Smart Energy Combo Control Option
The surgical system addresses the limitations of existing imaging systems by providing adaptive energy control in surgical end effectors, enabling efficient tissue handling and rapid procedural transitions through dynamic energy algorithm switching.
Patent Information
- Application Number
- JP2023520176
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-10-02
- Filing Date
- 2021-09-29
- Publication Date
- 2025-09-01
- Estimated Expiration
- 2041-09-29
AI Technical Summary
Surgical imaging systems often fail to recognize and convey critical three-dimensional structural information and may not adapt energy modalities effectively during surgical procedures, leading to inefficiencies in tissue handling and procedure speed.
A surgical system with a powered end effector featuring adaptive energy combo control, allowing dynamic switching between energy algorithms based on internal and external parameters, and communication with a surgical hub for real-time adjustments.
Enhances surgical efficiency by enabling rapid transitions between energy modalities, improving tissue handling and overall procedure speed through intelligent energy management.
Smart Images

Figure 0007731980000001 
Figure 0007731980000002 
Figure 0007731980000003
Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application is related to the following concurrently filed applications, the contents of each of which are incorporated herein by reference: ●Agent reference number END9287USNP1, titled METHOD FOR OPERATING TIERED OPERATION MODES IN A SURGICAL SYSTEM. [Background technology]
[0002] Surgical systems often incorporate imaging systems that can enable clinician(s) to view the surgical site and / or one or more portions thereof on one or more displays, such as, for example, a monitor. The display(s) can be local to the surgical theater and / or remote. The imaging system can include a scope with a camera that views the surgical site and transmits the view to a display viewable by the clinician. Scopes include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, esophagogastroduodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, ureteroscopes, and exoscopes. Imaging systems may be limited by the information they can recognize and / or convey to the clinician(s). For example, certain hidden structures, physical contours, and / or dimensions in three-dimensional space may not be recognized during surgery by a particular imaging system. Additionally, certain imaging systems may not be able to communicate and / or convey certain information to the clinician(s) during surgery. Summary of the Invention [Means for solving the problem]
[0003] According to embodiments of the present invention, a surgical system may include a graduated access feature. The surgical system may be used to analyze at least a portion of a surgical field. Based on control parameters, the system may scale various capabilities, such as visualization processing, endocutter communication, endocutter algorithm updates, smart cartridge connectivity, smart motor control for the circular stapler, smart energy control, cloud analytics, hub connectivity control, and / or hub visualization and control interaction. Control parameters may include, for example, system aspects such as processing power or bandwidth and / or identification of an appropriate service tier.
[0004] According to further embodiments of the present invention, the following examples are provided. 1. A powered surgical end effector having controllable jaws configured to operate on tissue; 1. A powered surgical end effector comprising: a first electrode configured to deliver a first energy configured to seal tissue within the controllable jaws, the first energy being operated by a first energy algorithm; a second electrode configured to deliver a second energy configured to seal tissue within the controllable jaws, the second energy being operated by a second energy algorithm; an updatable memory storing a default control algorithm configured to simultaneously control both the first energy algorithm and the second energy algorithm; and a processor, the processor configured to: operate in a first mode at a first time, wherein in the first mode, the processor is configured to operate according to the default control algorithm; and receive data that causes the processor to automatically operate in a second mode at a second time after the first time, wherein in the second mode, the processor is configured to operate according to an alternative control algorithm configured to simultaneously update control of both the first energy algorithm and the second energy algorithm.
[0005] A powered surgical end effector is thus provided with an adaptive energy combo control option. Accordingly, the powered end effector, in conjunction with its associated energy combo instrument or system, has at least two energy modalities (e.g., RF monopolar, RF bipolar, and ultrasonic). Each energy algorithm can dynamically control energy application as the device progresses through different stages of operation, e.g., tissue coagulation and tissue cutting. Furthermore, according to various examples above, the energy algorithm can be automatically and simultaneously adjusted based on other parameters, such as internal device parameters, tissue impedance, or measurements related to external sources (e.g., EMR databases, other instrumentation in the procedure, situational awareness). By providing an updatable memory that can then cause the processor to operate according to a second mode with an alternate control algorithm, the surgical end effector can be reconfigured for two different energy algorithms for surgical stapling effective for different surgical situations requiring different energy modalities. The ability to switch from a default control algorithm to an alternate control algorithm is important to enable surgical procedures to move quickly from one stage to another, for example, within the same overall surgical procedure. This may improve the overall speed at which stapling is performed with different energy modalities during a surgical procedure, and thus the overall effectiveness of the surgery being performed. 2. The powered surgical end effector described in Example 1, further comprising a transmitter and a receiver configured to establish a communication path between the powered surgical end effector and an external device. 3. The powered surgical end effector of example 2, wherein the data received at the second time is from an external device via a receiver. 4. The powered surgical end effector of example 3, wherein the external device is a surgical hub. 5. The powered surgical end effector of example 3, wherein the external device is a cloud computing system. 6. A powered surgical end effector as described in any one of Examples 1 to 5, wherein the data received at the second time relates to one or more control parameters including power consumption, temperature, applied pressure, and / or tissue characteristics.
[0006] Different values of these control parameters may be effective at different stages of the surgical procedure. 7. A powered surgical end effector as described in any one of Examples 1 to 5, wherein the data received at the second time relates to a measure of force exerted by the powered surgical end effector.
[0007] Thus, this embodiment may provide dynamic feedback from the end effector indicative of the current surgical situation, and in this manner, the end effector may be adapted to operate in a second mode that is more appropriate and effective for the current surgical situation. 8. A powered surgical end effector as described in any one of Examples 1 to 5, wherein the data received at the second time relates to supplemental information including situational awareness, hospital input, and / or user input. 9. The powered surgical end effector of Example 8, wherein the second mode updates the power level and / or clamp pressure of the powered surgical end effector. 10. A powered surgical end effector comprising: a controllable jaw configured to operate on tissue; a first electrode configured to deliver a first energy configured to seal tissue within the controllable jaw, wherein the first energy sealing system is operated by a first energy algorithm; a second electrode configured to deliver a second energy configured to seal tissue within the controllable jaw, wherein the second energy sealing system is operated by a second energy algorithm; an updatable memory storing a default control algorithm configured to simultaneously control both the first energy algorithm and the second energy algorithm; and a processor configured to determine whether to operate in a first mode or a second mode, wherein in the first mode the processor is configured to operate according to the default control algorithm and in the second mode the processor is configured to operate according to an alternative control algorithm configured to simultaneously update control of both the first energy algorithm and the second energy algorithm.
[0008] A powered surgical end effector is thus provided with an adaptive energy combo control option. Accordingly, the powered end effector, in conjunction with its associated energy combo instrument or system, has at least two energy modalities (e.g., RF monopolar, RF bipolar, and ultrasonic). Each energy algorithm can dynamically control energy application as the device progresses through different stages of operation, e.g., tissue coagulation and tissue cutting. Furthermore, according to various examples above, the energy algorithm can be automatically and simultaneously adjusted based on other parameters, such as internal device parameters, tissue impedance, or measurements related to external sources (e.g., EMR databases, other instrumentation in the procedure, situational awareness). By providing an updatable memory that can then cause the processor to operate according to a second mode with an alternate control algorithm, the surgical end effector can be reconfigured for two different energy algorithms for surgical stapling effective for different surgical situations requiring different energy modalities. The ability to switch from a default control algorithm to an alternate control algorithm is important to enable surgical procedures to move quickly from one stage to another, for example, within the same overall surgical procedure. This may improve the overall speed at which stapling is performed with different energy modalities during a surgical procedure, and thus the overall effectiveness of the surgery being performed. 11. A powered surgical end effector as described in Example 10, further comprising a transmitter and a receiver configured to establish a communication path between the powered surgical end effector and an external device. 12. The powered surgical end effector of example 11, wherein the external device is a surgical hub. 13. The powered surgical end effector of example 11, wherein the external device is a cloud computing system. 14. A powered surgical end effector described in any one of Examples 10 to 13, wherein the decision to operate in the first mode or the second mode is based on one or more control parameters including power consumption, temperature, applied pressure, and / or tissue characteristics.
[0009] Different values of these control parameters may be effective at different stages of the surgical procedure. 15. A powered surgical end effector described in any one of Examples 10 to 13, wherein the decision to operate in the first mode or the second mode is based on a measure of force exerted by the powered surgical end effector.
[0010] Thus, this embodiment can provide dynamic feedback from the end effector indicative of the current surgical situation, and the end effector can be adapted to operate in a second mode that is more appropriate and effective for the current surgical situation. 16. A powered surgical end effector described in any one of Examples 10 to 13, wherein the decision to operate in the first mode or the second mode is based on supplemental information including situational awareness, hospital input, and / or user input. 17. A powered surgical end effector as described in Example 16, wherein the second mode updates the power level and / or clamp pressure of the powered surgical end effector. 18. A surgical hub comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and a powered surgical end effector; and a processor, wherein the processor is configured to: determine whether communication is available with the powered surgical end effector configured to operate in a first mode or a second mode, wherein in the first mode the powered surgical end effector operates according to a default control algorithm configured to simultaneously control both a first energy algorithm and a second energy algorithm; receive data from the powered surgical end effector via the receiver; determine based on the received data whether the surgical end effector should operate in the first mode or the second mode; and based on the determination, transmit updated data to operate the powered surgical end effector in the second mode, wherein in the second mode the surgical end effector operates according to an alternative control algorithm configured to simultaneously update control of both the first energy algorithm and the second energy algorithm.
[0011] The surgical hub thus provides an adaptive energy combo control option for the surgical end effector. In this way, the surgical hub can operate the powered surgical end effector according to a second mode with an alternate control algorithm as opposed to the default control algorithm. The surgical end effector can be reconfigured for effective surgical stapling for different surgical situations requiring different energy modalities for two different energy algorithms. The ability to switch from the default control algorithm to the alternate control algorithm is important for allowing stages of a surgical procedure to move quickly from one to the other, for example, within the same overall surgical procedure. This can improve the overall speed at which stapling with different energy modalities is performed during a surgical procedure and, ultimately, the overall effectiveness of the procedure being performed. Because communication availability is determined, the switch from the first mode based on the default control algorithm to the second mode based on the alternate control algorithm occurs only if communication is available. This means that in the absence of a connected environment, the end effector operates in its standard (default) configuration with no algorithm updates, and treatment can proceed regardless of whether communication with the hub is available. Thus, if a communication failure occurs, the surgical procedure can continue, however, when hub communication is available, energy control and updates can be adapted to system conditions. 19. The surgical hub of Example 18, wherein the determination of whether communication is available is determined by available processing power, memory, bandwidth, software revision, or subscription level. 20. The surgical hub of Examples 17 or 18, wherein the data relates to supplemental information including situational awareness, hospital input, and / or user input.
[0012] According to a further embodiment of the present invention, there is provided a powered surgical end effector comprising: a controllable jaw configured to operate on tissue; an updatable memory having a default actuation algorithm stored thereon; and a processor configured to: operate in a first mode at a first time, wherein the processor is configured to operate aspects of the controllable jaw according to the default actuation algorithm; and receive data causing the processor to operate in a second mode at a second time after the first time, wherein the processor is configured to operate aspects of the controllable jaw according to an alternative actuation algorithm.
[0013] According to a further embodiment of the present invention, there is provided a powered surgical end effector comprising: a controllable jaw configured to operate on tissue; an updatable memory having a default actuation algorithm stored therein; and a processor configured to determine whether to operate in a first mode or a second mode, wherein in the first mode the processor is configured to operate aspects of the jaw according to the default actuation algorithm and wherein in the second mode the processor is configured to operate aspects of the jaw according to an alternative actuation algorithm.
[0014] According to a further embodiment of the present invention, a surgical hub is provided comprising: a transmitter and a receiver configured to establish a communication path between the surgical hub and a powered surgical end effector; and a processor configured to: determine whether communication is available with a powered surgical end effector configured to operate in a first mode or a second mode, wherein in the first mode the powered surgical end effector operates aspects of a controllable jaw according to a default actuation algorithm stored in an updatable memory of the powered surgical end effector; receive data from the powered surgical end effector via the receiver; determine based on the received data whether the surgical end effector should operate in the first mode or the second mode; and based on the determination, transmit updated data for operating the powered surgical end effector in the second mode, wherein in the second mode the powered surgical end effector operates aspects of the controllable jaw according to an alternative actuation algorithm. [Brief explanation of the drawings]
[0015] [Figure 1] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 2] 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. [Figure 3] 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, according to at least one aspect of the present disclosure. [Figure 4] 1 illustrates a surgical data network comprising a modular communications hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one aspect of the present disclosure. [Figure 5]1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 6] 1 illustrates a surgical hub comprising multiple modules coupled to a modular control tower, according to at least one embodiment of the present disclosure. [Figure 7] 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 8] 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. [Figure 9] 1 shows a diagram of a context-aware surgical system according to at least one aspect of the present disclosure. [Figure 10] 1 illustrates a timeline of an exemplary surgical procedure and inferences that a surgical hub can make from data detected at each step in the surgical procedure, in accordance with at least one aspect of the present disclosure. [Figure 11] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 12] FIG. 1 is a block diagram illustrating a functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 13] FIG. 1 is a block diagram of a computer-implemented interactive surgical system configured to adaptively generate control program updates for modular devices, in accordance with at least one aspect of the present disclosure. [Figure 14] 1 illustrates a surgical system including a handle having a controller and a motor, an adapter releasably coupled to the handle, and a loading unit releasably coupled to the adapter, according to at least one aspect of the present disclosure. [Figure 15A] 1 illustrates an example flow for determining an operating mode and operating in the determined mode, in accordance with at least one aspect of the present disclosure. [Figure 15B]1 illustrates an example flow for changing an operational mode in accordance with at least one aspect of the present disclosure. [Figure 16] FIG. 1 is a schematic diagram of a robotic surgical instrument configured to manipulate a surgical tool described herein, in accordance with at least one aspect of the present disclosure. [Figure 17] FIG. 1 shows a block diagram of a surgical instrument programmed to control distal translation of a displacement member, according to at least one aspect of the present disclosure. [Figure 18] FIG. 1 is a schematic diagram of a surgical instrument configured to control various functions, according to at least one aspect of the present disclosure. [Figure 19] 1 is a system configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communications hub, according to at least one aspect of the present disclosure. [Figure 20] 1 illustrates an example of a generator, according to at least one embodiment of the present disclosure. [Figure 21] 1 is a surgical system including a generator and various surgical instruments usable with the generator, according to at least one aspect of the present disclosure. [Figure 22] FIG. 1 is a diagram of a context-aware surgical system according to at least one aspect of the present disclosure. [Figure 23A] 1 illustrates a first exemplary modular energy system configuration including a header module and a display screen presenting a graphical user interface (GUI) for relaying information about modules connected to the header module, according to at least one embodiment of the present disclosure. [Figure 23B] 24B is a diagram of the modular energy system shown in FIG. 24A mounted on a cart, according to at least one embodiment of the present disclosure. [Figure 24A]1 is a second exemplary modular energy system configuration including a header module, a display screen, an energy module, and an extended energy module connected together and mounted on a cart, according to at least one embodiment of the present disclosure. [Figure 24B] 25B is a third exemplary modular energy system configuration similar to the second configuration shown in FIG. 25A, except that the header module lacks a display screen, according to at least one embodiment of the present disclosure. [Figure 25] 10 is a fourth exemplary modular energy system configuration including a header module, a display screen, an energy module, an extended energy module, and a technology module connected together and mounted on a cart, according to at least one embodiment of the present disclosure. [Figure 26] 10 is a fifth exemplary modular energy system configuration including a header module, a display screen, an energy module, an extended energy module, a technology module, and a visualization module connected together and mounted on a cart, according to at least one embodiment of the present disclosure. [Figure 27] FIG. 10 is a diagram of a modular energy system including communicatively connectable surgical platforms, according to at least one embodiment of the present disclosure. [Figure 28] FIG. 1 is a perspective view of a header module of a modular energy system including a user interface, according to at least one embodiment of the present disclosure. [Figure 29] FIG. 1 is a block diagram of a stand-alone hub configuration of a modular energy system according to at least one embodiment of the present disclosure. [Figure 30] FIG. 10 is a block diagram of a hub configuration of a modular energy system integrated with a surgical control system, according to at least one aspect of the present disclosure. [Figure 31] FIG. 1 is a block diagram of a user interface module coupled to a communication module of a modular energy system according to at least one embodiment of the present disclosure. [Figure 32] FIG. 1 is a block diagram of an energy module of a modular energy system according to at least one embodiment of the present disclosure. [Figure 33A] FIG. 1 illustrates a block diagram of an energy module coupled to a header module of a modular energy system, according to at least one embodiment of the present disclosure. [Figure 33B] FIG. 1 illustrates a block diagram of an energy module coupled to a header module of a modular energy system, according to at least one embodiment of the present disclosure. [Figure 34A] 1 illustrates a block diagram of a header / user interface (UI) module of a hub modular energy system, according to at least one embodiment of the present disclosure. [Figure 34B] 1 illustrates a block diagram of a header / user interface (UI) module of a hub modular energy system, according to at least one embodiment of the present disclosure. [Figure 35] FIG. 10 is a block diagram of an energy module of a hub, according to at least one embodiment of the present disclosure. [Figure 36] 1 illustrates a system for communication between a surgical instrument, a surgical hub, and a cloud computing system according to at least one aspect of the present disclosure. [Figure 37] FIG. 10 illustrates a logic flow diagram of a process for updating an algorithm of a surgical instrument, in accordance with at least one aspect of the present disclosure. [Figure 38] FIG. 10 illustrates another logic flow diagram of a process for updating an algorithm of a surgical instrument, in accordance with at least one aspect of the present disclosure. [Figure 39] FIG. 10 illustrates another logic flow diagram of a process for updating an algorithm of a surgical instrument, in accordance with at least one aspect of the present disclosure. [Figure 40] FIG. 10 illustrates a logic flow diagram of a process for a surgical hub to update algorithms of a surgical instrument, according to at least one aspect of the present disclosure. [Figure 41]1 illustrates a logic flow diagram of a process for altering or blending energy modalities of a surgical instrument based on detected threshold parameters, in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0016] The applicant of the present application owns the following concurrently filed U.S. patent applications, each of which is incorporated herein by reference in its entirety: • U.S. Patent Application No. 16 / 562,170 (Attorney Docket No. END9070USNP8), entitled "MANAGING SIMULTANEOUS MONOPOLAR OUTPUTS USING DUTY CYCLE AND SYNCHRONIZATION," filed September 5, 2019, now U.S. Patent Application Publication No. 2020 / 0078079.
[0017] 1 , a computer-implemented interactive surgical system 100 may include one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 may include at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one example, as shown in FIG. 1 , a surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with each other and / or with the hub 106. In some aspects, a surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P may be integers greater than or equal to 1.
[0018] In various aspects, visualization system 108 may include one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIG. 2. In one aspect, visualization system 108 may include interfaces for HL7, PACS, and EMR. The various components of visualization system 108 are described under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1), entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the entire disclosure of which is incorporated herein by reference.
[0019] As shown in FIG. 2 , primary display 119 is positioned in the sterile field for visibility to the operator of operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 may include a first non-sterile display 107 and a second non-sterile display 109 facing opposite each other. Visualization system 108, guided by hub 106, is configured to utilize displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, hub 106 may cause visualization system 108 to display snapshots of the surgical site recorded by imaging device 124 on non-sterile display 107 or 109 while maintaining a live video of the surgical site on primary display 119. The snapshots on non-sterile display 107 or 109 may, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.
[0020] In one aspect, the hub 106 may also be configured to send diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to a primary display 119 in the sterile field for viewing by a sterile operator at the operating table. In one example, the input may be in the form of a modification to a snapshot displayed on the non-sterile display 107 or 109, which may be sent by the hub 106 to the primary display 119.
[0021] 2 , a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 may also be configured to coordinate information flow to the display of the surgical instrument 112. See, for example, U.S. Patent Application Publication No. 2019-0200844(A1), entitled “METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY,” filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 can be sent by the hub 106 to the surgical instrument display 115 in the sterile field, where it can be viewed by the operator of the surgical instrument 112. Exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, under the heading "Surgical Instrument Hardware" in U.S. Patent Application Publication No. 2019-0200844(A1) entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, the entire disclosure of which is incorporated herein by reference.
[0022] FIG. 2 shows an example of a surgical system 102 being used to perform a surgical procedure on a patient lying on an operating table 114 in an operating room 116. A robotic system 110 may be used as part of the surgical system 102 in the surgical procedure. The robotic system 110 may include a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. While the surgeon views the surgical site through the surgeon's console 118, the patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 through a minimally invasive incision in the patient's body. Images of the surgical site are acquired by a medical imaging device 124, which may be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 may be used to process and then display images of the surgical site to the surgeon through the surgeon's console 118.
[0023] Other types of robotic systems can be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019-0201137(A1), entitled "METHOD OF ROBOTIC HUB COMMUNICATION, DETECTION, AND CONTROL," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,407), the entire disclosure of which is incorporated herein by reference.
[0024] Various examples of cloud-based analytics methods implemented by the cloud 104 and suitable for use with the present disclosure are described in U.S. Patent Application Publication No. 2019-0206569(A1), entitled "METHOD OF CLOUD BASED DATA ANALYTICS FOR USE WITH THE HUB," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,403), the entire disclosure of which is incorporated herein by reference.
[0025] In various embodiments, the imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors may include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.
[0026] The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. The one or more illumination sources may be directed to illuminate a portion of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.
[0027] The one or more illumination sources may be configured to emit electromagnetic energy within the visible spectrum as well as the invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or luminous spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and is sometimes referred to as visible light or simply light. The typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.
[0028] The invisible spectrum (i.e., non-radiative spectrum) is the portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths less than about 380 nm and greater than about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, which constitutes invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, which constitutes invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.
[0029] In various aspects, imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cystoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngological-nephroscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.
[0030] Imaging devices may employ multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths, including frequencies beyond the visible light range, e.g., IR and ultraviolet light. Spectral imaging can extract additional information that cannot be captured by the red, green, and blue receptors of the human eye. The use of multispectral imaging is described in more detail under the heading "Advanced Imaging Acquisition Module" in U.S. Patent Application Publication No. 2019-0200844(A1), entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY," filed December 4, 2018 (U.S. Patent Application No. 16 / 209,385), the entire disclosure of which is incorporated herein by reference. Multispectral monitoring can be a useful tool for repositioning the surgical field after the surgical task is complete to perform one or more of the above-mentioned tests on the treated tissue. It is self-evident that strict sterilization of the operating room and surgical equipment is necessary in any surgical procedure. The strict hygiene and sterilization conditions required in the "surgical field," i.e., the operating room or procedure room, require the highest possible sterility of all medical devices and equipment. Part of the above sterilization process includes the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It is understood that the sterile field can be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field can be considered the area immediately surrounding the patient prepared for the surgical procedure. The sterile field can include cleaned team members wearing appropriate clothing, as well as all equipment and fixtures within the area.
