Interactive surgical system with device and data status processing capabilities

Abstract

The present invention discloses a surgical hub, which is configured to authenticate data communications with a surgical device. The surgical hub includes a processor and a memory storing instructions, the instructions being executable by the processor to: transmit a public key to a detected surgical device; receive a message from the surgical device, the message being encrypted using the public key associated with the surgical hub, the encrypted message comprising a shared key associated with the surgical device and a checksum function associated with the shared key, wherein the shared key comprises an identifier assigned to the surgical device; decrypt the encrypted message using a private key associated with the public key to display the shared key and the checksum function; receive data communications from the surgical device, the data communications being encrypted using the shared key and comprising a checksum value derived based on the data communications via the checksum function; and decrypt the data communications using the shared key.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 649,302, filed on March 28, 2018, entitled “INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES,” the disclosure of which is incorporated herein by reference in its entirety.

[0003] This patent application also claims priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application Serial No. 62 / 611,341, filed on December 28, 2017, entitled “INTERACTIVE SURGICAL PLATFORM,” U.S. Provisional Patent Application Serial No. 62 / 611,340, filed on December 28, 2017, entitled “CLOUD-BASED MEDICAL ANALYTICS,” and U.S. Provisional Patent Application Serial No. 62 / 611,339, filed on December 28, 2017, entitled “ROBOT ASSISTED SURGICAL PLATFORM,” the disclosure of each of which is incorporated herein by reference in its entirety. Background Art

[0004] The present disclosure relates to various surgical systems. Surgery is typically performed in a surgical operating room or room in a medical facility, such as a hospital. A sterile field is typically formed around the patient. The sterile field may include appropriately dressed scrubbed team members, as well as all furniture and fixtures in the area. Various surgical devices and systems are used to perform surgical procedures. Summary of the invention

[0005] In one general aspect, a surgical hub is provided. The surgical hub is configured to authenticate data communications with a surgical device. The surgical hub includes a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to: detect that a surgical device is communicatively coupled to the surgical hub; transmit a public key associated with the surgical hub to the surgical device; and receive a message from the surgical device. The message is encrypted using a public key associated with the surgical hub. The encrypted message includes a shared key associated with the surgical device and a checksum function associated with the shared key. The shared key includes an identifier assigned to the surgical device. The instructions executable by the processor also decrypt the encrypted message using a private key associated with the transmitted public key to display the shared key and the checksum function; receive data communications from the surgical device; and decrypt each data communication using the shared key until the surgical device is detached from the surgical hub. Each data communication is encrypted using a shared key received from the surgical device. Each data communication includes a checksum value derived via a checksum function based on the data of each received communication. The integrity of each data communication can be verified based on its associated checksum value.

[0006] In another general aspect, another surgical hub is provided. The surgical hub is configured to authenticate data communications with a surgical device. The surgical hub includes a control circuit configured to: detect that a surgical device is communicatively coupled to the surgical hub; transmit a public key associated with the surgical hub to the surgical device; and receive a message from the surgical device. The message is encrypted using a public key associated with the surgical hub. The encrypted message includes a shared key associated with the surgical device and a checksum function associated with the shared key. The shared key includes an identifier assigned to the surgical device. The control circuit is configured to also decrypt the encrypted message using a private key associated with the transmitted public key to display the shared key and the checksum function; receive data communications from the surgical device; and decrypt each data communication using the shared key until the surgical device is detached from the surgical hub. Each data communication is encrypted using a shared key received from the surgical device. Each data communication includes a checksum value derived via a checksum function based on the data of each received communication. The integrity of each data communication can be verified based on its associated checksum value.

[0007] In yet another general aspect, another surgical hub is provided. The surgical hub is configured to authenticate a surgical device coupled to the surgical hub. The surgical hub includes a processor and a memory coupled to the processor. The memory stores instructions that can be executed by the processor to: detect that a surgical device is communicatively coupled to the surgical hub; receive an encrypted identifier and a source ID from the surgical device; transmit a first message from the surgical hub to a server of a surgical device manufacturer associated with the source ID, and receive a second message from the server of the surgical device manufacturer. The first message includes an encrypted identifier, and the first message is encrypted using a public key associated with the surgical device manufacturer. The second message is encrypted using a public key associated with the surgical hub. The encrypted second message includes a shared key associated with the encrypted identifier of the surgical device. The instructions that can be executed by the processor also: decrypt the encrypted second message using a private key to display a shared key associated with the encrypted identifier of the surgical device, the private key being associated with the public key used to encrypt the second message; and decrypt the encrypted identifier of the surgical device using the shared key to display an identifier for authenticating the surgical device and its manufacturer. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The features of the various aspects are particularly described in the appended claims. However, the various aspects (relating to surgical organizations and methods) and further objects and advantages thereof may best be understood by reference to the following description taken in conjunction with the following drawings.

[0009] Figure 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure.

[0010] Figure 2 A surgical system for performing a surgical procedure in an operating room according to at least one aspect of the present disclosure.

[0011] Figure 3 A surgical hub is paired with a visualization system, a robotic system, and a smart instrument according to at least one aspect of the present disclosure.

[0012] Figure 4 A partial perspective view of a surgical hub housing and a combination generator module slidably received in a drawer of the surgical hub housing according to at least one aspect of the present disclosure.

[0013] Figure 5 is a perspective view of a combination generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation device according to at least one aspect of the present disclosure.

[0014] Figure 6A single power bus attachment for multiple lateral docking ports of a lateral modular housing configured to accommodate a plurality of modules is shown in accordance with at least one aspect of the present disclosure.

[0015] Figure 7 A vertical modular housing configured to house a plurality of modules according to at least one aspect of the present disclosure is shown.

[0016] Figure 8 A surgical data network including a modular communication hub configured to connect modular devices located in one or more operating rooms of a medical facility or any room in a medical facility dedicated to surgical procedures to a cloud is shown in accordance with at least one aspect of the present disclosure.

[0017] Fig. 9 A computer-implemented interactive surgical system according to at least one aspect of the present disclosure.

[0018] Fig.10 A surgical hub comprising multiple modules coupled to a modular control tower is shown in accordance with at least one aspect of the present disclosure.

[0019] Fig.11 An aspect of a universal serial bus (USB) hub device in accordance with at least one aspect of the present disclosure is shown.

[0020] Fig.12 A logic diagram of a control system for a surgical instrument or tool according to at least one aspect of the present disclosure is shown.

[0021] Fig.13 Control circuitry configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure is shown.

[0022] Fig.14 Combinatorial logic circuits configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure are shown.

[0023] Fig.15 A sequential logic circuit configured to control various aspects of a surgical instrument or tool according to at least one aspect of the present disclosure is shown.

[0024] Fig.16 A surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure is shown.

[0025] Fig.17 is a schematic diagram of a robotic surgical instrument configured to operate the surgical tools described herein according to at least one aspect of the present disclosure.

[0026] Fig.18 A block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure is shown.

[0027] Fig.19 is a schematic diagram of a surgical instrument configured to control various functions according to at least one aspect of the present disclosure.

[0028] Fig. 20 A simplified block diagram of a generator configured to provide, among other benefits, inductorless tuning in accordance with at least one aspect of the present disclosure.

[0029] Fig.21 A generator according to at least one aspect of the present disclosure is shown. Fig. 20 An example of a form of a generator).

[0030] Fig. 22 A combination generator in accordance with at least one aspect of the present disclosure is shown.

[0031] Fig.23 A method of capturing data from a combination generator and transmitting the captured generator data to a cloud-based system in accordance with at least one aspect of the present disclosure is shown.

[0032] Fig.24 Data grouping of combined generator data in accordance with at least one aspect of the present disclosure is shown.

[0033] Fig.25 An encryption algorithm in accordance with at least one aspect of the present disclosure is shown.

[0034] Fig.26 Another encryption algorithm in accordance with at least one aspect of the present disclosure is shown.

[0035] Fig. 27 Yet another encryption algorithm according to at least one aspect of the present disclosure is shown.

[0036] Fig.28 A high-level representation of a datagram is shown in accordance with at least one aspect of the present disclosure.

[0037] Fig.29 According to at least one aspect of the present disclosure, Fig.28 A more detailed representation of a datagram.

[0038] Fig.30 According to at least one aspect of the present disclosure, Fig.28 Another representation of a datagram.

[0039] Fig.31A method of identifying surgical data associated with a failure event and prioritizing transmission of the identified surgical data to a cloud-based system in accordance with at least one aspect of the present disclosure is presented.

[0040] Fig.32 According to at least one aspect of the present disclosure, Fig.28 Another representation of a datagram.

[0041] Fig.33 A partial manual timeline of a surgical procedure performed in an operating room via a surgical system in accordance with at least one aspect of the present disclosure is shown.

[0042] Fig.34 Ultrasonic echogenicity of an operating room wall is shown to determine the distance between a surgical hub and the operating room wall in accordance with at least one aspect of the present disclosure.

[0043] Fig.35 A logic flow diagram of a method according to at least one aspect of the present disclosure depicting a control program or logic configuration for a surgical hub that is paired with surgical devices of a surgical system located within the boundaries of an operating room.

[0044] Fig.36 is a logic flow diagram of a method according to at least one aspect of the present disclosure, depicting a control program or logic configuration for selectively making and breaking connections between devices of a surgical system.

[0045] Fig.37 1 is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control program or logic configuration for selectively re-evaluating the boundaries of an operating room upon detection of a new device.

[0046] Fig.38 A logic flow diagram of a method according to at least one aspect of the present disclosure depicts a control program or logic configuration for selectively re-evaluating the boundaries of an operating room after disconnection from a paired device.

[0047] Fig.39 A logic flow diagram of a method according to at least one aspect of the present disclosure depicting a control program or logic configuration for re-evaluating the boundaries of an operating room by a surgical hub upon detecting a change in the position of the surgical hub.

[0048] Fig.40 is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control program or logic configuration for selectively forming connections between devices of a surgical system.

[0049] Fig.41is a logic flow diagram of a method according to at least one aspect of the present disclosure, depicting a control program or logic configuration for selectively making and breaking connections between devices of a surgical system.

[0050] Fig.42 A surgical hub is shown that pairs a first device and a second device of a surgical system in an operating room according to at least one aspect of the present disclosure.

[0051] Fig.43 A surgical hub according to at least one aspect of the present disclosure is shown that does not pair a first device and a second device of a surgical system in an operating room, but pairs the first device with a third device in the operating room.

[0052] Fig.44 A logic flow diagram of a method according to at least one aspect of the present disclosure depicting a control program or logic configuration for making and breaking connections between devices of a surgical system in an operating room during a surgical procedure based on the progression of steps of the surgical procedure.

[0053] Fig.45 A logic flow diagram of a method according to at least one aspect of the present disclosure depicts a control program or logic configuration for superimposing information from one or more still frames of a real-time stream originating from a distal surgical site onto the real-time stream.

[0054] Fig.46 1 is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control program or logic configuration for distinguishing surgical steps of a surgical procedure.

[0055] Fig.47 is a logic flow diagram of method 3230 according to at least one aspect of the present disclosure, which depicts a control program or logic configuration for distinguishing surgical steps of a surgical procedure.

[0056] Fig.48 3240 according to at least one aspect of the present disclosure, which depicts a control program or logic configuration for identifying a staple cartridge based on information derived from one or more still frames of staples deployed from the staple cartridge into tissue.

[0057] Fig.49 is a partial view of a surgical system in an operating room according to at least one aspect of the present disclosure, the surgical system including a surgical hub having an imaging module that communicates with an imaging device at a distal surgical site.

[0058] Fig.50 Shown is a partial view of stapled tissue receiving first and second staple shots in an end-to-end arrangement in accordance with at least one aspect of the present disclosure.

[0059] Fig.51 Shown are three rows of staples deployed on one side of tissue being stapled and cut by a surgical stapler in accordance with at least one aspect of the present disclosure.

[0060] Fig.52 Non-anodized staples and anodized staples are shown in accordance with at least one aspect of the present disclosure.

[0061] Fig.53 1 is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control program or logic configuration for coordinating control arrangements between surgical hubs.

[0062] Fig.54 Interaction between two surgical hubs in an operating room according to at least one aspect of the present disclosure.

[0063] Fig.55 A logic flow diagram of a method according to at least one aspect of the present disclosure depicting a control program or logic configuration for coordinating control arrangements between surgical hubs.

[0064] Fig.56 Interaction between two surgical hubs in different operating rooms (“OR1” and “OR3”) is shown in accordance with at least one aspect of the present disclosure.

[0065] Fig.57 An auxiliary display in an operating room ("OR3") showing a surgical site during colorectal surgery is shown in accordance with at least one aspect of the present disclosure.

[0066] Fig.58 A personal interface or tablet in OR1 displaying a surgical site of OR3 is shown in accordance with at least one aspect of the present disclosure.

[0067] Fig.59 Shown is a perspective view of a surgical site of OR3 displayed on a primary display of OR1 in accordance with at least one aspect of the present disclosure.

[0068] Fig.60 A personal interface or tablet computer showing an OR1 layout showing available displays in accordance with at least one aspect of the present disclosure is shown.

[0069] Fig.61 Shown is a suggestion of a transection location of a surgical site of OR3 made by a surgical operator in OR1 via a personal interface or tablet in OR1 in accordance with at least one aspect of the present disclosure.

[0070] Fig.62 A timeline depicting situational awareness of a surgical hub is shown in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION

[0071] The applicant of the present patent application owns the following U.S. Provisional Patent Applications filed on March 28, 2018, each of which is incorporated herein by reference in its entirety:

[0072] U.S. Provisional Patent Application Serial No. 62 / 649,302, entitled “INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES”;

[0073] U.S. Provisional Patent Application Serial No. 62 / 649,294, entitled “DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”;

[0074] U.S. Patent Application Serial No. 62 / 649,300, entitled “SURGICAL HUB SITUATIONAL AWARENESS”;

[0075] U.S. Provisional Patent Application Serial No. 62 / 649,309, entitled “SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”;

[0076] U.S. Provisional Patent Application Serial No. 62 / 649,310, entitled “COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”;

[0077] U.S. Provisional Patent Application Serial No. 62 / 649,291, entitled “USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”;

[0078] U.S. Patent Application Serial No. 62 / 649,296, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”;

[0079] U.S. Provisional Patent Application Serial No. 62 / 649,333, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”;

[0080] U.S. Provisional Patent Application Serial No. 62 / 649,327, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”;

[0081] U.S. Provisional Patent Application Serial No. 62 / 649,315, entitled “DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK”;

[0082] U.S. Patent Application Serial No. 62 / 649,313, entitled “CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”;

[0083] U.S. Provisional Patent Application Serial No. 62 / 649,320, entitled “DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”;

[0084] U.S. Provisional Patent Application Serial No. 62 / 649,307, entitled “AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”; and

[0085] U.S. Provisional Patent Application Serial No. 62 / 649,323, entitled “SENSING ARRANGEMENTS FOR Robot-Assisted Surgical PlatformS”

[0086] The applicant of the present patent application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:

[0087] U.S. Patent Application Serial No. ____________, entitled “INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES”; Attorney Docket No. END8499USNP / 170766;

[0088] U.S. Patent Application Serial No. ____________, entitled “Surgical hub coordination of control and communication of operating room devices”; Attorney Docket No. END8499USNP2 / 170766-2;

[0089] U.S. Patent Application Serial No. ____________, entitled “Spatial awareness of surgical hubs in operating rooms; Attorney Docket No. END8499USNP3 / 170766-3;

[0090] U.S. Patent Application Serial No. ____________, entitled “Cooperative utilization of data derived from secondary sources by intelligent surgical hubs”; Attorney Docket No. END8499USNP4 / 170766-4;

[0091] U.S. Patent Application Serial No. ____________, entitled “Surgical hub control arrangements”; Attorney Docket No. END8499USNP5 / 170766-5;

[0092] U.S. Patent Application Serial No. ____________ entitled “DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”; Attorney Docket No. END8500USNP / 170767;

[0093] U.S. Patent Application Serial No. ____________ entitled “COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS”; Attorney Docket No. END8500USNP1 / 170767-1;

[0094] U.S. Patent Application Serial No. ____________, entitled “SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT”; Attorney Docket No. END8500USNP2 / 170767-2;

[0095] U.S. Patent Application Serial No. ____________ entitled “DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETERWITH AN OUTCOME”; Attorney Docket No. END8500USNP3 / 170767-3;

[0096] U.S. Patent Application Serial No. ____________, entitled “SURGICAL HUB SITUATIONAL AWARENESS”; Attorney Docket No. END8501USNP / 170768;

[0097] U.S. Patent Application Serial No. ____________, entitled “SURGICAL SYSTEM DISTRIBUTED PROCESSING”; Attorney Docket No. END8501USNP1 / 170768-1;

[0098] U.S. Patent Application Serial No. ____________, entitled “AGGREGATION AND REPORTING OF SURGICAL HUB DATA”; Attorney Docket No. END8501USNP2 / 170768-2;

[0099] U.S. Patent Application Serial No. ____________ entitled “SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”; Attorney Docket No. END8502USNP / 170769;

[0100] U.S. Patent Application Serial No. ____________ entitled “DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE”; Attorney Docket No. END8502USNP1 / 170769-1;

[0101] U.S. Patent Application Serial No. ____________, entitled “STERILE FIELD INTERACTIVE CONTROL DISPLAYS”; Attorney Docket No. END8502USNP2 / 170769-2;

[0102] U.S. Patent Application Serial No. ____________, entitled “COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”; Attorney Docket No. END8503USNP / 170770;

[0103] U.S. Patent Application Serial No. ____________ entitled “USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”; Attorney Docket No. END8504USNP / 170771;

[0104] U.S. Patent Application Serial No. ____________ entitled “CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY”; Attorney Docket No. END8504USNP1 / 170771-1; and

[0105] · U.S. Patent Application Serial No. ____________, entitled “DUAL CMOS ARRAY IMAGING”; Attorney Docket No. END8504USNP2 / 170771-2.

[0106] The applicant of the present patent application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:

[0107] U.S. Patent Application Serial No. ____________, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”; Attorney Docket No. END8506USNP / 170773;

[0108] U.S. Patent Application Serial No. ____________, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”; Attorney Docket No. END8506USNP1 / 170773-1;

[0109] U.S. Patent Application Serial No. ____________ entitled “CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”; Attorney Docket No. END8507USNP / 170774;

[0110] U.S. Patent Application Serial No. ____________ entitled “CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGETRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET”; Attorney Docket No. END8507USNP1 / 170774-1;

[0111] U.S. Patent Application Serial No. ____________, entitled “Cloud-based Medical Analytics for Medical Facility Segmented Individualization of Instrument Function”; Attorney Docket No. END8507USNP2 / 170774-2;

[0112] U.S. Patent Application Serial No. ____________, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”; Attorney Docket No. END8508USNP / 170775;

[0113] U.S. Patent Application Serial No. ____________ entitled “DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK”; Attorney Docket No. END8509USNP / 170776; and

[0114] U.S. Patent Application Serial No. ____________, entitled “CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”; Attorney Docket No. END8510USNP / 170777.

