can, for example, determine and monitor the operational state of generator 800. For the PSD 822 processor, the operational state of generator 800 can determine, for example, which control and / or diagnostic processes are implemented by the PSD 822 processor. For the UI 836 processor, the operational state of generator 800 can determine, for example, which elements of a UI (for example, display screens , sounds) are presented to a user. The respective UI and PSD processors 822 and 836 can independently maintain the current operational state of generator 800, as well as recognize and evaluate possible transitions out of the current operational state. The PSD 822 processor can act as the master in this relationship, and can determine when transitions between operational states should occur. The UI 836 processor can be aware of valid transitions between operational states, and can confirm that a particular transition is adequate. For example, when the DSP 822 processor instructs the UI 836 processor to transition to a specific state, the UI 836 processor can verify that the requested transition is valid.
[00208] [00208] The non-isolated stage 804 can also contain an 838 controller for monitoring input devices (for example, a capacitive touch sensor used to turn the generator 800 on and off, a capacitive touch screen). In certain forms, controller 838 may comprise at least one processor and / or other controller device in communication with the UI processor
[00209] [00209] In certain ways, when generator 800 is in an "off" state, controller 838 can continue to receive operational power (for example, through a line from a generator 800 power supply, such as the power supply 854 discussed below). In this way, controller 838 can continue to monitor an input device (for example, a capacitive touch sensor located on a front panel of generator 800) to turn generator 800 on and off. When generator 800 is in the off state, the controller 838 can wake up the power supply (for example, enable one or more DC / DC voltage converters 856 of the power supply 854 to operate), if the activation of the "on / off" input device is detected by a user . The controller
[00210] [00210] In certain forms, controller 838 may cause generator 800 to provide audible feedback or other sensory feedback to alert the user that an on or off sequence has been initiated. This type of alert can be provided at the beginning of an on or off sequence, and before the start of other processes associated with the sequence.
[00211] [00211] In certain forms, the isolated stage 802 may comprise an instrument interface circuit 840 to, for example, offer a communication interface between a control circuit of a surgical instrument (for example, a control circuit comprising switches handle) and non-isolated stage 804 components, such as logic device 816, DSP processor 822 and / or UI processor 836. Instrument interface circuit 840 can exchange information with non-isolated stage 804 components via of a communication link that maintains an adequate degree of electrical isolation between the isolated and non-isolated stages 802 and 804, for example, an infrared (IR) based communication link. Power can be supplied to the instrument interface circuit 840 using, for example, a low-drop voltage regulator powered by an isolation transformer driven from the non-isolated stage 804.
[00212] [00212] In one form, the instrument interface circuit 840 may comprise a logic circuit 842 (for example, a logic circuit, a programmable logic circuit, PGA, FPGA, PLD) in communication with a signal conditioning circuit 844. The signal conditioning circuit 844 can be configured to receive a periodic signal from logic circuit 842 (e.g., a 2 kHz square wave) to generate a bipolar interrogation signal that has an identical frequency. The question mark can be generated, for example, using a bipolar current source powered by a differential amplifier. The question mark can be communicated to a surgical instrument control circuit (for example, using a conductive pair on a cable that connects the generator 800 to the surgical instrument) and monitored to determine a state or configuration of the control circuit . The control circuit can comprise numerous switches, resistors and / or diodes to modify one or more characteristics (for example, amplitude, rectification) of the question mark so that a state or configuration of the control circuit is unambiguously discernible, based on one or more characteristics. In one form, for example, the signal conditioning circuit 844 may comprise an ADC circuit for generating samples of a voltage signal appearing between inputs of the control circuit, resulting from the passage of the interrogation signal through it. Logic circuit 842 (or a non-isolated stage component 804) can then determine the status or configuration of the control circuit based on the samples of ADC circuits.
[00213] [00213] In one form, the instrument interface circuit 840 may comprise a first data circuit interface 846 to enable the exchange of information between logic circuit 842 (or another element of the instrument interface circuit 840) and a first data circuit disposed in a surgical instrument or otherwise associated with it. In certain ways, for example, a first data circuit may be arranged on a wire integrally attached to a handle of the surgical instrument, or on an adapter to interface between a specific type or model of surgical instrument and the 800 generator. The first data circuit can be deployed in any suitable manner and can communicate with the generator in accordance with any suitable protocol, including, for example, as described here with respect to the first data circuit. In certain forms, the first data circuit may comprise a non-volatile storage device, such as an EEPROM device. In certain ways, the first data circuit interface 846 can be implemented separately from logic circuit 842 and comprises a suitable circuitry (for example, separate logic devices, a processor) to allow communication between logic circuit 842 and the first data circuit. In other forms, the first data circuit interface 846 can be integral with logic circuit 842.
[00214] [00214] In certain forms, the first data circuit can store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other types of information. This information can be read by the instrument interface circuit 840 (for example, logic circuit 842), transferred to a component of the non-isolated stage 804 (for example, to logic device 816, PSD processor 822 and / or processor UI 836) for presentation to a user by means of an output device and / or to control a function or operation of the generator 800. Additionally, any type of information can be communicated to the first data circuit for storage in the same via the first interface of data circuit 846 (for example, using logic circuit 842). This information may include, for example, an updated number of operations in which the surgical instrument was used and / or the dates and / or times of its use.
[00215] [00215] As previously discussed, a surgical instrument can be removable from a handle (for example, the multifunctional surgical instrument can be removable from the handle) to promote interchangeability and / or disposability of the instrument. In such cases, conventional generators may be limited in their ability to recognize specific instrument configurations being used, as well as to optimize the control and diagnostic processes as needed. The addition of readable data circuits to surgical instruments to address this issue is problematic from a compatibility point of view, however. For example, designing a surgical instrument so that it remains backward compatible with generators that lack the indispensable data reading functionality may be impractical due, for example, to different signaling schemes, design complexity and cost. The forms of instruments discussed here address these concerns through the use of data circuits that can be implemented in existing surgical instruments, economically and with minimal design changes to preserve the compatibility of surgical instruments with current generator platforms.
[00216] [00216] Additionally, the shapes of the generator 800 may allow communication with instrument-based data circuits. For example, generator 800 can be configured to communicate with a second data circuit contained in an instrument (for example, the multifunctional surgical instrument). In some ways, the second data circuit can be implemented in a manner similar to that of the first data circuit described here. The instrument interface circuit 840 may comprise a second data circuit interface 848 to enable such communication. In one form, the second data circuit interface 848 can comprise a three-state digital interface, although other interfaces can also be used. In certain ways, the second data circuit can generally be any circuit for transmitting and / or receiving data. In one form, for example, the second data circuit can store information related to the specific surgical instrument with which it is associated. This information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument was used, and / or any other types of information.
[00217] [00217] In some ways, the second data circuit can store information about the ultrasonic and / or electronic properties of an associated ultrasonic transducer, end actuator or ultrasonic drive system. For example, the first data circuit can indicate an initialization frequency slope, as described here. In addition or alternatively, any type of information can be communicated to the second data circuit for storage in it via the second data circuit interface 848 (for example, using logic circuit 842). This information may include, for example, an updated number of operations in which the surgical instrument was used and / or the dates and / or times of its use. In certain ways, the second data circuit can transmit data captured by one or more sensors (for example, an instrument-based temperature sensor). In certain ways, the second data circuit can receive data from generator 800 and provide an indication to a user (for example, a light-emitting indication or other visible indication) based on the received data.
[00218] [00218] In certain ways, the second data circuit and the second data circuit interface 848 can be configured so that communication between logic circuit 842 and the second data circuit can be carried out without the need to provide additional conductors for this purpose (for example, dedicated cable conductors connecting a handle to the 800 generator). In one way, for example, information can be communicated to and from the second data circuit using a wire bus communication scheme, implemented in existing wiring, as one of the conductors used to transmit interrogation signals to from signal conditioning circuit 844 to a control circuit on a handle. In this way, changes or modifications to the design of the surgical device that may otherwise be necessary are minimized or reduced. In addition, due to the fact that different types of communications implemented on a common physical channel can be separated based on frequency, the presence of a second data circuit can be "invisible" to generators that do not have the essential functionality of reading data, which, therefore, allows the backward compatibility of the surgical instrument.
[00219] [00219] In certain forms, the isolated stage 802 may comprise at least one blocking capacitor 850-1 connected to the output of the trigger signal 810b to prevent the passage of direct current to a patient. A single blocking capacitor may be required to comply with medical regulations and standards, for example. Although failures in single-capacitor designs are relatively uncommon, such failures can still have negative consequences. In one form, a second blocking capacitor 850-2 can be placed in series with the blocking capacitor 850-1, with current dispersion of one point between the blocking capacitors 850-1 and 850-2 being monitored, for example , by an ADC 852 circuit for sampling a voltage induced by leakage current. Samples can be received, for example, via logic circuit 842. Based on changes in the scattering current (as indicated by the voltage samples), generator 800 can determine when at least one of the blocking capacitors 850-1, 850- 2 failed, thus offering a benefit over single capacitor designs that have a single point of failure.
[00220] [00220] In certain forms, the non-isolated stage 804 may comprise a power supply 854 to provide direct current power with suitable voltage and current. The power supply may comprise, for example, a 400 W power supply to deliver a system voltage of 48 VDC. The power supply 854 can additionally comprise one or more DC / DC voltage converters 856 to receive the output from the power supply to generate DC outputs at the voltages and currents required by the various components of generator 800. As discussed above in relation to the controller 838, one or more of the 856 DC / DC voltage converters can receive an input from the 838 controller when the activation of the "on / off" input device by a user is detected by the 838 controller, to enable the operation or awakening of the 856 DC / DC voltage converters.
[00221] [00221] Figure 21 illustrates an example of a generator 900, which is a form of generator 800 (Figure 20). The 900 generator is configured to supply multiple types of energy to a surgical instrument. The 900 generator provides ultrasonic and RF signals to power a surgical instrument, independently or simultaneously. Ultrasonic and RF signals can be provided alone or in combination and can be provided simultaneously. As indicated above, at least one generator output can provide multiple types of energy (for example, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be supplied separately or simultaneously to the end actuator to treat tissue.
[00222] [00222] Generator 900 comprises a processor 902 coupled to a waveform generator 904. Processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a coupled memory to processor 902, not shown for clarity of description. The digital information associated with a waveform is provided to the waveform generator 904 that includes one or more DAC circuits to convert the digital input to an analog output. The analog output is powered by an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to a power transformer 908. The signals are coupled by the power transformer 908 to the secondary side, which is on the patient isolation side. A first signal of a first energy modality is supplied to the surgical instrument between the terminals identified as ENERGY1 and RETURN. A second signal of a second energy modality is coupled by a 910 capacitor and is supplied to the surgical instrument between the terminals identified as ENERGY2 and RETURN. It will be recognized that more than two types of energy can be issued and, therefore, the subscript "n" can be used to designate that up to n ENERGY terminals can be provided, where n is a positive integer greater than 1. It will also be acknowledged that up to "n" return paths, RETURN can be provided without departing from the scope of this description.
[00223] [00223] A second voltage detection circuit 912 is coupled through the terminals identified as ENERGY1 and the RETURN path to measure the output voltage between them. A second voltage detection circuit 924 is coupled through the terminals identified as ENERGY2 and the RETURN path to measure the output voltage between them. A current detection circuit 914 is arranged in series with the RETURN leg on the secondary side of the power transformer 908 as shown to measure the output current for any energy modality. If different return paths are provided for each energy modality, then a separate current detection circuit would be provided on each return leg. The outputs of the first and second voltage detection circuits 912, 924 are supplied to the respective isolation transformers 916, 922 and the output of the current detection circuit 914 is supplied to another isolation transformer 918. The outputs of the isolation transformers 916 , 928, 922 on the primary side of the power transformer 908 (non-isolated side of the patient) are supplied to one or more ADC 926 circuits. The digitized output from the ADC 926 circuit is provided to processor 902 for further processing and computation. The output voltages and the output current feedback information can be used to adjust the output voltage and the current supplied to the surgical instrument, and to compute the output impedance, among other parameters. Input / output communications between the 902 processor and the patient's isolated circuits are provided via a 920 interface circuit. The sensors may also be in electrical communication with the 902 processor via the 920 interface circuit.
[00224] [00224] In one aspect, impedance can be determined by processor 902 by dividing the output of the first voltage detection circuit 912 coupled over the terminals identified as ENERGY1 / RETURN or the second voltage detection circuit 924 coupled over the terminals identified as ENERGY2 / RETURN, by the output of the current detection circuit 914 arranged in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first and second voltage detection circuits 912, 924 are provided to separate transformer isolations 916, 922 and current detection circuit 914 output is provided to another isolation transformer 916. Digitized current and voltage detection measurements from ADC circuit 926 are provided to processor 902 to compute impedance. As an example, the first ENERGIA1 energy modality can be ultrasonic energy and the second ENERGIA2 energy modality can be RF energy. However, in addition to the ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. In addition, although the example illustrated in Figure 21 shows a single RETURN return path that can be provided for two or more energy modes, in other respects, multiple RETURN return paths can be provided for each ENERGY energy mode. Thus, as described here, the impedance of the ultrasonic transducer can be measured by dividing the output of the first voltage detection circuit 912 by the current detection circuit 914 and the fabric impedance can be measured by dividing the output of the second voltage detection circuit 924 through current detection circuit 914.
[00225] [00225] As shown in Figure 21, generator 900 comprising at least one output port may include a power transformer 908 with a single output and multiple taps to provide power in the form of one or more energy modalities, such as ultrasonic , Bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others, for example to the end actuator depending on the type of tissue treatment being performed. For example, the 900 generator can supply higher voltage and lower current power to drive an ultrasonic transducer, lower voltage and higher current to drive RF electrodes to seal the tissue or with a coagulation waveform for point clotting using electrosurgical electrodes Monopolar or bipolar RF. The output waveform of generator 900 can be oriented, switched or filtered to provide frequency to the end actuator of the surgical instrument. The connection of an ultrasonic transducer to the output of generator 900 would preferably be located between the output identified as ENERGY1 and RETURN, as shown in Figure 21. In one example, a connection of bipolar RF electrodes to the output of generator 900 would preferably be located between the output identified as ENERGY2 and the RETURN. In the case of a monopolar output, the preferred connections would be an active electrode (for example, light beam or other probe) for the ENERGIA2 output and a suitable return block connected to the RETURN output.