[0031] Referring now to FIG. 3 , a hub 106 is shown in communication with a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, a storage array 134, and an operating room mapping module 133. In certain embodiments, as shown in FIG. 3 , the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128. During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, the aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines. An embodiment of the present disclosure presents a surgical hub for use in a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combination generator module slidably receivable within the hub enclosure's docking station. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one embodiment, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.In one embodiment, the fluid line is a first fluid line, and a second fluid line extends from a remote surgical site to an aspiration and irrigation module slidably received within the hub enclosure. In one embodiment, the hub enclosure includes a fluid interface. Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular enclosure 136 is configured to house and facilitate interactive communication between various generators. One advantage of the hub's modular enclosure 136 is that it allows for rapid removal and / or replacement of various modules. Aspects of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure includes a first energy generator module configured to generate a first energy for application to tissue and a first docking station including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts and the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts. In addition to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data and second power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts and the second energy generator module is slidably movable out of electrical engagement with the second power and second data contacts.In addition, the modular surgical enclosure also includes a communication bus between the first and second docking ports configured to facilitate communication between the first and second energy generator modules. Referring to FIG. 3 , an aspect of the present disclosure is presented regarding a hub modular enclosure 136 that enables modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, and 128. The generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit slidably insertable into the hub modular enclosure 136. The generator module 140 may be configured to connect to a monopolar device 142, a bipolar device 144, and an ultrasonic device 146. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular enclosure 136. The hub modular enclosure 136 may be configured to facilitate insertion of multiple generators and interactive communication between the generators docked to the hub modular enclosure 136 such that the multiple generators function as a single generator.
[0032] FIG. 4 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 can also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network and configure each port within the network hub 207 or network switch 209. An intelligent surgical data network may be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.
[0033] Modular devices 1a-1n located in an operating room may be coupled to a modular communication hub 203. A network hub 207 and / or a network switch 209 may be coupled to a network router 211 to connect devices 1a-1n to the cloud 204 or a local computer system 210. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to the network switch 209. The network switch 209 may be coupled to the network hub 207 and / or a network router 211 to connect devices 2a-2m to the cloud 204. Data associated with devices 2a-2n may be transferred to the cloud 204 via the network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to the local computer system 210 for local data processing and manipulation.
[0034] It will be appreciated that the surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. The modular communications hub 203 may be housed within a modular control tower configured to accept multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be housed in the modular control tower. The modular communications hub 203 is connected to a display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example, during a surgical procedure. In various embodiments, devices 1a-1n / 2a-2m may include various modules such as, for example, 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 communications module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and / or a non-contact sensor module, among other modular devices that may be connected to the modular communications hub 203 of the surgical data network 201.
[0035] In one aspect, the surgical data network 201 may include a combination of a network hub, a network switch, and a network router that connects the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer 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. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to "a type of Internet-based computing" in which various services, such as servers, storage, and applications, are delivered via the Internet to a modular communications hub 203 and / or computer system 210 located in an operating room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services can perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0036] By applying cloud computer data processing techniques to data collected by devices 1a-1n / 2a-2m, the surgical data network can provide improved surgical outcomes, reduced costs, and improved patient satisfaction. After tissue sealing and cutting procedures, at least some of devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of the sealed tissue. Using cloud-based computing, at least some of devices 1a-1n / 2a-2m can be used to diagnostically examine data, including images of body tissue samples, to identify pathologies, such as the effects of disease. Such data can include tissue localization and margin confirmation, as well as phenotyping. At least some of devices 1a-1n / 2a-2m can be used to identify anatomical structures of the body using various sensors integrated with imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by devices 1a-1n / 2a-2m, including image data, can be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data may be analyzed to improve the outcome of the surgical procedure by determining whether further treatments can be performed, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and the use of standardized techniques can provide useful feedback to either confirm or suggest modifications to surgical treatment and surgeon performance.
[0037] The operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. The network hub 207, in one aspect, may be implemented as a local network broadcast device operating on the physical layer of the Open System Interconnection (OSI) model. The network hub may provide connectivity to devices 1a-1n located within the same operating room network. The network hub 207 may collect data in the form of packets and send them to a router in half-duplex mode. The network hub 207 may not store media access control / Internet Protocol (MAC / IP) information for forwarding any device data. Only one of the devices 1a-1n may transmit data through the network hub 207 at a time. The network hub 207 may not have a routing table or intelligence regarding where to send the information; it broadcasts all network data across each connection and to a remote server 213 (FIG. 4) on the cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.
[0038] The operating room devices 2a-2m may be connected to the network switch 209 via wired or wireless channels. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 may be a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and may function in full-duplex mode. Multiple devices 2a-2m can transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.
[0039] The network hub 207 and / or the network switch 209 may be coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and may function in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.
[0040] In one embodiment, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub can expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between devices 1a-1n and 2a-2m located in the operating room.
[0041] In an embodiment, operating room devices 1a-1n / 2a-2m can communicate with modular communications hub 203 via the Bluetooth wireless technology standard to exchange data over short distances from fixed and mobile devices (using short-wavelength UHF radio waves in the 2.4-2.485 GHz ISM band) and to establish a personal area network (PAN). Operating room devices 1a-1n / 2a-2m can communicate with modular communications hub 203 via numerous wireless or wired communications standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, New Radio (NR), Long Term Evolution (LTE), and any other wireless and wired protocols designated as Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as 3G, 4G, 5G, and beyond. The computing module may include multiple communication modules, for example, a first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.
[0042] The modular communications hub 203 can serve as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and can handle data types known as frames. The frames can carry data generated by the devices 1a-1n / 2a-2m. Once the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211, which forwards this data to cloud computing resources using a number of wireless or wired communications standards or protocols, as described herein.
[0043] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communications hub 203 may generally be easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking operating room devices 1a-1n / 2a-2m.
[0044] FIG. 5 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 6, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210.
[0045] As shown in the embodiment of FIG. 5 , modular control tower 236 may be coupled to an imaging module 238 that may be coupled to an endoscope 239, a generator module 240 that may be coupled to an energy device 241, a smoke evacuation module 226, a suction / irrigation module 228, a communications module 230, a processor module 232, a storage array 234, a smart device / instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. Operating room devices may be coupled to cloud computing resources and data storage via modular control tower 236. Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Devices / instruments 235, visualization system 208, among others, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols as described herein. Modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging module, device / instrument display, and / or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with the images and overlaid images.
[0046] FIG. 6 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 may comprise a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for local processing, visualization, and imaging. As shown in FIG. 6, the modular communications hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 6, each of the network hubs / switches in the modular communications hub 203 may include three downstream ports and one upstream port. The upstream network hub / switch may be connected to a processor to provide communications connectivity to cloud computing resources and a local display 217. Communication to the cloud 204 may occur via either a wired or wireless communications channel.
[0047] The surgical hub 206 may use the non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating room using either an ultrasonic non-contact measurement device or a laser-based non-contact measurement device. The ultrasonic-based non-contact sensor module can scan the operating room by transmitting bursts of ultrasound and receiving echoes as they bounce off the perimeter walls of the operating room, as described in U.S. Patent Application Publication No. 2019-0200844(A1) entitled "METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE AND DISPLAY" (U.S. Patent Application No. 16 / 209,385), filed December 4, 2018, under the heading "Surgical Hub Spatial Awareness Within an Operating Room," and the sensor module is configured to determine the size of the operating room and adjust Bluetooth pairing distance limits. The laser-based non-contact sensor module may scan the operating room by transmitting laser light pulses, receiving laser light pulses that reflect off the exterior walls of the operating room, and comparing the phase of the transmitted pulses to the received pulses, for example, to determine the size of the operating room and adjust Bluetooth pairing distance limits.
[0048] Computer system 210 may include a processor 244 and a network interface 245. Processor 244 may be coupled to a communications module 247, storage 248, memory 249, non-volatile memory 250, and input / output interface 251 via a system bus. The system bus may be any of several types of bus structures, including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus using any of a variety of available bus architectures, including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), MicroChannel Architecture (MSA), Enhanced ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Device Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus.
[0049] Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product data sheet.
[0050] In one aspect, the processor 244 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.
[0051] System memory may include both volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile 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. RAM is available in many forms, including static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync link DRAM (SLDRAM), and direct RAM (DRRAM).
[0052] The computer system 210 may also include removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage may include, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage may include the above storage media, either independently or in combination with other storage media. Other storage media include, but are not limited to, optical disk drives such as compact disc ROM drives (CD-ROMs), compact disc recordable drives (CD-R drives), compact disc rewritable drives (CD-RW drives), or digital versatile disc ROM drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of disk storage devices to the system bus.
[0053] It should be understood that the computer system 210 may include software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment. Such software may include an operating system. The operating system, which may be stored on disk storage, may function to control and allocate resources of the computer system. System applications may take advantage of resource management by the operating system through program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein may be implemented with various operating systems or combinations of operating systems.
[0054] A user can input commands or information into the computer system 210 through input devices coupled to the I / O interface 251. Input devices may include, but are not limited to, pointing devices such as a mouse, trackball, stylus, or touchpad; keyboards; microphones; joysticks; gamepads; satellite dishes; scanners; TV tuner cards; digital cameras; digital video cameras; webcams; and the like. These and other input devices connect to the processor through the system bus via interface ports. Interface ports include, for example, serial ports, parallel ports, game ports, and USB. Output devices use some of the same types of ports as input devices. Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. Output adapters may be provided to illustrate that there may be several output devices, such as monitors, displays, speakers, and printers, among other output devices that may require special adapters. Output adapters may include, by way of example and not limitation, video and sound cards that provide a means of connection between the output device and the system bus. It should be noted that other devices and / or systems of devices, such as remote computers, may provide both input and output capabilities.
[0055] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as a cloud computer. A remote cloud computer can be a personal computer, a server, a router, a network PC, a workstation, a microprocessor-based appliance, a peer device, or other common network node, but typically includes many or all of the elements described with respect to a computer system. For simplicity, only a memory storage device is shown with the remote computer. A remote computer may be logically connected to the computer system through a network interface and then physically connected via a communications connection. The network interface may encompass communications networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies may include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, and the like. WAN technologies may include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and its variants, packet-switched networks, and Digital Subscriber Lines (DSL).
[0056] In various embodiments, the computer system 210 of FIG. 6 , the imaging module 238 of FIG. 5 and FIG. 6 , and / or the visualization system 208, and / or the processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) used to process digital images. The image processor may employ parallel computing using single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.
[0057] The communications connection may refer to the hardware / software used to connect the network interface to the bus. While the communications connection is shown internal to the computer system for clarity of illustration, the communications connection may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as regular telephone-grade modems, modems including cable modems and DSL modems, ISDN adapters, and Ethernet cards.
[0058] FIG. 7 shows a logic diagram of a surgical instrument or tool control system 470 according to one or more embodiments of the present disclosure. The system 470 may include control circuitry. The control circuitry may include a microcontroller 461 with a processor 462 and a memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, operably couples a longitudinally movable displacement member to drive the I-beam knife element. A tracking system 480 may be configured to determine the position of the longitudinally movable displacement member. The position information may be provided to the processor 462, which may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the positions of the firing member, firing bar, and I-beam knife element. Additional motors may be provided to the tool driver interface to control I-beam firing, closure tube movement, shaft rotation, and articulation. A display 473 may display various operating conditions of the instrument and may include touchscreen functionality for data entry. Information displayed on the display 473 can be overlaid with images acquired via the endoscopic imaging module.
[0059] In one embodiment, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product datasheet.
[0060] In one embodiment, the microcontroller 461 may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.
[0061] The microcontroller 461 may be programmed to perform various functions, such as precise control over the speed and position of the knife and articulation system. In one embodiment, the microcontroller 461 may include a processor 462 and memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical linkage to the articulation or knife system. In one embodiment, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be easily substituted for use in the tracking system 480 with an absolute positioning system. A detailed description of absolute positioning systems is provided in U.S. Patent Application Publication No. 2017 / 0296213, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety.
[0062] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate a response within the microcontroller 461 software. The calculated response may be compared to the measured response of the actual system to obtain an "observed" response, which is used to determine actual feedback. The observed response may be a suitably adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, allowing for detection of external influences on the system.
[0063] In one embodiment, the motor 482 may be controlled by a motor driver 492 and may be used by the surgical instrument or tool firing system. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In some embodiments, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including field effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery, which may include multiple battery cells connected in series, that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be lithium-ion batteries, which may be connectable to and separable from the power supply assembly.
[0064] The motor driver 492 may be the A3941 available from Allegro Microsystems, Inc. The A3941 492 may be a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs), specifically designed for inductive loads such as brushed DC motors. The driver 492 may include an intrinsic charge pump regulator, which can provide full (>10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the required battery supply voltage above the N-channel MOSFET. An internal charge pump for the high-side drive allows DC (100% duty cycle) operation. The full-bridge may be driven in fast or slow decay mode using diode or synchronous rectification. In slow decay mode, current recirculation is possible through either the high-side or low-side FET. The power FETs may be protected from shoot-through by a resistor-adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.
[0065] The tracking system 480 may include a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for an absolute positioning system may provide a unique position signal corresponding to the location of the displacement member. In some embodiments, the displacement member may represent a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In some embodiments, the displacement member may represent a firing member that may be adapted and configured to include a rack of drive teeth. In some embodiments, the displacement member may represent a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Thus, as used herein, the term displacement member may be used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, firing member, firing bar, I-beam, or any element that can be displaced. In one aspect, a longitudinally movable drive member may be coupled to a firing member, firing bar, and I-beam. Thus, the absolute positioning system may, in effect, track the linear displacement of an I-beam by tracking the linear displacement of a longitudinally movable drive member. In various aspects, the displacement member may be coupled to any suitable position sensor 472 for measuring linear displacement. Thus, the longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor. The linear displacement sensor may include a linear variable differential transformer (LVDT), a differential variable reluctance transducer (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical detection system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical detection system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
[0066] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly mounted in meshing engagement with a set of drive teeth or rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to several linear longitudinal translations of the displacement member. The gearing and sensor arrangement may be connected to a linear actuator by a rack and pinion arrangement or to a rotary actuator by a spur gear or other connection. A power source may provide power to the absolute positioning system, and an output indicator may display the output of the absolute positioning system. The displacement member may represent a longitudinally movable drive member including a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member may represent a longitudinally movable firing member, a firing bar, an I-beam, or a combination thereof.
[0067] One revolution of the sensor element associated with position sensor 472 may correspond to a longitudinal linear displacement d1 of the displacement member, where d1 is the longitudinal linear distance traveled by the displacement member from point "a" to point "b" after one revolution of the sensor element coupled to the displacement member. The sensor mechanism may be coupled via a gear reduction that results in the position sensor 472 completing one or more revolutions relative to the full stroke of the displacement member. The position sensor 472 may complete multiple revolutions relative to the full stroke of the displacement member.
[0068] A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of the position sensor 472. The state of the switches may be fed back to the microcontroller 461, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+...dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may comprise a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.
[0069] Position sensor 472 may comprise any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or a vector component of the magnetic field. The technologies used to produce both types of magnetic sensors may involve many aspects of physics and electronics. Technologies used to sense magnetic fields may include, among others, search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, optical fiber, magneto-optical, and microelectromechanical systems-based magnetic sensors.
[0070] In one embodiment, the position sensor 472 of the tracking system 480 with an absolute positioning system may comprise a magnetic rotary absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 may be a low-voltage, low-power component and includes four Hall-effect elements in an area of the position sensor 472 that may be located above the magnet. A high-resolution ADC and a smart power management controller may also be provided on-chip. A Coordinate Rotation Digital Computer (CORDIC) processor, also known as the Digit-by-Digit Method and the Boulder algorithm, may be provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. The angular position, alarm bits, and magnetic field information may be transmitted to the microcontroller 461 via a standard serial communications interface, such as a serial peripheral interface (SPI) interface. The position sensor 472 may provide 12-bit or 14-bit resolution and may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.
[0071] A tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply converts a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensors may be provided to measure physical parameters of the physical system. In some embodiments, other sensors may include sensor arrangements such as those described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system may take into account properties such as mass, inertia, viscous friction, and induced drag in order to predict what the state and output of the physical system will be given knowledge of the input.
[0072] The absolute positioning system can provide the absolute position of the displacement member upon powering up the instrument without retracting or advancing the displacement member to a reset (zero or home) position, as may be required with conventional rotary encoders that simply count the number of forward or backward steps taken by the motor 482 to estimate the position of the device actuator, drive bar, knife, etc.
[0073] A sensor 474, such as a strain gauge or micro-strain gauge, may be configured to measure one or more parameters of the end effector, such as the amplitude of strain exerted on the anvil during clamping, which may be indicative of the closure force applied to the anvil. The measured strain may be converted to a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, a sensor 476, such as a load sensor, may measure the closure force applied to the anvil by the closure drive system. For example, the sensor 476, such as a load sensor, may measure the firing force applied to the I-beam during the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sled, which is configured to cam the staple driver upward and drive the staples into deforming contact with the anvil. The I-beam may also include a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by 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, for example, to the current drawn by motor 482. The measured force may be converted to a digital signal and provided to processor 462.
[0074] In one form, a strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force applied by the end effector to the tissue being treated. A system for measuring the force applied to tissue grasped by the end effector may include a strain gauge sensor 474, such as a micro-strain gauge, which can be configured to measure one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the jaw members of the end effector during clamping, which can be indicative of tissue compression. The measured strain can be converted to a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to operate the knife element, for example, to cut tissue captured between the anvil and the staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. The magnetic field sensor measurements can also be converted to a digital signal and provided to the processor 462.
[0075] Measurements of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474, 476, respectively, can be used by microcontroller 461 to characterize a selected position of the firing member and / or a corresponding value of firing member velocity. In one example, memory 468 can store techniques, equations, and / or look-up tables that can be used by microcontroller 461 during evaluation.
[0076] The surgical instrument or tool control system 470 may also include wired or wireless communication circuitry for communicating with the modular communications hub 203 as shown in FIGS.
[0077] 8 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions. In certain examples, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain examples, the motors of the robotic surgical instrument 600 can be individually activated to produce firing, closing, and / or articulation motions in the end effector. The firing, closing, and / or articulation motions can be transmitted to the end effector via, for example, a shaft assembly.
[0078] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transfer the firing motion generated by the motor 602 to the end effector, particularly to displace an I-beam element. In certain examples, the firing motion generated by the motor 602 may, for example, deploy staples from a staple cartridge into tissue captured by the end effector and / or advance a cutting blade of the I-beam element to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the motor 602.
[0079] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, which may be configured to transmit the closure motion generated by the motor 603 to the end effector, specifically to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motion may transition the end effector from an open configuration to an approximation configuration, for example, to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.
[0080] In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606 a, 606 b. The motors 606 a, 606 b may be operatively coupled to corresponding articulation motor drive assemblies 608 a, 608 b, which may be configured to transfer articulation motion generated by the motors 606 a, 606 b to an end effector. In certain examples, the articulation motion may, for example, cause the end effector to articulate relative to the shaft.
[0081] As described herein, a surgical instrument or tool may include multiple motors that can be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool can be activated individually or separately to perform one or more functions while other motors remain stopped. For example, articulation motors 606 a, 606 b can be activated to articulate the end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and / or advance a cutting blade while articulation motor 606 remains stopped. Additionally, closure motor 603 can be activated simultaneously with firing motor 602 to distally advance a closure tube and I-beam element, as described in more detail herein below.
[0082] In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can accommodate one of the multiple motors at a time. For example, the common control module 610 may be individually connectable and detachable to multiple motors of a robotic surgical instrument. In certain examples, the multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, the multiple motors of a surgical instrument or tool can be individually and selectively engaged with the common control module 610. In certain examples, the common control module 610 can selectively switch from interfacing with one of the multiple motors of the surgical instrument or tool to interfacing with another of the multiple motors of the surgical instrument or tool.
[0083] In at least one example, common control module 610 can be selectively switched between operative engagement with articulation motors 606 a, 606 b and operative engagement with either firing motor 602 or closure motor 603. In at least one embodiment, as shown in FIGURE 8, switch 614 can be moved or transitioned between multiple positions and / or states. For example, in a first position 616, switch 614 can electrically couple common control module 610 to firing motor 602, in a second position 617, switch 614 can electrically couple common control module 610 to closure motor 603, in a third position 618 a, for example, switch 614 can electrically couple common control module 610 to first articulation motor 606 a, and in a fourth position 618 b, switch 614 can electrically couple common control module 610 to second articulation motor 606 b. In certain examples, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b at the same time. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.
[0084] Each of the motors 602, 603, 606a, 606b may be equipped with a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaws or by a torque sensor on the motor that actuates the jaws.
[0085] 8, common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may modulate power transferred from a power supply 628 to a motor coupled to common control module 610 based on input from, for example, a microcontroller 620 ("controller"). In certain examples, microcontroller 620 may be used to determine, for example, the current drawn by a motor while the motor is coupled to common control module 610, as described herein.
[0086] In particular examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In particular examples, memory 624 may store various program instructions that, when executed, cause processor 622 to perform multiple functions and / or calculations described herein. In particular examples, one or more of memory units 624 may be coupled to processor 622, for example.
[0087] In certain examples, power supply 628 may be used to, for example, power microcontroller 620. In certain examples, power supply 628 may include a battery (or "battery pack" or "power pack"), such as, for example, a lithium-ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power surgical instrument 600. Multiple battery cells connected in series may be used as power supply 628. In certain examples, power supply 628 may be, for example, replaceable and / or rechargeable.
[0088] In various examples, the processor 622 can control the motor drivers 626 to control the position, direction of rotation, and / or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor drivers 626 to stop and / or disable the motors coupled to the common control module 610. The term "processor," as used herein, should be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to a few integrated circuits. A processor may be a general-purpose programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides a result as output. Because it may have internal memory, it may be an example of sequential digital logic. A processor may operate on numbers and symbols represented in the binary system.
[0089] Processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In a particular example, microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other features readily available in the product datasheet, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with module 4410. Accordingly, the present disclosure should not be limited in this context.
[0090] The memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are connectable to the common control module 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b. Such program instructions may cause the processor 622 to control the firing, closing, and articulation functions according to inputs from algorithms or control programs of the surgical instruments or tools.
