Regional location tracking of components of modular energy system
Patent Information
- Application Number
- JP2024116780
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2019-09-05
- Filing Date
- 2024-07-22
- Publication Date
- 2025-10-30
- Estimated Expiration
- 2039-09-06
AI Technical Summary
The operating room (OR) is cluttered with various pieces of equipment, each requiring unique techniques and user interfaces, leading to confusion and inefficiency for surgical staff.
A modular surgical platform with a regional location tracking module that integrates multiple components and uses geographic location data to streamline equipment interfaces and reduce the number of devices needed, facilitated by a surgical platform with a regional location tracking module and an external device connection for activation codes based on geographic location.
This solution reduces equipment footprint and enhances surgical staff efficiency by integrating and streamlining equipment interfaces, thereby improving the operational efficiency in the OR.
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Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Non-provisional Patent Application No. 16 / 562,177, filed September 5, 2019, and entitled REGIONAL LOCATION TRACKING OF COMPONENTS OF A MODULAR ENERGY SYSTEM, the disclosure of which is incorporated herein by reference in its entirety.
[0002] This application also claims the benefit of U.S. Provisional Patent Application No. 62 / 826,584, filed March 29, 2019, entitled "MODULAR SURGICAL PLATFORM ELECTRICAL ARCHITECTURE," the entire disclosure of which is incorporated herein by reference.
[0003] This application also claims the benefit of U.S. Provisional Patent Application No. 62 / 826,587, filed March 29, 2019, entitled "MODULAR ENERGY SYSTEM CONNECTIVITY," the entire disclosure of which is incorporated herein by reference.
[0004] This application also claims the benefit of U.S. Provisional Patent Application No. 62 / 826,588, filed March 29, 2019, entitled “MODULAR ENERGY SYSTEM INSTRUMENT COMMUNICATION TECHNIQUES,” the entire disclosure of which is incorporated herein by reference.
[0005] This application also claims the benefit of U.S. Provisional Patent Application No. 62 / 826,592, filed March 29, 2019, entitled "MODULAR ENERGY DELIVERY SYSTEM," the entire disclosure of which is incorporated herein by reference.
[0006] This application also claims the benefit of U.S. Provisional Patent Application No. 62 / 728,480, filed September 7, 2018, entitled "MODULAR ENERGY SYSTEM AND USER INTERFACE," the entire disclosure of which is incorporated herein by reference. [Background technology]
[0007] The present disclosure relates to various surgical systems, including modular electrosurgical and / or ultrasonic surgical systems. Operating rooms (ORs) are a tangled web of cords, equipment, and people due to the number of different devices required to complete each surgical procedure, so ORs need streamlined capital solutions. This is the reality for every OR in every marketplace around the world. Capital equipment is a major source of confusion within the OR, as most capital equipment performs one task or job, and each type of capital equipment requires a unique technology or method for use and has a unique user interface. Summary of the Invention [Problem to be solved by the invention]
[0008] Thus, there is an unmet consumer need to consolidate capital equipment and other surgical technologies to improve surgical staff efficiency during surgical procedures by reducing the equipment footprint in the OR, streamlining equipment interfaces, and reducing the number of devices the surgical staff must operate. [Means for solving the problem]
[0009] A surgical platform comprising one or more components and a regional location tracking module configured to connect to an external device, receive external device geographic location data from the external device, and implement geographic location specific functionality based on the geographic location data received from the external device.
[0010] A method for determining a location of one or more components of a surgical platform, the method comprising: in response to detecting that an application running on a user device has been logged in, collecting, by the application, geographic location data of the user device from the user device; and receiving, by the application, a request for an activation code, the activation code identifying the geographic location data.
[0011] A method for upgrading software logic for one or more components of a surgical platform via an application on a user device, the method comprising: collecting geographic location data from the user device; providing an activation code, the activation code identifying the geographic location data of the user device; determining whether the geographic location data of the user device matches geographic location data pre-stored in the one or more components; and rejecting the software logic upgrade in response to determining that the geographic location data of the user device does not match the geographic location data pre-stored in the one or more components. [Brief description of the drawings]
[0012] The various aspects described herein, both as to organization and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, in which: [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. [Diagram 2] 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one embodiment of the present disclosure. [Diagram 3] 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, in accordance with at least one aspect of the present disclosure. [Figure 4]FIG. 13 is a partial perspective view of a surgical hub enclosure and a combination generator module slidably receivable within a drawer of the surgical hub enclosure, according to at least one embodiment of the present disclosure. [Diagram 5] FIG. 1 is a perspective view of a combination generator module including bipolar, ultrasonic, and monopolar contacts and a smoke evacuation component according to at least one embodiment of the present disclosure. [Figure 6] 1 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, according to at least one embodiment of the present disclosure. [Figure 7] 1 illustrates a vertical modular housing configured to receive a plurality of modules, according to at least one embodiment of the present disclosure. [Figure 8] 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 in a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one embodiment of the present disclosure. [Figure 9] 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 10] 1 illustrates a surgical hub comprising a plurality of modules coupled to a modular control tower in accordance with at least one embodiment of the present disclosure. [Figure 11] 1 illustrates one embodiment of a Universal Serial Bus (USB) network hub device in accordance with at least one embodiment of the present disclosure. [Figure 12] 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one embodiment of the present disclosure. [Figure 13] 1 illustrates a control circuit configured to control an aspect of a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 14]1 illustrates a combinatorial logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 15] 1 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool, in accordance with at least one aspect of the present disclosure. [Figure 16] 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, in accordance with at least one aspect of the present disclosure. [Figure 17] 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 18] FIG. 1 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member, in accordance with at least one embodiment of the present disclosure. [Figure 19] 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 20] A system 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 aspect of the present disclosure. [Figure 21] 1 illustrates an example of a generator, according to at least one embodiment of the present disclosure. [Figure 22] According to at least one aspect of the present disclosure, a surgical system includes a generator and various surgical instruments usable with the generator. [Diagram 23] FIG. 1 is a diagram of a situationally aware surgical system according to at least one aspect of the present disclosure. [Figure 24] FIG. 1 illustrates a diagram of various modules and other components that can be combined to customize a modular energy system, according to at least one embodiment of the present disclosure. [Figure 25A]1 is a first exemplary modular energy system configuration including a header module and a display screen that renders a graphical user interface (GUI) for relaying information about modules connected to the header module, in accordance with at least one embodiment of the present disclosure. [Figure 25B] 25B is a modular energy system as shown in FIG. 25A mounted on a cart, according to at least one embodiment of the present disclosure. [Figure 26A] 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 to a cart, according to at least one embodiment of the present disclosure. [Figure 26B] 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 27] FIG. 4 is a fourth exemplary modular energy system configuration including a header module, a display screen, an energy module, an aerial expansion energy module, and a technology module connected together and mounted to a cart, in accordance with at least one embodiment of the present disclosure. [Figure 28] FIG. 5 is a fifth exemplary modular energy system configuration including a header module connected together and mounted to a cart, a display screen, an energy module, an extended energy module, a technology module, and a visualization module, in accordance with at least one embodiment of the present disclosure. [Figure 29] FIG. 1 illustrates a modular energy system including a communicatively connectable surgical platform in accordance with at least one embodiment of the present disclosure. [Diagram 30] 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. [Diagram 31] 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. [Diagram 32] FIG. 13 is a block diagram of a hub configuration of a modular energy system integrated with a surgical control system according to at least one embodiment of the present disclosure. [Diagram 33] FIG. 13 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. [Diagram 34] FIG. 2 is a block diagram of an energy module of a modular energy system according to at least one embodiment of the present disclosure. [Figure 35A] 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 35B] 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 36A] 34 illustrates a block diagram of a header / user interface (UI) module of a modular energy system of a hub, such as the header module shown in FIG. 33, in accordance with at least one embodiment of the present disclosure. [Figure 36B] 34 illustrates a block diagram of a header / user interface (UI) module of a modular energy system of a hub, such as the header module shown in FIG. 33, in accordance with at least one embodiment of the present disclosure. [Figure 37] FIG. 3C is a block diagram of an energy module of a hub, such as the energy module shown in FIGS. 31-36B, according to at least one embodiment of the present disclosure. [Figure 38] FIG. 1 is a schematic diagram of a system including a surgical platform, an application, and an external device, according to at least one aspect of the present disclosure. [Figure 39]FIG. 13 is a process logic diagram illustrating a control program or logic configuration for determining the geographic location of one or more components of a surgical platform in accordance with at least one aspect of the present disclosure. [Diagram 40] FIG. 13 is a logic diagram of a process illustrating a control program or logic configuration for upgrading software logic for one or more components of a surgical platform based on the geographic location of the one or more components in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0013] The applicant of the present application owns the following concurrently filed U.S. patent applications, the disclosures of each of which are incorporated herein by reference in their entirety: U.S. Patent Application Serial No. END9067USNP1 / 180679-1M, entitled "METHOD FOR CONSTRUCTING AND USING A MODULAR SURGICAL ENERGY SYSTEM WITH MULTIPLE DEVICES"; U.S. Patent Application Serial No. END9069USNP1 / 180681-1M, entitled "METHOD FOR ENERGY DISTRIBUTION IN A SURGICAL MODULAR ENERGY SYSTEM"; U.S. Patent Application Serial No. END9069USNP2 / 180681-2, entitled "SURGICAL MODULAR ENERGY SYSTEM WITH A SEGMENTED BACKPLANE"; U.S. Patent Application Serial No. END9069USNP3 / 180681-3, entitled "SURGICAL MODULAR ENERGY SYSTEM WITH FOOTER MODULE"; U.S. Patent Application Docket No. END9069USNP4 / 180681-4, entitled "POWER AND COMMUNICATION MITIGATION ARRANGEMENT FOR MODULAR SURGICAL ENERGY SYSTEM"; U.S. Patent Application Serial No. END9069USNP5 / 180681-5, entitled "MODULAR SURGICAL ENERGY SYSTEM WITH MODULLE POSITIONAL AWARENESS SENSING WITH VOLTAGE DETECTION"; U.S. Patent Application Serial No. END9069USNP6 / 180681-6, entitled "MODULAR SURGICAL ENERGY SYSTEM WITH MODULE POSITIONAL AWARENESS SENSING WITH TIME COUNTER"; U.S. Patent Application Serial No. END9069USNP7 / 180681-7, entitled "MODULAR SURGICAL ENERGY SYSTEM WITH MODULLE POSITIONAL AWARENESS WITH DIGITAL LOGIC"; U.S. Patent Application Serial No. END9068USNP1 / 180680-1M, entitled "METHOD FOR CONTROLLING AN ENERGY MODULE OUTPUT"; U.S. Patent Application Serial No. END9068USNP2 / 180680-2, entitled "ENERGY MODULE FOR DRIVING MULTIPLE ENERGY MODALITIES"; U.S. Patent Application Serial No. END9068USNP3 / 180680-3, entitled "GROUNDING ARRANGEMENT OF ENERGY MODULES"; U.S. Patent Application Serial No. END9068USNP4 / 180680-4, entitled "BACKPLANE CONNECTOR DESIGN TO CONNECT STACKED ENERGY MODULES"; U.S. Patent Application Serial No. END9068USNP5 / 180680-5, entitled "ENERGY MODULE FOR DRIVING MULTIPLE ENERGY MODALITIES THROUGH A PORT"; U.S. Patent Application Serial No. END9068USNP6 / 180680-6, entitled "SURGICAL INSTRUMENT UTILIZING DRIVE SIGNAL TO POWER SECONDARY FUNCTION"; U.S. Patent Application Serial No. END9038USNP1 / 180529-1M, entitled "METHOD FOR CONTROLLING A MODULAR ENERGY SYSTEM USER INTERFACE"; U.S. Patent Application Serial No. END9038USNP2 / 180529-2, entitled "PASSIVE HEADER MODULE FOR A MODULAR ENERGY SYSTEM"; U.S. Patent Application Serial No. END9038USNP3 / 180529-3 entitled "CONSOLIDATED USER INTERFACE FOR MODULAR ENERGY SYSTEM"; U.S. Patent Application Serial No. END9038USNP4 / 180529-4, entitled "AUDIO TONE CONSTRUCTION FOR AN ENERGY MODULE OF A MODULAR ENERGY SYSTEM"; U.S. Patent Application Serial No. END9038USNP5 / 180529-5, entitled "ADAPTABLY CONNECTABLE AND REASIGNABLE SYSTEM ACCESSORIES FOR MODULAR ENERGY SYSTEM"; U.S. Patent Application Serial No. END9070USNP1 / 180682-1M, entitled "METHOD FOR COMMUNICATING BETWEEN MODULES AND DEVICES IN A MODULAR SURGICAL SYSTEM"; · U.S. Patent Application Serial No. END9070USNP2 / 180682-2, entitled "FLEXIBLE HAND-SWITCH CIRCUIT"; U.S. Patent Application Serial No. END9070USNP3 / 180682-3, entitled "FIRST AND SECOND COMMUNICATION PROTOCOL ARRANGEMENT FOR DRIVING PRIMARY AND SECONDARY DEVICES THROUGH A SINGLE PORT"; U.S. Patent Application Serial No. END9070USNP4 / 180682-4 entitled "FLEXIBLE NEUTRAL ELECTRODE"; U.S. Patent Application Serial No. END9070USNP5 / 180682-5, entitled "SMART RETURN PAD SENSING THROUGH MODULATION OF NEAR FIELD COMMUNICATION AND CONTACT QUALITY MONITORING SIGNALS"; U.S. Patent Application Docket No. END9070USNP6 / 180682-6, entitled "AUTOMATIC ULTRASONIC ENERGY ACTIVATION CIRCUIT DESIGN FOR MODULAR SURGICAL SYSTEMS"; U.S. Patent Application Serial No. END9070USNP7 / 180682-7, entitled "COORDINATED ENERGY OUTPUTS OF SEPARATE BUT CONNECTED MODULES"; U.S. Patent Application Serial No. END9070USNP8 / 180682-8, entitled "MANAGING SIMULTANEOUS MONOPOLAR OUTPUTS USING DUTY CYCLE AND SYNCHRONIZATION"; U.S. Patent Application Serial No. END9070USNP9 / 180682-9, entitled "PORT PRESENCE DETECTION SYSTEM FOR MODULAR ENERGY SYSTEM"; U.S. Patent Application Serial No. END9070USNP10 / 180682-10, entitled "INSTRUMENT TRACKING ARRANGEMENT BASED ON REAL TIME CLOCK INFORMATION"; U.S. Patent Application Serial No. END9070USNP11 / 180682-11, entitled "REGIONAL LOCATION TRACKING OF COMPONENTS OF A MODULAR ENERGY SYSTEM"; · U.S. Patent Application Serial No. END9212USDP1 / 190370D entitled "ENERGY MODULE"; U.S. Patent Application Serial No. END9213USDP1 / 190371D, entitled “ENERGY MODULE MONOPOLAR PORT WITH FOURTH SOCKET AMONG THREE OTHER SOCKETS”; U.S. Patent Application Serial No. END9214USDP1 / 190372D entitled "BACKPLANE CONNECTOR FOR ENERGY MODULE"; and · U.S. Patent Application Serial No. END9215USDP1 / 190373D, entitled “ALERT SCREEN FOR ENERGY MODULE.”
