stapling device with both compulsory and discretionary interlocks based on detected parameters

专利摘要:
the present invention relates to a surgical stapling instrument. the surgical stapling instrument includes an anvil configured to grip tissue, a stapler configured to drive surgical staples through tissue and form them against the anvil, a first sensor for detecting a first parameter of the surgical stapling instrument, and a second sensor to detect a second parameter of the surgical stapling instrument. a motor is coupled to the anvil. the motor is configured to move the anvil from a first position to a second position. a control circuit is coupled to the motor and the first and second sensors. the control circuit is configured to perform an electronic latching process to prevent stapler operation based on the first and second detected parameters.
公开号:BR112020013137A2
申请号:R112020013137-7
申请日:2018-11-14
公开日:2020-12-01
发明作者:Frederick E. Shelton Iv；Chester O. Baxter Iii；Jason L. Harris
申请人:Ethicon Llc；
IPC主号:

专利说明:

[0001] [0001] This patent application claims the benefit of US non-provisional patent application Serial No. 16/182,234 entitled STAPLING
[0002] [0002] The present application claims priority under 35 U.S.C. $119(e) for U.S. Provisional Patent Application No. 62/729,185 entitled POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUT-
[0003] [0003] The present application claims priority under 35 USC$119(e) for US provisional patent application No. 62/659,900, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on June 30, 2018, to the application of provisional US patent No. 62/692,748, entitled SMART ENERGY ARCHITECTURE, filed on June 30, 2018 and to provisional US patent application No. 62/692,768, entitled SMART ENERGY DEVICES, filed on June 30, 2018, whose description of each one of which is incorporated herein by reference in its entirety.
[0004] [0004] The present application claims priority under 35 U.S.C.$
[0005] [0005] The present application also claims priority under 35 USC8$119(e) of US provisional patent application No. 62/650,898 filed March 30, 2018 entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, of provisional US patent application serial no. 62/650,887, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, filed on March 30, 2018, of provisional US patent application serial no. 62/650,882, entitled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed on March 30, 2018, and the provisional US patent application Serial No. 62/650,877, entitled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS, filed on March 30, 2018, whose description of each is incorporated herein by reference in its entirety.
[0006] [0006] The present application also claims priority under 35 USC$ 119(e) of US provisional patent application serial No. 62/640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR, filed on March 8, 2018, and US provisional patent application Serial No. 62/640,415, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR, filed on March 8, 2018, whose respective description is incorporated herein by reference, in its entirety.
[0007] [0007] The present application also claims priority under 35 USC$ 119(e) of US provisional patent application serial No. 62/611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed on December 28, 2017, of the patent application Provisional US Serial No. 62/611,340, entitled CLOUD-BASED MEDICAL ANALYTICS, filed on December 28, 2017, and provisional US Patent Application Serial No. 62/611,339, entitled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28 December 2017, the description of each of which is incorporated herein by way of reference, in its entirety. BACKGROUND OF THE INVENTION
[0008] [0008] The present invention relates to various surgical systems. Surgical procedures are typically performed in theaters or surgical operating rooms in a healthcare facility such as a hospital. A sterile field is typically created around the patient. The sterile field may include brushing team members, who are appropriately dressed, and all furniture and accessories in the area. Various devices and surgical systems are used in the performance of a surgical procedure. SUMMARY OF THE INVENTION
[0009] [0009] In one aspect, the present description provides a surgical stapling instrument. A surgical stapling instrument includes an anvil configured to hold tissue; a stapler configured to drive surgical staples through tissue and form against the anvil; a position sensor coupled to the anvil configured to detect the anvil gap; an anvil-coupled sensor configured to detect tissue compression force; a motor coupled to the anvil, the motor being configured to move the anvil from a first position to a second position; a control circuit coupled to the motor and to the position sensor and to the sensor, and the control circuit is configured to: determine the anvil span; comparing the anvil span to a predetermined span; determine the tissue compression force; compare the strength of
[0010] [0010] In one aspect, the present disclosure provides a surgical stapling instrument. A surgical stapling instrument includes an anvil configured to hold tissue; a stapler configured to drive surgical staples through tissue and form against the anvil; a first sensor for detecting a first parameter of the surgical stapling instrument; a second sensor for detecting a second parameter of the surgical stapling instrument; a motor coupled to the anvil, the motor being configured to move the anvil from a first position to a second position; and a control circuit coupled to the motor and the first and second sensors, the control circuitry being configured to perform an electronic latching process to prevent stapler operation based on the first and second parameters detected. .
[0011] [0011] In yet another aspect, the present disclosure provides a surgical stapling instrument. A surgical stapling instrument includes an anvil configured to hold tissue; a circular stapler configured to drive surgical staples through tissue and form against the anvil; a first sensor for detecting a condition of the surgical stapling instrument; a second sensor for detecting a secondary measurement from the surgical stapling instrument; a motor coupled to the anvil, the motor being configured to move the anvil from a first position to a second position; and a control circuit coupled to the motor and the first and second sensors, the control circuitry being configured to perform an adjustable electronic locking process to prevent actuation of the stapler based on the detected condition and secondary measurement. FIGURES
[0012] [0012] The various aspects described here, both with regard to the organization and the methods of operation, together with objects and additional advantages thereof, can be better understood by referring to the description presented below, considered together with the attached drawings as follows.
[0013] [0013] Figure 1 is a block diagram of an interactive computer-implemented surgical system, in accordance with at least one aspect of the present disclosure.
[0014] [0014] 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.
[0015] [0015] Figure 3 is a central surgical controller paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present description.
[0016] [0016] Figure 4 is a partial perspective view of a central surgical controller housing, and a combination generator module slidably received in a central surgical controller housing, according to at least one aspect of the present description.
[0017] [0017] 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.
[0018] [0018] Figure 6 illustrates different power bus connectors for a plurality of side-coupled ports of a modular side cabinet configured to receive a plurality of modules, in accordance with at least one aspect of the present description.
[0019] [0019] Figure 7 illustrates a vertical modular housing configured to receive a plurality of modules, in accordance with at least one aspect of the present description.
[0020] [0020] Figure 8 illustrates a surgical data network comprising a central modular communication controller configured to connect modular devices located in one or more operating rooms of a healthcare facility, or any environment in a healthcare facility. public services specially equipped for surgical operations, to the cloud, in accordance with at least one aspect of the present description.
[0021] [0021] Figure 9 illustrates an interactive computer-implemented surgical system, in accordance with at least one aspect of the present description.
[0022] [0022] Figure 10 illustrates a central surgical controller comprising a plurality of modules coupled to the modular control tower, in accordance with at least one aspect of the present description.
[0023] [0023] Figure 11 illustrates an aspect of a universal serial bus (USB) network central controller device, in accordance with at least one aspect of the present disclosure.
[0024] [0024] Figure 12 is a block diagram of a cloud computing system comprising a plurality of intelligent surgical instruments coupled to central surgical controllers that can connect to the cloud component of the cloud computing system, in accordance with at least one aspect of the present description.
[0025] [0025] Figure 13 is a functional module architecture of a cloud computing system, according to at least one aspect of the present description.
[0026] [0026] Figure 14 illustrates a diagram of a surgical system with situational awareness, according to at least one aspect of the present description.
[0027] [0027] Figure 15 is a timeline representing the situational recognition of a central surgical controller, in accordance with at least one aspect of the present description.
[0028] [0028] Figure 16 illustrates a logic diagram of a surgical instrument or tool control system, according to at least one aspect of the present description.
[0029] [0029] Figure 17 illustrates a control circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present description.
[0030] [0030] Figure 18 illustrates a combinational logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present description.
[0031] [0031] Figure 19 illustrates a sequential logic circuit configured to control aspects of the surgical instrument or tool, in accordance with at least one aspect of the present description.
[0032] [0032] Figure 20 illustrates a surgical instrument or tool comprising a plurality of motors that can be activated to perform various functions, in accordance with at least one aspect of the present description.
[0033] [0033] Figure 21 is a schematic diagram of a surgical instrument configured to operate a surgical tool described therein, in accordance with at least one aspect of the present disclosure.
[0034] [0034] Figure 22 illustrates a block diagram of a surgical instrument configured to control various functions, in accordance with at least one aspect of the present description.
[0035] [0035] Figure 23 is a schematic diagram of a surgical instrument configured to control various functions, in accordance with at least one aspect of the present disclosure.
[0036] [0036] Figure 24 represents a perspective view of a circular stapling surgical instrument, in accordance with at least one aspect of the present description.
[0037] [0037] Figure 25 represents an exploded view of the handle and drive shaft assemblies of the instrument of Figure 24, in accordance with at least one aspect of the present description.
[0038] [0038] Figure 26 represents a cross-sectional view of the instrument handle assembly of Figure 24, according to at least one aspect of the present description.
[0039] [0039] Figure 27 represents an enlarged partial cross-sectional view of the motor and battery assemblies of Figure 24, according to at least one aspect of the present description.
[0040] [0040] Figure 28A represents a side elevation view of an operational mode selection assembly of the instrument of Figure 24, with a first gear disengaged from a second gear, in accordance with at least one aspect of the present description.
[0041] [0041] Figure 28B represents a side elevation view of the operating mode selector assembly of Figure 28A, with the first gear engaged with the second gear, in accordance with at least one aspect of the present description.
[0042] [0042] Figure 29A represents an enlarged longitudinal cross-sectional view of a stapling head assembly of the instrument of Figure 24 showing an anvil in an open position, in accordance with at least one aspect of the present disclosure.
[0043] [0043] Figure 29B represents an enlarged longitudinal sectional view of the stapling head assembly of Figure 29A showing the anvil in a closed position, in accordance with at least one aspect of the present disclosure.
[0044] [0044] Figure 29C represents an enlarged longitudinal cross-sectional view of the stapling head assembly of Figure 29A showing a staple driver and a blade in a fired position, in accordance with at least one aspect of the present disclosure.
[0045] [0045] Figure 30 represents an enlarged partial cross-sectional view of a clamp formed against the anvil, in accordance with at least one aspect of the present description.
[0046] [0046] Figure 31 is a graphical representation of a first pair of graphs depicting anvil span and tissue compression force as a function of time for illustrative shots of a stapling instrument, in accordance with at least one aspect of the present description.
[0047] [0047] Figure 32 is a graphical representation of a second pair of graphs depicting anvil span and tissue compression force as a function of time for illustrative shots of a stapling instrument, in accordance with at least one aspect of the present description.
[0048] [0048] Figure 33 is a schematic diagram of a motor-equipped circular clipping device illustrating valid fabric span, actual span, normal swath span, and out of sash span, in accordance with at least an aspect of the present description.
[0049] [0049] Figure 34 is a logic flow diagram of a process that represents a control program or a logic configuration to provide discretionary or mandatory latches according to detected parameters compared to limits, according to at least one aspect of the present description.
[0050] [0050] Figure 35 is a diagram illustrating a range of fabric spans and resulting staple shapes, in accordance with at least one aspect of the present disclosure.
[0051] [0051] Figure 36 is a graphical representation of three force-to-close (FTC) curves as a function of time, in accordance with at least one aspect of the present description.
[0052] [0052] Figure 37 is a detailed graphical representation of a force-to-close (FTC) curve as a function of time, in accordance with at least one aspect of the present description. DESCRIPTION
[0053] [0053] The applicant of the present application holds the following US patent applications, filed on November 6, 2018, the description of each being incorporated herein by reference, in their entirety: * US patent application No. 16 /182.224, entitled SURGICAL NETWORK, INSTRUMENT, AND CLOUD RESPONSES BASED ON
[0054] [0054] The applicant of the present application holds the following US patent applications filed on September 10, 2018, the description of each being incorporated herein by reference, in its entirety: * US Provisional Patent Application No. 62 /729,183, entitled A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK
[0055] [0055] The applicant of the present application holds the following US Patent Application Nos., filed on August 28, 2018, the description of each being incorporated herein by reference in its entirety: * US Patent Application No. 16 /115,214, entitled ESTIMATING
[0056] [0056] The applicant of the present application holds the following US patent applications, filed on August 23, 2018, the description of each being incorporated herein by reference in its entirety: * US Provisional Patent Application No. 62/721,995, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION; * US Provisional Patent Application No. 62/721,998, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS; * US Provisional Patent Application No. 62/721,999, entitled IN-
[0057] [0057] The applicant of the present application holds the following US patent applications, filed on June 30, 2018, the description of each of which is incorporated herein by reference in its entirety: * US Provisional Patent Application No. 62/692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE; * US Provisional Patent Application No. 62/692,748, entitled SMART ENERGY ARCHITECTURE; and * US Provisional Patent Application No. 62/692,768, entitled SMART ENERGY DEVICES.
[0058] [0058] The applicant of the present application holds the following US patent applications, filed on June 29, 2018, the description of each of which is incorporated herein by reference in its entirety: * US patent application no. serial 16/024,090, entitled CA-
[0059] [0059] The applicant of the present application holds the following US provisional patent applications, filed on June 28, 2018, the description of each of which is incorporated herein by reference in their entirety:
[0060] [0060] The applicant of the present application holds the following US provisional patent applications, filed on April 19, 2018, the description of each of which is incorporated herein by reference in their entirety: * US provisional patent application serial no. 62/659,900, entitled METHOD OF HUB COMMUNICATION.
[0061] [0061] The applicant of the present application holds the following provisional US patent applications, filed on March 30, 2018, the description of each of which is incorporated herein by reference in its entirety: * US Provisional Patent Application No. 62/650,898 filed March 30, 2018 entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS; * US Provisional Patent Application Serial No. 62/650,887, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES; * US Provisional Patent Application Serial No. 62/650,882, entitled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and * US Provisional Patent Application Serial No. 62/650,877 entitled SURGICAL SMOKE EVACUATION SENSING AND CONTROLS.
[0062] [0062] The applicant of the present application holds the following US patent applications, filed on March 29, 2018, the description of each of which is incorporated herein by reference in its entirety: * US patent application no. serial 15/940,641 entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES; * US Patent Application Serial No. 15/940,648 entitled IN-
[0063] [0063] The applicant of the present application holds the following provisional US patent applications, filed on March 28, 2018, the description of each of which is incorporated herein by reference in their entirety:
[0064] [0064] The applicant of the present application holds the following provisional US patent applications, filed on March 8, 2018, the description of each of which is incorporated herein by reference in its entirety: * US Provisional Patent Application No. serial 62/640,417 entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR; and * US Provisional Patent Application Serial No. 62/640,415 entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.
[0065] [0065] The applicant of the present application holds the following provisional US patent applications, filed on December 28, 2017, the description of each of which is incorporated herein by reference in its entirety: * Application for US Provisional Patent Serial No. 62/611,341 entitled INTERACTIVE SURGICAL PLATFORM; * US provisional patent application serial no. 62/611,340, entitled CLOUD-BASED MEDICAL ANALYTICS; and * US Provisional Patent Application Serial No. 62/611,339,
[0066] [0066] 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 in the attached description. The illustrative examples may be implemented or incorporated in other aspects, variations and modifications, and may be practiced or performed in a variety of ways. Furthermore, except where otherwise indicated, the terms and expressions used in the present invention have been chosen for the purpose of describing the illustrative examples for the convenience of the reader and not for the purpose of limiting the same. In addition, it is to be understood that one or more of the aspects, aspect expressions, and/or examples described below may be combined with any one or more of the other aspects, aspect expressions, and/or examples described below. Central surgical controllers
[0067] [0067] Referring to Figure 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., cloud 104 which may include a remote server 113 coupled to a device storage 105). Each surgical system 102 includes at least one central surgical controller 106 communicating with the cloud 104 which may include a remote server 113. In one example, as illustrated in Figure 1, the surgical system 102 includes a display system 108, a robotic system 110, a handheld surgical instrument, and smart 112 that are configured to communicate with each other and/or the central controller 106. In some aspects, a surgical system 102 may include a number M of central controllers 106, a N number of visualization systems 108, an O number of robotic systems
[0068] [0068] In various aspects, the smart instruments 112 as described herein with reference to Figures 1 to 7 can be implemented as a circular stapling device equipped with 201800 (Figures 24 to 30) and 202080 (Figures 31 to 30) engine. 37). Smart instruments 112 (e.g. devices 12 to 1h) such as the motor-equipped circular stapling device 201800 (Figures 24 to 30) and 202080 (Figures 31 to 37) are configured to operate on a surgical data network 201, as described with reference to Figure 8.
[0069] [0069] Figure 2 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 the surgical system 102. The robotic system 110 includes a surgeon's console 118, a patient carriage 120 (surgical robot), and a robotic central surgical controller 122. The patient carriage 120 can manipulate at least one detachably attached surgical tool 117 through a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. An image of the surgical site may be obtained by a medical imaging device 124, which can be manipulated by patient cart 120 to orient imaging device 124. Robotic central controller 122 can be used to process the images. from the surgical site for subsequent display to the surgeon via the surgeon's console 118.
[0070] [0070] Other types of robotic systems can be readily adapted for use with the Surgical System 102. Several examples of robotic systems and surgical instruments that are suitable for use with the present description are described in Provisional Patent Application Serial No. 62 /611,339, titled ROBOT ASSISTED SURGICAL PLATFORM, filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.
[0071] [0071] Several examples of cloud-based analysis that are performed by cloud 104, and 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 way of reference, in its entirety.
[0072] [0072] In various aspects, the imaging device 124 includes at least an Image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.
[0073] [0073] 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.
[0074] [0074] One or more lighting sources can be configured to radiate electromagnetic energy in the visible spectrum as well as 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 may be called visible light or simply light. A typical human eye will respond to wavelengths in air that are from about 380 nm to about 750 nm.
[0075] [0075] The invisible spectrum (ie the non-luminous spectrum) is that portion of the electromagnetic spectrum lying below and above the visible spectrum (ie wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths longer than about 750 nm are longer than the visible red spectrum, and they become invisible infrared (IR), microwave, radio, and electromagnetic radiation. Wavelengths shorter than about 380 nm are shorter than the ultraviolet spectrum, and they become invisible ultraviolet, x-ray, and gamma-ray electromagnetic radiation.
[0076] [0076] In many respects, the 124 imaging device 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, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagus-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and ureteroscope.
[0077] [0077] In one aspect, the imaging device uses multi-spectrum monitoring to discriminate topography and underlying structures. A multispectral image is one that captures image data within wavelength ranges along the electromagnetic spectrum. Wavelengths can be separated by filters or through the use of instruments that are sensitive to specific wavelengths, including light of frequencies beyond the visible light range, eg IR and ultraviolet light. Spectral images can allow the extraction of additional information that the human eye cannot capture with its red, green and blue color receptors. The use of multispectral imaging is described in greater detail under the title "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62/611,341 entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017 , the description of which is incorporated herein by way of 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 previously described tests on treated tissue.
[0078] [0078] 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 the imaging device 124 and its connectors and components. It will be understood that the sterile field may be considered a specified area, such as inside a tray or over a sterile towel, which is considered to be free of microorganisms, or the sterile field may be considered an area, immediately around a patient, that has been prepared for a surgical procedure. The sterile field may include the brushing team members, who are properly dressed, and all furniture and accessories in the area.
[0079] [0079] 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 with respect to the field. sterile, as illustrated in Figure 2. In one aspect, the visualization system 108 includes an interface for HL7, PACS and EMR. Various components of the visualization system 108 are described under the title "Advanced Imaging Acquisition Module" in US Provisional Patent Application Serial No. 62/611,341 entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, the description of which is here incorporated by way of reference in its entirety.
[0080] [0080] As illustrated in Figure 2, a primary screen 119 is positioned in the sterile field to be visible to the operator at the operating table 114. In addition, a viewing tower 111 is positioned outside the sterile field. Viewing tower 111 includes a first non-sterile screen 107 and a second non-sterile screen 109, which are opposite each other. The display system 108, guided by the central controller 106, is configured to use screens 107, 109, and 119 to coordinate the flow of information for operators in and out of the sterile field. For example, the central controller 106 may cause the visualization system 108 to 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 transmission to the live view of the surgical site on the main screen 119. The non-sterile screen snapshot 107 or 109 may allow a non-sterile operator to perform a diagnostic step relevant to the surgical procedure, for example.
[0081] [0081] In one aspect, the central controller 106 is also configured to route diagnostic input or feedback by a non-sterile operator at the viewing tower 111 to the primary screen 119 within the sterile field, where it can be viewed by a sterile operator on the operating table. In one example, the input 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 the main screen 119 by the central controller 106.
[0082] [0082] With reference to Figure 2, a surgical instrument 112 is being used in the surgical procedure as part of the surgical system
[0083] [0083] Now referring to Figure 3, a central controller 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld smart surgical instrument
[0084] [0084] During a surgical procedure, the application of energy to the tissue, for sealing and/or cutting, is usually 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 lost 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 modular housing of the 136 central controller provides a unified environment to manage power, data and fluid lines, which reduces the frequency of interleaving between such lines.
[0085] [0085] Aspects of the present description feature a central surgical controller for use in a surgical procedure that involves the application of energy to tissue at a surgical site. The central surgical controller includes a central controller housing and a combination generator module slidably received in a docking station of the central controller housing. The docking station includes data and power contacts. The combined generator module includes two or more of an ultrasonic power generating component, a bipolar RF power generating component, and a monopolar RF power generating component that 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 for connecting the combined generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid , and/or the particulates generated by the application of therapeutic energy to tissue, and a fluid line that extends from the remote surgical site to the smoke evacuation component.
[0086] [0086] 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 slidably received in the housing of the central controller. In one aspect, the central controller housing comprises a fluid interface.
[0087] [0087] 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 tissue, while a different type of energy may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue while an ultrasonic generator can be used to cut sealed tissue. Aspects of the present description present a solution in which a modular housing of the central controller 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the central modular housing 136 is that it allows for rapid removal and/or replacement of multiple modules.
[0088] [0088] Aspects of the present description feature a modular surgical sheath for use in a surgical procedure that involves application of energy to tissue. The modular surgical housing includes a first power generating module configured to generate a first power for application to tissue, and a first docking station comprising a first docking port that includes first data and power contacts, the first grinding wheel being - the power generator module is slidingly movable in an electrical coupling with the power and data contacts and the first power generating module being slidingly movable out of the electrical coupling with the first power and data contacts.
[0089] [0089] In addition to the above, the modular surgical sheath also includes a second power generator module configured to generate a second power, different from the first power, for application to tissue, and a second docking station that comprises There is a second coupling port that includes second data and power contacts, the second power generating module being slidingly movable in electrical engagement with the power and data contacts, and the second module being power generator is slidingly movable out of electrical coupling with the second power and data contacts.
[0090] [0090] In addition, the modular surgical cabinet also includes a communication bus between the first docking port and the second docking port, configured to facilitate communication between the first power generating module and the second power generating module. .
[0091] [0091] With reference to Figures 3 to 7, aspects of the present description are presented for a modular housing of the central controller 136 that allows the modular integration of a generator module 140, a smoke evacuation module 126, and a suction/irrigation module 128. The central modular housing 136 further facilitates interactive communication between modules 140, 126, 128. As illustrated in Figure 5, generator module 140 can be a generator module with single-pole components, integrated bipolar and ultrasonic devices, supported in a single cabinet unit 139 sliderable into the central modular housing 136. As illustrated in Figure 5, the generator module 140 can be configured to connect to a monopolar device 146, a bipolar device 147 and an ultrasonic device 148. Alternatively, generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules that interact across the central modular housing 136. The central modular housing 136 can be configured to facilitate the insertion of multiple generators and interactive communication between the generators anchored in the central modular housing 136 so that the generators would act as a single generator.
[0092] [0092] In one aspect, the central modular housing 136 comprises a modular power and communication backplane 149 with external and wireless communication heads to allow removable attachment of modules 140, 126, 128 and interactive communication. among them.
[0093] [0093] In one aspect, the central modular housing 136 includes docking stations, or drawers, 151, here also called drawers, which are configured to slide-receive modules 140, 126, 128. Figure 4 illustrates a partial perspective view of a central surgical controller housing 136, and a combined generator module 145 slidably received in a docking station 151 of the central surgical controller housing 136. A docking port 152 with power and data contacts on a rear side of the combined generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of a corresponding docking station 151 of the central controller modular housing 136 as the combined generator module 145 is slid into position in the corresponding docking station 151 of the central controller modular housing 136. In one aspect, the combined generator module 145 includes a bipolar, ultrasonic and monopolar module and a smoke evacuation module integrated into a single bay unit 139, as illustrated in Figure 5.
[0094] [0094] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that transports trapped smoke/fluid collection away from a surgical site and to, for example, the smoke evacuation module 126. Vacuum suction originating from the smoke evacuation module 126 can draw smoke into an opening of a utility conduit in the surgical site. The utility conduit, coupled to the fluid line, may be in the form of a flexible tube terminating at the smoke evacuation module 126. The utility conduit and fluid line define a fluid path that extends toward the smoke evacuation module 126 which is received in the housing of the central controller 136.
[0095] [0095] In various aspects, the suction/irrigation module 128 is coupled to a surgical tool comprising a fluid aspiration 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.
[0096] [0096] In one aspect, the surgical tool includes a drive shaft that has an end actuator at a distal end thereof and at least one energy treatment associated with the end actuator, a suction tube, and a irrigation tube. The suction tube may have an inlet port at a distal end thereof and the suction tube extends through the drive shaft. Similarly, an irrigation tube may extend through the drive shaft and may have an inlet port near the power application implement. The power delivery 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.
[0097] [0097] The irrigation tube can be in fluid communication with a source of fluid, and the suction tube can be in fluid communication with a vacuum source. The fluid source and/or the vacuum source may be housed in the suction/irrigation module 128. In one example, the fluid source and/or the vacuum source may be housed in the housing of the central controller 136 separately from the suction/irrigation module 128. In such an example, a fluid interface may be configured to connect the suction/irrigation module 128 to the fluid source and/or the vacuum source.
[0098] [0098] In one aspect, the modules 140, 126, 128 and/or their corresponding docking stations in the central modular housing 136 may include alignment features that are configured to align the docking ports of the modules in engagement with each other. their counterparts in the central modular housing docking stations
[0099] [0099] In some respects, the units 151 of the central modular housing 136 are the same or substantially the same size, and the modules are adjusted in size to be received in the units 151. For example, the side supports 155 and/or 156 can be larger or smaller depending on the module size. In other respects, the 151 drawers are different in size and are each designed to accommodate a specific module.
[0100] [0100] In addition, the contacts of a specific module can be keyed to engage with the contacts of a specific unit to avoid inserting a module into a unit with contact mismatch.
[0101] [0101] As illustrated 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 modules housed in the central modular housing 136. The docking ports 150 of the central modular housing 136 may alternatively or additionally facilitate interactive wireless communication between modules housed in the central modular housing 136. Any suitable wireless communication may be used, such as, for example, Air Titan-Bluetooth.
[0102] [0102] Figure 6 illustrates individual power bus connectors for a plurality of side docking ports of a modular side compartment 160 configured to receive a plurality of modules from a central surgical controller 206. The modular compartment side 160 is configured to receive and laterally interconnect modules 161. Modules 161 are slidably inserted into docking stations 162 of side modular compartment 160, which includes a backplate for interconnecting modules 161. As illustrated in Figure 6, modules 161 are arranged sideways in a modular side cabinet 160. Alternatively, modules 161 can be arranged vertically in a modular side cabinet.