[00226] [00226] Additional details are disclosed in US Patent Application Publication No. 2017/0086914 entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL
[00227] [00227] As used throughout this description, the term "wireless" and its derivatives can be used to describe circuits, devices, systems, methods, techniques, communication channels etc., which can communicate data through the use of electromagnetic radiation modulated using a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some ways they may not. The communication module can implement any of a number of wireless and wired communication standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, evolution long-term evolution (LTE), Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other protocols without wired and wired which are designated as 3G, 4G, 5G, and beyond. The computing module can include a plurality of communication modules. For example, a first communication module can be dedicated to short-range wireless communications like Wi-Fi and Bluetooth, and a second communication module can be dedicated to longer-range wireless communications like GPS, EDGE, GPRS, CDMA , WiMAX, LTE, Ev-DO, and others.
[00228] [00228] As used in the present invention a processor or processing unit is an electronic circuit that performs operations on some external data source, usually memory or some other data flow. The term is used in the present invention to refer to the central processor (central processing unit) in a computer system or systems (specifically systems on a chip (SoCs)) that combine several specialized "processors".
[00229] [00229] As used here, a system on a chip or system on the chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all components of a computer or other electronic systems . It can contain digital, analog, mixed and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), i-Fi module, or coprocessor. An SoC may or may not contain internal memory.
[00230] [00230] As used here, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; a SoC can include a microcontroller as one of its components. A microcontroller can contain one or more core processing units (CPUs) along with memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash or OTP ROM is also often included on the chip, as well as a small amount of RAM. Microcontrollers can be used for integrated applications, in contrast to microprocessors used in personal computers or other general purpose applications that consist of several separate integrated circuits.
[00231] [00231] As used in the present invention, the term controller or microcontroller can be an independent chip or IC (integrated circuit) device that interfaces with a peripheral device. This can be a connection between two parts of a computer or a controller on an external device that manages the operation of (and connection to) that device.
[00232] [00232] Any of the processors or microcontrollers in the present invention can be any implemented by any single-core or multi-core processor, such as those known under the trade name of ARM Cortex by Texas Instruments. In one respect, the processor may be a Core Cortex-M4F LM4F230H5QR ARM processor, available from Texas Instruments, for example, which comprises an integrated 256 KB single-cycle flash memory, or other non-volatile memory, up to 40 MHz , a seek-ahead buffer to optimize performance above 40 MHz, a 32 KB single cycle serial random access memory (SRAM), an internal read-only memory (ROM) loaded with StellarisWare® software, a memory only 2 KB electrically erasable programmable readout (EEPROM), one or more pulse width modulation (PWM) modules, one or more analog quadrature encoder (QEI) inputs, one or more "analog to digital" converters 12-bit (ADC) with 12 channels of analog input, details of which are available for the product data sheet.
[00233] [00233] In one aspect, the processor may comprise a safety controller that comprises two controller-based families, such as TMS570 and RM4x, known under the tradename Hercules ARM Cortex R4, also by Texas Instruments. The safety controller can be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while providing scalable performance, connectivity and memory options.
[00234] [00234] The modular devices include the modules (as described in connection with Figures 3 and 9, for example) that are receivable within a central surgical controller and the devices or surgical instruments that can be connected to the various modules in order to connect or pair with the corresponding central surgical controller. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, power generators, fans, insufflators and displays. The modular devices described here can be controlled by control algorithms. The control algorithms can be executed on the modular device itself, on the central surgical controller to which the specific modular device is paired, or on both the modular device and the central surgical controller (for example, through a distributed computing architecture). In some examples, the control algorithms of the modular devices control the devices based on the data detected by the modular device itself (that is, by sensors on, over or connected to the modular device). This data can be related to the patient being operated on (for example, tissue properties or insufflation pressure) or to the modular device itself (for example, the rate at which a knife is being advanced, the motor current, or the levels of energy). For example, a control algorithm for a surgical stapling and cutting instrument can control the rate at which the instrument's motor drives its knife through the fabric according to the resistance encountered by the knife as it progresses. Cloud-based system hardware and functional modules
[00235] [00235] Figure 22 is a block diagram of the interactive surgical system implemented by computer, according to at least one aspect of the present description. In one aspect, the computer-implemented interactive surgical system is configured to monitor and analyze data related to the operation of various surgical systems that include central surgical controllers, surgical instruments, robotic devices and operating rooms or healthcare facilities. The computer-implemented interactive surgical system comprises a cloud-based analytical system. Although the cloud-based analytical system is described as a surgical system, it is not necessarily limited as such and could be a cloud-based general medical system. As illustrated in Figure 22, the cloud-based analytical system comprises a plurality of surgical instruments 7012 (they may be the same or similar to instruments 112), a plurality of central surgical controllers 7006 (they may be the same or similar to central controllers 106) and a surgical data network 7001 (can be the same or similar to network 201) to couple central surgical controllers 7006 to cloud 7004 (can be the same or similar to cloud 204). Each of the plurality of central surgical controllers 7006 is communicatively coupled to one or more surgical instruments
[00236] [00236] In addition, surgical instruments 7012 may comprise transceivers for transmitting data to and from their corresponding central surgical controllers 7006 (which may also comprise transceivers). Combinations of surgical instruments 7012 and corresponding central controllers 7006 can indicate specific locations, such as operating rooms in healthcare facilities (for example, hospitals), for performing medical operations. For example, the memory of a central surgical controller 7006 can store location data. As shown in Figure 22, cloud 7004 comprises central servers 7013 (can be the same or similar to remote server 7013), application servers for central controllers 7002, data analysis modules 7034 and an input / output interface ("I / O ") 7006. Central servers 7013 of cloud 7004 collectively administer the cloud-based computing system, which includes monitoring requests from client 7006 central surgical controllers and managing the processing capacity of the 7004 cloud to execute requests. Each of the central servers 7013 comprises one or more processors 7008 coupled with suitable memory devices that may include volatile memory 7010, such as random access memory (RAM), and non-volatile memory, such as magnetic storage devices. The 7010 memory devices can comprise machine executable instructions that, when executed, cause the 7008 processors to run the 7034 data analysis modules for cloud-based data analysis, operations, recommendations and other operations described below. In addition, processors 7008 can run data analysis modules 7034 independently or in conjunction with applications for central controllers run independently by central controllers 7006. Central servers 7013 also comprise aggregated medical data databases 2212, which can reside in memory 2210.
[00237] [00237] Based on connections with several 7006 surgical centers through the 7001 network, the 7004 cloud can aggregate data from specific data generated by various 7012 surgical instruments and their corresponding 7006 central controllers. Such aggregate data can be stored in aggregate medical databases 7012 of cloud 7004. In particular, cloud 7004 can advantageously perform data analysis and operations on aggregate data to produce insights and / or perform functions that individual 7006 central controllers would not be able to run on their own. To that end, as shown in Figure 22, cloud 7004 and central surgical controllers 7006 are communicatively coupled to transmit and receive information. The I / O interface 7006 is connected to the plurality of central surgical controllers 7006 through the network 7001. In this way, the I / O interface 7006 can be configured to transfer information between the central surgical controllers 7006 and the data databases aggregate doctors 7011. Consequently, the 7006 I / O interface can facilitate read / write operations of the cloud-based analytical system. Such read / write operations can be performed in response to requests from central controllers 7006. These requests can be transmitted to central controllers 7006 through applications for central controllers. The 7006 I / O interface can include one or more high-speed data ports, which can include USB ports, IEEE 1394 ports, as well as interfaces
[00238] [00238] The configuration of the specific cloud-based computing system described in this description is designed specifically to address various issues that arise within the context of medical operations and procedures performed using medical devices, such as surgical instruments 7012, 112. In particular, the 7012 surgical instruments can be digital surgical devices configured to interact with the 7004 cloud to implement techniques to improve the performance of surgical operations. Various 7012 surgical instruments and / or 7006 central surgical controllers can comprise touch-controlled user interfaces so that doctors can control aspects of interaction between the 7012 surgical instruments and the cloud
[00239] [00239] Figure 23 is a block diagram that illustrates the functional architecture of the interactive surgical system implemented by computer, according to at least one aspect of the present description. The cloud-based analytical system includes a plurality of data analysis modules
[00240] [00240] 7034 that can be run by 7008 cloud 7004 processors to provide data analysis solutions for problems that arise specifically in the medical field. As shown in Figure 23, the functions of the 7034 cloud-based data analysis modules can be assisted by applications for central controllers 7014 hosted by the application servers for central controllers 7002 that can be accessed on central surgical controllers 7006. The computing processors in cloud 7008 and applications for central controllers 7014 can operate together to perform data analysis modules 7034. The application program interfaces (API) 7016 define the set of protocols and routines corresponding to applications for central controllers 7014. Additionally , APIs 7016 manage the storage and retrieval of data to and from the aggregated medical databases 7012 for the operations of 7014 applications. 7018 caches also store data (for example, temporarily) and are coupled to APIs 7016 for further recovery efficient use of data used by 7014 applications. data analysis 7034 in Figure 23 includes modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, update of 7026 control programs, analysis of patient results 7028, recommendations 7030 and classification and prioritization of data 7032 Other suitable data analysis modules could also be implemented by the 7004 cloud, according to some aspects. In one respect, data analysis modules are used for specific recommendations based on analysis of trends, results and other data.
[00241] [00241] For example, the 7022 data collection and aggregation module could be used to generate self-describing data (for example, metadata) including the identification of notable features or configurations (for example, trends), management of redundant data sets and data storage in paired data sets that can be grouped by surgery, but not necessarily linked to surgical dates and actual surgeons. In particular, paired data sets generated from 7012 surgical instrument operations may comprise applying a binary classification, for example, a bleeding or non-bleeding event. More generally, the binary classification can be characterized as a desirable event (for example, a successful surgical procedure) or an undesirable event (for example, a wrong or failed surgical instrument 7012). The aggregated self-describing data can correspond to individual data received from various groups or subgroups of central surgical controllers 7006. Consequently, the 7022 data collection and aggregation module can generate aggregated metadata or other data organized based on raw data received from the central surgical controllers. 7006. For this purpose, 7008 processors can be operationally coupled with applications for 7014 central controllers and 7011 aggregated medical data databases to perform 7034 data analysis modules. The 7022 data collection and aggregation module can store the aggregated organized data in the aggregated medical data databases 2212.
[00242] [00242] The resource optimization module 7020 can be configured to analyze this aggregated data to determine an optimal use of resources for a particular or group of healthcare facilities or a specific facility. For example, the resource optimization module 7020 can determine an ideal request point for surgical stapling instruments 7012 for a group of healthcare facilities based on the corresponding expected demand for such instruments 7012. The resource optimization module 7020 it could also assess resource use or other operational configurations of various health care facilities to determine whether resource use could be improved. Similarly, the 7030 recommendation module can be configured to analyze aggregated organized data from the 7022 data collection and aggregation module to provide recommendations. For example, the 7030 recommendations module could recommend for health care facilities (for example, medical providers such as hospitals) that a specific 7012 surgical instrument should be upgraded to an improved version based, for example, on a rate of greater than expected error. In addition, the 7030 recommendation module and / or the 7020 resource optimization module could recommend better supply chain parameters as points for new product requests and provide suggestions for different 7012 surgical instruments, their uses or procedural steps to improve surgical results. Health care facilities can receive such recommendations through the corresponding 7006 central surgical controllers. More specific recommendations on parameters or configurations for various 7012 surgical instruments can also be provided. Central controllers 7006 and / or surgical instruments 7012 may also have display screens that display data or recommendations provided by the 7004 cloud.
[00243] [00243] The 7028 patient results analysis module can analyze surgical results associated with the currently used operating parameters of 7012 surgical instruments. The 7028 patient results analysis module can also analyze and evaluate other potential operational parameters.
[00244] [00244] The cloud-based analytical system can include security features implemented by the 7004 cloud. These security features can be managed by the authorization and security module 7024. Each central surgical controller 7006 can have unique credentials associated with username, password and other appropriate security credentials. These credentials can be stored in memory 7010 and be associated with an allowable level of access from the cloud. For example, based on the provision of accurate credentials, a central surgical controller 7006 can be given access to communicate with the cloud to a predetermined point (for example, it can only participate in the transmission and reception of certain types of information). For this purpose, the aggregated medical data databases 7011 of the cloud 7004 may comprise a database of authorized credentials to verify the accuracy of the credentials provided. Different credentials can be associated with different levels of permission to interact with the 7004 cloud, such as a predetermined access level to receive data analysis generated by the cloud
[00245] [00245] Surgical Instruments 7012 can use wireless transceivers to transmit wireless signals that can represent, for example, authorization credentials for access to the corresponding central controllers 7006 and the 7004 cloud. Wired transceivers can also be used to transmit signals. These authorization credentials can be stored in the respective memory devices of the surgical instruments 7012. The authorization and security module 7024 can determine whether the authorization credentials are accurate or false. The 7024 authorization and security module can also generate authorization credentials dynamically to provide more security. Credentials could also be encrypted, such as using hash-based encryption. After the appropriate authorization has been transmitted, the surgical instruments 7012 can transmit a signal to the corresponding central controllers 7006 and, finally, to the cloud 7004 to indicate that the instruments 7012 are ready to obtain and transmit medical data. In response, the 7004 cloud can move to a state enabled to receive medical data for storage in the aggregated medical data databases 7011. This availability for data transmission could be indicated, for example, by a light indicator on instruments 7012. The 7004 cloud can also transmit signals to 7012 surgical instruments to update its associated control programs. The 7004 cloud can transmit signals that are targeted to a specific class of 7012 surgical instruments (for example, electrosurgical instruments) so that software updates for control programs are transmitted only to surgical instruments
[00246] [00246] The cloud-based analytical system can allow monitoring of multiple healthcare facilities (eg medical facilities like hospitals) to determine improved practices and recommend changes (through the 2030 recommendations module, for example) as needed . In this way, cloud 7004 processors 7008 can analyze the data associated with a healthcare facility to identify the facility and aggregate the data to other data associated with other healthcare facilities in a group. Groups could be defined based on similar operating practices or geographic location, for example. In this way, the 7004 cloud can provide analysis and recommendations for the entire group of healthcare facilities. The cloud-based analytical system could also be used to increase situational awareness. For example, 7008 processors can predictively model the effects of recommendations on cost and effectiveness for a given facility (in relation to general operations and / or various medical procedures). The cost and effectiveness associated with that specific facility can also be compared to a corresponding local region of other facilities or any other comparable facilities.