[0014] Before describing the various aspects of the surgical device and generator in detail, it is noted that the exemplary embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The exemplary embodiments may be implemented or incorporated in other aspects, variations, and modifications and may be practiced or carried out in various ways. Moreover, unless otherwise specified, the terms and expressions used herein have been selected for the convenience of the reader and for the purpose of describing the exemplary embodiments and not for the purpose of limiting them. Furthermore, it is to be understood that one or more of the aspects, aspect expressions, and / or embodiments described below can be combined with any one or more of the other aspects, aspect expressions, and / or embodiments described below.
[0015] Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical devices may be configured, for example, to transect and / or coagulate tissue during a surgical procedure. Aspects of the electrosurgical devices may be configured, for example, to transect, coagulate, scale, weld, and / or desiccate tissue during a surgical procedure.
[0016] Surgical System Hardware 1, a computer-implemented interactive surgical system 100 includes 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 includes at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one embodiment, as shown in FIG. 1, the surgical systems 102 include a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 configured to communicate with each other and / or with the hub 106. In some aspects, the 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 are integers equal to or greater than 1.
[0017] FIG. 2 illustrates an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in a surgical room 116. A robotic system 110 is used as part of the surgical system 102 in the surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. 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 while the surgeon views the surgical site through the surgeon's console 118. Images of the surgical site can be obtained by a medical imaging device 124, which can be manipulated and directed by the patient side cart 120. The robotic hub 122 can be used to process images of the surgical site and then display the processed images to the surgeon through the surgeon's console 118.
[0018] Other types of robotic systems can be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,339, filed December 28, 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM," the disclosure of which is incorporated herein by reference in its entirety.
[0019] Various examples of cloud-based analytical methods implemented by cloud 104 and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.
[0020] In various embodiments, the image capture device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, Charge-Coupled Device (CCD) sensors and Complementary Metal-Oxide Semiconductor (CMOS) sensors.
[0021] 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.
[0022] The one or more illumination sources may be configured to emit electromagnetic energy in the visible and invisible spectrum. The visible spectrum, sometimes referred to as the optical spectrum or emission spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye, and may also be referred to as visible light, or simply light. A typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.
[0023] The invisible spectrum (i.e., the non-radiative spectrum) is the portion of the electromagnetic spectrum that lies 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 are invisible infrared (IR), microwave, and wireless electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, which are invisible ultraviolet, X-ray, and gamma ray electromagnetic radiation.
[0024] In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. 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, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.
[0025] In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within a specific wavelength range from across the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments that can sense specific wavelengths of light, including frequencies beyond the visible light range, e.g., IR and ultraviolet light. Spectral imaging can allow for the extraction of additional information that the human eye cannot capture with its red, green and blue receptors. The use of multispectral imaging is described in detail in U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, in the section entitled "Advanced Imaging Acquisition Module," the entire disclosure of which is incorporated herein by reference. Multispectral monitoring can be a useful tool to reposition the surgical field after a surgical task is completed in order to perform one or more of the above-mentioned tests on the tissue being treated.
[0026] It is self-evident that any surgical procedure requires strict sterilization of the operating room and surgical equipment. The strict sanitary and sterile conditions required in the "surgical theater", i.e., the operating room or treatment room, require the utmost sterility of all medical devices and equipment. Part of the sterilization process described above 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 may be considered a specific area that is deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field may be considered the area immediately surrounding the patient who is prepared for the surgical procedure. The sterile field may include cleaned team members in appropriate clothing, and all the fixtures and fixtures in the area.
[0027] In various aspects, the visualization system 108 includes one or more imaging sensors strategically positioned relative to the sterile field, as shown in Figure 2, one or more image processing units, one or more storage arrays, and one or more displays. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. The various components of the visualization system 108 are described in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.
[0028] As shown in FIG. 2, the primary display 119 is positioned within the sterile field so as to be visible to an operator positioned at the operating table 114. Additionally, a visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. A visualization system 108 guided by the hub 106 is configured to utilize the displays 107, 109, and 119 to coordinate information flow to operators inside and outside the sterile field. For example, the hub 106 can cause the visualization system 108 to maintain a live view of the surgical site on the primary display 119 while displaying snapshots of the surgical site recorded by the imager 124 on the non-sterile displays 107 or 109. The snapshots on the non-sterile displays 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.
[0029] In one aspect, the hub 106 is also configured to send diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 in the sterile field to a primary display 119 in the sterile field for viewing by a sterile operator located at the operating table. In one example, the input may be in the form of a correction to a snapshot displayed on the non-sterile display 107 or 109 that can be sent by the hub 106 to the primary display 119.
[0030] 2, a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 is also configured to coordinate information flow to the display of the surgical instrument 112, for example in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. 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 the diagnostic input or feedback 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, in the section entitled "SURGICAL INSTRUMENT HARDWARE" and in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference.
[0031] 3, there is shown a hub 106 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, and a storage array 134. In certain aspects, as shown in FIG. 3, the hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128.
[0032] During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become entangled during a surgical procedure. Valuable time may be lost addressing this issue during a surgical procedure. Untangling the lines may require unplugging the lines from their corresponding modules, which may require resetting the modules. The hub's modular enclosure 136 provides a unified environment for managing the power, data, and fluid lines, reducing the frequency of such tangling between the lines.
[0033] Aspects of the present disclosure present 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 a docking station of the hub enclosure. The docking station includes data contacts 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 aspect, 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.
[0034] In one aspect, 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 that is slidably received within the hub enclosure. In one aspect, the hub enclosure includes a fluid interface.
[0035] Certain surgical procedures may require the application of more than one energy type 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 quick removal and / or replacement of various modules.
[0036] Aspects of the present disclosure present a modular surgical enclosure for use in a surgical procedure involving the application of energy to tissue, the modular surgical enclosure including 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, the first energy generator module slidably movable into electrical engagement with the power and data contacts, and the first energy generator module slidably movable out of electrical engagement with the first power and data contacts.
[0037] 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 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 data contacts.
[0038] In addition, the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.
[0039] 3-7, aspects of the disclosure are presented with respect to a hub modular enclosure 136 that allows for modular integration of the generator module 140, the smoke evacuation module 126, and the suction / irrigation module 128. The hub modular enclosure 136 further facilitates interactive communication between the modules 140, 126, and 128. As shown in FIG. 5, the generator module 140 may be a generator module that includes integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit 139 that is slidably insertable into the hub modular enclosure 136. As shown in FIG. 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular enclosure 136. The hub's modular enclosure 136 may be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked to the hub's modular enclosure 136 such that the multiple generators function as a single generator.
[0040] In one aspect, the hub's modular enclosure 136 includes a modular power and communications backplane 149 with external and wireless communication headers to enable removable attachment of and interactive communication between the modules 140, 126, 128.
[0041] In one aspect, the hub modular enclosure 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. Figure 4 shows a partial perspective view of the surgical hub enclosure 136 and a combination generator module 145 that is slidably receiveable in the docking station 151 of the surgical hub enclosure 136. On the rear side of the combination generator module 145 is a docking port 152 having power and data contacts that is configured to engage with a corresponding docking port 150 having power and data contacts of the corresponding docking station 151 of the hub modular enclosure 136 when the combination generator module 145 is slid into position within the corresponding docking station 151 of the hub modular enclosure 136. In one embodiment, the combination generator module 145 includes a bipolar, ultrasonic and monopolar module and a smoke evacuation module integrated together in a single housing unit 139, as shown in FIG.
[0042] In various aspects, the smoke evacuation module 126 includes fluid lines 154 that transport captured / collected smoke and / or fluid away from the surgical site, for example, to the smoke evacuation module 126. Vacuum suction generated from the smoke evacuation module 126 can draw smoke into openings in utility conduits at the surgical site. Utility conduits coupled to the fluid lines may be in the form of flexible tubing that terminates at the smoke evacuation module 126. The utility conduits and fluid lines define a fluid pathway that extends toward the smoke evacuation module 126, which is received within the hub enclosure 136.
[0043] In various aspects, the aspiration / irrigation module 128 is coupled to a surgical tool that includes suction and aspiration fluid lines. In one embodiment, the suction and aspiration fluid lines are in the form of flexible tubing that extends from the surgical site towards the aspiration / irrigation module 128. One or more drive systems may be configured to effect irrigation and aspiration of fluids to and from the surgical site.
[0044] In one aspect, the surgical tool includes a shaft having an end effector at its distal end and at least one energy treatment portion associated with the end effector, a suction tube, and an irrigation tube. The suction tube can have an inlet port at its distal end, and the suction tube extends through the shaft. Similarly, the irrigation tube can extend through the shaft and have an inlet port proximate to the energy delivery instrument. The energy delivery instrument is configured to deliver ultrasonic and / or RF energy to the surgical site and is initially coupled to the generator module 140 by a cable extending through the shaft.
[0045] The irrigation tube can be in fluid communication with a fluid source and the suction tube can be in fluid communication with a vacuum source. The fluid source and / or vacuum source can be housed within the aspiration / irrigation module 128. In one example, the fluid source and / or vacuum source can be housed within the hub enclosure 136, separate from the aspiration / irrigation module 128. In such an example, a fluid interface can be configured to connect the aspiration / irrigation module 128 to the fluid source and / or vacuum source.
[0046] In one aspect, the modules 140, 126, 128 and / or their corresponding docking stations on the hub's modular enclosure 136 may include alignment features configured to align the docking ports of the modules into engagement with their counterparts in the docking stations of the hub's modular enclosure 136. For example, as shown in FIG. 4, the combination generator module 145 includes a side bracket 155 configured to slidably engage with a corresponding bracket 156 of the corresponding docking station 151 of the hub's modular enclosure 136. The brackets cooperate to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub's modular enclosure 136.
[0047] In some aspects, the drawers 151 of the hub's modular enclosure 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are different sizes from one another, each designed to accommodate a particular module.
[0048] Additionally, keying features may be provided to engage contacts on a particular module with contacts on a particular drawer to prevent insertion of the module into a drawer with incompatible contacts.
[0049] 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between modules housed within the hub's modular enclosure 136. Alternatively or additionally, the docking port 150 of the hub's modular enclosure 136 may facilitate wireless interactive communication between modules housed within the hub's modular enclosure 136. Any suitable wireless communication may be used, such as, for example, Air Titan-Bluetooth.
[0050] 6 illustrates individual power bus attachments of multiple lateral docking ports of a lateral modular housing 160 configured to receive multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect modules 161. The modules 161 are slidably inserted into a docking station 162 of the lateral modular housing 160 that includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the modules 161 are arranged laterally within the lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically within the lateral modular housing.
[0051] FIG. 7 illustrates a vertical modular housing 164 configured to receive a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into a docking station or drawer 167 of the vertical modular housing 164 that includes a backplane for interconnecting the modules 165. Although the drawer 167 of the vertical modular housing 164 is vertically oriented, in certain cases the vertical modular housing 164 may include a horizontally oriented drawer. Additionally, the modules 165 may interact with each other via a docking port of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of the modules 165. Additionally, the vertical modular housing 164 includes a master module 178 that houses a plurality of sub-modules that are slidably received within the master module 178.
[0052] In various aspects, the imaging module 138 includes a built-in video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is configured with a modular housing that can be assembled with a light source module and a camera module. The housing can be a disposable housing. In at least one example, the disposable housing is removably coupled with a reusable controller, a light source module, and a camera module. The light source module and / or the camera module can be selectively selected depending on the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for beam scanning imaging. Similarly, the light source module can be configured to deliver white light or different light depending on the surgical procedure.
[0053] During a surgical procedure, it may be inefficient to remove a surgical device from the surgical field and replace it with another surgical device including a different camera or a different light source. Temporary loss of view of the surgical field may result in undesirable results. The modular imaging device of the present disclosure is configured to allow replacement of a light source module or a camera module midstream during a surgical procedure without the need to remove the imaging device from the surgical field.
[0054] In one aspect, the imaging device comprises a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module that can be configured for snap-fit engagement with the first channel. A second channel is configured to slidably receive a light source module that can be configured for snap-fit engagement with the second channel. In another example, the camera module and / or the light source module can be rotated into a final position within their corresponding channels. A threaded engagement may be used instead of a snap-fit engagement.
[0055] In various embodiments, multiple imaging devices are placed at different locations within the surgical field to provide multiple fields of view. The imaging module 138 can be configured to switch between the imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from the different imaging devices.
[0056] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Patent No. 7,995,045, issued Aug. 9, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which is incorporated herein by reference in its entirety. Additionally, U.S. Patent No. 7,982,776, issued Jul. 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems may be integrated with the imaging module 138. Additionally, U.S. Patent Application Publication No. 2011 / 0306840, published December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS," and U.S. Patent Application Publication No. 2014 / 0243597, published August 28, 2014, entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE," are each incorporated herein by reference in their entirety.
[0057] FIG. 8 illustrates a surgical data network 201 comprising a modular communication hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility, or any room in a medical facility with specialized equipment for surgical procedures, to a cloud-based system (e.g., cloud 204, which may include a remote server 213 coupled to storage device 205). In one aspect, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communication 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 go from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port in 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.
[0058] Modular devices 1a-1n located in the operating room may be coupled to the modular communication hub 203. A network hub 207 and / or a network switch 209 may be coupled to a network router 211 to connect the devices 1a-1n to the cloud 204 or a local computer system 210. Data associated with the devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with the 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 the devices 2a-2m to the cloud 204. Data associated with the devices 2a-2n may be transferred to the cloud 204 via the network router 211 for data processing and manipulation. Data associated with the devices 2a-2m may also be transferred to the local computer system 210 for local data processing and manipulation.
[0059] 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 in a modular control tower configured to receive 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 aspects, 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 a modular communications hub 203 of a surgical data network 201.
[0060] In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es) and network router(s) that connect 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 may 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 a local server or personal device to handle software applications. The term "cloud" may be used as a metaphor for the "internet", although the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "a type of internet-based computing" where various services such as servers, storage and applications are delivered via the internet to a modular communication 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 communication hub 203 and / or computer system 210. The cloud infrastructure may be maintained by a cloud service provider. In this context, the 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. The cloud computing services may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0061] By applying cloud computer data processing techniques to data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of the sealed tissue after tissue sealing and cutting procedures. At least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data, including images of samples of body tissue, to identify pathology, such as disease effects, using cloud-based computing. Such data includes tissue localization and margin confirmation, as well as phenotypes. At least some of the devices 1a-1n / 2a-2m can be used to identify body anatomical structures using various sensors integrated with the imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by the devices 1a-1n / 2a-2m, including image data, may 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 pursued, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions and 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 treatments and surgeon performance.
[0062] In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via wired or wireless channels depending on the configuration of the devices 1a-1n with respect to the network hub. The network hub 207 may be implemented in one aspect as a local network broadcast device that works on the physical layer of the Open System Interconnection (OSI) model. The network hub provides connectivity to the devices 1a-1n located in the same operating room network. The network hub 207 collects data in the form of packets and sends them to the router in half-duplex mode. The network hub 207 does not store media access control / Internet Protocol (MAC / Internet Protocol, IP) for forwarding any device data. Only one of the devices 1a-1n can send data at a time through the network hub 207. The network hub 207 does not have a routing table or intelligence on where to send the information and broadcasts all network data across each connection and to the remote server 213 (FIG. 9) on the cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose security risks and cause bottlenecks.
[0063] In another implementation, 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 is 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 functions 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.
[0064] The network hub 207 and / or the network switch 209 are coupled to a network router 211 for connecting 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 sending 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 at different locations, such as different networks located in 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 functions in full duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.
[0065] 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 may 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 over wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located in the operating room.
[0066] In another embodiment, the operating room devices 1a-1n / 2a-2m can communicate with the 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 ISM band of 2.4-2.485 GHz) and to create a personal area network (PAN). In another embodiment, the operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via a number of 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, 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, Ev-DO, etc.