[0115] The applicant of the present patent application owns the following U.S. patent applications filed on March 29, 2018, each of which is incorporated herein by reference in its entirety:

[0116] U.S. Patent Application Serial No. ____________, entitled “DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMs”; Attorney Docket No. END8511USNP / 170778;

[0117] U.S. Patent Application Serial No. ____________, entitled “COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”; Attorney Docket No. END8511USNP1 / 170778-1;

[0118] U.S. Patent Application Serial No. ____________, entitled “CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”; Attorney Docket No. END8511USNP2 / 170778-2;

[0119] U.S. Patent Application Serial No. ____________, entitled “AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”; Attorney Docket No. END8512USNP / 170779;

[0120] U.S. Patent Application Serial No. ____________, entitled “CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”; Attorney Docket No. END8512USNP1 / 170779-1;

[0121] U.S. Patent Application Serial No. ____________, entitled “COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICALPLATFORMS”; Attorney Docket No. END8512USNP2 / 170779-2;

[0122] U.S. Patent Application Serial No. ____________, entitled “DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”; Attorney Docket No. END8512USNP3 / 170779-3; and

[0123] U.S. Patent Application Serial No. ____________, entitled “SENSING ARRANGEMENTS FOR Robot-Assisted Surgical PlatformS”; Attorney Docket No. END8513USNP / 170780.

[0124] Before describing in detail various aspects of the surgical device and generator, it should be noted that the application or use of the illustrative examples is not limited to the details of the configuration and arrangement of the components shown in the drawings and detailed description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications, and may be practiced or performed in a variety of ways. In addition, unless otherwise indicated, the terms and expressions used herein are selected for the convenience of the reader to describe the exemplary embodiments and are not for limiting purposes. Moreover, it should be understood that one or more of the aspects, expressions of aspects and / or examples described below may be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.

[0125] See also Figure 1, the 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 that may include the remote server 113. In one example, as Figure 1 As shown in , the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with each other and / or with the hub 106. In some aspects, the surgical system 102 may include M number of hubs 106, N number of visualization systems 108, O number of robotic systems 110, and P number of handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to one.

[0126] Figure 3 An example of a surgical system 102 is shown for performing a surgical procedure on a patient lying flat on an operating table 114 in a surgical operating room 116. A robotic system 110 is used as part of the surgical system 102 during a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robotic hub 122. While the surgeon views the surgical site through the surgeon's console 120, the patient side cart 117 can manipulate at least one removably coupled surgical tool 118 through a minimally invasive incision in the patient's body. Images of the surgical site can be obtained through a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process images of the surgical site for subsequent display to the surgeon through the surgeon's console 118.

[0127] Other types of robotic systems may 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 Serial No. 62 / 611,339, filed on December 28, 2017, entitled “ROBOT ASSISTED SURGICAL PLATFORM,” the disclosure of which is incorporated herein by reference in its entirety.

[0128] Various examples of cloud-based analytics performed by the cloud 104 and suitable for use in the present disclosure are described in U.S. Provisional Patent Application Serial No. 62 / 611,340, filed on December 28, 2017, entitled “CLOUD-BASED MEDICAL ANALYTICS,” the disclosure of which is incorporated herein by reference in its entirety.

[0129] In various aspects, imaging 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.

[0130] The optics of 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 portions 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.

[0131] One or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as in the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and may be referred to as visible light or simply light. A typical human eye will respond to wavelengths in the range of about 380 nm to about 750 nm in air.

[0132] The invisible spectrum (i.e., non-luminescent spectrum) is the portion of the electromagnetic spectrum below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwaves, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma-ray electromagnetic radiation.

[0133] In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, choledochoscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngeal-renal endoscopes, sigmoidoscopes, thoracoscopes, and hysteroscopes.

[0134] In one aspect, the imaging device employs multispectral monitoring to discern topography and underlying structure. A multispectral image is an image that captures image data within a specific wavelength range across the electromagnetic spectrum. The wavelengths may be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and ultraviolet. Spectral imaging may allow for the extraction of additional information that the human eye fails to capture with its red, green, and blue receptors. The use of multispectral imaging is described in more detail under the title “Advanced Imaging Acquisition Module” in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring may be a useful tool for repositioning the surgical field after completing the surgical task to perform one or more of the previously described tests on the treated tissue.

[0135] It is self-evident that during any surgical procedure, the operating room and surgical equipment need to be strictly sterilized. The strict sanitary and sterile conditions required in a "surgical room" (i.e., an operating room or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize any material that contacts the patient or penetrates the sterile field, including the imaging device 124 and its attachments and devices. It should be understood that the sterile field can be considered to be a designated area that is considered to be free of microorganisms, such as within a tray or sterile towels, or the sterile field can be considered to be the area around the patient that has been prepared for surgical procedures. The sterile field can include a scrubbed team member that is appropriately dressed, as well as all furniture and fixtures in the area.

[0136] In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays strategically arranged relative to the sterile field, such as Figure 2 . In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described in U.S. Provisional Patent Application Serial No. 62 / 611,341, filed on December 28, 2017, entitled “INTERACTIVE SURGICAL PLATFORM,” under the title “Advanced Imaging Acquisition Module,” the disclosure of which is incorporated herein by reference in its entirety.

[0137] like Figure 2, the main display 119 is positioned in the sterile field to be visible to the operator at the operating table 114. In addition, the 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 that are separated from each other. The visualization system 108 guided by the hub 106 is configured to coordinate the flow of information to the operators inside and outside the sterile field using the displays 107, 109 and 119. For example, the hub 106 can cause the imaging system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109, while maintaining a real-time feed of the surgical site on the main display 119. The snapshot on the non-sterile display 107 or 109 can allow the non-sterile operator to perform diagnostic steps related to the surgical procedure, for example.

[0138] In one aspect, the hub 106 is also configured to route diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to a primary display 119 within the sterile field, where it can be viewed by a sterile operator at the operating table. In one example, the input can be a modified form of a snapshot displayed on a non-sterile display 107 or 109, which can be routed to the primary display 119 via the hub 106.

[0139] See also Figure 2 , the surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. The hub 106 is also configured to coordinate the flow of information to the display of the surgical instrument 112. For example, U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 can be routed by the hub 106 to the surgical instrument display 115 within the sterile field, where the operator of the surgical instrument 112 can observe the input or feedback. Exemplary surgical instruments suitable for the surgical system 102 are described under the title “Surgical Instrument Hardware” in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0140] See now Figure 3, the hub 106 is depicted as communicating with the visualization system 108, the robotic system 110, and the handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In certain aspects, as Figure 3 As shown in , the hub 106 also includes a smoke evacuation module 126 and / or a suction / rinsing module 128.

[0141] During surgery, energy application to tissue for sealing and / or cutting is usually associated with smoke evacuation, suction of excess fluid and / or flushing of tissue. Fluid lines, power lines and / or data lines from different sources are usually tangled during surgery. Valuable time can be lost in solving this problem during surgery. Disconnecting a line may require disconnecting the line from its corresponding module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power lines, data lines and fluid lines, which reduces the frequency of tangling between such lines.

[0142] Various aspects of the present disclosure provide a surgical hub for use in a surgical procedure involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably accommodated in a docking base of the hub housing. The docking base includes data contacts and power contacts. The combination generator module includes two or more of an ultrasonic energy generator device, a bipolar RF energy generator device, and a monopolar RF energy generator device seated in a single unit. In one aspect, the combination generator module also includes a smoke exhaust device for connecting the combination generator module to at least one energy delivery cable of a surgical instrument, at least one smoke exhaust device configured to exhaust smoke, fluid, and / or particles generated by applying therapeutic energy to tissue, and a fluid line extending from a distal surgical site to the smoke exhaust device.

[0143] In one aspect, the fluid line is a first fluid line and the second fluid line extends from the distal surgical site to an aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.

[0144] Certain surgical procedures may require more than one energy type to be applied to tissue. One energy type may be more conducive to cutting tissue, while another different energy type may be more conducive to sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut sealed tissue. Aspects of the present disclosure provide a solution in which a hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the hub modular housing 136 is the ability to quickly remove and / or replace various modules.

[0145] Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking base including a first docking port, the first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts,

[0146] Further describing the above, the modular surgical shell also includes a second energy generator module, which is configured to generate a second energy different from the first energy for application to tissue, and a second docking base, which includes a second docking port, the 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 wherein the second energy generator is slidably movable out of electrical contact with the second power and data contacts.

[0147] In addition, the modular surgical shell also includes a communication bus between the first docking port and the second docking port, which is configured to facilitate communication between the first energy generator module and the second energy generator module.

[0148] See also Figure 3-7 , aspects of the present disclosure are presented as a hub modular housing 136 that allows modular integration of the generator module 140, the smoke evacuation module 126, and the suction / irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. Figure 5 As shown in , the generator module 140 may be a generator module having integrated monopolar devices, bipolar devices, and ultrasonic devices supported in a single housing unit 139 that is slidably inserted into the hub modular housing 136. Figure 5 As shown in , 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 generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact through the hub modular housing 136. The hub modular housing 136 may be configured to facilitate insertion of multiple generators and interactive communication between the generators docked into the hub modular housing 136 so that the generators will act as a single generator.

[0149] In one aspect, the hub modular housing 136 includes a modular power and communications backplane 149 with external and wireless communications connectors to enable removable attachment of the modules 140, 126, 128 and interactive communications therebetween.

[0150] In one aspect, the hub modular housing 136 includes a docking base or drawer 151 (also referred to herein as a drawer) that is configured to slidably accommodate the modules 140, 126, 128. Figure 4 A partial perspective view of a surgical hub housing 136 and a combination generator module 145 slidably received in a docking station 151 of the surgical hub housing 136 is shown. A docking port 152 having power and data contacts on a back side of the combination generator module 145 is configured to engage a corresponding docking port 150 with the power and data contacts of a corresponding docking station 151 of the hub modular housing 136 when the combination generator module 145 is slid into place within the corresponding docking station 151 of the hub modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasonic and monopolar modules and a smoke evacuation module integrated together into a single housing unit 139, such as Figure 5 as shown in .

[0151] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that delivers captured / collected smoke and / or fluid from the surgical site to, for example, the smoke evacuation module 126. Vacuum suction from the smoke evacuation module 126 can draw smoke into an opening of a common conduit at the surgical site. The common conduit coupled to the fluid line can be in the form of a flexible tube that terminates at the smoke evacuation module 126. The common conduit and the fluid line define a fluid path that extends toward the smoke evacuation module 126 housed in the hub housing 136.

[0152] In various aspects, the suction / irrigation module 128 is coupled to a surgical tool including an aspiration fluid line and a suction fluid line. In one example, the aspiration fluid line and the suction fluid line are in the form of flexible tubes extending from the surgical site toward the suction / irrigation module 128. One or more drive systems can be configured to flush fluid to the surgical site and to aspirate fluid from the surgical site.

[0153] In one aspect, the surgical tool comprises a shaft having an end effector at its distal end and at least one energy treatment associated with the end effector, a suction tube, and a flushing tube. The suction tube may have an inlet at its distal end, and the suction tube extends through the shaft. Similarly, the suction tube may extend through the shaft and may have an inlet adjacent to an energy delivery tool. The energy delivery tool is configured to deliver ultrasonic energy and / or RF energy to a surgical site and is coupled to a generator module 140 by a cable initially extending through the shaft.

[0154] The irrigation tube may be in fluid communication with a fluid source, and the aspiration tube may be in fluid communication with a vacuum source. The fluid source and / or vacuum source may be seated in the suction / irrigation module 128. In one example, the fluid source and / or vacuum source may be seated in the hub housing 136 independently of the suction / irrigation module 128. In such examples, a fluid interface is capable of connecting the suction / irrigation module 128 to the fluid source and / or vacuum source.

[0155] In one aspect, the modules 140, 126, 128 and / or their corresponding docking stations on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules to engage with their corresponding ports in the docking stations of the hub modular housing 136. For example, Figure 4 As shown in , the combination generator module 145 includes a side bracket 155, which is configured to slidably engage with a corresponding bracket 156 of a corresponding docking base 151 of the hub modular housing 136. The bracket cooperates to guide the docking port contacts of the combination generator module 145 to electrically engage with the docking port contacts of the hub modular housing 136.

[0156] In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the size of the module is adjusted to be accommodated in the drawer 151. For example, the side brackets 155 and / or 156 can be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are different sizes and each is designed to accommodate a specific module.

[0157] Additionally, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting a module into a drawer with mismatched contacts.

[0158] like Figure 4 As shown in , the docking port 150 of one drawer 151 can be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between modules seated in the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 can facilitate wireless interactive communication between modules seated in the hub modular housing 136. Any suitable wireless communication can be employed, such as, for example, Air Titan-Bluetooth.

[0159] Figure 6A single power bus attachment is shown for multiple lateral docking ports of a lateral modular housing 160 configured to accommodate multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally accommodate and interconnect modules 161. The modules 161 are slidably inserted into docking bases 162 of the lateral modular housing 160, which includes a bottom plate for interconnecting the modules 161. Figure 6 As shown in FIG, the modules 161 are arranged transversely in the transverse modular housing 160. Alternatively, the modules 161 may be arranged vertically in the transverse modular housing.

[0160] Figure 7 A vertical modular housing 164 is shown that is configured to accommodate a plurality of modules 165 of a surgical hub 106. The modules 165 are slidably inserted into a docking station or drawer 167 of the vertical modular housing 164, which includes a bottom plate for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in some cases, the vertical modular housing 164 may include drawers arranged horizontally. In addition, the modules 165 can interact with each other through the docking ports of the vertical modular housing 164. Figure 7 In the example of FIG. 1 , a display 177 is provided for displaying data related to the operation of the module 165. In addition, the vertical modular housing 164 includes a main module 178 that seats a plurality of sub-modules that are slidably received in the main module 178.

[0161] In various aspects, the imaging module 138 includes an integrated video processor and a modular light source, and is suitable for use with various imaging devices. In one aspect, the imaging device is composed of a modular housing that can be equipped 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 to a reusable controller, light source module, and camera module. The light source module and / or camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. On the other hand, the camera module includes a CMOS sensor. On the other hand, the camera module is configured for scanning beam imaging. Similarly, the light source module can be configured to deliver white light or different light, depending on the surgical procedure.

[0162] During a surgical procedure, it may be inefficient to remove a surgical device from the surgical field and replace the surgical device with another surgical device that includes a different camera or a different light source. Temporarily losing sight of the surgical field may lead to undesirable consequences. The modular imaging device of the present disclosure is configured to allow mid-stream replacement of a light source module or a camera module during a surgical procedure without having to remove the imaging device from the surgical field.

[0163] In one aspect, an imaging device includes a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module, which can be configured to snap-fit ​​into engagement with the first channel. A second channel is configured to slidably receive a light source module, which can be configured to snap-fit ​​into 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 respective channels. A threaded engagement can be used in place of a snap-fit ​​engagement.

[0164] In various examples, multiple imaging devices are placed at different locations in the surgical field to provide multiple views. The imaging module 138 can be configured to switch between imaging devices to provide the best view. In various aspects, the imaging module 138 can be configured to integrate images from different imaging devices.

[0165] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Patent No. 7,995,045, entitled “COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR”, issued on August 9, 2011, which is incorporated herein by reference in its entirety. In addition, U.S. Patent No. 7,982,776, entitled “SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD”, issued on July 19, 2011, describes various systems for removing motion artifacts from image data, which is incorporated herein by reference in its entirety. Such systems may be integrated with imaging module 138. In addition, U.S. Patent Application Publication No. 2011 / 0306840, published on December 15, 2011, entitled “CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS,” and U.S. Patent Application Publication No. 2014 / 0243597, published on August 28, 2014, entitled “SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE,” each of which is incorporated herein by reference in its entirety.

[0166] Figure 8A surgical data network 201 is shown that includes 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 that is specifically equipped for surgical operations to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communication hub 203 includes a network hub 207 and / or a network switch 209 that communicates with a network router. The modular communication hub 203 may 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, enabling it to be transferred from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuration of each port in the network hub 207 or network switch 209. The intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

[0167] Modular devices 1a-1n located in an operating room may be coupled to a modular communication hub 203. A network hub 207 and / or a network switch 209 may be coupled to a network router 211 to connect devices 1a-1n to a cloud 204 or a local computer system 210. Data associated with devices 1a-1n may be transmitted to a cloud-based computer via a router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transmitted to a 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 a network switch 209. A network switch 209 may be coupled to a network hub 207 and / or a network router 211 to connect devices 2a-2m to a cloud 204. Data associated with devices 2a-2n may be transmitted to a cloud 204 via a network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transmitted to a local computer system 210 for local data processing and manipulation.

[0168] It should be understood that the surgical data network 201 can be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. The modular communication hub 203 can be included in a modular control tower that is configured to accommodate multiple devices 1a-1n / 2a-2m. A local computer system 210 can also be included in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images obtained by some of the devices 1a-1n / 2a-2m during a surgical procedure, for example. In various aspects, devices 1a-1n / 2a-2m may include, for example, various modules, such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device connected to a display, and / or a non-contact sensor module in other modular devices that can be connected to a modular communication hub 203 of a surgical data network 201.

[0169] In one aspect, the surgical data network 201 may include a combination of (one or more) network hubs, (one or more) network switches, and (one or more) network routers that connect the devices 1a-1n / 2a-2m to the cloud. Any or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transmit the data to the cloud computer for data processing and manipulation. It should be understood that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" can be used as a metaphor for "Internet", although the term is not limited to this. Therefore, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing", in which different services (such as servers, storage, and applications) are delivered to a modular communication hub 203 and / or a computer system 210 located in a surgical room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and a device connected to the modular communication hub 203 and / or the computer system 210 via the Internet. The cloud infrastructure can be maintained by a cloud service provider. In this case, 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. Cloud computing services may perform a large number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

[0170] Applying cloud computer data processing technology to the data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical results, reduced costs and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status to evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. At least some of the devices 1a-1n / 2a-2m can be used to identify pathology, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes positioning and edge confirmation of tissue and phenotype. At least some of the devices 1a-1n / 2a-2m can be used to identify the anatomical structure of the body using various sensors integrated with imaging devices and technologies (such as overlapping images captured by multiple imaging devices). The data (including image data) collected by the devices 1a-1n / 2a-2m can be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve surgical outcomes by determining whether further treatment can be pursued, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and precision robotic applications to tissue-specific sites and conditions. Such data analysis can be further processed using outcome analysis, and using standardized methods can provide helpful feedback to confirm surgical treatments and surgeon behavior, or suggest modifications to surgical treatments and surgeon behavior.