[00247] [00247] The 7032 data classification and prioritization module can prioritize and classify data based on severity (for example, the severity of a medical event associated with the data, unpredictability, distrust). This sorting and prioritization can be used in conjunction with the functions of the other 7034 data analysis modules described above to improve cloud-based data analysis and the operations described here. For example, the 7032 data classification and prioritization module can assign a priority to the data analysis performed by the 7022 data collection and aggregation module and the 7028 patient outcome analysis modules. Different levels of prioritization can result in responses specific from the 7004 cloud (corresponding to a level of urgency) as referral for faster response, special processing, deletion of aggregated medical data databases 7011 or other appropriate responses. In addition, if necessary, the 7004 cloud can transmit a request (for example, a push message) through the application servers to central controllers for additional data from corresponding 7012 surgical instruments. The push message can result in a notification displayed on the corresponding 7006 central controllers to request support or additional data. This push message may be necessary in situations where the cloud detects a significant irregularity or out-of-bounds result and the cloud cannot determine the cause of the irregularity. Central 7013 servers can be programmed to trigger this push message in certain significant circumstances, such as when it is determined that the data differs from an expected value beyond a predetermined threshold or when it appears that security has been compromised, for example.
[00248] [00248] Additional example details for the various functions described are provided in the following descriptions. Each of the various descriptions can use the cloud architecture as described in Figures 22 and 23 as an example of implementing hardware and software. Usage, resource and efficiency modeling for medical facilities
[00249] [00249] Aspects of this description are presented for a cloud-based analytical system, communicatively coupled to a plurality of central controllers and smart medical instruments, and configured to provide personalized recommendations to local health care facilities regarding the use of supplies and other resources to improve efficiency and optimize resource allocation. A health care facility, such as a hospital or medical clinic, can develop a set of practices for obtaining, using and disposing of various medical supplies that are often derived from routines and traditions maintained over time. The behaviors of a medical facility are typically risk averse, and they would generally be hesitant to adopt new and better practices unless and until a better practice is demonstrated convincingly. Similarly, even if a better usage or efficiency model has been developed at a nearby facility, it is difficult for a local facility to adopt the improved practice because 1) each facility may be more actively resistant to outside changes and 2) there are many unknowns about how or why the improved practice works at the nearby facility compared to what is done by the local facility. In addition, even if a medical facility wants to improve its practices, it may be unable to do so optimally because it lacks sufficient knowledge of other facilities in similar situations, whether facilities in your region, of a similar size and / or with similar practices and patients, among other aspects.
[00250] [00250] To help facilitate the dissemination of best practices among multiple medical facilities, it would be desirable that a common source could be aware of the contexts of multiple medical facilities and be able to determine what changes should be made in a specific medical facility, with knowledge of the practices of any or all of the multiple facilities.
[00251] [00251] In some respects, a cloud-based system communicatively coupled to knowledge centers in a medical facility, such as one or more medical centers, can be configured to aggregate medical resource usage data from multiple medical facilities. The cloud-based system can then correlate medical resource usage data with the results of these facilities, and may be able to identify various patterns within the data. For example, in some ways, the cloud-based system can identify which hospitals generate the least amount of waste per unit cost, based on an aggregation of all waste and acquisition data obtained from medical facilities in a wide geographic region ( for example, all surgical centers in Japan). The cloud-based system can be configured to identify which medical facility produced the least amount of waste per unit cost, and then can analyze which practices differentiate that medical facility. If a trend is found, the cloud-based system can disseminate this information to all medical facilities in similar situations to improve its practices. This analysis can help improve inventory management, productivity efficiency, or the overall efficiency of a medical facility. Improved inventory management can help make surgical devices and other medical resources used at their highest performance levels over extended periods, compared to if resources had been managed ineffectively, and medical devices can therefore , be used continuously even when they are older and more worn out.
[00252] [00252] In general, the cloud-based system can be configured to aggregate data from multiple medical facilities; something that no installation would be able to do on its own. In addition, the cloud-based system can be configured to analyze the broadest data set, controlling common variables such as the type of practice, type of patient, number of patients, similar geographic region, which facilities use similar types of instruments, etc.; something that a facility would not be able to analyze on its own.
[00253] [00253] Thus, the cloud-based system of the present description may be able to find more precise causalities that generate best practices in a given installation, and can then be disseminated to all other installations. In addition, the cloud-based system may be able to provide data from all different sources, which no installation may be able to do on its own.
[00254] [00254] With reference to Figure 24, an example illustration of an organization of several resources is shown, correlated to specific types of surgical categories. There are two bars for each category, with dashed line bars 7102,
[00255] [00255] The cloud-based system can be configured to identify waste products that were collected and were not used, or that were collected and used in a way that was not beneficial to the patient or the surgery. To do this, the cloud-based system can record all the inventory records for obtaining and disposing in memory. During each procurement, it is possible to analyze and insert an inventory entry, and the bar codes of each inventory item can identify the type of product, for example. In some ways, smart disposal containers can be used to automatically record when a product is being disposed of. These containers can ultimately be connected to the cloud-based system, either through one or more central surgical controllers, or through a separate inventory management system throughout the facility. Each installation can be tracked by its location, for example through defined GPS coordinates, entered address or similar. This data can be organized in memory using one or more databases with various metadata associated with them, such as date and time of use, place of origin, type of procedure for which it will be used, if applicable, cost per item, expiration date, if applicable, and so on.
[00256] [00256] In addition, the cloud-based system can be configured to identify failed or misused products and track where the product was used, and can archive those results. For example, each surgical instrument communicatively coupled to a central surgical controller can transmit a record of when the instrument was used, such as to trigger a clamp or apply ultrasonic energy. Each record can be transmitted via the instrument and, finally, recorded on the cloud-based system. The instrument's action can be associated with a result, either at the same time or with a general result that indicates whether the procedure was successful or not. The action can be associated with an accurate timestamp that places it at an exact point during surgery, and all surgery actions are also automatically recorded in the cloud, including surgery start and end times. This allows all health care workers to focus on their respective roles during surgery, rather than worrying about a specific time when an action by a medical instrument occurred. Medical instrument records can be used to identify which products may have been wasted during surgery, and the cloud-based system can be configured in this way to also identify usage trends.
[00257] [00257] In some aspects, the cloud-based system can be configured to perform analysis of product trends associated with the total length or quantity of the product, to identify insufficient uses or discarded products. For example, the cloud-based system can place the use of a product within a known period of time when a surgical procedure is taking place, with a timestamp. The cloud-based system can then record an amount of resources used during that procedure, and can compare the materials used in that procedure with procedures in similar situations performed elsewhere. With that, it is possible to reach several conclusions by the cloud-based system. For example, the cloud-based system can provide recommendations for a mix that provides smaller portions or an alternative use that results in less product waste. As another example, the cloud-based system can provide a suggestion or change to the specified protocol of specialized kits that would organize the product in a manner more in line with the institution's detected use. As yet another example, the cloud-based system can provide a suggestion or a change to the protocol for alternative mixtures of the product that would be more in line with the detected use and therefore should result in less product waste. As yet another example, the cloud-based system can provide a recommendation on how to adjust a medical procedure during surgery based on the timing of actions that occur before or after an event that typically results in a waste of resources, such as misuse or multiple uses, based on the identification of a correlation or pattern that actions during surgery that occur within a certain time interval in relation to a previous action tend to result in actions that generate waste. These analyzes can be obtained in part with the use of algorithms that try to optimize the available resources with their disposal rates, taking into account several factors such as misuse, native practices of the surgeons or the facility as a whole, and so on.
[00258] [00258] Still with reference to Figure 24, based on the organization of used and unused products, the cloud-based system can also generate several other conclusions. For example, the cloud-based system can be configured to generate a correlation of unused products with the fixed cost. The cloud-based system can also generate a calculation of expired products and how this impacts rates of change with inventory. It can also generate an indication of where in the supply chain the product is not being used and how it is being accounted for. It can also generate ways to reduce costs or inventory space by finding substitutions of some resources for others for the same procedure. This can be based on comparing similar practices in different medical facilities that use different resources to perform the same procedures.
[00259] [00259] In some respects, the cloud-based system can be configured to analyze the use of inventory for any and all medical products and perform acquisition management to determine when to obtain new products. The cloud-based system can optimize the use of inventory space to determine the best way to use the available space, given the usage fees for certain products compared to others. Often, inventory may not be carefully monitored for a product's shelf life. If certain products are used less frequently, but there are a lot of them, it can be identified that the storage space is misallocated. Therefore, the cloud-based system can better allocate storage space to reflect the actual use of the resource.
[00260] [00260] To obtain improvements in this area, in some aspects, the cloud-based system can, for example, identify missing or insufficient products in an operating room (OR, "operating room") for a specified procedure. The cloud-based system can then provide an alert or notification,
[00261] [00261] In some aspects, the use of the device within a procedure is monitored by the cloud-based system and compared for a given segment (for example, individual surgeon, individual hospital, network of hospitals, region, etc.) with the use device for similar procedures in other segments. Recommendations are presented to optimize usage based on the unitary resource used or expenses to provide such a resource. In general, the cloud-based system can focus on a comparison of product usage between the different institutions to which it is connected.
[00262] [00262] Figure 25 provides an example illustration of how data is analyzed by the cloud-based system to provide a comparison between multiple facilities to compare resource usage. In general, the cloud-based system 7200 can obtain usage data from all facilities, like any of the types of data described with respect to Figure 24 and can associate each data with several other metadata, such as time, procedure, result of the procedure , cost, date of purchase, and so on. Figure 25 shows an example set of data 7202 being uploaded to the cloud 7200, with each circle in set 7202 representing a result and one or more resources and contextual metadata that may be relevant to generate the result. In addition, 7204 high-performance results and their associated contextual resources and metadata are also sent to the 7200 cloud, although at the time of upload, it may not be clear which data has very good results or just average (or below average) results . The cloud-based system can identify which use of resources is associated with better results compared to an average or expected result. This can be based on determining which resources, for example, last longer, are not wasted as often, or cost less per unit of time or unitary resource. The cloud-based system can analyze the data to determine the best results based on any and all of these variables, or even one or more combinations of them. The trends identified can then be used to find a correlation or can induce the request for additional data associated with those data points. If a pattern is found, these recommendations can be alerted to a user to examine possible ways to optimize the use and efficiency of resources.
[00263] [00263] The example graph 7206 provides a visual representation of an example of trend or pattern that the cloud can obtain from the analysis of data of resources and results, according to some aspects. In this example, the cloud-based system may have analyzed resource data and results from various stapler shots and their relationship to surgery performance. The cloud-based system may have gathered data from multiple medical facilities, and multiple surgeons within each facility, based on trigger data recorded automatically during each surgery that is generated directly from the operation of the surgical staplers themselves. Performance results can be based on post-operative analyzes and / or immediate results during surgery, for example, whether there is a bleeding event or a successful wound closure. Based on all the data, trends can be determined, and here, you can find that there is a small window in the number of shots that results in the best performance results, in the "a" range, as shown. The magnitude of this performance compared to the most common number of shots is shown as the "b" interval. Since the number of shots that result in the best results may not be what is commonly practiced, it may not be immediately easy to discover these results without the aggregation and analysis capabilities of the cloud-based system.
[00264] [00264] As another example, it is possible to obtain the type of cartridge, color and use of accessories that are monitored for vertical gastrectomy procedures for individual surgeons within the same hospital. The data can reveal that the average cost of the procedure is higher for a given surgeon compared to others in the same hospital, even though the patient's results are the same. The hospital is then informed and encouraged to analyze differences in the use of the device, techniques, etc. in search of cost optimization potentially through the elimination of accessories.
[00265] [00265] In some aspects, the cloud-based system can also identify special cases. For example, it is possible to identify information about specific costs provided within the hospital, including OR time, device usage and personnel. These aspects can be unique to a specific OR or installation. The cloud-based system can be configured to suggest efficiencies in the use of OR time (scheduling), device inventory, etc.
[00266] [00266] In some aspects, the cloud-based system can also be configured to compare the cost-benefit of robotic surgery with traditional methods, such as laparoscopic procedures for a given type of procedure. The cloud-based system can compare device costs, OR time, patient discharge times, effectiveness of the procedure performed by a robot compared to the procedure performed only by surgeons, and the like. Association of local usage trends with the resource acquisition behavior of the broader data set (individualized change)
[00267] [00267] According to some aspects of the cloud-based system, while the description above focuses on a determination of efficiency (ie value) and optimization based on it, here, this section is concerned with identifying which local practices can better disseminated to other medical facilities in similar situations.
[00268] [00268] A health care facility, such as a hospital or medical clinic, can develop a set of practices on how to use medical devices to assist medical procedures that are often derived from routines and traditions maintained over time. The behaviors of a medical facility are typically risk averse, and they would generally be hesitant to adopt new and better practices unless and until a better practice is demonstrated convincingly. Similarly, even if a practice of using a device or adjusting a procedure has been developed at a nearby facility, it is difficult for a local facility to adopt the improved practice because 1) each facility may be more actively resistant to changes in and 2) there are many unknowns about how or why the improved practice works at the nearby facility compared to what is done by the local facility. In addition, even if a medical facility wants to improve its practices, it may be unable to do so optimally because it lacks sufficient knowledge of other facilities in similar situations, whether facilities in your region, of a similar size and / or with similar practices and patients, among other aspects.