[0091] For example, one or more mechanisms and / or sensors, such as sensor 630, can be used to alert processor 622 to program instructions to use in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In certain examples, sensor 630 can include a position sensor that can be used to sense the position of switch 614, for example. Thus, processor 622 can use program instructions associated with firing an I-beam of the end effector when it detects, for example, via sensor 630, that switch 614 is in first position 616; processor 622 can use program instructions associated with closing an anvil when it detects, for example, that switch 614 is in second position 617 via sensor 630; and processor 622 can use program instructions associated with articulating the end effector when it detects, for example, via sensor 630, that switch 614 is in third position 618a or fourth position 618b.
[0092] 9 shows a diagram of a context-aware surgical system 5100 in accordance with at least one aspect of the present disclosure. In some examples, the data sources 5126 may include, for example, the modular device 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular device itself), a database 5122 (e.g., an EMR database containing patient records), and patient monitoring devices 5124 (e.g., a blood pressure (BP) monitor and an electrocardiogram (EKG) monitor). The surgical hub 5104 may be configured to derive contextual information regarding the surgical procedure from the data based, for example, on a particular combination of the received data or a particular order in which the data is received from the data sources 5126. The contextual information inferred from the received data may include, for example, the type of surgical procedure being performed, the particular step of the surgical procedure the surgeon is performing, the type of tissue being operated on, or the body cavity that is the target of the procedure. This ability by some aspects of the surgical hub 5104 to derive or infer information related to the surgical procedure from the received data may also be referred to as “situational awareness.” In one example, the surgical hub 5104 may incorporate a situational awareness system, which is hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to the surgical procedure from received data.
[0093] The situation awareness system of the surgical hub 5104 may be configured to derive context information from data received from the data sources 5126 in a variety of different ways. In one example, the situation awareness system may include a pattern recognition system or a machine learning system (e.g., an artificial neural network) trained with training data to correlate various inputs (e.g., data from the database 5122, the patient monitoring devices 5124, and / or the modular devices 5102) with corresponding context information related to the surgical procedure. In other words, the machine learning system may be trained to accurately derive context information related to the surgical procedure from provided inputs. In an example, the situation awareness system may include a lookup table that stores pre-characterized context information related to the surgical procedure in association with one or more inputs (or ranges of inputs) corresponding to the context information. In response to querying with one or more inputs, the lookup table can return corresponding context information for the situation awareness system to control the modular devices 5102. In embodiments, the contextual information received by the situational awareness system of the surgical hub 5104 may be associated with a particular control adjustment or set of control adjustments of one or more modular devices 5102. In embodiments, the situational awareness system may include additional machine learning systems, lookup tables, or other such systems that, when provided with the contextual information as input, generate or retrieve one or more control adjustments of one or more modular devices 5102.
[0094] A surgical hub 5104 incorporating a situational awareness system can provide many benefits to the surgical system 5100. One benefit can include improved interpretation of sensed and collected data, which can improve processing accuracy and / or use of the data during the surgical procedure. Returning to the previous example, the situational aware surgical hub 5104 can determine what type of tissue is being operated on, and thus, if an unexpectedly high force to close the end effector of the surgical instrument is detected, the situational aware surgical hub 5104 can properly accelerate or decelerate the motor of the surgical instrument to match the tissue type.
[0095] The type of tissue being operated on can affect the adjustments made to the compression speed and load threshold of the surgical stapling and severing instrument for a particular tissue gap measurement. The context-aware surgical hub 5104 can infer whether the surgical procedure being performed is a thoracic or abdominal procedure, which allows the surgical hub 5104 to determine whether the tissue being clamped by the end effector of the surgical stapling and severing instrument is pulmonary (in the case of a thoracic procedure) or stomach (in the case of an abdominal procedure). The surgical hub 5104 can then adjust the compression speed and load threshold of the surgical stapling and severing instrument appropriately for the tissue type.
[0096] The type of body cavity being operated on during an insufflation procedure can affect the function of the smoke evacuator. The situation-aware surgical hub 5104 can determine if the surgical site is under pressure (by determining that the surgical procedure is utilizing insufflation) and determine the procedure type. Generally, certain procedure types can be performed within specific body cavities, so the surgical hub 5104 can control the motor speed of the smoke evacuator appropriately for the body cavity being operated on. Thus, the situation-aware surgical hub 5104 can provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.
[0097] The type of procedure being performed can affect the optimal energy level at which an ultrasonic surgical instrument or a radio frequency (RF) electrosurgical instrument operates. For example, an arthroscopic procedure may require a higher energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is immersed in fluid. The context-aware surgical hub 5104 can determine whether the surgical procedure is an arthroscopic procedure. The surgical hub 5104 can then adjust the RF power level or ultrasonic amplitude (i.e., "energy level") of the generator to compensate for the fluid-filled environment. Relatedly, the type of tissue being operated on can affect the optimal energy level at which an ultrasonic surgical instrument or an RF electrosurgical instrument operates. The context-aware surgical hub 5104 can determine which type of surgical procedure is being performed and then customize the energy level of the ultrasonic surgical instrument or the RF electrosurgical instrument, respectively, according to the tissue geometry expected for the surgical procedure. Additionally, the context-aware surgical hub 5104 may be configured to adjust the energy level of the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than simply on a procedure-by-procedure basis. The context-aware surgical hub 5104 may determine which step of the surgical procedure is being performed or will continue to be performed, and then update the generator and / or the control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy level to a value appropriate for the expected tissue type according to the step of the surgical procedure.
[0098] In embodiments, data may be drawn from additional data sources 5126 to improve conclusions the surgical hub 5104 draws from one data source 5126. The situation-aware surgical hub 5104 may augment the data received from the modular device 5102 with contextual information constructed about the surgical procedure from other data sources 5126. For example, the situation-aware surgical hub 5104 may be configured to determine whether hemostasis has occurred (i.e., whether bleeding at the surgical site has stopped) according to video or image data received from a medical imaging device. However, in some cases, the video or image data may be inconclusive. Thus, in one example, the surgical hub 5104 may be further configured to compare a physiological measurement (e.g., blood pressure sensed by a BP monitor communicatively connected to the surgical hub 5104) with visual or image data of hemostasis (e.g., from a medical imaging device 124 ( FIG. 2 ) communicatively coupled to the surgical hub 5104) to make a determination regarding the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take physiological measurement data into account to provide additional context when analyzing the visualization data, which can be useful when the visualization data may not be conclusive or incomplete on its own.
[0099] For example, the situation-aware surgical hub 5104 can proactively activate a generator to which an RF electrosurgical instrument is connected if it is determined that a subsequent step in a procedure requires the use of the instrument. By proactively activating the energy source, the instrument can be ready for use as soon as the previous step in the procedure is completed.
[0100] The situation-aware surgical hub 5104 can determine whether the current or subsequent steps in the surgical procedure require different views or magnifications on the display according to the feature(s) of the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then proactively change the displayed views (e.g., provided by a medical imaging device for the visualization system 108) appropriately, so that the display automatically adjusts throughout the surgical procedure.
[0101] The context-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed next, and whether specific data or data comparisons are required for that step of the surgical procedure. The surgical hub 5104 can be configured to automatically call up data screens based on the step of the surgical procedure being performed, without waiting for the surgeon to ask for specific information.
[0102] Errors may be checked during the setup of a surgical procedure or during the course of a surgical procedure. For example, the situation-aware surgical hub 5104 may determine whether the surgical field is properly or optimally set up for the surgical procedure being performed. The surgical hub 5104 may be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product locations, or setup requirements, and then compare the current surgical field layout to a standard layout for the type of surgical procedure the surgical hub 5104 has determined is being performed. In some examples, the surgical hub 5104 may be configured to compare the list of items for the procedure and / or the list of devices paired with the surgical hub 5104 to a recommended or expected manifest of items and / or devices for a given surgical procedure. If a discontinuity exists between the lists, the surgical hub 5104 may be configured to provide an alert indicating that a particular modular device 5102, patient monitoring device 5124, and / or other surgical item is missing. In some examples, the surgical hub 5104 can be configured to determine the relative distance or relative position of the modular device 5102 and the patient monitoring device 5124, for example, by a proximity sensor. The surgical hub 5104 can compare the relative positions of the devices to a recommended or predicted layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide an alert indicating that the current layout of the surgical procedure deviates from the recommended layout.
[0103] The situation-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or otherwise deviating from an expected sequence of actions during a surgical procedure. For example, the surgical hub 5104 may be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) a corresponding list of steps or sequences of equipment use, and then compare the steps being performed or the equipment being used during the surgical procedure with the expected steps or equipment for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In some examples, the surgical hub 5104 may be configured to provide an alert indicating that an unexpected action is being performed or an unexpected device is being utilized at a particular step in the surgical procedure.
[0104] The surgical instruments (and other modular devices 5102) may be adjusted to the specific circumstances of each surgical procedure (such as for different tissue types) and to verify actions during the surgical procedure. Subsequent steps, data, and display adjustments may be provided to the surgical instruments (and other modular devices 5102) in the operating room according to the specific circumstances of the procedure.
[0105] FIG. 10 illustrates a timeline 5200 of an exemplary surgical procedure and the context information the surgical hub 5104 may derive from data received from data sources 5126 at each step of the surgical procedure. The following description of the timeline 5200 shown in FIG. 9 also refers to FIG. 9. The timeline 5200 may illustrate typical steps taken by nurses, surgeons, and other medical personnel during the course of a lung segmentectomy procedure, beginning with the setup of the surgical site and concluding with the transport of the patient to a post-operative recovery room. The context-aware surgical hub 5104 can receive data from the data sources 5126 throughout the course of the surgical procedure, including data generated each time medical personnel utilize a modular device 5102 paired with the surgical hub 5104. The surgical hub 5104 receives this data from the paired modular device 5102 and other data sources 5126 and can continually derive inferences (i.e., context information) about the ongoing procedure as new data is received, such as which step of the procedure is occurring at any given time. The situational awareness system of the surgical hub 5104 may be capable of, for example, recording data regarding the procedure to generate a report, verifying steps being taken by medical personnel, providing data or prompts (e.g., via a display screen) that may be relevant to particular treatment steps, adjusting the modular device 5102 based on the situation (e.g., activating a monitor, adjusting the FOV of a medical imaging device, or changing the energy level of an ultrasonic surgical instrument or an RF electrosurgical instrument), and taking any other such action described herein.
[0106] As a first step 5202 in this exemplary procedure, hospital personnel can retrieve the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, the surgical hub 5104 determines that the procedure to be performed is thoracic surgery. Second, 5204, the personnel can scan incoming medical supplies for the procedure. The surgical hub 5104 cross-references the scanned supplies with a list of supplies that may be utilized in various types of procedures and confirms that the combination of supplies is compatible with a thoracic procedure. Furthermore, the surgical hub 5104 may also be able to determine that the procedure is not a wedge resection (either because the incoming supplies do not include specific supplies required for a thoracic wedge resection or are otherwise not compatible with a thoracic wedge resection). Third, 5206, medical personnel can scan a patient band via a scanner 5128 communicatively connected to the surgical hub 5104. The surgical hub 5104 can then verify the patient's identity based on the scanned data. In a fourth step 5208, medical personnel turn on the auxiliary devices. The auxiliary equipment utilized may vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case includes a smoke evacuator, an insufflator, and a medical imaging device. Once activated, the auxiliary device, which is a modular device 5102, may automatically pair with a surgical hub 5104, which may be located within a particular proximity of the modular device 5102, as part of its initialization process. The surgical hub 5104 may then derive contextual information regarding the surgical procedure by detecting the type of modular device 5102 that is paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 5104 may determine that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices 5102. Based on a combination of data from the patient's EMR, a list of medical supplies to be used in the procedure, and the types of modular devices 5102 connecting to the hub, the surgical hub 5104 may roughly deduce the particular procedure the surgical team will be performing.Once the surgical hub 5104 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources 5126 (e.g., modular device 5102 and patient monitoring devices 5124) to deduce which steps of the surgical procedure the surgical team is performing. In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices 5124 to the patient. The EKG electrodes and other patient monitoring devices 5124 can be paired with the surgical hub 5104. Once the surgical hub 5104 begins receiving data from the patient monitoring devices 5124, the surgical hub 5104 can confirm that the patient is in the operating room, for example, as described in process 5207. In a sixth step 5212, medical personnel can induce anesthesia in the patient. The surgical hub 5104 can infer that the patient is under anesthesia based on data from the modular device 5102 and / or the patient monitoring device 5124, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Upon completion of the sixth step 5212, the pre-operative portion of the lung segmentectomy surgery is complete and the surgical portion begins.
[0107] In seventh 5214, the lung of the patient being operated on may be collapsed (while ventilation is switched to the contralateral lung). The surgical hub 5104 may, for example, infer from ventilator data that the patient's lung has been collapsed. The surgical hub 5104 may compare the detection of the patient's collapsed lung with the expected steps of the procedure (which may be accessed or retrieved in advance) and therefore infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung may be the first surgical step in this particular procedure. In eighth 5216, the medical imaging device 5108 (e.g., a scope) may be inserted and video footage from the medical imaging device may begin. The surgical hub 5104 may receive medical imaging device data (i.e., video or image data) through a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 5104 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 5104 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that a wedge resection has not already been taken into account by the surgical hub 5104 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (FIG. 2) may be utilized to determine contextual information regarding the type of procedure being performed in various ways, such as by determining the angle of the medical imaging device pointed relative to the visualization of the patient's anatomy, by monitoring the number or medical imaging devices being utilized (i.e., activated and paired with the surgical hub 5104), and by monitoring the type of visualization device being utilized. For example, one technique for performing a VATS lobectomy may position the camera above the diaphragm in the anterior-inferior corner of the patient's thoracic cavity, while one technique for performing a VATS segmentectomy may position the camera in an intercostal position anterior to the segmental fissure. The situational awareness system may be trained to recognize the position of the medical imaging device according to the visualization of the patient's anatomy, for example, using pattern recognition or machine learning techniques.An exemplary technique for performing a VATS lobectomy may utilize a single medical imaging device. An exemplary technique for performing a VATS segmentectomy utilizes multiple cameras. An exemplary technique for performing a VATS segmentectomy utilizes an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize the segmental fissure, which is not utilized in a VATS lobectomy. By tracking any or all of this data from the medical imaging device 5108, the surgical hub 5104 can determine the particular type of surgical procedure being performed and / or the technique being used for the particular type of surgical procedure.
[0108] At ninth 5218, the surgical team may begin the incision step of the procedure. Because the surgical hub 5104 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it may infer that the surgeon is in the process of incising and separating the patient's lungs. The surgical hub 5104 may cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the steps of the procedure described above have been completed) corresponds to the incision step. At tenth 5220, the surgical team may proceed to the ligation step of the procedure. Because the surgical hub 5104 may receive data from the surgical stapling and severing instrument indicating that the instrument is being fired, it may infer that the surgeon is ligating arteries and veins. As with the previous step, the surgical hub 5104 may derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the steps in the retrieved process. At eleventh 5222, the segmentectomy portion of the procedure may be performed. Based on data from the surgical stapling and severing instrument (including data from its cartridge), the surgical hub 5104 can infer that the surgeon is transecting parenchyma. The cartridge data can correspond, for example, to the size or type of staples being fired by the instrument. Because different types of staples are applied to different types of tissue, the cartridge data can indicate the type of tissue being stapled and / or transected. In this case, the type of staples being fired is applied to parenchyma (or other similar tissue type), allowing the surgical hub 5104 to infer that the segmentectomy portion of the procedure is being performed. Subsequently, in a twelfth step 5224, a nodule dissection step is performed. Based on data received from the generator indicating that an RF or ultrasonic instrument is being fired, the surgical hub 5104 can infer that the surgical team is dissecting nodules and performing a leak test. In this particular procedure, the RF or ultrasonic instrument utilized after the parenchyma has been transected corresponds to the nodule dissection step, allowing the surgical hub 5104 to make this inference.It should be noted that surgeons will routinely alternate between surgical stapling / severing instruments and surgical energy (e.g., RF or ultrasonic) instruments depending on the particular step in the procedure, as different instruments are better suited for particular tasks. Thus, the particular sequence in which the stapling / severing instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. Once the twelfth step 5224 is completed, the incision is closed and the post-operative portion of the procedure can begin.
[0109] In a thirteenth step 5226, the patient may be awakened from anesthesia. The surgical hub 5104 may estimate that the patient is awakening from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase). Finally, a fourteenth step 5228 may be a step in which medical personnel remove the various patient monitoring devices 5124 from the patient. Thus, the surgical hub 5104 may estimate that the patient is being transported to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices 5124. As can be seen from this exemplary procedure description, the surgical hub 5104 can determine or estimate when each step of a given surgical procedure is occurring according to data received from various data sources 5126 communicatively coupled to the surgical hub 5104.
[0110] As shown in the first step 5202 of the timeline 5200 shown in FIG. 10 , in addition to utilizing patient data from the EMR database(s) to estimate the type of surgical procedure to be performed, the patient data can also be utilized by the situation-aware surgical hub 5104 to generate control adjustments for the paired modular devices 5102.
[0111] FIG. 11 is a block diagram of a computer-implemented interactive surgical system according to at least one embodiment of the present disclosure. In one embodiment, the computer-implemented interactive surgical system may be configured to monitor and analyze data related to the operation of various surgical systems, including surgical hubs, surgical instruments, robotic devices, and surgical sites or medical facilities. The computer-implemented interactive surgical system may include a cloud-based analysis system. While the cloud-based analysis system may be described as a surgical system, it may not necessarily be limited to such and may be a cloud-based medical system. As shown in FIG. 11 , the cloud-based analysis system may include a plurality of surgical instruments 7012 (which may be the same as or similar to instrument 112), a plurality of surgical hubs 7006 (which may be the same as or similar to hub 106), and a surgical data network 7001 (which may be the same as or similar to network 201) for coupling the surgical hubs 7006 to cloud 7004 (which may be the same as or similar to cloud 204). Each of the plurality of surgical hubs 7006 may be communicatively coupled to one or more surgical instruments 7012. The hub 7006 may also be communicatively coupled to a cloud 7004 of computer-implemented interactive surgical systems via a network 7001. The cloud 7004 may be a remote, centralized source of hardware and software for storing, manipulating, and communicating data generated based on the operation of various surgical systems. As shown in FIG. 11 , access to the cloud 7004 may be achieved via the network 7001, which may be the Internet or some other suitable computer network. The surgical hub 7006, which may be coupled to the cloud 7004, may be considered the client side of a cloud computing system (i.e., a cloud-based analysis system). A surgical instrument 7012 may be paired with the surgical hub 7006 for control and performance of various surgical procedures or operations described herein.
[0112] Additionally, the surgical instrument 7012 may include a transceiver for data transmission to and from a corresponding surgical hub 7006 (which may also include a transceiver). The combination of the surgical instrument 7012 and the corresponding hub 7006 can indicate a specific location, such as a surgical site within a medical facility (e.g., a hospital) for providing a medical procedure. For example, the memory of the surgical hub 7006 can store the location data. As shown in FIG. 11 , the cloud 7004 includes a central server 7013 (which may be the same as or similar to the remote server 7013), a hub application server 7002, a data analysis module 7034, and an input / output ("I / O") interface 7006. The central server 7013 of the cloud 7004 collectively manages the cloud computing system, which includes monitoring requests by the client modules 7006 and managing the processing power of the cloud 7004 to execute those requests. Each of the central servers 7013 may include one or more processors 7008 coupled to a suitable memory device 7010, which may include volatile memory such as random access memory (RAM) and non-volatile memory such as a magnetic storage device. The memory device 7010 may include machine-executable instructions that, when executed, cause the processor 7008 to execute a data analysis module 7034 for cloud-based data analysis, actions, recommendations, and other operations described below. Further, the processor 7008 may execute the data analysis module 7034 independently or in conjunction with a hub application executed independently by the hub 7006. The central server 7013 may also include a database 2212 of aggregated medical data, which may reside in the memory 2210.
[0113] Based on its connection to the various surgical hubs 7006 via the network 7001, the cloud 7004 can aggregate data from the various surgical instruments 7012 and the particular data generated by their corresponding hubs 7006. Such aggregated data may be stored in an aggregated medical database 7012 of the cloud 7004. Specifically, the cloud 7004 can advantageously perform data analysis and operations on the aggregated data to provide insights and / or perform functions that individual hubs 7006 cannot accomplish on their own. To this end, as shown in FIG. 11 , the cloud 7004 and the surgical hubs 7006 are communicatively coupled to send and receive information. An I / O interface 7006 is connected to the multiple surgical hubs 7006 via the network 7001. In this manner, the I / O interface 7006 can be configured to transfer information between the surgical hubs 7006 and the aggregated medical data database 7011. Thus, the I / O interface 7006 can facilitate read / write operations of the cloud-based analysis system. Such read / write operations may be performed in response to requests from the hub 7006. These requests may be sent to the hub 7006 via a hub application. The I / O interface 7006 may include one or more high-speed data ports, which may include a universal serial bus (USB) port, an IEEE 1394 port, and Wi-Fi and Bluetooth I / O interfaces for connecting the cloud 7004 to the hub 7006. The hub application server 7002 of the cloud 7004 may be configured to host and provide shared functionality to software applications (e.g., hub applications) executed by the surgical hub 7006. For example, the hub application server 7002 may manage requests by the hub application through the hub 7006, control access to the database 7011 of aggregated medical data, and perform load balancing. The data analysis module 7034 is described in further detail with reference to FIG. 12 .
[0114] The particular cloud computing system configurations described in this disclosure may be specifically designed to address various problems that arise in the context of medical surgeries and procedures performed using medical devices such as surgical instruments 7012, 112. In particular, the surgical instruments 7012 may be digital surgical devices configured to interact with the cloud 7004 to implement techniques for improving surgical outcomes. The various surgical instruments 7012 and / or the surgical hub 7006 may include touch-controlled user interfaces so that a clinician may control aspects of the interaction between the surgical instruments 7012 and the cloud 7004. Other suitable user interfaces for control, such as an auditory-controlled user interface, may also be used.