[0067] The modular communications hub 203 can act as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles data types known as frames. Frames 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 by using any number of wireless or wired communications standards or protocols as described herein.
[0068] 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 is generally easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking the operating room devices 1a-1n / 2a-2m.
[0069] FIG. 9 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 that may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210. As shown in the embodiment of FIG. 9, the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuator module 226, a suction / irrigation module 228, a communication 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. The operating room devices are coupled to cloud computing resources and data storage via the modular control tower 236. The robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. The devices / instruments 235, visualization system 208, among others, may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols as described herein. The 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 images and overlay images.
[0070] FIG. 10 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communication 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. 10, the modular communication hub 203 can be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 to transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches in the modular communication hub 203 includes three downstream ports and one upstream port. The upstream network hub / switch is connected to a processor to provide communication connections to cloud computing resources and a local display 217. Communication to the cloud 204 can be via either wired or wireless communication channels.
[0071] The surgical hub 206 uses 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. As described in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety, in which the sensor module is configured to determine the size of the operating room and adjust the distance limit for Bluetooth pairing, the ultrasonic-based non-contact sensor module scans the operating room by transmitting bursts of ultrasound and receiving echoes as the bursts of ultrasound reflect off the exterior walls of the operating room. The laser-based non-contact sensor module scans the operating room, for example, by transmitting laser light pulses, receives the laser light pulses that reflect off the exterior walls of the operating room, and compares the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the distance limit for Bluetooth pairing.
[0072] The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled to a communication module 247, a storage 248, a memory 249, a non-volatile memory 250, and an input / output interface 251 via a system bus. The system bus may be any of several types of bus structure(s) 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, examples of which include, but are not limited to, 9-bit bus, Industry Standard Architecture (ISA), MicroChannel Architecture (MSA), Enhanced ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus.
[0073] The 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. The processor core includes on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a pre-fetch 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.
[0074] In one embodiment, the processor 244 may include a safety controller, including two controller families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4 from Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limiting applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity and memory options.
[0075] System memory includes 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. In addition, RAM is available in many forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), SyncLink DRAM (SLDRAM), and direct RAMbus RAM (DRRAM).
[0076] The computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as 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 can 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 disk ROM drives (CD-ROM), compact disk recordable drives (CD-R drives), compact disk rewriteable drives (CD-RW drives), or digital versatile disk ROM drives (DVD-ROM). Removable or non-removable interfaces may be used to facilitate connection of disk storage devices to the system bus.
[0077] It should be appreciated that the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in a preferred operating environment. Such software includes an operating system. The operating system, which may be stored on disk storage, functions to control and allocate resources of the computer system. System applications take advantage of the operating system's management of resources through program modules and program data stored either in system memory or on disk storage. It should be appreciated that the various components described herein can be implemented with various operating systems or combinations of operating systems.
[0078] A user inputs commands or information into the computer system 210 through input device(s) coupled to the I / O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, gamepad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, webcam, and the like. These and other input devices connect to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, and USB. Output device(s) use some of the same types of ports as the input device(s). 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 are provided to illustrate that there are some output devices such as monitors, displays, speakers, and printers, among other output devices that require special adapters. Output adapters 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 computer(s), provide both input and output capabilities.
[0079] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) can be personal computers, servers, routers, network PCs, workstations, microprocessor-based devices, peer devices, or other common network nodes, but typically include many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown with the remote computer(s). The remote computer(s) are logically connected to the computer system through a network interface, which is then physically connected through a communication connection. The network interface encompasses communication networks, such as local area networks (LANs) and wide area networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and variations thereof, packet-switched networks, and Digital Subscriber Lines (DSL).
[0080] In various aspects, the computer system 210 of FIG. 10, the imaging module 238 and / or the visualization system 208 and / or the processor module 232 of FIGS. 9-10 may include an image processor, an image processing engine, a media processor, or any specialized digital signal processor (DSP) used to process digital images. The image processor may use 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.
[0081] The communications connection(s) refers to the hardware / software used to connect the network interface to the bus. Although the communications connections are shown internal to the computer system for clarity of illustration, the communications connections may 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.
[0082] FIG. 11 illustrates a functional block diagram of one embodiment of a USB network hub 300 device in accordance with at least one embodiment of the present disclosure. In the embodiment shown, the USB network hub device 300 uses a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 that conform to the USB 2.0 standard. The upstream USB transceiver port 302 is a differential rooted data port that includes a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, with each port including a differential data plus (DP1-DP3) output paired with a differential data minus (DM1-DM3) output.
[0083] The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. Fully compliant USB transceivers are built into the circuitry of the upstream USB transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full speed and low speed devices by automatically setting the ramp-up speed depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes hub power logic 312 to manage power.
[0084] The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in Chapter 8 of the USB specification. The SIE 310 typically understands signaling down to the transaction level. Functions it handles may include packet recognition, transaction reordering, detection / generation of SOP, EOP, RESET and RESUME signals, clock / data separation, non-return to zero inverted (NRZI) data encoding / decoding and bit stuffing, CRC generation and checking (token and data), packet ID (PID) generation and checking / decoding, and / or serial-to-parallel and parallel-to-serial conversion. 310 receives a clock input 314 and is coupled to a suspend / resume logic and frame timer 316 circuit and a hub repeater circuit 318 for controlling communication between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 via port logic circuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326 via interface logic to control commands from a serial EEPROM via a serial EEPROM interface 330 .
[0085] In various aspects, the USB network hub 300 can connect up to 127 functions organized in up to six logical layers to a single computer. Additionally, the USB network hub 300 can connect to all peripherals using a standardized four-wire cable that provides both communication and power distribution. The power configurations are bus-powered and self-powered. The USB network hub 300 may be configured to support four modes of power management: bus-powered hub with either individual port power management or ganged port power management, and self-powered hub with either individual port power management or ganged port power management. In one aspect, using a USB cable, the USB network hub 300, the upstream USB transceiver port 302 is plugged into a USB host controller, and the downstream USB transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, and so on.
[0086] Surgical Instrument Hardware 12 illustrates 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 comprises a control circuit. The control circuit includes a microcontroller 461 with a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor driver 492 operatively couples the longitudinally movable displacement member to drive the clamp arm closure member. A tracking system 480 is configured to determine a position of the longitudinally movable displacement member. The position information is provided to the processor 462, which can be programmed or configured to determine a position of the longitudinally movable drive member and a position of the closure member. Additional motors may be provided in the tool driver interface to control the movement of the closure tube, the rotation of the shaft, the articulation, or the closure of the clamp arm, or a combination of the above. A display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on the display 473 can be overlaid with images acquired via the endoscopic imaging module.
[0087] 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 an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including, for example, 256KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40MHz, a pre-fetch buffer to improve performance above 40MHz, 32KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2KB 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 data sheet.
[0088] In one embodiment, the microcontroller 461 may include a safety controller, including two controller families such as 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 limiting applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity and memory options.
[0089] The microcontroller 461 may be programmed to perform various functions such as precise control of the speed and position of the knife, articulation system, clamp arm, or combinations of the above. In one aspect, the microcontroller 461 includes a processor 462 and a 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 aspect, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be easily substituted for use with the tracking system 480 with the absolute positioning system. A detailed description of the absolute positioning system 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.
[0090] 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 is compared to the measured response of the actual system to obtain an "observed" response, which is used to determine the actual feedback. The observed response is a suitably adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.
[0091] In one aspect, the motor 482 may be controlled by a motor driver 492 and may be used by the firing system of the surgical instrument or tool. In various configurations, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In other configurations, 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 that 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 battery cells. In at least one example, the battery cells may be lithium ion batteries that may be connectable to and separable from the power supply assembly.
[0092] The motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is 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 has an intrinsic charge pump regulator that provides 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 above battery supply voltage for the N-channel MOSFETs. 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 FETs. The power FETs are protected from shoot-through by 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.
[0093] The tracking system 480 includes a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents 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 another aspect, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinally movable member for opening and closing a clamp arm, which may be adapted and configured to include a rack of drive teeth. In another aspect, the displacement member represents a clamp arm closure member configured to open and close a clamp arm of a stapler, ultrasonic, or electrosurgical device, or a combination of the above. Thus, as used herein, the term displacement member is used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, a clamp arm, or any element that can be displaced. Thus, the absolute positioning system can actually track the displacement of a clamp arm by tracking the linear displacement of a longitudinally movable drive member. In other aspects, the absolute positioning system may be configured to track the position of the clamp arm during the opening and closing process. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, or the clamp arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact displacement sensor or a 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 with a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system with a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical detection system with a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical detection system with a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
[0094] The electric motor 482 may include a rotatable shaft operatively interfaced with a gear assembly mounted in meshing engagement with a set or rack of drive teeth on the displacement member. The sensor element may be operatively coupled to the gear assembly such that one revolution 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 provides power to the absolute positioning system and an output indicator may display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member represents a longitudinally movable firing member that opens and closes the clamp arm.
[0095] One revolution of the sensor element associated with the position sensor 472 corresponds to a linear longitudinal displacement d1 of the displacement member, where d1 is the linear longitudinal distance the displacement member travels 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 for a full stroke of the displacement member. The position sensor 472 may complete multiple revolutions for a full stroke of the displacement member.
[0096] 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 is fed back to the microcontroller 461 which applies logic to calculate the linear longitudinal displacement d1+d2+...d of the displacement member. n The output of the position sensor 472 is provided to the microcontroller 461. The sensor mechanism position sensor 472 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.
[0097] The position sensor 472 may comprise any number of magnetic sensing elements, such as magnetic sensors classified based on 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 involve many aspects of physics and electronics. Technologies used to sense magnetic fields include search coils, fluxgates, optical pumping, nuclear precession, SQUID, 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, among others.
[0098] In one aspect, the position sensor 472 of the tracking system 480 with absolute positioning system comprises a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 472 is interfaced with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the area of the position sensor 472 located above the magnet. Also provided on the chip is a high resolution ADC and a smart power management controller. A Coordinate Rotation Digital Computer (CORDIC) processor, also known as the Digit-by-Digit method and the Boulder algorithm, is 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 are transmitted to the microcontroller 461 via a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. The position sensor 472 provides 12-bit or 14-bit resolution and may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.
[0099] A tracking system 480 with an absolute positioning system may include and / or be programmed to implement a feedback controller, such as PID, state feedback, and adaptive controllers. The power supply converts the signal from the feedback controller into a physical input to the system, in this case voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some embodiments, the other sensor(s) 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 average and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, induced resistance, etc., in order to predict what the state and output of the physical system will be given knowledge of the input.
[0100] The absolute positioning system provides the absolute position of the displacement member upon powering up of 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.
[0101] The sensor 474, e.g., a strain gauge or micro strain gauge, is configured to measure one or more parameters of the end effector, e.g., the amplitude of strain exerted on the anvil during the clamping operation, which can be indicative of the closure force applied to the anvil. The measured strain is converted to a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, a sensor 476, e.g., a load sensor, can measure the closure force that the closure drive system applies to the anvil in a stapler or clamp arm in an ultrasonic or electrosurgical instrument. For example, the sensor 476, e.g., a load sensor, can measure the firing force applied to a closure member coupled to a clamp arm of a surgical instrument or tool, or the force applied by the clamp arm to tissue located in the jaws of an ultrasonic or electrosurgical instrument. Alternatively, a current sensor 478 can be used to measure the current drawn by the motor 482. The displacement member can also be configured to engage and open and close the clamp arm. The force sensor can be configured to measure the clamp force on the tissue. The force required to advance the displacement member can correspond to the current drawn by the motor 482, for example. The measured force is converted to a digital signal and provided to a processor 462 .
[0102] In one form, a strain gauge sensor 474 can be used to measure the force applied by the end effector to the tissue. 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 the tissue gripped by the end effector includes a strain gauge sensor 474, such as a micro strain gauge 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 a clamping operation, which may be indicative of tissue compression. The measured strain is 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. The load sensor 476 can measure the force used to operate the clamp arm element, for example, to capture tissue between the clamp arm and an ultrasonic blade or to capture tissue between the clamp arm and the jaws of an electrosurgical instrument. The magnetic field sensor can be used to measure the thickness of the captured tissue. The magnetic field sensor measurements can also be converted to digital signals and provided to the processor 462.
[0103] Measurements of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, as 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 the velocity of the firing member. In one example, memory 468 can store techniques, equations, and / or look-up tables that can be used by microcontroller 461 in the evaluation.
[0104] The surgical instrument or tool control system 470 may also include wired or wireless communication circuitry for communicating with a modular communications hub as shown in Figures 8-11.
[0105] FIG. 13 illustrates a control circuit 500 configured to control an embodiment of a surgical instrument or tool according to one embodiment of the present disclosure. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 can comprise a microcontroller comprising one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuit 504 stores machine executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement various processes described herein. The processor 502 can be any one of a number of single-core or multi-core processors known in the art. The memory circuit 504 can comprise volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present disclosure.
[0106] 14 illustrates a combinational logic circuit 510 configured to control an aspect of a surgical instrument or tool, according to one aspect of the present disclosure. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 may comprise a finite state machine comprising combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data through the combinational logic 512, and provide an output 516.
[0107] FIG. 15 illustrates a sequential logic circuit 520 configured to control an aspect of a surgical instrument or tool according to one aspect of the disclosure. The sequential logic circuit 520 or the combinatorial logic 522 can be configured to implement various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, the combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 can store a current state of the finite state machine. In certain examples, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data through the combinatorial logic 522, and provide an output 528. In other aspects, the circuit may include a combination of a processor (e.g., the processor 502 of FIG. 13) and a finite state machine that implements various processes herein. In other aspects, the finite state machine may include a combination of combinational logic (eg, combinational logic 510 of FIG. 14) and sequential logic 520.
[0108] 16 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 a firing, closing, and / or articulation motion in the end effector. The firing, closing, and / or articulation motion can be transmitted to the end effector via a shaft assembly, for example.
[0109] In particular examples, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operatively coupled to a firing motor drive assembly 604, which may be configured to transfer a firing motion generated by the motor 602 to an end effector, specifically to displace a clamp arm closure member. The closure member may be retracted by reversing the direction of the motor 602, thereby further opening the clamp arm.
[0110] 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 a closure motion generated by the motor 603 to an end effector, specifically to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, which may be configured to transmit a closure motion generated by the motor 603 to an end effector, specifically to displace a closure tube to close the clamp arm and compress tissue between the clamp arm and either the ultrasonic blade or the jaw member of the electrosurgical device. The closure motion may, for example, transition the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.
[0111] In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operatively coupled to corresponding articulation motor drive assemblies 608a, 608b, which may be configured to transfer articulation motion generated by the motors 606a, 606b to an end effector. In certain examples, the articulation motion may, for example, cause the end effector to articulate relative to the shaft.
[0112] As discussed above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool may be activated individually or separately to perform one or more functions while other motors remain stopped. For example, articulation motors 606a, 606b may be activated to articulate an end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 may be activated to fire multiple staples and / or advance a cutting blade while articulation motor 606 remains stopped. Additionally, closure motor 603 may be activated simultaneously with firing motor 602 to distally advance a closure tube or member, as described in more detail herein below.
[0113] 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 separable to multiple motors of a robotic surgical instrument. In certain examples, 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, multiple motors of a surgical instrument or tool can be independently and selectively engaged with the common control module 610. In certain examples, the common control module 610 can be selectively switched 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.