[00269] [00269] To help facilitate the dissemination of best practices among multiple medical facilities, it would be desirable that a common source could be aware of the contexts of multiple medical facilities and be able to determine what changes should be made in a specific medical facility, with knowledge of the practices of any or all of the multiple facilities.
[00270] [00270] In some aspects, a cloud-based system communicatively coupled to knowledge centers in a medical facility, such as one or more medical centers, can be configured to aggregate resource usage data and patient results from multiple medical facilities. The cloud-based system can then correlate resource usage data with the results of these facilities, and may be able to identify various patterns within the data. For example, in some ways, the cloud-based system can identify which hospitals produce the best results for a given type of procedure, based on an aggregation of all patient outcome data for that specific procedure over a wide geographic region (for example, example, all surgical centers in Germany). The cloud-based system can be configured to identify which medical facility produced a better procedure result compared to the average across the geographic region, and then can analyze what procedural differences occur at that medical facility. If a trend is found and one or more differences are identified, the cloud-based system can disseminate this information to all medical facilities in similar situations to improve its practices.
[00271] [00271] In general, the cloud-based system can be configured to aggregate data from multiple medical facilities; something that no installation would be able to do on its own. In addition, the cloud-based system can be configured to analyze the broadest data set, controlling common variables such as the type of practice, type of patient, number of patients, similar geographic region, which facilities use similar types of instruments, etc.; something that a facility would not be able to analyze on its own.
[00272] [00272] In this way, the cloud-based system of the present description may be able to find more precise causalities that generate best practices in a given installation, and can then be disseminated to all other installations. In addition, the cloud-based system may be able to provide data from all different sources, which no installation may be able to do on its own.
[00273] [00273] The cloud-based system can be configured to generate conclusions about the effectiveness of any local installation in several ways. For example, the cloud-based system can determine whether an on-site treatment facility is using a mix or product use that differs from the community as a whole, and whether its results are superior. The cloud-based system can then correlate the differences and highlight them for use in other facilities, another central surgical controller or in clinical sales, for example. In general, this information can be widely disseminated in a way that no single installation could have had access to or knowledge of, including the installation that practiced this improved procedure.
[00274] [00274] As another example, the cloud-based system can determine whether the local installation has equal or inferior results to the community as a whole. The cloud-based system can then correlate suggestions and provide that information back to the local facility as recommendations. The system can display data showing its performance in relation to the others, and it can also present suggestions about what this installation is doing compared to what is being done by all the others. Again, the local facility may not even know that it has an inefficiency in this regard, and not even the others may realize that they are using their resources more efficiently, so that no one would ever know how to examine these issues without the cloud-based system providing a view. overview of all data.
[00275] [00275] These suggestions can come in several forms. For example, the cloud-based system can provide recommendations at the acquisition level, suggesting better costs for similar results. As another example, the cloud-based system can provide recommendations at the OR level, when the procedure is being planned and equipped, and less desirable products are being used, suggesting other techniques and product mixes that would be in line with the general community that is getting better results. As yet another example, the cloud-based system can show results comparison needs that take into account the surgeon's experience, possibly through a count of similar cases performed by the surgeon from data in the cloud. In some respects, an individual's learning curve can be reported against a larger set of data, such as the expectation of better results or the surgeon's performance in relation to colleagues to obtain a balanced level of results.
[00276] [00276] Figure 26 illustrates an example of how the 7300 cloud-based system can determine the trends in the effectiveness of an aggregated data set 7302 across entire regions, according to some aspects. Here, for each circle in the 7302 data set, the use of devices, cost and results of a procedure are monitored and compared for a given segment (for example, individual surgeon, individual hospital, hospital network, region, etc.) with the use of devices, cost and results of similar procedures in other segments. This data can have metadata that associates it with a specific installation. In general, a result of a procedure can be linked to multiple types of data associated with it, such as what resources were used, which procedure was performed, who performed the procedure, where the procedure was performed, and so on. The data linked to the result can then be presented as a data pair. The data can be subdivided in several ways, such as between good and inferior results, filtered by specific facilities, specific demographic data, and so on. A regional filter 7304 is shown visually as an example. The 7302 data set contains good results and inferior results, with inferior results being darkened for contrast.
[00277] [00277] Figure 26 also shows examples of graphs that have these distinctions and can be derived from the aggregated data set 7302, using one or more pairs of data. Graph 7306 shows a global analysis in one example, while a segmented analysis by region is provided in another graph 7308. Statistical analysis can be performed to determine whether the results are statistically significant. In graph 7306, the cloud-based system can determine that no statistical difference was found between good results and inferior results based on occurrence rates. On the other hand, in graph 7308, the cloud-based system can determine that there is a statistically higher occurrence of inferior results for a given region, when filtering for a specific region. Recommendations are presented to share results against the cost and against the use of the device, and all combinations thereof, to help provide information for the optimization of the results in relation to the costs of the procedure, with the use of the device being potentially one of the main factors contributing to the differences, according to some aspects.
[00278] [00278] As another example, a cartridge type and color are monitored for lobectomy procedures for individual surgeons within the same hospital. The data reveal that the average cost for a surgeon is higher on average for that surgeon, even though the average length of stay is less. The hospital is informed by the cloud-based system and is encouraged to analyze differences in device usage, techniques, etc. in search of improvements in patient results.
[00279] [00279] In some aspects, the cloud-based system can also be configured to provide predictive modeling of changes in procedures, product mixes and time for a given local population or for the general population as a whole. Predictive modeling can be used to assess, for example, the impact on resource use, resource efficiency and resource performance.
[00280] [00280] Figure 27 provides an exemplary illustration of some types of analysis that the cloud-based system can be configured to perform to provide forecasting modeling, according to some aspects. The cloud-based system can combine your knowledge of the steps and instruments needed to perform a procedure, and can compare different paths through various metrics, such as the resources used, time, cost of the procedure, and the like. In this example from graph 7400, a thoracic lobectomy procedure is analyzed using two different types of methods to perform the same procedure. Option A describes a disposable ultrasonic instrument according to the method to perform the procedure, while option B shows a combination of different methods that, in aggregate, perform the same procedure. The graphic illustration can help a surgeon or administrator to see how resources are used and their cost. Option B is divided into multiple sections, including sterilization costs, reusable dissectors and additional time in the OR to perform the procedure. The cloud-based system can be configured to convert these relatively abstract notions into a quantitative cost value based on a combination of your knowledge of time spent in the OR, staff salaries and resource costs per unit of time in the OR, and the resources used for sterilization and reusable dissectors and their associated costs. The cloud-based system can be configured to associate the various amounts of resources and costs with your knowledge of the steps required to perform the thoracic lobectomy procedure using the method prescribed in option B.
[00281] [00281] As another example, graph 7404 in Figure 27 shows a comparison between the use of a long ultrasonic dissector and a reusable monopolar dissector to perform several portions of a procedure. Graph 7404 shows a comparison in terms of the time required to perform each portion of the procedure for each instrument. The surgeon may then be able to select which instrument may be desired for a specific procedure. The split times can be automatically recorded empirically during real-time procedures, with the times for each portion of the general procedure being divided due to the knowledge of the cloud-based system about the expected sequence to perform the procedure. The demarcations between each portion can be defined by a surgeon who provides an entry to manually denote when each change occurs. In other cases, the cloud-based system may use situational awareness to determine when a portion of the procedure has ended based on how the devices are used and not used. The cloud-based system can aggregate several of these procedures, performed by multiple surgeons and multiple facilities, and then calculate an average time for each section, for example.
[00282] [00282] As another example, graph 7402 in Figure 27 shows an example of a graphical interface to compare the relative cost of using the long ultrasonic dissector or a reusable monopolar dissector, according to some aspect. The value of each instrument per unit of time is displayed for a specific procedure. The data used to generate these values may be similar to those obtained for graphs 7400 and 7404, according to some examples. The graphical display can allow a succinct description of key efficiency points that would be most useful for making a determination. This analysis can help a surgeon to see how valuable an instrument is for a given procedure.
[00283] [00283] In general, to perform predictive modeling, the cloud-based system can combine its knowledge of the exact steps to perform a procedure, which instruments can be used to perform each step and its aggregated data on how each instrument performs each specific step . A surgeon may not have the combination of such knowledge to provide such an assessment on his own. Predictive modeling can therefore be the result of continuous data capture and monitoring across multiple facilities, which would not be possible without the cloud-based system.
[00284] [00284] In some respects, the cloud-based system can also obtain information from multiple sources (for example, central controller data collection sources, printed material, etc.) to identify the ideal procedural technique. Several other examples of how predictive modeling can be used include: (1) sigmoidectomy: multi-quadrant surgery; what is the best order of operations, etc .; (2) RYGB: what is the ideal limb length, etc., based on the circumstances for that patient; (3) Lobectomy: how many and which lymph nodes must be removed; and (4) VSG: Suppository size and distance from the pylorus.
[00285] [00285] In some respects, when a suggestion is made to a surgeon, the surgeon is given the option to refuse future suggestions like this, or to continue. In addition, through the interface with the central controller, the surgeon can request additional information from the cloud-based system to use in his decision. For example, the surgeon may want to isolate schedules for a more localized set of data, such as the specific facility or a certain demographic region that best serves the patient undergoing surgery. The data can change if, for example, the patient is a child or if the patient is a woman. Device configuration changes based on the surgeon, region, hospital or patient parameters (preoperative)
[00286] [00286] Similar to the section above, the cloud-based system can also be configured to monitor configurations of intelligent instruments and, more generally, configurations that use multiple intelligent instruments, such as an operating room being prepared for surgery. For similar reasons, as described above, in order to improve medical efficacy and efficiency, it may be useful to compare a procedure configuration in any specific medical facility with aggregated data relating to the procedure configurations in multiple other medical facilities.
[00287] [00287] The cloud-based system of this description can be configured to aggregate data relating to configurations of intelligent medical instruments and operating room (OR) using multiple intelligent medical instruments. Smart medical instruments can include: handheld devices that are communicatively coupled to a medical data tower and are configured to generate sensor data; and robotic instruments that perform procedures in a more automated way. The cloud-based system can be configured to detect irregularities in an OR configuration, whether they are related to which devices are present in the room and / or which materials are used to create a product mix during a medical procedure. The irregularities can be based on the comparison of the materials and equipment present in the OR with other configurations of other medical facilities for a similar situation. The cloud-based system can then generate a change in firmware, software or other settings and transmit these changes to surgical devices as a device update.
[00288] [00288] In this way, the cloud-based system of the present description may be able to identify errors and find more precise causalities that generate best practices in a given installation, and can then be disseminated to all other installations. In addition, the cloud-based system may be able to provide data from all different sources, which no installation may be able to do on its own. This can enable safer and more efficient medical practices and operating room procedures in general.
[00289] [00289] In some ways, the cloud-based system can be configured to provide instrument configuration recommendations, and even generate the appropriate device configuration changes, to customize the performance for them of a previously specified user.
[00290] [00290] For example, the cloud-based system can focus on a user of a surgical device or surgeon based on a comparison of current use of a device with historical trends in a broader data set. As some examples, the cloud-based system can provide recommendations on what type of cartridge to use based on what the user previously used for the specific procedure or just what the specific surgeon wants in general. The cloud-based system can access data based on the specific surgeon, the type of procedure and the type of instruments used to make this determination.
[00291] [00291] As another example, the cloud-based system can provide a recommendation based on an identified anatomy indicated on a cartridge display. As another example, the cloud-based system can provide a recommendation referring to the gripping and firing speed of a baseline surgical device, based on previous local usage data that it has stored in its memory.
[00292] [00292] As yet another example, the cloud-based system can perform a comparison of the tissue interaction of the current device with a historical average for the same surgeon, or for the same step in the same procedure for a segment of surgeons in the database . The cloud-based system can again access all the steps used to perform a procedure, and can access a catalog of all data while performing a specific step in a procedure by all surgeons who have ever performed that procedure in their network. The recommendation may also come from an analysis of how the current surgical device has been observed to interact with tissue historically. This type of analysis can be useful because it is often not possible for large amounts of patient data to be collected on how precisely a surgical device interacts with tissue. In addition, a surgeon typically only knows his experience, and is unaware of the experience of other surgeons for the same procedure. The cloud, on the other hand, is able to collect all of this data and provide new insights that any individual surgeon would not know on their own.
[00293] [00293] As another example: In stapling, more than one of the following are known: color of the cartridge, type of stapler, procedure, step of the procedure, patient information, grip strength over time, previous firing information, deformations end actuator, etc. This information is compared with a historical average for a similar data set.
[00294] [00294] Figure 28 provides a graphic illustration of a type of exemplary analysis that the cloud-based system can perform to provide these recommendations, according to some aspects. In this example, graph 7500 shows data for parenchyma clip trigger analysis. In 7502 bar charts, several types of staples are used, with each staple color reflecting a different amount of force applied to the surgical site. The y-axis (left) associated with 7502 bar graphs reflects a percentage level of use of this type of staple color, where each color shows bar graphs for three different categories: average regional usage (in this case, in Japan), usage global average with the best results, and the average use of the local facility. Based on this data, the cloud-based system can be configured to develop a recommendation of which clamps should be changed for a given situation. Consequently, a number of suggested actions are shown on graph 7506. Graph 7500 also shows a set of line graphs 7504 that reflect a percentage of prolonged air leaks (the y-axis on the right) for each color used, and for each type category (regional, global average, installation average). If the clips are too thick and do not match the thickness of the fabric, there could be holes in the clips that would lead to undesirable air leaks. Here, the cloud-based system can provide a recommendation based on all data shown, as well as data not shown, according to some aspects. The cloud-based system can simply provide a recommendation in the form of a letter like the tag, and the surgeon can check whether the data supports that finding and decide whether to accept the recommendation from the cloud-based system.