[0115] FIG. 12 is a block diagram illustrating the functional architecture of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. The cloud-based analysis system may include multiple data analysis modules 7034 that may be executed by a processor 7008 of a cloud 7004 to provide data analysis solutions to problems that arise specifically in the medical field. As shown in FIG. 12 , the functionality of the cloud-based data analysis modules 7034 may be supported via a hub application 7014 hosted by a hub application server 7002 that may be accessed on a surgical hub 7006. The cloud processor 7008 and the hub application 7014 may work in conjunction to execute the data analysis modules 7034. An application program interface (API) 7016 may define a set of protocols and routines corresponding to the hub application 7014. Additionally, the API 7016 may manage the storage and retrieval of data from a centralized medical database 7012 for operation of the applications 7014. A cache 7018 may also be coupled to the API 7016 to store data (e.g., temporarily) and for more efficient retrieval of data used by the applications 7014. 12 may include modules for resource optimization 7020, data collection and aggregation 7022, authorization and security 7024, control program updates 7026, patient outcome analysis 7028, recommendations 7030, and data classification and prioritization 7032. Other suitable data analysis modules may also be implemented by the cloud 7004, according to some aspects. In one aspect, the data analysis module may be used to make specific recommendations based on an analysis of trends, outcomes, and other data.
[0116] For example, the data collection and aggregation module 7022 may be used to generate self-describing data (e.g., metadata), including identifying notable features or configurations (e.g., trends), managing redundant data sets, and storing data in paired data sets that may be grouped by procedure but not necessarily matched to actual surgical procedure dates and surgeons. In particular, paired data sets generated from the operation of the surgical instrument 7012 may include applying a binary classification, such as a bleeding or non-bleeding event. More generally, the binary classification may be characterized as either a desired event (e.g., a successful surgical procedure) or an undesired event (e.g., a misfired or misused surgical instrument 7012). The aggregated self-describing data may correspond to individual data received from various groups or subgroups of the surgical hub 7006. Thus, the data collection and aggregation module 7022 may generate aggregated metadata or other organized data based on the raw data received from the surgical hub 7006. To this end, the processor 7008 may be operatively coupled to the hub application 7014 and the database of aggregated medical data 7011 for executing the data analysis module 7034. The data collection and aggregation module 7022 may store the aggregated, organized data in the database of aggregated medical data 2212.
[0117] The resource optimization module 7020 can be configured to analyze this aggregated data to determine optimal use of resources for a particular medical facility or group of medical facilities. For example, the resource optimization module 7020 can determine an optimal order point for surgical stapling instruments 7012 for a group of medical facilities based on corresponding predicted demand for surgical stapling instruments 7012. The resource optimization module 7020 can also evaluate resource usage or other operating configurations of various medical facilities to determine whether resource usage can be improved. Similarly, the recommendation module 7030 can be configured to analyze the aggregated organizational data from the data collection and aggregation module 7022 to provide recommendations. For example, the recommendation module 7030 can recommend to a medical facility (e.g., a health care provider such as a hospital) that a particular surgical instrument 7012 should be upgraded to an improved version based, for example, on a higher than expected error rate. Additionally, the recommendation module 7030 and / or resource optimization module 7020 can recommend better supply chain parameters, such as product reorder points, and provide suggestions for different surgical instruments 7012, their use, or procedural steps to improve surgical outcomes. The medical facility can receive such recommendations via the corresponding surgical hub 7006. More specific recommendations regarding the parameters or configurations of various surgical instruments 7012 can also be provided. The hub 7006 and / or surgical instruments 7012 can each also have a display screen that displays the data or recommendations provided by the cloud 7004.
[0118] The patient outcome analysis module 7028 may analyze surgical outcomes associated with the currently used operating parameters of the surgical instrument 7012. The patient outcome analysis module 7028 may also analyze and evaluate other potential operating parameters. In this regard, the recommendation module 7030 may use these other potential operating parameters to make recommendations based on resulting in better surgical outcomes, such as a better seal or less bleeding. For example, the suggestion module 7030 may be able to send suggestions to the surgical 7006 regarding when to use a particular cartridge with a corresponding stapling surgical instrument 7012. Thus, the cloud-based analysis system may be configured to analyze large-scale collected raw data and provide centralized recommendations (advantageously determined based on aggregated data) across multiple medical facilities while controlling for common variables. For example, the cloud-based analysis system may analyze, evaluate, and / or aggregate type of medical procedure, type of patient, number of patients, geographic similarities between medical providers using similar types of instruments, etc., in ways that no single medical facility could analyze independently. The control program update module 7026 can be configured to implement recommendations for various surgical instruments 7012 when the corresponding control programs are updated. For example, the patient outcome analysis module 7028 can identify correlations linking particular control parameters to successful (or unsuccessful) outcomes. Such correlations can be addressed when an updated control program is sent to the surgical instrument 7012 via the control program update module 7026. Updates to the instrument 7012, which can be sent via the corresponding hub 7006, may incorporate aggregated performance data collected and analyzed by the data collection and aggregation module 7022 of the cloud 7004. Additionally, the patient outcome analysis module 7028 and recommendation module 7030 can identify improved ways to use the instrument 7012 based on the aggregated performance data.
[0119] The cloud-based analysis system may include security features implemented by the cloud 7004. These security features may be managed by the authorization and security module 7024. Each surgical hub 7006 may have associated unique credentials, such as a username, password, and other suitable security credentials. These credentials may be stored in memory 7010 and associated with an authorized cloud access level. For example, based on providing accurate credentials, the surgical hub 7006 may be granted access to communicate with the cloud to a predetermined extent (e.g., send or receive certain defined types of information). To this end, the cloud 7004's aggregated medical data database 7011 may include a database of certified credentials to verify the accuracy of the provided credentials. Different credentials may be associated with various levels of permission for interaction with the cloud 7004, such as a predetermined access level for receiving data analyses generated by the cloud 7004. Additionally, for security purposes, the cloud may maintain a database of hubs 7006, instruments 7012, and other devices, which may include a "blacklist" of prohibited devices. Specifically, surgical hubs 7006 listed on the blacklist may not be permitted to interact with the cloud, while surgical instruments 7012 listed on the blacklist may not have functional access to the corresponding hub 7006 and / or may be prevented from fully functioning when paired with the corresponding hub 7006. Additionally or alternatively, the cloud 7004 may flag instruments 7012 based on incompatibility or other specified criteria. In this manner, counterfeit medical devices and the inappropriate reuse of such devices across the cloud-based analysis system may be identified and addressed.
[0120] The surgical instrument 7012 may use a wireless transceiver to transmit a wireless signal that may represent, for example, authorization credentials for access to the corresponding hub 7006 and the cloud 7004. A wired transceiver may also be used to transmit the signal. Such authorization credentials may be stored in a respective memory device of the surgical instrument 7012. The authorization and security module 7024 may determine whether the authorization credentials are accurate or forged. The authorization and security module 7024 may also dynamically generate authorization credentials for enhanced security. The credentials may also be encrypted, such as by using hash-based encryption. Upon transmitting the appropriate authorization, the surgical instrument 7012 may transmit a signal to the corresponding hub 7006 and ultimately the cloud 7004 indicating that the instrument 7012 is ready to acquire and transmit medical data. In response, the cloud 7004 may transition to a state capable of receiving medical data for storage in the aggregated medical data database 7011. This readiness to transmit data may be indicated, for example, by a light indicator on the instrument 7012. The cloud 7004 may also send signals to the surgical instruments 7012 to update their associated control programs. The cloud 7004 may send signals directed to a particular class of surgical instruments 7012 (e.g., electrosurgical instruments) so that software updates to control programs are sent only to the appropriate surgical instruments 7012. Additionally, the cloud 7004 may 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 are identified as having a common manufacturing defect, the cloud 7004 may change the authorization credentials corresponding to this group to implement an operational lockout for this group.
[0121] The cloud-based analytics system may enable monitoring of multiple healthcare facilities (e.g., healthcare facilities such as hospitals) to determine improved practices and recommend changes accordingly (e.g., via the suggestions module 2030). Thus, the processor 7008 of the cloud 7004 may analyze data associated with an individual healthcare facility to identify the facility and aggregate that data with other data associated with other healthcare facilities. Groups may be defined, for example, based on similar operational behavior or geographic location. In this manner, the cloud 7004 may provide broader analysis and recommendations for groups of healthcare facilities. The cloud-based analytics system may also be used for enhanced situational awareness. For example, the processor 7008 may predictively model the effect of recommendations on cost and effectiveness for a particular facility (compared to overall operations and / or various healthcare procedures). The costs and effectiveness associated with that particular facility may also be compared to the corresponding local area of other facilities or any other comparable facilities.
[0122] The data classification and prioritization module 7032 may prioritize and classify data based on criticality (e.g., the severity, surprise, or suspiciousness of the medical event associated with the data). This classification and prioritization may be used in conjunction with other data analysis module 7034 functionality described herein to improve the cloud-based analyses and operations described herein. For example, the data classification and prioritization module 7032 may assign priorities to data analyses performed by the data collection and aggregation module 7022 and the patient outcome analysis module 7028. Different priority levels may result in specific responses from the cloud 7004 (corresponding to the level of urgency), such as elevation for rapid response, special handling, exclusion from the aggregated medical data database 7011, or other suitable responses. Additionally, if necessary, the cloud 7004 may send a request (e.g., a push message) via the hub application server for additional data from the corresponding surgical instrument 7012. The push message may result in a notification being displayed on the corresponding hub 7006 to request support or additional data. This push message may be needed in situations where the cloud detects a significant irregularity or outlier and the cloud is unable to determine the cause of the irregularity. The central server 7013 can be programmed to trigger this push message in certain critical situations, such as when data is determined to differ from expected values by more than a predetermined threshold, or when security is suspected.
[0123] Further exemplary details regarding the various described functions are provided in the following description, each of which may utilize a cloud architecture, as illustrated in Figures 11 and 12 as one example of a hardware and software implementation.
[0124] 13 shows a block diagram of a computer-implemented adaptive surgical system 9060 configured to adaptively generate control program updates for a modular device 9050, in accordance with at least one embodiment of the present disclosure. In some examples, the surgical system may include a surgical hub 9000, a plurality of modular devices 9050 communicatively coupled to the surgical hub 9000, and an analysis system 9100 communicatively coupled to the surgical hub 9000. While a single surgical hub 9000 is shown, it should be noted that the surgical system 9060 may include any number of surgical hubs 9000, which may be connected to form a network of surgical hubs 9000 communicatively coupled to the analysis system 9010. In some examples, the surgical hub 9000 may include a processor 9010 coupled to the memory 9020 to execute instructions stored in the memory 9020, and a data relay interface 9030 through which data is transmitted to the analysis system 9100. In some examples, the surgical hub 9000 may further include a user interface 9090 having an input device 9092 (e.g., a capacitive touchscreen or keyboard) for receiving input from a user and an output device 9094 (e.g., a display screen) for providing output to the user. The output may include data from a query entered by the user, suggestions for products or product mixes to use in a given procedure, and / or instructions for actions to be taken before, during, or after a surgical procedure. The surgical hub 9000 may further include an interface 9040 for communicatively coupling a modular device 9050 to the surgical hub 9000. In one aspect, the interface 9040 may include a transceiver communicatively connectable to the modular device 9050 via a wireless communication protocol. The modular device 9050 may include, for example, a surgical stapling and cutting instrument, an electrosurgical instrument, an ultrasonic instrument, an aspirator, a ventilator, and a display screen. In some instances, the surgical hub 9000 may also be communicatively coupled to one or more patient monitoring devices 9052, such as an EKG monitor or a BP monitor.In some examples, the surgical hub 9000 may also be communicatively coupled to one or more databases 9054 or external computer systems, such as an EMR database of the medical facility in which the surgical hub 9000 is located.
[0125] When the modular devices 9050 are connected to the surgical hub 9000, the surgical hub 9000 can sense or receive perioperative data from the modular devices 9050 and then associate the received perioperative data with surgical procedure outcome data. The perioperative data may indicate how the modular devices 9050 were controlled during the course of a surgical procedure. The procedure outcome data includes data associated with results from a surgical procedure (or steps thereof), which may include whether the surgical procedure (or steps thereof) had a positive or negative outcome. For example, the outcome data may include whether a patient suffered a post-operative complication from a particular procedure or whether there was a leak (e.g., bleeding or air leak) at a particular staple or incision line. The surgical hub 9000 may obtain surgical procedure outcome data by receiving data from an external source (e.g., from an EMR database 9054), by directly detecting an outcome (e.g., via one of the connected modular devices 9050), or by inferring the occurrence of an outcome through a situational awareness system. For example, data regarding post-operative complications can be retrieved from the EMR database 9054, and data regarding staple or incision line leakage events can be directly detected or inferred by the situational awareness system. Surgical procedure outcome data can be inferred by the situational awareness system from data received from various data sources, including the modular device 9050 itself, the patient monitoring device 9052, and the database 9054 to which the surgical hub 9000 is connected.
[0126] The surgical hub 9000 may transmit associated modular device 9050 data and outcome data to the analysis system 9100 for processing. By transmitting both perioperative data indicating how the modular device 9050 is controlled and procedural outcome data, the analysis system 9100 can correlate different modalities of controlling the modular device 9050 with surgical outcomes for specific procedure types. In some examples, the analysis system 9100 may include a network of analysis servers 9070 configured to receive data from the surgical hub 9000. Each of the analysis servers 9070 may include a memory and a processor coupled to the memory that executes instructions stored in the memory to analyze the received data. In some examples, the analysis servers 9070 may be connected in a distributed computing architecture and / or utilize a cloud computing architecture. Based on this paired data, the analysis system 9100 can then learn optimal or preferred operating parameters for various types of modular devices 9050, generate adjustments to the control programs of the modular devices 9050 in the surgical field, and then transmit (or "push") updates to the control programs of the modular devices 9050.
[0127] Further details regarding the computer-implemented interactive surgical system 9060, including the surgical hub 9000 and various modular devices 9050 connectable thereto, are described in connection with Figures 5 and 6.
[0128] 14 illustrates a surgical system 6500 according to the present disclosure, which may include a surgical instrument 6502 that may communicate with a console 6522 or a portable device 6526 via a local area network 6518 or a cloud network 6520 by wired or wireless connection. In various aspects, the console 6522 and the portable device 6526 may be any suitable computing devices. The surgical instrument 6502 may include a handle 6504, an adapter 6508, and a loading unit 6514. The adapter 6508 releasably couples to the handle 6504, and the loading unit 6514 releasably couples to the adapter 6508 such that the adapter 6508 transfers force from the drive shaft to the loading unit 6514. The adapter 6508 or the loading unit 6514 may include a force gauge (not explicitly shown) disposed therein to measure force exerted on the loading unit 6514. The loading unit 6514 may include an end effector 6530 having a first jaw 6532 and a second jaw 6534. The loading unit 6514 may be an in-situ loading or multi-fire loading unit (MFLU) that allows a clinician to fire multiple fasteners multiple times without the loading unit 6514 having to be removed from the surgical site to reload the loading unit 6514.
[0129] The first jaw 6532 and the second jaw 6534 may be configured to clamp tissue therebetween, fire fasteners through the clamped tissue, and sever the clamped tissue. The first jaw 6532 may be configured to fire at least one fastener multiple times or may be configured to include a replaceable multi-fire fastener cartridge containing multiple fasteners (e.g., staples, clips, etc.) that can be fired two or more times before being replaced. The second jaw 6534 may include an anvil that deforms or otherwise secures fasteners around tissue as the fasteners are ejected from the multi-fire fastener cartridge.
[0130] The handle 6504 may include a motor coupled to the drive shaft to affect rotation of the drive shaft. The handle 6504 may include a control interface for selectively activating the motor. The control interface may include buttons, switches, levers, sliders, a touch screen, and any other suitable input mechanism or user interface that can be engaged by a clinician to activate the motor.
[0131] The control interface of the handle 6504 may be in communication with a controller 6528 of the handle 6504 to selectively activate the motor to affect rotation of the drive shaft. The controller 6528 may be disposed within the handle 6504 and configured to receive input from the control interface and adapter data from the adapter 6508 or loading unit data from the loading unit 6514. The controller 6528 may analyze the input from the control interface and the data received from the adapter 6508 and / or the loading unit 6514 to selectively activate the motor. The handle 6504 may also include a display viewable by a clinician while using the handle 6504. The display may be configured to display portions of the adapter or loading unit data before, during, or after firing of the instrument 6502.
[0132] The adapter 6508 may include an adapter identification device 6510 disposed therein, and the loading unit 6514 includes a loading unit identification device 6516 disposed therein. The adapter identification device 6510 may be in communication with a controller 6528, and the loading unit identification device 6516 may be in communication with the controller 6528. It will be understood that the loading unit identification device 6516 may be in communication with the adapter identification device 6510, which relays or passes through communications from the loading unit identification device 6516 to the controller 6528.
[0133] The adapter 6508 may also include multiple sensors 6512 (one shown) disposed about its periphery to detect various conditions of the adapter 6508 or the environment (e.g., whether the adapter 6508 is connected to a loading unit, whether the adapter 6508 is connected to a handle, whether the drive shaft is rotating, the torque of the drive shaft, the strain on the drive shaft, the temperature within the adapter 6508, the number of times the adapter 6508 has been fired, the peak force of the adapter 6508 during firing, the total amount of force applied to the adapter 6508, the peak retract force of the adapter 6508, the number of times the adapter 6508 has been dwelled during firing, etc.). The multiple sensors 6512 may provide input to the adapter identification device 6510 in the form of data signals. The data signals of the multiple sensors 6512 may be stored in the adapter identification device 6510 or may be used to update the adapter data stored in the adapter identification device 6510. The data signals of the multiple sensors 6512 may be analog or digital. The plurality of sensors 6512 may include a force gauge for measuring the force exerted on the loading unit 6514 during firing.
[0134] The handle 6504 and adapter 6508 may be configured to interconnect the adapter identification device 6510 and the loading unit identification device 6516 with the controller 6528 via an electrical interface. The electrical interface may be a direct electrical interface (i.e., including electrical contacts that engage with each other to transmit energy and signals therebetween). Additionally or alternatively, the electrical interface may be a contactless electrical interface for wirelessly transmitting (e.g., inductively transmitting) energy and signals therebetween. It is also contemplated that the adapter identification device 6510 and the controller 6528 may wirelessly communicate with each other via a wireless connection separate from the electrical interface.
[0135] The handle 6504 may include a transmitter 6506 configured to transmit instrument data from the controller 6528 to other components of the system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522, or the portable device 6526). The transmitter 6506 may also receive data (e.g., cartridge data, loading unit data, or adapter data) from other components of the system 6500. For example, the controller 6528 may transmit instrument data to the console 6528 including the serial number of an attached adapter (e.g., adapter 6508) attached to the handle 6504, the serial number of a loading unit (e.g., loading unit 6514) attached to the adapter, and the serial number of a multi-fire fastener cartridge (e.g., multi-fire fastener cartridge) loaded in the loading unit. The console 6522 may then transmit data (e.g., cartridge data, loading unit data, or adapter data) associated with the attached cartridge, loading unit, and adapter, respectively, back to the controller 6528. The controller 6528 can display a message on a local device display or send a message via transmitter 6506 to the console 6522 or portable device 6526 to display the message on the display 6524 or portable device screen, respectively.
[0136] 15A shows an exemplary flow for determining an operating mode and operating in the determined mode. The computer-implemented interactive surgical system and / or components and / or subsystems of the computer-implemented interactive surgical system may be configured to be updated. Such updates may include the inclusion of features and benefits that were not available to the user prior to the update. These updates may be established by any hardware, firmware, and software update method suitable for introducing the features to the user. For example, interchangeable / swappable (e.g., hot-swappable) hardware components, flashable firmware devices, and updatable software systems may be used to update the computer-implemented interactive surgical system and / or components and / or subsystems of the computer-implemented interactive surgical system.
[0137] An update may be contingent on any suitable criterion or set of criteria. For example, an update may be contingent on one or more hardware capabilities of the system, such as processing power, bandwidth, resolution, etc. For example, an update may be contingent on one or more software aspects, such as the purchase of specific software code. For example, an update may be contingent on a purchased service tier. A service tier may represent a feature and / or set of features that a user is entitled to use in connection with the computer-implemented interactive surgical system. A service tier may be determined by a license code, an e-commerce server authentication interaction, a hardware key, a username / password combination, a biometric authentication interaction, a public / private key exchange interaction, etc.
[0138] At 10704, a system / device parameter may be identified. A system / device parameter may be any element or set of elements upon which an update is conditioned. For example, the computer-implemented interactive surgical system may detect a particular bandwidth of communication between a modular device and a surgical hub. For example, the computer-implemented interactive surgical system may detect an indication of a purchase of a particular service tier.
[0139] At 10708, an operational mode may be determined based on the identified system / device parameters. This determination may be made by a process that maps system / device parameters to operational modes. The process may be a manual and / or automatic process. The process may be the result of local and / or remote computation. For example, a client / server interaction may be used to determine the operational mode based on the identified system / device parameters. For example, local software and / or locally embedded firmware may be used to determine the operational mode based on the identified system / device parameters. For example, a hardware key, such as a secure microprocessor, may be used to determine the operational mode based on the identified system / device parameters.
[0140] At 10710, operation may proceed according to the determined operating mode. For example, the system or device may proceed to operate in a default operating mode. For example, the system or device may proceed to operate in an alternate operating mode. The operating mode may be dictated by control hardware, firmware, and / or software already present in the system or device. The operating mode may be dictated by newly installed / updated control hardware, firmware, and / or software.
[0141] 15B shows an example functional block diagram for changing the operational mode. The upgradeable element 10714 may include an initialization component 10716. The initialization component 10716 may include any hardware, firmware, and / or software suitable for determining the operational mode. For example, the initialization component 10716 may be part of a system or device startup procedure. The initialization component 10716 can be involved in interactions to determine the operational mode of the upgradeable element 10714. For example, the initialization component 10716 may interact with, for example, a user 10730, an external resource 10732, and / or a local resource 10718. For example, the initialization component 10716 may receive a license key from the user 10730 to determine the operational mode. The initialization component 10716 may query an external resource 10732, such as a server, using the serial number of the upgradeable device 10714 to determine the operational mode. For example, the initialization component 10716 may query local resources 10718, such as a local query to determine the amount of available bandwidth and / or a local query of a hardware key to determine the operating mode, for example.
[0142] The upgradeable element 10714 may include one or more operational components 10720, 10722, 10726, 10728 and an operational pointer 10724. The initialization component 10716 may instruct the operational pointer 10724 to direct the operation of the upgradeable element 10741 to the operational components 10720, 10722, 10726, 10728 corresponding to the determined operational mode. The initialization component 10716 may instruct the operational pointer 10724 to direct the operation of the upgradeable element to the default operational component 10720. For example, the default operational component 10720 may be selected in the condition that no other alternative operational mode has been determined. For example, the default operational component 10720 may be selected in the condition of an initialization component failure and / or interaction failure. The initialization component 10716 may direct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to the resident operation component 10722. For example, a particular feature may be present in the upgradeable component 10714 but require activation to operate. The initialization component 10716 may direct the operation pointer 10724 to direct the operation of the upgradeable component 10714 to install a new operation component 10728 and / or a newly installed operation component 10726. For example, new software and / or firmware may be downloaded. The new software and / or firmware may include code that enables features represented by a selected operation mode. For example, new hardware components may be installed to enable a selected operation mode.