[0103] [0103] 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. , which includes a back panel for interconnecting modules 165. Although the drawers 167 of the vertical modular cabinet 164 are arranged vertically, in certain cases, a modular vertical cabinet 164 may include drawers that are disposed laterally. In addition, the modules 165 can interact with each other through the docking ports of the vertical modular cabinet 164. In the example of Figure 7, a screen 177 is provided to show data relevant to the operation of the modules 165. In addition, the vertical modular compartment 164 includes a master module 178 that houses a plurality of submodules that are slidably received in the master module 178.
[0104] [0104] In many 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 housing that can be assembled with a light source module and a camera module. The compartment can be a disposable compartment. In at least one example, the disposable housing is detachably coupled to a reusable controller, a light source module, and a camera module. The light source module and/or the camera module can be selectively chosen 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 to image the scanned beam. Similarly, the light source module can be configured to provide either a white light or a different light depending on the surgical procedure.
[0105] [0105] 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 replacement of a light source module or a midstream camera module during a surgical procedure, without the need to remove the imaging device. of the surgical field.
[0106] [0106] In one aspect, the imaging device comprises a tubular housing that includes a plurality of channels. A first channel is configured to slide in the Camera module, which can be configured to snap-fit with the first channel. A second channel is configured to slide-receive the camera module, which can be configured to snap-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 hitch can be used instead of a snap fit.
[0107] [0107] In several examples, multiple imaging devices are placed in different positions in the surgical field to provide multiple views. The imaging module 138 can be configured to switch between imaging devices to provide an optimal view. In various aspects, the imaging module 138 can be configured to integrate images from different imaging devices.
[0108] [0108] Various image processors and imaging devices suitable for use with the present disclosure are described in US Patent No. 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, issued August 9, 2011 which is incorporated herein as a reference in its entirety. In addition, U.S. Patent No. 7,982,776 entitled SBI MOTION ARTI-FACT REMOVAL APPARATUS AND METHOD, issued July 19, 2011, which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts. - ment of image data. Such systems can be integrated with the imaging module 138. In addition, the publication of US patent application No. 2011/0306840, entitled CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS, published on December 15, 2011, and the publication of the application for US Patent No. 2014/0243597, entitled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published August 28, 2014, which are each incorporated herein by reference in their entirety.
[0109] [0109] 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 which a utility facility specially equipped for surgical operations, to a cloud-based system (e.g., 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 network central controller 207 and/or a network switch 209 in communication with a network router. The modular communication central controller 203 may 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 data, allowing data to be transmitted from one device (or segment) to another and to cloud computing resources. An intelligent surgical data network includes facilities to allow traffic to pass through the surgical data network to be monitored and to configure each port on the network central controller 207 or network switch 209. An intelligent surgical data network can be call from a central controller or controllable switch. A central switching controller reads the destination address of each packet and then forwards the packet to the correct port.
[0110] [0110] Modular devices 1a to 1n located in the operating room can be coupled to the central modular communication controller 203. The central network controller 207 and/or the network switch 209 can be coupled to a network router 211 to connect devices 1a to 1n to the cloud 204 or to the local computer system 210. Data associated with devices 1a to 1h can be transferred to cloud-based computers via the router for remote data processing and manipulation. Data associated with devices 1a to 1n may also be transferred to local computer system 210 for processing and manipulation of local data. Modular devices 2a to 2m located in the same operating room can also be coupled to a network switch 209. The network switch 209 can be coupled to the network central controller 207 and/or network router 211 to connect the 2a a 2m to cloud 204. Data associated with devices 2a to 2n can be transferred to cloud 204 via network router 211 for data processing and manipulation. Data associated with devices 2a to 2m may also be transferred to the local computer system 210 for processing and manipulation of the local data.
[0111] [0111] It will be understood that the surgical data network 201 may be expanded by interconnecting the multiple network core controllers 207 and/or the multiple network switches 209 with multiple network routers 211. tar contained in a modular control tower configured to receive multiple devices 1a to 1n/2a to 2m. The local computer system 210 may also be contained in a modular control tower. The modular communication central controller 203 is connected to a screen 212 to show the images obtained by some of the devices 1a to 1n/2a to 2m, for example, during surgical procedures. In various aspects, devices 1a to 1n/2a to 2m may include, for example, various modules such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction/irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device coupled to a screen and/or a sensor module without contact, among other modular devices that can be connected to the modular communication center 203 of the surgical data network 201.
[0112] [0112] In one aspect, the surgical data network 201 may comprise a combination of central network controller(s), network switches, and network routers that connect 1a to 1n/2a devices. at 2m to the cloud. Any or all 1a to 1n/2a to 2m devices coupled to the network central 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 relies on sharing computing resources rather than 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 central communication controller. modular communication 203 and/or computer system 210 located in the operating room (e.g., a fixed, mobile, temporary room or space, or field of operation) and devices connected to the modular communication central controller 203 and/or the system computer 210 via the Internet. 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 1a to 1n/2a to 2m devices located in one or more operating rooms.
[0113] [0113] By applying cloud computer data processing techniques to data collected by 1a to 1n/2a to 2m devices, the surgical data network provides better surgical outcomes, reduced costs, and better customer satisfaction. part of the patient. At least some of the 1a to 1n/2a to 2m devices can be used to view tissue states to assess the occurrence of leaks or perfusion of sealed tissue after a tissue sealing and cutting procedure. At least some of the 1a to 1n/2a to 2m devices can be used to identify pathology, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes confirmation of tissue location and margin and phenotypes. At least some of the 1a to 1n/2a to 2m devices 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. Data collected by devices 1a to 1n/2a to 2m, including image data, can be transferred to the cloud 204 or the local computer system 210 or both for data processing and manipulation including data processing. image processing and manipulation. Data can be analyzed to improve surgical procedure outcomes by determining whether additional treatment, such as application of endoscopic intervention,
[0114] [0114] In one implementation, OR devices 1a to 1n can be connected to the central modular communication controller 203 via a wired or wireless channel depending on the configuration of devices 1a to 1h in a controller network center. 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 network central controller provides connectivity to devices 1a to 1n located on the same network as the OR. The central network controller 207 collects data in the form of packets and sends them to the router in "half duplex" mode. The network central controller 207 does not store any media access control/Internet protocol (MAC/IP) to transfer the device data. Only one of the devices 1a to 1n at a time can send data through the network central controller 207. The network central 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 the cloud 204. The central network controller 207 can detect basic network errors such as collisions, but having all (assuming that) the information transmitted to multiple input ports can be a safety risk and cause bottlenecks.
[0115] [0115] In another implementation, operating room devices 2a to 2m can be connected to a network switch 209 via a wired or wireless channel. The network switch 209 works at the data connection layer of the OSI model. Network switch 209 is a multicast device for connecting devices 2a to 2m located in the same operation center to the network. Network switch 209 sends data in the form of frames to network router 211 and operates in full duplex mode. Multiple devices 2a to 2m can send data at the same time through network switch 209. Network switch 209 stores and uses MAC addresses of devices 2a to 2m to transfer data.
[0116] [0116] Network central controller 207 and/or network switch 209 are coupled to network router 211 for a connection to cloud 204. Network router 211 operates at the network layer of the OSI model. Network router 211 creates a route to transmit data packets received from network central controller 207 and/or network switch 211 to a cloud-capable computer for further processing and manipulation of data collected by anyone. or all devices 1a to 1n/ 2a to 2m. Network Router 211 can be used to connect two or more different networks located in different locations, such as different operating rooms in the same healthcare facility or different networks located in different operating rooms in different facilities. of health services. The network router 211 sends data in the form of packets to the cloud 204 and operates in full duplex mode. Multiple devices can send data at the same time. Network router 211 uses |P addresses to transfer data.
[0117] [0117] In one example, the network central controller 207 can be implemented as a USB central controller, which allows multiple USB devices to be connected to a host computer. The USB central controller can expand a single USB port to several levels so that there are more ports available for connecting devices to the system's host computer. The central network controller 207 may include wired or wireless capabilities to receive information about a wired channel or a wireless channel. In one aspect, a wireless short-range, broadband, wireless radio communication protocol wireless USB can be used for communication between devices la to In and devices 2a to 2m situated in the living room. surgery.
[0118] [0118] In other examples, OR devices 1a to 1n/2a to 2m can communicate with the 203 modular communication central controller via standard wireless Bluetooth technology for exchanging data over short distances ( using short-wavelength UHF radio waves in the 2.4 to 2.485 GHz ISM band) from fixed and mobile devices and building personal area networks (PANs). In other respects, OR devices 1a to 1n/2a to 2m can communicate with the 203 modular communication central controller via a number of wireless and wired communication standards or protocols, including but not limited to limited to, Wi-Fi (IEZE 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 may 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.
[0119] [0119] The modular communication central controller 203 can serve as a central connection for one or all of the 1a to 1n/2a to 2m operating room devices and handles a type of data known as frames. Frames carry the data generated by devices 1a to 1n/2a to 2m. When a frame is received by the central modular communication controller 203, it is amplified and transmitted to the network router 211, which transfers the data to cloud computing resources using a series of wireless communication standards or protocols. or wired, as described in the present invention.
[0120] [0120] Modular Communications Core Controller 203 can be used as a standalone device or be connected to compatible network core controllers and network switches to form a larger network. The 203 Modular Communications Central Controller is generally easy to install, configure, and maintain, making it a good choice for the OR network of 1a to 1n/2a to 2m devices.
[0121] [0121] Figure 9 illustrates an interactive, computer-implemented surgical system 200. The interactive, computer-implemented surgical system 200 is similar in many ways to the interactive, computer-implemented surgical system 100. For example, the interactive, computer-implemented surgical system 200 is similar in many respects to the interactive, computer-implemented surgical system. , computer-implemented 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 that may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 comprises a modular control tower 236 connected to multiple operating room devices such as, for example, smart surgical instruments, robots, and other computerized devices located in the operating room. As shown in Figure 10, the modular control tower 236 comprises a central modular communication controller 203 coupled to a computer system 210. As illustrated in the example of Figure 9, the modular control tower 236 is coupled to a module of communication. imaging 238 that is coupled to an endoscope 239, a generator module 240 that is coupled to a power device 241, a smoke evacuation module 226, a suction/irrigation module 228, a communication module 230, a module processor 232, a storage array 234, an intelligent device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. Operating room devices are coupled to cloud computing capabilities. and data storage via modular control tower 236. Robotic central controller 222 can also be connected to modular control tower 236 and cloud computing resources. Devices/Instruments 235, visualization systems 208, among others, can be coupled to the modular control tower 236 through wired or wireless communication standards or protocols, as described in the present invention. Modular control tower 236 can be coupled to a central controller display 215 (e.g., monitor, display) to display and overlay images received from the imaging module, device/instrument display, and/or other imaging systems. view 208. The central controller screen can also display data received from devices connected to the modular control tower together with images and overlay images.
[0122] [0122] 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 modular communication controller 203, for example, a device network connectivity, and a computer system 210 to provide local processing, display, 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 (e.g. devices) that can be connected to the modular communication central controller 203 and transfer data associated with the modules to the 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 upstream central controller/network switch is connected to a processor to provide a communication link to cloud computing resources and a local display 217. Communication to the cloud 204 may be via a communication channel. wired or wireless.
[0123] [0123] The central surgical controller 206 uses 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 laser or ultrasonic measurement devices. An ultrasound-based non-contact sensor module scans the operating room by transmitting an ultrasound burst and receiving the echo as it bounces off the perimeter of an operating room walls, as described under the heading "Surgical Hub Spatial Awareness Within an Operating Room" in US Provisional Patent Application Serial No. 62/611,341, entitled INTERACTIVE SURGICAL PLATFORM, filed December 28, 2017, which is incorporated herein by reference in full. - suchity, in which the sensor module is configured to determine the size of the operating room and adjust the limits of the Bluetooth pairing distance. A laser-based non-contact sensor module scans the operating room by transmitting pulses of laser light, receiving pulses of laser light that bounce off the perimeter walls of the operating room, and comparing the phase of the transmitted pulse to the received pulse. to determine the size of the operating room and to adjust the Bluetooth pairing distance limits, for example.
[0124] [0124] The computer system 210 comprises a processor 244 and a network interface 245. The processor 244 is coupled to a communication module 247, storage 248, memory 249, non-volatile memory 250, and input/output interface. 251 over 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 local bus using any variety of available bus architectures including , but not limited to, 9-bit bus, Industry Standard Architecture (ISA), Micro-Charmel Architecture (MSA), Extended ISA (EISA), Smart Drive Electronics (IDE), VESA Local Bus (VLB) , Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), POMCIA (Personal Computer Memory Card International Association) bus, Personal Computer Memory Card International Association Small Computer Systems (SCSI), or any other proprietary bus.
[0125] [0125] The 244 processor can be any single-core or multi-core processor, such as those known under the tradename ARM Cortex available from Texas Instruments. In one aspect, 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 prefetch 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 the StellarisWareO program, memory only programmable and electrically erasable readout (EEPROM), one or more pulse width modulation (PWM) modules,
[0126] [0126] In one aspect, the 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 safety critical applications IEC 61508 and ISO 26262, among others, to provide advanced built-in safety features while providing scalable performance, connectivity and memory options.
[0127] [0127] System memory includes volatile memory 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 nonvolatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. Additionally, RAM is available in many forms such as SRAM, Dynamic RAM (DRAM), Synchronous DRAM (SDRAM), Double Data Rate SDRAM (DDR SDRAM), Enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and Direct RAM Rambus RAM (DRRAM).
[0128] [0128] 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).
[0129] [0129] It is to be understood that the computer system 210 includes software that acts as an intermediary between the users and the basic computer resources 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 management capabilities by the operating system through program modules and “program data stored in system memory or on the storage disk. It should be noted that several components described here can be implemented with various operating systems or combinations of operating systems.
[0130] [0130] A user enters commands or information into the computer system 210 through the input device(s) coupled to the 1/O interface 251. Input devices include, but are not limited to, a pointing device 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). 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, displays, 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 connecting the output device to the system bus. It should be noted that other devices and/or device systems, such as remote computers, provide input and output capabilities.
[0131] [0131] 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. Remote cloud computers can be a personal computer, server, router, networked personal computer, workstation, microprocessor-based device, peer device, or other common network node, and the like, and typically include many or all elements described in relation to the computer system. For the sake of brevity, only one memory storage device is illustrated with the remote computer. Remote computers are logically connected to the computer system through a network interface and then physically connected through a communication link. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE
[0132] [0132] In various aspects, the computer system 210 of Figure 10, the imaging module 238 and/or the visualization system 208, and/or the processor module 232 of Figures 9 to 10, may comprise a 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 instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) technologies to increase speed and efficiency. The digital image processing engine can perform a number of tasks. The image processor can be a system on an integrated circuit with a multi-core processor architecture.
[0133] [0133] 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 may also be external to the computer system 210. Hardware/software required for connection to the network interface includes, for purposes only illustrative, internal and external technologies such as modems, including regular serial telephone modems, cable modems and DSL modems, ISDN adapters and Ethernet cards.
[0134] [0134] In various aspects, the devices/instruments 235 described with reference to Figures 9 to 10 can be implemented as a motor-equipped circular stapling device.
[0135] [0135] Figure 11 illustrates a functional block diagram of an aspect of a USB 300 network central controller device, in accordance with at least one aspect of the present disclosure. In the illustrated aspect, the USB 300 network central controller device uses a TUSB2036 integrated circuit central controller available from Texas Instruments. The USB 300 Network Central Controller is a CMOS device that provides one USB upstream transceiver port 302 and up to three USB downstream transceiver ports 304, 306, 308 in compliance with the USB 2.0 specification. Upstream USB transceiver port 302 is a differential data root port comprising a "minus" differential data input (DMO) paired with a "plus" differential data input (DPO). The three downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including "plus" differential data outputs (DP1-DP3) paired with "minus" differential data outputs (DM1-DP3). DM3).
[0136] [0136] The USB 300 network central controller device is implemented with a digital state machine instead of a microcontroller, and no firmware programming is required. Fully compatible USB transceivers are integrated in the loop for USB upstream transceiver port 302 and all USB downstream transceiver ports 304, 306, 308. USB downstream transceiver ports 304, 306, 308 support both full-speed and low-speed devices by automatically setting the scan rate according to the speed of the device attached to the ports. The USB 300 network central controller device can be configured in either bus-powered or self-powered mode and includes 312 central power logic to manage power.
[0137] [0137] The USB 300 Network Central Controller Device includes a 310 Serial Interface Engine (SIE). The SIE 310 is the hardware front end of the USB 300 network central controller and handles most of the protocol described in Chapter 8 of the USB specification. The SIE 310 typically understands 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, non-return data encoding/decoding to inverted zero (NRZI), CRC generation and verification (token and data), packet ID (PID) generation and verification/decoding, and/or serial-parallel/parallel-series conversion. The 310 receives a clock input 314 and is coupled to a suspend/resume and frame timer logic circuit 316 and a repeater circuit of the central controller 318 to control communication between the USB upstream transceiver port 302 and downstream USB transceiver ports 304, 306, 308 via the logic circuits of ports 320, 322, 324. The SIE 310 is coupled to a command decoder 326 via the logic interface to control the commands of a serial EEPROM via a 330 series EEPROM interface.
[0138] [0138] In many respects, the USB 300 network central controller can connect 127 functions configured in up to six logical layers (levels) to a single computer. In addition, the USB 300 network central controller can connect all peripherals using a standard four-wire cable that provides both communication and power distribution. Power settings are bus-powered and self-powered modes. The USB 300 network central controller can be configured to support four power management modes: a bus-powered central controller, with single port power management or grouped port power management, and the self-powered central controller, with single port power management or grouped port power management. In one aspect, with the use of a USB cable, the USB network core controller 300, the USB upstream transceiver port 302 is plugged into a USB host controller, and the USB downstream transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, and so on.
[0139] [0139] Additional details regarding the structure and function of the central surgical controller and/or networks of central surgical controllers can be found in US provisional patent application No. 62/659,900, entitled METHOD OF HUB COMMUNICATION, filed in 19 April 2018, which is hereby incorporated by way of reference, in its entirety. Cloud system hardware and functional modules
[0140] [0140] Figure 12 is a block diagram of the computer-implemented interactive surgical system, in accordance with 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.
[0141] [0141] In addition, the 7012 surgical instruments may comprise transceivers for transmitting data to and from their corresponding 7006 central surgical controllers (which may also comprise transceivers). Combinations of 7012 surgical instruments and corresponding 7006 central controllers can point to specific locations, such as operating rooms in healthcare facilities (eg, hospitals), to provide medical operations. For example, the memory of a 7006 central surgical controller can store location data. As shown in Figure 12, cloud 7004 comprises central servers 7013 (which may be the same or similar to remote server 113 in Figure 1 and/or remote server 213 in Figure 9), application servers for central controllers 7002, mobile 7034 data analysis modules and an input/output ("I/O") interface
[0142] [0142] Based on connections to multiple 7006 surgical central controllers through the 7001 network, the 7004 cloud can aggregate the specific data generated by the various 7012 surgical instruments and their corresponding 7006 central controllers. Such aggregated data may be stored within the aggregated medical databases 7011 of the cloud 7004. In particular, the cloud 7004 may advantageously perform data analysis and operations on the aggregated data to produce information and/or perform individual functions that the controllers individual 7006 switches could not reach on their own. For this purpose, as shown in Figure 12, the cloud 7004 and the central surgical controllers 7006 are communicatively coupled to transmit and receive information. The 7007 I/O interface is connected to the plurality of 7006 central surgical controllers via the 7001 network. In this way, the 7006 I/O interface can be configured to transfer information between the 7006 central surgical controllers and the bases. 7012 aggregated medical data data. Consequently, the 7007 I/O interface can facilitate the read/write operations of the cloud-based data analytics system. Such read/write operations may be performed in response to requests from central controllers
[0143] [0143] The specific cloud computing system configuration described in this description is specifically designed to address various issues raised in the context of medical operations and procedures performed using medical devices such as 7012 surgical instruments , 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. Multiple 7012 surgical instruments and/or 7006 central surgical controllers can comprise touch-controlled user interfaces so clinicians can control aspects of interaction between 7012 surgical instruments and the cloud
[0144] [0144] Figure 13 is a block diagram illustrating the functional architecture of the computer-implemented interactive surgical system, in accordance with at least one aspect of the present description. The cloud based data analysis system includes a plurality of data analysis modules 7034 that can be executed by the 7008 processors of the cloud 7004 to provide data analysis solutions to problems that arise specifically in the medical field. As shown in Figure 13, the functions of the 7034 cloud-based data analysis modules can be supported through 7014 Central Controller Applications hosted by the 7002 Central Controller Application Servers that can be accessed on 7006 Central Surgical Controllers. 7008 cloud computing processors and 7014 central controller applications can work together to run 7034 data analysis modules. 7016 application programming interfaces (APIs) define the set of protocols and routines that corresponds to the 7014 central controller applications. Additionally, the 7016 APIs manage the storage and retrieval of data in/from the 7011 aggregated medical databases for the operations of the 7014 applications. The 7018 caches also store data ( e.g. temporarily) and are coupled with 7016 APIs for more efficient retrieval of data used by applications
[0145] [0145] For example, the 7022 data collection and aggregation module could be used to generate self-describing data (e.g. metadata) including the identification of notable features or configuration (e.g. trends), management of data sets of redundant data and storing the data in embedded data sets.
[0146] [0146] The 7020 Resource Optimization Module can be configured to analyze this aggregated data to determine an optimal use of resources for a specific healthcare facility or group of healthcare facilities. For example, the 7020 resource optimization module can determine an optimal order point for 7012 surgical stapling instruments for a group of healthcare facilities based on the corresponding forecast demand for such 7012 instruments.
[0147] [0147] The 7028 Patient Outcome Analysis Module can analyze surgical results associated with currently used operating parameters of the 7012 Surgical Instruments. The 7028 Patient Outcome Analysis Module can also analyze and evaluate other operating parameters in potential. In this context, the 7030 recommendations module could recommend the use of these other parameters.
[0148] [0148] The 7026 driver update module can be configured to implement various 7012 surgical instrument recommendations when corresponding driver programs are updated. For example, the 7028 patient outcome analysis module could identify correlations linking specific control parameters to successful (or unsuccessful) outcomes. Such correlations can be resolved when updated control programs are transmitted to 7012 surgical instruments through the 7026 control program update module. Updates to 7012 instruments that are transmitted through a corresponding 7006 central controller may incorporate aggregated performance data that has been collected and analyzed by the 7022 data collection and aggregation module of the 7004 cloud. Additionally, the 7028 patient outcome analysis module and the 7030 recommendations module could identify improved methods of using the 7012 instruments based on data from aggregate performance.
[0149] [0149] The cloud-based data analytics system can include security features implemented by the 7004 cloud. These security features can be managed by the 7024 security and authorization module. Each 7006 central surgical controller can have unique credentials associated with it such as username, password, and other appropriate security credentials. These credentials can be stored in memory 7010 and be associated with a permitted cloud access level. For example, based on providing accurate credentials, a 7006 central surgical controller can be granted access to communicate with the cloud to a predetermined degree (e.g., it can only participate in transmitting or receiving certain defined types of data). information). For this purpose, the aggregated medical 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 permission levels for interacting with the 7004 cloud, such as a predetermined access level to receive the data analytics generated by the 7004 cloud.
[0150] [0150] Additionally, for security purposes, the cloud could maintain a database of 7006 central controllers, 7012 instruments, and other devices that may comprise a "blacklist" of prohibited devices. In particular, a blacklisted 7006 central surgical controller may not be allowed to interact with the cloud, while blacklisted 7012 surgical instruments may not have functional access to a corresponding 7006 central controller and/or may be prevented from fully functioning when paired with their corresponding 7006 central controller. Additionally or alternatively, the 7004 cloud can identify 7012 instruments based on incompatibility or other specified criteria. In this way, counterfeit medical devices and inappropriate reuse of such devices throughout the cloud-based data analytics system can be identified and addressed.
[0151] [0151] Surgical instruments 7012 can use wireless transceivers to transmit wireless signals that can represent, for example, credentials to authorize access to the corresponding central controllers 7006 and the cloud 7004. Wired transceivers can also be used to transmit signals. Such authorization credentials can be stored in the respective memory devices of the 7012 surgical instruments. The authorization and security module 7024 can determine whether the authorization credentials are accurate or falsified. The 7024 authorization and security module can also dynamically generate authorization credentials for increased security. Credentials could also be encrypted, such as using hash-based encryption. After transmitting proper authorization, the 7012 surgical instruments can transmit a signal to the corresponding 7006 central controllers and finally to the 7004 cloud, to indicate that the 7012 instruments are ready to obtain and transmit medical data. In response, the 7004 cloud can transition to an enabled state to receive medical data for storage in the 7011 Aggregate Medical Data Databases. This data transmission availability could be indicated by a light indicator on the 7012 instruments. , for example. The 7004 cloud can also transmit signals to the 7012 surgical instruments to update their associated control programs. The 7004 cloud can transmit signals that are directed to a specific class of 7012 surgical instruments (eg, electrosurgical instruments) so that software updates for control programs are transmitted only to the appropriate 7012 surgical instruments. In addition, the 7004 cloud could be used to implement system-wide solutions to address local or global issues based on selective data transmission and authorization credentials. For example, if a group of surgical instruments 7012 is identified as having a common manufacturing defect, the cloud 7004 can change the authorization credentials corresponding to this group to implement an operational lockout of the group.
[0152] [0152] Cloud-based data analytics system can enable monitoring of multiple healthcare facilities (e.g. medical facilities such as hospitals) to determine improved practices and recommend changes (via 2030 recommendations module , for example) properly. In this way, 7008 processors in the 7004 cloud can analyze data associated with a healthcare facility to identify the facility and aggregate the data with other data associated with other healthcare facilities in a group. Groups could be defined based on similar operational practices or geographic location, for example. In this way, the 7004 cloud can provide analysis and recommendations regarding a health service facility that spans an entire group. The cloud-based data analysis system could also be used to improve situational awareness. For example, 7008 processors can predictively demonstrate the effects of recommendations on cost and effectiveness for a specific facility (in relation to operations and/or various general medical procedures). The cost and effectiveness associated with that specific installation can also be compared to a corresponding local area of other installations or any other comparable installations.