[00295] [00295] As another example, the cloud-based system can be configured to provide a recommendation for ultrasonic sheet capacities or lengths based on the likelihood of finding vascular structures in a procedure. Similar to what is described above with reference to Figure 28, the cloud-based system can collect the relevant blade length data, and the respective results that were obtained from various central surgical controllers, and illustrate the various results of using different blade lengths in a specific procedure. A recommendation can be provided in a graphic display where the surgeon can check the recommendation using the graphic presentation created by the cloud-based system.
[00296] [00296] In some ways, the cloud-based system is also configured to provide recommendations to the team on which devices to use for an upcoming procedure. These recommendations can be based on a combination of the surgeon's preference (selection list) compared to historical device usage rates for the same procedures performed by some segments of the broader database, as well as recommendations or uses in different facilities that produce the best results. Data can be obtained by pairing good results with metadata, such as which devices were used to obtain these good results. Recommendations can be influenced by other factors, including patient information, demographic data, etc.
[00297] [00297] Similarly, in some respects, the cloud-based system can also provide identification of used instruments that may not be the preferred device for a given procedure. Blacklisting can more clearly eliminate any obviously flawed use of devices to help surgeons make the best decisions. This data can be obtained from the manufacturer's input, analysis of unsatisfactory results, specific input provided to the cloud-based system, and so on.
[00298] [00298] In addition, when inquiring about the properties of the tissue (elasticity, impedance, perfusion rate), a specific device with a given set of parameters (claw preload) could be suggested for use from the current stock in inventory by the cloud-based system. Some of the metadata associated with the results of previous procedures may include a description of the type of tissue being operated on, and an associated description of the physical characteristics of that tissue. The cloud-based system can then extract trends or patterns based on different types of procedures, but having in common all procedures that deal with similar types of tissue. This type of analysis can be used as a secondary recommendation, when a new or unknown procedure should be used and new suggestions are welcome. If the recommendation is accepted, the cloud-based system can be configured to generate the change in parameters and transmit them to the interconnected medical device, via the central surgical controller, to make the medical device readily available for use in the adjusted procedure.
[00299] [00299] In some respects, device configuration recommendations may include suggestions for accessories for devices based on pre-surgical imaging or data collected locally during the start of a procedure. That is, this accessory suggestion can be for use on or with devices based on the local correlation of use with the effectiveness of the device. As an example, based on a given procedure, surgeon and patient information, bleeding in one case must be tightly controlled and therefore the cloud-based system can conclude that reinforcement is recommended for all staple shots.
[00300] [00300] In some ways, the cloud-based system can also be configured to provide insight into any newly launched product that is available and suitable for operation, as well as instructions for use (IFU). Data can be collected from one or more central surgical controllers, or from factory direct information for newly launched products. The cloud-based system can download the information and make the information available to multiple central medical controllers in multiple facilities.
[00301] [00301] In some respects, in relation to any of the above examples of recommendations being provided by the cloud-based system, the cloud-based system can also inversely provide alerts or other signals when a suggested or device configuration is not followed or not is taken into account. The cloud-based system can be configured to access procedure data from a central surgical controller during a surgical procedure, for example. The central surgical controller can collect data on what type of device is being used during a procedure. The cloud-based system can monitor the progress of the process by checking whether an accepted method or device is used in the correct order or prescribed for the procedure. If there are deviations, so that a specific device is not expected or a step is skipped, the cloud-based system can send an alert to the central surgical controller stating that a specific device is not being used correctly, for example. This would occur in real time, as the timing of the procedure is important for patient safety. Segmented individualization of the instrument's function for the medical facility
[00302] [00302] In some ways, the cloud-based system can also be configured to provide recommendations or automatically adjust the settings of the surgical instrument to take into account specific differences in a medical facility. Although there are several similarities that can be normalized across multiple facilities, there may also be specific differences that must be taken into account. For example, demographic differences in patients, physiological differences in patients more native to a local population, differences in procedures - for example, preferences of each individual surgeon - and availability of specific instruments by region or other differences may motivate certain adjustments in a given facility doctor.
[00303] [00303] The cloud-based system of the present description can be configured to aggregate not only data relating to intelligent medical instrument configurations and operating room (OR) configurations using multiple intelligent medical instruments, but also data that highlight specific differences that may be exclusive to that region or specific medical facility. The cloud-based system can then take into account adjustments to device configurations or recommendations for changes in procedures based on these differences. For example, the cloud-based system may first provide a baseline recommendation on how an intelligent instrument should be used, based on best practices discovered by the aggregated data. In this way, the cloud-based system can increase the recommendation to take into account one or more unique differences specific to a medical facility. Examples of these differences are described above. The cloud-based system can be informed about which demographic and patient data generated the ideal baseline procedure, and then compare the on-site demographic and patient data with that data. The cloud-based system can develop or extrapolate a correlation from this baseline configuration to develop an adjustment or offset that takes into account differences in demographic and patient data.
[00304] [00304] Thus, the cloud-based system of this description may be able to make ideal adjustments specific to each medical facility or even specific to each operating room or surgeon. Adjustments can provide better performance that takes into account the best practices observed, as well as any unique differences.
[00305] [00305] In some aspects, the cloud-based system can be configured to provide changes in the variation of use of the instrument to improve the results. For example, the cloud-based system can identify a localized side effect that is due to a specific way of using a surgical device. Figure 29 provides an illustration of how the cloud-based system can perform analyzes to identify a statistical correlation for a local issue that is linked to how a device is used in the localized configuration. The 7600 cloud can aggregate usage data from all types of devices and record its results. The data set can be filtered down to the level of only those results that used the specific device in question. The cloud-based system can then perform statistical analysis to determine if there is a trend in how procedures are performed in a given installation when using that device. A pattern that suggests that there is a consistent flaw in the way the device is used in this installation can arise, represented as the 7602 data points that demonstrate the statistical correlation. Additional data can then be analyzed, to see if a second pattern can emerge compared to how others are using the device in the aggregate. A suggestion can be provided when a pattern is identified and targeted to the local result outside the 7604 limits. In other cases, the cloud-based system may provide an installation-specific update for the device to compensate for local practice of how that device is used.
[00306] [00306] In some aspects, the cloud-based system can be configured to communicate the deviation to the specific user and the recommendation of a different technique or use to improve the results of the specific device. The cloud-based system can transmit the data for display on the central surgical controller to illustrate what changes need to be made.
[00307] [00307] As an example: A stapler configured with a means to detect the force required to secure the device transmits data indicating that the grip force is still changing rapidly (viscoelastic fluency) when the surgeon starts firing the staple, and is observed that the staple line bleeds more times than expected. The cloud-based system and / or device is able to communicate a need to wait longer (for example, 15 seconds) before triggering the device to improve results. This can be based on performing the statistical analysis described in Figure 29 using data points from similar procedures aggregated from multiple surgeons and multiple facilities. At the time of surgery, it would be impracticable or impractical for anyone on the surgery team to reach these conclusions without the help of the cloud-based system, adding this knowledge and reaching such conclusions.
[00308] [00308] In some aspects, the cloud-based system can also be configured for the intentional deployment of control algorithms on devices with a usage criterion that meets specific criteria. For regional differences, the cloud-based system can adjust the control algorithms for various surgical devices. A different amount of force can be applied to a device for patients in another demographic region, for example. As another example, surgeons can have different uses for one type of surgical device, and control algorithms can be adjusted to take this into account. The cloud-based system can be configured to send a wide-area update to a device, and can target the identifications of regional and specific instruments that allow updates targeted to your control programs.
[00309] [00309] In some ways, the cloud-based system can provide the encoding of the serial numbers of sales units and / or individual devices, which allows updated control programs to be sent to a specific device or specific groups of devices with response to specific criteria or thresholds.
[00310] [00310] Furthermore, according to some aspects, the cloud-based system can be configured to perform the analysis of perioperative data in comparison with result data looking for correlations that identify exceptional results (positive and negative). The analysis can be performed at multiple levels (for example, individual, hospital and geographic filters (for example, city, county, state, country, etc.)). In addition, regional confirmation of improved results can be directed to only a limited geographical area, as changes are known to occur only within a limited area. The ability to adjust devices to regional preferences, techniques and surgical preferences may allow for slightly different improvements for specific region areas.
[00311] [00311] In addition to directly changing instrument settings, the cloud-based system can also be configured to provide recommendations for different instruments or suggestions for equivalent devices due to regional availability. That is, an equivalent suggestion of a device to perform a specific function can be recommended by the cloud-based system, in the event that a device is missing and a specific region has a general or excessive availability of the different device that can be used to service equivalent purpose.
[00312] [00312] For example, the cloud-based system can determine which stapling devices for PPH hemorrhoids or curved cutting devices 30 are only available in Italy due to a unique procedure configuration or university hospital procedure design. As another example, the cloud-based system may determine that there is an Asia-specific open and TX vascular stapler use due to cost sensitivity, lack of laparoscopic adoption and patient's chest cavity size and preferred university hospital techniques. As another example, the cloud-based system can provide awareness messages to OR staff about substandard counterfeit products available in a given region. This data can be obtained from ingesting information from multiple sources, such as inputs provided by specialists and doctors, and employing machine learning and natural language processing to interpret trends and news related to a local area. Figure 30 provides a graphic illustration of an example of how some devices can satisfy equivalent use compared to an intended device. Here, a 7702 circular stapling device is compared to a 7704 compression ring for use in a PPH 7700 stapler for hemorrhoidectomy procedures. The type of analysis performed to meet the recommendations of the cloud-based system can be similar to that described in Figure 29. The cloud-based system can provide a view of this suggestion, as well as an analysis of its efficiency and resource usage, in the example view 7706 that can be shown on a screen on a central surgical controller. In this case, the cost of the instrument is compared, as well as the time and effectiveness of each type of instrument. The cloud-based system can produce these recommendations by obtaining examples of use from different facilities, noting how other facilities and doctors handle the same procedure.
[00313] [00313] In some respects, the cloud-based system can also be configured to provide a central surgical controller with local and decision tree suggestions for post-operative care, based on data processed during the procedure and data analysis trends cloud-based results or performance of aggregate devices from broader population groups.
[00314] [00314] In some respects, the cloud-based system can provide upgradeable decision trees for post-operative care suggestions, based on the situational usage measured by the device. Postoperative treatment decisions can initially be derived from traditionally known responses that doctors would normally recommend. Once additional data is made available, for example, from the aggregation of types of postoperative care from other facilities, or from the analysis of new types of care from printed materials or research on new surgical devices, the decision can be updated by the cloud-based system. The decision tree can be displayed on a central surgical controller and graphically.
[00315] [00315] When using this decision tree, it is possible to provide feedback to each node to inform how effective the current solutions are. Data can be fed based on any feedback provided by patients. A doctor or data administrator does not need to perform any analysis on the fly, but the cloud-based system can aggregate all the data and watch what trends may arise. Feedback can then be provided to update the decision tree.
[00316] [00316] In some aspects, the cloud-based system can incorporate operational data and device performance to propose activities and post-operative monitoring. For example, various patient measures can change which decisions in postoperative care should be made. Measurements may include, but are not limited to: (a) blood pressure; (b) low hematocrit level; (c) PTT (partial thromboplastin time); (d) INR (international standardized ratio); (e) oxygen saturation; (f) changes in ventilation and (g) x-ray data.
[00317] [00317] As another example, the anesthesia protocol can dictate which postoperative decisions should be made. This can take into account: (a) any fluids administered; (b) anesthesia time; and (3) medications, as some non-limiting examples.
[00318] [00318] As another example, types of drugs can also play a role. Warfarin application is a good example. A postoperative patient has abnormal PTT and INR, for example. As the patient is taking Warfarin, potential treatments could include vitamin K, factor 7 or administration of plasma (ffp). Plavix can be another example. A postoperative patient has abnormal PTT and INR. Since the patient is taking Plavix, potential treatments for warfarin would be ineffective. Instead, platelet administration may be the suggestion in the decision tree.
[00319] [00319] As a fourth example, post-operative instructions may be provided depending on the type of procedure. Some non-limiting examples include colorectal time for solid foods (motility); and (b) time for physical activity and PT. These varied decisions can be reflected in the decision tree, and all types of branching decisions can be stored in the cloud-based system and updated when additional data is acquired from any connected facility.
[00320] [00320] Figure 31 provides several examples of how some data can be used as variables in deciding how the post-operative decision tree can branch. As shown, some 7802 factors may include the parameters used in surgical devices, such as the trigger force (FTF) used in an operation, or the closing force (FTC) used in a surgical device. Graph 7800 shows a graph of visual representation of how the FTC and FTF curves can relate to each other. Other factors include compression rate, waiting time and clamp adaptability. Based on some of these variables, a type of postoperative care must be adjusted. In this case, a multi-factor analysis is applied, which can be excessively complex to calculate or modify without the aid of the processing capacity of a cloud-based system. This example suggests that a 7804 decision tree provided by the cloud-based system can be more than just a two-dimensional decision tree. To take multiple variables into account to make a single decision, the decision tree generated by the cloud may be visually available for perhaps only a portion, and the final conclusion may need to be displayed without a complete display of all the other branches that were not considered . Graph 7806 can be an example of providing additional information on how to respond within the decision tree. Situational recognition
[00321] [00321] Situational recognition is the ability of some aspects of a surgical system to determine or infer information related to a surgical procedure from data received from databases and / or instruments. The information may include the type of procedure being performed, the type of tissue being operated on, or the body cavity that is the subject of the procedure. With contextual information related to the surgical procedure, the surgical system can, for example, improve the way in which it controls the modular devices (for example, a robotic arm and / or robotic surgical instrument) that are connected to it and provide information or contextualized suggestions to the surgeon during the course of the surgical procedure. Situational recognition can be applied to perform and / or improve any of the functions described in Figures 22 to 31, for example.