[0143] 16 is a schematic diagram of a robotic surgical instrument 700 configured to manipulate a surgical tool described herein, according to one embodiment of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of an obturator tube, shaft rotation and articulation using either single or multiple articulation drive couplings. In one embodiment, the surgical instrument 700 may be programmed or configured to individually control a firing member, a closure member, a shaft member, or one or more articulating members, or a combination thereof. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, or one or more articulating members, or a combination thereof.
[0144] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control a clamp arm 716 and closure member 714 portion of the end effector 702 via multiple motors 704a-704e, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721, a shaft 740, and one or more articulating members 742a, 742b. A position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. Another sensor 738 may be configured to provide feedback to the control circuit 710. A timer / counter 731 provides timing and counting information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.
[0145] In one aspect, the control circuitry 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor(s) to perform one or more tasks. In one aspect, the timer / counter 731 provides an output signal, such as an elapsed time or digital count, to the control circuitry 710 to correlate the position of the closure member 714 determined by the position sensor 734 with the output of the timer / counter 731 so that the control circuitry 710 can determine the position of the closure member 714 at a particular time (t) relative to a starting position or time (t) when the closure member 714 is at a particular position relative to the starting position. The timer / counter 731 may be configured to measure elapsed time, count an external event, or time an external event.
[0146] In one aspect, the control circuit 710 may be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or a closure control program based on the tissue condition. The firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a slower speed and / or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher speed and / or with higher power. The closure control program may control the closure force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and articulating members 742a, 742b.
[0147] In one aspect, the control circuit 710 can generate motor set point signals. The motor set point signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e, as described herein. In some examples, the motors 704a-704e may be brushed DC electric motors. For example, the speed of the motors 704a-704e may be proportional to the respective motor drive signals. In some examples, the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Also, in some examples, the motor controllers 708a-708e may be omitted, and the control circuit 710 may directly generate the motor drive signals.
[0148] In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program for a closed-loop configuration. The instrument response may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, the total pulse width of the motor drive signal, etc. After the open-loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the displacement member's stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity.
[0149] In one aspect, the motors 704a-704e can receive power from an energy source 712. The energy source 712 may be a DC power supply driven by a mains AC power supply, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to respective movable mechanical elements, such as the closure member 714, the clamp arm 716, the shaft 740, the joint 742a, and the joint 742b, via respective transmission mechanisms 706a-706e. The transmission mechanisms 706a-706e may include one or more gears or other coupling components for coupling the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the closure member 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuitry 710 as the closure member 714 translates distally and proximally. The control circuitry 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some examples, the position sensor 734 may be omitted. If any of the motors 704a-704e are stepper motors, the control circuitry 710 may track the position of the closure member 714 by summing the number and direction of steps the motor 704 is commanded to take. The position sensor 734 may be located within the end effector 702 or in any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.
[0150] In one aspect, the control circuit 710 is configured to drive a firing member, such as the closure member 714 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission mechanism 706a, which is coupled to the closure member 714. The transmission mechanism 706a includes a moving mechanical element, such as a rotating element and a firing member, to control the movement of the closure member 714 distally and proximally along the longitudinal axis of the end effector 702. In one aspect, the motor 704a can be coupled to a knife gear assembly including a knife gear reduction set including a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to fire or displace the closure member 714. The position sensor 734 may be configured to provide a feedback signal to the control circuit 710 regarding the position of the closure member 714 or the firing member along the firing stroke. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor controller 708a. In response to the firing signal, the motor 704a can drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the closure member 714 translates distally, the clamp arm 716 closes against the ultrasonic blade 718.
[0151] In one aspect, the control circuit 710 is configured to drive a closure member, such as the clamp arm 716 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708b, which provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission mechanism 706b, which is coupled to the clamp arm 716. The transmission mechanism 706b includes a movable mechanical element, such as a rotating element and a closure member, for controlling the movement of the clamp arm 716 from open and closed positions. In one aspect, the motor 704b is coupled to a closure gear assembly including a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closure force feedback signal to the control circuit 710. The closure force feedback signal is indicative of the closure force applied to the clamp arm 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 can provide a closure force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control 708b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.
[0152] In one aspect, the control circuit 710 is configured to rotate a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708c, which in turn provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission mechanism 706c, which is coupled to the shaft 740. The transmission mechanism 706c includes a movable mechanical element, such as a rotating element, for controlling the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is coupled to a rotational transmission mechanism assembly including a tubular gear segment formed on (or attached to) the proximal end of the proximal closure tube for operably engaging with a rotational gear assembly operably 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 shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.
[0153] In one aspect, control circuit 710 is configured to articulate end effector 702. Control circuit 710 provides a motor set point to motor controller 708d, which in turn provides a drive signal to motor 704d. The output shaft of motor 704d is coupled to torque sensor 744d. Torque sensor 744d is coupled to transmission mechanism 706d, which is coupled to articulation member 742a. Transmission mechanism 706d includes a movable mechanical element, such as an articulation element, for controlling ±65° of articulation of end effector 702. In one aspect, motor 704d is coupled to an articulation nut, which is rotatably journaled on a proximal end portion of the distal spine portion and rotatably driven by an articulation gear assembly on the proximal end portion of the distal spine portion. Torque sensor 744d provides an articulation force feedback signal to control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.
[0154] In another embodiment, the articulation function of the robotic surgical system 700 may include two articulation members or linkages 742a, 742b. These articulation members 742a, 742b are driven by separate disks on a robot interface (rack) driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the articulation linkages 742a, 742b may be driven antagonistically relative to the other linkage to provide resistive holding motion and load to the head when the head is not moving, and to provide articulation motion when the head is articulating. The articulation members 742a, 742b are attached to the head at a defined radius as the head rotates. Therefore, the mechanical advantage of the push-pull linkage changes as the head rotates. This change in mechanical advantage may be more pronounced with other articulation linkage drive systems.
[0155] In one aspect, one or more of the motors 704a-704e may comprise a gearbox and a brushed DC motor with a mechanical linkage to a firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate moving mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are the unmeasured and unpredictable effects of things like tissue, surroundings, and friction on a physical system. Such external influences are sometimes referred to as drags that act against one of the electric motors 704a-704e. External influences, such as drag, can cause the operation of a physical system to deviate from the desired operation of the physical system.
[0156] In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 734 may be interfaced with the control circuit 710 to provide the absolute positioning system. The position may include multiple Hall effect elements positioned above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and Voider's algorithm, which implements simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.
[0157] 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 effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 738 may include magnetic sensors, field sensors, strain gauges, load cells, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 702. The sensors 738 may include one or more sensors. The sensors 738 may be located on the clamp arm 716 to determine the position of the tissue using split electrodes. The torque sensors 744a-744e may be configured to sense forces, such as firing force, closure force, and / or articulation force, among others. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member in the rack and its position, (3) which portion of the ultrasonic blade 718 has tissue on it, and (4) the load and position on both articulation rods.
[0158] In one aspect, the one or more sensors 738 may comprise strain gauges, such as micro-strain gauges, configured to measure the magnitude of strain in the clamp arm 716 during clamping. The strain gauges provide an electrical signal whose amplitude varies with the magnitude of strain. The sensor 738 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718. The sensor 738 may be configured to detect the impedance of the tissue portion located between the clamp arm 716 and the ultrasonic blade 718, which impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0159] In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, among others. In other implementations, the sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, or an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include a non-electrical conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.
[0160] In one aspect, the sensor 738 may be configured to measure the force exerted by the closure drive system on the clamp arm 716. For example, one or more sensors 738 may be located at the interaction point between the closure tube and the clamp arm 716 to detect the closure force exerted by the closure tube on the clamp arm 716. The force exerted on the clamp arm 716 may be indicative of tissue compression caused by the tissue portion trapped between the clamp arm 716 and the ultrasonic blade 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closure force exerted on the clamp arm 716 by the closure drive system. The one or more sensors 738 may be sampled by a processor in the control circuitry 710 in real time during the clamping operation. The control circuitry 710 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force exerted on the clamp arm 716 in real time.
[0161] In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted to a digital signal and provided to the control circuit 710. The control circuit 710 can be configured to simulate the actual system response of the instrument in controller software. The displacement member can be actuated to move the closure member 714 within the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be one of any feedback controller, including, but not limited to, a PID, state feedback, linear quadratic (LQR), and / or adaptive controller. The robotic surgical instrument 700 can include a power supply for converting a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force. Additional details are disclosed in U.S. Patent Application No. 15 / 636,829, filed June 29, 2017, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT," which is incorporated herein by reference in its entirety.
[0162] 17 shows a schematic diagram of a surgical instrument 750 configured to control the distal translation of a displacement member, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 750 is programmed to control the distal translation of a displacement member, such as a closure member 764. The surgical instrument 750 includes an end effector 752, which may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
[0163] The position, movement, displacement, and / or translation of a linear displacement member, such as closure member 764, can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Because closure member 764 is coupled to a longitudinally movable drive member, the position of closure member 764 can be determined by measuring the position of the longitudinally movable drive member using position sensor 784. Accordingly, in the following description, the position, displacement, and / or translation of closure member 764 can be achieved by position sensor 784 as described herein. Control circuitry 760 may be programmed to control the translation of a displacement member, such as closure member 764. In some examples, control circuitry 760 may comprise one or more microcontrollers, microprocessors, or other suitable processors to execute instructions that cause the processor(s) to control a displacement member, e.g., closure member 764, in the manner described. In one aspect, the timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuitry 760 to correlate the position of the closure member 764 determined by the position sensor 784 with the output of the timer / counter 781 so that the control circuitry 760 can determine the position of the closure member 764 at a particular time (t) relative to a starting position. The timer / counter 781 may be configured to measure elapsed time, count an external event, or time an external event.
[0164] The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754, as described herein. In some examples, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor, and the motor drive signal 774 may include a PWM signal provided to one or more stator windings of the motor 754. Also, in some examples, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.
[0165] The motor 754 may receive power from an energy source 762. The energy source 762 may be or may include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closure member 764 via a transmission mechanism 756. The transmission mechanism 756 may include one or more gears or other coupling components for coupling the motor 754 to the closure member 764. A position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuitry 760 as the closure member 764 translates distally and proximally. The control circuitry 760 may track the pulses to determine the position of the closure member 764. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the closure member 764. Also, in some examples, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuitry 760 may track the position of the closure member 764 by summing the number and direction of steps that the motor 754 is commanded to take. The position sensor 784 may be located in the end effector 752 or in any other portion of the instrument.
[0166] The control circuitry 760 can be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensors 788 may include one or more sensors.
[0167] The one or more sensors 788 may comprise strain gauges, such as micro-strain gauges, configured to measure the magnitude of strain in the clamp arm 766 during clamping. The strain gauges provide an electrical signal whose amplitude varies with the magnitude of strain. The sensor 788 may comprise a pressure sensor configured to detect pressure created by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect the impedance of the tissue portion located between the clamp arm 766 and the ultrasonic blade 768, which impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0168] The sensor 788 may be configured to measure the force exerted on the clamp arm 766 by the closure drive system. For example, one or more sensors 788 may be located at the interaction point between the closure tube and the clamp arm 766 to detect the closure force exerted on the clamp arm 766 by the closure tube. The force exerted on the clamp arm 766 may be indicative of tissue compression caused by the tissue portion trapped between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force exerted on the clamp arm 766 by the closure drive system. The one or more sensors 788 may be sampled by a processor in the control circuit 760 in real time during the clamping operation. The control circuit 760 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force exerted on the clamp arm 766 in real time.
[0169] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the closure member 764 corresponds to the current drawn by the motor 754. The force is converted to a digital signal and provided to the control circuit 760.
[0170] The control circuitry 760 can be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the closure member 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 can include a feedback controller, which can be one of any feedback controller, including, but not limited to, a PID, state feedback, LQR, and / or adaptive controller. The surgical instrument 750 can include a power supply for converting a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force.
[0171] The actual drive system of the surgical instrument 750 is configured to drive the displacement, cutting, or closure member 764 via a brushed DC motor with a gearbox and mechanical linkage to the articulation and / or knife system. Another example is an electric motor 754 that operates, for example, the displacement member and articulation driver of an interchangeable shaft assembly. External influences are the unmeasured and unpredictable effects of things like tissue, surroundings, and friction on a physical system. These external influences are sometimes referred to as obstacles that act against the electric motor 754. External influences, such as obstacles, can cause the operation of a physical system to deviate from the desired operation of the physical system.
[0172] Various exemplary embodiments are directed to a surgical instrument 750 including an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, a motor 754 may drive a displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 positioned opposite the clamp arm 766. A clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When the instrument 750 is ready to be used, the clinician can provide a firing signal, for example, by pressing a trigger on the instrument 750. In response to the firing signal, the motor 754 can drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the displacement member translates distally, the closure member 764 with a cutting element positioned at its distal end can cut tissue between the ultrasonic blade 768 and the clamp arm 766 .
[0173] In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as the closure member 764, based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on the tissue condition. The control program may dictate the distal movement of the displacement member. Different control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and / or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or with higher power.
[0174] In some examples, the control circuit 760 may initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of the instrument 750 during the open-loop portion of the stroke, the control circuit 760 may select a firing control program. The instrument response may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to the motor 754 during the open-loop portion, the total pulse width of the motor drive signal, etc. After the open-loop portion, the control circuit 760 may implement the selected firing control program for a second portion of the displacement member's stroke. For example, during the closed-loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Additional details are disclosed in U.S. Patent Application No. 15 / 720,852, filed September 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," which is incorporated herein by reference in its entirety.
[0175] 18 is a schematic diagram of a surgical instrument 790 configured to control various functions, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as a closure member 764. The surgical instrument 790 includes an end effector 792, which may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768, which may replace or operate in conjunction with one or more RF electrodes 796 (shown in dashed lines). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769, which is driven by an ultrasonic generator 771.
[0176] In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid-state switch, a Hall effect device, an MR device, a GMR device, a magnetometer, among others. In other implementations, the sensor 638 may be a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, an ultraviolet sensor, among others. Furthermore, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include a non-electrical conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.
[0177] In one aspect, position sensor 784 may be implemented as an absolute positioning system, including a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. Position sensor 784 may be interfaced with control circuit 760 to provide an absolute positioning system. The position may include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as digit-by-digit and Voider's algorithm, which implements simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.
[0178] In some examples, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 760 may track the position of the closure member 764 by summing the number and direction of steps the motor is commanded to take. The position sensor 784 may be located in the end effector 792 or in any other part of the instrument.
[0179] The control circuitry 760 can be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 792. The sensors 788 may include one or more sensors.
[0180] An RF energy source 794 is coupled to the end effector 792 and is applied to the RF electrode 796 when the RF electrode 796 is provided within the end effector 792 in place of the ultrasonic blade 768 or when the RF electrode 796 is provided to operate in conjunction with the ultrasonic blade 768. For example, the ultrasonic blade may be made of a conductive metal and used as a return path for the electrosurgical RF current. A control circuit 760 controls the delivery of RF energy to the RF electrode 796.
[0181] Additional details are disclosed in U.S. Patent Application No. 15 / 636,096, filed June 28, 2017, entitled "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME," which is incorporated herein by reference in its entirety.
[0182] 19 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communications hub, in accordance with at least one embodiment of the present disclosure. In one embodiment, the generator module 240 is configured to execute an adaptive ultrasonic blade control algorithm 802. In another embodiment, the device / instrument 235 is configured to execute an adaptive ultrasonic blade control algorithm 804. In another embodiment, both the generator module 240 and the device / instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804.
[0183] The generator module 240 may include a patient-isolated stage that communicates with a non-isolated stage via a power transformer. The secondary winding of the power transformer is housed within the isolated stage and may include a tap configuration (e.g., center-tapped or non-center-tapped) to define a drive signal output for delivering drive signals to various surgical instruments, such as ultrasonic surgical instruments, RF electrosurgical instruments, and multifunction surgical instruments including ultrasonic and RF energy modes that can be delivered singly or simultaneously. Specifically, the drive signal output can output an ultrasonic drive signal (e.g., a 420 V root-mean-square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output can output an RF electrosurgical drive signal (e.g., a 100 V RMS drive signal) to the RF electrosurgical instrument 241.
[0184] FIG. 20 illustrates an example of a generator 900, a form of generator configured to couple with an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network comprising the modular communications hub shown in FIG. 19 . The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, for delivering energy to the surgical instrument. The RF and ultrasonic signals may be provided alone or in combination, or simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be delivered individually or simultaneously to an end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in memory coupled to the processor 902, which is not shown for clarity of disclosure. Digital information related to the waveforms is provided to the waveform generator 904, which includes one or more DAC circuits for converting the digital input to an analog output. The analog output is provided to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled across the power transformer 908 to a secondary side on the patient-isolated side. A first signal of a first energy modality is provided to the surgical instrument between terminals labeled ENERGY1 and RETURN. A second signal of a second energy modality is coupled across a capacitor 910 and provided to the surgical instrument between terminals labeled ENERGY2 and RETURN. It will be understood that more than two energy modalities may be output, and thus the subscript "n" may be used to indicate that up to n ENERGYn terminals may be provided, where n is a positive integer greater than 1.It will also be appreciated that up to "n" return paths (RETURN) may be provided without departing from the scope of this disclosure.
[0185] A first voltage sense circuit 912 is coupled across the terminals labeled ENERGY1 and RETURN paths and measures the output voltage therebetween. A second voltage sense circuit 924 is coupled across the terminals labeled ENERGY2 and RETURN paths and measures the output voltage therebetween. A current sense circuit 914 is disposed in series with the RETURN section on the secondary side of the power transformer 908 shown to measure the output current of either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit must be provided in each return section. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to corresponding isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side (non-patient-isolated side) of the power transformer 908 are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculations. Feedback information of the output voltage and output current can be used to calculate parameters such as output impedance to adjust the output voltage and current provided to the surgical instrument. Input / output communication between the processor 902 and the patient isolation circuit is provided via the interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.
[0186] In one aspect, the impedance may be determined by the processor 902 by dividing either the output of a first voltage sense circuit 912 coupled across the terminals labeled ENERGY1 / RETURN or the output of a second voltage sense circuit 924 coupled across the terminals labeled ENERGY2 / RETURN by the output of a current sense circuit 914 disposed in series with the RETURN section of the secondary side of the power transformer 908. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 916. Digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 to calculate the impedance. As an example, the first energy modality ENERGY1 may be ultrasound energy and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to ultrasound energy modalities and bipolar or monopolar RF energy modalities, other energy modalities may include irreversible and / or reversible electroporation energy, and / or microwave energy, among others. Also, while the example illustrated in FIG. 21 shows that a single return path RETURN may be provided to two or more energy modalities, in other aspects, multiple return paths RETURN may be provided to each energy modality ENERGY. Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the impedance of the tissue may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.
[0187] As shown in FIG. 20 , a generator 900 with at least one output port can include a power transformer 908 with a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities, such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others, depending on the type of tissue treatment being performed. For example, the generator 900 can deliver high-voltage, low-current energy to drive an ultrasonic transducer, low-voltage, high-current energy to drive an RF electrode to seal tissue, or energy having a coagulation waveform for spot coagulation using either monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 can be directed, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the generator 900 output will preferably be located between the outputs labeled ENERGY1 and RETURN shown in FIG. 20 . In one embodiment, the connection to the output of the RF bipolar electrode generator 900 would preferably be located between the output labeled ENERGY2 and the output labeled RETURN. For a unipolar output, the preferred connection would be to connect the active electrode (e.g., a pencil or other probe) to the ENERGY2 output and a suitable return pad to the RETURN output.
[0188] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published March 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety.
[0189] As used throughout this description, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that may communicate data through the use of modulated electromagnetic radiation over a non-solid medium. This term does not imply that the associated devices do not include any wires, although in some aspects they may not be present. The communication modules may implement any of a number of wireless or wired communication standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and beyond. A computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.
[0190] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually memory) or some other data stream. The term is used herein to refer to a system that combines many specialized "processors" or the central processor (central processing unit) within a computer system (especially a system on a chip (SoC)).
[0191] As used herein, a system on a chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It can include digital, analog, mixed-signal, and often high-frequency functions, all on a single substrate. An SoC integrates a microcontroller (or microprocessor) with modern peripheral devices such as a graphics processing unit (GPU), Wi-Fi module, or coprocessor. An SoC may or may not include built-in memory.
[0192] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to an SoC, which may include a microcontroller as one of its components. A microcontroller can house one or more core processing units (CPUs) along with memory and programmable input / output peripherals. Program memory and a small amount of RAM in the form of ferroelectric RAM, NOR flash, or OTP ROM are often also included on the chip. Microcontrollers may be used for embedded applications, as opposed to microprocessors used in personal computers or other general-purpose applications, which are made up of various individual chips.
[0193] As used herein, the term controller or microcontroller may be a standalone IC or chip device that interfaces with a peripheral device, or it may be the link between two parts: a computer or controller on an external device that manages the operation of (and connections with) that device.
[0194] Any processor or microcontroller described herein may be implemented by any single-core or multi-core processor, such as those known by the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with Stellaris Ware® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels. More details are available in the product datasheet.
[0195] In one aspect, the processor may include a safety controller, including two controller-based families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.
[0196] Modular devices include modules that are receivable within a surgical hub and surgical devices or instruments that can be connected to various modules to connect or pair with corresponding surgical hubs. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, aspirators, and displays. The modular devices described herein can be controlled by a control algorithm. The control algorithm can execute on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the modular device's control algorithm controls the device based on data sensed by the modular device itself (i.e., by sensors within, on, or connected to the modular device). This data can be related to the patient during surgery (e.g., tissue characteristics or insufflation pressure) or related to the modular device itself (e.g., advancing knife speed, motor current, or energy level). For example, a control algorithm for a surgical stapling and severing instrument may control the speed at which the instrument's motor drives the knife through tissue based on the resistance offered by the knife as it advances.
[0197] 21 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunction surgical instrument 1108 is a combination ultrasonic / RF electrosurgical instrument. The generator 1100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1100 may be configurable for use with a variety of different types of surgical devices, including, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instrument 1106, and the multifunction surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. 21 , the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108; however, in one form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on a front panel of a console for the generator 1100. The input device 1110 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.