[0171] In one specific implementation, operating room devices 1a-1n may be connected to the modular communication hub 203 via a wired channel or a wireless channel, depending on the configuration of the devices 1a-1n to the network hub. In one aspect, the network hub 207 may be implemented as a local network broadcast device that operates on the physical layer of the open system interconnection (OSI) model. The network hub provides connections to devices 1a-1n located in the same operating room network. The network hub 207 collects data in the form of packets and sends it to a router in half-duplex mode. The network hub 207 does not store any media access control / Internet protocol (MAC / IP) for transmitting device data. Only one of the devices 1a-1n can send data through the network hub 207 at a time. The network hub 207 has no knowledge of where to send information and broadcasts all network data on each connection and to the remote server 213 ( Fig. 9 ) Routing tables or intelligence that broadcasts all network data. The network hub 207 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can pose security risks and cause bottlenecks.

[0172] In another specific implementation, the operating room devices 2a-2m can be connected to the network switch 209 through a wired channel or a wireless channel. The network switch 209 operates in 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 sends data to the network router 211 in the form of a frame and operates in full-duplex mode. Multiple devices 2a-2m can send data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to transmit data.

[0173] The network hub 207 and / or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 operates in the network layer of the OSI model. The network router 211 creates a route for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources to further process and manipulate data collected by any or all of the devices 1a-1n / 2a-2m. The network router 211 can be used to connect two or more different networks located in different locations, such as, for example, different operating rooms in the same medical facility or different networks located in different operating rooms in different medical facilities. The network router 211 sends data to the cloud 204 in the form of packets and operates in full-duplex mode. Multiple devices can send data simultaneously. The network router 211 uses IP addresses to transmit data.

[0174] In one example, 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 to multiple levels so that more ports are available to connect devices to a host system computer. The network hub 207 may include wired or wireless capabilities for receiving information through a wired channel or a wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in an operating room.

[0175] In other examples, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard for exchanging data from fixed and mobile devices over short distances (using short wavelength UHF radio waves in the ISM band of 2.4 to 2.485 GHz) and building a personal area network (PAN). In other aspects, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE) and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0176] The modular communication hub 203 can serve as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles data types called frames. The frames carry data generated by the devices 1a-1n / 2a-2m. When the modular communication hub 203 receives a frame, it is amplified and transmitted to the network router 211, which transmits the data to the cloud computing resources using multiple wireless or wired communication standards or protocols as described herein.

[0177] Modular communication hub 203 can be used as a standalone device or connected to compatible network hubs and network switches to form a larger network. Modular communication hub 203 is generally easy to install, configure and maintain, making it a good option for networking operating room devices 1a-1n / 2a-2m.

[0178] Fig. 9A computer-implemented interactive surgical system 200 is shown. 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 in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 that is connected to a plurality of operating room devices, such as, for example, smart surgical instruments, robots, and other computerized devices located in the operating room. Fig.10 As shown in FIG, modular control tower 236 includes modular communication hub 203 coupled to computer system 210. Fig. 9 As shown in the example of , 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 robotic hub 222 can also be connected to the modular control tower 236 and cloud computing resources. The devices / instruments 235, the visualization system 208, etc. can be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 can be coupled to a hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device / instrument display, and / or other visualization system 208. The hub display may also combine graphics and overlay images to display data received from devices connected to the modular control tower.

[0179] Fig.10 A surgical hub 206 is shown comprising a plurality of modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communication hub 203 (e.g., network connectivity means) and a computer system 210 to provide, for example, local processing, visualization, and imaging. Fig.10 As shown in , the modular communication hub 203 can be hierarchically configured to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 and transmit data associated with the modules to the computer system 210, cloud computing resources, or both. Fig.10As shown in , 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 the processor to provide communication connections with cloud computing resources and local display 217. Communication with the cloud 204 can be carried out through wired or wireless communication channels.

[0180] The surgical hub 206 employs a non-contact sensor module 242 to measure the size of the operating room and generates a map of the surgical room using an ultrasound or laser-based non-contact measurement device. The ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound waves and receiving the echoes as they bounce off the walls of the operating room, as described in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, under the title “Surgical Hub Spatial Awareness Within an Operating Room,” which is incorporated herein by reference in its entirety, wherein the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limit. The laser-based non-contact sensor module scans the operating room by transmitting laser pulses, receiving laser pulses that bounce off the walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.

[0181] 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 device 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 structures including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus using any of a variety of available bus architectures including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), Micro Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other peripheral bus.

[0182] Controller 244 may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be a commercially available ARM Cortex-M4F processor core, such as the Texas Instruments LM4F230H5QR, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle sequential random access memory (SRAM), a 32KB MCU loaded with Internal read-only memory (ROM) for software, 2KB electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which can be found in the product data sheet.

[0183] In one aspect, the processor 244 may include a safety controller including two families based on controllers such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4, also produced by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

[0184] System memory includes volatile memory and non-volatile memory. The basic input / output system (BIOS), which contains basic routines such as transferring information between elements within the computer system during startup, is stored in non-volatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM) that acts as external cache memory. In addition, RAM is available in a variety of forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM) enhanced SDRAM (ESDRAM), synchronous link DRAM (SLDRAM) and direct Rambus RAM (DRRAM).

[0185] Computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage may include storage media individually or in combination with other storage media, including but not limited to optical disk drives such as optical disk ROM devices (CD-ROM), optical disk recordable drives (CD-R drives), optical disk rewritable drives (CD-RW drives), or digital universal disk ROM drives (DVD-ROM). In order to facilitate the connection of the disk storage device to the system bus, a removable or non-removable interface may be used.

[0186] It should be understood that the computer system 210 includes software that acts as an intermediary between a user and the basic computer resources described in a suitable operating environment. Such software includes an operating system. An operating system that can be stored on a disk storage device is used to control and allocate the resources of the computer system. System applications use the operating system to manage resources through program modules and program data stored in system memory or disk storage devices. It should be understood that the various devices described herein can be implemented with various operating systems or combinations of operating systems.

[0187] The user inputs commands or information into the computer system 210 through (one or more) input devices coupled to the I / O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, a touch ball, a stylus, a touch pad, a keyboard, a microphone, a joystick, a game pad, a satellite dish, a scanner, a TV tuner card, a digital camera, a digital video camera, a web camera, etc. These and other input devices are connected to the processor through the system bus via (one or more) interface ports. (One or more) interface ports include, for example, serial ports, parallel ports, game ports, and USB. (One or more) output devices use the same type of port as (one or more) input devices. Thus, for example, a USB port can be used to provide input to the computer system and 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) that require special adapters among other output devices. Output adapters include, by way of example, but are not limited to, video and sound cards that provide connection means between output devices and the system bus. It should be noted that other devices or systems of devices such as (one or more) remote computers provide both input capabilities and output capabilities.

[0188] The computer system 210 can operate in a networked environment using a logical connection with one or more remote computers (such as (one or more) cloud computers) or local computers. (One or more) remote cloud computers can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other public network nodes, etc., and generally include many or all of the elements described relative to the computer system. For simplicity, only a memory storage device with (one or more) remote computers is shown. (One or more) remote computers are logically connected to the computer system through a network interface, and then physically connected via a communication connection. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet / IEEE 802.3, token ring / IEEE 802.5, etc. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks such as integrated services digital networks (ISDN) and their variants, packet switching networks, and digital subscriber lines (DSL).

[0189] In various aspects, Fig.10 computer system 210, imaging module 238 and / or visualization system 208, and / or Figure 9-10 The processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) for processing digital images. The image processor may employ parallel computing with single instruction, multiple data (SIMD) or multiple instructions, multiple data (MIMD) techniques to improve speed and efficiency. The digital image processing engine may perform a range of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

[0190] The communication connection(s) refers to the hardware / software used to connect the network interface to the bus. Although the communication connections are shown for exemplary clarification within the computer system, they may also be located external to the computer system 210. The hardware / software necessary to connect to the network interface includes internal and external technologies such as modems, including conventional telephone grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards for exemplary purposes only.

[0191] Fig.11A functional block diagram of one aspect of a USB network hub 300 device according to one aspect of the present disclosure is shown. In the illustrated aspect, the USB network hub device 300 employs a TUSB2036 integrated circuit hub from Texas Instruments. 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 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP0) input paired with a differential data positive (DM0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, each of which includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.

[0192] The USB network hub 300 device is implemented with a digital state machine rather than a microcontroller, and does not require firmware programming. A fully compatible USB transceiver is integrated into the circuit for 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 devices and low-speed devices by automatically setting the conversion rate according to the speed of the device attached to the port. The USB network hub 300 device can be configured to be in bus-powered mode or self-powered mode, and includes a hub power logic 312 for managing power.

[0193] 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 protocols described in Chapter 8 of the USB specification. The SIE 310 generally includes up to transaction-level signaling. The functions it handles may include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection / generation, clock / data separation, non-return to zero inversion (NRZI) data encoding / decoding and digit filling, CRC generation and verification (token and data), packet ID (PID) generation and verification / decoding, and / or serial-to-parallel / parallel-to-serial conversion. The 310 receives a clock input 314 and is coupled to a pause / resume logic and frame timer 316 circuit and a hub repeater circuit 318 to control the communication between the upstream USB transceiver port 302 and the downstream USB transceiver port 304, 306, 308 through the port logic circuit 320, 322, 324. SIE 310 is coupled to command decoder 326 via interface logic to control commands from the serial EEPROM via serial EEPROM interface 330 .

[0194] In various aspects, the USB network hub 300 can connect 127 functions configured in up to six logical layers (hierarchies) to a single computer. In addition, the USB network hub 300 can be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power is configured as a bus-powered mode and a self-powered mode. The USB network hub 300 can be configured to support four power management modes: a bus-powered hub with individual port power management or a complete set of port power management, and a self-powered hub with individual port power management or a complete set of port power management. In one aspect, the USB network hub 300, the upstream USB transceiver port 302 is inserted into the USB host controller using a USB cable, and the downstream USB transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, etc.

[0195] Surgical Instrument Hardware

[0196] Fig.12 A logic diagram of a control system 470 of a surgical instrument or tool according to one or more aspects of the present disclosure is shown. The system 470 includes a control circuit. The control circuit includes a microcontroller 461, which includes 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 is operably coupled to a longitudinally movable displacement member to drive an I-beam blade element. The tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to the processor 462, which can be programmed or configured to determine the position of the longitudinally movable drive member and the position of the firing member, the firing rod, and the I-beam blade element. Additional motors can be provided at the tool driver interface to control I-beam firing, closure tube travel, shaft rotation, and joint movement. The display 473 displays a variety of operating conditions of the instrument and can include a touch screen function for data input. The information displayed on the display 473 can be superimposed with an image acquired via an endoscopic imaging module.

[0197] In one aspect, the microprocessor 461 can be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In one aspect, the microcontroller 461 can be a LM4F230H5QR ARM Cortex-M4F processor core available from, for example, Texas Instruments, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle SRAM, a 32-bit MCU, and a 32-bit MCU. Internal ROM for software, 2KB of EEPROM, one or more PWM modules, one or more QEI analogs, one or more 12-bit ADCs with 12 analog input channels, details of which can be found in the product datasheet.

[0198] In one aspect, the microcontroller 461 may include a safety controller including two families based on controllers such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

[0199] The microcontroller 461 can be programmed to perform various functions, such as precise control of the speed and position of the knife and articulation system. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 can be a brushed DC (DC) motor having a gear box and a mechanical link to the articulation or knife system. In one aspect, the motor driver 492 can be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily replaced for use in the tracking system 480 including an absolute positioning system. A detailed description of the absolute positioning system is described in U.S. Patent Application Publication No. 2017 / 0296213 entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT" published on October 19, 2017, which is incorporated herein by reference in its entirety.

[0200] The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement member and articulation system. The microcontroller 461 can be configured to calculate the response in the software of the microcontroller 461. The calculated response is compared to the measured response of the actual system to obtain the "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that balances the smooth continuous nature of the simulated response with the measured response, which can detect external influences on the system.

[0201] In one aspect, the motor 482 can be controlled by a motor driver 492 and can be adopted by the firing system of a surgical instrument or tool. In various forms, the motor 482 can be a brushed DC drive motor with a maximum rotation speed of about 25,000 RPM. In other arrangements, 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 a field effect transistor (FET). The motor 482 can be powered by a power assembly that can be releasably mounted to a handle assembly or a tool housing for supplying control power to a surgical instrument or tool. The power assembly may include a battery that may include a plurality of battery cells connected in series that can be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and / or rechargeable. In at least one example, the battery cell may be a lithium-ion battery that can be coupled to the power assembly and can be separated from the power assembly.

[0202] Driver 492 may be an A3941 available from Allegro Microsystems, Inc. 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. Driver 492 includes a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows the A3941 to operate at reduced gate drive as low as 5.5V. A bootstrap capacitor may be used to provide the above-mentioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side driver allows DC (100% duty cycle) operation. The full bridge may be driven in fast decay mode or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation may pass through the high-side or low-side FETs. The power FETs are protected from breakdown by resistor-adjustable dead time. The integral diagnostics provide indications of 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 the tracking system 480 including the absolute positioning system.

[0203] 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, which includes a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member, which can be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a firing rod or an I-beam, each of which can be adapted and configured to include a rack of drive teeth. Therefore, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, a firing member, a firing rod, an I-beam, or any element that can be displaced. In one aspect, the longitudinally movable drive member is coupled to the firing member, the firing rod, and the I-beam. Therefore, the absolute positioning system can actually track the linear displacement of the I-beam by tracking the linear displacement of the longitudinally movable drive member. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, a longitudinally movable drive member, firing member, firing rod or I-beam 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 including a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system including a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical sensing system including a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system including a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.

[0204] The electric motor 482 may include a rotatable shaft operably interfacing with a gear assembly that is mounted on the displacement member in meshing engagement with a group or rack of drive teeth. The sensor element may be operably coupled to the gear assembly so that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The arrangement of the transmission and the sensor may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. The power source supplies power to the absolute positioning system, and the output indicator may display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member that includes 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, a firing rod, an I-beam, or a combination thereof.

[0205] A single rotation of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement of the displacement member, d1, where d1 is the longitudinal linear distance the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via a gear reduction that enables the position sensor 472 to complete only one or more rotations for a full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.

[0206] A series of switches (where n is an integer greater than one) may be employed alone or in combination with gear reduction to provide unique position signals for more than one rotation of the position sensor 472. The state of the switches is fed back to the microcontroller 461, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+...dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of this sensor arrangement may include a magnetic sensor, an analog rotation sensor (such as a potentiometer), an array of analog Hall effect elements that output a unique combination of position signals or values.

[0207] Position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector component of the magnetic field. The technologies used to produce the above two types of magnetic sensors cover many aspects of physics and electronics. Technologies for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spins, superconducting quantum interference devices (SQUIDs), Hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetosensitive diodes, magnetosensitive transistors, optical fibers, magneto-optics, and magnetic sensors based on micro-electromechanical systems, among others.

[0208] In one aspect, the position sensor 472 for the tracking system 480 including the absolute positioning system includes a magnetic rotation absolute positioning system. The position sensor 472 can be implemented as an AS5055EQFT monolithic magnetic rotation position sensor, which can be purchased from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power device and includes four Hall effect elements in the area of ​​the position sensor 472 located on the magnet. A high resolution ADC and an intelligent power management controller are also provided on the chip. A coordinate rotation digital computer (CORDIC) processor (also known as the bitwise method and Volder algorithm) is provided to perform a simple and efficient algorithm to calculate hyperbolic and trigonometric functions, which only requires addition, subtraction, digit shift and table lookup operations. The angular position, alarm bit 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 or 14 bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4×4×0.85 mm package.

[0209] The tracking system 480 including the absolute positioning system may include and / or may be programmed to implement a feedback controller such as a PID, state feedback, and an adaptive controller. The power source converts the signal from the feedback controller into a physical input to the system: in this case, a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by the position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, (one or more) other sensors may include sensor arrangements such as those described in U.S. Patent 9,345,481, entitled “STAPLE CARTRIDGE TISSUE THICKNESS,” issued on May 24, 2016, which is incorporated herein by reference in its entirety; U.S. Patent Application Publication 2014 / 0263552, entitled “STAPLE CARTRIDGE TISSUETHICKNESS,” published on September 18, 2014, which is incorporated herein by reference in its entirety; and U.S. Patent Application Serial No. 15 / 628,175, entitled “TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT,” filed on June 20, 2017, 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 will have a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuits to combine the calculated response with the measured response using an algorithm (such as weighted average and theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system by knowing the input.

[0210] Thus, the absolute positioning system provides the absolute position of the displacement member when the instrument is powered on, and does not retract or advance the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders, which simply count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, etc.

[0211] Sensor 474 (such as, for example, a strain gauge or micro strain gauge) is configured to measure one or more parameters of the end effector, such as, for example, the amplitude of the strain applied to the anvil during the clamping operation, which can indicate the closing force applied to the anvil. The measured strain is converted into a digital signal and provided to the processor 462. Alternatively or in addition to sensor 474, sensor 476 (such as a load sensor) can measure the closing force applied to the anvil by the closed drive system. Sensor 476, such as, for example, a load sensor can measure the firing force applied to the I-beam in the firing stroke of the surgical instrument or tool. The I-beam is configured to engage a wedge-shaped sliding member, which is configured to enable the nail driver to cam upward to push the nail out to contact with the deformation of the anvil. The I-beam also includes a sharp cutting edge, which can be used to cut off tissue when the I-beam is pushed distally by the firing rod. Alternatively, a current sensor 478 can be used to measure the current consumed by the motor 482. The force required to advance the firing member may correspond to, for example, the current consumed by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.

[0212] In one form, a strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force on the tissue processed by the end effector. A system for measuring the force applied to the tissue grasped by the end effector includes a strain gauge sensor 474, such as, for example, a micro strain gauge, which is configured to measure, for example, one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain applied to the jaw member of the end effector during the clamping operation, which can indicate tissue compression. The measured strain is converted into 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 the tissue captured between the anvil and the nail magazine. A magnetic field sensor can be used to measure the thickness of the captured tissue. The measurement value of the magnetic field sensor can also be converted into a digital signal and provided to the processor 462.