[0153] [0153] The 7032 Data Classification and Prioritization Module can prioritize and classify data based on severity (eg severity of a medical event associated with the data, unpredictability, distrust). This classification and prioritization can be used in conjunction with the functions of the other 7034 data analysis modules described above to improve the cloud-based data analysis and 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 7028 patient outcome analysis modules. Different levels of prioritization can result in responses specific from the 7004 cloud (corresponding to a level of urgency) such as progression to a rapid response, special processing, deletion from the aggregated 7011 medical data base, or other appropriate responses. Furthermore, if necessary, the 7004 cloud can transmit a request (eg, a push message) through the application servers to central controllers for additional data from corresponding 7012 surgical instruments. The automatic message may result in a notification displayed on the corresponding 7006 central controllers to request support or additional data. This automatic message may be necessary in situations where the cloud detects a significant irregularity or out-of-bounds results and the cloud cannot determine the cause of the irregularity. Central 7013 servers can be programmed to activate this automatic message in certain significant circumstances, such as when data is determined to differ from an expected value beyond a predetermined threshold, or when it appears that security has been compromised, for example.
[0154] [0154] In various aspects, the 7012 surgical instrument(s) described above with reference to Figures 12 and 13 can be implemented as a circular stapling device equipped with a 201800 motor (Figures 24 to 30) and 202080 (Figures 31 to 37). Consequently,
[0155] [0155] While a "smart" device, including control algorithms responsive to detected data, may be an improvement over a "stupid" device that operates without carrying the detected data, some detected data may be incomplete or inconclusive when considered in isolation, that is, without the context of the type of surgical procedure being performed or the type of tissue undergoing the surgery. Without knowing the context of the procedure (for example, knowing the type of tissue undergoing surgery, or the type of procedure being performed), the control algorithm may incorrectly or suboptimally control the modular device, provided the detected data without specific context. For example, the optimal way for a control algorithm to control a surgical instrument in response to a certain detected parameter may vary according to the particular tissue type being operated on. This is due to the fact that different types of tissue have different properties (eg tear strength) and thus respond differently to actions performed by surgical instruments. Therefore, it may be desirable for a surgical instrument to perform different actions when the same measurement is detected for a specific parameter. As a specific example, the ideal way to control a surgical stapling and cutting instrument, in response to the instrument sensing an unexpectedly high force to close its end actuator, will vary depending on whether the tissue type is susceptible or resistant. to tearing. For tissues that are susceptible to tearing, such as lung tissue, the instrument's control algorithm would optimally decelerate the motor in response to an unexpectedly high force to close to prevent tissue tearing. For tissue that is tear resistant, such as stomach tissue, the instrument's control algorithm would optimally accelerate the motor in response to an unexpectedly high force to close to ensure that the end actuator is properly secured to the tissue. Not knowing whether lung or stomach tissue has been trapped, the control algorithm may make a decision that is less than ideal.
[0156] [0156] One solution utilizes a central surgical controller including a system configured to derive information about the surgical procedure being performed based on data received from various data sources, and then control the modular devices accordingly. Paired. In other words, the central surgical controller is configured to infer information about the surgical procedure from the data received and then control the modular devices paired with the central surgical controller based on the inferred context of the surgical procedure. Figure 14 illustrates a diagram of a situational awareness surgical system 5100, in accordance with at least one aspect of the present disclosure. In some examples, data sources 5126 include, for example, modular devices 5102 (which may include sensors configured to detect parameters associated with the patient and/or the modular device itself), databases 5122 (e.g., an EMR database containing the patient's chart), and 5124 monitoring devices (eg, a blood pressure (BP) monitor and an electrocardiography (ECG) monitor).
[0157] [0157] A central surgical controller 5104 that can be similar to the surgical controller 106 in many ways can be configured to derive contextual information related to the surgical procedure from the data based on, for example, the combination(s)( s) of data received or in the specific order in which the data are received from the 5126 data sources. Contextual information inferred from the data received may include, for example, the type of surgical procedure being performed, the specific step of the surgical procedure that the surgeon is performing, the type of tissue being operated on, or the body cavity that is the object of the procedure. This ability by some aspects of the 5104 central surgical controller to derive or infer information related to the surgical procedure from received data, can be called "situational awareness." In one example, the 5104 central surgical controller may incorporate a situational awareness system, which is the hardware and/or programming associated with the 5104 central surgical controller that derives contextual information related to the surgical procedure based on the data received.
[0158] [0158] The 5104 central surgical controller situational awareness system can be configured to derive contextual information from the data received from the 5126 data sources in various ways. In one example, the situational awareness system includes a pattern recognition system, or machine learning system (eg, an artificial neural network), that has been trained on training data to correlate various inputs (eg. , data from databases 5122, patient monitoring devices 5124, and/or modular devices 5102) to corresponding contextual information pertaining to a surgical procedure. In other words, a machine learning system can be trained to accurately derive contextual information regarding a surgical procedure from the inputs provided. In another example, the situational awareness system may include a lookup table that stores pre-characterized contextual information referring to a surgical procedure in association with one or more entries (or ranges of entries) corresponding to contextual information. In response to a query with one or more entries, the lookup table may return the corresponding contextual information to the situational awareness system to control the 5102 modular devices. In one exemplification, the contextual information received by the situational awareness system of the 5104 central surgical controller, are associated with a specific control setting or set of control settings for one or more 5102 modular devices. In another example, the situational awareness system includes an additional machine learning system, table or other such system, generating or retrieving one or more control settings for one or more modular devices 5102, when provided the contextual information as input.
[0159] [0159] A 5104 central surgical controller, which incorporates a situational awareness system, provides several benefits to the 5100 surgical system. One benefit includes improving the interpretation of detected and captured data, which in turn improves the accuracy of pro- cessation and/or use of data during the course of a surgical procedure. To return to an earlier example, a central surgical controller 5104 endowed with situational awareness could determine what type of tissue was being operated on; therefore, when an unexpectedly high force is detected to close the surgical instrument end actuator, the situational awareness central surgical controller 5104 could correctly accelerate or decelerate the surgical instrument motor for the tissue type.
[0160] [0160] As another example, the type of tissue being operated on can affect the adjustments that are made to the load thresholds and compression ratio of a surgical stapling and cutting instrument for a specific tissue gap measurement. A situational awareness central surgical controller 5104 could infer whether a surgical procedure being performed is a thoracic or abdominal procedure, allowing the central surgical controller 5104 to determine whether tissue pinched by an instrument-end actuator surgical stapling and cutting material is lung tissue (for a thoracic procedure) or stomach tissue (for an abdominal procedure). The 5104 central surgical controller can then appropriately adjust the surgical cutting and stapling instrument's compression rate and load thresholds for the tissue type.
[0161] [0161] As yet another example, the type of body cavity being operated on during an insufflation procedure can affect the function of a smoke evacuator. A 5104 situational awareness central surgical controller can determine whether the surgical site is under pressure (by determining that the surgical procedure is using insufflation) and determine the type of procedure. As one type of procedure is generally performed in a specific body cavity, the central surgical controller 5104 can then properly control the smoke evacuator motor speed for the body cavity being operated on.
[0162] [0162] As yet another example, the type of procedure being performed can affect the optimal energy level for an ultrasonic surgical instrument or radio frequency (RF) electrosurgical instrument to operate. Arthroscopic procedures, for example, require higher energy levels because the end actuator of the ultrasonic surgical instrument, or RF electrosurgical instrument, is immersed in fluid. A central surgical controller with situational awareness 5104 can determine whether the surgical procedure is an arthroscopic procedure. The 5104 central surgical controller can then adjust the RF power level or ultrasonic amplitude of the generator (ie, the "power level") to compensate for the fluid-filled environment. Related to this, the type of tissue being operated on can affect the optimal energy level at which an ultrasonic surgical instrument or RF electrosurgical instrument operates. A 5104 situation-aware central surgical controller can determine what type of surgical procedure is being performed and then customize the power level for the ultrasonic surgical instrument or RF electrosurgical instrument, respectively, according to the profile. of tissue expected for the surgical procedure. In addition, a 5104 situation-aware central surgical controller can be configured to adjust the power level to the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than just on a procedure-by-procedure basis. A 5104 situational awareness central surgical controller can determine which step of the surgical procedure is being performed or will be performed subsequently and then update the control algorithms for the generator and/or ultrasonic surgical instrument or electrosurgical instrument of RF to adjust the energy level to an appropriate value for the tissue type, according to the surgical procedure step.
[0163] [0163] As yet another example, data can be extracted from additional data sources 5126 to improve the conclusions that the central surgical controller 5104 draws from a data source 5126. A central surgical controller with situational awareness 5104 can automatically supplement the data it receives from the modular devices 5102 with contextual information it has accumulated regarding the surgical procedure from other data sources 5126. For example, a central surgical controller with situational awareness 5104 can be configured to determine whether hemostasis has occurred (ie, bleeding has stopped at a surgical site), according to video or image data received from a medical imaging device. However, in some cases, the video or image data may be inconclusive. Therefore, in one example, the central surgical controller 5104 can be further configured to compare a physiological measurement (e.g., blood pressure detected by a BP monitor communicatively connected to the central surgical controller 5104) with the visual or imaging data of hemostasis (eg, from a Medical Imaging Device 124 (Figure 2) communicably coupled to the Central Surgical Controller 5104) to make a determination on the integrity of the staple line or tissue bond. In other words, the 5104 central surgical controller's situational awareness system can consider physiological measurement data to provide additional context in analyzing the visualization data. Additional context can be useful when visualization data may be inconclusive or incomplete on its own.
[0164] [0164] Another benefit includes proactively and automatically controlling 5102 paired modular devices according to the specific step of the surgical procedure being performed to reduce the number of times medical personnel are required to interact with or control the 5100 Surgical System during the course of a surgical procedure. For example, a situational awareness central surgical controller 5104 can proactively activate the generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in the procedure requires the use of the RF electrosurgical instrument. instrument. Proactively activating the power source allows the instrument to be ready for use once the preceding step in the procedure is complete.
[0165] [0165] As another example, a situational awareness central surgical controller 5104 could determine whether the current or subsequent stage of the surgical procedure requires a different view or degree of screen magnification, depending on the feature(s) in the surgical site that the surgeon is expected to need to see. The central surgical controller 5104 could then proactively change the view displayed (provided, for example, by a medical imaging device to the viewing system 108) so that the screen automatically adjusts throughout the surgical procedure.
[0166] [0166] As yet another example, a situational awareness central surgical controller 5104 could determine which stage of the surgical procedure is being performed or will be performed subsequently and whether specific data or comparisons between the data will be required for that stage of the surgical procedure. The 5104 Central Surgical Controller can be configured to automatically call up screens based on data about the stage of the surgical procedure being performed, without waiting for the surgeon to request specific information.
[0167] [0167] Another benefit includes error checking during setup.
[0168] [0168] As another example, the Situational Awareness Central Surgical Controller 5104 could determine if the surgeon (or other medical personnel) was making a mistake or otherwise deviating from the expected course of action during the course of a surgical procedure. For example, the 5104 central surgical controller can be configured to determine the type of surgical procedure being performed, retrieve the corresponding list of steps or order of use of the equipment (e.g. from a memory), and then compare the steps being performed or the equipment being used during the course of the surgical procedure with the steps or equipment expected for the type of surgical procedure that the 5104 Central Surgical Controller has determined is being executed. In one example, the 5104 central surgical controller can be configured to provide an alert indicating that an unexpected action is being performed or an unexpected device is being used at a specific step in the surgical procedure.
[0169] [0169] Overall, the situational awareness system for the 5104 Central Surgical Controller improves surgical procedure outcomes by adjusting surgical instruments (and other 5102 modular devices) to the specific context of each surgical procedure. (such as adjusting to different types of tissue), and when validating actions during a surgical procedure. The situational awareness system also improves the surgeon's efficiency in performing surgical procedures by automatically suggesting next steps, providing data, and adjusting screens and other 5102 modular devices in the operating room according to the specific context. of the procedure.
[0170] [0170] In one aspect, as described later in this document with reference to Figures 24 to 40, the modular device 5102 is implemented as a circular stapling device equipped with motor 201800 (Figures 24 to 30) and 202080 (Figures 31). to 37). Consequently, the modular device 5102 implemented as a circular clipping device equipped with motor 201800 (Figures 24 to 30) and 202080 (Figures 31 to 37) is configured to function as a data source 5126 and to interact with the 5122 database and 5124 remote monitoring devices. The 5102 modular device implemented as a circular stapling device equipped with motor 201800 (Figures 24 to 30) and 202080 (Figures 31 to 37) is additionally configured to Interact with the 5104 Central Surgical Controller to provide information (e.g. data and control) to the 5104 Central Surgical Controller and receive information (e.g. data and control) from the 5104 Central Surgical Controller.
[0171] [0171] Now with reference to Figure 15, a timeline 5200 is shown representing the situational recognition of a central controller, such as the central surgical controller 106 or 206 (Figures 1 to 11), for example. Timeline 5200 is an illustrative surgical procedure and contextual information that the central surgical controller 106, 206 can derive from data received from data sources at each step in the surgical procedure. The 5200 timeline shows the typical steps that would be taken by nurses, surgeons, and other medical personnel during the course of a lung segmentectomy procedure, starting with the operating room setup and ending with transferring the patient to a postoperative recovery room.
[0172] [0172] Situational awareness from a central surgical controller 106, 206 receives data from data sources throughout the course of the surgical procedure, including data generated each time the medical team uses a modular device that is paired with the OR 106 , 206. The central surgical controller 106,
[0173] [0173] In the first step 5202, in this illustrative procedure, hospital staff members retrieve the patient's electronic medical record (PEP) from the hospital's PEP database. Based on PEP patient selection data, the central surgical controller 106, 206 determines that the procedure to be performed is a thoracic procedure.
[0174] [0174] In the second step 5204, team members scan the entry of medical supplies for the procedure. The 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 combination of supplies corresponds to a thoracic procedure. Additionally, the central surgical controller 106, 206 is also able to determine that the procedure is not a wedge procedure (because input supplies either lack certain supplies that are needed for a thoracic wedge procedure or , otherwise the inlet supplies do not correspond to a thoracic wedge procedure).
[0175] [0175] In the third step 5206, the medical team scans the patient's band with a scanner that is communicably connected to the central surgical controller 106, 206. The surgical controller 106, 206 can then confirm the patient's identity based on the data scanned.
[0176] [0176] In the fourth step 5208, the medical team turns on the auxiliary equipment. The auxiliary equipment in use 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 are modular devices can automatically pair with the central surgical controller 106, 206 that is situated within a specific neighborhood of the modular devices as part of their startup process. The surgical controller 106, 206 can then derive contextual information about the surgical procedure by detecting the types of modular devices paired with it during this preoperative or startup 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 the electronic patient record (PEP) data, 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 that
[0177] [0177] In the fifth step 5210, team members attach electrocardiogram (ECG) electrodes and other patient monitoring devices to the patient. ECG electrodes and other patient monitoring devices are able to pair with the central surgical controller 106, 206. As the central surgical controller 106, 206 begins to receive data from the patient monitoring devices , the central surgical controller 106, 206 thereby confirms that the patient is in the operating room.
[0178] [0178] In the sixth step 5212, the medical team induces anesthesia in the patient. The 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 thereof, for example. Upon completion of the sixth step 5212, the preoperative portion of the pulmonary segmentectomy procedure is completed and the operative portion begins.
[0179] [0179] 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. The central surgical controller 106, 206 can infer that the operative portion of the procedure has started as it can com-
[0180] [0180] In the eighth step 5216, the medical imaging device (eg, an endoscope) is inserted and the video of the medical imaging device is started. The central surgical controller 106, 206 receives data from the medical imaging device (i.e., the 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 laparoscopic surgical procedure portion has commenced. Additionally, the central surgical controller 106, 206 may determine that the specific procedure in progress is a segmentectomy rather than a lobectomy (note that a wedge procedure has already been ruled out by the central surgical controller 106, 206 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (Figure 2) can be used to determine contextual information about the type of procedure being performed in several different ways, including determining the angle at which the medical imaging device is oriented. in relation to viewing the patient's anatomy, monitoring the number or medical imaging devices in use (ie, which are activated and paired with the central surgical controller 106, 206), and monitoring the types of viewing devices used. For example, a technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest cavity above the diaphragm, while a technique for performing a VATS segmentectomy places the camera in an intercostal position anterior to the segmental fissure. Using standard recognition techniques or machine learning, for example, the situational recognition system can be trained to recognize the positioning of the medical imaging device according to the visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy uses a single medical imaging device, while another technique for performing a VATS segmentectomy uses multiple cameras. As yet another example, a technique for performing a VATS segmentectomy uses an infrared light source (which can be communicably coupled to the central surgical controller as part of the visualization system) to visualize the segmental fissure, which is not is used in a VATS lobectomy. By tracking any or all of this medical imaging device data, the central surgical controller 106, 206 can thus determine the specific type of surgical procedure in progress and/or the technique in use for a specific type of surgery. surgical procedure.
[0181] [0181] In the ninth step 5218, the surgical team starts the dissection step of the procedure. The 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 indicates that an energy instrument is being fired. The central surgical controller 106, 206 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that a power instrument is being fired at that point in the process (i.e., after completion of the previously discussed steps of the procedure) corresponds to the dissection stage. In certain cases, the power instrument may be a power tool mounted on a robotic arm of a robotic surgical system.
[0182] [0182] In the tenth step 5220 of the procedure, the surgical team proceeds to the ligation step. The 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 triggered. Similar to the previous step, the central surgical controller 106, 206 can derive this inference by cross-referencing the data received from the surgical stapling and cutting instrument with the steps retrieved in the process. In certain cases, the surgical instrument may be a surgical tool mounted on a robotic arm of a robotic surgical system.
[0183] [0183] In the eleventh step 5222, the segmentectomy procedure portion is performed. The 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. Cartridge data may correspond to the size or type of staple being fired by the instrument, for example. As different types of staples are used for different types of tissue, the cartridge data can thus indicate the type of tissue being stapled and/or transected. In this case, the type of staple that is fired is used for the parenchyma (or other similar types of tissue), which allows the central surgical controller 106, 206 to infer what portion of the segmentectomy procedure is being performed.
[0184] [0184] 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 data received from the generator that indicates which ultrasonic or RF instrument is being triggered. For this particular 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/surgical cutting instruments and surgical energy instruments (i.e., RF or ultrasonic) depending on the specific step in the procedure because different instruments are better suited to specific tasks. Therefore, the specific sequence in which the cutting/stapling instruments and surgical energy instruments are used may indicate which step of the procedure the surgeon is performing. Furthermore, in certain cases, robotic tools may be used for one or more steps in a surgical procedure and/or hand-held surgical instruments may 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 completion of the twelfth step 5224, the incisions are closed and the post-operative portion of the procedure begins.
[0185] [0185] In the thirteenth step 5226, the patient's anesthesia is reversed. The central surgical controller 106, 206 can infer that the patient is coming off anesthesia based on ventilator data (ie, the patient's respiratory rate begins to increase), for example.
[0186] [0186] Finally, in the fourteenth step 5228, the medical team removes the various patient monitoring devices from the patient. The 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 data received from the various data sources that are coupled from communicable mode to central surgical controller 106, 206.
[0187] [0187] In many respects, the motor-equipped circular stapling devices 201800 (Figures 24 to 30) and 202080 (Figures 31 to 37) are configured to function in situational awareness in a surgical controller environment, such as the 106 or 206 (Figures 1 to 11), for example, as shown in timeline 5200. Situational recognition is further described in US provisional patent application serial no. 62/659,900 entitled METHOD OF HUB COMMUNICATION, filed on April 19, 2018, 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 described herein, for example, may be controlled by the central controller 106, 206 based on its situational recognition and/or feedback from components of the system. same and/or based on cloud information 104. Surgical instrument hardware
[0188] [0188] Figure 16 illustrates a logic diagram of a module of a control system 470 of a surgical instrument or tool, according to one or more aspects of the present description. System 470 comprises a control circuit. The control circuit includes a microcontroller 461 comprising a processor 462 and a memory.
[0189] [0189] In one aspect, the 461 microcontroller can be any single-core or multi-core processor, such as those known under the tradename ARM Cortex available from Texas Instruments. In one aspect, the main microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor, available from Texas Instruments, for example, comprising an integrated 256KB single-cycle flash memory, or other nonvolatile memory, up to 40 MHz, a prefetch 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 the StellarisWare€O program, programmable and electrically erasable read-only memory (EEPROM) of 2 KB, one or more pulse width modulation (PWM) modules, one or more analogue quadrature encoder (QEI) inputs , and/or one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, details of which are available in the product data sheet.
[0190] [0190] In one aspect, the microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x known under the tradename Hercules ARM Cortex R4, also available from Texas Instruments. The safety controller can be specifically configured for safety critical applications IEC 61508 and ISO 26262, among others, to provide advanced built-in safety features while providing scalable performance, connectivity and memory options.
[0191] [0191] The 461 microcontroller can be programmed to perform various functions, such as precisely controlling the speed and position of the joint and knife systems. In one aspect, microcontroller 461 includes a processor 462 and memory 468. Electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical connections with a linkage system or scalpel. In one aspect, a 492 motor starter may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be readily substituted for use in the 480 tracking system which comprises an absolute positioning system. A detailed description of an absolute positioning system is given in US patent application publication No. 2017/0296213 entitled SYS-
[0192] [0192] The 461 microcontroller can be programmed to provide precise control of the speed and position of displacement members and linkage systems. The 461 microcontroller can be configured to compute a response in the microcontroller software
[0193] [0193] In one aspect, the 482 motor can be controlled by the 492 motor driver and can be used by the triggering system of the instrument or surgical tool. In various forms, the 482 motor can be a brushed direct current (DC) drive motor, with a maximum rotational speed of approximately 25,000 RPM, for example. In other arrangements, the 482 motor may include a brushless motor, a wireless motor, a synchronous motor, a stepper motor, or any other suitable type of electric motor. Motor driver 492 may comprise an H-bridge driver comprising field effect transistors (FETs), for example. The 482 motor can be powered by a power pack releasably mounted in the grip assembly or tool housing to provide control power to the instrument or surgical tool. The power package may comprise a battery which may include a number of battery cells connected in series, which may be used as the power source to power the instrument or surgical tool. In certain circumstances, the battery cells in the power pack may be replaceable and/or rechargeable. In at least one example, the battery cells can be lithium-ion batteries that can be attachable and detachable from the power package.
[0194] [0194] The 492 motor driver can be an A3941, available from Allegro Microsystems, Inc. The 492 A3941 driver is a full bridge controller for use with semiconductor metal oxide field effect (MOSFET) transistors. external power, N-channel, specifically designed for inductive loads such as brushed DC motors. The 492 driver comprises a single charge pump regulator that provides full gate drive (>10V) for batteries with voltages up to 7V and allows the A3941 to operate with a reduced gate drive, up to 5.5V. input command can be used to supply the voltage in excess of that supplied by the battery needed for N-channel MOSFETs. An internal charge pump for the upside drive allows direct current operation (100% duty cycle ). The entire bridge can be driven in fast or slow decay modes using diodes or synchronous rectification. In slow-fall mode, current recirculation can be via FET from either the upside or the downside. Power FETs are protected from the shoot-through effect by programmable dead-time resistors. Built-in diagnostics provide indication of undervoltage, overtemperature and power bridge faults and can be configured to protect power MOSFETs under most short circuit conditions. Other motor drives can be readily replaced for use in the 480 tracking system comprising an absolute positioning system.
[0195] [0195] 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 472 position sensor 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 in mesh with a corresponding drive gear of a gear reducer assembly. In other aspects, the displacement member represents the trigger member, which may be adapted and configured to include a rack of driving teeth. In yet another aspect, the displacement member represents the firing bar or knife, each of which may be adapted and configured to include a rack of driving teeth.
[0196] [0196] The 482 electric motor may include a rotating drive shaft, which operationally interfaces with a gear set, which is mounted in coupling engagement with a set or rack of drive teeth on the gear member. drive. A sensing element may be operatively coupled to a gear assembly so that a single revolution of position sensing 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 via a rack and pinion array, or a rotary actuator via a sprocket or other connection. A power supply supplies power to the absolute positioning system and an output indicator can show the output of the absolute positioning system. The drive member represents the longitudinally movable drive member comprising a rack of drive teeth formed therein for engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents the longitudinally movable firing member, firing bar, knife or combinations thereof.
[0197] [0197] A single revolution of the sensing element associated with the position sensor 472 is equivalent to a linear longitudinal displacement 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 sensing element coupled to the displacement member. The sensor array may be connected via a gear reduction which results in the position sensor 472 completing one or more revolutions for the full stroke of the displacement member. Position sensor 472 can complete multiple revolutions for the full stroke of the displacement member.
[0198] [0198] A series of switches, where n is an integer greater than one, can be employed alone or in combination with a gear reduction to provide a single position signal for more than one revolution of the 472 position sensor. of the switches is transmitted back to the microcontroller 461 which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1 + d2 + ... dh of the displacement member. The output of position sensor 472 is provided to microcontroller 461. In various embodiments, position sensor 472 of the sensor array may comprise a magnetic sensor, an analog rotary sensor, such as a potentiometer, or a series of analog Hall-effect elements. , which output a unique combination of position signals or values.
[0199] [0199] Position sensor 472 can comprise any number of magnetic sensing elements, such as 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 flowmeter, saturated flow, optical pumping, nuclear precession, SQUID, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive/piesoelectric compounds, magnetodiode, magnetic transistor, optical fiber, magneto-optic and magnetic sensors based on microelectromechanical systems, among others.
[0200] [0200] In one aspect, the position sensor 472 for the tracking system 480 which comprises an absolute positioning system comprises a magnetic rotary absolute positioning system. The 472 position sensor can be implemented as a single integrated circuit, ASSOSSEQFT, magnetic, rotary position sensor,
[0201] [0201] The 480 tracking system comprising an absolute positioning system may comprise and/or be programmed to implement a feedback controller, such as a PID, status feedback, and adaptive controller. A power supply converts the feedback controller signal into a physical input to the system, in this case voltage. Other examples include a voltage, current, and power PWM. Other sensors may be provided in order to measure physical system parameters in addition to the position measured by the 472 position sensor. In some respects, the other sensors may include sensor arrangements as described in US patent no.
[0202] [0202] 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 reset position (zero or start). ), as may be required by conventional rotary encoders that merely count the number of forward or backward steps the 482 motor has taken to infer the position of an actuator device, drive bar, scalpel, and the like.
[0203] [0203] A 474 sensor, such as a strain gauge or a micro-strain gauge, is configured to measure one or more end actuator parameters, such as the magnitude 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 processor 462. Alternatively, or in addition to sensor 474, a sensor 476, such as a load sensor, can measure the closing force applied by the actuation system. anvil closure. The 476 sensor, such as a load sensor, can measure the firing force applied to a knife in a firing stroke of the instrument or surgical tool. The knife is configured to engage a wedge slider, which is configured to move up the clamp drivers to force the clamps to deform in contact with an anvil. The knife includes a sharp cutting edge that can be used to separate tissue as the knife is advanced distally through the firing bar. Alternatively, a current sensor 478 may be used to measure the current drawn by the motor 482. The force required to advance the firing member may correspond to the current drawn by the motor 482, for example. The measured power is converted into a digital signal and fed to the 462 processor.