[0114] In at least one example, the common control module 610 can be selectively switched between operative engagement with the articulation motors 606a, 606b and operative engagement with either the firing motor 602 or the closure motor 603. In at least one embodiment, as shown in FIG. 16 , the switch 614 can be moved or transitioned between a number of positions and / or states. For example, in a first position 616, the switch 614 can electrically couple the common control module 610 to the firing motor 602, in a second position 617, the switch 614 can electrically couple the common control module 610 to the closure motor 603, in a third position 618a, for example, the switch 614 can electrically couple the common control module 610 to the first articulation motor 606a, and in a fourth position 618b, the switch 614 can electrically couple the common control module 610 to the second articulation motor 606b. 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 606a, 606b simultaneously. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.
[0115] 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.
[0116] 16, 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, for example, based on input from a microcontroller 620 ("controller"). In certain examples, as described above, for example, microcontroller 620 may be used to determine the current drawn by a motor while the motor is coupled to common control module 610.
[0117] In certain examples, the microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In certain examples, the memory 624 may store various program instructions that, when executed, may cause the processor 622 to perform a number of functions and / or calculations described herein. In certain examples, one or more of the memory units 624 may be coupled to the processor 622, for example. In various aspects, the microcontroller 620 may communicate via wired or wireless channels, or a combination thereof.
[0118] In certain examples, the power source 628 may be used, for example, to power the microcontroller 620. In certain examples, the power source 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 the surgical instrument 600. Multiple battery cells connected in series may be used as the power source 628. In certain examples, the power source 628 may be, for example, replaceable and / or rechargeable.
[0119] In various examples, the processor 622 can control the motor driver 626 to control the position, direction, and / or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor driver 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. The processor 622 is a general-purpose programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides the results as output. It is an example of sequential digital logic since it has an internal memory. The processor operates on numbers and symbols represented in the binary system.
[0120] In one example, the 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, the 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 data sheet, 256KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40MHz, a pre-fetch buffer to improve performance above 40MHz, 32KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2KB of EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels. Other microcontrollers may be readily substituted for use with the module 4410. Thus, the present disclosure should not be limited in this context.
[0121] In certain examples, 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 606a, 606b. Such program instructions may cause the processor 622 to control the firing, closing, and articulation functions according to inputs from an algorithm or control program of the surgical instrument or tool.
[0122] In certain examples, one or more mechanisms and / or sensors, such as, for example, sensor 630, can be used to alert processor 622 to program instructions to be used in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closure, and articulation of 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 a closure member coupled to a clamp arm 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 anvil when it detects, for example, via sensor 630 that switch 614 is in second position 617, and processor 622 can use program instructions associated with articulation of the end effector when it detects, for example, via sensor 630 that switch 614 is in third position 618a or fourth position 618b.
[0123] 17 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 the distal / proximal translation of a displacement member, the distal / proximal displacement of an closure tube, the rotation and articulation of a shaft, using either a single or multiple articulation drive joints. 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 articulation members, or a combination thereof. The surgical instrument 700 includes a control circuit 710 configured to control a motorized firing member, a closure member, a shaft member, or one or more articulation members, or a combination thereof.
[0124] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the clamp arm 716 and closure member 714 portions of the end effector 702, 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 via a number of motors 704a-704e. 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 may be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.
[0125] 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 a position of the closure member 714 determined by the position sensor 734 with the output of the timer / counter 731, such that the control circuitry 710 can determine a 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.
[0126] In one aspect, the control circuitry 710 may be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuitry 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuitry 710 may be programmed to select a firing control program or a closing control program based on the tissue condition. The firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better treat different tissue conditions. For example, when thicker tissue is present, the control circuitry 710 may be programmed to translate the displacement member at a slower speed and / or with less power. When thinner tissue is present, the control circuitry 710 may be programmed to translate the displacement member at a higher speed and / or with more power. The closing control program may control the closing force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and the articulating members 742a, 742b.
[0127] In one aspect, the control circuitry 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 circuitry 710 may directly generate the motor drive signals.
[0128] 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 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 sum of the pulse widths of the motor drive signals, 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 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.
[0129] In one aspect, the motors 704a-704e can receive power from an energy source 712. The energy source 712 may be a DC power source driven by a mains AC power source, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to respective moveable 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 moveable 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 up the number and direction of steps the motor 704 is instructed to take. The position sensor 734 may be located in the end effector 702 or in any other part 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.
[0130] 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 the motor control 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 movable mechanical element, such as a rotating element and a firing member, for controlling the movement of the closure member 714 in the distal and proximal directions along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may 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 is indicative of the force required to fire or displace the closure member 714. The position sensor 734 may be configured to provide the position of the closure member 714 or the firing member along the firing stroke as a feedback signal to the control circuit 710. 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 may provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a may 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.
[0131] In one aspect, the control circuit 710 is configured to drive a closure member, such as a clamp arm 716 portion of the end effector 702. The control circuit 710 provides motor settings to a motor control 708b, which provides a drive signal to a motor 704b. An 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 an open position and a closed position. 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.
[0132] 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 the motor control 708c, which 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 to be operably engaged by 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 is representative of 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.
[0133] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708d, which provides a drive signal to the motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission mechanism 706d that is coupled to the articulation member 742a. The transmission mechanism 706d includes a movable mechanical element such as an articulation element for controlling the ±65° articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut that 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. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702. A sensor 738, such as a articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.
[0134] 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 with respect to the other linkage to provide a resistive holding motion and load to the head when the head is not moving, and to provide an 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. Thus, 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.
[0135] In one aspect, one or more of the motors 704a-704e may comprise a gearbox and a brushed DC motor with a mechanical link to a firing member, a closure member, or an 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 unmeasured and unpredictable influences of things such as tissue, surroundings, and friction on a physical system. Such external influences may be referred to as drags that act against one of the electric motors 704a-704e. External influences such as drags may cause the operation of a physical system to deviate from the desired operation of the physical system.
[0136] In one embodiment, the position sensor 734 may be implemented as an absolute positioning system. In one embodiment, 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 interface with the control circuit 710 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 the digit-by-digit method and the Boulder algorithm, which is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting and table lookup operations.
[0137] In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensor 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 sensor 738 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. The sensor 738 may be located on the clamp arm 716 to determine the position of the tissue using a split electrode. 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.
[0138] In one aspect, the one or more sensors 738 may comprise a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the clamp arm 716 during the clamped state. The strain gauge provides an electrical signal that varies in amplitude with the magnitude of strain. The sensor 738 may comprise a pressure sensor configured to detect pressure created 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 a tissue portion located between the clamp arm 716 and the ultrasonic blade 718, which impedance is indicative of the thickness and / or fullness of the tissue located therebetween.
[0139] 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, 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 non-conductor-containing switches, ultrasonic switches, accelerometers, and inertial sensors, among others.
[0140] 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 an interaction point between a 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 representative of tissue compression experienced by a tissue section captured 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 by the closure drive system on the clamp arm 716. The one or more sensors 738 may be sampled by a processor of the control circuitry 710 in real time during the clamping operation. The control circuitry 710 receives the real time sample measurements to provide and analyze time based information to assess the closure force exerted on the clamp arm 716 in real time.
[0141] 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 response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the closure member 714 in the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be any one of any feedback controllers, 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 to convert the 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 Ser. No. 15 / 636,829, filed Jun. 29, 2017, entitled “CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT,” which is incorporated by reference in its entirety.
[0142] 18 shows a schematic diagram of a surgical instrument 750 configured to control 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 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.
[0143] The position, movement, displacement and / or translation of a linear displacement member, such as the closure member 764, can be measured by an absolute positioning system, a sensor mechanism and a position sensor 784. Because the closure member 764 is coupled to a longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement and / or translation of the closure member 764 can be achieved by the position sensor 784 as described herein. The control circuitry 760 may be programmed to control the translation of a displacement member, such as the closure member 764. In some examples, the 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, such as the 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 such 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 external events, or measure the time of an external event.
[0144] The control circuitry 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 circuitry 760 may directly generate the motor drive signal 774.
[0145] The motor 754 can 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 can 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. The position sensor 784 can sense the position of the closure member 764. The position sensor 784 can be or may 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 can include an encoder configured to provide a series of pulses to the control circuitry 760 as the closure member 764 translates in the distal and proximal directions. The control circuitry 760 can 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 can 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 can 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 can be located in the end effector 752 or in any other portion of the instrument.
[0146] 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 comprise 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 can include one or more sensors.
[0147] The one or more sensors 788 may comprise a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the clamp arm 766 during the clamped state. The strain gauge provides an electrical signal that varies in amplitude 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 a tissue portion located between the clamp arm 766 and the ultrasonic blade 768, which impedance is indicative of the thickness and / or fullness of the tissue located therebetween.
[0148] The sensor 788 may be configured to measure the force exerted by the closure drive system on the clamp arm 766. For example, one or more sensors 788 may be located at an interaction point between a closure tube and the clamp arm 766 to detect the closure force exerted by the closure tube on the clamp arm 766. The force exerted on the clamp arm 766 may be representative of tissue compression experienced by a tissue section captured between the clamp arm 766 and the ultrasonic blade 768. The one or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force exerted by the closure drive system on the clamp arm 766. The one or more sensors 788 may be sampled by a processor of the control circuitry 760 in real time during the clamping operation. The control circuitry 760 receives the real time sample measurements to provide and analyze time based information to assess the closure force exerted on the clamp arm 766 in real time.
[0149] 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.
[0150] 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 any one of any feedback controllers, including, but not limited to, a PID, state feedback, LQR and / or adaptive controller. The surgical instrument 750 can include a power supply to convert 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.
[0151] The actual drive system of the surgical instrument 750 is configured to drive the displacement, cutting or closure member 764 by a brushed DC motor with a gearbox and mechanical connection to the articulation and / or knife system. Another example is an electric motor 754 that operates, for example, the displacement member and the articulation driver of an interchangeable shaft assembly. External influences are unmeasured and unpredictable influences of things like tissue, surroundings and friction on the physical system. Such 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 the physical system to deviate from the desired operation of the physical system.
[0152] Various exemplary embodiments are directed to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, a motor 754 may drive a displacement member in a distal and proximal direction 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 may provide a firing signal, for example, by pressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member in a distal direction 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, a 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 .
[0153] 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, for example, 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 describe 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 less 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 more power.
[0154] 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 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 response of the instrument 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 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 Ser. No. 15 / 720,852, filed Sep. 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," which is incorporated by reference in its entirety.
[0155] 19 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 distal translation of a displacement member, such as a closure member 764. The surgical instrument 790 includes an end effector 792 that may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 that 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 that is driven by an ultrasonic generator 771.
[0156] 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. 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 788 may include a non-conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.
[0157] In one aspect, the position sensor 784 may be implemented as an absolute positioning system with a magnetic rotary absolute positioning system implemented as an AS5055EQFT single chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 784 may interface with the 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 the digit-by-digit method and the Boulder algorithm, which is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting and table lookup operations.
[0158] In some examples, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuitry 760 can 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 can be located in the end effector 792 or in any other portion of the instrument.
[0159] 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 comprise 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 can include one or more sensors.
[0160] An RF energy source 794 is coupled to the end effector 792 and is applied to an 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.
[0161] Additional details are disclosed in U.S. patent application Ser. No. 15 / 636,096, filed Jun. 28, 2017, entitled "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME," which is incorporated by reference in its entirety.
[0162] Generator Hardware In various aspects, the smart ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize the tissue type. An algorithm for detecting tissue collagen / elasticity ratio to adjust the amplitude of the distal tip of the ultrasonic blade is described in the following sections of this disclosure. Various aspects of the smart ultrasonic energy device are described herein, for example, in connection with Figures 12-19. Thus, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with Figures 12-19 and their associated description.
[0163] In certain surgical procedures, it is desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device may be adjusted based on the location of the tissue within the jaws of the ultrasonic end effector, for example, the location of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasonic transducer may be used to identify what percentage of the tissue is located at the distal or proximal end of the end effector. The response of the ultrasonic device may be based on the tissue type or tissue compressibility. In another aspect, the parameters of the ultrasonic device may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be adjusted based on the ration of collagen to elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue may be detected using various techniques including infrared (IR) surface reflectance and emissivity. The force applied to the tissue by the clamp arm and / or the stroke of the clamp arm to create gap and compression. Electrical continuity across the jaw with electrodes can be used to determine what percentage of the jaw is covered with tissue.
[0164] 20 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 adaptive ultrasonic blade control algorithm(s) 802. In another embodiment, the device / instrument 235 is configured to execute adaptive ultrasonic blade control algorithm(s) 804. In another embodiment, both the generator module 240 and the device / instrument 235 are configured to execute adaptive ultrasonic blade control algorithms 802, 804.
[0165] The generator module 240 may include a patient-isolated stage that communicates with the non-isolated stage via a power transformer. A 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 configuration) for defining 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 alone or simultaneously. Specifically, the drive signal output can output an ultrasonic drive signal (e.g., a 420V 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 100V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to FIGS. 21-22.
[0166] The generator module 240, or the device / instrument 235, or both, are coupled to a modular control tower 236, e.g., as described with reference to Figures 8-11, which is connected to a number of operating room devices, such as intelligent surgical instruments, robots, and other computerized devices located in the operating room.
[0167] FIG. 21 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 with a modular communication hub as shown in FIG. 20. 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, and may be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be 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 a memory coupled to the processor 902, 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 to convert 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 between terminals labeled ENERGY1 and RETURN on the surgical instrument. A second signal of a second energy modality is coupled across a capacitor 910 and provided between terminals labeled ENERGY2 and RETURN on the surgical instrument. More than two energy modalities may be output, thus the subscript "n" indicates a maximum of n ENERGY modalities. nIt will be understood that n is a positive integer greater than 1. n ) may be provided without departing from the scope of the present disclosure.
[0168] 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 an interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.
[0169] In one aspect, the impedance may be determined by the processor 902 by dividing the output of either the first voltage sense circuit 912 coupled across the terminals labeled ENERGY1 / RETURN or the 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. Yet, in addition to ultrasound energy modalities and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. Also, while the example shown in FIG. 21 illustrates that a single return path (RETURN) may be provided to two or more energy modalities, in other embodiments, multiple return paths RETURN n However, each energy modality ENERGY n Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sense circuit 912 by the current sense circuit 914, and the impedance of the tissue may be measured by dividing the output of the second voltage sense circuit 924 by the current sense circuit 914.
[0170] As shown in FIG. 21, 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, 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. For example, the generator 900 can deliver high voltage and low current energy to drive an ultrasonic transducer, deliver low voltage and high current energy to drive an RF electrode to seal tissue, or deliver energy with 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 output of the generator 900 will preferably be located between the output labeled ENERGY1 and RETURN as shown in FIG. 21. In one example, the connection of the RF bipolar electrode to the output of the generator 900 would preferably be located between the output labeled ENERGY2 and RETURN. In the case of a monopolar output, it would be preferable 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.
[0171] 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.
[0172] 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. The 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.
[0173] 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) in a computer system (especially a systems on a chip (SoC)).
[0174] 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 peripherals such as a graphics processing unit (GPU), Wi-Fi module, or co-processor. An SoC may or may not include built-in memory.
[0175] 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 may 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 separate chips.
[0176] 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 of a computer or controller on an external device that manages the operation of (and connections with) that device.
[0177] Any of the processors or microcontrollers described herein 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 aspect, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. This processor core includes on-chip memory of 256KB of single-cycle flash memory or other non-volatile memory up to 40MHz, a pre-fetch buffer to improve performance beyond 40MHz, 32KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels. More details are available in the product data sheet.