[0198] The generator 1100 is configured to drive multiple surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104, which includes a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 acoustically coupled to the ultrasonic transducer 1120 and a clamp arm 1140. The handpiece 1105 includes a trigger 1143 for actuating the clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c for energizing and driving the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, 1134c can be configured to energize the ultrasonic transducer 1120 using the generator 1100.
[0199] The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in clamp arms 1142 a, 1142 b and return through an electrical conductor portion of the shaft 1127. The electrodes are coupled to and energized by a bipolar energy source within the generator 1100. The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1142 a, 1142 b and an energy button 1135 for actuating an energy switch to supply energy to the electrodes in the end effector 1124.
[0200] The generator 1100 is also configured to drive a multifunction surgical instrument 1108. The multifunction surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 that activates the clamp arm 1146 and a combination of toggle buttons 1137a, 1137b, 1137c for energizing and driving the ultrasonic blade 1149 or other functions. The toggle buttons 1137a, 1137b, 1137c can be configured to energize the ultrasonic transducer 1120 using the generator 1100 and also to energize the ultrasonic blade 1149 using a bipolar energy source housed within the generator 1100.
[0201] The generator 1100 is configurable for use with a variety of surgical instruments. According to various configurations, the generator 1100 may be configurable for use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunction surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. In the configuration of FIG. 22 , the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108; however, in other configurations, the generator 1100 may be integrally formed with any one of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. The input device 1110 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Further aspects of generators for digitally generating electrical signal waveforms and surgical instruments are described in U.S. Patent Application Publication No. 2017-0086914(A1), which is incorporated herein by reference in its entirety.
[0202] In one aspect, the surgical hub 106 may be embodied as a modular energy system 2000, as shown in connection with FIGS. 22-28 . The modular energy system 2000 may include a variety of different modules 2001 that are connectable to one another in a stacked configuration. In one aspect, the modules 2001 may be physically and communicatively coupled when stacked or otherwise connected together into a single assembly. Furthermore, the modules 2001 may be interchangeably connectable to one another in different combinations or arrangements. In one aspect, each of the modules 2001 may include a consistent or universal array of connectors disposed along their upper and lower surfaces, thereby allowing any module 2001 to be connected to another module 2001 in any arrangement (although in some aspects, a particular module type, such as a header module 2002, may be configured to function as the topmost module in a stack, for example). The modular energy system 2000 may also include a variety of different components or accessories that may be connectable to or otherwise associated with the modules 2001. In another embodiment, the modular energy system 2000 may be a separate system from the surgical hub 106. In such an embodiment, the modular energy system 2000 may be communicatively coupleable to the surgical hub 206 for transmitting and / or receiving data therebetween.
[0203] Modular energy system 2000 can be assembled from a variety of different modules 2001, some examples of which are shown in FIG. 22. Each of the different types of modules 2001 can provide different functions, thereby allowing modular energy systems 2000 to be assembled into different configurations to customize the functionality and capabilities of the modular energy system 2000 by customizing the modules 2001 included in each modular energy system 2000. The modules 2001 of modular energy system 2000 can include, for example, a header module 2002 (which can include a display screen 2006), an energy module 2004, a technology module 2040, and a visualization module 2042. In the embodiment shown, the header module 2002 is configured to function as the top or uppermost module in the modular energy system stack and therefore may lack connectors along its top surface. In another embodiment, the header module 2002 can be configured to be positioned at the bottom or be the bottom module in the modular energy system stack and therefore may lack connectors along its bottom surface. In yet another aspect, the header module 2002 may be configured to be positioned in an intermediate position within the modular energy system stack and, therefore, may include connectors along both its bottom and top surfaces. The header module 2002 may be configured to control system-wide settings for each module 2001 and its connected components through physical controls 2011 on the header module 2002 and / or through a graphical user interface (GUI) 2008 displayed on the display screen 2006. Such settings could include activation of the modular energy system 2000, alarm volume settings, footswitch settings, settings icons, user interface appearance or configuration, surgeon profile logged into the modular energy system 2000, and / or the type of surgical procedure being performed.The header module 2002 may also be configured to provide communication, processing, and / or power for the modules 2001 connected to the header module 2002. The energy module 2004 may be configured to generate one or more energy modalities for driving the electrosurgical and / or ultrasonic surgical instruments connected thereto. The technology module 2040 may be configured to provide additional or extended control algorithms (e.g., electrosurgical or ultrasonic control algorithms for controlling the energy output of the energy module 2004). The visualization module 2042 is configured to interface with a visualization device (i.e., a scope) and, accordingly, can provide enhanced visualization capabilities.
[0204] The modular energy system 2000 may further include various accessories 2029 connectable to the module 2001 to control the functionality of the module 2001 or otherwise configured to function in conjunction with the modular energy system 2000. The accessories 2029 may include, for example, a single pedal footswitch 2032, a dual pedal footswitch 2034, and a cart 2030 for supporting the modular energy system 2000 thereon. The footswitches 2032, 2034 may be configured, for example, to control the activation or function of a particular energy modality output by the energy module 2004.
[0205] By utilizing modular components, the illustrated modular energy system 2000 provides a surgical platform that grows with technology availability and is customizable to fit the needs of the facility and / or surgeon. Additionally, the modular energy system 2000 supports combo devices (e.g., electrosurgical and ultrasonic energy dual generators) and software-driven algorithms for customized effects on tissue. Still further, the surgical system architecture reduces the capital equipment footprint by combining multiple technologies critical to the procedure into a single system.
[0206] 23A , the header module 2002, in some embodiments, may include a display screen 2006 that displays a GUI 2008 for relaying information regarding the modules 2001 connected to the header module 2002. In some embodiments, the GUI 2008 of the display screen 2006 may provide a unified point of control for all of the modules 2001 that make up a particular configuration of the modular energy system 2000. Various embodiments of the GUI 2008 are discussed in more detail below in connection with FIG. 28 . In alternative embodiments, the header module 2002 may lack the display screen 2006, or the display screen 2006 may be removably connected to the housing 2010 of the header module 2002. In such embodiments, the header module 2002 may be communicatively coupleable to an external system configured to display information generated by the modules 2001 of the modular energy system 2000. For example, in a robotic surgical application, the modular energy system 2000 may be communicatively coupleable to a robotic cart or robotic control console configured to display information generated by the modular energy system 2000 to an operator of the robotic surgical system. As another example, the modular energy system 2000 may be communicatively coupleable to a mobile display carried by or attached to a surgical staff member such that the information can be viewed on the mobile display. In yet another example, the modular energy system 2000 may be communicatively coupleable to a surgical hub 2100 or another computer system that may include a display 2104, as shown in FIG. 27 .In embodiments utilizing a user interface that is separate or otherwise distinct from the modular energy system 2000, the user interface may be wirelessly connectable to the modular energy system 2000 as a whole, or to one or more of the modules 2001, such that the user interface can display information from the connected modules 2001. With further reference to FIG. 23A , the energy module 2004 may include a port assembly 2012 that includes a number of different ports configured to deliver different energy modalities to corresponding surgical instruments connectable thereto. In the particular embodiment shown in FIGS. 24-30 , the port assembly 2012 includes a bipolar port 2014, a first monopolar port 2016 a, a second monopolar port 2018 b, a neutral port 2018 (to which a monopolar return pad can be connected), and a combination energy port 2020. However, this particular combination of ports is provided for illustrative purposes only, and alternative combinations of ports and / or energy modalities may be possible for the port assembly 2012.
[0207] As described above, the modular energy system 2000 can be assembled into different configurations. Furthermore, different configurations of the modular energy system 2000 may also be usable for different types of surgical procedures and / or different tasks. For example, FIGS. 23A and 23B show a first exemplary configuration of the modular energy system 2000 including a header module 2002 (including a display screen 2006) and an energy module 2004 connected together. Such a configuration may be suitable for laparoscopic and open surgery, for example.
[0208] FIG. 24A shows a second exemplary configuration of the modular energy system 2000 including a header module 2002 (including a display screen 2006), a first energy module 2004a, and a second energy module 2004b connected together. By stacking two energy modules 2004a, 2004b, the modular energy system 2000 can provide a pair of port assemblies 2012a, 2012b for expanding the array of energy modalities deliverable by the modular energy system 2000 from the first configuration. Thus, the second configuration of the modular energy system 2000 can accommodate two or more bipolar / monopolar electrosurgical instruments, three or more bipolar / monopolar electrosurgical instruments, etc. Such a configuration may be particularly suitable for complex laparoscopic and open surgical procedures. FIG. 24B shows a third exemplary configuration similar to the second configuration, except that the header module 2002 lacks the display screen 2006. This configuration may be suitable for robotic surgical or mobile display applications, as discussed above.
[0209] 25 shows a fourth exemplary configuration of a modular energy system 2000 including a header module 2002 (including a display screen 2006), a first energy module 2004a, a second energy module 2004b, and a technology module 2040 connected together. Such a configuration may be suitable for surgical applications where particularly complex or computationally intensive control algorithms are required. Alternatively, the technology module 2040 may be a newly released module that complements or extends the functionality of a previously released module (such as the energy module 2004).
[0210] 26 illustrates a fifth exemplary configuration of the modular energy system 2000 including a header module 2002 (including a display screen 2006), a first energy module 2004a, a second energy module 2004b, a technology module 2040, and a visualization module 2042 connected together. Such a configuration may be suitable for endoscopic procedures by providing a dedicated surgical display 2044 for relaying a video feed from a scope coupled to the visualization module 2042. It should be noted that the configurations shown in FIGS. 23A-27 and described above are provided merely to illustrate various concepts of the modular energy system 2000 and should not be construed to limit the modular energy system 2000 to the specific aforementioned configurations.
[0211] As mentioned above, the modular energy system 2000 may be communicatively coupleable to an external system, such as a surgical hub 2100, as shown in FIG. 27. Such an external system may include a display screen 2104 for displaying a visual feed from an endoscope (or camera or another such visualization device) and / or data from the modular energy system 2000. Such an external system may also include a computer system 2102 for performing calculations or otherwise analyzing data generated or provided by the modular energy system 2000, for controlling functions or modes of the modular energy system 2000, and / or for relaying data to a cloud computing system or another computer system. Such an external system may also coordinate actions among multiple modular energy systems 2000 and / or other surgical systems.
[0212] 28 , in some aspects, the header module 2002 can include or support a display 2006 configured to display a GUI 2008, as described above. The display screen 2006 can include a touch screen for receiving input from a user in addition to displaying information. The controls displayed on the GUI 2008 can correspond to the modules 2001 connected to the header module 2002. In some aspects, different portions or regions of the GUI 2008 can correspond to particular modules 2001. For example, a first portion or region of the GUI 2008 can correspond to a first module, and a second portion or region of the GUI 2008 can correspond to a second module. As different and / or additional modules 2001 are connected to the modular energy system stack, the GUI 2008 can adjust to correspond to different and / or additional controls for each newly added module 2001 or to remove controls for each removed module 2001. Each portion of the display corresponding to a particular module connected to the header module 2002 may display controls, data, user prompts, and / or other information corresponding to that module. For example, in FIG. 28 , the first or upper portion 2052 of the illustrated GUI 2008 displays controls and data associated with the energy module 2004 connected to the header module 2002. Specifically, the first portion 2052 of the GUI 2008 for the energy module 2004 provides a first widget 2056 a corresponding to the bipolar port 2014, a second widget 2056 b corresponding to the first monopolar port 2016 a, a third widget 2056 c corresponding to the second monopolar port 2016 b, and a fourth widget 2056 d corresponding to the combination energy port 2020. Each of these widgets 2056a-d provides data associated with the widget's corresponding port in the port assembly 2012, as well as controls for controlling the mode and other features of the energy modality delivered by the energy module 2004 through each port in the port assembly 2012.For example, widgets 2056a-d may be configured to display the power level of a surgical instrument connected to their respective ports, change the operating mode of a surgical instrument connected to their respective ports (e.g., change a surgical instrument from a first power level to a second power level and / or change a monopolar surgical instrument from a "spray" mode to a "blend" mode), and the like.
[0213] In one aspect, the header module 2002 may include various physical controls 2011 in addition to or instead of the GUI 2008. Such physical controls 2011 may include, for example, a power button that controls activation of each module 2001 connected to the header module 2002 in the modular energy system 2000. Alternatively, the power button may be displayed as part of the GUI 2008. Thus, the header module 2002 may act as a single point of contact, eliminating the need to individually activate and deactivate each individual module 2001 from which the modular energy system 2000 is built.
[0214] In one aspect, the header module 2002 can display still images, video, animation, and / or information associated with the surgical module 2001 on which the modular energy system 2000 is constructed or a surgical device communicatively coupled to the modular energy system 2000. The still images and / or video displayed by the header module 2002 can be received from an endoscope or another visualization device communicatively coupled to the modular energy system 2000. The animation and / or information in the GUI 2008 can be overlaid on or displayed adjacent to the image or video feed.
[0215] In one aspect, modules 2001 other than the header module 2002 can be configured to relay information to the user as well. For example, the energy module 2004 can include light assemblies 2015 disposed around each of the ports of the port assembly 2012. The light assemblies 2015 can be configured to relay information about the port to the user according to their color or state (e.g., blinking). For example, the light assemblies 2015 can change from a first color to a second color when a plug is fully seated in its respective port. In one aspect, the color or state of the light assemblies 2015 can be controlled by the header module 2002. For example, the header module 2002 can cause the light assembly 2015 of each port to display a color corresponding to the color indication of the port on the GUI 2008.
[0216] FIG. 29 is a block diagram of a standalone hub configuration of a modular energy system 3000 in accordance with at least one embodiment of the present disclosure, and FIG. 30 is a block diagram of a hub configuration of a modular energy system 3000 integrated with a surgical control system 3010 in accordance with at least one embodiment of the present disclosure. As shown in FIGS. 31 and 32 , the modular energy system 3000 can be utilized as a standalone unit or integrated with a surgical control system 3010 to control and / or receive data from one or more surgical hub units. In the example shown in FIGS. 29 and 30 , the integrated header / VI module 3002 of the modular energy system 3000 includes a header module and a UI module integrated together as a single module. In other embodiments, the header module and UI module can be provided as separate components communicatively coupled via a data bus 3008.
[0217] 29 , an example standalone modular energy system 3000 includes an integrated header module / user interface (UI) module 3002 coupled to an energy module 3004. Power and data are transmitted between the integrated header / VI module 3002 and the energy module 3004 through a power interface 3006 and a data interface 3008. For example, the integrated header / VI module 3002 can transmit various commands to the energy module 3004 through the data interface 3008. Such commands can be based on user input from the UI. As a further example, power may be transmitted to the energy module 3004 through the power interface 3006.
[0218] 30 , the surgical hub configuration includes a modular energy system 3000 integrated with a control system 3010 and an interface system 3022 for managing, among other things, data and power transfer to and / or from the modular energy system 3000. The modular energy system shown in FIG. 32 includes an integrated header / VI module 3002, a first energy module 3004, and a second energy module 3012. In one embodiment, a data transmission path is established between a system control unit 3024 of the control system 3010 and the second energy module 3012 (through the first energy module 3004) and the header / VI module 3002 (through the data interface 3008). Additionally, a power path extends between the integrated header / VI module 3002 and the second energy module 3012 through the power interface 3006 and through the first energy module 3004. In other words, in one aspect, the first energy module 3004 is configured to function as a power and data interface between the second energy module 3012 and the integrated header / VI module 3002 through the power interface 3006 and the data interface 3008. This arrangement allows the modular energy system 3000 to be expanded by seamlessly connecting additional energy modules 3004, 3012 already connected to the integrated header / VI module 3002 without requiring dedicated power and energy interfaces within the integrated header / VI module 3002.
[0219] A system control unit 3024, which may be referred to herein as a control circuit, control logic, microprocessor, microcontroller, logic, or FPGA, or various combinations thereof, is coupled to a system interface 3022 via an energy interface 3026 and an appliance communication interface 3028. The system interface 3022 is coupled to a first energy module 3004 via a first energy interface 3014 and a first appliance communication interface 3016. The system interface 3022 is coupled to a second energy module 3012 via a second energy interface 3018 and a second appliance communication interface 3020. When additional modules, such as additional energy modules, are stacked within the modular energy system 3000, additional energy and communication interfaces are provided between the system interface 3022 and the additional modules.
[0220] As described in more detail below, the energy modules 3004, 3012 are connectable to the hub and can be configured to generate electrosurgical energy (e.g., bipolar or monopolar), ultrasonic energy, or a combination thereof (referred to herein as "advanced energy" modules) for various energy surgical instruments. Generally, the energy modules 3004, 3012 include a hardware / software interface, an ultrasonic controller, an advanced energy RF controller, a bipolar RF controller, and control algorithms executed by a controller that receives outputs from the controller and controls the operation of the various energy modules 3004, 3012 accordingly. In various aspects of the present disclosure, the controllers described herein may be implemented as control circuitry, control logic, microprocessors, microcontrollers, logic, or FPGAs, or various combinations thereof.
[0221] 31-33 are block diagrams of various modular energy systems connected together to form a hub, according to at least one embodiment of the present disclosure. FIGS. 31-33 show various diagrams (e.g., circuit or control diagrams) of a hub module. The modular energy system 3000 includes a plurality of energy modules 3004 ( FIG. 32 ), 3012 ( FIG. 33 ), a header module 3150 ( FIG. 33 ), a UI module 3030 ( FIG. 31 ), and a communications module 3032 ( FIG. 31 ), according to at least one embodiment of the present disclosure. The UI module 3030 includes a touchscreen 3046 that displays various relevant information and various user controls for controlling one or more parameters of the modular energy system 3000. The UI module 3030 is attached to the top header module 3150 but is housed separately from the header module 3150 so that it can be operated independently. For example, the UI module 3030 may be picked up by a user and / or reattached to the header module 3150. Additionally or alternatively, the UI module 3030 can be moved slightly relative to the header module 3150 to adjust its position and / or orientation. For example, the UI module 3030 can be tilted and / or rotated relative to the header module 3150.
[0222] In some aspects, the various hub modules can include light piping around the physical ports for communicating instrument status and can also connect elements on the screen to corresponding instruments. Light piping is one example of lighting technology that can be used to alert a user to the status of a surgical instrument attached / connected to a physical port. In one aspect, illuminating a physical port with a particular light prompts a user to connect a surgical instrument to the physical port. In another example, illuminating a physical port with a particular light alerts a user to an error associated with an existing connection with a surgical instrument.
[0223] Referring to FIG. 31 , a block diagram of a user interface (UI) module 3030 coupled to a communications module 3032 via a pass-through hub connector 3034 is shown, in accordance with at least one aspect of the present disclosure. The UI module 3030 may be provided as a separate component from the header module 3150 (shown in FIG. 33 ) and may be communicatively coupled to the header module 3150 via the communications module 3032, for example. In one aspect, the UI module 3030 may include a UI processor 3040 configured to represent declarative visualizations and behaviors received from other connected modules and to perform other centralized UI functionality such as system configuration (e.g., language selection, module association, etc.). The UI processor 3040 may be, for example, a processor or system-on-module (SOM) running a framework such as Qt, .NET WPF, or a web server.
[0224] In the illustrated example, the UI module 3030 includes a touchscreen 3046, a liquid crystal display (LCD) 3048, and an audio output 3052 (e.g., speaker, buzzer). The UI processor 3040 is configured to receive touchscreen input from a touch controller 3044 coupled between the touchscreen 3046 and the UI processor 3040. The UI processor 3040 is configured to output visual information to the LCD display 3048 and audio information to the audio output 3052 via an audio amplifier 3050. The UI processor 3040 interfaces with the communications module 3032 via a switch 3042 coupled to the pass-through hub connector 3034 and is configured to receive, process, and forward data from a source device to a destination device and control data communication therebetween. DC power is supplied to the UI module 3030 via a DC / DC converter module 3054. DC power is passed through the pass-through hub connector 3034 and through the power bus 3006 to the communications module 3032. Data is passed through the pass-through hub connector 3034 and through the data bus 3008 to the communications module 3032. The switches 3042, 3056 receive, process, and forward data from the source device to the destination device.
[0225] Continuing with FIG. 33 , the communications module 3032, as well as various surgical hubs and / or surgical systems, may include a gateway 3058 configured to shuttle select traffic (i.e., data) between two different networks (e.g., an internal network and / or a hospital network) running different protocols. The communications module 3032 includes a first pass-through hub connector 3036 for coupling the communications module 3032 to other modules. In the example shown, the communications module 3032 is coupled to the UI module 3030. The communications module 3032 is coupled to other modules (e.g., an energy module) via a second pass-through hub connector 3038 and is configured to couple the communications module 3032 to other modules via a switch 3056 disposed between the first pass-through hub connector 3036 and the second pass-through hub connector 3038 to receive, process, and forward data from a source device to a destination device and control data communication therebetween. The switch 3056 is also coupled to a gateway 3058 to communicate information between the external communication port and the UI module 3030 and other connected modules. The gateway 3058 may be coupled to various communication modules, such as, for example, an Ethernet module 3060 for communicating with a hospital or other local network, a Universal Serial Bus (USB) module 3062, a WiFi module 3064, and a Bluetooth module 3066, among others. The communication modules may be physical boards located within the communication module 3032 or may be ports that couple to remote communication boards.
[0226] In some aspects, all of the modules (i.e., removable hardware) are controlled by a single UI module 3030 disposed on or integral with the header module. FIG. 33 illustrates a standalone header module 3150 to which the UI module 3030 can be attached. FIGS. 29, 30, and 34 illustrate an integrated header / VI module 3002. Returning now to FIG. 31, in various aspects, by integrating all of the modules into a single responsive UI module 3002, the system provides a simpler way to control and monitor multiple pieces of equipment at once. This approach significantly reduces the footprint and complexity in the operating room (OR).
[0227] Referring to FIG. 32 , a block diagram of an energy module 3004 is shown, in accordance with at least one embodiment of the present disclosure. The communications module 3032 ( FIG. 31 ) is coupled to the energy module 3004 via a second pass-through hub connector 3038 of the communications module 3032 and a first pass-through hub connector 3074 of the energy module 3004. The energy module 3004 may be coupled to other modules, such as the second energy module 3012 shown in FIG. 33 , via a second pass-through hub connector 3078. Returning to FIG. 32 , a switch 3076 disposed between the first pass-through hub connector 3074 and the second pass-through hub connector 3078 receives, processes, and forwards data from a source device to a destination device and controls data communication therebetween. Data is received and transmitted via a data bus 3008. The energy module 3032 includes a controller 3082 for controlling various communication and processing functions of the energy module 3004.
[0228] DC power is received and transmitted by the energy module 3004 over the power bus 3006. The power bus 3006 is coupled to the DC / DC converter module 3138 to provide power to the adjustable regulators 3084, 3107 and the isolated DC / DC converter ports 3096, 3112, 3132.