[0204] [0204] In one form, a 474 strain gauge sensor can be used to measure the force applied to 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 tissue held by the end actuator comprises a strain gauge sensor 474, such as a microstrain gauge, which is configured to measure one or more end actuator parameters, for example. In one aspect, the 474 strain gauge sensor can measure the amplitude or magnitude of mechanical stress exerted on a gripper 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 processor 462 of a microcontroller 461. A load sensor 476 can measure the force used to operate the knife element, for example, to cut the tissue captured between the anvil and the staple cartridge. A magnetic field sensor can be used to measure the thickness of captured tissue. The magnetic field sensor measurement can also be converted to a digital signal and fed to the 462 processor.
[0205] [0205] Measurements of tissue compression, tissue thickness, and/or the force required to close the end actuator on the tissue, as respectively measured by sensors 474, 476, can be used by microcontroller 461 to characterize the selected position of the triggering member and/or the corresponding value of the triggering member speed. In one case, a memory 468 may store a technique, an equation and/or a look-up table that may be used by the microcontroller 461 in the evaluation.
[0206] [0206] The 470 control system of the instrument or surgical tool may also comprise wired or wireless communication circuits for communication with the central modular communication controller shown in Figures 1 to 14. The 470 control system can be used by the 201800 motor-equipped circular stapling instrument (Figures 24 to 30), (Figures 31 to 37) to control aspects of the 201800, 202080 motor-equipped circular stapling instruments. Control system aspects 470 po - must be used by circular stapling instruments equipped with motor 201800, 202080 to detect the position of the anvil, tissue compression forces, among others, using 472, 474, 476, the tracking system 480 and the sensor of chain
[0207] [0207] Figure 17 illustrates a control circuit 500 configured to control aspects of the surgical instrument or tool in accordance with an aspect of the present disclosure. Control circuit 500 can be configured to implement various processes described here. Control circuit 500 may comprise a microcontroller comprising one or more processors 502 (e.g., microprocessor, microcontroller) coupled to at least one memory circuit 504. Memory circuit 504 stores machine-executable instructions which, when executed by processor 502, cause processor 502 to execute machine instructions to implement various of the processes described herein. Processor 502 can be any of a number of single-core or multi-core processors known in the art. The 504 memory circuit may comprise volatile and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of this disclosure.
[0208] [0208] Figure 18 illustrates a combinational logic circuit 510 configured to control aspects of the instrument or surgical tool in accordance with an aspect of the present disclosure. Combinational logic circuit 510 can be configured to implement various processes described herein. Combinational logic circuit 510 may comprise a finite state machine comprising combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data by combinational logic 512, and provide an output. 516.
[0209] [0209] Figure 19 illustrates a sequential logic circuit 520 configured to control aspects of the instrument or surgical tool in accordance with an aspect of the present disclosure. Sequential logic circuit 520 or combinational logic 522 can be configured to implement the process described herein. The sequential logic circuit 520 may comprise a finite state machine. The sequential logic circuit 520 may comprise a combinational logic 522, at least a memory circuit 524, a clock 529 and, for example. 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 aspects, the circuit may comprise a combination of a processor (eg, processor 502, Figure 17) and a finite state machine to implement various processes of the present invention. In other aspects, the finite state machine may comprise a combination of a combinational logic circuit (e.g., a combinational logic circuit 510, Figure 18) and sequential logic circuit 520.
[0210] [0210] Figure 20 illustrates a surgical instrument or tool 600 comprising a plurality of motors that can be activated to perform various functions. In certain cases, a first motor may be activated to perform a first function, a second motor may be activated to perform a second function, a third motor may be activated to perform a third function, a fourth motor may be activated to perform a fourth function, and so on. In certain cases, the plurality of motors of surgical instrument 600 may be individually activated to cause triggering, closing, and/or pivoting movements in the end actuator. The triggering, closing and/or articulation movements can be transmitted to the end actuator via a drive shaft assembly, for example.
[0211] [0211] In certain cases, the instrument system or surgical tool may include a trigger motor 602. The trigger motor 602 may be operatively coupled to a trigger motor drive assembly 604, which may be configured to transmit motion. triggers, generated by the motor 602, to the end actuator, particularly to displace the cutting element. In certain cases, the triggering motions generated by the 602 motor can cause staples to be positioned from the staple cartridge onto the fabric captured by the end actuator and/or the cutting edge of the cutting element to be advanced to in order to cut the captured tissue, for example. The cutting element can be retracted by reversing the direction of the motor 602.
[0212] [0212] In certain cases, the surgical instrument or tool may include a closing motor 603. The closing motor 603 may be operatively coupled to a closing motor drive assembly 605 which can be configured to transmit closing movements, generated by motor 603 to the end actuator, particularly to displace a closure tube to close the anvil and compress tissue between the anvil and staple cartridge. Closing movements can cause the end actuator to transition from an open configuration to a close configuration to capture tissue, for example. The end actuator can be transitioned to an open position by reversing the direction of motor 603. In a circular stapler implementation, motor 603 can be coupled to a trocar portion of a circular stapler portion of a clamping device. motor-equipped stapling. Motor 603 can be used to advance and retract the trocar.
[0213] [0213] In certain cases, the surgical instrument or tool may include one or more linkage motors 606a, 606b, for example. Motors 606a, 606b may be operatively coupled to linkage motor drive assemblies 608a, 608b, which may be configured to transmit linkage motions generated by motors 606a, 606b to the end actuator. In certain cases, linkage movements can cause the end actuator to link with respect to the drive shaft assembly, for example.
[0214] [0214] As described above, the instrument or surgical tool may 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 may be activated individually or separately to perform one or more functions, while other motors remain inactive. For example, pivot motors 606a, 606b can be activated to cause the end actuator to pivot while trigger motor 602 remains inactive. Alternatively, trigger motor 602 may be activated to trigger the plurality of staples, and/or advance the cutting edge, while linkage motor 606 remains inactive. In addition, the closing motor 603 can be activated simultaneously with the firing motor 602 to cause the closing tube or cutting element to advance distally, as described in more detail later in this document.
[0215] [0215] 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 a plurality of motors at a time. For example, the common control module 610 may be attachable to, and separable from, the plurality of individual surgical instrument motors. In certain cases, a plurality of instrument or surgical tool motors may share one or more common control modules, such as the common control module 610. In certain cases, a plurality of instrument or surgical tool motors may be individually and selectively coupled to the common control module 610. In certain cases, the common control module 610 may be selectively switched between interfacing with one of a plurality of motors of the instrument or surgical tool to interfacing with another one of the plurality of motors of the instrument or surgical tool.
[0216] [0216] In at least one example, the common control module 610 can be selectively switched between operational engagement with linkage motors 606a, 606B, and operating engagement with trip motor 602 or closing motor 603 In at least one example, as illustrated in Figure 20, a switch 614 may be moved or transitioned between a plurality of positions and/or states. In first position 616, switch 614 can electrically couple common control module 610 to trigger 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, key 614 can electrically couple common control module 610 to first linkage motor 606a; and in a fourth position 618b, key 614 can electrically couple common control module 610 to second linkage motor 606b, for example. In certain cases, control modules co-
[0217] [0217] Each of the 602, 603, 606a, 606b motors 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 way, such as through force sensors on the outer sides of the jaws or by a torque sensor on the motor that drives the jaws.
[0218] [0218] In various cases, as illustrated in Figure 20, the common control module 610 may comprise a motor driver 626 which may comprise one or more H-bridge FETs. The motor driver 626 may modulate the power transmitted from a power supply 628 to a motor coupled to the common control module 610, based on input from a microcontroller 620 (the "controller"), for example. 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.
[0219] [0219] In certain examples, the microcontroller 620 may include a microprocessor 622 (the "processor") and one or more non-transient computer readable media or memory units 624 (the "memory"). In certain cases, memory 624 may store multiple program instructions which, when executed, may 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 may be coupled to the processor 622, for example.
[0220] [0220] In certain cases, the power supply 628 can be used to supply power to the microcontroller 620, for example. In certain cases, the power source 628 may comprise a battery (or "battery pack" or "battery"), 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 power source 628. In certain cases In some cases, the power source 628 may be replaceable and/or rechargeable, for example.
[0221] [0221] In various cases, processor 622 may control motor driver 626 to control the position, direction of rotation, and/or speed of a motor that is coupled to common control module 610. In certain cases In these cases, the 622 processor may signal the 626 motor driver to stop and/or disable a motor that is coupled to the 610 common control module. It should be understood that the term "processor" as used herein includes any microprocessor, microcontroller, or other suitable basic computing device that embodies the functions of a computer's central processing unit (CPU) in an integrated circuit or, at most, a few integrated circuits. The processor is a multipurpose programmable 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.
[0222] [0222] In one example, the 622 processor can be any single-core or multi-core processor, such as those known by the trade name ARM Cortex from Texas Instruments. In certain cases, the 620 microcontroller may be an LM 4F230H5QR, available from Texas Instruments, for example. In at least one example, the
[0223] [0223] In certain cases, memory 624 may include program instructions for controlling each of the surgical instrument motors 600 that are attachable to common control module 610. For example, memory 624 may include program instructions for controlling the trigger motor 602, the closing motor 603 and the hinge motors 606a, 606b. Such program instructions can cause the 622 processor to control the trigger, close, and articulation functions according to inputs from the surgical instrument or tool control algorithms or programs.
[0224] [0224] In certain cases, one or more mechanisms and/or sensors, such as sensors 630, can be used to alert the processor 622 to program instructions that need to be used in a specific configuration. For example, sensors 630 can prompt processor 622 to use program instructions associated with triggering, closing, and linking the end actuator. In certain cases, sensors 630 may comprise position sensors that may be used to detect the position of key 614, for example. Consequently, processor 622 can use the program instructions associated with triggering the end actuator knife upon detection, through sensors 630, for example, that switch 614 is in first position 616; processor 622 may use 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 program instructions associated with linkage of the end actuator upon detection through sensors 630, eg, that key 614 is in third or fourth position 618a, 618b.
[0225] [0225] The surgical instrument 600 may also comprise wired or wireless communication circuits for communication with the central modular communication controller shown in Figures 1 through
[0226] [0226] Figure 21 is a schematic diagram of a surgical instrument 700 configured to operate a surgical tool described herein, in accordance with one aspect of that description. The 700 Surgical Instrument can be programmed or configured to control distal/proximal translation of a displacement limb, distal/proximal displacement of a closure tube, rotation of the drive shaft, and articulation, either with one or several linkage drive links. In one aspect, the surgical instrument 700 may be programmed or configured to individually control a trigger member, a closure member, a drive shaft member, and/or one or more articulation members. Surgical instrument 700 comprises a control circuit 710 configured to control motor-driven triggering members, closing members, driving shaft members, and/or one or more pivot members. In one aspect, the surgical instrument 700 is representative of a hand-held surgical instrument. In another aspect, the surgical instrument 700 is representative of a robotic surgical instrument. In other respects, the Surgical Instrument 700 is representative of a combination of a handheld and robotic surgical instrument. In various aspects, the surgical stapler 700 may be representative of a linear stapler or a circular stapler.
[0227] [0227] In one aspect, the surgical instrument 700 comprises a control circuit 710 configured to control an anvil 716 and a cutting portion 714 (or cutting element including a sharp cutting edge) of an end actuator 702, a staple cartridge 718, a drive shaft 740 and one or more pivot members 742a, 742b through a plurality of motors 704a to 704e. A position sensor 734 can be configured to provide knife position feedback 714 to the control circuit 710. Other sensors 738 can be configured to provide feedback to the control circuit 710. A timer/counter 731 provides timing information. and counting to control circuit 710. A power source 712 may be provided to operate motors 704a through 704e and a current sensor 736 provides motor current feedback to control circuit 710. Motors 704a through 704e may be operated individually - ly by the control circuit 710 in an open-loop or closed-loop feedback control.
[0228] [0228] 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 circuit 731 provides an output signal, such as elapsed time or a digital count, to control circuit 710 to correlate the position of knife 714, as determined by position sensor 734, with the output of the knife. timer/counter 731 so that control circuit 710 can determine the position of knife 714 at a specific time (t) relative to an initial position or time (t) when knife 714 is in a specific position relative to a starting position. The 731 timer/counter can be configured to measure elapsed time, count external events, or measure external events.
[0229] [0229] In one aspect, the control circuit 710 can be programmed to control functions of the end actuator 702 based on one or more tissue conditions. The 710 control circuit can be programmed to directly or indirectly sense tissue conditions, such as thickness, as described here. The 710 control circuit can be programmed to select a trigger control program or close 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 best handle different tissue conditions. For example, when thicker fabric is present, control circuit 710 can be programmed to translate the displacement member at a slower speed and/or at a lower power. When thinner tissue is present, the control circuit 710 can be programmed to translate the displacement member at a higher speed and/or with greater power. A closure control program can control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of the drive shaft 740 and pivot members 742a, 742b.
[0230] [0230] In one aspect, the control circuit 710 can generate motor setpoint signals. Motor setpoint signals can be provided to various 708a to 708e motor controllers. Engine controllers 708a through 708e may comprise one or more circuits configured to provide engine start signals to engines 704a through 704e in order to drive engines 704a through 704e as described herein. In some examples, motors 704a to 704e may be brushed direct current electric motors. For example, the speed of motors 704a to 704e may be proportional to the respective motor drive 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 supplied to one or more stator windings of motors 704a to 704e. Also, in some examples, the motor controllers 708a through 708e may be omitted and the control circuit 710 may directly generate the motor drive signals.
[0231] [0231] In one aspect, the control circuit 710 may initially operate each of the motors 704a through 704e in an open circuit configuration for a first open circuit portion of the travel member's stroke. Based on the response of surgical instrument 700 during the open-loop portion of the stroke, control circuit 710 may select a trigger control program in a closed-loop configuration. The instrument response may include a translation of the distance from the displacement member during the open circuit portion, an elapsed time during the open circuit portion, the power supplied to one of the motors 704a to 704e during the open circuit portion, a sum of pulse widths of a motor drive signal, etc. After the open circuit portion, control circuit 710 may implement the selected trigger control program for a second portion of the displacement member stroke. For example, during a portion of the closed-loop stroke, control circuit 710 may modulate one of the motors 704a to 704e based on translating data describing a closed-loop displacement member position to translate the displacement member to a constant speed.
[0232] [0232] In one aspect, motors 704a through 704e may receive power from a power source 712. The power source 712 may be a DC power source driven by an AC mains power supply, a battery, a super capacitor, or any other suitable power source. Motors 704a to 704e can be mechanically coupled to individual movable mechanical elements such as knife 714, anvil 716, drive shaft 740, articulation 742a and articulation 742b, via respective transmissions 706a to 706e. Transmissions 706a to 706e may include one or more gears or other connecting components to couple the engines 704a to 704e to the moving mechanical elements. A position sensor 734 may detect a position of knife 714. Position sensor 734 may be or include any type of sensor that is capable of generating position data that indicates a position of knife 714. In some examples, the position sensor 734 may include an encoder configured to supply a series of pulses to control circuit 710 as knife 714 translates distally and proximally. Control circuit 710 can track pulses to determine the position of knife 714. Other suitable position sensors can be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals that indicate the movement of knife 714. Also, in some examples, position sensor 734 may be omitted. When any of the motors 704a to 704e is a stepper motor, the control circuit 710 can track the position of the knife 714 by aggregating the number and direction of steps that the motor 704 has been instructed to perform. Position sensor 734 may be located on end actuator 702 or any other portion of the instrument. The outputs of each of the motors 704a to 704e include a torque sensor 744a to 744e to sense force and have an encoder to sense the rotation of the drive shaft.
[0233] [0233] In one aspect, the control circuit 710 is configured to drive a trigger member such as the knife portion 714 of the end actuator 702. The control circuit 710 provides a motor setpoint for a motor control 708a , which provides a start signal for the 704a motor. The motor output drive shaft 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a which is coupled to the knife 714. The transmission 706a comprises moving mechanical elements, such as rotating elements, and a triggering member to control distally and proximally the movement of the knife. 714 along a longitudinal axis of the end actuator 702. In one aspect, the motor 704a may be coupled to the knife gear assembly, which includes a knife gear reduction assembly that includes a first drive gear. knife drive and a second knife drive gear. A torque sensor 744a provides a trigger force feedback signal to the control circuit 710. The trigger force signal represents the force required to trigger or move the knife 714. A position sensor 734 can be configured to provide the position of the knife 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end actuator 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 702. control circuit 710. When ready for use, control circuit 710 can provide a trigger signal to motor control 708a. In response to the trigger signal, the motor 704a may drive the trigger member distally along the longitudinal axis of the end actuator 702 from an initial proximal position of the stroke to a terminal distal position of the stroke relative to to the initial course position. As the displacement member translates distally, a knife 714 with a cutting element positioned at a distal end advances distally to cut tissue located between the staple cartridge 718 and the anvil 716.
[0234] [0234] In one aspect, the control circuit 710 is configured to drive a closing member, such as the anvil portion 716 of the end actuator 702. The control circuit 710 provides a motor setpoint for a motor control. 708b, which provides a drive signal to the motor 704b. The 704b motor output drive shaft is coupled to a 744b torque sensor. Torque sensor 744b is coupled to a transmission 706b which is coupled to anvil 716. Transmission 706b comprises movable mechanical elements, such as rotating elements and a closing member, to control the movement of 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 mesh with the closing sprocket. The 744b torque sensor provides a closing force feedback signal to the 710 control circuit. The closing force feedback signal represents the closing force applied to the anvil 716. 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 in the end actuator 702 can provide the closing force feedback signal to the control circuit 710. A pivoting anvil 716 is positioned opposite the staple cartridge 718. When ready for use, the control circuit 710 can provide a close signal to the motor control 708b. In response to the closing signal, the motor 704b advances a closing member to clamp the tissue between the anvil 716 and the staple cartridge 718.
[0235] [0235] 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 to a 708c motor control, which provides a start signal to the 704c motor. The output drive 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 rotating elements, to control the rotation of the drive shaft 740 clockwise or counterclockwise. -time up to and above 360º. In one aspect, the 704c motor is coupled to a swivel drive assembly, which includes a tube gear segment that is formed over (or attached to) the proximal end of the proximal closure tube for operable engagement by a gear set. rotational that is operationally supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational 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 circuit. control 710.
[0236] [0236] In a circular stapler implementation, the 706c drive element is coupled to the trocar to advance or retract the trocar. In one aspect, the drive shaft 740 is part of a closure system comprising a trocar 201904 and a trocar actuator 201906, as discussed in more detail with reference to Figures 29A through 29 later in this document. Accordingly, control circuit 710 controls motor control circuit 708c to control motor 704c to advance or retract the trocar. A 744c torque sensor is provided to measure the torque applied by the 704c motor drive shaft to the 706c transmission components employed in advancing and retracting the trocar. Position sensor 734 may include a variety of sensors to track the position of the trocar, anvil 716, or knife 714, or any combination thereof. Other sensors 738 may be employed to measure a variety of parameters including the position or velocity of the trocar, the anvil 716 or the knife 714, or any combination thereof. Torque sensor 744c, position sensor 734 and sensors 738 are coupled to control circuit 710 as inputs to various processes to control the operation of surgical instrument 700 in a desired manner.
[0237] [0237] In one aspect, the control circuit 710 is configured to pivot the end actuator 702. The control circuit 710 provides a motor set point to a motor control 708d, which provides a drive signal to the 704d engine. The output drive shaft of the 704d motor is coupled to a 744d torque sensor. Torque sensor 744d is coupled to a transmission 706d which is coupled to a pivot member 742a. Transmission 706d comprises movable mechanical elements, such as articulation elements, to control articulation of end actuator 702 + 65°. In one aspect, the motor 704d is coupled to a pivot nut, which is pivotally seated on the proximal end portion of the distal column portion and pivotally driven therein by a pivot gear assembly. The 744d torque sensor provides a linkage force feedback signal to the 710 control circuit. The linkage force feedback signal represents the linkage force applied to the 702 end actuator. a linkage encoder can provide the linkage position of the end actuator 702 to the control circuit 710.
[0238] [0238] In another aspect, the articulation function of the robotic surgical system 700 may comprise two articulation members, or links, 742a, 742b. These pivot members 742a, 742b are driven by separate disks at the robot interface (the rack), which are driven by the two motors 708d, 708e. When separate trigger motor 704a is provided, each pivot link 742a, 742b can be actuated antagonistically with respect to the other link to provide resistive holding motion and a load to the head when it is not moving and to provide a joint movement when the head is articulated. Pivot members 742a, 742b attach to the head at a fixed radius when the head is rotated. Consequently, the mechanical advantage of the push and pull link changes when the head is rotated. This change in mechanical advantage may be more pronounced with other linkage drive systems.
[0239] [0239] In one aspect, the one or more motors 704a to 704e may comprise a brushed DC motor with a gearbox and mechanical linkages to a trigger member, closing member or pivot member. Another example includes electric motors 704a to 704e which operate the moving mechanical elements such as the displacement member, pivot links, closing tube and drive shaft. An external influence is an unreasonable and unpredictable influence of things like tissue, surrounding bodies, and friction on the physical system. This external influence can be called drag,
[0240] [0240] In one aspect, the 734 position sensor can be implemented as an absolute positioning system. In one aspect, position sensor 734 may comprise an absolute rotary magnetic positioning system implemented as a single integrated circuit rotary magnetic position sensor, ASSOSSEQFT, available from Austria Microsystems, AG. The 734 position sensor can interface with the 710 control circuit to provide an absolute positioning system. The position can include multiple Hall effect elements situated 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 to calculate hyperbolic and trigonometric functions that require only addition, subtraction, bit shift, and table lookup operations.
[0241] [0241] In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 may be positioned on the end actuator 702 and adapted to work with the surgical instrument 700 to measure the various parameters. - derivatives such as span distance as a function of time, tissue compression as a function of time and anvil deformation as a function of 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 a current sensor for rasita, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other sensor suitable for measuring one or more parameters of the end actuator 702. Sensors 738 may include one or more sensors. Sensors 738 may be located on the platform of staple cartridge 718 to determine tissue location using segmented electrodes. Torque sensors 744a through 744e can be configured to detect forces such as trigger force, closing force, and/or linkage force, among others. Accordingly, the control circuit 710 can detect (1) the closing load experienced by the distal closing tube and its position, (2) the firing member in the rack and its position, (3) which portion of the cartridge blade 718 has fabric therein and (4) the load and position on both pivot rods.
[0242] [0242] In one aspect, the one or more sensors 738 may comprise a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain on anvil 716 during a pinched condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. Sensors 738 may comprise a pressure sensor configured to sense a pressure generated by the presence of compressed tissue between anvil 716 and staple cartridge 718. Sensors 738 may be configured to detect the impedance of a section of tissue lying between the anvil 716 and the staple cartridge 718 which is indicative of the thickness and/or completeness of the tissue situated therebetween.
[0243] [0243] In one aspect, 738 sensors can be implemented as one or more limit switches, electromechanical devices, solid state switches, Hall effect devices, magneto-resistive (MR) devices, giant magneto-resistive (GMR) devices. ), 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, switches can be solid state devices such as transistors (eg FET, junction FET, MOSFET, bipolar and the like). In other implementations, 738 sensors may include conductorless electrical switches, ultrasonic switches, accelerometers, and inertia sensors, among others.
[0244] [0244] In one aspect, the 738 sensors 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 closure tube and the anvil 716 to detect the closure forces applied by the closure tube to 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
[0245] [0245] In one aspect, a current sensor 736 may be used to measure the current drawn by each of the motors 704a to 704e. The force required to advance any of the moving mechanical elements such as the knife 714 corresponds to the current drawn by one of the motors 704a to 704e. The power is converted to a digital signal and supplied to the control circuit 710. The control circuit 710 can be configured to simulate the instrument's actual system response in the controller software. A displacement member can be actuated to move a knife 714 in the end actuator 702 at or near a target speed. Surgical instrument 700 may include a feedback controller, which can be one or any of the feedback controllers, including, but not limited to, a PID controller, a status feedback, a linear quadratic regulator (LQR), and/or or an adaptive controller, for example. Surgical instrument 700 may include a power source to convert the feedback controller signal into a physical input such as housing voltage, pulse width modulated voltage, frequency modulated voltage, current, torque and/or force, for example. Additional details are described in US Patent Application Serial No. 15/636,829, titled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, filed June 29, 2017, which is incorporated herein by reference in its entirety. .
[0246] [0246] The surgical instrument 700 may also comprise wired or wireless communication circuits for communication with the modular communication central controller shown in Figures 1 to 14. The surgical instrument 700 may be the circular stapling instrument equipped with engine 201800 (Figures 24 to 30), 202080 (Figures 31 to 37).
[0247] [0247] Figure 22 illustrates a block diagram of a surgical instrument 750 configured to control various functions in accordance with one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control the distal translation of a displacement member, such as the knife 764, or other suitable cutting element. Surgical instrument 750 comprises an end actuator 752 which may comprise an anvil 766, a knife 764 (including a sharp cutting edge) and a removable staple cartridge 768.
[0248] [0248] The position, movement, displacement and/or translation of a linear displacement member such as the 764 knife can be measured by an absolute positioning system, sensor array and a 784 position sensor. knife 764 is coupled to a longitudinally movable drive member, the position of the knife 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor
[0249] [0249] Control circuit 760 may generate a motor setpoint signal 772. The motor setpoint signal 772 may be provided to a motor controller 758. Motor controller 758 may comprise one or more circuits configured to provide a drive signal from motor 774 to motor 754 to drive motor 754 as described in the present invention. In some examples, the 754 motor may be a DC motor with a brushed DC electric motor. For example, the speed of motor 754 may be proportional to the drive signal of motor 774. In some examples, motor 754 may be a brushless DC electric motor and the drive signal of motor 774 may comprise a PWM signal supplied to a or more stator windings of motor 754. Also, in some examples, motor controller 758 may be omitted, and control circuit 760 may generate motor drive signal 774 directly.
[0250] [0250] The 754 engine can be powered by a power source
[0251] [0251] In a circular stapler implementation, the drive element 756 can be coupled to the trocar to advance or retract the trocar, to the knife 764 to advance or retract the knife 764, or to the anvil 766 to advance or retract the anvil 766. These functions can be implemented with a single engine using a suitable clutch mechanism or they can be implemented using separate engines as shown with reference to Figures 21, for example. In one aspect, transmission 756 is part of a closure system comprising a trocar 201904 and a trocar actuator 201906 as discussed in more detail with reference to Figures 29A through 29C later in this document. Consequently, control circuit 760 controls motor control circuit 758 to control motor 754 to advance or retract the trocar. Similarly, the 754 motor may be configured to advance or retract the knife 764 and advance or retract the anvil 766. A torque sensor may be provided to measure the torque applied by the motor drive shaft 754 to the transmission components 756 employed. in advancing and retracting the trocar, knife 764 or anvil 766, or combinations thereof. Position sensor 784 may include a variety of sensors to track the position of the trocar, knife 764, or anvil 766, or any combination thereof. Other sensors 788 may be employed to measure a variety of parameters including the position or speed of the trocar, knife 764 or anvil 766, or any combination thereof. Torque sensor, 784 position sensor and sensors
[0252] [0252] The 760 control circuit can be in communication with one or more 788 sensors. The 788 sensors can be positioned on the 752 end actuator and adapted to work with the 750 surgical instrument to measure the various derived parameters such as distance span versus time, tissue compression versus time, and anvil stress versus time. The 788 sensors may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an 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. In one aspect, 788 sensors can be configured to determine the position of a trocar in a circular stapler.
[0253] [0253] The one or more sensors 788 may comprise a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain on anvil 766 during a pinch 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 tissue situated therebetween.
[0254] [0254] The 788 sensors can be configured to measure the forces exerted on the 766 anvil by a closing drive system. For example, one or more sensors 788 may be at a point of interaction between the closure tube and the anvil 766 to detect closure forces applied by a closure tube to the anvil.
[0255] [0255] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the knife 764 corresponds to the current drawn by the motor 754. The force is converted to a digital signal and supplied to the circuit. control 760.