[0178] In one aspect, the processor may include a safety controller, which includes two controller families such as 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 limiting applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity and memory options.
[0179] Modular devices include modules that can be received in a surgical hub (e.g., as described in connection with FIG. 3 and FIG. 9 ) 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 be executed on the modular device itself, on the surgical hub to which the 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 control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, 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, the control algorithm of 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.
[0180] 22 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 multi-function 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, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. 22, 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 for generating signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.
[0181] The generator 1100 is configured to drive a number of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and 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 actuating 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.
[0182] 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 hand piece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in clamp arms 1142a, 1142b and back through a conductor portion of the shaft 1127. The electrodes are coupled to and energized by a bipolar energy source in the generator 1100. The hand piece 1107 includes a trigger 1145 for operating the clamp arms 1142a, 1142b and an energy button 1135 for actuating an energy switch to supply energy to the electrodes in the end effector 1124.
[0183] The generator 1100 is also configured to drive a multifunction surgical instrument 1108. The multifunction surgical instrument 1108 includes a hand piece 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 hand piece 1109 includes a trigger 1147 that operates the clamp arm 1146, and a combination of toggle buttons 1137a, 1137b, 1137c to energize and drive 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.
[0184] 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 types of different surgical devices including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function 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, but in another configuration, the generator 1100 may be integrally formed with any one of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As mentioned above, the generator 1100 includes an input device 1110 located on a 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 the generator for digitally generating an electrical signal waveform and a surgical instrument are described in U.S. Patent Application Publication No. US-2017-0086914-A1, which is incorporated herein by reference in its entirety.
[0185] Situational Awareness Although an "intelligent" device that includes a control algorithm that responds to sensed data may be an improvement over a "dumb" device that operates without considering the sensed data, some sensed data may be incomplete or inconclusive when considered alone, i.e., without the context of the type of surgical procedure being performed or the type of tissue being operated on. Without knowing the procedure context (e.g., knowing the type of tissue being operated on or the type of procedure being performed), the control algorithm may inaccurately or suboptimally control the modular device when given sensed data that does not include the specific context. For example, the optimal method for a control algorithm to control a surgical instrument in response to a particular sensed parameter may vary depending on the particular type of tissue being operated on. This is due to the fact that different tissue types have different properties (e.g., resistance to tearing) and therefore respond differently to actions taken by a surgical instrument. Thus, it may be desirable for the surgical instrument to take different actions even when the same measurement is sensed for a particular parameter. As one specific example, the optimal way for a surgical stapling and severing instrument to control its end effector in response to sensing an unexpectedly high force to close depends on whether the type of tissue is susceptible to tearing or resistant to this. For tissue that is susceptible to tearing, such as lung tissue, the instrument's control algorithm optimally ramps down the motor in response to an unexpectedly high force to close to avoid tearing the tissue. For tissue that is resistant to tearing, such as stomach tissue, the instrument's control algorithm optimally ramps up the motor in response to an unexpectedly high force to close to ensure that the end effector is properly clamped to the tissue. Without knowing whether lung tissue or stomach tissue is being clamped, the control algorithm may make suboptimal decisions.
[0186] One solution utilizes a surgical hub that includes a system configured to derive information about the surgical procedure being performed based on data received from various data sources and then control the paired modular devices accordingly. In other words, the surgical hub is configured to infer information about the surgical procedure from the received data and then control the modular devices paired with the surgical hub based on the inferred context of the surgical procedure. FIG. 23 shows a diagram of a situation-aware surgical system 5100 according to at least one aspect of the present disclosure. In some examples, the data sources 5126 include, for example, the modular devices 5102 (which may include sensors configured to detect parameters associated with the patient and / or the modular devices themselves), a database 5122 (e.g., an EMR database including 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 about the surgical procedure from the data based, for example, on a particular combination of data received or a particular order in which 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 subject 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 be referred to as "situational awareness." In one example, the surgical hub 5104 may incorporate a situational awareness system that is hardware and / or programming associated with the surgical hub 5104 that derives contextual information related to the surgical procedure from the received data.
[0187] The situational awareness system of the surgical hub 5104 may be configured to derive contextual information from data received from the data sources 5126 in a variety of different ways. In one example, the situational awareness system includes 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 monitors 5124, and / or the modular devices 5102) with corresponding contextual information for the surgical procedure. In other words, the machine learning system may be trained to accurately derive contextual information for the surgical procedure from the inputs provided. In another example, the situational awareness system may include a lookup table that stores pre-characterized contextual information for the surgical procedure in correspondence with one or more inputs (or ranges of inputs) that correspond to the contextual information. In response to a query with one or more inputs, the lookup table may return corresponding contextual information for the situational awareness system to control the modular devices 5102. In one example, the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments of one or more modular devices 5102. In another example, the situational awareness system includes an additional machine learning system, lookup table, or other such system that generates or looks up one or more control adjustments of one or more modular devices 5102 when provided with the contextual information as an input.
[0188] A surgical hub 5104 incorporating a situational awareness system provides many benefits to the surgical system 5100. One benefit includes improved interpretation of sensed and collected data, which improves processing accuracy and / or use of the data during the course of a surgical procedure. To return to the previous example, the situationally aware surgical hub 5104 can determine what type of tissue is being operated on, and thus, when an unexpectedly high force is detected to close the end effector of the surgical instrument, the situationally aware surgical hub 5104 can properly ramp up or down the motors of the surgical instrument to match the type of tissue.
[0189] As another example, the type of tissue being operated on may 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 may estimate 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 thoracic surgery) or stomach (in the case of abdominal surgery). The surgical hub 5104 may then adjust the compression speed and load threshold of the surgical stapling and severing instrument appropriately for the type of tissue.
[0190] As yet another example, the type of body cavity being operated on during an insufflation procedure may affect the functionality of the smoke evacuator. The context-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. Since the procedure type is generally performed within a particular body cavity, the surgical hub 5104 can control the motor speed of the smoke evacuator appropriately for the body cavity being operated on. Thus, the context-aware surgical hub 5104 can provide a consistent amount of smoke evacuation for both thoracic and abdominal procedures.
[0191] As yet another example, the type of procedure being performed may affect the optimal energy level at which an ultrasonic surgical instrument or a radio frequency (RF) electrosurgical instrument operates. For example, an arthroscopic procedure requires a higher energy level because the end effector of the ultrasonic surgical instrument or RF electrosurgical instrument is submerged in fluid. The context-aware surgical hub 5104 may determine if the surgical procedure is an arthroscopic procedure. The surgical hub 5104 may 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 may affect the optimal energy level at which an ultrasonic surgical instrument or a RF electrosurgical instrument operates. The context-aware surgical hub 5104 may determine what 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 expected tissue profile for the surgical procedure. Additionally, the context-aware surgical hub 5104 may be configured to adjust the energy levels of the ultrasonic surgical instrument or RF electrosurgical instrument throughout the course of a surgical procedure, rather than just by procedure. The context-aware surgical hub 5104 can determine which step of the surgical procedure is being performed or will be performed subsequently, and then update the generator and / or the control algorithms of the ultrasonic surgical instrument or RF electrosurgical instrument to set the energy levels to a value appropriate for the expected tissue type according to the step of the surgical procedure.
[0192] As yet another example, the surgical hub 5104 may draw data from additional data sources 5126 to improve conclusions the surgical hub 5104 draws from one data source 5126. The context-aware surgical hub 5104 may augment data received from the modular device 5102 with contextual information built about the surgical procedure from other data sources 5126. For example, the context-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 not be conclusive. 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 about the integrity of a staple line or tissue weld. In other words, the situational awareness system of the surgical hub 5104 can take into account the physiological measurement data to provide additional context when analyzing the visualization data. The additional context can be useful in cases where the visualization data may not be conclusive or incomplete by itself.
[0193] Another benefit includes proactively and automatically controlling the paired modular devices 5102 according to the particular step of the surgical procedure being performed to reduce the number of times a medical professional is required to interact with or control the surgical system 5100 during the course of a surgical procedure. For example, a situationally aware surgical hub 5104 can proactively activate a generator to which an RF electrosurgical instrument is connected if it determines that a subsequent step of the procedure requires the use of the instrument. By proactively activating the energy source, the instrument can be ready for use as soon as the preceding step of the procedure is completed.
[0194] As another example, the context-aware surgical hub 5104 can determine whether a current or subsequent step in a surgical procedure requires a different view or degree of magnification on the display according to the feature(s) at the surgical site that the surgeon is expected to need to see. The surgical hub 5104 can then proactively modify the displayed view (e.g., provided by a medical imaging device for the visualization system 108) appropriately, so that the display automatically adjusts throughout the surgical procedure.
[0195] As yet another example, the context-aware surgical hub 5104 can determine which step of a surgical procedure is being performed or will be performed later, and whether specific data or comparisons between data 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.
[0196] Another benefit includes checking for errors during the setup or course of a surgical procedure. For example, the context-aware surgical hub 5104 can determine whether the surgical site is properly or optimally set up for the surgical procedure being performed. The surgical hub 5104 can be configured to determine the type of surgical procedure being performed, retrieve (e.g., from memory) the corresponding checklist, product location, or setup needs, and then compare the current surgical site layout to a standard layout for the type of surgical procedure that the surgical hub 5104 has determined is being performed. In one example, the surgical hub 5104 can be configured to compare a list of items for the procedure (e.g., scanned by a suitable scanner) and / or a 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 can be configured to provide a warning indicating that a particular modular device 5102, patient monitor 5124, and / or other surgical item is missing. In one example, the surgical hub 5104 can be configured to determine the relative distance or position of the modular devices 5102 and the patient monitoring devices 5124, for example, by proximity sensors. The surgical hub 5104 can compare the relative positions of the devices to a recommended or expected layout for a particular surgical procedure. If a discontinuity exists between the layouts, the surgical hub 5104 can be configured to provide a warning indicating that the current layout of the surgical procedure deviates from the recommended layout.
[0197] As another example, the context-aware surgical hub 5104 can determine whether a surgeon (or other medical personnel) is making an error or otherwise deviating from a desired course of action during the course of 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 a memory) a corresponding list of steps or sequences of equipment usage, and then compare the steps being performed, or equipment being used, during the course of 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 one example, the surgical hub 5104 may be configured to provide a warning indicating that an unexpected action is being performed or an unexpected device is being utilized at a particular step in the surgical procedure.
[0198] Overall, the situational awareness system for the surgical hub 5104 improves the outcome of surgical procedures by adjusting surgical instruments (and other modular devices 5102) for the specific context of each surgical procedure (e.g., adjusting for different tissue types) and validating actions during a surgical procedure. The situational awareness system also improves the efficiency of the surgeon in performing a surgical procedure by automatically suggesting next steps, providing data, and adjusting displays and other modular devices 5102 within the surgical site according to the specific context of the procedure.
[0199] Modular Energy Systems Due to the amount of equipment required to perform surgical procedures, ORs worldwide have become a tangled web of cords, equipment, and personnel. Surgical capital equipment tends to be a major source of this problem, as most surgical capital equipment performs a single specialized task. Due to their specialized nature, surgeons are required to utilize multiple different types of equipment in the course of a single surgical procedure, which may force ORs to stockpile two or even more pieces of surgical capital equipment, such as energy generators. Each of these pieces of surgical capital equipment must be individually plugged into a power source and may be connected to one or more other devices that are passed between OR personnel, creating angles of cords that must be navigated. Another problem faced in modern ORs is that each of these specialized pieces of surgical capital equipment has its own user interface and must be controlled independently from other equipment in the OR. This makes it complicated to properly control multiple different pieces of equipment connected to each other, and forces users to be trained on and memorize different types of user interfaces (which may further change based on the task or surgical procedure being performed, in addition to changing between each of the capital equipment). This cumbersome and complicated process may require the need for even more individuals to be present in the OR and can create hazards if multiple devices are not properly controlled with each other. Thus, consolidating surgical capital equipment technology into a single system that can flexibly accommodate the needs of the surgeon to reduce the footprint of surgical capital equipment in the OR would simplify the user experience, reduce clutter in the OR, and prevent the difficulties and hazards associated with simultaneously controlling multiple pieces of capital equipment. Furthermore, making such a system extensible or customizable would allow new technology to be conveniently incorporated into existing surgical systems, eliminating the need to replace the entire surgical system or require OR personnel to learn new user interfaces or equipment controls with each new technology.
[0200] As described in FIGS. 1-11 , the surgical hub 106 can be configured to interchangeably receive a variety of modules that can interface with a surgical device (e.g., a surgical instrument or smoke evacuator) or provide a variety of other functions (e.g., communications). In one aspect, the surgical hub 106 can be embodied as a modular energy system 2000 as shown in connection with FIGS. 24-30 . The modular energy system 2000 can include a variety of different modules 2001 that can be connected to one another in a stacked configuration. In one aspect, the modules 2001 can be physically and communicatively coupled when stacked or otherwise connected together into a single assembly. Additionally, the modules 2001 can be interchangeably connectable to one another in different combinations or arrangements. In one aspect, each of the modules 2001 can 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 the header module 2002, can be configured to function as the top module in a stack, for example). In another aspect, the modular energy system 2000 can include a housing configured to receive and hold the module 2001 as shown in Figures 3 and 4. The modular energy system 2000 can also include a variety of different components or accessories that can also be connected to or otherwise associated with the module 2001. In another aspect, the modular energy system 2000 can be embodied as a generator module 140, 240 of the surgical hub 106 (Figures 3 and 10). In yet another aspect, the modular energy system 2000 can 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.
[0201] The modular energy system 2000 can be assembled from a variety of different modules 2001, some examples of which are shown in FIG. 24. Each of the different types of modules 2001 can provide different functions, thereby allowing the modular energy system 2000 to be assembled in different configurations to customize the function and capability of the modular energy system 2000 by customizing the modules 2001 included in each modular energy system 2000. The modules 2001 of the modular energy system 2000 can include, for example, a header module 2002 (which may 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 top module in the modular energy system stack and thus may lack connectors along its top surface. In another aspect, the header module 2002 can be configured to be positioned at the bottom or lowest module in the modular energy system stack and therefore may lack a connector along its bottom surface. In yet another aspect, the header module 2002 can be configured to be positioned at an intermediate position in the modular energy system stack and therefore may include connectors along both its bottom and top surfaces. The header module 2002 can be configured to control system-wide settings of each module 2001 and connected components through physical controls 2011 thereon and / or a graphical user interface (GUI) 2008 rendered on the display screen 2006. Such settings can include activation of the modular energy system 2000, alarm volume, foot switch settings, settings icons, user interface appearance or configuration, surgeon profile logged into the modular energy system 2000, and / or type of surgical procedure to be 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, which may also be referred to as a generator module 140, 240 (FIGS. 3 and 10), may be configured to generate one or more energy modalities for driving an electrosurgical and / or ultrasonic surgical instrument, such as described above in connection with the generator 900 shown in FIG. 21. 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 may be configured to interface with a visualization device (i.e., a scope), thus providing increased visualization capabilities.
[0202] The modular energy system 2000 can further include various accessories 2029 connectable to the module 2001 or configured to function in conjunction with the modular energy system 2000 to control the functionality of the module 2001. The accessories 2029 can include, for example, a single pedal foot switch 2032, a dual pedal foot switch 2034, and a cart 2030 for supporting the modular energy system 2000 thereon. The foot switches 2032, 2034 can be configured, for example, to control the activation or functionality of a particular energy modality output by the energy module 2004.