[0213] The microcontroller 461 can characterize the corresponding values ​​of the selected position of the firing member and / or the velocity of the firing member using the measurements of tissue compression, tissue thickness, and / or the force required to close the end effector measured by the sensors 474, 476, respectively. In one example, the memory 468 can store techniques, formulas, and / or lookup tables that can be used by the microcontroller 461 in the evaluation.

[0214] The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with the modular communication hub, such as Figure 8-11 as shown in .

[0215] Fig.13A control circuit 500 is shown, which is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 may be configured to implement various processes described herein. The circuit 500 may include a microcontroller, which includes 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 cause the processor 502 to execute machine instructions to implement various processes described herein when executed by the processor 502. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. The memory circuit 504 may include a volatile storage medium and a non-volatile storage medium. The processor 502 may include an instruction processing unit 506 and an operation unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

[0216] Fig.14 Combinatorial logic circuit 510 is shown, which is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. Combinatorial logic circuit 510 can be configured to implement various processes described herein. Combinatorial logic circuit 510 may include a finite state machine that includes combinatorial logic 512 that is configured to receive data associated with a surgical instrument or tool at input 514, process the data through combinatorial logic 512, and provide output 516.

[0217] Fig.15 A sequential logic circuit 520 configured to control various aspects of a surgical instrument or tool is shown according to one aspect of the present disclosure. The sequential logic circuit 520 or the combinatorial logic 522 may be configured to implement the 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 may store the current state of the finite state machine. In some cases, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with a 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 processor (e.g., the processor 502, Fig.13 ) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may include a combinational logic circuit (e.g., combinational logic circuit 510, Fig.14 ) and a sequential logic circuit 520.

[0218] Fig.16A surgical instrument or tool is shown that includes multiple motors that can be activated to perform various functions. In some cases, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, and a third motor can be activated to perform a third function. In some cases, multiple motors of the robotic surgical instrument 600 can be individually activated to cause a firing motion, a closing motion, and / or an articulation motion in an end effector. The firing motion, the closing motion, and / or the articulation motion can be transmitted to the end effector, for example, via a shaft assembly.

[0219] In some cases, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transmit the firing motion generated by the motor 602 to the end effector, specifically for displacing the I-beam element. In some cases, the firing motion generated by the motor 602 may cause, for example, a staple to be deployed from a staple cartridge into tissue captured by the end effector and / or cause the cutting edge of the I-beam element to be advanced to cut the captured tissue. The I-beam element may be retracted by reversing the direction of the motor 602.

[0220] In some cases, the surgical instrument or tool may include a closing motor 603. The closing motor 603 may be operably coupled to a closing motor drive assembly 605, which is configured to transmit the closing motion generated by the motor 603 to the end effector, specifically for displacing the closing tube to close the anvil and compress the tissue between the anvil and the staple cartridge. The closing motion may cause, for example, the end effector to transition from an open configuration to a close configuration to capture tissue. The end effector may be transitioned to an open position by reversing the direction of the motor 603.

[0221] In some cases, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operably coupled to respective articulation motor drive assemblies 608a, 608b, which may be configured to transmit the articulation generated by the motors 606a, 606b to the end effector. In some cases, the articulation may cause the end effector to articulate relative to an axis, for example.

[0222] As described above, surgical instruments or tools may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of surgical instruments or tools may be individually or independently activated to perform one or more functions, while other motors remain inactive. For example, articulation motors 606a, 606b may be activated to articulate the end effector, while firing motor 602 remains inactive. Alternatively, firing motor 602 may be activated to fire multiple nails and / or advance the cutting edge, while articulation motor 606 remains inactive. In addition, closing motor 603 may be started simultaneously with firing motor 602 to advance the closing tube and I-beam element toward the distal side, as described in more detail below.

[0223] In some cases, 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 some cases, the common control module 610 can adjust one of the multiple motors at a time. For example, the common control module 610 can be individually coupled to multiple motors of the surgical instrument and can be separated from the multiple motors of the surgical instrument. In some cases, multiple motors of the surgical instrument or tool can share one or more common control modules such as the common control module 610. In some cases, multiple motors of the surgical instrument or tool can independently and selectively engage the common control module 610. In some cases, the common control module 610 can switch from interfacing with one of the multiple motors of the surgical instrument or tool to interfacing with another of the multiple motors of the surgical instrument or tool.

[0224] In at least one example, the common control module 610 can selectively switch between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closing motor 603. Fig.16 As shown in , the switch 614 can move or change between multiple positions and / or states. In the first position 616, the switch 614 can electrically couple the common control module 610 to the firing motor 602; in the second position 617, the switch 614 can electrically couple the common control module 610 to the closing motor 603; in the third position 618a, the switch 614 can electrically couple the common control module 610 to the first joint motion motor 606a; and in the fourth position 618b, the switch 614 can electrically couple the common control module 610 to, for example, the second joint motion motor 606b. In some cases, a separate common control module 610 can be electrically coupled to the firing motor 602, the closing motor 603, and the joint motion motors 606a, 606b at the same time. In some cases, the switch 614 can be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switch mechanism.

[0225] Each of the motors 602, 603, 606a, 606b may include 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 on the outside of the jaws or by a torque sensor of the motor used to actuate the jaws.

[0226] In various cases, such as Fig.16 As shown in , the common control module 610 may include a motor driver 626, which may include one or more H-bridge field effect FETs. The motor driver 626 may regulate the power transmitted from a power source 628 to a motor coupled to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In some cases, when a motor is coupled to the common control module 610, the microcontroller 620 may be used, for example, to determine the current consumed by the motor, as described above.

[0227] In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform a number of functions and / or calculations described herein. In some cases, one or more of memory units 624 may be coupled to processor 622, for example.

[0228] In some cases, the power source 628 can be used, for example, to power the microcontroller 620. In some cases, the power source 628 can include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some cases, the battery pack can be configured to be releasably mounted to the handle for powering the surgical instrument 600. A plurality of battery cells connected in series can be used as the power source 628. In some cases, the power source 628 can be, for example, replaceable and / or rechargeable.

[0229] In various cases, the processor 622 may control the motor driver 626 to control the position, rotation direction, and / or speed of the motor coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and / or deactivate the motor coupled to the common controller 610. It should be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functions of the central processing unit (CPU) of a computer on one integrated circuit or at most several integrated circuits. A processor is a multi-purpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides a result as output. Because the processor has internal memory, it is an example of sequential digital logic. The operating objects of the processor are numbers and symbols represented in the binary number system.

[0230] In one example, processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In some cases, microcontroller 620 may be, for example, LM 4F230H5QR available from Texas Instruments. In at least one example, Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle SRAM, a 32-bit MCU with 16-bit MCU and 16-bit MCU with 16-bit MCU. Internal ROM for software, 2KB of EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Other microcontrollers can be easily substituted for use with module 4410. Therefore, the present disclosure should not be limited to this context.

[0231] In some cases, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that may be coupled to the common controller 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 based on input from an algorithm or control program of the surgical instrument or tool.

[0232] In some cases, one or more mechanisms and / or sensors (such as sensor 630) can be used to alert the processor 622 to program instructions that should be used in a particular setting. For example, the sensor 630 can alert the processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In some cases, the sensor 630 can include, for example, a position sensor that can be used to sense the position of the switch 614. Thus, the processor 622 can use program instructions associated with firing the I-beam of the end effector when, for example, the sensor 630 detects that the switch 614 is in the first position 616; the processor 622 can use program instructions associated with closing the anvil when, for example, the sensor 630 detects that the switch 614 is in the second position 617; and the processor 622 can use program instructions associated with articulating the end effector when, for example, the sensor 630 detects that the switch 614 is in the third position 618a or the fourth position 618b.

[0233] Fig.17 7 is a schematic diagram of a robotic surgical instrument 700 configured to operate the surgical tools described herein according to one aspect of the present disclosure. The robotic surgical instrument 700 can be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of a closure tube, shaft rotation, and articulation with a single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to individually control a firing member, a closure member, an axis member, and / or one or more articulation members. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, an axis member, and / or one or more articulation members.

[0234] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the anvil 716 and I-beam 714 (including sharp cutting edges) portions of the end effector 702 via a plurality of motors 704a-704e, a removable staple cartridge 718, an axis 740, and one or more articulation members 742a, 742b. A position sensor 734 may be configured to provide position feedback of the I-beam 714 to the control circuit 710. Other sensors 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.

[0235] In one aspect, the control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to perform one or more tasks. In one aspect, the timer / counter circuit 731 provides an output signal to the control circuit 710, such as an elapsed time or a digital count, to correlate the position of the I-beam 714 as determined by the position sensor 734 with the output of the timer / counter 731 so that the control circuit 710 can determine the position of the I-beam 714 at a particular time (t) relative to a starting position or a time (t) when the I-beam 714 is at a particular position relative to a starting position. The timer / counter 731 can be configured to measure elapsed time, count external events, or time external events.

[0236] In one aspect, the control circuit 710 can be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuit 710 can be programmed to sense tissue conditions, such as thickness, directly or indirectly, as described herein. The control circuit 710 can be programmed to select a firing control program or a closing control program based on the tissue conditions. The firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 710 can be programmed to translate the displacement member at a lower speed and / or at a lower power. When thinner tissue is present, the control circuit 710 can be programmed to translate the displacement member at a higher speed and / or at a higher power. The closing control program can control the closing force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and the articulation members 742a, 742b.

[0237] In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point signal 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 corresponding motor drive signals. In some examples, the motors 704a-704e may be brushless DC motors, and the corresponding motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Moreover, in some examples, the motor controllers 708a-708e may be omitted, and the control circuit 710 may directly generate the motor drive signals.

[0238] In one aspect, the control circuit 710 can initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the travel, the control circuit 710 can select a firing control program in a closed-loop configuration. The response of the instrument can include the translation distance of the displacement member during the open-loop portion, the time consumed 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 signal, etc. After the open-loop portion, the control circuit 710 can implement the selected firing control program for a second portion of the travel of the displacement member. For example, during the closed-loop portion of the travel, the control circuit 710 can modulate one of the motors 704a-704e based on the translation data describing the position of the displacement member in a closed-loop manner to cause the displacement member to translate at a constant speed.

[0239] In one aspect, the motors 704a-704e may receive power from the energy source 712. The energy source 712 may be a DC power source driven by a main AC power source, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to separate movable mechanical elements, such as the I-beam 714, the anvil 716, the shaft 740, the articulation 742a, and the articulation 742b, via corresponding transmissions 706a-706e. The transmissions 706a-706e may include one or more gears or other linkage devices to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the I-beam 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicating the position of the I-beam 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 when the I-beam 714 is translated toward the distal side and toward the proximal side. The control circuit 710 can track the pulses to determine the position of the I-beam 714. Other suitable position sensors can be used, including, for example, proximity sensors. Other types of position sensors can provide other signals indicating the movement of the I-beam 714. Moreover, in some examples, the position sensor 734 can be omitted. In the case where any of the motors 704a-704e is a stepper motor, the control circuit 710 can track the position of the I-beam 714 by aggregating the number and direction of steps that the motor 704 has been instructed to perform. The position sensor 734 can be located in the end effector 702 or at 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 the rotation of the drive shaft.

[0240] In one aspect, the control circuit 710 is configured to drive a firing member such as an I-beam 714 portion of the end effector 702. The control circuit 710 provides a motor set point to a 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 706a coupled to the I-beam 714. The transmission 706a includes a movable mechanical element such as a rotating element and a firing member to control the movement of the I-beam 714 along the longitudinal axis of the end effector 702 toward the distal and proximal sides. In one aspect, the motor 704a can be coupled to a knife gear assembly, which includes a knife gear reduction group, and the knife gear reduction group includes a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to fire or displace the I-beam 714. The position sensor 734 can be configured to provide the position of the I-beam 714 along the firing stroke or the position of the firing member 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 can provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a can drive the firing member from the proximal stroke start position to the distal end of the stroke start position along the longitudinal axis of the end effector 702. When the firing member is translated toward the distal side, the I-beam 714 having a cutting element positioned at the distal end is advanced toward the distal side to cut the tissue between the staple cartridge 718 and the anvil 716.

[0241] In one aspect, the control circuit 710 is configured to drive a closing member, such as the anvil 716 portion of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708b, which provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission 706b coupled to the anvil 716. The transmission 706b includes a movable mechanical element such as a rotating element and a closing member to control the movement of the anvil 716 from an open position and a closed position. In one aspect, the motor 704b is coupled to a closing gear assembly, which includes a closing reduction gear set supported to mesh with a closing spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal represents the closing force applied to the anvil 716. The position sensor 734 can be configured to provide the position of the closing member as a feedback signal to the control circuit 710. The additional sensor 738 in the end effector 702 can provide a closing force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned opposite the staple cartridge 718. When ready for use, the control circuit 710 can provide a closing signal to the motor control 708b. In response to the closing signal, the motor 704b advances the closing member to grasp the tissue between the anvil 716 and the staple cartridge 718.

[0242] In one aspect, the control circuit 710 is configured to rotate an axis member such as the axis 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 706c coupled to the axis 740. The transmission 706c includes a movable mechanical element such as a rotating element to control the axis 740 to rotate clockwise or counterclockwise more than 360°. In one aspect, the motor 704c is coupled to a rotation transmission assembly, which includes a tube gear section formed on (or attached to) the proximal end of the proximal closure tube to be operably engaged by a rotation gear assembly operably supported on a tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the axis 740. The position sensor 734 may be configured to provide the position of the closing 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.

[0243] 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 control 708d, which provides a drive signal to a motor 704d. The output of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d coupled to the articulation member 742a. ​​The transmission 706d includes a movable mechanical element such as an articulation element to control the articulation of the end effector 702 ± 65°. 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 and rotatably driven thereon by an articulation gear assembly. 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 an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710 .

[0244] On the other hand, the joint motion function of the robotic surgical system 700 may include two joint motion components or connecting rods 742a, 742b. These joint motion components 742a, 742b are driven by a separate disk on the robot interface (rack) driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the joint motion connecting rods 742a, 742b can be driven in an antagonistic manner relative to another connecting rod so as to provide resistance to the head to maintain motion and load when the head is not moving, and to provide joint motion when the head is articulated. When the head rotates, the joint motion components 742a, 742b are attached to the head with a fixed radius. Therefore, when the head rotates, the mechanical advantage of the push-pull connecting rod changes. This change in mechanical advantage can be more obvious for other joint motion connecting rod drive systems.

[0245] In one aspect, one or more motors 704a-704e may include a brushed DC motor with a gearbox and a mechanical link with a firing member, a closing member, or an articulation member. Another example includes an electric motor 704a-704e that operates a movable mechanical element such as a displacement member, an articulation link, a closing tube, and an axis. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body, and friction on a physical system. Such external influences may be referred to as drag, which acts relative to one of the electric motors 704a-704e. External influences such as drag may cause the operation of a physical system to deviate from the desired operation of the physical system.

[0246] In one aspect, the position sensor 734 can be implemented as an absolute positioning system. In one aspect, the position sensor 734 can include a magnetic rotation absolute positioning system implemented as an AS5055EQFT monolithic magnetic rotation position sensor, which can be purchased from Austria Microsystems, AG. The position sensor 734 can interface with the control circuit 710 to provide an absolute positioning system. The position can include a Hall effect element located above the magnet and coupled to a CORDIC processor, which is also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions, which only require addition operations, subtraction operations, digit shift operations, and table lookup operations.

[0247] In one aspect, the control circuit 710 may communicate 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 include a magnetic sensor, a magnetic field sensor, a strain gauge, a load sensor, 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 nail magazine 718 platform to determine tissue position using segmented electrodes. The torque sensors 744a-744e may be configured to sense forces such as firing forces, closing forces, and / or joint motion forces, etc. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the portion of the staple cartridge 718 having tissue thereon, and (4) the loads and positions on the two articulation rods.

[0248] In one aspect, one or more sensors 738 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of the strain in the anvil 716 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 738 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect the impedance of the tissue section between the anvil 716 and the staple cartridge 718, which indicates the thickness and / or completeness of the tissue located therebetween.

[0249] 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, and the like. In other implementations, the sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switch may be a solid-state device, such as a transistor (e.g., a FET, a junction FET, a MOSFET, a bipolar transistor, and the like). In other implementations, the sensor 738 may include a non-electrical conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and the like.

[0250] In one aspect, the sensor 738 may be configured to measure the force applied by the closure drive system to the anvil 716. For example, one or more sensors 738 may be located at the interaction point between the closure tube and the anvil 716 to detect the closing force applied by the closure tube to the anvil 716. The force applied to the anvil 716 may represent the tissue compression experienced by the tissue segment captured between the anvil 716 and the staple cartridge 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closing force applied by the closure drive system to the anvil 716. One or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. The control circuit 710 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to the anvil 716 in real time.

[0251] In one aspect, the current sensor 736 can be used to measure the current consumed by each of the motors 704a-704e. The force required to propel any of the movable mechanical elements (such as the I-beam 714) corresponds to the current consumed by one of the motors 704a-704e. The force is converted into 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 software of the controller. The displacement member can be actuated to move the I-beam 714 in the end effector 702 at a target speed or close to the target speed. The robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers, including but not limited to, for example, PID, state feedback, linear square (LQR) and / or adaptive controllers. The robotic surgical instrument 700 may include a power source to, for example, convert a signal from the feedback controller into a physical input, such as a housing 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 TECHNIQUESFOR ROBOTIC SURGICAL INSTRUMENT,” which is incorporated herein by reference in its entirety.

[0252] Fig.18 A block diagram of a surgical instrument 750 programmed to control distal translation of a displacement member is shown according to one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control distal translation of a displacement member such as an I-beam 764. The surgical instrument 750 includes an end effector 752, which may include an anvil 766, an I-beam 764 (including a sharp cutting edge), and a removable staple cartridge 768.

[0253] The position, movement, displacement and / or translation of a linear displacement member such as the I-beam 764 can be measured by an absolute positioning system, a sensor arrangement and a position sensor 784. Since the I-beam 764 is coupled to a longitudinally movable drive member, the position of the I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Therefore, in the following description, the position, displacement and / or translation of the I-beam 764 can be achieved by the position sensor 784 as described herein. The control circuit 760 can be programmed to control the translation of a displacement member such as the I-beam 764. In some examples, the control circuit 760 may include one or more microcontrollers, microprocessors or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the I-beam 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 circuit 760 to correlate the position of the I-beam 764 as determined by the position sensor 784 with the output of the timer / counter 781 so that the control circuit 760 can determine the position of the I-beam 764 at a particular time (t) relative to the starting position. The timer / counter 781 can be configured to measure elapsed time, count external events, or time external events.

[0254] The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754, as described herein. In some examples, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor, and the motor drive signal 774 may include a PWM signal provided to one or more stator windings of the motor 754. Moreover, in some examples, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.