[0229] In one embodiment, the energy module 3004 can include an ultrasonic broadband amplifier 3086, which in one embodiment may be a linear Class H amplifier capable of generating arbitrary waveforms at low total harmonic distortion (THD) levels and may drive a harmonic transducer. The ultrasonic broadband amplifier 3086 is powered by a step-down adjustable regulator 3084 to maximize efficiency and controlled by a controller 3082, which may be implemented as a digital signal processor (DSP) via a direct digital synthesis (DDS). The DDS may be embedded in the transducer DSP or implemented in a field programmable gate array (FPGA), for example. The controller 3082 controls the ultrasonic broadband amplifier 3086 via a digital-to-analog converter 3106 (DAC). The output of the ultrasonic broadband amplifier 3086 is fed to an ultrasonic power transformer 3088, which is coupled to the ultrasonic energy output portion of the advanced energy receiver 3100. Ultrasonic voltage (V) and current (I) feedback (FB) signals, which may be used to calculate ultrasonic impedance, are fed back to the controller 3082 through the input portion of the advanced energy receiver 3100 via an ultrasonic VI FB transformer 3092. The ultrasonic voltage and current feedback signals are returned to the controller 3082 through an analog-to-digital converter 3102 (A / D). Also coupled to the controller 3082 through the advanced energy receiver 3100 is an isolated DC / DC converter port 3096, which receives DC power from the power bus 3006, and a medium bandwidth data port 3098.
[0230] In one aspect, the energy module 3004 can include a wideband RF power amplifier 3108, which in one aspect is a linear class H amplifier capable of generating arbitrary waveforms and driving RF loads at a range of output frequencies. The wideband RF power amplifier 3108 is fed by an adjustable buck regulator 3107 to maximize efficiency and is controlled by a controller 3082, which may be implemented as a DSP via a DDS. The DDS may be embedded in the DSP or implemented in an FPGA, for example. The controller 3082 controls the wideband RF amplifier 3086 via a DAC 3122. The output of the wideband RF power amplifier 3108 may be fed through an RF selection relay 3124, which is configured to receive and selectively transmit the output signal of the wideband RF power amplifier 3108 to various other components of the energy module 3004. In one aspect, the output signal of the wideband RF power amplifier 3108 may be provided through an RF selection relay 3124 to an RF power transformer 3110 coupled to an RF output portion of a bipolar RF energy receiver 3118. Bipolar RF voltage (V) and current (I) feedback (FB) signals, which may be used to calculate RF impedance, are fed back to the controller 3082 through the input portion of the bipolar RF energy receiver 3118 via an RF VI FB transformer 3114. The RF voltage and current feedback signals are returned to the controller 3082 through an AID 3120. Also coupled to the controller 3082 through the bipolar RF energy receiver 3118 are an isolated DC / DC converter port 3112, which receives DC power from the power bus 3006, and a low-bandwidth data port 3116.
[0231] As mentioned above, in one aspect, the energy module 3004 can include an RF selection relay 3124 driven by a controller 3082 (e.g., FPGA) at a rated coil current for actuation, which can also be set to a lower holding current via pulse width modulation (PWM) to limit steady-state power dissipation. Switching of the RF selection relay 3124 is accomplished by a force-inductive (safety) relay, and the state of the contact is sensed by the controller 3082 as mitigation of any single fault condition. In one aspect, the RF selection relay 3124 is configured to be in a first state, where an output RF signal received from an RF source, such as the wideband RF power amplifier 3108, is transmitted to a first component of the energy module 3004, such as the RF power transformer 3110 of the bipolar energy receiver 3118. In a second aspect, the RF selection relay 3124 is configured to be in a second state, and an output RF signal received from an RF source, such as the wideband RF power amplifier 3108, is transmitted to a second component, such as an RF power transformer 3128 of a monopolar energy receiving portion 3136, described in more detail below. In a general aspect, the RF selection relay 3124 is configured to be driven by the controller 3082 to switch between a plurality of states, such as a first state and a second state, and to transmit the output RF signal received from the RF power amplifier 3108 between different energy receiving portions of the energy module 3004.
[0232] As mentioned above, the output of wideband RF power amplifier 3108 can also be fed through RF select relay 3124 to wideband RF power transformer 3128 of RF monopolar receiver 3136. Unipolar RF voltage (V) and current (I) feedback (FB) signals, which can be used to calculate RF impedance, are fed back to controller 3082 through the input of monopolar RF energy receiver 3136 via RF VI FB transformer 3130. The RF voltage and current feedback signals are returned to controller 3082 through AID 3126. Also coupled to controller 3082 through monopolar RF energy receiver 3136 are isolated DC / DC converter port 3132, which receives DC power from power bus 3006, and low bandwidth data port 3134.
[0233] The output of the wideband RF power amplifier 3108 may also be supplied to the wideband RF power transformer 3090 of the advanced energy receiving portion 3100 through an RF selection relay 3124. RF voltage (V) and current (I) feedback (FB) signals, which may be used to calculate RF impedance, are fed back to the controller 3082 through the input portion of the advanced energy receiving portion 3100 via an RF VI FB transformer 3094. The RF voltage and current feedback signals are returned to the controller 3082 through the AID 3104.
[0234] FIG. 33 is a block diagram of a second energy module 3012 coupled to a header module 3150, according to at least one embodiment of the present disclosure. The first energy module 3004 shown in FIG. 32 is coupled to the second energy module 3012 shown in FIG. 35 by coupling the second pass-through hub connector 3078 of the first energy module 3004 to the first pass-through hub connector 3074 of the second energy module 3012. In one embodiment, the second energy module 3012 may be an energy module similar to the first energy module 3004, as shown in FIG. 33. In another embodiment, the second energy module 2012 may be a different energy module than the first energy module, such as the energy module shown in FIG. 35, which will be described in more detail. Adding the second energy module 3012 to the first energy module 3004 adds functionality to the modular energy system 3000.
[0235] The second energy module 3012 is coupled to the header module 3150 by connecting the pass-through hub connector 3078 to the pass-through hub connector 3152 of the header module 3150. In one aspect, the header module 3150 may include a header processor 3158 configured to manage power button functionality 3166, software upgrades through an upgrade VSB module 3162, system time management, and a gateway to an external network (i.e., a hospital or the cloud) via an Ethernet module 3164, which may run different protocols. Data is received by the header module 3150 through the pass-through hub connector 3152. The header processor 3158 is also coupled to a switch 3160 to receive, process, and forward data from source devices to destination devices and control data communication therebetween. The header processor 3158 is also coupled to an OTS power supply 3156, which is coupled to a mains power input module 3154.
[0236] FIG. 34 is a block diagram of a header / user interface (VI) module 3002 for a hub, such as the header module shown in FIG. 31 , in accordance with at least one embodiment of the present disclosure. The header / VI module 3002 includes a header power module 3172, a header radio module 3174, a header VSB module 3176, a header audio / screen module 3178, a header network module 3180 (e.g., Ethernet), a backplane connector 3182, a header wait processor module 3184, and a header footswitch module 3186. These functional modules interact to provide the header / VI 3002 functionality. A header / VI controller 3170 controls each of the functional modules and communication between them and includes safety limit control logic modules 3230, 3232 coupled between the header / VI controller 3170 and an isolation communication module 3234 coupled to the header footswitch module 3186. A security coprocessor 3188 is coupled to the header / UI controller 3170.
[0237] Header power module 3172 includes a mains power entry module 3190 coupled to an OTS power supply unit 3192 (PSU). Low-voltage DC (e.g., 5V) standby power is supplied from OTS PSU 3192 to header / UI module 3002 and other modules over low-voltage power bus 3198. High-voltage DC (e.g., 60V) is supplied from OTS PSU 3192 to header / UI module 3002 over high-voltage bus 3200. High-voltage DC supplies DC / DC converter module 3196 as well as isolated DC / DC converter module 3236. A standby processor 3204 in header / standby module 3184 provides PSU / enable signal 3202 to OTS PSU 3192.
[0238] The header wireless module 3174 includes a WiFi module 3212 and a Bluetooth module 3214. Both the WiFi module 3212 and the Bluetooth module 3214 are coupled to the header / VI controller 3170. The Bluetooth module 3214 is used to connect devices without cables, and the Wi-Fi module 3212 provides high-speed access to a network such as the Internet and can be used to create a wireless network that can link multiple devices, such as multiple energy modules or other modules and surgical instruments, among other devices located in the operating room. Bluetooth is a wireless technology standard used to exchange data over short distances, such as less than 30 feet.
[0239] Header USB module 3176 includes USB port 3216 coupled to header / VI controller 3170. USB module 3176 provides a standard cable connection interface for modules and other electronic devices via short-range digital data communication. USB module 3176 allows modules with USB devices to connect to each other via a USB cable and transfer digital data.
[0240] The header audio / screen module 3178 includes a touch screen 3220 coupled to a touch controller 3218. The touch controller 3218 is coupled to the header / UI controller 3170 to read input from the touch screen 3220. The header / UI controller 3170 drives an LCD display 3224 via a display / port video output signal 3222. The header / UI controller 3170 is coupled to an audio amplifier 3226 to drive one or more speakers 3228.
[0241] In one aspect, the header / UI module 3002 provides a touchscreen 3220 user interface configured to control one control or module connected to the header module 3002 in the modular energy system 3000. The touchscreen 3220 can be used to maintain a single point of access for a user to adjust all modules connected in the modular energy system 3000. Additional hardware modules (e.g., a smoke evacuation module) may be visible at the bottom of the user interface LCD display 3224 when connected to the header / UI module 3002 and may disappear from the user interface LCD display 3224 when disconnected from the header / UI module 3002.
[0242] Additionally, the user touch screen 3220 may provide access to settings for modules installed in the modular energy system 3000. Additionally, the layout of the user interface LCD display 3224 may be configured to change according to the number and type of modules connected to the header / UI module 3002. For example, for a first application where one energy module and one smoke evacuation module are connected to the header / UI module 3002, a first user interface may be displayed on the LCD display 3224, and for a second application where two energy modules are connected to the header / UI module 3002, a second user interface may be displayed on the LCD display 3224. Additionally, as modules are connected and disconnected from the modular energy system 3000, the user interface may change its display on the LCD display 3224.
[0243] In one aspect, the header / UI module 3002 provides a user interface LCD display 3224 configured to display corresponding port lighting on a colored LCD display. In one aspect, the coloring of the LED lights around the instrument panel and its corresponding ports are the same or otherwise correspond to one another. Each color can, for example, convey a unique meaning. In this manner, a user can quickly assess which instrument an instruction refers to and the nature of the instruction. Furthermore, an instruction regarding an instrument can be represented by a change in color of the LED lights around its corresponding port and the coloring of that module. Furthermore, the alignment of the on-screen message and the hardware / software port can also serve to communicate that action must be taken on the hardware, rather than on the interface. In various aspects, all other instruments can be used while an alarm is occurring on another instrument. This allows a user to quickly assess which instrument an instruction refers to and the nature of the instruction.
[0244] In one aspect, the header / UI module 3002 provides a user interface screen configured to display on the LCD display 3224 to present treatment options to the user. In one aspect, the user interface may be configured to present the user with a series of options (e.g., arranged from general to detailed). After each selection is made, the modular energy system 3000 represents the next level until all selections are complete. These settings may be managed locally and transferred via secondary means (e.g., a USB thumb drive). Alternatively, the settings may be managed via a portal and automatically distributed to all connected systems within the hospital.
[0245] The procedure options may include, for example, a list of factory-preset options categorized by specialist, procedure, and procedure type. Once the user has completed their selection, the header module can be configured to set any connected instruments to the pre-set settings for that particular procedure. The procedure options may also include, for example, a list of surgeons, followed by specialist, procedure, and type. Once the user has completed their selection, the system can suggest the surgeon's preferred instruments and set the settings for those instruments according to the surgeon's preferences (i.e., a profile associated with each surgeon that stores the surgeon's preferences).
[0246] In one aspect, the header / UI module 3002 provides a user interface screen configured to display important appliance settings on the LCD display 3224. In one aspect, each appliance panel displayed on the user interface's LCD display 3224 corresponds in arrangement and content to an appliance plugged into the modular energy system 3000. When a user taps on a panel, it may expand to reveal additional settings and options for that particular appliance, and the remainder of the screen may, for example, be dimmed or otherwise de-emphasized.
[0247] In one aspect, the header / UI module 3002 provides a user interface instrument settings panel configured to include / display instrument-specific controls, allowing the user to increase or decrease its output intensity, toggle specific functions, pair it with system accessories such as a footswitch connected to the header footswitch module 3186, access advanced instrument settings, and find additional information about the instrument. In one aspect, the user can tap / select the “Advanced Settings” control to expand an advanced settings drawer displayed on the user interface LCD display 3224. In one aspect, the user can then tap / select an icon in the upper right corner of the instrument settings panel or tap anywhere outside the panel, and the panel will collapse to its original state. In these aspects, the user interface is configured to display only the most important instrument settings, such as power level and power mode, on the ready / home screen of each instrument panel on the LCD display 3224. This is to maximize the size and readability of the system from a remote location. In some aspects, the panels and the settings therein can be scaled proportionally to the number of instruments connected to the system to further improve readability. As more instruments are connected, the panel is scaled to accommodate a greater amount of information.
[0248] The header network module 3180 includes multiple network interfaces 3264, 3266, 3268 (e.g., Ethernet) for network connecting the header / UI module 3002 to other modules of the modular energy system 3000. In the example shown, one network interface 3264 may be a third-party network interface, another network interface 3266 may be a hospital network interface, and yet another network interface 3268 may be located on the backplane network interface connector 3182.
[0249] The header standby processor module 3184 includes a standby processor 3204 coupled to an on / off switch 3210. The standby processor 3204 performs an electrical continuity test by determining whether current flows in the continuity loop 3206. The continuity test is performed by placing a small voltage across the continuity loop 3206. A serial bus 3208 couples the standby processor 3204 to the backplane connector 3182.
[0250] The header footswitch module 3186 includes a controller 3240 coupled to a plurality of analog footswitch ports 3254, 3256, 3258 through a plurality of corresponding presence / ID and switch status modules 3242, 3244, 3246, respectively. The controller 3240 is also coupled to an auxiliary port 3260 via a presence / ID and switch status module 3248 and a transceiver module 3250. The auxiliary port 3260 is powered by an auxiliary power module 3252. The controller 3240 is coupled to the header / UI controller 3170 via an isolated communications module 3234, and first and second safety limit control modules 3230, 3232. The header footswitch module 3186 also includes a DC / DC converter module 3238.
[0251] In one aspect, the header / UI module 3002 provides a user interface screen configured to display on the LCD display 3224 for controlling a footswitch connected to any one of the analog footswitch ports 3254, 3256, 3258. In some aspects, when a user plugs into any one of the analog footswitch ports 3254, 3256, 3258 in an instrument that is not manually activated, the instrument panel appears with a warning icon next to the footswitch icon. The instrument settings may be grayed out, for example, because the instrument cannot be activated without using a footswitch.
[0252] When a user plugs a footswitch into any one of the analog footswitch ports 3254, 3256, 3258 in a footswitch, a pop-up appears indicating the footswitch is assigned to that instrument. A footswitch icon indicates that the footswitch is plugged into and assigned to an instrument. The user can then tap / select on the icon to assign, reassign, unassign, or otherwise change the settings associated with that footswitch. In these aspects, the system is configured to use logic to automatically assign footswitches to instruments that are not manually activated, thereby allowing single or dual pedal footswitches to be further assigned to the appropriate instruments. If a user wishes to manually assign / reassign a footswitch, there are two flows that can be utilized.
[0253] In one aspect, the header / UI module 3002 provides a global footswitch button. When the user taps the global footswitch icon (located in the upper right corner of the user interface LCD display 3224), the footswitch assignment overlay appears and the contents of the instrument module dim. A (e.g., photorealistic) representation of each attached footswitch (dual or single pedal) appears at the bottom or on the corresponding instrument panel if not assigned to an instrument. The user can then drag and drop these illustrations to and from the boxed icons in the footswitch assignment overlay to assign, unassign, and reassign footswitches to their respective instruments.
[0254] In one aspect, the header / UI module 3002 provides a user interface screen displayed on the LCD display 3224 showing footswitch auto-assignment in accordance with at least one aspect of the present disclosure. As discussed above, the modular energy system 3000 can be configured to auto-assign footswitches to appliances that do not involve manual activation. In some aspects, the header / UI module 3002 can be configured to correlate the color displayed on the user interface LCD display 3224 to the light of the module itself as a means of tracking physical ports using user interface elements.
[0255] In one aspect, the header / UI module 3002 may be configured to show various uses of the user interface with different numbers of modules connected to the modular energy system 3000. In various aspects, the overall layout or proportion of the user interface elements displayed on the LCD display 3224 may be based on the number and type of appliances plugged into the header / UI module 3002. These scalable graphics can provide a means to utilize more of the screen for better visualization.
[0256] In one aspect, the header / UI module 3002 may be configured to present a user interface screen on the LCD display 3224 to indicate which ports of modules connected to the modular energy system 3000 are active. In some aspects, the header / UI module 3002 may be configured to indicate active versus inactive ports by highlighting the active ports and dimming the inactive ports. In one aspect, ports may be color-coded when active (e.g., yellow for monopolar tissue coagulation, blue for bipolar tissue cutting, blue for bipolar tissue cutting, and warm white for high-energy tissue cutting). Additionally, the displayed color matches the color of the light plumbing surrounding the port. The coloring may further indicate that while an instrument is active, the user cannot change settings on other instruments. As another example, the header / UI module 3002 may be configured to indicate the bipolar, monopolar, and ultrasound ports of a first energy module as active, and the monopolar port of a second energy module as active as well.
[0257] In one aspect, the header / VI module 3002 may be configured to present a user interface screen on the LCD display 3224 for displaying a global settings menu. In one aspect, the header / VI module 3002 may be configured to display a menu on the LCD display 3224 for controlling global settings across any modules connected to the modular energy system 3000. The global settings menu may, for example, always be displayed in a consistent location (e.g., always available in the upper right corner of the main screen).
[0258] In one aspect, the header / VI module 3002 may be configured to present a user interface screen on the LCD display 3224 configured to prevent changes to settings while a surgical instrument is being used. In one example, the header / VI module 3002 may be configured to prevent settings from being changed via the displayed menu when a connected instrument is active. The user interface screen may include, for example, an area (e.g., the upper left corner) reserved to indicate instrument activation while the settings menu is open. In one aspect, a user opens bipolar settings while monopolar coagulation is active. In one aspect, the settings menu can then be used once activation is complete. In one aspect, the header / VI module 3002 may be configured to not overlay any menus or other information over the area dedicated to showing important instrument information in order to maintain the display of important information.
[0259] In one aspect, the header / VI module 3002 may be configured to present a user interface screen on the LCD display 3224 configured to display instrument errors. In one aspect, instrument error warnings may be displayed on the instrument panel itself, allowing the user to continue using other instruments while a nurse troubleshoots the error. This allows the user to continue with the procedure without having to stop the procedure to debug the instrument.
[0260] In one aspect, the header / VI module 3002 may be configured to present a user interface screen on the LCD display 3224 to display different modes or settings available for various instruments. In various aspects, the header / VI module 3002 may be configured to display a settings menu appropriate for the type or application of the surgical instrument connected to the stack / hub. Each settings menu may provide options such as different power levels and energy delivery profiles appropriate for the particular instrument type. In one aspect, the header / VI module 3002 may be configured to display different modes available for bipolar cutting, monopolar cutting, and monopolar coagulation applications.
[0261] In one embodiment, the header / VI module 3002 may be configured to present a user interface screen on the LCD display 3224 to display pre-selected settings. In one embodiment, the header / VI module 3002 may be configured to receive the selection of instrument / device settings before an instrument is plugged in, so that the modular energy system 3000 is prepared before the patient enters the operating room. In one embodiment, the user can simply click on a port and then change the settings for that port. In the illustrated embodiment, the selected port appears faded to indicate that the settings have been set, but no instrument is plugged in to the port.
[0262] FIG. 35 is a block diagram of an energy module 3270 of a hub, such as the energy modules shown in FIGS. 29, 30, 32, and 33, according to at least one embodiment of the present disclosure. The energy module 3270 is configured to couple to header modules, header / VI modules, and other energy modules via a first pass-through hub connector 3272 and a second pass-through hub connector 3276. A switch 3076 disposed between the first pass-through hub connector 3272 and the second pass-through hub connector 3276 receives, processes, and forwards data from a source device to a destination device and controls data communication therebetween. Data is received and transmitted via a data bus 3008. The energy module 3270 includes a controller 3082 for controlling various communication and processing functions of the energy module 3270.
[0263] DC power is received and transmitted by energy module 3270 over power bus 3006. Power bus 3006 is coupled to DC / DC converter module 3138 to provide power to adjustable regulators 3084, 3107 and isolated DC / DC converter ports 3096, 3112, 3132.
[0264] In one embodiment, the energy module 3270 can include an ultrasonic wideband amplifier 3086, which in one embodiment may be a linear class H amplifier capable of generating arbitrary waveforms at low total harmonic distortion (THD) levels and may drive a harmonic transducer. The ultrasonic wideband amplifier 3086 is powered by a step-down adjustable regulator 3084 to maximize efficiency and controlled by a controller 3082, which may be implemented as a digital signal processor (DSP) via a direct digital synthesis (DDS). The DDS may be embedded in the transducer DSP or implemented in a field programmable gate array (FPGA), for example. The controller 3082 controls the ultrasonic wideband amplifier 3086 via a digital-to-analog converter 3106 (DAC). The output of the ultrasonic wideband amplifier 3086 is fed to an ultrasonic power transformer 3088, which is coupled to the ultrasonic energy output portion of the advanced energy receiver 3100. Ultrasonic voltage (V) and current (I) feedback (FB) signals, which may be used to calculate ultrasonic impedance, are fed back to the controller 3082 through the input portion of the advanced energy receiver 3100 via an ultrasonic VI FB transformer 3092. The ultrasonic voltage and current feedback signals are returned to the controller 3082 through an analog multiplexer 3280 and a dual analog-to-digital converter 3278 (AID). In one aspect, the dual AID 3278 has a sampling rate of 80 MSPS. Also coupled to the controller 3082 through the advanced energy receiver 3100 are an isolated DC / DC converter port 3096, which receives DC power from the power bus 3006, and a medium bandwidth data port 3098.