[0203] By utilizing modular components, the illustrated modular energy system 2000 provides a surgical platform that grows with technology availability and is customizable to the needs of the facility and / or surgeon. Additionally, the modular energy system 2000 supports combination devices (e.g., dual electrosurgical and ultrasonic energy generators) and software-driven algorithms for customized tissue effects. Still further, the surgical system architecture reduces the primary footprint by combining multiple technologies critical to the procedure into a single system.
[0204] The various modular components available in association with the modular energy system 2000 can include a monopolar energy generator, a bipolar energy generator, a dual electrosurgical / ultrasonic energy generator, a display screen, as well as various other modules and / or other components, some of which are also described above in association with FIGS. 1-11.
[0205] 25A , the header module 2002, in some aspects, may include a display screen 2006 that renders a GUI 2008 for relaying information regarding the modules 2001 connected to the header module 2002. In some aspects, the GUI 2008 of the display screen 2006 may provide a unified control point for all of the modules 2001 that make up a particular configuration of the modular energy system 2000. Various aspects of the GUI 2008 are described in more detail below in connection with FIG. 30. In alternative aspects, the header module 2002 may lack a display screen 2006, or the display screen 2006 may be removably connected to the housing 2010 of the header module 2002. In such aspects, 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 coupled 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 coupled to a mobile display that may be transported or secured to a surgical staff member for viewing. In yet another example, the modular energy system 2000 may be communicatively coupled to a surgical hub 2100, or another computer system that may include a display 2104, as shown in FIG. 29. In aspects 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 entire modular energy system 2000, or to one or more of the modules 2001 therein, such that the user interface may display information from the module 2001 to which it is connected.
[0206] 25A, the energy module 2004 can include a port assembly 2012 that includes a number of different ports configured to deliver different energy modalities to a corresponding surgical instrument connectable thereto. In the particular embodiment shown in FIGS. 24-30, the port assembly 2012 includes a bipolar port 2014, a first monopolar port 2016a, a second monopolar port 2018b, a neutral electrode 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 discussed above, the modular energy system 2000 can be assembled into different configurations. Additionally, different configurations of the modular energy system 2000 may also be available for different surgical procedure types and / or different tasks. For example, FIGS. 25A and 25B 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 surgical procedures, for example.
[0208] FIG. 26A illustrates 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 the 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, and the like. Such a configuration may be particularly suitable for complex laparoscopic and open surgical procedures. FIG. 26B illustrates 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] 27 illustrates 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 disclosed module that complements or extends the functionality of a previously disclosed module (such as the energy module 2004).
[0210] 28 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. 25A-29 and described above are provided merely to illustrate various concepts of the modular energy system 2000 and should not be construed as limiting the modular energy system 2000 to the particular 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. 29. Such an external system may include a display screen 2104 for displaying a visual feed from an endoscope (or camera or other 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 operations between multiple modular energy systems 2000 and / or other surgical systems (e.g., visualization systems 108 and / or robotic systems 110, as described in connection with FIGS. 1 and 2).
[0212] 30, 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 module(s) 2001 connected to the header module 2002. In some aspects, different portions or regions of the GUI 2008 can correspond to a particular module 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 module 2001 that is removed. 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. 30 , 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 2056a corresponding to the bipolar port 2014, a second widget 2056b corresponding to the first monopolar port 2016a, a third widget 2056c corresponding to the second monopolar port 2016b, and a fourth widget 2056d corresponding to the combination energy port 2020. Each of these widgets 2056a-d provides data associated with the widget's corresponding port of 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 the respective port of 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, and to change the operating mode of a surgical instrument connected to their respective ports (e.g., changing a surgical instrument from a first power level to a second power level and / or changing a monopolar surgical instrument from a “spray” mode to a “blend” mode), etc.
[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 the 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 and may eliminate the need to individually activate and deactivate each individual module 2001 from which the modular energy system 2000 is constructed.
[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 a 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 ports to a 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 the 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 assemblies 2015 of each port to display a color corresponding to the color representation of the port on the GUI 2008.
[0216] FIG. 31 is a block diagram of a stand-alone hub configuration of a modular energy system 3000 according to at least one embodiment of the present disclosure, and FIG. 32 is a block diagram of a hub configuration of a modular energy system 3000 integrated with a surgical control system 3010 according to at least one embodiment of the present disclosure. As shown in FIGS. 31 and 32, the modular energy system 3000 may be utilized as a stand-alone unit or integrated with a surgical control system 3010 that controls and / or receives data from one or more surgical hub units. In the example shown in FIGS. 31 and 32, the integrated header / UI 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 the UI module may be provided as separate components communicatively coupled via a data bus 3008.
[0217] As shown in FIG. 31 , an example of a 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 / UI module 3002 and the energy module 3004 through a power interface 3006 and a data interface 3008. For example, the integrated header / UI module 3002 can send 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] In FIG. 32, the surgical hub configuration includes a modular energy system 3000 integrated with a control system 3010 and an interface system 3022 for managing 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 / UI module 3002, a first energy module 3004, and a second energy module 3012. In one embodiment, a data transmission path is established between the system control unit 3024 of the control system 3010 and the second energy module 3012 (through the first energy module 3004) and the header / UI module 3002 (through the data interface 3008). Additionally, a power path extends through the first energy module 3004 through the power interface 3006 between the integrated header / UI module 3002 and the second energy module 3012. In other words, in one aspect, the first energy module 3004 is configured to act as a power and data interface between the second energy module 3012 and the integrated header / UI 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 to the energy modules 3004, 3012 already connected to the integrated header / UI module 3002 without requiring dedicated power and energy interfaces in the integrated header / UI 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 the system interface 3022 via an energy interface 3026 and an appliance communication interface 3028. The system interface 3022 is coupled to the first energy module 3004 via a first energy interface 3014 and a first appliance communication interface 3016. The system interface 3022 is coupled to the 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 can be connected to the hub and configured to generate electrosurgical energy (e.g., bipolar or monopolar), ultrasonic energy, or combinations thereof (referred to herein as "advanced energy" modules) for various energy surgical instruments. In general, the energy modules 3004, 3012 include a hardware / software interface, an ultrasonic controller, an advanced energy RF controller, a bipolar RF controller, and a control algorithm executed by a controller that receives output 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] 33-35 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. 33-35 show various views (e.g., circuit or control diagrams) of a hub module. The modular energy system 3000 includes a plurality of energy modules 3004 (FIG. 34), 3012 (FIG. 35), a header module 3150 (FIG. 35), a UI module 3030 (FIG. 33), and a communication module 3032 (FIG. 33), according to at least one embodiment of the present disclosure. The UI module 3030 includes a touch screen 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 so that it can be operated independently of the header module 3150. 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 to communicate 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] 33, a block diagram of a user interface (UI) module 3030 coupled to a communication 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. 35) and communicatively coupled to the header module 3150 via the communication 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 also to perform other centralized UI functions 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 touch screen 3046, a liquid crystal display (LCD) 3048, and an audio output 3052 (e.g., speaker, buzzer). The UI processor 3040 is configured to receive touch screen input from a touch controller 3044 coupled between the touch screen 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 communication 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 provided 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 source devices to destination devices.
[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 illustrated example, 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 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. 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 that is disposed on or integral with the header module. FIG. 35 illustrates a standalone header module 3150 to which the UI module 3030 can be attached. FIGS. 31, 32, and 36 illustrate an integrated header / UI module 3002. Returning now to FIG. 33, 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. 34, a block diagram of an energy module 3004 is shown according to at least one embodiment of the present disclosure. The communication module 3032 (FIG. 33) is coupled to the energy module 3004 via a second pass-through hub connector 3038 of the communication 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 a second energy module 3012 shown in FIG. 35, via a second pass-through hub connector 3078. Returning to FIG. 34, 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 through 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 a 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 wideband amplifier 3086, which in one embodiment is a linear class H amplifier capable of generating any waveform at low total harmonic distortion (THD) levels and can drive harmonic transducers. The ultrasonic wideband amplifier 3086 is fed by a step-down adjustable regulator 3084 to maximize efficiency and is controlled by a controller 3082, which can be implemented as a digital signal processor (DSP) via a direct digital synthesizer (DDS). The DDS can be embedded in the 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 (DAC) 3106. 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 routed 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 are 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 any waveform and driving an RF load at a range of output frequencies. The wideband RF power amplifier 3108 is fed by an adjustable step-down 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 a 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. The RF selection relay 3124 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 to an RF power transformer 3110 coupled to an RF output portion of a bipolar RF energy receiver 3118 through an RF selection relay 3124. Bipolar RF voltage (V) and current (I) feedback (FB) signals that may be used to calculate RF impedance are fed back to the controller 3082 through an 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 A / D 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 the 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 a mitigation of any single fault condition. In one aspect, the RF selection relay 3124 is configured to be in a first state, and 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 the RF power transformer 3128 of the 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, 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 the wideband RF power amplifier 3108 may also be fed to a wideband RF power transformer 3128 of the RF monopolar receiver 3136 through the RF selection relay 3124. 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 the RF VI FB transformer 3130. The RF voltage and current feedback signals are returned to the controller 3082 through the A / D 3126. 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.
[0233] The output of the wideband RF power amplifier 3108 may also be provided to a 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 that 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 A / D 3104.
[0234] FIG. 35 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. 34 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. 35. 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. 37, 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 can include a header processor 3158 configured to manage power button functionality 3166, software upgrades through an upgrade USB module 3162, system time management, and a gateway to an external network (i.e., hospital or cloud) via an Ethernet module 3164 that 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 coupled to a mains power input module 3154.
[0236] FIG. 36 is a block diagram of a header / user interface (UI) module 3002 for a hub, such as the header module shown in FIG. 33, according to at least one embodiment of the present disclosure. The header / UI module 3002 includes a header power module 3172, a header radio module 3174, a header USB 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 foot switch module 3186. These functional modules interact to provide the header / UI 3002 functionality. A header / UI 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 / UI controller 3170 and an isolation communication module 3234 coupled to the header foot switch module 3186. A security coprocessor 3188 is coupled to the header / UI controller 3170.
[0237] The 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 provided from the OTS PSU 3192 over a low voltage power bus 3198 to the header / UI module 3002 and other modules. High voltage DC (e.g., 60V) is provided from the OTS PSU 3192 over a high voltage bus 3200 to the header / UI module 3002. High voltage DC supplies the DC / DC converter module 3196 as well as the isolated DC / DC converter module 3236. A standby processor 3204 in the header / standby module 3184 provides a PSU / enable signal 3202 to the 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 / UI controller 3170. The Bluetooth module 3214 is used to connect devices without using cables, and the WiFi 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 a USB port 3216 coupled to the header / UI controller 3170. The USB module 3176 provides a standard cable connection interface for modules and other electronic devices via short-range digital data communication. The USB module 3176 allows modules with USB devices to be connected to each other via a USB cable to 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 a 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 touch screen 3220 user interface configured to control one control or module connected to the header module 3002 in the modular energy system 3000. The touch screen 3220 can be used to maintain a single access point 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 attached to 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 on the LCD display coloring and corresponding port lighting. 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 way, the user can quickly assess which instrument the instruction refers to and the nature of the instruction. Furthermore, the instruction regarding the instrument can be represented by a change in color of the LED lights lined up around its corresponding port and the coloring of that module. Furthermore, the alignment of the message on the screen and the hardware / software port can also serve to communicate that an action must be taken on the hardware, not on the interface. In various aspects, all other instruments can be used while an alarm is occurring on another instrument. This allows the user to quickly assess which instrument the 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., which may be arranged from general to detailed). After each selection is made, the modular energy system 3000 represents the next level until all selections are completed. These settings may be managed locally and transferred via secondary means (such as a USB thumb drive). Alternatively, the settings may be managed via a portal and automatically distributed to all connected systems in the hospital.
[0245] The procedure options may include, for example, a list of factory pre-configured options categorized by specialist, procedure, and type of procedure. Once the user selection is completed, the header module may be configured to set any connected instruments to the pre-configured settings for that particular procedure. The procedure options may also include, for example, a list of surgeons, then specialists, procedures, and types. Once the user completes the selection, the system may 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 with / displaying instrument specific controls to allow the user to increase or decrease the intensity of its output, toggle specific functions, pair it with a system accessory 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 top right corner of the instrument settings panel or tap anywhere outside of the panel, and the panel will shrink 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 illustrated example, 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 checking if 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 number of analog footswitch ports 3254, 3256, 3258 through a number of corresponding presence / ID and switch state modules 3242, 3244, 3246, respectively. The controller 3240 is also coupled to an auxiliary port 3260 via a presence / ID and switch state 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 to control 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 hand activated, the instrument panel appears with a warning icon next to the footswitch icon. The instrument settings may be grayed out, for example, since the instrument cannot be activated without using a footswitch.
[0252] When a user plugs into any one of the analog footswitch ports 3254, 3256, 3258 in a footswitch, a popup appears indicating that 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, which allows for further assignment of single or dual pedal footswitches to appropriate instruments. If a user wishes to 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 top 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 that shows 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 instruments that do not involve hand 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 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 the 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, the ports may be colored when they are active (e.g., yellow for monopolar tissue coagulation, blue for bipolar tissue cutting, blue for bipolar tissue cutting, and warm white for advanced energy tissue cutting). Additionally, the displayed color matches the color of the light plumbing surrounding the port. The coloring may further indicate that while the instrument is active, the user cannot change the settings of 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 / UI 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 / UI module 3002 may be configured to display a menu on the LCD display 3224 to control 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 / UI 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 embodiment, the header / UI module 3002 may be configured to prevent settings from being changed via a displayed menu when a connected instrument is active. The user interface screen may include, for example, an area (e.g., the top left corner) reserved to indicate instrument activation while the settings menu is open. In one aspect, a user opens a bipolar setting while monopolar coagulation is active. In one aspect, the settings menu may then be used once activation is complete. In one aspect, the header / UI module 3002 may be configured to not overlay any menu or other information over an area dedicated to showing key instrument information in order to maintain display of key information.
[0259] In one aspect, the header / UI module 3002 may be configured to show 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 the 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 / UI 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 / UI module 3002 may be configured to display a settings menu appropriate for the type or application of the surgical instrument(s) 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 / UI module 3002 may be configured to display different modes available for bipolar cutting, monopolar cutting, and monopolar coagulation applications.
[0261] In one aspect, the header / UI module 3002 may be configured to present a user interface screen on the LCD display 3224 to display preselected settings. In one aspect, the header / UI module 3002 may be configured to receive a selection of instrument / device settings such that the modular energy system 3000 is prepared before a patient enters the operating room. In one aspect, a user can simply click on a port and then change the settings for that port. In the illustrated aspect, the selected port appears faded to indicate that the settings have been set, but there is no instrument plugged into the port.
[0262] FIG. 37 is a block diagram of an energy module 3270 of a hub, such as the energy modules shown in FIGS. 31, 32, 34, and 35, according to at least one embodiment of the disclosure. The energy module 3270 is configured to couple to header modules, header / UI modules, and other energy modules via a first pass-through hub connector 3272, 3276 and a second pass-through hub connector 3272, 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 through 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 the energy module 3270 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.
[0264] In one embodiment, the energy module 3270 can include an ultrasonic wideband amplifier 3086, which in one embodiment is a linear class H amplifier capable of generating any waveform at low total harmonic distortion (THD) levels and can drive a harmonic transducer. The ultrasonic wideband amplifier 3086 is fed by a step-down adjustable regulator 3084 to maximize efficiency and is controlled by a controller 3082, which can be implemented as a digital signal processor (DSP) via a direct digital synthesiser (DDS). The DDS can 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 routed to the controller 3082 through an analog multiplexer 3280 and a dual analog to digital converter 3278 (A / D). In one aspect, the dual A / D 3278 has a sampling rate of 80 MSPS. 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.