[0255] The motor 754 may receive power from the energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via the transmission 756. The transmission 756 may include one or more gears or other linkage components to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicating the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 when the I-beam 764 translates toward the distal side and toward the proximal side. The control circuit 760 may track these pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicating the movement of the I-beam 764. Moreover, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuit 760 can track the position of I-beam 764 by aggregating the number and direction of steps motor 754 has been instructed to perform. Position sensor 784 may be located in end effector 752 or at any other portion of the instrument.

[0256] The control circuit 760 may communicate with one or more sensors 788. The sensor 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 sensor 788 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 752. The sensor 788 may include one or more sensors.

[0257] One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of the strain in the anvil 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of the tissue section between the anvil 766 and the staple cartridge 768, which indicates the thickness and / or completeness of the tissue located therebetween.

[0258] The sensor 788 may be configured to measure the force applied by the closure drive system to the anvil 766. For example, one or more sensors 788 may be located at the interaction point between the closure tube and the anvil 766 to detect the closing force applied by the closure tube to the anvil 766. The force applied to the anvil 766 may represent the tissue compression experienced by the tissue segment captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied by the closure drive system to the anvil 766. One or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during the clamping operation. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to the anvil 766 in real time.

[0259] A current sensor 786 may be employed to measure the current consumed by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

[0260] The control circuit 760 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the I-beam 764 in the end effector 752 at a target speed or close to the target speed. The surgical instrument 750 may include a feedback controller, which may be one of any feedback controllers, including but not limited to, for example, PID, state feedback, LQR, and / or adaptive controllers. The surgical instrument 750 may include a power source to, for example, convert a signal from the feedback controller into a physical input, such as a housing voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force.

[0261] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member or I-beam 764 through a brushed DC motor with a gear box and mechanical connection to the articulation and / or knife system. Another example is an electric motor 754 that operates the displacement member and articulation drive of, for example, an interchangeable shaft assembly. External influences are the unmeasured, unpredictable effects of things such as tissue, surrounding body, and friction on the physical system. Such external influences can be referred to as drag acting relative to the electric motor 754. External influences such as drag can cause the operation of the physical system to deviate from the desired operation of the physical system.

[0262] Various exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 with a motor-driven surgical stapling and cutting tool. For example, a motor 754 can drive a displacement member distally and proximally along the longitudinal axis of the end effector 752. The end effector 752 can include a pivotable anvil 766, and when configured for use, a staple cartridge 768 is positioned opposite the anvil 766. The clinician can hold tissue between the anvil 766 and the staple cartridge 768, as described herein. When the instrument 750 is ready to be used, the clinician can provide a firing signal, for example, by pressing a trigger of the instrument 750. In response to the firing signal, the motor 754 can drive the displacement member distally from a proximal stroke start position to a stroke end position distal to the stroke start position along the longitudinal axis of the end effector 752. When the displacement member translates distally, an I-beam 764 with a cutting element positioned at the distal end can cut tissue between the staple cartridge 768 and the anvil 766.

[0263] In various examples, the surgical instrument 750 may include a control circuit 760 that is programmed to control the distal translation of a displacement member (such as an I-beam 764) based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, directly or indirectly, as described herein. The control circuit 760 may be programmed to select a firing control program based on the tissue conditions. The firing control program may describe the distal movement of the displacement member. Different firing 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 lower speed and / or at a lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or at a higher power.

[0264] In some examples, the control circuit 760 may initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's travel. Based on the response of the instrument 750 during the open-loop portion of the travel, the control circuit 760 may select a firing control program. The response of the instrument may include the distance the displacement member was translated 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 sum of the pulse widths of the motor drive signal, etc. After the open-loop portion, the control circuit 760 may implement the selected firing control program for a second portion of the displacement member's travel. For example, during the closed-loop portion of the travel, the control circuit 760 may adjust the motor 754 in a closed-loop manner based on the translation data describing the position of the displacement member so that the displacement member translates at a constant speed. Additional details are disclosed in U.S. patent application serial number 15 / 720,852, filed on September 29, 2017, entitled “SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT,” which is incorporated herein by reference in its entirety.

[0265] Fig.19 is a schematic diagram of a surgical instrument 790 configured to control various functions according to one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control distal translation of a displacement member such as an I-beam 764. The surgical instrument 790 includes an end effector 792, which may include an anvil 766, an I-beam 764, and a removable staple cartridge 768 that may be interchangeable with an RF cartridge 796 (shown in phantom).

[0266] 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, and the like. In other implementations, the sensor 638 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switch may be a solid-state device, such as a transistor (e.g., a FET, a junction FET, a MOSFET, a bipolar transistor, and the like). In other implementations, the sensor 788 may include a non-electric conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and the like.

[0267] In one aspect, the position sensor 784 can be implemented as an absolute positioning system including a magnetic rotary absolute positioning system implemented as an AS5055EQFT monolithic magnetic rotary position sensor, available from Austria Microsystems, AG. The position sensor 784 interfaces with the control circuit 760 to provide an absolute positioning system. The position may include a Hall effect element located above a magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions, which only require addition operations, subtraction operations, bit shift operations, and table lookup operations.

[0268] In one aspect, the I-beam 764 can be implemented as a knife member including a knife body that operably supports the tissue cutting blade thereon, and the I-beam can also include an anvil engagement tab or feature and a channel engagement feature or foot. In one aspect, the staple cartridge 768 can be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, the RF cartridge 796 can be implemented as an RF cartridge. These and other sensor arrangements are described in U.S. patent application serial number 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.

[0269] The position, movement, displacement and / or translation of a linear displacement member such as the I-beam 764 can be measured by an absolute positioning system, a sensor arrangement, and a position sensor, represented as position sensor 784. Since the I-beam 764 is coupled to a longitudinally movable drive member, the position of the I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Therefore, in the following description, the position, displacement and / or translation of the I-beam 764 can be achieved by the position sensor 784 as described herein. The control circuit 760 can be programmed to control the translation of a displacement member such as the I-beam 764 as described herein. In some examples, the control circuit 760 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the I-beam 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 circuit 760 to correlate the position of the I-beam 764 as determined by the position sensor 784 with the output of the timer / counter 781 so that the control circuit 760 can determine the position of the I-beam 764 at a particular time (t) relative to the starting position. The timer / counter 781 can be configured to measure elapsed time, count external events, or time external events.

[0270] The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754, as described herein. In some examples, the motor 754 may be a brushed DC electric motor. For example, the speed of the motor 754 may be proportional to the motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor, and the motor drive signal 774 may include a PWM signal provided to one or more stator windings of the motor 754. Moreover, in some examples, the motor controller 758 may be omitted, and the control circuit 760 may directly generate the motor drive signal 774.

[0271] The motor 754 may receive power from the energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via the transmission 756. The transmission 756 may include one or more gears or other linkage components to couple the motor 754 to the I-beam 764. The position sensor 784 may sense the position of the I-beam 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicating the position of the I-beam 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 when the I-beam 764 translates toward the distal side and toward the proximal side. The control circuit 760 may track these pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicating the movement of the I-beam 764. Moreover, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuit 760 may track the position of I-beam 764 by aggregating the number and direction of steps the motor has been instructed to perform. Position sensor 784 may be located in end effector 792 or at any other portion of the instrument.

[0272] The control circuit 760 may communicate with one or more sensors 788. The sensor 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 sensor 788 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 792. The sensor 788 may include one or more sensors.

[0273] One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of the strain in the anvil 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of the tissue section between the anvil 766 and the staple cartridge 768, which indicates the thickness and / or completeness of the tissue located therebetween.

[0274] The sensor 788 may be configured to measure the force applied by the closure drive system to the anvil 766. For example, one or more sensors 788 may be located at the interaction point between the closure tube and the anvil 766 to detect the closing force applied by the closure tube to the anvil 766. The force applied to the anvil 766 may represent the tissue compression experienced by the tissue segment captured between the anvil 766 and the staple cartridge 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied by the closure drive system to the anvil 766. One or more sensors 788 may be sampled in real time by the processor portion of the control circuit 760 during the clamping operation. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to the anvil 766 in real time.

[0275] A current sensor 786 may be employed to measure the current consumed by the motor 754. The force required to advance the I-beam 764 corresponds to the current consumed by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

[0276] When the RF cartridge 796 is loaded in the end effector 792 in place of the staple cartridge 768, the RF energy source 794 is coupled to the end effector 792 and applied to the RF cartridge 796. The control circuit 760 controls the delivery of RF energy to the RF cartridge 796.

[0277] Additional details are disclosed in U.S. patent application serial number 15 / 636,096, filed on June 28, 2017, entitled “SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME,” which is incorporated herein by reference in its entirety.

[0278] Generator Hardware

[0279] Fig. 208 is a simplified block diagram of a generator 800 configured to provide, among other benefits, inductor-free tuning. Additional details of the generator 800 are described in U.S. Pat. No. 9,060,775, entitled “SURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES,” issued on June 23, 2015, which is incorporated herein by reference in its entirety. The generator 800 may include a patient-isolated stage 802 that communicates with a non-isolated stage 804 via a power transformer 806. A secondary winding 808 of the power transformer 806 is contained in the isolation stage 802 and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define drive signal outputs 810a, 810b, 810c for delivering drive signals to different surgical instruments, such as ultrasonic surgical instruments, RF electrosurgical instruments, and multi-function surgical instruments including ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. Specifically, the drive signal outputs 810a, 810c can output ultrasonic drive signals (e.g., 420V root mean square (RMS) drive signals) to an ultrasonic surgical instrument, and the drive signal outputs 810b, 810c can output RF electrosurgical drive signals (e.g., 100V RMS drive signals) to an electrosurgical instrument, where the drive signal output 810b corresponds to the center tap of the power transformer 806.

[0280] In some forms, the ultrasonic drive signal and the electrosurgical drive signal can be provided simultaneously to different surgical instruments and / or a single surgical instrument having the ability to deliver both ultrasonic energy and electrosurgical energy to tissue, such as a multifunctional surgical instrument. It should be understood that the electrosurgical signal provided to a dedicated electrosurgical instrument and / or provided to a combined multifunctional ultrasonic / electrosurgical instrument can be a therapeutic level signal or a sub-therapeutic level signal, wherein the sub-therapeutic signal can be used, for example, to monitor tissue or instrument conditions and provide feedback to the generator. For example, an ultrasonic signal and an RF signal can be delivered separately or simultaneously from a generator having a single output port to provide a desired output signal to the surgical instrument, as will be discussed in more detail below. Therefore, the generator can combine ultrasonic energy and electrosurgical RF energy and deliver the combined energy to the multifunctional ultrasonic / electrosurgical instrument. A bipolar electrode can be placed on one or both jaws of the end effector. In addition to electrosurgical RF energy, one jaw can be driven simultaneously by ultrasonic energy. Ultrasonic energy can be used to dissect tissue, while electrosurgical RF energy can be used for vessel sealing.

[0281] The non-isolated stage 804 may include a power amplifier 812 having an output connected to a primary winding 814 of a power transformer 806. In certain forms, the power amplifier 812 may include a push-pull amplifier. For example, the non-isolated stage 804 may also include a logic device 816 for providing a digital output to a digital-to-analog converter (DAC) circuit 818, which in turn provides a corresponding analog signal to an input of the power amplifier 812. In certain forms, the logic device 816 may include a programmable gate array (PGA), an FPGA, a programmable logic device (PLD), among other logic circuits. Thus, by controlling the input of the power amplifier 812 via the DAC circuit 818, the logic device 816 may control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal appearing at the drive signal outputs 810a, 810b, 810c. In certain forms, as described below, the logic device 816 in conjunction with a processor (e.g., a DSP discussed below) may implement a plurality of DSP-based algorithms and / or other control algorithms to control parameters of the drive signal output by the generator 800.

[0282] Power may be provided to the power rail of the power amplifier 812 by a switch-mode regulator 820 (e.g., a power converter). In certain forms, the switch-mode regulator 820 may include, for example, an adjustable buck regulator. The non-isolated stage 804 may also include a first processor 822, for example, in one form, the first processor may include a DSP processor, such as an Analog Devices ADSP-21469 SHARC DSP available from Analog Devices, Norwood, MA, although any suitable processor may be employed in various forms. In certain forms, the DSP processor 822 may control the operation of the switch-mode regulator 820 in response to voltage feedback data received by the DSP processor 822 from the power amplifier 812 via an ADC circuit 824. In one form, for example, the DSP processor 822 may receive as input a waveform envelope of a signal (e.g., a radio frequency signal) amplified by the power amplifier 812 via the ADC circuit 824. The DSP processor 822 can then control the switch mode regulator 820 (e.g., via a PWM output) so that the rail voltage provided to the power amplifier 812 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 812 based on the waveform envelope, the efficiency of the power amplifier 812 can be significantly improved relative to a fixed rail voltage amplifier solution.

[0283] In certain forms, the logic device 816 in conjunction with the DSP processor 822 may implement a digital synthesis circuit such as a direct digital synthesizer control scheme to control the waveform shape, frequency and / or amplitude of the drive signal output by the generator 800. In one form, for example, the logic device 816 may implement a DDS control algorithm by recalling waveform samples stored in a dynamically updated lookup table (LUT) (such as a RAM LUT), which may be embedded in an FPGA. The control algorithm is particularly useful for ultrasound applications where an ultrasonic transducer such as an ultrasonic transducer may be driven by a pure sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the overall distortion of the motional branch current may correspondingly minimize or reduce adverse resonance effects. Because the waveform shape of the drive signal output by the generator 800 is affected by various sources of distortion present in the output drive circuit (e.g., power transformer 806, power amplifier 812), voltage and current feedback data based on the drive signal can be input into an algorithm (such as an error control algorithm implemented by the DSP processor 822) that compensates for distortion by appropriately pre-distorting or modifying the waveform samples stored in the LUT in a dynamic and ongoing manner (e.g., in real time). In one form, the amount or degree of pre-distortion applied to the LUT samples can be based on the error between the calculated motional branch current and the desired current waveform shape, which can be determined on a sample-by-sample basis. In this way, the pre-distorted LUT samples, when processed by the drive circuit, can cause the motional branch drive signal to have a desired waveform shape (e.g., a sinusoidal shape) to optimally drive the ultrasonic transducer. Therefore, in such forms, when the distortion effects are taken into account, the LUT waveform samples will not exhibit the desired waveform shape of the drive signal, but rather will exhibit the waveform shape required to ultimately produce the desired waveform shape of the motional branch drive signal.

[0284] The non-isolated stage 804 may also include a first ADC circuit 826 and a second ADC circuit 828 coupled to the output of the power transformer 806 via respective isolation transformers 830, 832 for respectively sampling the voltage and current of the drive signal output by the generator 800. In certain forms, the ADC circuits 826, 828 may be configured to sample at a high speed (e.g., 80 megasamples per second (MSPS)) to enable oversampling of the drive signal. In one form, for example, the sampling speed of the ADC circuits 826, 828 may achieve an oversampling of the drive signal by approximately 200x (depending on the frequency). In certain forms, the sampling operation of the ADC circuits 826, 828 may be performed by having a single ADC circuit receive the input voltage and current signals via a two-way multiplexer. By using high speed sampling in forms of the generator 800, among other things, calculations of complex currents flowing through the motional branches (which in some forms can be used to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and calculation of actual power consumption with high accuracy can be achieved. The voltage and current feedback data output by the ADC circuits 826, 828 can be received and processed by the logic device 816 (e.g., first-in, first-out (FIFO) buffer, multiplexer), and stored in a data memory for subsequent retrieval by, for example, the DSP processor 822. As described above, the voltage and current feedback data can be used as input to an algorithm for pre-distorting or modifying LUT waveform samples in a dynamic and ongoing manner. In some forms, when voltage and current feedback data pairs are acquired, it may be necessary to index each stored voltage and current feedback data pair based on or otherwise associated with the corresponding LUT sample output by the logic device 816. Synchronizing the LUT samples and the voltage and current feedback data in this manner facilitates accurate timing and stability of the pre-distortion algorithm.

[0285] In certain forms, the voltage and current feedback data may be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. In one form, for example, the voltage and current feedback data may be used to determine the impedance phase. The frequency of the drive signal may then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the impedance phase measurement accuracy. The determination of the phase impedance and frequency control signal may be implemented in the DSP processor 822, for example, where the frequency control signal is provided as an input to a DDS control algorithm implemented by the logic device 816.

[0286] In another form, for example, current feedback data may be monitored in order to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point may be specified directly or determined indirectly based on a particular voltage amplitude and power set point. In certain forms, control of the current amplitude may be achieved, for example, by a control algorithm in the DSP processor 822, such as a proportional integral derivative (PID) control algorithm. Variables controlled by the control algorithm to appropriately control the current amplitude of the drive signal may include, for example, the scale of the LUT waveform samples stored in the logic device 816 and / or the full-scale output voltage of the DAC circuit 818 (which provides input to the power amplifier 812) via the DAC circuit 834.

[0287] The non-isolated stage 804 may also include a second processor 836, which is used to provide, among other things, user interface (UI) functions. In one form, the UI processor 836 may include, for example, an Atmel AT91SAM9263 processor with an ARM 926EJ-S core purchased from Atmel Corporation (San Jose, California). Examples of UI functions supported by the UI processor 836 may include auditory and visual user feedback, communication with peripheral devices (e.g., via a USB interface), communication with a foot switch, communication with an input device (e.g., a touch screen display), and communication with an output device (e.g., a speaker). The UI processor 836 may communicate with the DSP processor 822 and the logic device 816 (e.g., via an SPI bus). Although the UI processor 836 may primarily support UI functions, in some forms, the UI processor may also cooperate with the DSP processor 822 to mitigate risks. For example, the UI processor 836 may be programmed to monitor various aspects of user input and / or other input (e.g., touch screen input, foot switch input, temperature sensor input) and disable the drive output of the generator 800 when an error condition is detected.

[0288] In certain forms, for example, both the DSP processor 822 and the UI processor 836 can determine and monitor the operating state of the generator 800. For the DSP processor 822, the operating state of the generator 800 can indicate, for example, which control and / or diagnostic processes are implemented by the DSP processor 822. For the UI processor 836, the operating state of the generator 800 can indicate, for example, which elements of the UI (e.g., display screen, sound) are presented to the user. The respective DSP processor 822 and UI processor 836 can independently maintain the current operating state of the generator 800 and identify and evaluate possible transitions of the current operating state. The DSP processor 822 can act as the principal in this relationship and determine when a transition between operating states will occur. The UI processor 836 can note valid transitions between operating states and can confirm whether a particular transition is appropriate. For example, when the DSP processor 822 commands the UI processor 836 to transition to a particular state, the UI processor 836 can verify that the requested transition is valid. If the UI processor 836 determines that the requested transition between states is invalid, the UI processor 836 can cause the generator 800 to enter a fault mode.