[00322] [00322] Now with reference to Figure 32, a time line 5200 is shown representing the situational recognition of a central controller, such as the central surgical controller 106 or 206, for example. Timeline 5200 is an illustrative surgical procedure and the contextual information that the central surgical controller 106, 206 can derive from data received from data sources at each stage in the surgical procedure. Timeline 5200 represents the typical steps that would be taken by nurses, surgeons, and other medical personnel during the course of a pulmonary segmentectomy procedure, starting with the setup of the operating room and ending with the transfer of the patient to an operating room. postoperative recovery.
[00323] [00323] The central surgical controller with situational recognition 106, 206 receives data from data sources throughout the course of the surgical procedure, including the data generated each time medical personnel use a modular device that is paired with the central surgical controller 106 , 206. Central surgical controller 106, 206 can receive this data from paired modular devices and other data sources and continuously derive inferences (ie, contextual information) about the ongoing procedure as new data is received, such as which step of the procedure is being carried out at any given time. The situational recognition system of the central surgical controller 106, 206 is capable of, for example, recording data related to the procedure to generate reports, checking the steps being taken by medical personnel, providing data or warnings (for example, through a display) that may be relevant to the specific step of the procedure, adjust the modular devices based on the context (for example, activate monitors, adjust the field of view (FOV) of the medical imaging device, or change the energy level of a ultrasonic surgical instrument or RF electrosurgical instrument), and take any other action described above.
[00324] [00324] In the first step 5202, in this illustrative procedure, members of the hospital team retrieve the patient's electronic medical record (PEP) from the hospital's PEP database. Based on patient selection data in the PEP, the central surgical controller 106, 206 determines that the procedure to be performed is a thoracic procedure.
[00325] [00325] In the second stage 5204, the team members scan the entry of medical supplies for the procedure. Central surgical controller 106, 206 cross-references the scanned supplies with a list of supplies that are used in various types of procedures and confirms that the supply mix corresponds to a thoracic procedure. In addition, the central surgical controller 106, 206 is also able to determine that the procedure is not a wedge procedure (because the inlet supplies have an absence of certain supplies that are necessary for a thoracic wedge procedure or, otherwise, that inlet supplies do not correspond to a thoracic wedge procedure).
[00326] [00326] In the third step 5206, medical personnel scan the patient's band with a tomograph that is communicably connected to the central surgical controller 106, 206. The central surgical controller 106, 206 can then confirm the patient's identity based on the scanned data.
[00327] [00327] In the fourth step 5208, the medical staff turns on the auxiliary equipment. The auxiliary equipment being used may vary according to the type of surgical procedure and the techniques to be used by the surgeon, but in this illustrative case they include a smoke evacuator, an insufflator and a medical imaging device. When activated, auxiliary equipment that is modular devices can automatically pair with the central surgical controller 106, 206 which is located within a specific neighborhood of modular devices as part of their initialization process. The central surgical controller 106, 206 can then derive contextual information about the surgical procedure by detecting the types of modular devices that correspond with it during that preoperative or initialization phase. In this particular example, the central surgical controller 106, 206 determines that the surgical procedure is a VATS (video-assisted thoracic surgery) procedure based on this specific combination of paired modular devices. Based on the combination of data from the electronic patient record (PEP), the list of medical supplies to be used in the procedure, and the type of modular devices that connect to the central controller, the central surgical controller 106, 206 can, in general , infer the specific procedure that the surgical team will perform. After the central surgical controller 106, 206 recognizes which specific procedure is being performed, the central surgical controller 106, 206 can then retrieve the steps of that process from a memory or from the cloud and then cross the data it subsequently receives from the connected data sources (for example, modular devices and patient monitoring devices) to infer which stage of the surgical procedure the surgical team is performing.
[00328] [00328] In the fifth step 5210, the team members fix the electrocardiogram (ECG) electrodes and other patient monitoring devices on the patient. ECG electrodes and other patient monitoring devices are able to pair with central surgical controller 106, 206. As central surgical controller 106, 206 begins to receive data from patient monitoring devices, central surgical controller 106, 206 thus confirming that the patient is in the operating room.
[00329] [00329] In the sixth step 5212, the medical personnel induced anesthesia in the patient. Central surgical controller 106, 206 can infer that the patient is under anesthesia based on data from modular devices and / or patient monitoring devices, including ECG data, blood pressure data, ventilator data, or combinations of themselves, for example. After the completion of the sixth step 5212, the preoperative portion of the lung segmentectomy procedure is completed and the operative portion begins.
[00330] [00330] In the seventh step 5214, the lung of the patient being operated on is retracted (while ventilation is switched to the contralateral lung). The central surgical controller 106, 206 can infer from the ventilator data that the patient's lung has been retracted, for example. Central surgical controller 106, 206 can infer that the operative portion of the procedure started when it can compare the detection of the patient's lung collapse at the expected stages of the procedure (which can be accessed or retrieved earlier) and thus determine that the collapse of the patient lung is the first operative step in this specific procedure.
[00331] [00331] In the eighth step 5216, the medical imaging device (for example, a display device) is inserted and the video from the medical imaging device is started. Central surgical controller 106, 206 receives data from the medical imaging device (i.e., video or image data) through its connection to the medical imaging device. Upon receipt of data from the medical imaging device, the central surgical controller 106, 206 can determine that the portion of the laparoscopic surgical procedure has started. In addition, the central surgical controller 106, 206 can determine that the specific procedure being performed is a segmentectomy, rather than a lobectomy (note that a wedge procedure has already been discarded by the central surgical controller 106, 206 based on the data received in the second step 5204 of the procedure). The medical imaging device data 124 (Figure 2) can be used to determine contextual information about the type of procedure being performed in a number of different ways, including by determining the angle at which the medical imaging device is oriented in in relation to visualizing the patient's anatomy, monitoring the number or medical imaging devices being used (ie, which are activated and paired with the operating room 106, 206), and monitoring the types of visualization devices used.
[00332] [00332] In the ninth step 5218 of the procedure, the surgical team starts the dissection step. Central surgical controller 106, 206 can infer that the surgeon is in the process of dissecting to mobilize the patient's lung because he receives data from the RF or ultrasonic generator that indicate that an energy instrument is being fired. The central surgical controller 106, 206 can cross-check the received data with the steps retrieved from the surgical procedure to determine that an energy instrument being fired at that point in the process (that is, after the completion of the previously discussed steps of the procedure) corresponds to the step of dissection. In certain cases, the energy instrument may be a power tool mounted on a robotic arm in a robotic surgical system.
[00333] [00333] In the tenth step 5220 of the procedure, the surgical team proceeds to the connection step. Central surgical controller 106, 206 can infer that the surgeon is ligating the arteries and veins because he receives data from the surgical stapling and cutting instrument indicating that the instrument is being fired. Similar to the previous step, the central surgical controller 106, 206 can derive this inference by crossing the reception data of the stapling and surgical cutting instrument with the steps recovered in the process. In certain cases, the surgical instrument can be a surgical tool mounted on a robotic arm of a robotic surgical system.
[00334] [00334] In the eleventh step 5222, the segmentectomy portion of the procedure is performed. Central surgical controller 106, 206 can infer that the surgeon is transecting the parenchyma based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond to the size or type of clamp being triggered by the instrument, for example. As different types of staples are used for different types of fabrics, the cartridge data can thus indicate the type of fabric being stapled and / or transected. In this case, the type of clamp that is fired is used for the parenchyma (or other similar types of tissue), which allows the central surgical controller 106, 206 to infer which segmentectomy portion of the procedure is being performed.
[00335] [00335] In the twelfth step 5224, the node dissection step is then performed. The central surgical controller 106, 206 can infer that the surgical team is dissecting the node and performing a leak test based on the data received from the generator that indicates which ultrasonic or RF instrument is being fired. For this specific procedure, an RF or ultrasonic instrument being used after the parenchyma has been transected corresponds to the node dissection step, which allows the central surgical controller 106, 206 to make this inference. It should be noted that surgeons regularly switch between surgical stapling / cutting instruments and surgical energy instruments (that is, RF or ultrasonic) depending on the specific step in the procedure because different instruments are better adapted for specific tasks. Therefore, the specific sequence in which the cutting / stapling instruments and surgical energy instruments are used can indicate which stage of the procedure the surgeon is performing. In addition, in certain cases, robotic tools can be used for one or more steps in a surgical procedure and / or Hand held surgical instruments can be used for one or more steps in the surgical procedure. The surgeon can switch between robotic tools and hand-held surgical instruments and / or can use the devices simultaneously, for example. After the completion of the twelfth stage 5224, the incisions are closed and the post-operative portion of the process begins.
[00336] [00336] In the thirteenth stage 5226, the patient's anesthesia is reversed. The central surgical controller 106, 206 can infer that the patient is emerging from anesthesia based on ventilator data (i.e., the patient's respiratory rate begins to increase), for example.
[00337] [00337] Finally, in the fourteenth step 5228 is that medical personnel remove the various patient monitoring devices from the patient. Central surgical controller 106, 206 can thus infer that the patient is being transferred to a recovery room when the central controller loses ECG, blood pressure and other data from patient monitoring devices. As can be seen from the description of this illustrative procedure, the central surgical controller 106, 206 can determine or infer when each step of a given surgical procedure is taking place according to the data received from the various data sources that are communicably coupled to the controller central surgery 106, 206.
[00338] [00338] Situational recognition is further described in US Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, the description of which is incorporated herein by reference in its entirety. In certain cases, the operation of a robotic surgical system, including the various robotic surgical systems disclosed here, for example, can be controlled by the central controller 106, 206 based on its situational perception and / or feedback from its components and / or based on information from cloud 102.
[00339] [00339] Various aspects of the subject described in this document are defined in the following numbered examples.
[00340] [00340] Example 1. A cloud-based medical analytical system comprising: at least one processor; at least one memory coupled in communication with at least one processor; an input / output interface configured to access data from a plurality of medical central controller type communication devices, each communicatively coupled to at least one surgical instrument; and a database that resides in at least one memory and is configured to store the data; at least one memory stores executable instructions for at least one processor to: aggregate patient outcome data from the plurality of central medical controllers, with patient outcome data comprising: data related to the steps performed and the corresponding lead times execution of each step in procedures with the patient; data related to a result of each patient procedure performed; data related to medical resources used in patient procedures; for each item of data related to the medical resource: location data describing the medical facilities to which the said medical resource was allocated; and, for each item of data related to the outcome of the patient's procedure, data indicating the success or failure of the procedure; aggregate data for capturing medical resources from central medical controllers; determine a correlation between positive results from patient outcome data and fundraising data; generate a medical recommendation to change a medical resource capture practice based on the correlation; and cause the medical recommendation to be displayed on a plurality of central medical controllers located in different medical facilities.
[00341] [00341] Example 2. The cloud-based medical analytical system of Example 1 in which at least one memory stores executable instructions from at least one processor to: evaluate patient outcome data and facility capture data specific medical; Determine whether a performance level for the specific medical facility is below average compared to other medical facilities, based on a comparison between the assessed patient outcome data and the resource capture data for the specific medical facility. and generate a localized recommendation to change a specific medical facility practice.
[00342] [00342] Example 3. The cloud-based medical analytical system of any of Examples 1 and 2 in which the localized recommendations comprise instructions for reviewing a medical procedure to take into account the surgeon's experience level.
[00343] [00343] Example 4. The cloud-based medical analytical system of any of Examples 1 to 3 in which the localized recommendation comprises instructions for reviewing resource inventory management in order to reduce the inventory of a first product and increase the inventory of a second product.
[00344] [00344] Example 5. The cloud-based medical analytical system of any of Examples 1 to 4 in which at least one memory stores executable instructions from at least one processor to: evaluate patient outcome data and capture data resources related to a geographic region; determine whether a performance level for medical facilities in the geographic region is below average compared to a global average for medical facilities, based on a comparison between the assessed patient outcome data and the resource capture data for the medical facility's geographic region with aggregated patient outcome data; and generate a regionalized recommendation to change a practice of medical facilities that belong to the geographic region.
[00345] [00345] Example 6. The cloud-based medical analytical system of any of Examples 1 to 5 in which at least one memory stores executable instructions from at least one processor to: perform trend analysis and expected changes in demographic data from a population; and generate a predictive modeling recommendation indicating an instruction to change a medical procedure or an inventory of one or more medical products over a period of time to accommodate expected changes in demographic data, based on trend analysis.
[00346] [00346] Example 7. The cloud-based medical analytical system of any of Examples 1 to 6 in which: at least one memory stores executable instructions from at least one processor to: compare performance metrics from a first method to conduct a procedure physician with performance metrics from a second method to conduct the same medical procedure; and generate a predictive modeling recommendation indicating an instruction to perform the first method for conducting the medical procedure based on performance comparison.
[00347] [00347] Example 8. A non-transitory, computer-readable medium that stores computer-readable instructions executable by at least one processor from a cloud-based analytical system to: aggregate patient outcome data from the plurality of central medical controllers, being that patient outcome data comprises: data related to the steps performed and the corresponding times of execution of each step in procedures with the patient; data related to a result of each patient procedure performed; data related to medical resources used in patient procedures; for each item of data related to the medical resource: location data describing the medical facilities to which the said medical resource was allocated; and, for each item of data related to the outcome of the patient's procedure, data indicating the success or failure of the procedure; aggregate data for capturing medical resources from central medical controllers; determine a correlation between positive results from patient outcome data and fundraising data; generate a medical recommendation to change a medical resource capture practice based on the correlation; and cause the medical recommendation to be displayed on a plurality of central medical controllers located in different medical facilities.
[00348] [00348] Example 9. The computer-readable non-transitory media of Example 8 in which the instructions are additionally executable for: evaluating patient outcome data and resource capture data for a specific medical facility; Determine whether a performance level for the specific medical facility is below average compared to other medical facilities, based on a comparison between the assessed patient outcome data and the resource capture data for the specific medical facility. and generate a localized recommendation to change a specific medical facility practice.