[0265] In one aspect, the energy module 3270 can include, among other things, a plurality of wideband RF power amplifiers 3108, 3286, 3288, each of which in one aspect is a linear class H amplifier capable of generating any waveform and driving an RF load at a range of output frequencies. Each of the wideband RF power amplifiers 3108, 3286, 3288 is fed by an adjustable step-down 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 an RF output signal from the adjustable step-down regulator 3107. Additionally, unlike the energy modules 3004, 3012 shown and described in FIG. 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 the adjustable step-down regulator 3107 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 fed to an RF power transformer 3090 coupled to an RF output section of the advanced energy receiving section 3100. 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 an input section of the advanced energy receiving section 3100 via an RF VI FB transformer 3094. The RF voltage and current feedback signals are routed to the controller 3082 through the RF VI FB transformer 3094, which is coupled to a dual A / D 3282, which is coupled to an analog multiplexer 3284 and the controller 3082. In one aspect, the dual A / D 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. Monopolar 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 routed to the controller 3082 through an analog multiplexer 3284 and a dual A / D 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 portion of the bipolar RF energy receiver 3118 via an RF VI FB transformer 3114. The RF voltage and current feedback signals are routed to the controller 3082 through an analog multiplexer 3280 and a dual A / D 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 receptacle 3292. Power is provided to NE receptacle 3292 from monopolar receptacle 3136.
[0271] 31-37, the modular energy system 3000 can be configured to detect the presence of an instrument 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 prevents the need to allocate a dedicated presence pin on the MTD connector to a single purpose, instead allowing multi-purpose functionality of the MTD signal pins 6-9 while continuously monitoring the presence of an instrument.
[0272] In one aspect, referring to Figures 31-37, the modules of the modular energy system 3000 can include an optical link that allows high speed communication (10-50 Mb / sec) across the patient isolation boundary. This link carries device communications, mitigation signals (such as watchdog), and low bandwidth runtime data. In some aspects, the optical link does not include real-time sampling data that can be done on the non-isolated side.
[0273] 31-37, a module of the modular energy system 3000 can include a multi-function circuit block that can (i) read the presence resistance via an A / D and current source, (ii) communicate with legacy instruments via a Hand Switch Q protocol, (iii) communicate with instruments via a 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. 31-37, the modules of the modular energy system 3000 can include an amplifier pulse / stim / aux DC amplifier. This is a flexible use amplifier based on a full bridge output and incorporates functional isolation. This allows its differential output to be referenced to any output connection on the applied part (except for the monopolar active electrode in some embodiments). 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, FET drive, etc. The output voltage and current are sensed with functionally isolated voltage and current feedback to provide accurate impedance and power measurements to the 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] Regional Location Tracking of Modular Energy System Components In one aspect, a surgical platform is provided. The surgical platform may include one or more components and a regional location tracking module. The regional location tracking module may be configured to interface with an external device, receive external device geographic location data from the external device, and implement geographic location specific functionality based on the geographic location data received from the external device.
[0276] In another aspect, a method is provided for determining a location of one or more components of a surgical platform. The method may include collecting, by an application executing on a user device, geographic location data of the user device from the user device in response to detecting that the application has been logged in. The method may further include receiving, by the application, a request for an activation code identifying the geographic location data.
[0277] In another aspect, a method is provided for upgrading software logic for one or more components of a surgical platform via an application on a user device. The method may include collecting geographic location data from the user device and providing an activation code that identifies the geographic location data of the user device. The method may further include determining whether the geographic location data of the user device matches geographic location data pre-stored in the one or more components, and rejecting the software logic upgrade in response to determining that the geographic location data of the user device does not match the geographic location data pre-stored in the one or more components.
[0278] Generally, conventional surgical devices or components (e.g., generators) do not have the ability to identify their location. However, the need or priority of features of a surgical device / component may vary depending on the region / country. For example, some features that are more preferred or necessary in one region (e.g., Japan) may be less preferred or unnecessary in another region (e.g., the United States). In some cases, a surgical device / component provider may want to restrict the use of a surgical device / component (or some features of the device / component) in a particular region due to various factors such as government regulations, regional marketing strategies, etc. Without geographic location information for a surgical device or component, it would be difficult for a surgical device / component provider to provide regionally specific (hardware / software) features for the surgical device / component or to restrict the use of a surgical device / component (or some features of the device / component) in a particular region.
[0279] A GPS receiver can be purchased and installed separately in an existing conventional surgical device / component to track the geographic location of the surgical device / location, but additional costs and labor are required for purchasing and installing the GPS receiver, and the installation process can be cumbersome or difficult. For example, there may not be adequate space inside the existing conventional surgical device / component for installation of the GPS receiver. The GPS receiver can be installed outside the surgical device / component (e.g., on the outer wall of the surgical device / component), but it is difficult to manage the GPS receiver and there is a risk of losing the GPS receiver.
[0280] Aspects of the present disclosure may address the above-identified deficiencies of conventional surgical devices / components. For example, in various aspects, a surgical platform including an energy module, a header module, an extended energy module, a technology module, a visualization module, various modules and other components that can be combined to customize the surgical platform, a surgical system including a communicatively connectable surgical platform, and / or a header module including a user interface as discussed with reference to FIGS. 24-30 according to various aspects of the present disclosure may be configured to have geographic location tracking functionality, such as, for example, a regional location tracking functionality. The regional location tracking functionality may be implemented within the surgical platform components or systems via an application or other software module that can interface with an application or web interface located on a separate device. For example, the application or web interface may be used via a device of a user, such as a sales representative. This would allow for identification of the regional location of the surgical platform system or components based on the GPS location of the device. For example, the user device may establish a connection with the surgical platform components or systems and transmit GPS or other location information (e.g., cellular tower triangulation, etc.) to the surgical platform components or systems. In this way, components or systems of the surgical platform will know what their geographic location is and will be able to implement geographic location specific functionality.
[0281] In some aspects, the installer can log into an application or web interface via a user device. The application / web interface can collect location data from the user device. The installer can request an activation code. The activation code may be provided to the installer via the user device. The activation code may identify a geographic location of a system or component of the surgical platform for storage. The installer can then enter the activation code into a system or component of the surgical platform user interface. The geographic location may be stored on the system or component of the surgical platform.
[0282] In some aspects, the location may be determined by Bluetooth / WiFi communication between a bring your own device (BYOD) and the surgical platform components or systems. The surgical platform components or systems may check the GPS location on the BYOD to confirm the location. In some aspects, the location may be determined by connecting the surgical platform components or systems to a user device / application and periodically checking the location. In some aspects, the location may be determined by embedding a Global System for Mobile Communications (GSM) receiver in the header module to periodically check the location. In some aspects, the location may be determined by region-specific products programmed with a country / region code that sets the country / region of the surgical platform components or systems when they are plugged in.
[0283] Some implementation features may include, for example, requiring re-registration after every software upgrade or a certain period of time, among other implementation features, and / or requiring re-registration between two output verifications, among other implementation features. In some aspects, a user may initiate the software upgrade process via an application / web interface on the user device. The application / web interface may collect location data from the user device and provide a code. The user may enter a software activation code. The surgical platform components or systems may determine whether the location of the user device matches pre-stored location data of the surgical platform components or systems. If there is no match, the software upgrade may be rejected. If there is a match, the software upgrade may be provided to the surgical platform components or systems that match the geographically specific configuration. The surgical platform components or systems are then ready for use.
[0284] Aspects of the regional location tracking of various components or systems of a surgical platform according to the present disclosure may be advantageous because they may provide the ability to identify regional locations of components or systems of a surgical platform while allowing for regionally specific software features for the components or systems of the surgical platform to generators or other components or systems of the surgical platform. Also, the components or systems of the surgical platform may be able to adopt regionally specific instrument feature preferences that can vary as a function of region. Aspects of the present disclosure may also provide a cost-effective way of restricting the use of a surgical system / component (or some features of the system / component) in some regions while allowing the use of the surgical system / component and its features in other regions. Additional features and advantages of the disclosed methods, systems, and devices are described below.
[0285] FIG. 38 shows a high level schematic diagram of a system 20000 according to at least one embodiment of the present disclosure. The system 20000 may include a surgical platform 20010. The surgical platform 20010 may include one or more components 20020A-F. In various embodiments, the one or more components 20020A-F may include an energy module (e.g., a generator), a header module, an extended energy module, a technology module, a visualization module, a combinable module, or any combination thereof. In some embodiments, the energy module (e.g., a generator) may generate a WiFi signal that can power the system. In various embodiments, the surgical platform 20010 may also include a geographic location tracking module 20030, a storage unit / device 20040, and a surgical system 20050.
[0286] In some aspects, the local location tracking module 20030 and / or the storage unit / device 20040 may be part of one or more of the components 20020A-F and / or the surgical system 20050. In other aspects, the local location tracking module 20030 and / or the storage unit / device 20040 may be separate from one or more of the components 20020A-F and / or the surgical system 20050. Similarly, in some aspects, one or more of the components 20020A-F may be part of the surgical system 20050. In other aspects, one or more of the components 20020A-F may be separate from the surgical system 20050. In some aspects, the surgical system 20050 may be similar to the systems described in FIGS. 1, 2, 9, and 22-30. For example, the surgical system 20050 may include a header module including a communicatively connectable surgical platform and / or a user interface.
[0287] The system 20000 may also include an application 20060 and an external device 20070. In some aspects, the application 20060 may be any software application or web interface. The application 20060 may be used via a device of a user representative of the sales. In various aspects, the external device may be a BYOD, including but not limited to a mobile device, computer, laptop, personal computer, tablet computer, or any other type of BYOD. The application 20060 may run / execute on the external device 20070 (and / or on an application server). In some aspects, the application 20060 and the external device 20070 may communicate with the surgical platform 20010 (e.g., the local location tracking module 20030 or other components) via, for example, a wired or wireless channel.
[0288] In various aspects, the surgical platform 20010 (e.g., components 20020A-F, regional location tracking module 20030, etc.) can interface with an external device 20070 and receive geographic location data of the external device 200070 from the external device 20070. The surgical platform 20010 (e.g., components 20020A-F, regional location tracking module 20030, etc.) can implement geographic location specific functionality based on the geographic location data received from the external device 20070. Implementation of geographic location specific functionality can include, but is not limited to, providing or restricting language options (e.g., automatic language selection for Korean in South Korea), certain automatic sequential operations of the surgical device / component, certain functionality of the surgical device / component, certain default settings of the surgical device / component, different maximum / minimum values of output / input allowed in a particular version of the surgical device / component (e.g., minimum / maximum power values) and / or software of the surgical device / component.
[0289] For example, in a country where lung surgery is more frequent than in another, a specific automatic sequential operation option for treating lung tissue may be provided (e.g., an automatic control algorithm that optimally ramps the motor in response to unexpectedly high forces to avoid tearing the tissue). In a country where stomach surgery is more frequent, a specific automatic sequential operation option for treating stomach tissue may be provided (e.g., an automatic control algorithm that optimally ramps the motor in response to unexpectedly large closing forces to ensure that the end effector is properly secured to the tissue). Additionally, maximum / minimum values for output / input of surgical devices / components (e.g., minimum / maximum power values) and / or availability of specific versions of software for surgical devices / components may vary by region / country.
[0290] In various aspects, the surgical platform 20010 (e.g., components 20020A-F, geographic location tracking module 20030, etc.) may determine the geographic location of one or more components 20020A-F based on the geographic location data received from the external device 20070. For example, the surgical platform 20010 may assume or consider that a geographic location in the geographic location data received from the external device 20070 refers to the geographic location of one or more components 20020A-F.
[0291] In various aspects, the surgical platform 20010 (e.g., components 20020A-F, regional location tracking module 20030, etc.) may determine the geographic location of one or more components 20020A-F by Bluetooth or WiFi communication between the external device 20070 and the surgical platform 20010. When the regional location tracking module 20030 / one or more components 20020A-F are connected to the external device 20070 via a Bluetooth or WiFi channel, the regional location tracking module 20030 / one or more components 20020A-F may receive or collect location information from the Bluetooth / WiFi device / application. For example, when the external device establishes a connection with a component or system of the surgical platform, it may transmit GPS or other location information (e.g., cellular tower triangulation, etc.) to the component or system of the surgical platform. In various aspects, some of the steps performed by the surgical platform may be performed by the application 20060 on behalf of the surgical platform.
[0292] In various aspects, the surgical platform 20010 (e.g., components 20020A-F, geographic location tracking module 20030, etc.) can verify a GPS location on the external device 20070 to verify geographic location data received from the external device 20070. In some aspects, the geographic location of one or more components 20020A-F may be determined by connecting one or more components 20020A-F to the external device 20070. For example, the geographic location of one or more components 20020A-F can be determined by physically connecting one or more components 20020A-F to the external device 20070 via a wired channel. In other examples, the geographic location of one or more components 20020A-F can be determined by connecting one or more components 20020A-F to the external device 20070 via a wireless channel. Examples of wireless channels / connections may include RFID (read only or read / write), Bluetooth, Zigbee, WiFi, IR, or any other suitable wireless protocol.
[0293] In some aspects, the surgical platform 20010 (e.g., components 20020A-F, regional location tracking module 20030, etc.) may periodically (e.g., hourly, daily, monthly, quarterly, yearly, etc.) check the geographic location data. For example, the regional location tracking module 20030 or components 20020A-F may periodically (e.g., hourly, daily, monthly, quarterly, yearly, etc.) receive geographic location data from the external device 20070 and check the received geographic location data each time the geographic location data is received from the external device 20070.
[0294] In some aspects, the surgical platform 20010 may further include a GSM receiver. The GSM receiver may be embedded in one or more of the components 20020A-F (e.g., a header module). In some aspects, the regional location tracking module 20030 or the components 20020A-F may use the GSM receiver to determine the geographic location of one or more of the components 20020A-F. The regional location tracking module 20030 or the components 20020A-F may use the GSM receiver to periodically check the geographic location of one or more of the components 20020A-F.
[0295] In various aspects, the geographic location of one or more of the components 20020A-F may be determined by using a region-specific product programmed with a region code. For example, the region code may set the geographic location of one or more of the components 20020A-F when the region-specific product is plugged into the one or more of the components 20020A-F.
[0296] The surgical platform 20010 may further include a processor. The processor may be any single-core or multi-core processor, such as that known by Texas Instruments under the trademark ARM Cortex. In one embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. The processor core includes on-chip memory of 256KB of single-cycle flash memory or other non-volatile memory up to 40MHz, a pre-fetch buffer to improve performance above 40MHz, 32KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2KB 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.
[0297] The surgical platform 20010 may also include system memory. System memory includes 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 the 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. In addition, RAM is available in many forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), SyncLink DRAM (SLDRAM), and direct RAM (DRRAM).
[0298] The surgical platform 20010 may also include removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage devices include, but are 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 devices 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 disk ROM drives (CD-ROM), compact disk recordable drives (CD-R drives), compact disk rewriteable drives (CD-RW drives), or digital versatile disk ROM drives (DVD-ROM). Removable or non-removable interfaces may be used to facilitate connection of the disk storage devices to the system bus.