[0256] [0256] The 760 control circuit can be configured to simulate the instrument's actual system response in the controller software. A displacement member may be actuated to move a knife 764 in the end actuator 752 at or near a target speed. Surgical instrument 750 may include a feedback controller, which can be one of any feedback controllers, including, but not limited to, a PID controller, a status feedback, LOR, and/or an adaptive controller. , for example. The surgical instrument 750 may include a power source to convert the feedback controller signal into a physical input such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force, for example.
[0257] [0257] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member or knife 764 by a brushed DC motor with gearbox and mechanical links to a linkage system and/or cutting. Another example is the 754 electric motor which operates the displacement member and linkage driver, for example, from an interchangeable drive shaft assembly. An external influence is an unmeasured and unpredictable influence of things like tissue, surrounding bodies, and friction on the physical system. This external influence can be called drag, which acts in opposition to the 754 electric motor. External influence, such as drag, can cause the functioning of the physical system to deviate from a desired operation of the physical system.
[0258] [0258] Several exemplifying aspects are directed to a surgical instrument 750 comprising an end actuator 752 with motor-driven surgical stapling and cutting implements. For example, a motor 754 may drive a displacement member distally and proximally along a longitudinal axis of the end actuator 752. The end actuator 752 may comprise a pivoting anvil 766 and, when configured for use, a staple cartridge 768 positioned opposite the anvil 766. A physician may hold tissue between anvil 766 and staple cartridge 768 as described in the present invention. When ready to use the 750 instrument, the clinician can provide a trigger signal, for example, by pressing a trigger on the 750 instrument. In response to the trigger signal, the 754 motor can drive the displacement member distally along the geo-axis. longitudinal metric of the end actuator 752 from a proximal stroke start position to a stroke start position distal to the stroke start position. As the displacement member moves distally, a knife 764 with a cutting element positioned at a distal end can cut tissue between the staple cartridge 768 and the anvil 766.
[0259] [0259] In various examples, the surgical instrument 750 may comprise a control circuit 760 programmed to control the distal translation of the displacement member, such as the knife 764, for example, based on one or more tissue conditions. . The 760 control circuit can be programmed to directly or indirectly detect tissue conditions, such as thickness, as described here. The 760 control circuit can be programmed to select a trigger control program based on tissue conditions. A trigger control program can describe the distal movement of the dislocation limb. Different trigger control programs can be selected to best handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 can be programmed to translate the displacement member at a slower speed and/or at a lower power. When thinner fabric is present, the control circuit 760 can be programmed to translate the displacement member at a higher speed and/or with greater power.
[0260] [0260] 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 stroke. Based on a response from the instrument 750 during the open circuit portion of the stroke, the control circuit 760 can select a trigger control program. The instrument response may include a translation distance of the displacement member during the open circuit portion, an elapsed time during the
[0261] [0261] The 750 surgical instrument may comprise wired or wireless communication circuits for communication with the central modular communication controller as shown in Figures 1 through
[0262] [0262] Figure 23 is a schematic diagram of a surgical instrument 790 configured to control various functions in accordance with one aspect of the present disclosure. In one aspect, surgical instrument 790 is programmed to control distal translation of a displacement member, such as knife 764. Surgical instrument 790 comprises an end actuator 792 which may comprise an anvil 766, a knife 764 and a 768 removable staple cartridge that is interchangeable with a 796 RF cartridge (shown in dashed line).
[0263] [0263] Referring to Figures 21 to 23, in various aspects, sensors 738, 788 can be implemented as a limit switch, electromechanical device, solid state switches, Hall effect devices, MR devices, GMR devices, magnetometers, between others. In other implementations, the 738, 788 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, switches can be solid state devices such as transistors (e.g. FET, junction FET, MOSFET, bipolar and the like). In other implementations, 738, 788 sensors may include conductorless electrical switches, ultrasonic switches, accelerometers, and inertia sensors, among others.
[0264] [0264] In one aspect, the position sensor 734, 784 can be implemented as an absolute positioning system, which comprises a rotating magnetic absolute positioning system implemented as a rotating magnetic position sensor, with a loop. single integrated, ASSOSSEQFT, available from Austria Microsystems, AG, Austria. Position sensor 734, 784 can interface with control circuit 760 to provide an absolute positioning system. Position may include multiple Hall effect elements situated 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 computing hyperbolic and trigonometric functions. that only require addition, subtraction, bit shift, and table lookup operations.
[0265] [0265] In one aspect, the knife 714, 764 may be implemented as a cutting member comprising a cutting body that operatively supports a fabric cutting blade therein and may additionally include anvil engaging flaps or features and features channel coupling or a base. In one aspect, the staple cartridge
[0266] [0266] The position, movement, displacement and/or translation of a linear displacement member, such as knife 714, 764, or anvil 716, 766, can be measured by an absolute positioning system, a sensor arrangement and a position sensor represented as the position sensor 734, 784. As the knife 714, 764 is coupled to a longitudinally movable drive member, the position of the trocar, knife 714, 764 or anvil 716 , 766 can be determined by measuring the position of the movable driving member longitudinally employing the position sensor 734, 784. Consequently, in the following description, the position, displacement and/or translation of the trocar, the knife 764 or anvil 716, 766 can be reached by position sensor 734, 784 as described here. A control circuit 710, 760 can be programmed to control translation of the displacement member, such as the trocar, knife 764, or anvil 716, 766, as described herein. The control circuit 710, 760, in some examples, may comprise one or more microcontrollers, microprocessors, or other processors suitable for executing the instructions that cause the processor or processors to control the shift member, for example, the trocar, knife 764, or anvil 716, 766 in the manner described. In one aspect,
[0267] [0267] Control circuit 710, 760 can generate a motor setpoint signal 772. The motor setpoint signal 772 (for each motor when multiple motors are used) can be supplied to a motor controller 708a -e, 758. Engine controller 708a-e, 758 may comprise one or more circuits configured to provide an engine start signal 774 to engine 704a-e, 754 to drive engine 704a-e, 754 as described herein . In some examples, the 704a-e, 754 motor may be a brushed DC electric motor. For example, the speed of the 704a-e, 754 motor may be proportional to the drive signal of the 774 motor. In some examples, the 704a-e, 754 motor may be a brushless DC electric motor and the motor drive 774 may comprise a pulse width modulation signal supplied to one or more stator windings of motor 704a-e, 754. Also, in some examples, motor controller 708a-e, 758 may be omitted, and control circuit 710, 760 can generate motor drive signal 774 directly.
[0268] [0268] The 704a-e motor, a battery, a supercapacitor or any other suitable power source. Motor 704a-e, 754 may be mechanically coupled to trocar, knife 764, or anvil 716, 766 via a transmission 706a-e, 756. Transmission 706a-e, 756 may include one or more gears or other gear components. connection to couple motor 704a-e, 754 to trocar, knife 764 or anvil 716, 766. A position sensor 734, 784 can detect a position of the trocar, knife 714, 764 or anvil 716, 766 Position sensor 734, 784 may be or include any type of sensor that is capable of generating position data indicating a position of the trocar 764 or anvil 716, 766. In some examples, the position sensor 734, 784 may include an encoder configured to provide a series of pulses to the control circuit 710, 760 as the trocar, knife 764 or anvil 716, 766 translates distally and proximally. Control circuit 710, 760 can track pulses to determine the position of the trocar, knife 714, 764, or anvil 716, 766. Other suitable position sensors can be used, including, for example, a sensor for proximity. Other types of position sensors may provide other signals that indicate movement of the trocar, knife 764, or anvil 716, 766. Also, in some examples, position sensor 734, 784 may be omitted. When the motor 704a-e, 754 is a stepper motor, the control circuit 710, 760 can track the position of the trocar, knife 714, 764, or anvil 716, 766 by aggregating the number and orientation of steps that the 704a-e engine, 754 was instructed to run. Position sensor 734, 784 may be located on end actuator 702, 752, 792 or any other portion of the instrument.
[0269] [0269] Control circuit 710, 760 may be in communication with one or more sensors 738, 788. Sensors 738, 788 may be positioned on end actuator 702, 752, 792 and adapted to work with surgical instrument 700, 750, 790 to measure the various derived parameters such as span distance as a function of time, tissue compression as a function of time, and anvil stress as a function of time. Sensors 738, 788 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a sensor capacitive, an optical sensor, and/or any other sensors suitable for measuring one or more end actuator parameters 702, 752, 792. Sensors 738, 788 may include one or more sensors.
[0270] [0270] The one or more sensors 738, 788 may comprise a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain on the anvil 716, 766 during a pinched condition. The voltage meter provides an electrical signal whose amplitude varies with the magnitude of the voltage. Sensors 738, 788 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between anvil 716, 766 and staple cartridge 718, 768. Sensors 738, 788 may be designed to detect the impedance of a section of tissue located between the anvil 716, 766 and the staple cartridge 718, 768 which is indicative of the thickness and/or completeness of the tissue located therebetween.
[0271] [0271] Sensors 738, 788 can be configured to measure the forces exerted on the anvil 716, 766 by the closing drive system. For example, one or more sensors 738, 788 may be at a point of interaction between the closing tube and the anvil 716, 766 to detect the closing forces applied by a closing tube to the anvil 716, 766. exerted on the anvil 716, 766 may be representative of the tissue compression experienced by the section of tissue captured between the anvil 716, 766 and the staple cartridge 738, 768. The one or more sensors 738, 788 may be positioned at various interaction points along the closing drive system to detect closing forces applied to the anvil
[0272] [0272] A current sensor 736, 786 may be employed to measure the current drawn by the motor 704a-e, 754. The force required to advance the trocar, knife 714, 764, or anvil 716, 766 corresponds to the current drawn by motor 704a-e, 754. Power is converted to a digital signal and supplied to control circuit 710, 760.
[0273] [0273] Referring to Figure 23, a 794 RF power source is coupled to the 792 end actuator and is applied to the 796 RF cartridge when the 796 RF cartridge is loaded into the 792 end actuator in place of the 796 RF cartridge. of clamps 768. Control circuit 760 controls the delivery of RF energy to the RF cartridge
[0274] [0274] The 790 surgical instrument may also comprise wired or wireless communication circuits for communication with the modular communication central controller shown in Figures 1 to 14. The 790 surgical instrument may be the circular stapling instrument equipped with engine 201800 (Figures 24 to 30), 202080 (Figures 31 to 37).
[0275] [0275] Additional details are described in US patent application Serial No. 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 incorporated herein by reference in its entirety.
[0276] [0276] In some cases, it may be desirable to provide motor-equipped control of a circular stapling instrument. The examples below include only an illustrative version of a circular stapling instrument where a single motor can be used to control both gripping and tissue cutting/stapling via a single rotary actuator. Figure 24 shows an example of a circular stapling instrument equipped with a 201800 motor. The instrument 201800 of this example comprises a stapling head assembly 201802, an anvil 201804, a drive shaft assembly 201806, a grip assembly 201808 and a rotary knob 201812. The 201802 stapling head assembly selectively attaches to the 201804 anvil. The 201802 stapling head assembly is intended to secure fabric between the staple pockets and staple former pockets of the 201804 anvil. - together with the stapling head, it comprises a cylindrical knife 201802 whose purpose is to cut the tissue captured between the stapling head assembly 201802 and the anvil 201804. The stapling head assembly inserts the staples 201802 through the captured tissue between the assembly of 201802 stapling head and 201804 anvil. The 201800 stapling tool can be used to create a secure tomosis (eg, an end-to-end anastomosis) within a patient's gastrointestinal tract or elsewhere. An outer tubular member 201810 is coupled to the actuator handle assembly 201808. The outer tubular member 201810 provides a mechanical base between the stapling head assembly 201802 and the grip assembly 201808.
[0277] [0277] The 201802 stapling head assembly is operable to clamp the fabric, cut the fabric and staple the fabric all in response to a single rotary input communicated through the 201806 drive shaft assembly. linearly translated through the 201806 drive shaft assembly are not required for the 201802 stapling head assembly, although the 201802 stapling head assembly may comprise a translation clutch feature. By way of example only, at least part of the 201802 Staple Head Assembly can be configured in accordance with at least some of the teachings of US Patent Application No. 13/716,318 entitled "Motor Driven Rotary Input Circular Stapler with Modular End Effector" filed December 17, 2012, and published as US Patent Publication No. 2014/0166728, filed June 19, 2014, the disclosure of which is incorporated herein by reference. Other suitable configurations for the 201802 stapling head assembly will be apparent to those skilled in the art, in view of the teachings presented herein.
[0278] [0278] The 201806 Drive Shaft Assembly couples the 201808 Handle Assembly with the 201802 Staple Head Assembly. The 201806 Drive Shaft Assembly comprises a single actuation feature, the 201814 Rotary Drive Actuator shown in Figure 25. The 201814 trigger actuator is intended to trigger the 201802 stapling head assembly to clamp the fabric, cut the fabric, and staple the fabric. Consequently, linear drive via the 201806 drive shaft assembly is not required, although the 201814 rotary drive actuator can translate longitudinally to switch between a fabric gripping mode and a fabric cutting/stapling mode. tissue. For example, the 201814 driver actuator can translate from a first longitudinal position, where rotation of the 201814 driver actuator provides tissue grip in the 201802 stapling head assembly, to a second longitudinal position, where rotation of the 210814 drive actuator provides tissue cutting and stapling on the 201802 stapling head assembly. Some versions of the 201806 drive shaft assembly may include one or more flexible sections. An example of a drive shaft assembly that is configured with flexible sections and that can be incorporated into the 201806 drive shaft assembly is disclosed in US Patent No. 13/716,323 entitled "Motor Driven Rotary Input Circular Stapler with Lockable Flexible Shaft" filed December 17, 2012, and published as US Patent Publication No. 2014/0166718, filed June 19, 2014, the description of which is incorporated herein by reference. Alternatively, the 201806 drive shaft assembly can be rigid along the length of the 201806 drive shaft assembly or have one or more flexible sections configured in some other way.
[0279] [0279] A grip assembly 201808 is shown in Figures 25 to 27. The grip assembly 201808 comprises a grip housing 201816, a motor housing 201818, a motor 201820, a battery 201822, a rotary knob 201812 and a 201826 trigger ring. The 201818 motor housing is positioned inside the 201816 handle housing. The 201816 handle housing comprises ribs (201827, 201828, 201830, 201832) that extend into the 201816 handle housing for su- carry the 201818 motor housing, as shown in Figure 26. The 201822 battery is positioned proximal to the 201820 motor inside the 201818 motor housing. The 201822 battery can be removed from the 201818 motor compartment for replacement, disposal, or recharged. As best seen in Figure 27, battery 201822 comprises electrical contacts 201834, 201836 that extend distally from battery 201822. Motor 201820 comprises electrical contacts 201838, 201840 that extend proximally from engine 201820 The electrical contact of the battery 201836 and the electrical contact of the motor 201840 are coupled through a conductive metal strap 201842. A screw 201844 couples the band 201842 to the housing of the motor 201818 to fix the position of the band 201842 in relation to to the motor housing 201818. Consequently, the band 201842 is configured to constantly couple the electrical contact of the battery 201836 and the electrical contact of the motor 201840.
[0280] [0280] As shown in Figure 27, an electrical contact of battery 201846 is coupled to a conductive metal strap 201848. The metal strap 201848 is secured to the motor housing 201818 by means of a conductive screw 201854. The electrical contact of the motor 201838 is attached to a conductive metal strap 201852. The metal strap 201852 is attached to the 201818 motor housing by means of a 201850 conductive screw. The 201818 motor housing is formed from an electrically insulating material (e.g. plastic ) and comprises annular contacts 201856, 201858 wrapped around the motor housing 201818. Bolts 201850, 201854 are each coupled with a respective annular contact 201856, 201858 to electrically couple the electrical contact of the battery 201834 and motor electrical contact 201838 to annular contacts 201856, 201858, respectively.
[0281] [0281] Another conductive metal strap 201860 is attached to the housing of the handle 201816. Each end of the metal strap 201860 forms a respective spring contact 201862, 201864. Motor housing 201818 translates proximally and/or distally with respect to to the grip housing 201816 to selectively couple and/or uncouple the spring contacts 201862, 201864 with the annular contacts 201856, 201858. In particular, when the motor housing 201818 is in a distal position, the spring contact 201862 engages annular contact 201856 and spring contact 201864 engages annular contact 201858 to couple the 201822 battery to the 201820 motor and provide power to the motor
[0282] [0282] A proximal end of the motor housing 201818 is fixedly attached to the knob 201812, as shown in Figure 25. In one aspect, the knob 201812 can be coupled to a motor to turn the knob 201812. The knob swivel 201812 protrudes proximally from handle housing 201816 and comprises slots 201868 that extend distally from knob 201812. Handle housing 201816 comprises matching teeth 201870 to selectively engage slots 201868. Swivel knob 201812 is pulled and/or pushed to translate motor housing 201818 into the housing of the 201816 handle. When the knob 201812 is in a proximal position, the slots 201868 are disengaged from the housing of the 201816 handle so that the knob 201812 and the 201818 motor housings are free to rotate with respect to the 201816 handle housing. This placement is used to provide Perform manual actuation of the 201802 stapling head assembly. When the 201812 knob is in a distal position, the 201868 slots engage the corresponding teeth 201870 in the 201816 grip housing to lock the 201812 knob and 201818 motor housing rotating relative to the grip housing
[0283] [0283] An operating mode selection assembly is positioned distal to the 201818 motor housing inside the grip housing
[0284] [0284] As shown in Figure 28A, grooves 201876 of second gear 201878 are positioned at a proximal end of drive shaft 201880 and extend distally. Grooves 201876 correspond to teeth of first gear 201874, so grooves 201876 are configured to fit within the recesses defined between the teeth. A pair of annular flanges 201882 are positioned at a distal end of the drive shaft 201880 and extend outwardly to engage an annular rib 201884 that extends into the housing of the grip 201816, thereby securing the longitudinal position of the second. gear 201878 inside the housing of the handle 201816. Although the annular rib
[0285] [0285] First gear 201874 is positioned around second gear 201878, as shown in Figures 28A and 28B. First gear 201874 is fixedly coupled to a distal end of motor housing 201818 so that first gear 201874 translates and rotates unitarily with the motor housing.
[0286] [0286] Again with reference to Figures 25 to 26, a distal end of the second gear 201878 is coupled to the actuator actuator 201814, so that the rotation of the second gear 201878 rotates the actuator actuator 201814. Consequently, when the second gear 201878 is turned, driver actuator 201814 is turned to adjust the gap distance d between anvil 201804 and stapling head assembly 201802. Handle housing 201816 additionally comprises a trigger ring 201826 and the coupling member 201890. Coupling member 201890 is clamped around recess 201892 of actuator actuator 201814, as shown in Figure 25. Consequently, coupling member 201890 translates with actuator actuator 201814, but the actuator actuator 201814 is free to rotate within the coupling member 201890. The coupling member 201890 comprises protuberances that extend outward from the coupling member 20 1890 that connect to the trigger ring
[0287] [0287] When the trigger ring 201826 is in a distal position, the protuberances 201890 of the coupling member are positioned within the slot 201894 of the housing of the 201816 grip. When the coupling member 201890 is positioned within the slot 201894, the coupling 201890 couples the trigger actuator 201814 with features in the 201802 stapling head assembly operable to adjust the gap distance d between the 201804 anvil and the 201802 stapling head assembly. For example, if the 201890 coupling element is rotated clockwise within slot 201894, span distance d is decreased to close anvil 201804 with respect to stapling head assembly 201802. If coupling member 201890 is rotated counterclockwise within slot 2018094 , the span distance d is increased to open the anvil 201804 with respect to the stapling head assembly 201802. A resilient member 201888 is positioned proximal to the mem. coupling member 201890 to tilt coupling member 201890 distally (Figure 25). A coupling member 201890 of the trigger ring 201826 can then be translated proximally through the slots. When the trigger ring 201826 is in the proximal position, the protuberances of the coupling member 201890 are positioned within a slot. When the 201890 coupling member is positioned within a slot, the 201890 coupling member couples the 201814 driver actuator with the features in the 201802 stapling head assembly that drives a knife and staples in response to rotation of actuator actuator 201814. For example, if the coupling element
[0288] [0288] As shown in Figure 26, a 201898 switch is positioned in the 201816 grip housing to align with the 201890 coupling member. When the motor-equipped operating mode is selected, the 201898 switch is configured to mate electrically the 201820 motor and 201822 battery when the 201898 key is pressed, and the 201898 key is configured to electrically decouple the 201820 motor and 201822 battery when the 201898 key is not pressed. Coupling member 201890 is configured to engage and depress key 201898 when coupling member 201890 is rotated.
[0289] [0289] Referring now to Figures 29A to 29C, in the present example, the instrument 201800 comprises a closing system and a triggering system. The closing system comprises a trocar 201904, a trocar actuator 201906 and a rotary knob 201812 (Figure 24). As previously discussed, the knob 201812 can be coupled to a motor to turn the knob 201812 clockwise or counterclockwise. Anvil 201804 can be attached to a distal end of Trocar 201904. Rotary Knob 201812 is operable to longitudinally translate Trocar 201904 relative to Stapling Head Assembly 201802, thus translating Anvil 201804 when Anvil 201804 is attached to the Trocar 201904, for clamping tissue between anvil 201804 and stapling head assembly 201804. The firing system comprises a trigger, a trigger actuation assembly, a trigger actuator 201908 and a staple driver 201910 The staple driver 201910 includes a cutting element, such as a knife 201912, configured to cut the fabric when the staple driver 201910 is driven longitudinally. In addition, the staples 201902 are positioned distally to a plurality of staple driver members 201910 so that the staple driver 201910 also drives the staples 201902 distally when the staple driver 201910 is longitudinally actuated. In this way, when the 201910 staple driver is driven through the 201908 driver actuator, the 201912, 201914 cutting limbs substantially simultaneously cut through the 201916 tissue and drive the 201902 staples distally of the 201802 staple head assembly into the tissue. . The components and functionality of the closing system and triggering system will be described in more detail below.
[0290] [0290] As shown in Figures 29A through 29C, the 201804 anvil is selectively attachable to the 201800 instrument to provide a surface against which the 201902 clamps can be curved to clamp material contained between the 201802 stapling head assembly and the anvil 201804. The anvil 201804 of the present example is selectively attachable to a trocar or pointed rod 201904 that extends distally from the stapling head assembly
[0291] [0291] The anvil head 201920 of the present example comprises a plurality of staple forming pockets 201936 formed on a proximal face 201940 of the anvil head 201920. Consequently, when the anvil 201804 is in the closed position and the staples 201902 are routed out of the stapling head assembly 201802 into the staple former pockets 201936, as shown in Figure 29C, the legs 201938 of the staples 201902 are folded to form the complete staples.
[0292] [0292] With anvil 201804 as a separate component, it should be understood that anvil 201804 may initially be inserted and attached to a portion of fabric 201916 before being attached to the stapling head assembly 201802. by way of example, the anvil 201804 can be inserted and secured to a first tubular tissue portion 201916 while the instrument 201800 is inserted and secured to a second tubular tissue portion 201916. For example, the first tubular tissue portion 201916 can be sutured to or around a portion of the anvil 201804, and the second tubular tissue portion 201916 may be sutured to or around the trocar
[0293] [0293] As shown in Figure 29A, anvil 201804 is then attached to trocar 201904. Trocar 201904 of the present example is shown in a more distal actuated position. Such an extended position for Trocar 201904 can provide a larger area to which tissue 201916 can be attached prior to attachment of anvil 201804. In addition, the extended position of Trocar 20190400 may also provide easier attachment of anvil 201804 to the trocar 201904. Trocar 201904 additionally includes a tapered distal tip. Such a tip may be able to pierce through tissue and/or assist in the insertion of the 201804 anvil into the 201904 trocar, although the tapered distal tip is merely optional. For example, in other versions, Trocar 201904 may have a blunt tip. In addition, or alternatively, the 201904 Trocar may include a magnetic portion (not shown) that can attract the 201804 Anvil towards the 201904 Trocar. Of course still additionally, the configurations and arrangements for the 201804 Anvil and the 201904 Trocar will be evident to those skilled in the art in view of the teachings of the present invention.
[0294] [0294] When anvil 201804 is attached to trocar 201904, the distance between a proximal face of anvil 201804 and a distal face of the stapling head assembly 201802 defines a span distance d. The trocar 201904 of the present example is longitudinally translatable in relation to the stapling head assembly 201802 through an adjustment knob 201812 (Figure 24) located at a proximal end of the actuator handle assembly.
[0295] [0295] Still referring to Figures 29A to 29C, a user sutures a portion of the tissue 201916 around the tubular member 201944 so that the head of the anvil 201920 is situated within a portion of the tissue 201916 to be stapled . When tissue 201916 is attached to anvil 201804, retaining clips 201924 and a portion of tubular member 201922 protrude out of tissue 201916 so that the user can attach anvil 201804 to trocar 201904. With tissue 201916 attached to the 201904 and/or another portion of the 201802 stapling head assembly, the user attaches the 201804 anvil to the 201904 trocar and drives the 201804 anvil proximally toward the 201802 stapling head assembly to reduce the span distance d. When the 201800 instrument is within operating range, the user then staples together the ends of the 201916 fabric, thereby forming a substantially contiguous tubular portion of the fabric.
[0296] [0296] The stapling head assembly 201802 of the present example is coupled to a distal end of the drive shaft assembly 201806 and comprises a tubular housing 201926 housing a sliding staple driver 201910 and a plurality of staples 201902 contained within of staple pockets 201928. The drive shaft assembly 201806 of the present example comprises an outer tubular member 201942 and a driver actuator 201908. The staples 201902 and staple pockets 201928 are arranged in a circular array over the tubular housing 201926. In the present example, staples 201902 and staple pockets 201928 are arranged in a pair of concentric annular rows of staples 201902 and staple pockets 201928. The staple driver 201910 is intended to act longitudinally inside the tubular housing 201926 in response to rotation of actuator handle assembly 201808 (Figure 24). As shown in Figures 29A to 29C, the clamp driver 201910 comprises a cylindrical member having a trocar opening 201930, a central recess 201932, and a plurality of members 201914 arranged circumferentially around the central recess 201932 and extending distally of the drive shaft assembly 201806. Each member 201914 is configured to contact and engage a corresponding clip 201902 of the plurality of clips 201902 within the clip pockets
[0297] [0297] The 201800, 202080 motor-equipped circular clipping instruments described here with reference to Figures 24 to 31 can be controlled using any of the control circuits described in connection with Figures 16 to 23. For example, the 470 control system described with reference to Figure 16. Additionally, the 201800 motor-equipped circular stapling instrument can be employed in a cloud environment and central controller as described in connection with Figures 1 to 15. Circular Stapler Control Algorithms
[0298] [0298] In various aspects the present description provides a motor-equipped stapling device that is configured with the circular stapler control algorithms to provide interlocks based on operating conditions and varied reactions based on type and conditions of operation. crash. In one aspect, a stapling device control algorithm can be configured to initiate discretionary and mandatory latches based on the marginal and necessary conditions for the motor-equipped stapler to operate. In another aspect, the reaction of mandatory electronic lockouts is to prohibit a device from working until the situation is resolved. Locks Based on Operating Conditions
[0299] [0299] In one aspect, a stapling device control algorithm can be configured to initiate discretionary and mandatory latches based on the marginal and necessary conditions for the motor-equipped stapler to operate. In one aspect, a control algorithm for a stapling device can be configured to implement both mandatory and discretionary latches based on parameters detected within the system. A discretionary lock pauses the automatic execution of a sequential operation, but can be overridden by user input, for example. A mandatory lock prevents the next sequential step, causing the user to back up an operation step and resolve the crash condition that induced the crash, for example. In one aspect, both compulsory and discretionary locks may have bounded upper and lower bounds. Consequently, a motor-equipped stapling device may comprise a combination of mandatory and discretionary interlocks.
[0300] [0300] In one aspect, a motor-equipped circular clipping device may comprise an adjustable electronic interlock that can prevent a system from actuation or adjust its function based on the detected condition and a secondary measurement. In one respect, the secondary measure could include the severity of the failure, a user input, or predefined comparison crash table, for example. Varied Reactions Based on Interlock Type and Conditions
[0301] [0301] The reaction of mandatory electronic interlocks is to prohibit a device from working until the situation is resolved. On the other hand, the reaction to a discretionary lock may be more subtle.
[0302] [0302] In one aspect, a stapling instrument can be configured to implement various control mechanisms to prevent or adjust the instrument's function based on the type of lockout. In one aspect, mandatory interlocks could be exclusively electronic, mechanical interlocks, or a combination of the two. In many ways that have two locks, the locks could be redundant or optionally used based on device settings. In one aspect, discretionary locks can be electronic locks, so they can be adjustable based on detected parameters. For example, discretionary interlocks can be a mechanical interlock that is electronically disabled, or they can be an electronic-only interlock.
[0303] [0303] Figure 31 is a graphical representation of a first pair of graphs 202000, 202020 depicting the anvil span and tissue compression force as a function of time for illustrative shots of a stapling instrument, according to the least one aspect of the present description. The tissue compression force F can also be expressed as the force to close (FTC). The 202000 top graph represents three separate anvil opening curves 202002, 202004, 202006 representative of anvil gap closure over time at three separate tissue compression forces, as shown in the 202020 bottom graph, where the span from anvil to is shown along the vertical axis and time is shown along the horizontal axis. The anvil span curves 202002, 202004, 202006 represent the anvil closing of a circular stapling device equipped with a 202080 motor (Figure 33) as a function of time t for fabric of variable hardness, constant thickness, and span. from the constant anvil õ, until the adjustment(s) of the anvil span to be made by a control algorithm. A control algorithm implemented by any of the control circuits described herein with reference to Figures 1 to 23 can be configured to adjust the anvil span in accordance with the sensed tissue compression force F compared to one or more different thresholds.
[0304] [0304] Turning now briefly to Figure 33, a schematic diagram of a circular stapling device equipped with a 202080 engine is shown illustrating the valid fabric span ô, the actual span ôreal, the normal range span ö2, and the off-range span. lane 53, in accordance with at least one aspect of the present disclosure. The motor-equipped circular stapling device 202080 includes a circular stapler 202082 and an anvil 202084, which retracts from an open position to a closed position to secure the tissue between the anvil 201084 and the stapler 202082. the anvil 202084 is completely clamped over the fabric, there will be a gap defined between the anvil 202084 and the stapler 202082. When the circular stapler 202082 is fired (e.g. triggered), the formation of the staple is dependent on the fabric gap 5. As shown in Figure 33, for a normal range span 62, clamps 202088 are well formed. When gap 4 is too small, clamps 202086 are very well formed and when gap 5 is too large, clamps 202090 are loosely formed.