[00349] [00349] Example 10. The non-transitory, computer-readable media of any of Examples 8 and 9 in which the localized recommendations comprise instructions for reviewing a medical procedure to take into account the surgeon's experience level.
[00350] [00350] Example 11. The computer readable non-transitory media of any of Examples 8 to 10 in which the localized recommendations include instructions for reviewing resource inventory management in order to reduce the inventory of a first product and increase the inventory of a second product.
[00351] [00351] Example 12. The non-transitory, computer-readable media of any of Examples 8 to 11 in which instructions are additionally executable to: evaluate patient outcome data and resource capture data for a specific medical facility belonging a geographic region; determine whether a performance level for medical facilities in the geographic region is below average compared to a global average for medical facilities, based on a comparison between the assessed patient outcome data and the resource capture data for the medical facility's geographic region with aggregated patient outcome data; and generate a regionalized recommendation to change a practice of medical facilities that belong to the geographic region.
[00352] [00352] Example 13. The non-transitory, computer-readable media of any of Examples 8 to 12, in which the instructions are additionally executable to: make analysis of trends and expected changes in the demographic data of a population; and generate a predictive modeling recommendation indicating an instruction to change a medical procedure or an inventory of one or more medical products over a period of time to accommodate expected changes in demographic data, based on trend analysis.
[00353] [00353] Example 14. The non-transitory, computer-readable media of any of Examples 8 to 13, in which the instructions are additionally executable to: compare performance metrics from a first method to conduct a medical procedure with performance metrics from a second method to conduct the same medical procedure; and generate a predictive modeling recommendation indicating an instruction to perform the first method for conducting the medical procedure based on performance comparison.
[00354] [00354] Example 15. A cloud-based medical analytical system comprising: at least one processor; at least one memory coupled in communication with at least one processor; an input / output interface configured to access data from a plurality of medical central controller type communication devices, each communicatively coupled to at least one surgical instrument; and a database that resides in at least one memory and is configured to store the data; and at least one memory stores executable instructions for at least one processor to: aggregate data from medical instruments from the plurality of central medical controllers, and data from medical instruments comprise: data related to physical parameters and performance of devices doctors; for each data related to the medical device: usage data related to medical procedures that used the medical device; and for each medical procedure: a result of the medical procedure; and the condition of the condition of the medical device during the medical procedure; determine a correlation between results of medical procedures and the condition status of medical devices that used the respective medical procedures; access live medical procedure data for a live medical procedure, with live medical procedure data comprising a description of the medical devices present in an operating room where the live medical procedure is being performed; determine an irregularity in the description of medical devices present in the medical procedure based on the determined correlation between the results and the medical devices used; and providing an alert to a central communication controller that is used in the operating room for the live medical procedure.
[00355] [00355] Example 16. The cloud-based analytical medical system of Example 15, in which the medical devices present in the operating room comprise a manual medical instrument and a robotic medical instrument.
[00356] [00356] Example 17. The cloud-based medical analytical system of any of Examples 15 and 16 in which at least one processor is additionally configured to generate a change in the firmware or software of a medical device present in the live medical procedure in concert with the alert provided.
[00357] [00357] Example 18. The cloud-based medical analytical system of any of Examples 15 to 17 in which the irregularity comprises the use of a medical resource in a medical device present in the live medical procedure that is inconsistent with the aggregated data from the medical instrument related to the medical procedure.
[00358] [00358] Example 19. The cloud-based medical analytical system of any of Examples 15 to 18 in which the alert comprises an instruction to change the tightening or firing speed of a medical device present in the live medical procedure.
[00359] [00359] Example 20. The cloud-based medical analytical system of any of Examples 15 to 19 in which the alert comprises an instruction to change the length of the ultrasonic blade of a medical device present in the live medical procedure.
[00360] [00360] Although several forms have been illustrated and described, it is not the applicant's intention to restrict or limit the scope of the claims attached to such detail. Numerous modifications, variations, alterations, substitutions, combinations and equivalents of these forms can be implemented and will occur to those skilled in the art without departing from the scope of the present description. In addition, the structure of each element associated with the shape can alternatively be described as a means of providing the function performed by the element. In addition, where materials are revealed for certain components, other materials can be used. It should be understood, therefore, that the preceding description and the appended claims are intended to cover all these modifications, combinations and variations that fall within the scope of the modalities presented. The attached claims are intended to cover all such modifications, variations, alterations, substitutions, modifications and equivalents.
[00361] [00361] The previous detailed description presented various forms of the devices and / or processes through the use of block diagrams, flowcharts and / or examples. Although these block diagrams, flowcharts and / or examples contain one or more functions and / or operations, it will be understood by those skilled in the art that each function and / or operation within these block diagrams, flowcharts and / or examples can be implemented, individually and / or collectively, through a wide range of hardware, software, firmware or virtually any combination thereof. Those skilled in the art will recognize, however, that some aspects of the aspects disclosed herein, in whole or in part, can be implemented in an equivalent manner in integrated circuits, such as one or more computer programs running on one or more computers (for example, as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (for example, as one or more programs running on one or more microprocessors), as firmware, or virtually as any combination of them, and that designing the circuitry and / or writing the code for the software and firmware would be within the scope of practice of those skilled in the art, in the light of this description. In addition, those skilled in the art will understand that the mechanisms of the subject described herein can be distributed as one or more program products in a variety of ways and that an illustrative form of the subject described here is applicable regardless of the specific type of transmission medium. signals used to effectively carry out the distribution.
[00362] [00362] The instructions used to program the logic to execute various revealed aspects can be stored in a memory in the system, such as dynamic random access memory (DRAM), cache, flash memory or other storage. In addition, instructions can be distributed over a network or through other computer-readable media. Thus, machine-readable media can include any mechanism to store or transmit information in a machine-readable form (for example, a computer), but is not limited to, floppy disks, optical discs, read-only compact disc ( CD-ROMs), and optical-dynamos discs, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), cards magnetic or optical, flash memory, or machine-readable tangible storage media used to transmit information over the Internet via an electrical, optical, acoustic cable or other forms of propagation signals (for example, carrier waves, infrared signal, digital signals, etc.). Consequently, computer-readable non-transitory media includes any type of machine-readable media suitable for storing or transmitting instructions or electronic information in a machine-readable form (for example, a computer).
[00363] [00363] As used in any aspect of the present invention, the term "control circuit" can refer to, for example, a set of wired circuits, programmable circuits (for example, a computer processor comprising one or more cores individual instruction processing units, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic matrix (PLA), or field programmable port arrangement ( FPGA)), state machine circuits, firmware that stores instructions executed by the programmable circuit, and any combination thereof.
[00364] [00364] As used in any aspect of the present invention, the term "logical" can refer to an application, software, firmware and / or circuit configured to perform any of the aforementioned operations. The software may be incorporated as a software package, code, instructions, instruction sets and / or data recorded on the computer-readable non-transitory storage media. The firmware can be embedded as code, instructions or instruction sets and / or data that are hard-coded (for example, non-volatile) in memory devices.
[00365] [00365] As used in any aspect of the present invention, the terms "component", "system", "module" and the like may refer to a computer-related entity, be it hardware, a combination of hardware and software, software or software running.
[00366] [00366] As used here in one aspect of the present invention, an "algorithm" refers to the self-consistent sequence of steps leading to the desired result, where a "step" refers to the manipulation of physical quantities and / or logical states that can, although they do not necessarily need to, take the form of electrical or magnetic signals that can be stored, transferred, combined, compared and manipulated in any other way. It is common use to call these signs bits, values, elements, symbols, characters, terms, numbers or the like. These terms and similar terms may be associated with the appropriate physical quantities and are merely convenient identifications applied to these quantities and / or states.
[00367] [00367] A network can include a packet switched network. Communication devices may be able to communicate with each other using a selected packet switched network communications protocol. An exemplary communications protocol may include an Ethernet communications protocol that may be able to allow communication using a transmission control protocol / Internet protocol (TCP / IP). The Ethernet protocol can conform to or be compatible with the Ethernet standard published by the Institute of Electrical and Electronics Engineers (IEEE) entitled "IEEE 802.3 Standard", published in December 2008 and / or later versions of this standard. Alternatively or in addition, communication devices may be able to communicate with each other using an X.25 communications protocol. The X.25 communications protocol can conform or be compatible with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or in addition, communication devices may be able to communicate with each other using a frame-relay communications protocol. The frame-relay communications protocol can conform to or be compatible with a standard promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, transceivers may be able to communicate with each other using an ATM communication protocol ("asynchronous transfer mode"). The ATM communication protocol can conform or be compatible with an ATM standard published by the ATM forum entitled "ATM-MPLS Network
[00368] [00368] Unless otherwise stated, as is evident from the description mentioned above, it is understood that, throughout the aforementioned description, discussions that use terms such as "processing", "computation", "calculation", "determination" , "display", or similar, refers to the action and processes of a computer system, or similar electronic computing device, which manipulates and transforms data represented as physical (electronic) quantities in the computer system's records and memories into others data similarly represented as physical quantities in the memories or records of the computer system, or on other similar devices for storing, transmitting or displaying such information.
[00369] [00369] One or more components in the present invention may be called "configured for", "configurable for", "operable / operational for", "adapted / adaptable for", "capable of", "conformable / conformed for", etc. Those skilled in the art will recognize that "configured for" may, in general, cover components in an active state and / or components in an inactive state and / or components in a standby state, except when the context determines otherwise.
[00370] [00370] The terms "proximal" and "distal" are used in the present invention with reference to a physician who handles the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the doctor, and the term "distal" refers to the portion located opposite the doctor. It will also be understood that, for the sake of convenience and clarity, spatial terms such as
[00371] [00371] Persons skilled in the art will recognize that, in general, the terms used here, and especially in the appended claims (for example, bodies of the appended claims) are generally intended as "open" terms (for example, the term "including" should be interpreted as "including, but not limited to", the term "having" should be interpreted as "having, at least", the term "includes" should be interpreted as "includes, but is not limited to ", etc.). It will also be understood by those skilled in the art that, when a specific number of a claim statement entered is intended, that intention will be expressly mentioned in the claim and, in the absence of such mention, no intention will be present. For example, as an aid to understanding, the following appended claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim statements. However, the use of such phrases should not be interpreted as implying that the introduction of a claim statement by the indefinite articles "one, ones" or "one, ones" limits any specific claim containing the mention of the claim entered to claims that contain only such a mention, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles, such as "one, ones" or "one, ones" (for example, "one, ones" and / or "one, ones" should typically be interpreted as meaning "at least one" or "one or more"); the same goes for the use of defined articles used to introduce claims.
[00372] [00372] Furthermore, even if a specific number of an introduced claim statement is explicitly mentioned, those skilled in the art will recognize that that statement must typically be interpreted as meaning at least the number mentioned (for example, the mere mention of "two mentions ", without other modifiers, typically means at least two mentions, or two or more mentions). In addition, in cases where a convention analogous to "at least one of A, B and C, etc." is used, in general this construction is intended to have the meaning in which the convention would be understood by (for example, "a system that has at least one of A, B and C "would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A, B and C together, etc.). In cases where a convention analogous to "at least one of A, B or C, etc." is used, in general this construction is intended to have the meaning in which the convention would be understood by (for example, "a system that have at least one of A, B and C "would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and / or A , B and C together, etc.). It will be further understood by those skilled in the art that typically a disjunctive word and / or phrase presenting two or more alternative terms, whether in the description, in the claims or in the drawings, should be understood as contemplating the possibility of including one of the terms, any of the terms or both terms, except where the context dictates something different. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B".
[00373] [00373] With respect to the attached claims, those skilled in the art will understand that the operations mentioned in them can, in general, be performed in any order. In addition, although several operational flow diagrams are presented in one or more sequences, it must be understood that the various operations can be performed in other orders than those shown, or can be performed simultaneously. Examples of such alternative orderings may include overlapping, merged, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, inverse or other variant orders, unless the context otherwise requires. In addition, terms such as "responsive to", "related to" or other adjectival participles are not intended in general to exclude these variants, unless the context otherwise requires.
[00374] [00374] It is worth noting that any reference to "one (1) aspect", "one aspect", "an exemplification" or "one (1) exemplification", and the like means that a particular feature, structure or feature described in connection with the aspect is included in at least one aspect. Thus, the use of expressions such as "in one (1) aspect", "in one aspect", "in an exemplification", "in one (1) exemplification", in several places throughout this specification does not necessarily refer the same aspect. In addition, specific features, structures or characteristics can be combined in any appropriate way in one or more aspects.
[00375] [00375] Any patent application, patent, non-patent publication or other description material mentioned in this specification and / or mentioned in any order data sheet is hereby incorporated by reference, to the extent that the materials incorporated are not inconsistent with that. Accordingly, and to the extent necessary, the description as explicitly presented herein replaces any conflicting material incorporated by reference to the present invention. Any material, or portion thereof, which is incorporated herein by reference, but which conflicts with the definitions, statements, or other description materials contained herein, will be incorporated here only to the extent that there is no conflict between the embedded material and the existing description material.
[00376] [00376] In summary, numerous benefits have been described that result from the use of the concepts described in this document. The previously mentioned description of one or more modalities has been presented for purposes of illustration and description. This description is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. One or more modalities were chosen and described in order to illustrate the principles and practical application to, thus, allow those skilled in the art to use the various modalities and with various modifications, as they are convenient to the specific use contemplated. It is intended that the claims presented in the annex define the global scope.