[0289] The non-isolated stage 804 may also include a controller 838 for monitoring input devices (e.g., capacitive touch sensors, capacitive touch screens for turning the generator 800 on and off). In certain forms, the controller 838 may include at least one processor and / or other controller device in communication with the UI processor 836. In one form, for example, the controller 838 may include a processor (e.g., a Meg168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one form, the controller 838 may include a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) to control and manage the collection of touch data from the capacitive touch screen.

[0290] In certain forms, when the generator 800 is in the "power off" state, the controller 838 may continue to receive operating power (e.g., via a line from a power source of the generator 800, such as the power source 854 discussed below). As such, the controller 838 may continue to monitor an input device (e.g., a capacitive touch sensor located on a front panel of the generator 800) for turning the generator 800 on and off. When the generator 800 is in the power off state, if activation of the user "on / off" input device is detected, the controller 838 may activate the power source (e.g., enable operation of one or more DC / DC voltage converters 856 of the power source 854). The controller 838 may thus initiate a sequence for transitioning the generator 800 to the "power on" state. Conversely, when the generator 800 is in the power on state, if activation of the "on / off" input device is detected, the controller 838 may initiate a sequence for transitioning the generator 800 to the power off state. In certain forms, for example, the controller 838 may report activation of an "on / off" input device to the UI processor 836, which in turn implements the required sequence of processes for transitioning the generator 800 to the power off state. In such forms, the controller 838 may not have an independent ability to remove power from the generator 800 after the power on state is established.

[0291] In some forms, the controller 838 may cause the generator 800 to provide audible or other sensory feedback to alert the user that a power-on or power-off sequence has been initiated. Such an alert may be provided at the start of a power-on or power-off sequence and before other processes associated with the sequence begin.

[0292] In certain forms, the isolated stage 802 may include an instrument interface circuit 840 to provide a communication interface, for example, between control circuitry of a surgical instrument (e.g., control circuitry including a handpiece switch) and components of the non-isolated stage 804, such as the logic device 816, the DSP processor 822, and / or the UI processor 836. The instrument interface circuit 840 may exchange information with components of the non-isolated stage 804 via a communication link, such as an IR-based communication link, that maintains a suitable degree of electrical isolation between the isolated stage 802 and the non-isolated stage 804. For example, the instrument interface circuit 840 may be powered using a low-dropout voltage regulator powered by an isolation transformer, which is driven from the non-isolated stage 804.

[0293] In one form, the instrument interface circuit 840 may include a logic circuit 842 (e.g., a logic circuit, a programmable logic circuit, a PGA, an FPGA, a PLD) in communication with a signal conditioning circuit 844. The signal conditioning circuit 844 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the logic circuit 842 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be transmitted to a surgical instrument control circuit (e.g., by using a conductor pair in a cable connecting the generator 800 to the surgical instrument) and monitored to determine the state or configuration of the control circuit. The control circuit may include a plurality of switches, resistors, and / or diodes to modify one or more characteristics of the interrogation signal (e.g., amplitude, rectification) so that the state or configuration of the control circuit can be uniquely discerned based on the one or more characteristics. In one form, for example, the signal conditioning circuit 844 may include an ADC circuit for generating a sample of a voltage signal appearing at the input of the control circuit due to the interrogation signal passing through the control circuit. Subsequently, logic circuit 842 (or a component of non-isolated stage 804 ) may determine a state or configuration of the control circuit based on the ADC circuit samples.

[0294] In one form, the instrument interface circuit 840 may include a first data circuit interface 846 to enable information exchange between the logic circuit 842 (or other elements of the instrument interface circuit 840) and the first data circuit disposed in the surgical instrument or otherwise associated with the surgical instrument. In some forms, for example, the first data circuit may be disposed in a cable integrally attached to the surgical instrument handpiece, or disposed in an adapter for interfacing a specific surgical device type or model with the generator 800. The first data circuit may be implemented in any suitable manner and may be communicated with the generator according to any suitable protocol including, for example, those described herein with respect to the first data circuit. In some forms, the first data circuit may include a non-volatile storage device, such as an EEPROM device. In some forms, the first data circuit interface 846 may be implemented separately from the logic circuit 842 and include suitable circuits (e.g., discrete logic devices, processors) to enable communication between the logic circuit 842 and the first data circuit. In other forms, the first data circuit interface 846 may be integrated with the logic circuit 842.

[0295] In some forms, the first data circuit may store information related to a specific surgical instrument associated therewith. Such information may include, for example, a model number, a serial number, a plurality of operations in which the surgical instrument has been used, and / or any other type of information. Such information may be read by the instrument interface circuit 840 (e.g., by the logic circuit 842), transmitted to the components of the non-isolated station 804 (e.g., to the logic device 816, the DSP processor 822, and / or the UI processor 836) to be presented to the user via an output device and / or to control the function or operation of the generator 800. In addition, any type of information may be transmitted to the first data circuit via the first data circuit interface 846 (e.g., using the logic circuit 842) to be stored therein. Such information may include, for example, an updated number of operations in which the surgical instrument is used and / or the date and / or time of its use.

[0296] As previously described, surgical instruments may be detachable from a handpiece (e.g., a multifunctional surgical instrument may be detachable from a handpiece) to facilitate instrument interchangeability and / or disposableity. In such cases, the ability of conventional generators to identify the specific instrument configuration being used and to optimize control and diagnostic processes accordingly may be limited. However, from a compatibility perspective, addressing this issue by adding readable data circuits to surgical instruments is problematic. For example, designing a surgical instrument to maintain backward compatibility with a generator that lacks the requisite data reading functionality may be impractical due to, for example, different signaling schemes, design complexity, and cost. The form of the instrument described herein addresses these issues by using data circuits that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical instrument with the current generator platform.

[0297] In addition, the form of the generator 800 can realize communication with the data circuit based on the instrument. For example, the generator 800 can be configured to communicate with the second data circuit contained in the instrument (e.g., a multifunctional surgical instrument). In some forms, the second data circuit can be implemented in a manner similar to the first data circuit described herein. The instrument interface circuit 840 may include a second data circuit interface 848 for realizing the communication. In one form, the second data circuit interface 848 may include a tri-state digital interface, but other interfaces may also be used. In some forms, the second data circuit may generally be any circuit for transmitting and / or receiving data. In one form, for example, the second data circuit may store information related to the associated specific surgical instrument. Such information may include, for example, a model number, a serial number, a plurality of operations in which the surgical instrument has been used, and / or any other type of information.

[0298] In some forms, the second data circuit may store information about the electrical and / or ultrasonic performance of the associated ultrasonic transducer, end effector, or ultrasonic drive system. For example, the first data circuit may indicate an aging frequency slope, as described herein. Additionally or alternatively, any type of information may be transmitted to the second data circuit via the second data circuit interface 848 (e.g., using the logic circuit 842) for storage therein. Such information may, for example, include an updated number of operations in which a surgical instrument is used and / or the date and / or time of its use. In certain forms, the second data circuit may transmit data collected by one or more sensors (e.g., an instrument-based temperature sensor). In certain forms, the second data circuit may receive data from the generator 800 and provide an indication to the user based on the received data (e.g., an LED indication or other visual indication).

[0299] In certain forms, the second data circuit and the second data circuit interface 848 may be configured such that communication between the logic circuit 842 and the second data circuit may be achieved without providing additional conductors for this purpose (e.g., dedicated conductors of a cable connecting the hand piece to the generator 800). In one form, information may be communicated to and from the second data circuit using, for example, a single bus communication scheme implemented on an existing cable (such as one of the conductors used to transmit the interrogation signal from the signal conditioning circuit 844 to the control circuit in the hand piece). In this way, design changes or modifications to the surgical instrument that may otherwise be necessary may be minimized or reduced. Furthermore, because the different types of communications implemented on a common physical channel may be frequency-band separated, the presence of the second data circuit may be "invisible" to generators that do not have the requisite data reading functionality, thereby enabling backward compatibility of surgical instruments.

[0300] In some forms, the isolation stage 802 may include at least one blocking capacitor 850-1 connected to the drive signal output 810b to prevent direct current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. Although errors are relatively rare in single capacitor designs, such errors may have adverse consequences. In one form, a second blocking capacitor 850-2 may be provided in series with the blocking capacitor 850-1, wherein current leakage from a point between the blocking capacitors 850-1 and 850-2 is monitored, for example, by an ADC circuit 852 to sample the voltage induced by the leakage current. These samples may be received, for example, by the logic circuit 842. Based on changes in the leakage current (as indicated by the voltage samples), the generator 800 can determine when at least one of the blocking capacitors 850-1 and 850-2 fails, thereby providing a benefit over a single capacitor design with a single point of failure.

[0301] In certain forms, the non-isolated stage 804 may include a power source 854 for delivering DC power at an appropriate voltage and current. The power source may include, for example, a 400W power source for delivering a system voltage of 48VDC. The power source 854 may also include one or more DC / DC voltage converters 856 for receiving the output of the power source to generate a DC output at the voltage and current required by the various components of the generator 800. As described above in conjunction with the controller 838, one or more of the DC / DC voltage converters 856 may receive input from the controller 838 when the controller 838 detects that a user initiates an "on / off" input device to enable operation of the DC / DC voltage converter 856 or wake up the DC / DC voltage converter.

[0302] Fig.21 An example of a generator 900 is shown, which is a generator 800 ( Fig. 20 ) is a form of a device. The generator 900 is configured to deliver multiple energy modes to a surgical instrument. The generator 900 provides RF signals and ultrasonic signals for independently or simultaneously delivering energy to a surgical instrument. The RF signal and the ultrasonic signal may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modes (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation and / or microwave energy, etc.) through a single port, and these signals may be delivered to the end effector separately or simultaneously to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory coupled to the processor 902, which is not shown for clarity of the present disclosure. Digital information associated with the waveform is provided to the waveform generator 904, which includes one or more DAC circuits to convert digital inputs into analog outputs. The analog output is fed to the amplifier 1106 for signal conditioning and amplification. The regulated and amplified output of amplifier 906 is coupled to power transformer 908. The signal is coupled to the secondary side in the patient isolation side through power transformer 908. A first signal of a first energy mode is provided to a surgical instrument between terminals labeled ENERGY1 and RETURN. A second signal of a second energy mode is coupled across capacitor 910 and provided to a surgical instrument between terminals labeled ENERGY2 and RETURN. It should be understood that more than two energy modes can be output, and thus the subscript "n" can be used to specify that up to n ENERGYn terminals can be provided, where n is a positive integer greater than 1. It should also be understood that up to "n" return paths RETURNn can be provided without departing from the scope of the present disclosure.

[0303] The first voltage sensing circuit 912 is coupled to terminals marked as ENERGY1 and RETURN paths to measure the output voltage between the two terminals. The second voltage sensing circuit 924 is coupled to terminals marked as ENERGY2 and RETURN paths to measure the output voltage between the two terminals. As shown, the current sensing circuit 914 is arranged in series with the RETURN branch on the secondary side of the power transformer 908 to measure the output current of any energy mode. If a different return path is provided for each energy mode, a separate current sensing circuit should be provided in each return branch. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to the corresponding isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (non-patient isolation side) 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 calculation. The output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and calculate parameters such as output impedance. Input / output communication between the processor 902 and the patient isolation circuit is provided through the interface circuit 920. The sensor can also be in electrical communication with the processor 902 through the interface 920.

[0304] In one aspect, the impedance may be determined by the processor 902 by dividing the output of a first voltage sensing circuit 912 coupled at both ends to terminals labeled ENERGY1 / RETURN or a second voltage sensing circuit 924 coupled at both ends to terminals labeled ENERGY2 / RETURN by the output of a current sensing circuit 914 arranged in series with the RETURN branch on the secondary side of the power transformer 908. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for calculating the impedance. For example, the first energy modality ENERGY1 may be ultrasonic energy, and the second energy modality ENERGY2 may be RF energy. However, in addition to ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, etc. Moreover, although Fig.21The illustrated example shows that a single return path RETURN may be provided for two or more energy modalities, but in other aspects, multiple return paths RETURNn may be provided for each energy modality ENERGYn. Thus, as described herein, the ultrasonic transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.

[0305] like Fig.21 As shown in , a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities (such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy with a higher voltage and lower current to drive an ultrasonic transducer, deliver energy with a lower voltage and higher current to drive an RF electrode for sealing tissue, or deliver energy with a coagulation waveform for use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be manipulated, 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 outputs labeled ENERGY1 and RETURN, as shown in FIG. Fig.21 In one example, the connection of the RF bipolar electrode to the generator 900 output will preferably be between the outputs labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be an active electrode (e.g., a pencil or other probe) at the ENERGY2 output and a suitable return pad connected to the RETURN output.

[0306] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published on March 30, 2017, entitled “TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS,” which is incorporated herein by reference in its entirety.

[0307] As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that can transmit data through a non-solid medium using modulated electromagnetic radiation. The term does not mean that the associated organization does not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, and its Ethernet derivatives, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0308] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually a memory or some other data stream). The term is used herein to refer to a central processing unit (Central Processing Unit) in one or more systems (especially System on Chip (SoC)) that combine multiple specialized "processors".

[0309] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It can contain digital, analog, mixed signal, and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), a Wi-Fi module, or a coprocessor. A SoC may or may not include built-in memory.

[0310] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for a microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; an SoC may include a microcontroller as one of its devices. A microcontroller may include one or more core processing units (CPUs) as well as memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory, or OTP ROM, as well as a small amount of RAM, is also often included on the chip. Compared to microprocessors used in personal computers or other general-purpose applications consisting of various discrete chips, microcontrollers can be used for embedded applications.

[0311] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between the two components of a computer or a controller on an external device that manages the operation of the device (and the connection to the device).

[0312] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be, for example, the LM4F230H5QR ARMCortex-M4F processor core available from Texas Instruments, which includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improving performance beyond 40 MHz, 32KB of single-cycle serial random access memory (SRAM), a 32-bit MCU loaded with 128-bit MCUs, and a 32-bit MCU. Internal read-only memory (ROM) for 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) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features that are readily available.

[0313] In one aspect, the processor may include a safety controller including two families based on controllers such as the TMS570 and RM4x also offered by Texas Instruments under the trade name Hercules ARMCortex R4. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

[0314] The modular device includes a module that can be accommodated in a surgical hub (such as a combination of Figure 3 and Fig. 9The invention relates to a surgical device or instrument that can be connected to various modules so as to be connected or paired with a corresponding surgical hub. The modular device includes, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. The modular device described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on a surgical hub paired with a specific modular device, 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 through the modular device). The data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which the knife is advanced, the motor current, or the energy level). For example, the control algorithm of a surgical suturing and cutting instrument can control the rate at which the motor of the instrument drives its knife through the tissue according to the resistance encountered by the knife as it advances.

[0315] Long-distance communication and status processing of devices and data

[0316] Surgical procedures are performed by different surgeons at different locations, and some surgeons have much less experience than other surgeons. For a given surgical procedure, there are many parameters that can be changed to try to achieve the desired result. For example, for a given surgical procedure using energy provided by a generator, the surgeon typically relies solely on experience to determine the mode of energy to be utilized, the level of output power to be utilized, the duration of energy application, etc., in order to try to obtain the desired result. In order to increase the likelihood of achieving the desired results for multiple different surgical procedures, each surgeon should be provided with best practice recommendations that are based on important relationships identified in a large and accurate data set of information associated with multiple surgical procedures performed in multiple locations over time. However, there are many ways in which such data sets may be damaged, inaccurate, and / or insecure, thereby making the applicability of best practice recommendations derived therefrom questionable. For example, for data sent from a source to a cloud-based system, the data may be lost during transportation to the cloud-based system, the data may be damaged during transportation to the cloud-based system, the confidentiality of the data may be included during transportation to the cloud-based system, and / or the content of the data may be changed during transportation to the cloud-based system.

[0317] Multiple operating rooms located in multiple locations may each be equipped with a surgical hub. When a given surgical procedure is performed in a given operating room, the surgical hub may receive data associated with the surgical procedure and transmit the data to the cloud-based system. Over time, the cloud-based system will receive a large data set of information associated with the surgical procedure. The data may be transmitted from the surgical hub to the cloud-based system in a manner that allows the cloud-based system to (1) verify the authenticity of the transmitted data, (2) authenticate each of the respective surgical hubs that transmitted the data, and (3) trace the path that the data followed from the respective surgical hubs to the cloud-based system.

[0318] Thus, in one aspect, the present disclosure provides a surgical hub for transmitting generator data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of surgical hubs. The surgical hub includes a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to receive data from a generator, encrypt the data, generate a message authentication code (MAC) based on the data, generate a datagram including the encrypted data, the generated MAC, a source identifier, and a destination identifier, and transmit the datagram to the cloud-based system. The data is structured into a data packet including at least two of the following fields: a field indicating a data source, a unique timestamp, a field indicating an energy mode of the generator, a field indicating a power output of the generator, and a field indicating a duration of the power output of the generator. The datagram allows the cloud-based system to decrypt the encrypted data of the transmitted datagram, verify the integrity of the data based on the MAC, verify the surgical hub as the source of the datagram, and verify the transmission path followed by the datagram between the surgical hub and the cloud-based system.

[0319] In various aspects, the present disclosure provides a control circuit that transmits generator data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of surgical hubs, as described above. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to transmit generator data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of surgical hubs, as described above.

[0320] In another aspect, the present disclosure provides a cloud-based system communicatively coupled to a plurality of surgical hubs. Each surgical hub is configured to transmit generator data associated with a surgical procedure to the cloud-based system. The cloud-based system includes a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to receive a datagram generated by the surgical hub, decrypt the encrypted generator data of the received datagram, verify the integrity of the generator data based on a MAC, verify the surgical hub as the source of the datagram, and verify the transmission path followed by the datagram between the surgical hub and the cloud-based system. The datagram includes generator data captured from a generator associated with the surgical hub, a MAC generated by the surgical hub based on the generator data, a source identifier, and a destination identifier. The generator data has been encrypted by the surgical hub. The encrypted generator data has been constructed into a data packet including at least two of the following fields: a field indicating a data source, a unique timestamp, a field indicating an energy mode, a field indicating a power output, and a field indicating a duration of the applied power.

[0321] In various aspects, the present disclosure provides a control circuit that transmits generator data associated with a surgical procedure to a cloud-based system. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to transmit generator data associated with a surgical procedure to a cloud-based system.