[0299] It should be appreciated that the surgical platform may include software that acts as an intermediary between users and the basic computer resources described in the preferred operating environment. Such software may include an operating system. The operating system, which may be stored on disk storage, functions to control and allocate resources of the computer system in the surgical platform. System applications 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 appreciated that the various components described herein may be implemented with various operating systems or combinations of operating systems.
[0300] 39 is a logic diagram of a process 20100 illustrating a control program or logic configuration for determining a geographic location of one or more components of a surgical platform, in accordance with at least one embodiment of the present disclosure. Although the exemplary process 20100 is described with reference to the logic diagram shown in FIG. 39, it will be understood that many other ways of performing acts associated with the method may be used. For example, the order of some of the blocks may be changed, certain blocks may be combined with other blocks, and some of the described blocks are optional.
[0301] In the illustrated embodiment, an application or logic 20060 executing on a user device may detect (20110) that it has been logged in. For example, a user may log into the application 20060 via a user device (e.g., external device 20070) and the application or logic 20060 may detect (20110) this login activity. The application may then collect (20120) geographic location data of the user device from the user device. For example, in response to the application or logic 20060 detecting 20110 that it has been logged in by a user device (e.g., external device 20070), the application or logic 20060 may collect (20120) geographic location data of the user device from the user device.
[0302] In various aspects, the application or logic 20060 may receive a request for an activation code (20130), where the activation code may identify geographic location data of the user device. For example, a user may send a request for an activation code to the application or logic 20060, where the application or logic 20060 may receive a request for an activation code (20130), where the request may include or identify geographic location data of the user device. The application may then provide the activation code via the user device (20140). For example, the application or logic 20060 may provide the activation code to the user via the external device 20070 (20140). The activation code may include information regarding the geographic location of the external device 20070. In some aspects, the activation code itself may not provide any information regarding the geographic location to the person reading the code, and may require a machine translation / table (e.g., 35379=US, 27123=KR) to translate the meaning of the code (e.g., geographic location). In other aspects, the activation code itself may provide geographic location information (eg, US, KR, JP) and may not require a machine translation / table to understand the activation code.
[0303] In some aspects, the application may interface (20150) with one or more components of the surgical platform. For example, the application or logic may interface with the surgical platform 20010 (e.g., components 20020A-F, regional location tracking module 20030, or any system UI provided by the surgical platform 20010) via a wired or wireless channel. The activation code may then be entered into the surgical platform 20010 (e.g., components 20020A-F, regional location tracking module 20030, or any system UI provided by the surgical platform 20010) via the application or logic. In some aspects, the user may directly enter the provided activation code into the surgical platform 20010. In some aspects, the activation code may be automatically entered into the surgical platform 20010 via the application or logic once it is generated by the application or logic.
[0304] In some aspects, the geographic location data may be stored (20160) on one or more components of the surgical platform. The geographic location data may be stored on one or more components of the surgical platform via an application or logic, components 20020A-F, the regional location tracking module 20030, or any system UI provided by the surgical platform 20010. In some aspects, the geographic location data may be stored on a storage unit / device 20040.
[0305] In some aspects, the application or logic 20060, or any module / application within the system 20000 (e.g., the geographic location tracking module 20030), may verify to determine whether the user device is an authorized device. For example, in response to determining that the user device includes an authorization code, it may be determined that the user device is an authorized device. In response to determining that the user device does not include an authorization code, it may be determined that the user device is not authorized. In some aspects, the authorization code may include any code issued by the surgical platform / component provider, or any information of the surgical platform / component, including a unique device identifier or serial number.
[0306] If the user device is determined to be unauthorized, the application or logic 20060, or any module / application within the system 20000, may prevent the user device from accessing the application and / or surgical platform. For example, if a user attempts to log into the application or logic or attempts to install the application or logic using an unauthorized device, such login or installation attempt may be denied. In other examples, if a user attempts to access the surgical platform using an unauthorized device, such access attempt may be denied. In this manner, aspects of the present disclosure may prevent attempts of unauthorized users (e.g., hackers) or devices to access the application and / or surgical platform, and ultimately, prevent attempts to arbitrarily set the geographic location of the surgical platform or its components.
[0307] 40 is a logic diagram of a process 20200 illustrating a control program or logic configuration for upgrading software logic for one or more components of a surgical platform based on the geographic location of the one or more components, in accordance with at least one aspect of the present disclosure. Although the exemplary process 20200 is described with reference to the logic diagram shown in FIG. 40, it will be understood that many other ways of performing acts associated with the method may be used. For example, the order of some of the blocks may be changed, certain blocks may be combined with other blocks, and some of the described blocks are optional.
[0308] In the illustrated embodiment, the application may collect geographic location data from the user device (20210). For example, in some aspects, a user initiates an upgrade process via an application or logic 20060 on a user device (e.g., external device 20070), and once the upgrade process is initiated, the application or logic 20060 may collect geographic location data from the user device (20210). In various aspects, the application may provide an activation code 20220, and the activation code may identify the geographic location data of the user device. In some aspects, the activation code may be entered into one or more components of the surgical platform (20230). For example, the activation code may be entered into the surgical platform 20010 (e.g., components 20020A-F, the regional location tracking module 20030, or any system UI provided by the surgical platform 20010) via the application or logic 20060. In some aspects, the user may directly enter the provided activation code into the surgical platform 20010. In some aspects, the activation code may be automatically entered into the surgical platform 20010 once generated by the application or logic.
[0309] In some aspects, the surgical platform may determine whether the geographic location data of the user device matches geographic location data pre-stored within one or more components (20240). For example, the surgical platform 20010 (e.g., a component, a regional location tracking module, or any other element within the surgical platform) may determine whether the provided geographic location data of the user device matches geographic location data pre-stored within the surgical platform 20010 (e.g., components 20020A-F). If it is determined that the geographic location data of the user device matches the geographic location data pre-stored within one or more components, an upgrade of the software logic of the one or more components may be enabled (20250). The software logic may then be upgraded (20260). For example, if it is determined that the provided geographic location data of the user device matches the geographic location data pre-stored within the surgical platform 20010, an upgrade of the software logic of the surgical platform 20010 (e.g., from software version 1.0 to software version 2.0) may be enabled. The software logic can then be upgraded (20260).
[0310] If it is determined that the geographic location data of the user device does not match the geographic location data pre-stored in one or more components, then an upgrade of the software logic of the one or more components may be rejected (20270). For example, if it is determined that the geographic location data of the user device does not match the geographic location data pre-stored in the surgical platform 20010, then an upgrade of the software logic of the surgical platform 20010 may be disabled and / or rejected. In some aspects, the steps set forth in blocks 20240-20270 may be performed by application or logic 20060, or any other application, on behalf of the surgical platform 20010.
[0311] In some aspects, the surgical platform or application may require this re-registration (e.g., verification of the position of the surgical platform / components) for every pre-specified event (such as a software upgrade), after a specific period of time, or periodically (e.g., monthly, quarterly, yearly, etc.). In some aspects, the surgical platform or application may require that re-registration occur between two output verifications.
[0312] In this manner, aspects of the present disclosure provide connectivity of the components or systems of the surgical platform described with reference to Figures 24-30. Allows the surgical platform to verify its location for geographic tracking purposes. Geo-tracking via BYOD allows region-specific instruments and software associated with the surgical platform to be automatically managed, and geo-tracking allows certain instruments and system functionality to only exist in a particular region, addressing specific user needs of a particular region. EXAMPLES
[0313] Example 1. A surgical platform comprising one or more components and a regional location tracking module configured to connect to an external device, receive external device geographic location data from the external device, and implement geographic location specific functionality based on the geographic location data received from the external device.
[0314] Example 2. The surgical platform of Example 1, wherein the geographic location tracking module is further configured to determine a geographic location of one or more components based on geographic location data received from an external device.
[0315] Example 3. A surgical platform described in any one of Examples 1-2, wherein the external device includes at least one of a mobile device and a computer.
[0316] Example 4. A surgical platform described in any one of Examples 1 to 3, wherein the one or more components include at least one of an energy module, a header module, an extended energy module, a technology module, a visualization module, and a combinable module.
[0317] Example 5. A surgical platform according to any one of Examples 1 to 4, further comprising a surgical system including a header module including a communicatively connectable surgical platform and / or a user interface.
[0318] Example 6. A surgical platform described in any one of Examples 1 to 5, wherein the geographic location of the one or more components is determined by Bluetooth or WiFi communication between an external device and the one or more components.
[0319] Example 7. A surgical platform described in any one of Examples 1 to 6, wherein one or more components are configured to verify a GPS location on the external device to verify geographic location data received from the external device.
[0320] Example 8. A surgical platform described in any one of Examples 1 to 7, wherein the geographic location of one or more components is determined by connecting one or more components to an external device.
[0321] Example 9. The surgical platform of any one of Examples 1-8, wherein the local location tracking module is further configured to periodically check the geographic location data.
[0322] Example 10. A surgical platform described in any one of Examples 1 to 9, further comprising a GSM receiver embedded in one or more components for periodically verifying the geographic location of the one or more components.
[0323] Example 11. A surgical platform as described in any one of Examples 1 to 10, wherein the geographic location of the one or more components is determined by using a region-specific product programmed with a region code, the region code being configured to set the geographic location of the one or more components when the region-specific product is plugged into the one or more components.
[0324] Example 12. A method for determining a location of one or more components of a surgical platform, comprising: in response to detecting that an application running on a user device has been logged in, collecting, by the application, geographic location data of the user device from the user device; and receiving, by the application, a request for an activation code, the activation code identifying the geographic location data.
[0325] Example 13. The method of example 12, further comprising providing, by the application, an activation code via the user device.
[0326] Example 14. The method of any one of Examples 12-13, further comprising storing the geographic location data on one or more components.
[0327] Example 15. The method of example 14, wherein the geographic location data is stored on one or more components via the application.
[0328] Example 16. The method of any one of Examples 12-15, further comprising validating the user device to determine whether the user device is an authorized device.
[0329] Example 17. The method of example 16, further comprising, in response to determining that the user device is not an authorized device, preventing the user device from accessing the application.
[0330] Example 18. The method of example 16, further comprising, in response to determining that the user device includes the authorization code, determining that the user device is an authorized device.
[0331] Example 19. A method for upgrading software logic for one or more components of a surgical platform via an application on a user device, the method comprising: collecting geographic location data from the user device; providing an activation code, the activation code identifying the geographic location data of the user device; determining whether the geographic location data of the user device matches geographic location data pre-stored in the one or more components; and rejecting the software logic upgrade in response to determining that the geographic location data of the user device does not match the geographic location data pre-stored in the one or more components.
[0332] Example 20. The method of Example 19, further comprising: enabling an upgrade of software logic in response to determining that the geographic location data of the user device matches geographic location data pre-stored in one or more components; and upgrading the software logic of the one or more components in response to upgrading the software logic.
[0333] While several embodiments have been shown and described, it is not the intention of the applicant to restrict or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these embodiments can be implemented and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described embodiments can be alternatively described as a means for providing the function performed by that element. Also, although materials are disclosed with respect to specific components, other materials may be used. It is therefore to be understood that the above description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.
[0334] The above detailed description has set forth various aspects of the apparatus and / or processes via the use of block diagrams, flow charts and / or examples. To the extent that such block diagrams, flow charts and / or examples include one or more functions and / or operations, it will be understood by those skilled in the art that each function and / or operation included in such block diagrams, flow charts and / or examples can be individually and / or collectively implemented by various hardware, software, firmware or virtually any combination thereof. Those skilled in the art will appreciate that some aspects of the embodiments disclosed herein may be equivalently implemented in whole or in part on an integrated circuit as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as substantially any combination thereof, and that designing circuitry and / or writing software and / or firmware code is within the skill of one of ordinary skill in the art in view of this disclosure. In addition, those skilled in the art will appreciate that the subject matter described herein may be distributed as one or more program products in a variety of forms, and that the specific embodiments of the subject matter described herein apply regardless of the particular type of signal-bearing medium used to actually effect the distribution.
[0335] The instructions used to program the logic to implement the various disclosed aspects may be stored in a system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Additionally, the instructions may be distributed over a network or by other computer-readable media. Machine-readable media may therefore include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including but not limited to floppy diskettes, optical disks, compact disks, read-only memories (CD-ROMs), as well as magneto-optical disks, read-only memories (ROMs), random access memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memories, or tangible machine-readable storage used to transmit information over the Internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Non-transitory computer-readable media may therefore include any type of tangible machine-readable media suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
[0336] The term "control circuitry" as used in any aspect of the present specification may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, a processing unit, a processor, a microcontroller, a microcontroller unit, a controller, a digital signal processor (DSP), a programmable logic device (PLD), a programmable logic array (PLA), or a field programmable gate array (FPGA)), a state machine circuit, firmware that stores instructions executed by the programmable circuit, and any combination thereof. The control circuitry may be embodied, collectively or individually, as circuits that form part of a larger system, such as, for example, an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially executes the processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially executes the processes and / or devices described herein), electrical circuitry forming a memory device (e.g., a form of random access memory) and / or electrical circuitry forming a communications device (e.g., a modem, a communications switch, or an optical-electrical facility). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.
[0337] As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions, or instruction sets, and / or hard-coded (e.g., non-volatile) data in a memory device.
[0338] As used in any aspect of this specification, the terms "component," "system," "module," etc. may refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.
[0339] As used in any aspect of this specification, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result, and the "steps" refer to manipulations of physical quantities and / or logical states, which may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.
[0340] The network may include a packet-switched network. The communication devices may communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include an Ethernet communication protocol that may enable communication using Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" published in December 2008 by the Institute of Electrical and Electronics Engineers (IEEE), and / or later versions of this standard. Alternatively or additionally, the communication devices may communicate with each other using an X.25 communication protocol. The X.25 communication protocol may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may communicate with each other using a Frame Relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published in August 2001 by the ATM Forum entitled "ATM-MPLS Network Interworking 2.0" and / or later versions of this standard. Of course, different and / or later developed connection-oriented network communication protocols are equally contemplated herein.
[0341] Unless expressly specified otherwise, and as will be apparent from the foregoing disclosure, discussions throughout the foregoing disclosure using terms such as "processing," "computing," "calculating," "determining," "displaying," and the like will be understood to refer to the actions and processing of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in the computer system's registers and memory into other data similarly represented as physical quantities in the computer system's memory or registers or other such information storage, transmission, or display devices.
[0342] One or more components may be referred to herein as being "configured to," "configurable to," "operable / operative to," "adapted / adaptable," "able to," "conformable / conformed to," etc. Those skilled in the art will understand that "configured to" may generally encompass active and / or inactive and / or standby components, unless the context requires otherwise.
[0343] The terms "proximal" and "distal" are used herein with reference to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0344] Those skilled in the art will understand that the terms used herein generally, and in the appended claims in particular (e.g., the body of the appended claims), are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," ...
Claims
1. 1. A method for determining a position of one or more components of a surgical platform, comprising: in response to detecting that an application executing on a user device has been logged in, collecting, by the application, geographic location data of the user device from the user device; receiving, by the application, a request for an activation code, the activation code identifying the geographic location data.
2. The method of claim 1 , further comprising providing, by the application, the activation code via the user device.
3. The method of claim 2 , further comprising storing the geographic location data on the one or more components.
4. The method of claim 3 , wherein the geographic location data is stored on the one or more components via the application.
5. The method of claim 1 , further comprising validating the user device to determine whether the user device is an authorized device.
6. The method of claim 5 , further comprising, in response to determining that the user device is not the authorized device, preventing the user device from accessing the application.
7. The method of claim 5 , further comprising: in response to determining that the user device includes an authorization code, determining that the user device is the authorized device.