[0305] [0305] Returning now to Figure 31, with reference to the top and bottom graphs 202000, 202020 and Figure 33, at the instant to the anvil 201084 is initially opened beyond the maximum anvil span ômax before the anvil 201084 reaches the point initial tissue contact 202008 at time t1. As shown, due to constant tissue thickness, t1 is a common tissue contact point for tissue having varying tissue hardness. At instant t1, the anvil span δ is still outside the ideal triggering zone 202016 shown between a maximum anvil span Δmax, defining a higher trip-locking threshold 202012, and a minimum anvil span μmin 202014, defining a lower trigger lock threshold 202014. From the initial contact point of tissue 202008 at time t, as anvil 201084 continues to close, the compressive force of tissue F begins to increase. The tissue compressive strength F will vary as a function of the tissue's biomechanical properties in terms of hardness. As indicated in the 202020 background graph, normal hardness fabric is represented by a first compressive strength curve of fabric 202022, high hardness fabric is represented by a second compressive strength curve of fabric 202024, and the low hardness fabric is represented by a third fabric compressive strength curve 202026.
[0306] [0306] As anvil 201084 continues to close between the maximum anvil span between ômax and the minimum anvil span ômin, the anvil span à reaches a point of the constant anvil span 202018 at instant to. As shown in the background graph 202020, at time t2 > the fabric compression force F for normal hardness fabric represented by the first fabric compression force curve 202022 is within the ideal trigger zone 202036, which is defined between a maximum compression force Fmax, setting an upper warning limit of 202032, and a minimum compression force Fmin, setting a lower warning limit
[0307] [0307] From time t2 to time t3, the anvil 201084 is kept in a constant span 5, as shown in the top graph 202000, by the three curves of the span of the anvil 202002, 202004 and 202006. This period of constant span 3, enables fabric deformation as shown in graph 202020, during which the average fabric compression force F slowly drops as shown by the three fabric compression force curves 202022, 202024 and 202026. The deformation of tissue is a phase that is inserted after the tissue is clamped and the average tissue compression force F reaches a predetermined limit and the closing movement of the anvil 201084, so that the anvil 201084 and the stapler 202082 hold the tissue between them for a predetermined time before starting the firing phase in which the staples and knife are deployed. During the tissue deformation phase the average tissue compressive force F drops over the time period between t2 and t3. Tissue, in part because it is composed of solid and liquid material, tends to stretch when compressed. One way to compensate for this property is "tissue warping". When tissue is compressed, a certain amount of tissue deformation can occur. Leaving the tissue compressed for an adequate period of time under certain circumstances to achieve tissue deformation can therefore yield benefits. One benefit may be proper clamp formation. This can contribute to an even staple line. Consequently, a certain amount of time can be given to allow tissue deformation before firing.
[0308] [0308] Now with reference also to Figure 23, after a period in which the anvil span ô is kept constant to allow the deformation of the tissue, at the instant ts, before the implantation of the clamps, the control circuit 760 at point 202010 determines whether a possible adjustment of the anvil 766 in relation to the staple cartridge 764 (anvil 201804 and stapler 202084 in Figure 33) is necessary. Consequently, the control circuit 760 determines whether the tissue compression force F is between the ideal trigger zone 202036, above the maximum compression force limit Fmax 202032, or below the minimum compression force limit Fmin 202034 and makes any Necessary adjustments for the anvil gap to. If the tissue compressive force F is between the ideal firing zone 202036, the control circuit 760 deploys the staples in the staple cartridge 768 and deploys the knife 764.
[0309] [0309] If the tissue compression force F is above the maximum compression force limit Fmax 202032, the 760 control circuit is configured to register an alert that the compression force is too tight and the anvil gap adjustment à, increases the waiting time before firing, decreases the firing speed, or enables a firing lock, or any combination thereof. The control circuit 760 can adjust the anvil gap by advancing the anvil 766 distally, for example in the opposite direction, of the staple cartridge 768 (the anvil 201804 and the stapler 202084 in Figure 33) to increase the anvil gap. à as shown by the segment of the anvil span curve 2002004 beyond the instant tz. As shown by the tissue compressive force curve segment 202024 beyond time t3, after the control circuit 760 increases the anvil span 6, the tissue compressive force F decreases within the ideal trigger zone 202036.
[0310] [0310] If the tissue compression force F is below the minimum compression force limit Fmin 202034, the 760 control circuit is configured to register an alert that the compression force is too loose and the anvil gap adjustment à, proceed with caution, or enable a trigger lock, or any combination thereof. Control circuit 760 is configured to adjust the gap of anvil 3 by retracting anvil 766 proximally, for example towards staple cartridge 768 (anvil 201804 and stapler 202084 in Figure 33) to decrease the anvil gap accordingly. shown by the segment of the curve of the anvil gap 2002006 beyond time t3, as shown by the segment of the curve of the compression force of the tissue 202026 beyond the instant t3, after the decrease of the gap of the anvil 3, the compression strength of the tissue F increases within the optimal trigger zone
[0311] [0311] Returning now to Figure 32, there is shown a graphic representation of a second pair of graphics 202040, 202060 representing the anvil span and tissue compression force as a function of time for illustrative shots of a stapling instrument, according to with at least one aspect of the present description. Top graph 202040 represents three separate anvil span curves 202042, 202046, 202046 representative of anvil span closure over time in three tissue thicknesses, where anvil span is shown along the geometric axis vertical and time is shown along the horizontal axis. The anvil span curves 202042, 202044, 202046 represent the anvil closure of a circular stapling device equipped with a 202080 motor (Figure 33) as a function of time t for fabric of variable thickness, constant hardness, and constant anvil span õ , until the adjustment(s) of the anvil span 5 is(are) made by a control algorithm. A control algorithm implemented by any of the control circuits described herein with reference to Figures 1 to 23 can be configured to adjust the anvil span in accordance with the sensed tissue compression force F compared to one or more different thresholds.
[0312] [0312] Referring now to the top and bottom graphs 202040, 202060 and Figure 33, at instant to the anvil 201084 is initially opened beyond the span of the anvil ômax before the anvil 201084 reaches a first tissue contact point 202048 for high-thickness fabric at time t1, where the compressive force curve from fabric 202064 to high-thickness fabric starts to increase. At time t1, the anvil span 3 is still outside the ideal trigger zone 202056 shown between a maximum anvil span Δmax, defining an upper tripping latch threshold 202052, and a minimum anvil span ômin, defining a latching threshold. bottom trigger 202054. As shown, due to constant tissue hardness and varying tissue thickness, the 201084 anvil contacts tissue at different times. For example, time t7 is a first fabric contact point 202048 for fabric that has high fabric thickness, time t2 is a second fabric touch point for fabric of normal thickness, and time t; is a 202058 third fabric contact point for thin fabric.
[0313] [0313] The first curve of the compressive force of tissue 202062 represents the compressive force for tissue of normal thickness and begins to increase at the instant t> when tissue of normal thickness initially comes into contact with the anvil 201804. The second curve from the compressive strength of the fabric 202064 represents the high thickness fabric and starts to increase at time t; when the thick tissue initially comes into contact with the anvil 201804. The third tissue compressive force curve 202066 represents the thin tissue and starts to increase at the instant ta when the thin tissue initially enters in contact with the anvil
[0314] [0314] As anvil 201084 continues to close between the maximum anvil span ômax and the minimum anvil span ômin, the anvil span à reaches a constant anvil span point at instant ta. As shown in background graph 202060, at instant ta the tissue compression force F for normal thickness tissue represented by the first tissue compression force curve 202062 is within the ideal trigger zone 202076, which is defined between a force of maximum compression Fmax, setting an upper warning limit of 202072, and a minimum compression force Fmin, defining a lower warning limit of 202074. At time t4 the compression force of the fabric F for the high-thickness fabric is represented by the second fabric compression force curve 202064 is above the upper warning limit 202072 outside the ideal trigger zone 202076 and the fabric compression force for the thin fabric represented by the third fabric compression force curve 202066 is below the lower alert threshold 202074 outside the ideal trigger zone 202076.
[0315] [0315] From the time ta to the time ts, the anvil 201084 is maintained in a constant span ôõ, as shown in the top graph 202040, by the three curves of the span of the anvil 202042, 202044 and 202046. This constant span period 3, enables tissue deformation as shown in graph 202060, during which the average tissue compression force F slowly drops as shown by the three tissue compression force curves 202062, 202064 and 202066. The tissue deformation is a phase that is inserted after the tissue is clamped and the average compression force of the tissue F reaches a predetermined limit and the closing motion of the anvil 201084, so that the anvil 201084 and the stapler 202082 hold the tissue between them for a predetermined time before starting the firing phase in which the staples and knife are deployed. During the tissue deformation phase the average tissue compressive force F drops over the time period between t2 and t3. Tissue, in part because it is composed of solid and liquid material, tends to stretch when compressed. One way to compensate for this property is "tissue warping". When tissue is compressed, a certain amount of tissue deformation can occur. Leaving the tissue compressed for an adequate period of time under certain circumstances to achieve tissue deformation can therefore yield benefits. One benefit may be proper clamp formation. This can contribute to an even staple line. Consequently, a certain amount of time can be given to allow tissue deformation before firing.
[0316] [0316] Now with reference also to Figure 23, after a period in which the span of the anvil 5 is kept constant to allow the deformation of the tissue, at the instant ts, before the implantation of the clamps, the control circuit 760 at point 202050 determines whether a possible adjustment of anvil 766 in relation to staple cartridge 764 (anvil 201804 and stapler 202084 in Figure 33) is necessary. Consequently, the control circuit 760 determines whether the tissue compressive force F is within the ideal trigger zone 202076, above the maximum compressive force limit Fmax 202072, or below the minimum compressive force limit Fmin 202074 and makes any Adjustments needed for anvil gap 5. If the tissue compressive force F is between the ideal firing zone 202076, the control circuit 760 deploys the staples to the staple cartridge 768 and deploys the knife 764.
[0317] [0317] If the tissue compression force F is above the maximum compression force limit Fmax 202072, the 760 control circuit is configured to register an alert that the compression force is too tight and the anvil gap adjustment à, increases the waiting time before firing, decreases the firing speed, or enables a firing lock, or any combination thereof. The control circuit 760 can adjust the anvil gap by advancing the anvil 766 distally, for example in the opposite direction, of the staple cartridge 768 (the anvil 201804 and the stapler 202084 in Figure 33) to increase the anvil gap. 5 as shown by the anvil span curve segment 2002044 beyond time ts. As shown by the tissue compressive force curve segment 202064 beyond time ts, after the control circuit 760 increases the anvil span δ, the tissue compressive force F decreases within the ideal trigger zone 202076.
[0318] [0318] If the tissue compression force F is below the minimum compression force limit Fmin 202074, the 760 control circuit is configured to register an alert that the compression force is too loose and the anvil gap adjustment oh, proceed with caution, or enable a trigger lock, or any combination thereof. The control circuit 760 is configured to adjust the anvil span δ by retracting the anvil 766 proximally, for example, toward the staple cartridge 768 (the anvil 201804 and the stapler 202084 in Figure 33) to decrease the anvil span accordingly. shown by the segment of the anvil span curve 202046 beyond the time ts. As shown by the tissue compressive force curve segment 202066 beyond time ts, after decreasing the anvil span 3, the tissue compressive force F increases into the optimal trigger zone
[0319] [0319] With reference to Figures 31 to 32, in one aspect, the anvil span can be determined by the controller 620 based on readings from the closing motor 603 as described with reference to Figure 20, for example. In one aspect, the anvil span can be determined by control circuit 710 based on readings from position sensor 734 coupled to anvil 716 as described with reference to Figure 21, for example. In one aspect, the span of anvil 5 may be determined by control circuit 760 based on readings from position sensor 784 coupled to anvil 766 as described with reference to Figures 22 and 23, for example.
[0320] [0320] With reference to Figures 31 to 32, in one aspect, the fabric compression force F can be determined by the controller 620 based on readings from the closing motor 603 as described with reference to Figure 20. For example, the tissue compressive strength F can be determined based on the motor current draw, where the higher current draw when closing the anvil is related to the greater tissue compressive strength. In one aspect, tissue compression force F can be determined by control circuit 710 based on readings from sensors 738, such as strain gauges, coupled to anvil 716 or staple cartridge 718 as described with reference to Figures 21, for example. In one aspect, tissue compression force F can be determined by control circuit 760 based on readings from sensors 788, such as strain gauges, coupled to anvil 766 as described with reference to Figures 22 to 23, for example.
[0321] [0321] Figure 34 is a logic flow diagram of a 202100 process representing a control program or logic configuration to provide discretionary or mandatory latches according to detected parameters compared to thresholds according to at least one aspect of the present description. As shown in Figure 34, according to a comparison of the anvil span measured against one or more limits and the measured tissue compressive force F (also called FTC) against one or more limits, an algorithm control system can enable the instrument to be triggered (eg triggered), without limitations, implement a discretionary lockout (eg provide an alert to the user) or implement a mandatory lockout of the instrument.
[0322] [0322] Consequently, with reference to Figures 22, 33 and 34, process 202100 will be described with reference to Figures 22 to 32. Control circuit 760 implements the algorithm for executing process 202100 where anvil 766 in Figure 23 is shown as anvil 202084 in Figure 33 and staple cartridge 768 in Figure 22 is shown as stapler 202082 in Figure 33. Additional details regarding the setup and operation of a circular stapling device 202080 equipped with a motor are described here with reference to Figures 24 to 30. Returning to process 202100, the control circuit 760 determines the span of anvil 5 as described in connection with Figures 31 and 32 based on the position sensor readings 784 coupled to anvil 766. When anvil span ô is ô3 > ômá,, the anvil span is out of range and the control circuit 760 engages a mandatory latch 202104. When anvil span 5 is ómaax > 52 > Omin, the anvil gap is in range and the control circuit 760 determines 202106 the fabric compression force F (FTC) as described with reference to Figure 36. As described above, the fabric compression force can be determined by the control circuit 760 based on the readings from strain gauge sensors 788 coupled to anvil 766 or staple cartridge 768. Alternatively, tissue compression force can be determined based on current draw by the 754 motor.
[0323] [0323] Now referring to Figures 34 and 36, when the FTC is less than an ideal FTC threshold (X; < Ideal FTC), zone A in Figure 36, the control circuit 760 performs 202108 an electronic latch without limits. When the FTC is between a maximum FTC limit and the ideal FTC limit (Max > X2 > Ideal), zone B in Figure 36, the 760 control circuit performs 202110 electronic locks without discretionary limits. In one aspect, under this condition, the control circuit 760 issues a warning in the form of a message or alert (audio, visual, tactile, etc.). When the FTC is greater than a maximum FTC limit (X3 > Margin), zone C in Figure 36, the control circuit performs 202112 discretionary electronic latches with limits. Under this condition, the 760 control circuit issues a warning in the form of a message or alert (audio, visual, tactile, etc.) and applies a wait period before triggering. In many respects, the 202080 circular stapling device includes adjustable electronic interlocks as described herein, which can prevent the 202082 stapler from operating or adjust the function of the 202080 motor-equipped circular stapling device based on a detected condition and on a secondary measure.
[0324] [0324] In one aspect, the control algorithm of the 202080 motor-equipped circular clipping device described in the present invention as the 202100 process can be configured to initiate discretionary and mandatory latches based on marginal and necessary conditions for the clipping device. circular stapling equipped with 202080 motor operate. In one aspect, the 202100 process for the 202080 motor-equipped circular stapling device can be configured to implement both mandatory and discretionary latches based on parameters detected within the system. A discretionary lock pauses the automatic execution of a sequential operation, but can be overridden by user input, for example. A mandatory crash prevents the next sequential step, causing the user to back up an operation step and resolve the crash condition that induced the crash, for example. In one respect, both compulsory and discretionary locks may have bounded upper and lower bounds. Accordingly, the motor-equipped circular clipping device 202080 may comprise a combination of discretionary and mandatory interlocks.
[0325] [0325] In one aspect, the control algorithm of the 202080 motor-equipped circular stapling device described here as the 202100 process can be configured to adjust electronic interlocks that can either prevent a system from actuation or adjust its function based on in the detected condition and a secondary measurement. The detected condition can be FTC, anvil displacement, span 3, clamp formation and the secondary measurement can include fault severity, a user input, or predefined comparison query table, for example.
[0326] [0326] In one aspect, the reaction of mandatory electronic interlocks is to prohibit the 202080 motor-equipped circular stapling device from operating until the situation is resolved. On the other hand, the reaction to a discretionary crash can be more subtle. For example, discretionary locking could include a warning indication, an alert requiring user consent to proceed, a change in the speed or strength of an actuation or waiting time, or a ban on certain functions being performed until the situation is resolved or stabilized. In operation, mandatory conditions for the 202080 motor-equipped circular stapling device may include, for example, having the 202084 anvil fully seated before clamping or the stapler cartridge being loaded with staples before firing. Workable conditions for the 202080 motor-equipped circular stapling device may include, for example, being within the acceptable staple height for a given tissue thickness or a minimum level of tissue compression. Additionally, different conditions could have both discretionary and mandatory level limits on the same parameter, eg power level within the battery.
[0327] [0327] In one aspect, the 202080 motor-equipped circular stapling device can be configured to implement various control mechanisms to prevent or adjust the function of the 202080 motor-equipped circular stapling device based on the type of interlock. In one respect, mandatory interlocks could be exclusively electronic, mechanical interlocks, or a combination of the two. In many ways that have two locks, the locks could be redundant or optionally used based on device settings. In one aspect, discretionary locks may be electronic locks, so they can be adjustable based on detected parameters. For example, discretionary interlocks can be a mechanical interlock that is electronically disabled, or they can be an electronic-only interlock.
[0328] [0328] Figure 35 is a diagram illustrating the anvil bands and corresponding clamp formation, in accordance with at least one aspect of the present disclosure. When the anvil span 202120 is between an upper limit 202126 and a lower limit 202128, clamp formation is adequate and within an acceptable range of clamp heights for a given range of fabric thickness or minimum fabric compression force. When the anvil span 202122 is greater than the upper limit 202126, the clamp formation is loose. When the anvil span 202124 is less than the lower limit 202128, the clamp formation is tight.
[0329] [0329] Figure 36 is a graphical representation 202150 of three force-to-close (FTC) curves 202152, 202154, 202156 as a function of time, in accordance with at least one aspect of the present disclosure. FTC 202152, 202154, 202156 curves are divided into three phases: hold, hold and fire. The grip phase has a common starting point, which means that the fabric has a common thickness and variable stiffness, as described in detail in Figure 31. At the end of the grip phase, there is a waiting period before starting the grip. firing phase to account for tissue deformation.
[0330] [0330] The first curve of FTC 202152 corresponds to fabric that has a low fabric hardness. During the gripping phase, the FTC 202152 curve exhibits an increase in tissue compression force that peaks below the optimal FTC 202158 threshold in zone A. At the end of the gripping phase, the circular stapling device equipped with motor 202080 (Figure 33) waits a user-controlled period 202162 before starting the firing phase to take tissue deformation into account.
[0331] [0331] The second curve of FTC 202154 corresponds to tissue having a normal tissue hardness. During the gripping phase, the FTC 202154 curve exhibits an increase in tissue compression force that peaks below the optimal FTC threshold 202158 and the maximum FTC threshold 202160 in zone B. At the end of the gripping phase, the device circular stapling machine equipped with motor 202080 (Figure 33) waits a user-controlled period 202164 before starting the firing phase to account for tissue deformation.
[0332] [0332] The third curve of FTC 202154 corresponds to fabric that has a high hardness. During the gripping phase, the FTC 202156 curve exhibits an increase in tissue compression force that peaks above the maximum FTC 202160 limit in zone C. At the end of the gripping phase, the circular stapling device equipped with motor 202080 (Figure 33) controls a waiting period 202166 before starting the firing phase to account for tissue deformation.
[0333] [0333] Figure 37 is a detailed graphical representation 202170 of an FTC 202172 curve as a function of time, in accordance with at least one aspect of the present disclosure. As shown, the FTC 202172 curve is divided into three phases: a hold phase, a hold phase, and a trigger phase. During the grip phase, the FTC curve 202172 exhibits an increase in tissue compressive force as indicated by the grip phase segment 202174. After the grip phase, there is a waiting period 202176 before starting the grip phase. shot. The waiting period 20 2176 can be controlled by the user or controlled by the device depending on the value of the fabric compression force in relation to the maximum and ideal compression force limits. During the firing phase, the tissue compression force increases as shown by the curve segment of FTC 202178 and then falls.
[0334] [0334] Various aspects of the subject matter described herein are defined in the following numbered examples: Example 1. A surgical stapling instrument comprising: an anvil configured to hold tissue; a stapler configured to drive surgical staples through tissue and form against the anvil; an anvil-coupled position sensor configured to detect the anvil gap; an anvil-coupled sensor configured to detect tissue compression force; a motor coupled to the anvil, the motor being configured to move the anvil from a first position to a second position; a control circuit coupled to the motor and to the position sensor and to the sensor, and the control circuit is configured to: determine the anvil span; comparing the anvil span to a predetermined span; determine the tissue compression force; comparing tissue compression force to a predetermined tissue compression force; perform an electronic locking process to prevent stapler operation based on comparing anvil span to predetermined span and comparing tissue compression force to a predetermined tissue compression force.
[0335] [0335] While various forms have been illustrated and described, it is not the intention of the claimant to restrict or limit the scope of the appended claims 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. Furthermore, the structure of each element associated with the form may alternatively be described as a means of providing the function performed by the element. In addition, when materials are described for certain components, other materials may be used. It is to be understood, therefore, that the foregoing description and the appended claims are intended to include all such modifications, combinations, and variations within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, alterations, substitutions, modifications and equivalents.
[0336] [0336] The preceding detailed description presented various forms of 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 may be implemented , individually and/or collectively, across a wide range of hardware, software, firmware, or practices.
[0337] [0337] The instructions used to program the logic to perform the various aspects described may be stored in 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 may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy disks, optical discs, memory-only compact discs, read-only memory (CD-ROMs), and magneto-optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, flash memory, or a tangible, machine-readable storage media used to transmit information over the Internet through electrical, optical, acoustic, or other forms of propagated signals (e.g., carriers, infrared signals, digital signals, etc.). Accordingly, non-transient computer-readable media includes any type of machine-readable media suitable for storing or transmitting instructions or electronic information in a form readable by a machine (eg, a computer).
[0338] [0338] As used in any aspect of the present invention, the term "control circuit" may refer to, for example, a set of wired, programmable circuits (e.g., a computer processor). which includes one or more individual instruction processing cores, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state machine circuitry, firmware that stores instructions executed by the programmable circuit, and any combination thereof. The control circuit may, collectively or individually, be incorporated as an electrical circuit that is part of a larger system, e.g. an integrated circuit (IC), an application-specific integrated circuit (ASIC), an on-chip system (SoC) ), desktop computers, laptop computers, tablet computers, servers, smart phones, etc. Accordingly, as used in the present invention, "control circuit" includes, but is not limited to, electrical circuits that have at least one discrete electrical circuit, electrical circuits that have at least one discrete electrical circuit. integrated electronic circuits
[0339] [0339] As used in any aspect of the present invention, the term "logic" may refer to an application, software, firmware, and/or circuit configured to perform any of the aforementioned operations. The software may be embedded as a software package, code, instructions, instruction sets, and/or data recorded on non-transient computer-readable storage media. Firmware can be embedded as code, instructions or sets of instructions and/or hard coded (eg, non-volatile) data in memory devices.
[0340] [0340] As used in any aspect of the present invention, the terms "component", "system", "module" and the like may refer to a computer-related entity, whether hardware, a combination of hardware and software, software or software running.
[0341] [0341] As used herein in any aspect, an "algorithm" refers to the self-consistent sequence of steps that lead to the desired result, where a "step" refers to the manipulation of physical quantities and/or logical states that can, though need not, necessarily take the form of electrical or magnetic signals that can be stored, transferred, combined, compared and otherwise manipulated. It is common usage 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 those quantities and/or states.
[0342] [0342] A network may include a packet switched network. Communication devices may be able to communicate with each other using a selected packet-switched network communications protocol. An example communications protocol may include an Ethernet communications protocol that may enable communication using a transmission control protocol/Internet protocol (TCP/IP). The Ethernet protocol may conform 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 that standard. Alternatively or additionally, communication devices may be able to communicate with each other using an X.25 communications protocol. The X.25 communications protocol may conform or be compatible with a standard promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, communication devices may be able to communicate with each other using a frame-relay communications protocol. The frame-relay communications protocol may conform or be compatible with a standard promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute.
[0343] [0343] Unless expressly stated to the contrary, as is evident from the preceding description, it is understood that throughout the preceding description, discussions that use terms such as "processing", or "computation", or "calculation", or " determination", or "display", or the like, refers to the action and processes of a computer, or similar electronic computing device, which manipulates and transforms data represented in the form of physical (electronic) quantities in the records and in computer memories on other data similarly represented as physical quantities in computer memories or records, or on other similar information storage, transmission or display devices.
[0344] [0344] One or more components may be referred to in the present invention as "configured for", "configurable for", "operable/operational for", "adapted/adaptable for", "capable of", "compliant mable/conformed to", etc. Those skilled in the art will recognize that "configured for" can generally encompass active-state components and/or idle-state components and/or standby-state components, unless the context dictates otherwise.
[0345] [0345] The terms "proximal" and "distal" are used in the present invention with reference to a physician who manipulates the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the physician, and the term "distal" refers to the portion located away from the physician. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "upwards" and "downwards" may be used in the present invention in connection with the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
[0346] [0346] Persons skilled in the art will recognize that, in general, the terms used herein, and particularly in the appended claims (e.g. bodies of appended claims) are generally intended as "open" terms (e.g. the term "including" shall be interpreted as "including, but not limited to", the term "having" shall be interpreted as "having at least", the term "includes" shall be interpreted as "includes, but not limits to", etc.). It will further be understood by those skilled in the art that where a specific number of an introduced claim mention is intended, such intention will be expressly mentioned in the claim and, in the absence of such a mention, no intention will be present. For example, as an aid to understanding, the following attached claims may contain the use of the introductory phrases "at least one" and "one or more" to introduce claim mentions. However, the use of such phrases should not be interpreted as implying that the introduction of a mention of the claim by the indefinite articles "a, ones" or "an, an" limits any specific claim containing the mention of the claim. introduced 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 "a, a" or "a, a" (e.g. eg, "one, ones" and/or "one, ones" should typically be interpreted to mean "at least one" or "one or more"); the same goes for the use of definite articles used to introduce claim mentions.
[0347] [0347] Furthermore, even if a specific number of an introduced claim mention is explicitly mentioned, those skilled in the art will recognize that such mention typically needs to be interpreted to mean at least the mentioned number (e.g., the mere mention of "two mentions", without other modifiers, typically means at least two mentions, or two or more mentions). Furthermore, in cases where a convention analogous to "at least one of A, B, and C, etc." is used, this construction is usually intended to have the sense in which the convention would be understood (e.g., "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, this construction is usually intended to have the sense in which the convention would be understood (e.g., "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.). It will further be understood by those skilled in the art that typically a disjunctive word and/or phrase having two or more alternative terms, whether in the description, claims or drawings, is to be understood as contemplating the possibility of including one of the terms, either either or both terms, unless the context dictates otherwise. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or
[0348] [0348] With respect to the appended claims, those skilled in the art will understand that the operations mentioned therein may, in general, be performed in any order. Furthermore, although various operational flow diagrams are presented in one or more sequences, it should be understood that the various operations may be performed in orders other than those illustrated, or may be performed simultaneously. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, inverse, or other variant orderings, unless the context dictates otherwise. Furthermore, terms such as "responsive to," "related to," or other adjectival participles are not generally intended to exclude these variants, unless the context dictates otherwise.
[0349] [0349] It is worth noting that any reference to "one (1) aspect", "an aspect", "an exemplification" or "one (1) exemplification", and the like means that a particular feature, structure or characteristic described in aspect connection is included in at least one aspect. Thus, the use of expressions such as "in one (1) aspect", "in one aspect", "in one exemplification", "in one (1) exemplification", in several places throughout this descriptive report does not necessarily refer to - love the same aspect. Furthermore, specific features, structures or features can be combined in any suitable way in one or more aspects.
[0350] [0350] Any patent application, patent, non-patent publication or other descriptive material mentioned in this specification and/or mentioned in any application data sheet is hereby incorporated by reference, to the extent that that the materials incorporated are not inconsistent therewith. In this way, and to the extent necessary,
[0351] [0351] In summary, numerous benefits have been described that result from employing the concepts described in this document. The aforementioned description of one or more embodiments 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 described. Modifications or variations are possible in light of the above teachings. One or more embodiments have been chosen and described for the purpose of illustrating the principles and practical application to thereby enable one skilled in the art to use the various embodiments and with various modifications as may be convenient for the particular use contemplated. The attached claims are intended to define the global scope.