[0322] In another aspect, the present disclosure provides a method that includes capturing data from a combination generator of a surgical hub during a surgical procedure, wherein the combination generator is configured to provide two or more different modes of energy. Encrypting the captured generator data, generating a MAC based on the captured generator data, generating a datagram including the encrypted generator data, the MAC, a source identifier, and a destination identifier, and transmitting the datagram from the surgical hub to a cloud-based system. The datagram allows the cloud-based system to verify the integrity of the transmitted generator data, verify the surgical hub as the source of the datagram, and determine a communication path followed by the datagram between the surgical hub and the cloud-based system.

[0323] By sending the captured generator data from multiple different surgical hubs to the cloud-based system, the cloud-based system is able to quickly build a large data set of information associated with multiple surgical procedures performed in multiple locations over time. In addition, due to the composition of the corresponding datagrams, for a given datagram, the cloud-based system is able to determine whether the datagram was originally sent by one of the surgical hubs (source verification), thereby providing an indication that the generator data received at the cloud-based system is legitimate data. For a given datagram, the cloud-based system is also able to determine whether the generator data received at the cloud-based system is the same as the generator data sent by the given surgical hub (data integrity), thereby allowing the authenticity of the received generator data to be verified. In addition, for a given datagram, the cloud-based system is also able to re-trace the communication path followed by the datagram, thereby allowing enhanced fault diagnosis in the case where the datagram received by the cloud-based system was originally sent from a device other than the surgical hub and / or the content of the datagram changes during transportation to the cloud-based system. It is worth noting that the present disclosure specifically refers to generator data. Here, the present disclosure should not be limited to being able to process only generator data. For example, the surgical hub 206 and / or cloud-based system 205 may process data from any component of the surgical system 202 coupled to the surgical hub 206 (e.g., imaging module 238, generator module 240, smoke evacuator module 226, suction / irrigation module 228, communication module 230, processor module 232, storage array 234, smart device / instrument 235, contactless sensor module 242, robotic hub 222, non-robotic surgical hub 206, wireless smart device / instrument 235, visualization system 208) and / or from any component coupled to / through such component in a manner similar to that discussed herein (e.g., see Figures 9 and 10 ) is data received by any device (e.g., endoscope 239, energy device 241).

[0324] Unfortunately, the results of surgical procedures are not always optimal. For example, failure events may occur, such as surgical device failure, undesired tissue perforation, undesired postoperative bleeding, etc. The occurrence of failure events can be attributed to any of a variety of different people and devices, including one or more surgeons, one or more devices associated with the surgical procedure, the patient's condition, and combinations thereof. When a given failure event occurs, it is not always clear who or what caused the failure event or how to reduce the incidence of failure events in conjunction with future surgical procedures.

[0325] During a given surgical procedure, a large amount of data associated with the surgical procedure may be generated and captured. All of the captured data may be transmitted to a surgical hub, and the captured data may be time stamped before or after being received at the surgical hub. When a fault event associated with the surgical procedure is detected and / or identified, it may be determined which of the captured data is associated with the fault event and / or which of the captured data is not associated with the fault event. In making this determination, the fault event may be defined as a time period including the detection / identification of the fault event before the fault event. Once a determination is made regarding the captured data associated with the fault event, the surgical hub may separate the captured data associated with the fault event from all other captured data, and the captured data may be separated based on tags, markers, etc. The captured data associated with the fault event may then be sorted in time based on the timestamp and the defined time period applicable to the fault event. The time-sorted captured data may then be transmitted to a cloud-based system for analysis with priority, wherein the priority is relative to the captured data not associated with the fault event. Regardless of whether the analysis identifies a device associated with the surgical procedure as the cause of the failure event, the surgical hub can tag the device so that the device can be removed from future use, further analyzed, and / or returned to the manufacturer.

[0326] When a given surgical procedure is performed, a large amount of data associated with the surgical procedure may be generated and captured. All of the captured data may be transmitted to a surgical hub, where all "personal" associations of the information may be stripped away. The captured data may be timestamped before being received at the surgical hub, after being received at the surgical hub, before being stripped of "personal" associations, or after being stripped of "personal" associations. The surgical hub may transmit the stripped data to a cloud-based system for subsequent analysis. Over time, the cloud-based system will receive large data sets of information associated with the surgical procedure. Therefore, in one aspect, the present disclosure provides a surgical hub for prioritizing surgical data associated with the surgical procedure to a cloud-based system that is communicatively coupled to a plurality of surgical hubs. The surgical hub includes a processor and a memory coupled to the processor. The memory stores instructions executable by the processor to capture surgical data, wherein the surgical data includes data associated with a surgical device, time stamp the captured surgical data, identify a failure event, identify a time period associated with the failure event, isolate the failure event surgical data from surgical data not associated with the failure event based on the identified time period, time-order the failure event surgical data by time stamp, encrypt the time-ordered failure event surgical data, generate a datagram including the encrypted failure event surgical data, and transmit the datagram to a cloud-based system. The datagram is structured to include a field including a flag that prioritizes the encrypted failure event surgical data over other encrypted data of the datagram. The datagram allows the cloud-based system to decrypt the encrypted failure event surgical data, focus analysis on the failure event surgical data rather than surgical data not associated with the failure event, and mark the surgical device associated with the failure event as at least one of: removed from an operating room, returned to a manufacturer, or inoperable in the future in the cloud-based system.

[0327] In various aspects, the present disclosure provides a control circuit that prioritizes generator data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of surgical hubs. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to prioritize surgical data associated with a surgical procedure to a cloud-based system communicatively coupled to a plurality of surgical hubs.

[0328] In another aspect, the present disclosure provides a method comprising: capturing data during a surgical procedure, transmitting the captured data to a surgical hub, time-stamping the captured data, identifying failure events associated with the surgical procedure, determining which of the captured data is associated with the failure events, separating the captured data associated with the failure events from all other captured data, sorting the captured data associated with the failure events by time, and prioritizing transmission of the time-sorted captured data to a cloud-based system.

[0329] By capturing a large amount of data associated with a surgical procedure, and by time-stamping the captured data, the portion of the captured data that is relevant to a detected / identified fault event can be more easily isolated from all of the other captured data, thereby allowing for a more focused subsequent analysis of only the relevant captured data. The data associated with the fault event can then be sorted in time (which requires less processing power than sorting all of the captured data in time), thereby allowing for the events that led to the detection / identification of the fault event to be more easily considered during subsequent analysis of the fault event. The time-sorted data can then be preferentially transmitted to a cloud-based system (which requires fewer communication resources than transmitting all of the captured data simultaneously), thereby allowing the cloud-based system to perform a focused subsequent analysis of the fault event in a more time-sensitive manner.

[0330] To help ensure that best practice recommendations are developed based on accurate data, it is desirable to ensure that the generator data received at the cloud-based system is the same as the generator data transmitted to the cloud-based system. Additionally, to help enable the cause of a fault event to be determined as quickly as possible, it is desirable to ensure that surgical data associated with the fault event is transmitted to the cloud-based system in a prioritized manner (relative to surgical data not associated with the fault event) so that analysis of the surgical data can be performed in an accelerated manner.

[0331] Various aspects of systems and methods for transmitting data associated with a surgical procedure are described herein. Fig. 9 As shown, various aspects of the computer-implemented interactive surgical system 200 include a device / instrument 235, a generator module 240, a modular control tower 236, and a cloud-based system 205. Fig.10 As shown, the device / instrument 235, the generator module 240 and the modular control tower 236 are components / parts of the surgical hub 206.

[0332] In various aspects, the generator module 240 of the surgical hub 206 can provide RF energy, such as monopolar RF energy, bipolar RF energy, and advanced bipolar energy and / or ultrasonic energy, to the devices / instruments 235 used in the surgical procedure. Therefore, the generator module 240 can be referred to as a combination generator. Examples of such combination generators are described in Fig. 22 , where a combination generator 3700 is shown to include a monopolar module 3702, a bipolar module 3704, an advanced bipolar module 3706, and an ultrasonic module 3708. When used during a surgical procedure, the respective energy modules (e.g., 3702, 3704, 3706, and / or 3708) of the combination generator 3700 may provide generator data to a data communications module 3710 of the combination generator 3700, such as the type of energy provided to the device instrument (e.g., RF energy, ultrasonic energy, RF energy, and ultrasonic energy), the type of RF energy (e.g., monopolar, bipolar, advanced bipolar), frequency, power output, duration, etc.

[0333] Fig.23 Various aspects of a method of capturing data from a combined generator 3700 and transmitting the captured generator data to a cloud-based system 205 are shown. It is worth noting that, as discussed herein, the present disclosure should not be limited to processing generator data. Fig.23 The method is similarly extended to other types of data received from other components coupled to the surgical hub 206 (e.g., imaging module data, smoke evacuator data, suction / irrigation data, device / instrument data). The method includes (1) capturing 3712 data from a combination generator 3700 of a surgical hub 206 during a surgical procedure, wherein the combination generator 3700 is configured to provide two or more different modes of energy; (2) encrypting 3714 the captured generator data; (3) generating 3716 a MAC based on the captured generator data; (4) generating 3718 a datagram comprising the encrypted generator data, the MAC, a source identifier, and a destination identifier; and (5) transmitting 3720 the datagram from the surgical hub 206 to a cloud-based system 205, wherein the datagram allows the cloud-based system 205 to (i) verify the integrity of the transmitted generator data, (ii) verify the surgical hub as the source of the datagram, and (iii) determine the communication path followed by the datagram between the surgical hub 206 and the cloud-based system 205.

[0334] More specifically, once the generator data is received at the data communication module 3710 of the combined generator 3700, the generator data may be transmitted to the modular communication hub 203 of the surgical hub 206 for subsequent communication with the cloud-based system 205. The data communication module 3710 may transmit the generator data to the modular communication hub 203 serially over a single communication line or in parallel over multiple communication lines, and such communications may be performed in real time or near real time. Alternatively, such communications may be performed in batches.

[0335] According to various aspects, components of the combined generator 3700 (e.g., the data communication module 3710) may organize the generator data into data packets before transmitting the generator data to the modular communication hub 203. Examples of such data packets are described in Fig.24 , where a data packet 3722 includes a preamble 3724 or self-describing data header that defines what the data is (e.g., combined generator data - CGD) and fields indicating where the generator data is coming from [e.g., combined generator ID number 3726 - (e.g., 017), unique timestamp 3728 (e.g., 08:27:16), energy mode utilized 3730 (e.g., RF, U, RF+U), RF energy type or RF mode 3732 (e.g., MP, BP, ABP), frequency 3734 (e.g., 500KHz), power output 3736 (e.g., 30 Watts), duration of applied power 3738 (e.g., 45 milliseconds), and authentication / identification credentials for data point 3740 (e.g., 01101011001011)]. The exemplary data packets 3722 may be considered self-describing data packets, and the combined generator 3700 and other intelligent devices (e.g., the surgical hub 206) may use self-describing data packets to minimize data size and data processing resources. Likewise, as discussed herein, the present disclosure should not be limited to processing generator data received from the combined generator 3700. Thus, Fig.24 The data grouping 3722 of the surgical hub 206 may be similarly generalized to other types of data received from other components coupled to the surgical hub 206. In one aspect, the data grouping 3722 may include data associated with the endoscope 239 received from components of the imaging module 238 (e.g., image data). In another aspect, the data grouping 3722 may include data associated with the smoke evacuation system received from components of the smoke evacuator module 226 (e.g., pressure, particle count, flow rate, motor speed). In yet another aspect, the data grouping 3722 may include data associated with the device / instrument received from components of the device / instrument 235 (e.g., temperature sensor data, firing data, sealing data). In various other aspects, the data grouping 3722 may similarly include data received from other components coupled to the surgical hub 206 (e.g., suction / irrigation module 228, non-contact sensor module 242).

[0336] Additionally, the data communications module 3710 may compress the generator data and / or encrypt the generator data prior to transmitting the generator data to the modular communications hub 203. The specific methods of compression and / or encryption may be the same or different than the compression and / or encryption that may be performed by the surgical hub 206, as described in more detail below.

[0337] Modular communication hub 203 can receive generator data transmitted from combined generator 3700 (e.g., via data communication module 3710), and the generator data can then be transmitted to cloud-based system 205 (e.g., via the Internet). According to various aspects, modular communication hub 203 can communicate with the cloud-based system 205 via hub 207 / switch 209 of modular communication hub 203 (see Fig.10 ) receives the generator data, and the generator data can be transmitted by the router 211 of the modular communication hub 203 (see Fig.10 ) to the cloud-based system 205. The generator data may be transmitted to the cloud-based system 205 in real-time, near real-time, or in batches, or may be stored at the surgical hub 206 prior to transmission to the cloud-based system 205. The generator data may be stored, for example, at the storage array 234 or memory 249 of the computer system 210 of the surgical hub 206.

[0338] In various aspects, for example, where the generator data received at the modular communication hub 203 is not encrypted, the generator data is encrypted prior to transmitting the received generator data to the cloud-based system 205 to help ensure the confidentiality of the generator data, both when it is stored at the surgical hub 206 and when it is transmitted to the cloud 204 using the Internet or other computer network. According to various aspects, a component of the surgical hub 206 utilizes an encryption algorithm to convert the generator data from a readable version to an encoded version, thereby forming encrypted generator data. The component of the surgical hub 206 that utilizes / executes the encryption algorithm can be, for example, the processor module 232, the processor 244 of the computer system 210, and / or a combination thereof. The encryption algorithm utilized / executed can be a symmetric encryption algorithm and / or an asymmetric encryption algorithm.

[0339] Using a symmetric encryption algorithm, the surgical hub 206 will encrypt the generator data using a shared key (e.g., a private key, a passphrase, a password). In such aspects, the recipient of the encrypted generator data (e.g., a cloud-based system 205) will then use the same shared key to decrypt the encrypted generator data. In such aspects, the surgical hub 206 and the recipient will need to have access to and / or know the same shared key. In one aspect, the shared key may be generated / selected by the surgical hub 206 and securely delivered (e.g., physically) to the recipient prior to encrypted transmission to the recipient.

[0340] Alternatively, using an asymmetric encryption algorithm, the surgical hub 206 will encrypt the generator data using a public key associated with a recipient (e.g., a cloud-based system 205). The public key may be received by the surgical hub 206 from a certificate authority that issues a digital certificate certifying that the public key is owned by the recipient. The certificate authority may be any entity trusted by the surgical hub 206 and the recipient. In such aspects, the recipient of the encrypted generator data will then decrypt the encrypted generator data using a private key (i.e., known only to the recipient) that is paired with the public key used by the surgical hub 206 to encrypt the generator data. Notably, in such aspects, the encrypted generator data can only be decrypted using the recipient's private key.

[0341] According to aspects of the present disclosure, components of the surgical system 202 (e.g., surgical devices / instruments 235, energy devices 241, endoscopes 239) are associated with unique identifiers, which may be in the form of serial numbers. Thus, according to various aspects of the present disclosure, when a component is coupled to the surgical hub 206, the component may establish a shared key with the surgical hub 206 using the unique identifier of the coupled component as a shared key. Additionally, in such aspects, the component may derive a checksum value by applying a checksum function / algorithm to the unique identifier and / or other data transmitted to the surgical hub 206. Here, the checksum function / algorithm is configured to output a significantly different checksum value if there is a modification to the underlying data.

[0342] In one aspect, a component may initially encrypt a coupled component's unique identifier using a public key associated with the surgical hub (e.g., received by the component from the surgical hub 206 upon connection / upon connection) and transmit the encrypted unique identifier to the surgical hub 206. In other aspects, a component may encrypt a coupled component's unique identifier and a derived checksum value using a public key associated with the surgical hub 206 and transmit the encrypted unique identifier and the linked / associated checksum value to the surgical hub 206.

[0343] In other aspects, the component may encrypt the unique identifier and checksum function / algorithm using a public key associated with the surgical hub 206 and transmit the encrypted unique identifier and checksum function / algorithm to the surgical hub 206. In such aspects, the surgical hub 206 will then decrypt the encrypted unique identifier or the encrypted unique identifier and linked / associated checksum value or the encrypted unique identifier and checksum function / algorithm using a private key (i.e., known only to the surgical hub 206) paired with the public key used by the component to encrypt the unique identifier.

[0344] Since the encrypted unique identifier can only be decrypted using the private key of the surgical hub 206, and the private key is only known by the surgical hub, this is a secure way to transmit the shared key (e.g., the unique identifier of the coupled component) to the surgical hub 206. In addition, in aspects where the checksum value is linked to / associated with the unique identifier, the surgical hub 206 may apply the same checksum function / algorithm to the decrypted unique identifier to generate a verification checksum value. If the verification checksum value matches the decrypted checksum value, the integrity of the decrypted unique identifier is further verified. In addition, in such aspects, with the shared key established, the component may encrypt future communications to the surgical hub 206, and the surgical hub 206 may decrypt future communications from the component using the shared key (e.g., the unique identifier of the coupled component). Here, according to various aspects, a checksum value may be derived for each communication between the component and the surgical hub 206 and transmitted by said each communication (e.g., a checksum value based on the transmitted data or at least a specified portion thereof). Here, a checksum function / algorithm (e.g., known by the surgical hub 206 and / or the components or transmitted when a shared key is established between the surgical hub 206 and the components, as described above) may be used to generate a verification checksum value for comparison to the transmitted checksum value, thereby further verifying the integrity of the data transmitted in each communication.

[0345] Notably, asymmetric encryption algorithms can be complex and can require significant computing resources to perform each communication. Therefore, establishing the unique identifier of the coupled component as a shared key is not only faster (e.g., no need to use a pseudo-random key generator to generate the shared key), but also improves the computational efficiency of all subsequent communications (e.g., allowing for faster, less complex symmetric encryption algorithms to be performed). In various aspects, this established shared key can be used by the component and the surgical hub 206 until the component is disconnected from the surgical hub (e.g., the surgical procedure is concluded).

[0346] According to other aspects of the present disclosure, components of the surgical system 202 (e.g., surgical devices / instruments 235, energy devices 241, endoscopes 239) may include subcomponents (e.g., handles, shafts, end effectors, cartridges), each of which is associated with its own unique identifier. Thus, according to various aspects of the present disclosure, when a component is coupled to the surgical hub 206, the component may establish a shared key with the surgical hub 206 using a unique compilation / string of unique identifiers (e.g., ordered or random) associated with the subcomponents that combine to form the coupled component. In one aspect, the component may initially encrypt the unique compilation / string of the coupled component using a public key associated with the surgical hub 206, and transmit the encrypted unique compilation / string to the surgical hub 206. In such aspects, the surgical hub 206 will then decrypt the encrypted unique compilation / string using a private key (i.e., known only to the surgical hub 206) paired with the public key used by the component to encrypt the unique compilation / string. Because the encrypted unique code / string can only be decrypted using the surgical hub 206's private key, and the private key is only known by the surgical hub 206, this is a secure way to communicate the shared key (e.g., the unique code / string of the coupled component) to the surgical hub 206. Further, in such aspects, with the shared key established, the component may encrypt future communications to the surgical hub 206, and the surgical hub 206 may decrypt future communications from the component using the shared key (e.g., the unique code / string of the coupled component).