权利要求:
Claims (20)
[1]
1. Cloud-based medical analytical system characterized by comprising: at least one processor; at least one memory coupled in communication with at least one processor; an input / output interface configured to access data from a plurality of medical central controller type communication devices, each communicatively coupled to at least one surgical instrument; and a database that resides in at least one memory and is configured to store the data; at least one memory stores executable instructions for at least one processor to: aggregate patient outcome data from the plurality of central medical controllers, with patient outcome data comprising: data related to the steps performed and the corresponding lead times execution of each step in procedures with the patient; data related to a result of each patient procedure performed; data related to medical resources used in patient procedures; for each item of data related to the medical resource: location data describing the medical facilities to which the said medical resource was allocated; and for each item of data related to the result of the patient procedure: data indicating the result as success or failure;
aggregate data for capturing medical resources from central medical controllers; determine a correlation between positive results from patient outcome data and fundraising data; generate a medical recommendation to change a medical resource capture practice based on the correlation; and cause the medical recommendation to be displayed on a plurality of central medical controllers located in different medical facilities.
[2]
2. Cloud-based analytical medical system according to claim 1, characterized in that at least one memory stores executable instructions for at least one processor to: evaluate patient outcome data and facility capture data specific medical; determine whether a specific medical facility's performance level is below average compared to other medical facilities, based on a comparison between the assessed patient outcome data and the resource capture data for the specific medical facility; and generate a localized recommendation to change a specific medical facility practice.
[3]
3. Cloud-based analytical medical system according to claim 2, characterized in that the localized recommendations comprise instructions for reviewing a medical procedure to take into account the surgeon's experience level.
[4]
4. Cloud-based analytical medical system according to claim 2, characterized in that the localized recommendations comprise instructions for reviewing resource inventory management in order to reduce the inventory of a first product and increase the inventory of a second product.
[5]
5. Cloud-based analytical medical system according to claim 1, characterized in that at least one memory stores executable instructions for at least one processor to: evaluate patient outcome data and resource capture data from medical facilities a geographic region; determine whether a performance level for medical facilities in the geographic region is below average compared to a global average for medical facilities, based on a comparison between the assessed patient outcome data and the resource capture data for the medical facility's geographic region with aggregated patient outcome data; and generate a regionalized recommendation to change a practice of medical facilities that belong to the geographic region.
[6]
6. Cloud-based medical analytical system, according to claim 1, characterized in that at least one memory stores executable instructions for at least one processor to: perform trend analysis and expected changes in the demographic data of a population; and generate a predictive modeling recommendation indicating an instruction to change a medical procedure or an inventory of one or more medical products over a period of time to accommodate expected changes in demographic data, based on trend analysis.
[7]
7. Cloud-based medical analytical system, according to claim 1, characterized in that at least one memory stores executable instructions for at least one processor to: perform the performance metrics of a second method to conduct the same medical procedure; and generate a predictive modeling recommendation indicating an instruction to perform the first method for conducting the medical procedure based on performance comparison.
[8]
8. Non-transient, computer-readable media characterized by storing computer-readable instructions executable by at least one processor from a cloud-based analytical system to: aggregate patient outcome data from the plurality of central medical controllers, with data from patient results include: data related to the steps performed and the corresponding times of execution of each step in procedures with the patient; data related to a result of each patient procedure performed; data related to medical resources used in patient procedures; for each item of data related to the medical resource: location data describing the medical facilities to which the said medical resource was allocated; and for each item of data related to the result of the patient procedure: data indicating the result as success or failure; aggregate data for capturing medical resources from central medical controllers; determine a correlation between positive results from patient outcome data and fundraising data; generate a medical recommendation to change a medical resource capture practice based on the correlation; and cause the medical recommendation to be displayed on a plurality of central medical controllers located in different medical facilities.
[9]
9. Non-transitory, computer-readable media, according to claim 8, characterized in that the instructions are additionally executable to: evaluate the data of patient results and the data of capture of resources of a specific medical facility; determine whether a performance level of the specific medical facility is below average compared to other medical facilities, based on a comparison of the assessed patient outcome data; and generate a localized recommendation to change a specific medical facility practice.
[10]
10. Non-transient, computer-readable media according to claim 9, characterized in that the localized recommendations comprise instructions for reviewing a medical procedure to take into account the level of experience of the surgeon.
[11]
11. Non-transitory, computer-readable media according to claim 9, characterized in that the localized recommendations comprise instructions for reviewing resource inventory management in order to reduce the inventory of a first product and increase the inventory of a second product.
[12]
12. Non-transient, computer-readable media according to claim 9, characterized in that the instructions are additionally executable to: evaluate the data of patient results and the data of capture of resources of medical facilities of a geographic region; determine whether a performance level for medical facilities in the geographic region is below average compared to a global average for medical facilities, based on a comparison between the assessed patient outcome data and the resource capture data for the medical facility's geographic region with aggregated patient outcome data; and generate a regionalized recommendation to change a practice of medical facilities that belong to the geographic region.
[13]
13. Non-transitory, computer-readable media, according to claim 9, characterized in that the instructions are additionally configured to: perform trend analysis and expected changes in the demographic data of a population; and generate a predictive modeling recommendation indicating an instruction to change a medical procedure or an inventory of one or more medical products over a period of time to accommodate expected changes in demographic data, based on trend analysis.
[14]
14. Computer readable non-transitory media according to claim 9, characterized in that the instructions are additionally configured to: compare performance metrics from a first method to conduct a medical procedure with performance metrics from a second method to conduct the same medical procedure; and generate a predictive modeling recommendation indicating an instruction to perform the first method for conducting the medical procedure based on performance comparison.
[15]
15. Cloud-based medical analytical system characterized by comprising: at least one processor;
at least one memory coupled in communication with at least one processor; an input / output interface configured to access data from a plurality of medical central controller type communication devices, each communicatively coupled to at least one surgical instrument; and a database that resides in at least one memory and is configured to store the data. and at least one memory stores executable instructions for at least one processor to: aggregate data from medical instruments from the plurality of central medical controllers, and data from medical instruments comprise: data related to physical parameters and performance of devices doctors; for each data related to the medical device: usage data related to medical procedures that used the medical device; and for each medical procedure: a result of the medical procedure; and the condition of the condition of the medical device during the medical procedure; determine a correlation between results of medical procedures and the condition status of medical devices that used the respective medical procedures; access live medical procedure data for a live medical procedure, with live medical procedure data comprising a description of the medical devices present in an operating room where the live medical procedure is being performed.
determine an irregularity in the description of medical devices present in the medical procedure based on the determined correlation between the results and the medical devices used; and providing an alert to a central communication controller that is used in the operating room for the live medical procedure.
[16]
16. Cloud-based analytical medical system according to claim 15, characterized in that the medical devices present in the operating room comprise a manual medical instrument and a robotic medical instrument.
[17]
17. Cloud-based medical analytical system according to claim 15, characterized in that the at least one processor is additionally configured to generate a change in the firmware or software of a medical device present in the live medical procedure in concert with the alert provided.
[18]
18. Cloud-based analytical medical system according to claim 15, characterized in that the irregularity comprises the use of a medical resource in a medical device present in the live medical procedure that is inconsistent with the aggregated data from the medical instrument related to the procedure doctor.
[19]
19. Cloud-based analytical medical system according to claim 15, characterized in that the alert comprises an instruction to change the tightening or firing speed of a medical device present in the live medical procedure.
[20]
20. Cloud-based medical analytical system according to claim 15, characterized in that the alert comprises an instruction to change the length of an ultrasonic blade of a medical device present in the live medical procedure.

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同族专利:

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公开号 | 公开日

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JP2021509504A|2021-03-25|

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EP3506283A1|2019-07-03|

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WO2019130078A1|2019-07-04|

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法律状态:
2021-11-30| B08F| Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]|Free format text: REFERENTE A 3A ANUIDADE. |

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2021-12-07| B350| Update of information on the portal [chapter 15.35 patent gazette]|

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2022-03-08| B08G| Application fees: restoration [chapter 8.7 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201762611341P| true| 2017-12-28|2017-12-28|

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US201762611340P| true| 2017-12-28|2017-12-28|

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US201762611339P| true| 2017-12-28|2017-12-28|

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US62/611,340|2017-12-28|

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US62/611,339|2017-12-28|

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US62/611,341|2017-12-28|

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US201862649333P| true| 2018-03-28|2018-03-28|

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US62/649,333|2018-03-28|

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US15/940,679|2018-03-29|

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PCT/IB2018/055750|WO2019130078A1|2017-12-28|2018-07-31|Cloud-based medical analytics for linking of local usage trends with the resource acquisition behaviors of larger data set|

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