权利要求:
Claims (18)
[1]
1. A surgical stapling instrument comprising: an anvil configured to hold tissue; a stapler configured to push surgical staples through tissue and shape them against the anvil; a position sensor coupled to the anvil configured to detect the anvil gap; an anvil-coupled sensor configured to detect tissue compression force; a motor coupled to the anvil, the motor being configured to move the anvil from a first position to a second position; and a control circuit coupled to the motor and to the position sensor and to the sensor, the control circuit being configured to: determine the anvil span; comparing the anvil span to a predetermined span; determine the tissue compression force; comparing the fabric compression force to a predetermined fabric compression force; perform an electronic locking process to prevent stapler operation based on comparing anvil span to predetermined span and comparing tissue compression force to a predetermined tissue compression force.
[2]
2. Surgical stapling instrument, according to claim 1, characterized in that the control circuit is configured to perform a compulsory electronic locking process to prevent stapler operation when the anvil span is greater than an anvil span limit preset maximum.
[3]
3. Surgical stapling instrument, according to claim 1, characterized in that the control circuit is configured to perform an electronic locking process without limit to prevent stapler operation when the tissue compression force is below a ideal tissue compression force limit.
[4]
4. Surgical stapling instrument, according to claim 1, characterized in that the control circuit is configured to perform a discretionary electronic locking process without limits to prevent stapler operation when the tissue compression force is between a ideal tissue compression force limit and a maximum tissue compression force limit.
[5]
5. Surgical stapling instrument, according to claim 1, characterized in that the control circuit is configured to perform a discretionary electronic locking process with a limit to prevent stapler operation when the tissue compression force is greater than a maximum tissue compression force limit.
[6]
6. Surgical stapling instrument, according to claim 5, characterized in that the control circuit is configured to execute a predetermined waiting period before enabling the operation of the stapler.
[7]
7. A surgical stapling instrument comprising: an anvil configured to hold tissue; a stapler configured to drive surgical staples through tissue and form against the anvil; a first sensor for detecting a first parameter of the surgical stapling instrument; a second sensor for detecting a second parameter of the surgical stapling instrument;
a motor coupled to the anvil, the motor being configured to move the anvil from a first position to a second position; and a control circuit coupled to the motor and the first and second sensors, the control circuit being configured to perform an electronic latching process to prevent stapler operation based on the first and second parameters detected.
[8]
8. Surgical stapling instrument, according to claim 7, characterized in that the control circuit is configured to perform a compulsory electronic locking process to prevent stapler operation when the first parameter detected is greater than a maximum threshold value default for the first parameter.
[9]
9. Surgical stapling instrument, according to claim 7, characterized in that the control circuit is configured to perform an electronic locking process without limit to prevent the operation of the stapler when the second parameter detected is below a limit value ideal for the second parameter.
[10]
10. Surgical stapling instrument, according to claim 7, characterized in that the control circuit is configured to perform a discretionary electronic locking process without limits to prevent stapler operation when the second parameter detected is between a threshold value ideal for the second parameter and a maximum threshold value for the second parameter.
[11]
11. Surgical stapling instrument, according to claim 7, characterized in that the control circuit is configured to perform a discretionary electronic locking process with limits to prevent stapler operation when the second parameter detected is greater than a value maximum limit for the second parameter.
[12]
12. Surgical stapling instrument, according to claim 11, characterized in that the control circuit is configured to execute a predetermined waiting period before enabling the operation of the stapler.
[13]
13. A surgical stapling instrument comprising: an anvil configured to hold tissue; a circular stapler configured to drive surgical staples through tissue and form against the anvil; a first sensor for detecting a condition of the surgical stapling instrument; a second sensor for detecting a secondary measurement of the surgical stapling instrument; a motor coupled to the anvil, the motor being configured to move the anvil from a first position to a second position; and a control circuit coupled to the motor and the first and second sensors, the control circuit being configured to perform an adjustable electronic locking process to prevent actuation of the stapler based on the detected condition and secondary measurement.
[14]
14. Surgical stapling instrument, according to claim 13, characterized in that the adjustable electronic locking process disables the operation of a mechanical locking.
[15]
15. Surgical stapling instrument, according to claim 13, characterized in that the adjustable electronic locking process disables the operation of an electronic locking.
[16]
Surgical stapling instrument according to claim 13, characterized in that the detected condition is the anvil gap and the secondary measurement is the tissue compression force.
[17]
17. Surgical stapling instrument according to claim 16, characterized in that when the anvil span is between a minimum and maximum anvil span limit and the tissue compression force is above a maximum force limit tissue compression, the control circuit must be configured to: increase the anvil span; increasing a predetermined waiting period before actuation of the circular stapler; reduce the speed at which the circular stapler is actuated; or run the adjustable electronic locking process to prevent stapler actuation.
[18]
18. Surgical stapling instrument according to claim 16, characterized in that when the anvil span is between a minimum and maximum anvil span limit and the tissue compression force is below a minimum force limit tissue compression, the control circuit must be configured to: decrease the anvil span; proceed carefully; or run the adjustable electronic locking process to prevent stapler actuation.