[0265] In one aspect, the energy module 3270 can include, among other things, multiple wideband RF power amplifiers 3108, 3286, 3288. In one aspect, each of the wideband RF power amplifiers 3108, 3286, 3288 is a linear class H amplifier capable of generating arbitrary waveforms and driving RF loads at a range of output frequencies. Each of the wideband RF power amplifiers 3108, 3286, 3288 is supplied by an adjustable buck regulator 3107 to maximize efficiency and is controlled by a controller 3082, which may be implemented as a DSP via a DDS. The DDS may be embedded in the DSP or implemented in an FPGA, for example. The controller 3082 controls the first wideband RF power amplifier 3108 via a DAC 3122.
[0266] 34 and 35, the energy module 3270 does not include an RF selection relay configured to receive the RF output signal from the adjustable step-down regulator 3107. Additionally, unlike the energy modules 3004, 3012 shown and described in FIGS. 34 and 35, the energy module 3270 includes multiple wideband RF power amplifiers 3108, 3286, 3288 instead of a single RF power amplifier. In one aspect, the adjustable step-down regulator 3107 can be switched between multiple states in which it outputs an output RF signal to one of the multiple wideband RF power amplifiers 3108, 3286, 3288 connected thereto. The controller 3082 is configured to switch the adjustable step-down regulator 3107 between multiple states. In a first state, the controller drives the adjustable step-down regulator 3107 to output the RF energy signal to the first wideband RF power amplifier 3108. In a second state, the controller drives the adjustable step-down regulator 3107 to output the RF energy signal to the second wideband RF power amplifier 3286. In a third state, the controller drives the adjustable step-down regulator 3107 to output the RF energy signal to the third wideband RF power amplifier 3288.
[0267] The output of the first wideband RF power amplifier 3108 can be provided to an RF power transformer 3090 coupled to the RF output section of the advanced energy receiving section 3100. RF voltage (V) and current (I) feedback (FB) signals, which can be used to calculate RF impedance, are fed back to the controller 3082 through the input section of the advanced energy receiving section 3100 via an RF VI FB transformer 3094. The RF voltage and current feedback signals are returned to the controller 3082 through the RF VI FB transformer 3094, which is coupled to a dual AID 3282, which is coupled to an analog multiplexer 3284 and the controller 3082. In one aspect, the dual AID 3282 has a sampling rate of 80 MSPS.
[0268] The output of the second RF wideband power amplifier 3286 is fed through an RF power transformer 3128 of the RF monopolar receiver 3136. Unipolar RF voltage (V) and current (I) feedback (FB) signals, which may be used to calculate RF impedance, are fed back to the controller 3082 through the input of the monopolar RF energy receiver 3136 via an RF VI FB transformer 3130. The RF voltage and current feedback signals are returned to the controller 3082 through an analog multiplexer 3284 and a dual AID 3282. Also coupled to the controller 3082 through the monopolar RF energy receiver 3136 are an isolated DC / DC converter port 3132, which receives DC power from the power bus 3006, and a low-bandwidth data port 3134.
[0269] The output of the third RF wideband power amplifier 3288 is fed through an RF power transformer 3110 of the bipolar RF receiver 3118. Bipolar RF voltage (V) and current (I) feedback (FB) signals, which may be used to calculate RF impedance, are fed back to the controller 3082 through the input of the bipolar RF energy receiver 3118 via an RF VI FB transformer 3114. The RF voltage and current feedback signals are returned to the controller 3082 through an analog multiplexer 3280 and a dual AID 3278. Also coupled to the controller 3082 through the bipolar RF energy receiver 3118 are an isolated DC / DC converter port 3112, which receives DC power from the power bus 3006, and a low-bandwidth data port 3116.
[0270] Contact monitor 3290 is coupled to NE receptor 3292. Power is supplied to NE receptor 3292 from monopolar receptor 3136.
[0271] 29-35, the modular energy system 3000 may be configured to detect the presence of an appliance in the receptacle 3100, 3118, 3136 via a photointerrupter, magnetic sensor, or other non-contact sensor integrated into the receptacle 3100, 3118, 3136. This approach avoids the need to assign a dedicated presence pin on the MTD connector to a single purpose, instead allowing multi-purpose functionality for the MTD signal pins 6-9 while continuously monitoring the presence of an appliance.
[0272] 29-35, the modules of the modular energy system 3000 can include an optical link that allows high-speed communication (10-50 Mb / s) across the patient isolation boundary. This link carries device communications, mitigation signals (such as watchdogs), and low-bandwidth runtime data. In some aspects, the optical link does not include real-time sampling data that can be performed on the non-isolated side.
[0273] 29-35, a module of the modular energy system 3000 can include a multi-function circuit block that can (i) read present resistance via the AID and current source, (ii) communicate with legacy instruments via the Hand Switch Q protocol, (iii) communicate with instruments via the local bus 1-Wire protocol, and (iv) communicate with CAN FD enabled surgical instruments. Once a surgical instrument is properly identified by the energy generator module, the associated pin functions and communication circuitry are enabled, while other unused functions are disabled and set to a high impedance state.
[0274] In one embodiment, referring to FIGS. 29-35, a module of the modular energy system 3000 can include a pulse / stim / aux DC amplifier. This is a flexible amplifier based on a full-bridge output and incorporates functional isolation, allowing its differential output to be referenced to any output connection on the applied part (except, in some embodiments, a unipolar active electrode). The amplifier output can be either small signal linear (pulse / stim) with waveform drive provided by a DAC or square wave drive, with moderate output power for DC applications such as DC motors, lighting, and FET drives. The output voltage and current are sensed with functionally isolated voltage and current feedback to provide accurate impedance and power measurements to an FPGA. Paired with a CAN FD-enabled instrument, this output can provide motor / motion control drive, while position or velocity feedback is provided by the CAN FD interface for closed-loop control.
[0275] FIG. 36 illustrates a system 36000 for communication between a surgical instrument 36002, a surgical hub 36024, and a cloud computing system 36036, in accordance with at least one embodiment of the present disclosure. The surgical instrument 36002 may be a powered surgical end effector. For example, the surgical instrument 36002 may refer to the surgical instrument 6502 ( FIG. 14 ) and / or the surgical instruments 1104, 1106, 1108 ( FIG. 21 ). The surgical instrument 36002 may include a generator 36003. For example, the generator 36003 may refer to the generator 900 described above in FIGS. 20-21 . The generator 36003 may provide power to the surgical instrument 36002 in the form of one or more energy modalities described herein, such as, for example, ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others, depending on the type of tissue treatment being performed. The surgical instrument 36002 may include a transmission mechanism 36004 and a receiver 36006. The transmission mechanism 36004 and the receiver 36006 may be configured to establish communication paths 36008 and 36010 between at least one external device. For example, the communication path 36008 may be between the surgical instrument 36002 and the surgical hub 36004, and the communication path 36010 may be between the surgical instrument 36002 and the cloud computing system 36036. The surgical instrument 36002 may include a controllable jaw 36012 that can be configured to operate on tissue. The controllable jaw 36012 may include a first jaw and a second jaw. Tissue to be operated on may be positioned between the first jaw and the second jaw and clamped by the first jaw and second jaw closing together. The surgical instrument 36002 may include an updatable memory 36016 that may store data including a control algorithm 36018, which may be a default control algorithm. The surgical instrument 36002 may include a processor 36014 that may be configured to operate the control algorithm 36018. The surgical instrument 36002 includes a first electrode 36020 that delivers a first energy and a second electrode 36022 that delivers a second energy.The first energy may be controlled by a first energy algorithm 36038, and the second energy may be controlled by a second energy algorithm 36040. The control algorithm 36018 may be configured to control the first energy algorithm 36038 and the second energy algorithm 36040. In embodiments, the surgical instrument 36002 may use at least two energy modalities in any suitable combination. In examples, the surgical instrument 36002 may use at least two energy modalities sequentially. The generator 36003 may deliver power to the first electrode 36020 and the second electrode 36022, such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, as described above.
[0276] The surgical hub 36024 may include a transmitter 36026 and a receiver 36028 that may be configured to establish communication paths 36008 and 36030 between the surgical hub 36024 and at least one external device. For example, the communication path 36008 may be between the surgical hub 36024 and the surgical instrument 36002. The communication path 36030 may be between the surgical hub 36004 and a cloud computing system 36036. The surgical hub 36004 may include data that includes a control algorithm 36034. The surgical hub 36024 may include a processor 36032 configured to receive and interpret the data that includes the control algorithm 36034.
[0277] The cloud computing system 36036 may constitute a cloud-based analysis system and may include one or more networked computing resources. The cloud computing system 36036 may be communicatively coupled to the surgical hub 36004 via communication path 36030. The cloud computing system 36036 may be communicatively coupled to the surgical instrument 36002 via communication path 36010. The cloud computing system 36036 may quickly and efficiently identify data based on specific criteria. In some situations, the cloud computing system 36036 may aggregate data determined from multiple surgical sites. The cloud computing system 36036 may process the aggregated data by data sorting, prioritization, and other types of data processing based on specific criteria or thresholds.
[0278] FIG. 37 shows a logic flow diagram of a process 37000 for updating an algorithm of a surgical instrument, according to at least one embodiment of the present disclosure. In 37002, the process 37000 may configure the surgical instrument 36002 to operate in a first mode. For example, the first mode may operate at a first time point. The first mode may be configured to operate via a control algorithm 36018 stored in the updatable memory 36016. When operating in the first mode, the control algorithm 36018 is operating according to a default control algorithm. The default control algorithm 36018 may simultaneously control both a first energy operated by a first energy algorithm 36038 and a second energy operated by a second energy algorithm 36040. In 37004, the process 37000 may determine, for example, whether the surgical instrument 36002 may receive data at a second time point after the first time point. If no, at 37006, the process 37000 may continue to operate in the first mode according to the default control algorithm. If yes, at 37008, the received data may cause the surgical instrument 36002 to automatically change from operating in the first mode to operating in the second mode. The second mode may be configured to operate according to an alternate control algorithm, which may be configured to simultaneously update the control of both the first energy algorithm 36038 and the second energy algorithm 36040. The modification of the control algorithm 36018 from the default control algorithm to the alternate control algorithm may be controlled by the generator 36003 as described above and / or by the surgical hub 36004. In embodiments, aspects of the control algorithm 36018 may be adjusted and / or updated during operation, for example. In embodiments, the control algorithm 36018 may be updated while the device is in service. In embodiments, the control algorithm 36018 may be updated during a maintenance period.
[0279] The received data may be received from an external source via the receiver 36006 of the surgical instrument 36002. For example, the external source may be the surgical hub 36004 and / or the cloud computing system 36036. In embodiments, the received data may relate to control parameters such as total power consumption, temperature, applied pressure, and / or tissue parameters. The tissue characteristics may relate to tissue type or tissue impedance, for example. Methods to help identify tissue types may use situational awareness, as described above. The surgical instrument 36002 may apply energy to the tissue according to an algorithm. The algorithm may modulate the energy modality, power, and / or other aspects of operation as the tissue progresses through coagulation and / or cutting. For example, the situational awareness system or method may identify the tissue type to address. The situational awareness system or method may be used, in part, to select and / or modify parameters of the algorithm. Such selection and / or modification may be used to optimize direct results and / or patient outcomes. For example, such selection and / or modification may provide improved direct results and / or patient outcomes compared to those provided by a generalized algorithm (e.g., an algorithm generalized to be suitable for a wide range of tissue types).
[0280] In embodiments, the received data may relate to a measure of force applied by the surgical instrument 36002. The force may be a direct / indirect measure of force. In embodiments, the received data may relate to supplemental information obtained through situational awareness, hospital input, and / or user input. In embodiments, control of the use of each of the energy modalities may be based on and / or influenced by various parameters, measurements, rules, procedures, inputs, algorithms, etc. In embodiments, energy modalities may be altered and / or blended to maximize sealing and / or cutting. In embodiments, energy modalities may be altered and / or blended to minimize residual heat within the surgical instrument 36002. In embodiments, the surgical instrument 36002 may include the upgradable element 3014 described above in FIG. 15B. The upgradable element 3014 may operate to update the operating mode of the control algorithm 36018 of the surgical instrument 36002 based on the received aggregate data. In examples, the surgical instrument 36002 may include a closure drive system such as described above in FIG. 16. The clamping pressure of the closure drive system may be applied to the tissue during delivery of energy. The amount of clamping pressure may be controlled according to a control algorithm 36018.
[0281] FIG. 38 shows a logic flow diagram of a process 38000 for updating algorithms of a surgical instrument according to at least one embodiment of the present disclosure. In 38002, the surgical instrument 36002 is configured to obtain a default control algorithm and an alternate control algorithm. The default control algorithm may correspond to data stored in the updatable memory 36018 of the surgical instrument 36002. The default operating algorithm can cause the surgical instrument 36002 to operate a first energy algorithm 36038 and a second energy algorithm 36040 according to a first mode. The alternate operating algorithm can correspond to data received from an external source. For example, the external source can be the surgical hub 36004 and / or the cloud computing system 36036. The alternate operating algorithm can cause the surgical instrument 36002 to operate a first energy algorithm 36038 and a second energy algorithm 36040 according to a second mode. At 38004, the surgical instrument 36002 determines whether it can operate according to a first mode, which may serve as a default mode. The determination may be based on control parameters of the surgical instrument 36002, such as total power consumption, temperature, applied pressure, and / or tissue parameters. The tissue characteristics may be related to tissue type or tissue impedance, for example. The method for assisting in identifying the tissue type may use situational awareness, as described above. In embodiments, the determination may be based on force measurements by the surgical instrument 36002. The force may be a direct / indirect measure of force. In embodiments, the determination may be based on supplemental information obtained through situational awareness, hospital input, and / or user input. If it is determined that the surgical instrument 36002 can operate in the first mode, then at 38006, the surgical instrument 36002 may operate in the first mode. At 38008, the surgical instrument 36002 determines whether it can operate according to a second mode, which may serve as an alternate mode. The determination may be based on control parameters of the surgical instrument 36002, such as total power consumption, temperature, applied pressure, and / or tissue parameters. The tissue characteristics may relate to tissue type or tissue impedance, for example.The method for assisting in identifying tissue type may use situational awareness, as described above. In embodiments, the determination may be based on a force measurement by the surgical instrument 36002. The force may be a direct / indirect measure of force. In embodiments, the determination may be based on supplemental information obtained through situational awareness, hospital input, and / or user input. If yes, at 38010, the surgical instrument 36002 may change from operating in a first mode to operating in a second mode. If yes, at 38012, the surgical instrument 36002 may continue operating in the first mode, which may be the default mode, as described above. In some embodiments, the surgical instrument 36002 may include the upgradable element 3014 described above in FIG. 15B. The upgradable element 3014 may operate to update the operating mode of one or more control algorithms of the surgical instrument 36002 based on the received aggregate data.
[0282] FIG. 39 shows a logic flow diagram of a process 39000 for updating algorithms of a surgical instrument according to at least one embodiment of the present disclosure. In 39002, the surgical instrument 36002 is configured to obtain a default control algorithm and an alternate control algorithm. The default control algorithm may correspond to data stored within the updatable memory 36018 of the surgical instrument 36002. The default control algorithm may operate the first energy algorithm 36038 and the second energy algorithm 36040 according to a first mode. The alternate control algorithm may correspond to data received from an external source. For example, the external source may be the surgical hub 36004 and / or the cloud computing system 36036. The alternate control algorithm may cause the surgical instrument 36002 to operate the first energy algorithm 36038 and the second energy algorithm 36040 according to a second mode. At 39004, the surgical instrument 36002 determines whether to operate in a first mode or a second mode. The determination may be based on control parameters of the surgical instrument 36002, such as total power consumption, temperature, applied pressure, and / or tissue parameters. The tissue characteristics may be related to tissue type or tissue impedance, for example. The method for assisting in identifying the tissue type may use situational awareness, as described above. In embodiments, the determination may be based on force measurements by the surgical instrument 36002. The force may be a direct / indirect measurement of force. In embodiments, the determination may be based on supplemental information obtained through situational awareness, hospital input, and / or user input. At 39006, if the surgical instrument 36002 determined to operate in the first mode at 39004, it may operate in the first mode. At 39008, if the surgical instrument 36002 determined to operate in the second mode at 39004, it may operate in the second mode. In some examples, the surgical instrument 36002 may include the upgradeable element 3014 described above in Figure 15B. The upgradeable element 3014 may operate to update the operating mode of one or more control algorithms of the surgical instrument 36002 based on the received aggregate data.
[0283] FIG. 40 shows a logic flow diagram of a process 40000 for a surgical hub to update algorithms of a surgical instrument, according to at least one embodiment of the present disclosure. At 40002, the surgical hub 36004 may seek communication with the surgical instrument 36002. The surgical hub 36004 may seek communication by sending a communication request to the surgical instrument 36002. At 40004, the surgical hub 36004 may determine whether communication is available with the surgical instrument 36002, which may be configured to operate in a first mode or a second mode. The determination of whether communication is available may be determined by, for example, available processing power, memory, bandwidth, software revision, or subscription level. Such subscription level may allow the control algorithm 36018 and / or other software to be updated. Such subscription level may be based, for example, on the current availability of network connectivity. The presence of network connectivity and / or interaction with the cloud computing system 36036 may provide the surgeon with the option to operate according to an algorithm provided by the cloud computing system 36036. If communication is not available, the process 40000 may return to 40002, where the surgical hub 36004 may seek communication with the surgical instrument 36002. If communication is available, at 40006, the surgical hub 36004 may receive data from the surgical instrument 36002 via the receiver 36028 and then upload the received data. At 40008, the surgical hub 36004 may determine whether the surgical instrument 36002 should operate in a first mode or a second mode based on the received data. The determination may be based on control parameters of the surgical instrument 36002, such as total power consumption, temperature, applied pressure, and / or tissue parameters. Tissue characteristics may be related, for example, to tissue type or tissue impedance. Methods to help identify ti...
Claims
1. 1. A powered surgical end effector, comprising: a controllable jaw configured to operate on tissue; a first electrode configured to deliver a first energy configured to seal the tissue within the controllable jaws, the first energy being manipulated by a first energy algorithm; a second electrode configured to deliver a second energy configured to seal the tissue within the controllable jaws, the second energy being operated by a second energy algorithm; and an updatable memory storing a default control algorithm configured to simultaneously control both the first energy algorithm and the second energy algorithm; a processor, the processor comprising: operating in a first mode at a first time, wherein in the first mode the processor is configured to operate according to the default control algorithm; and receiving, at a second time after the first time, data that causes the processor to automatically operate in a second mode, wherein in the second mode the processor is configured to operate according to an alternative control algorithm configured to simultaneously update the control of both the first energy algorithm and the second energy algorithm.
2. The powered surgical end effector of claim 1 , further comprising a transmitter and a receiver configured to establish a communication path between the powered surgical end effector and an external device.
3. The powered surgical end effector of claim 2 , wherein the data received at the second time is from the external device via the receiver.
4. The powered surgical end effector of claim 3 , wherein the external device is a surgical hub.
5. The powered surgical end effector of claim 3 , wherein the external device is a cloud computing system.
6. 6. The powered surgical end effector of claim 1, wherein the data received at the second time relates to one or more control parameters including power consumption, temperature, applied pressure, and / or characteristics of the tissue.
7. The powered surgical end effector of any one of claims 1 to 5, wherein the data received at the second time relates to a measure of force exerted by the powered surgical end effector.
8. The powered surgical end effector of any one of claims 1 to 5, wherein the data received at the second time relates to supplemental information including situational awareness, hospital input, and / or user input.
9. The powered surgical end effector of claim 8 , wherein the second mode updates a power level and / or a clamp pressure of the powered surgical end effector.
10. 1. A powered surgical end effector, comprising: a controllable jaw configured to operate on tissue; a first electrode configured to deliver a first energy configured to seal the tissue within the controllable jaws, the first energy being manipulated by a first energy algorithm; a second electrode configured to deliver a second energy configured to seal the tissue within the controllable jaws, the second energy being operated by a second energy algorithm; and an updatable memory storing a default control algorithm configured to simultaneously control both the first energy algorithm and the second energy algorithm; a processor configured to determine whether to operate in a first mode or a second mode; In the first mode, the processor is configured to operate according to the default control algorithm; In the second mode, the processor is configured to operate according to an alternative control algorithm configured to simultaneously update the control of both the first energy algorithm and the second energy algorithm.
11. The powered surgical end effector of claim 10, further comprising a transmitter and a receiver configured to establish a communication path between the powered surgical end effector and an external device.
12. The powered surgical end effector of claim 11 , wherein the external device is a surgical hub.
13. The powered surgical end effector of claim 11 , wherein the external device is a cloud computing system.
14. 14. The powered surgical end effector of claim 10, wherein the decision to operate in the first mode or the second mode is based on one or more control parameters including power consumption, temperature, applied pressure, and / or properties of the tissue.
15. 14. The powered surgical end effector of claim 10, wherein the decision to operate in the first mode or the second mode is based on a measure of force exerted by the powered surgical end effector.
16. 14. The powered surgical end effector of claim 10, wherein the decision to operate in the first mode or the second mode is based on supplemental information including situational awareness, hospital input, and / or user input.
17. The powered surgical end effector of claim 16, wherein the second mode updates a power level and / or a clamp pressure of the powered surgical end effector.
18. 1. A surgical hub comprising: a transmitter and receiver configured to establish a communication path between the surgical hub and a powered surgical end effector; a processor, the processor determining whether communication is available with the powered surgical end effector configured to operate in a first mode or a second mode, wherein in the first mode the powered surgical end effector operates according to a default control algorithm configured to simultaneously control both a first energy algorithm and a second energy algorithm; receiving data from the powered surgical end effector via the receiver; determining whether the surgical end effector should operate in the first mode or the second mode based on the received data; and and transmitting updated data based on the determination to operate the powered surgical end effector in the second mode, wherein in the second mode the surgical end effector operates according to an alternative control algorithm configured to simultaneously update the control of both the first energy algorithm and the second energy algorithm.
19. The surgical hub of claim 18, wherein the determination of whether communication is available is determined by available processing power, memory, bandwidth, software revision, or subscription level.
20. A surgical hub as described in claim 18 or 19, wherein the updated data that causes the powered surgical end effector to operate in the second mode is related to supplemental information including situational awareness, hospital input, and / or user input.
Citation Information
Patent Citations
Modular battery-powered handheld surgical instrument with multiple control programs
JP2019503231A
Variation of radio frequency and ultrasonic power levels in conjunction with different clamp arm pressures to achieve a predetermined heat flux or power applied to the tissue.
JP2021509336A
Variation of radio frequency and ultrasonic power level in cooperation with varying clamp arm pressure to achieve predefined heat flux or power applied to tissue
US20190201044A1
Adaptive control program updates for surgical devices
WO2019130075A1