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BR112020012908A2|2020-12-08|COMMUNICATION PROVISIONS FOR ROBOT ASSISTED SURGICAL PLATFORMS

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BR112021003621A2|2021-05-18|intelligent detection of the return block through near-field communication modulation and contact quality monitoring signals

---

BR112020013147A2|2020-12-01|ultrasonic energy device that varies the pressure applied by the clamping arm to provide limit pressure control at a cutting progression site

---

BR112020012809A2|2020-11-24|cloud-based medical analysis for linking local trends with resource capture behaviors of larger datasets

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BR112020013102A2|2020-12-01|cloud interface for attached surgical devices

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BR112021003795A2|2021-05-18|first and second communication protocol arrangements for driving primary and secondary devices through a single port

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BR112020013066A2|2020-12-01|surgical systems to detect irregularities in tissue distribution on the end actuator

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US20200405417A1|2020-12-31|Cooperative operation of robotic arms

同族专利:

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公开号 | 公开日

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US20190200997A1|2019-07-04|

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EP3505090A1|2019-07-03|

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EP3505090B1|2020-12-23|

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WO2019133138A1|2019-07-04|

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JP2021509332A|2021-03-25|

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CN111787872A|2020-10-16|

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法律状态:
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优先权:

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申请号 | 申请日 | 专利标题

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

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

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US201862640417P| true| 2018-03-08|2018-03-08|

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US201862692747P| true| 2018-06-30|2018-06-30|

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US201862729185P| true| 2018-09-10|2018-09-10|

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---