[0347] Likewise, asymmetric encryption algorithms can be complex and can require significant computing resources to perform each communication. Thus, establishing a unique compilation / string of coupled components (i.e., that can be easily combined by the components) as a shared key is not only faster (e.g., no need to use a pseudo-random key generator to generate the shared key), but also improves the computational efficiency of all subsequent communications (e.g., allowing for faster, less complex symmetric encryption algorithms to be performed). In various aspects, the established shared key can be used by the component and the surgical hub 206 until the component is disengaged from the surgical hub 206 (e.g., the surgical procedure is concluded). Further, in such aspects, since various subcomponents can be reusable (e.g., handles, shafts, end effectors), while other subcomponents may not be reusable (e.g., end effectors, cartridges), each new combination of subcomponents that combine to form the coupled component provides a unique compilation / string of characters that can be used as a shared key for the component to communicate with the surgical hub 206.

[0348] According to further aspects of the present disclosure, components of the surgical system 202 (e.g., surgical devices / instruments 235, energy devices 241, endoscopes 239) are associated with unique identifiers. Thus, according to various aspects of the present disclosure, when a component is coupled to the surgical hub 206, the surgical hub 206 can establish a shared key with a recipient (e.g., a cloud-based system 205) using the unique identifier of the coupled component. In one aspect, the surgical hub 206 can initially encrypt the unique identifier of the coupled component using a public key associated with the recipient, and transmit the encrypted unique identifier to the recipient. In such aspects, the recipient will then decrypt the encrypted unique identifier using a private key (i.e., known only to the recipient) paired with the public key used by the surgical hub 206 to encrypt the unique identifier. Since the encrypted unique identifier can only be decrypted using the recipient's private key, and the private key is only known to the recipient, this is a secure way to transmit the shared key (e.g., the unique identifier of the coupled component) to the recipient (e.g., a cloud-based system). Furthermore, in such aspects, where a shared key is established, the surgical hub 206 may encrypt future communications to a recipient (e.g., a cloud-based system 205), and the recipient may decrypt future communications from the surgical hub 206 using the shared key (e.g., a unique identifier of the coupled component).

[0349] Notably, asymmetric encryption algorithms can be complex and can require significant computing resources to perform each communication. Therefore, establishing a unique identifier of a coupled component (i.e., already available to the surgical hub 206) as a shared key is not only faster (e.g., no need to use a pseudo-random key generator to generate the shared key), but also improves the computational efficiency of all subsequent communications by, for example, allowing faster, less complex symmetric encryption algorithms to be performed. In various aspects, this established shared key can be used by the surgical hub 206 until the component is disconnected from the surgical hub (e.g., the surgical procedure is concluded).

[0350] According to still further aspects of the present disclosure, components of the surgical system 202 (e.g., surgical devices / instruments 235, energy devices 241, endoscopes 239) may include subcomponents (e.g., handles, shafts, end effectors, cartridges), each of which is associated with its own unique identifier. Thus, according to various aspects of the present disclosure, when a component is coupled to the surgical hub 206, the surgical hub 206 may establish a shared key with a recipient (e.g., a cloud-based system 205) using unique compilations / strings (e.g., ordered or random) of unique identifiers associated with the subcomponents that combine to form the coupled component.

[0351] In one aspect, the surgical hub 206 may initially encrypt the unique compilation / string of the coupled component using a public key associated with the recipient, and transmit the encrypted unique compilation / string to the recipient. In such aspects, the recipient will then decrypt the encrypted unique compilation / string using a private key (i.e., known only to the recipient) that is paired with the public key used by the surgical hub 206 to encrypt the unique compilation / string. Since the encrypted unique compilation / string can only be decrypted using the recipient's private key, and the private key is only known to the recipient, this is a secure way to transmit the shared key (e.g., the unique compilation / string of the coupled component) to the recipient. With the shared key established, the surgical hub 206 may encrypt future communications to the recipient (e.g., the cloud-based system 205), and the recipient may decrypt future communications from the surgical hub 206 using the shared key (e.g., the unique compilation / string of the coupled component). Again, asymmetric encryption algorithms can be complex and may require significant computing resources to perform each communication. Thus, establishing a unique compilation / string of coupled components (i.e., capable of being easily combined by the surgical hub 206) as a shared key is not only faster (e.g., eliminating the need to use a pseudo-random key generator to generate the shared key), but also improves the computational efficiency of all subsequent communications (e.g., allowing faster, less complex symmetric encryption algorithms to be executed).

[0352] In various aspects, this established shared key may be used by the surgical hub 206 until the component is detached from the surgical hub (e.g., the surgical procedure is concluded). Further, in such aspects, because various subcomponents may be reusable (e.g., handles, shafts, end effectors), while other subcomponents may not be reusable (e.g., end effectors, cartridges), each new combination of subcomponents that combine to form a coupled component provides a unique compilation / string of characters that may be used as a shared key for the surgical hub 206 to communicate with a recipient.

[0353] In some aspects, an encrypt-then-MAC (EtM) method may be used to generate encrypted generator data. An example of this method is Fig.253746) to generate ciphertext 3744 (i.e., encrypted generator data), and then generating MAC 3745 based on the resulting ciphertext 3744, key 3746, and MAC algorithm (e.g., hash function 3747). More specifically, ciphertext 3744 is processed by MAC algorithm using key 3746. In one aspect similar to the symmetric encryption discussed herein, key 3746 is a key accessible / known to surgical hub 206 and recipient (e.g., cloud-based system 205). In such aspects, the key is a shared key associated with / selected by the surgical hub 206, a shared key associated with / selected by the recipient, or a key selected via a pseudo-random key generator. For this method, the encrypted generator data (i.e., ciphertext 3744) and MAC 3745 will be transmitted together to the cloud-based system 205 as generally shown at 3748.

[0354] In other aspects, an encrypt-and-MAC (E&M) method may be used to generate encrypted generator data. An example of this method is Fig.26 3755 is shown in which a MAC 3755 is generated based on unencrypted generator data (i.e., plaintext 3752, such as data packet 3722), a key 3756, and a MAC algorithm (e.g., a hash function 3757). More specifically, plaintext 3752 is processed by a MAC algorithm using key 3756. In one aspect similar to the symmetric encryption discussed herein, key 3756 is a key accessible / known to the surgical hub 206 and the recipient (e.g., a cloud-based system 205). In such aspects, the key is a shared key associated with / selected by the surgical hub 206, a shared key associated with / selected by the recipient, or a key selected via a pseudo-random key generator. In addition, in such aspects, unencrypted generator data (i.e., plaintext 3752, such as data packet 3722) is encrypted 3753 (e.g., via key 3756) to produce ciphertext 3754. For this method, generally as shown at 3758, the MAC 3755 (i.e., generated based on the unencrypted generator data) and the encrypted generator data (i.e., the ciphertext 3754) will be transmitted together to the cloud-based system 205.

[0355] In another aspect, a MAC-then-encrypt (MtE) method may be used to generate encrypted generator data. An example of this method is Fig. 273765 is shown in which MAC 3765 is generated based on unencrypted generator data (i.e., plaintext 3762), key 3766 and MAC algorithm (e.g., hash function 3767). More specifically, plaintext 3762 is processed by MAC algorithm using key 3766. In one aspect similar to the symmetric encryption discussed herein, key 3766 is a key accessible / known to surgical hub 206 and recipient (e.g., cloud-based system 205). In such aspects, the key is a shared key associated with / selected by the surgical hub 206, a shared key associated with / selected by the recipient, or a key selected via a pseudo-random key generator. Then, unencrypted generator data (i.e., plaintext 3762) and MAC 3765 are encrypted together 3763 (e.g., via key 3766) to generate ciphertext 3764 based on both. For this method, generally as shown at 3768, the ciphertext 3764 (i.e., which includes the encrypted generator data and the encrypted MAC 3765) will be transmitted to the cloud-based system 205.

[0356] In an alternative aspect, a method for encrypting unencrypted generator data (e.g., Fig.25 and Fig.26 ) or unencrypted generator data and MAC (e.g. Fig. 27 ) may be different from the key used to generate the MAC (e.g., keys 3746, 3756, 3766). For example, the key used to encrypt the unencrypted generator data (e.g., Fig.25 and Fig.26 ) or unencrypted generator data and MAC (e.g. Fig. 27 ) can be a different shared key or public key associated with the recipient.

[0357] According to other aspects, instead of utilizing a MAC to provide subsequent assurance of data integrity to the cloud-based system 205, the surgical hub 206 may utilize a digital signature to allow the cloud-based system 205 to subsequently verify the integrity of the transmitted generator data. For example, the processor module 232 and / or the processor 244 of the computer system 210 may utilize one or more algorithms to generate a digital signature associated with the generator data, and the cloud-based system 205 may utilize the algorithm to determine the authenticity of the received generator data. The algorithms utilized by the processor module 232 and / or the processor 244 of the computer system 210 may include: (1) a key generation algorithm that uniformly selects a private key at random from a set of possible private keys, wherein the key generation algorithm outputs a private key and a corresponding public key; and (2) a signature algorithm that generates a digital signature associated with the generator data given the generator data and the private key. The cloud-based system 205 may utilize a signature verification algorithm that, given the received generator data, the public key, and the digital signature, may accept the received generator data as authentic if the digital signature is determined to be authentic, or may deem the generator data as compromised or altered if the digital signature is not determined to be authentic.

[0358] In accordance with other aspects of the present disclosure, the surgical hub 206 may utilize commercial authentication programs (e.g., secure hash algorithms, SHA-2 including SHA-256) to provide subsequent assurance of data integrity of generator data transmitted to the cloud-based system 205.

[0359] After the generator data has been encrypted (e.g., via EtM, E&M, MtE), the components of the surgical hub 206 may transmit the encrypted generator data to the cloud-based system 205. The components of the surgical hub 206 that transmit the encrypted generator data to the cloud-based system 205 may be, for example, the processor module 232, the hub 207 / switch 209 of the modular communication hub 203, the router 211 of the modular communication hub 203, the communication module 247 of the computer system 210, etc.

[0360] According to various aspects, communication of encrypted generator data over the Internet may follow IP, which: (1) defines datagrams that encapsulate the encrypted generator data to be delivered, and / or (2) defines an addressing method for marking datagrams with source and destination information. Fig.28 A high-level representation of an exemplary datagram 3770 is shown in FIG, where the datagram 3770 includes a header 3772 and a payload 3774, and may also include a trailer (not shown) among other aspects. Fig.29, where a header 3782 may include fields for information such as, for example, an IP address of a source 3786 sending the datagram (e.g., a router 211 of a modular communication hub 203), an IP address of a destination 3788 to receive the datagram (e.g., a cloud 204 and / or a remote server 213 associated with a cloud-based system 205), a type of service name (not shown), a header length 3790, a payload length 3792, and a checksum value 3794. In such aspects, the surgical hub 206 may also apply a checksum function / algorithm to the unencrypted generator data (i.e., plaintext 3742, e.g., data packet 3722) or at least a portion of the unencrypted generator data (e.g., a combined generator ID 3726) to derive a checksum value 3794. Here, the checksum function / algorithm is configured to output a significantly different checksum value if there is any modification (e.g., even a slight change) to the underlying data (e.g., generator data). After the encrypted generator data is decrypted by its recipient (e.g., cloud-based system 205), the recipient may apply the same checksum function / algorithm to the decrypted generator data to generate a verification checksum value. If the verification checksum value matches the checksum value 3794 (i.e., stored in the header 3782 of the received datagram 3780), the integrity of the received generator data is further verified. The payload 3784 may include the encrypted generator data 3796 and, if the encrypted generator data 3796 is less than the specified payload length, may also include padding 3798. Notably, the transmitted encrypted generator data 3796 may include a MAC, as described above. Fig.25 , Fig.26 and Fig. 27 In some aspects, the header 3782 may also include a specific path for the datagram to follow as it is transmitted from the surgical hub 206 to the cloud-based system 205 (e.g., from an IP address of the source, to an IP address of at least one intermediate network component (e.g., a designated router, a designated server), to an IP address of the destination).

[0361] According to various aspects, before the generator data is encrypted, the generator data may be time stamped (if not already time stamped by the combined generator 3700) and / or the generator data may be compressed (if not already compressed by the combined generator 3700). Time stamping allows the cloud-based system 205 to associate the generator data with other data (e.g., stripped patient data) that may be transmitted to the cloud-based system 205. Compression allows a smaller representation of the generator data to be subsequently encrypted and transmitted to the cloud-based system 205. With respect to compression, components of the surgical hub 206 may utilize a compression algorithm to convert a representation of the generator data into a smaller representation of the generator data, thereby allowing for more efficient and economical encryption of the generator data (e.g., less data to encrypt utilizes fewer processing resources) and more efficient and economical transmission of the encrypted generator data (e.g., within a payload of a datagram (e.g., Fig.28 and Fig.29 ) allows more generator data to be included in a given datagram, allows more generator data to be transmitted in a given time period, and / or allows generator data to be transmitted with fewer communication resources). The component of the surgical hub 206 that utilizes / executes the compression algorithm can be, for example, the processor module 232, the processor 244 of the computer system, and / or a combination thereof. The compression algorithm utilized / executed can be a lossless compression algorithm or a lossy compression algorithm.

[0362] Once the generator data and MAC for a given datagram have been received at the cloud-based system 205 (e.g., Fig.25 , label number 3748; Fig.26 , reference number 3758; and Fig. 27 , label 3768), the cloud-based system 205 can decrypt the encrypted generator data from the payload of the transmitted datagram to obtain the transmitted generator data.

[0363] In one respect, see Fig.25 , the recipient (e.g., the cloud-based system 205) may process the ciphertext 3744 through the same MAC algorithm using the same known / accessible key to produce an authentication MAC similar to the surgical hub 206. If the received MAC 3745 matches the authentication MAC, the recipient (e.g., the cloud-based system 205) may safely assume that the ciphertext 3744 has not been altered and is from the surgical hub 206. The recipient (e.g., the cloud-based system 205) may then decrypt the ciphertext 3744 (e.g., via the key 3746) to obtain the plaintext 3742 (e.g., data packets including generator data).

[0364] On the other hand, re-referencing Fig.26, the receiving party (e.g., the cloud-based system 205) can decrypt the ciphertext 3754 (e.g., via the key 3756) to obtain the plaintext 3752 (e.g., a data packet including the generator data). Then, similar to the surgical hub 206, the receiving party (e.g., the cloud-based system 205) can process the plaintext 3752 through the same MAC algorithm using the same known / accessible key to produce an authentication MAC. If the received MAC 3755 matches the authentication MAC, the receiving party (e.g., the cloud-based system 205) can safely assume that the plaintext 3752 has not been altered and is from the surgical hub 206.

[0365] On the other hand, see again Fig. 27 , the receiving party (e.g., the cloud-based system 205) can decrypt the ciphertext 3764 (e.g., via the key 3766) to obtain the plaintext 3762 (e.g., a data packet including the generator data) and the MAC 3765. Then, similar to the surgical hub 206, the receiving party (e.g., the cloud-based system 205) can process the plaintext 3762 through the same MAC algorithm using the same known / accessible key to produce an authentication MAC. If the received MAC 3765 matches the authentication MAC, the receiving party (e.g., the cloud-based system 205) can safely assume that the plaintext 3762 has not been altered and is from the surgical hub 206.

[0366] In an alternative aspect, a method for encrypting unencrypted generator data (e.g., Fig.25 and Fig.26 ) or unencrypted generator data and MAC (e.g. Fig. 27 ) may be different from the key used to generate the MAC (e.g., keys 3746, 3756, 3766). For example, the key used to encrypt the unencrypted generator data (e.g., Fig.25 and Fig.26 ) or unencrypted generator data and MAC (e.g. Fig. 27 ) may be a different shared key or public key associated with the recipient. In this regard, see Fig.25 , the recipient (e.g., cloud-based system 205) may, after verifying the authentication MAC (as described above) via key 3746, then decrypt the ciphertext 3744 (e.g., via a different shared key or private key associated with the recipient) to obtain plaintext 3742 (e.g., a data packet including generator data). In such aspects, see Fig.26 , the recipient may decrypt ciphertext 3754 (e.g., via a different shared key or private key associated with the recipient) to obtain plaintext 3752 (e.g., a data packet including generator data), and then verify the authentication MAC via key 3756 (as described above). In such aspects, see Fig. 27, the recipient may decrypt ciphertext 3764 (e.g., via a different shared key or private key associated with the recipient) to obtain plaintext 3762 (e.g., a data packet including generator data) and MAC 3765, and then verify the authentication MAC via key 3766 (as described above).

[0367] In conclusion, see Figure 25 to Figure 27 , if the authentication MAC determined / calculated by the cloud-based system 205 is the same as the MAC received with the datagram, the cloud-based system 205 can trust that the received generator data is authentic (i.e., it is the same as the generator data transmitted by the surgical hub 206) and that the data integrity of the transmitted generator data has not been compromised or altered. As described above, the recipient can further apply the plaintext 3742, 3752, 3762, or at least a portion thereof, to the same checksum function / algorithm (i.e., used by the surgical hub 206) to generate a verification checksum value based on the checksum value stored in the header of the transmitted datagram, thereby further verifying the integrity of the generator data.

[0368] Additionally, based on the decrypted datagram, the source (e.g., Fig.29 , referenced 3786) can be determined based on the header of the transmitted datagram. If the determined source is the identified source, the cloud-based system 205 can trust that the generator data originated from a trusted source, thereby providing source authentication and even more assurance of data integrity of the generator data. In addition, because each router that the datagram passes through along the path to the cloud-based system 205 includes its IP address and the communications it forwards, the cloud-based system 205 is able to trace the path followed by the datagram and identify each router that processed the datagram. The ability to identify the corresponding router may be helpful in the event that the content of the datagram received at the cloud-based system 205 is different from the content of the datagram originally transmitted by the surgical hub 206. For aspects where the communication path is pre-specified and included in the header of the transmitted datagram, the ability to identify the corresponding router can allow path verification and provide additional confidence in the authenticity of the received generator data.

[0369] In addition, according to various aspects, after verifying the received generator data, the cloud-based system 205 may transmit a message (e.g., a handshake or similar message) to the surgical hub 206 via the Internet or another communication network, confirming / guaranteeing that the datagram transmitted from the surgical hub 206 was received intact by the cloud-based system 205, thereby effectively closing the loop for that particular datagram.

[0370] Various aspects of the above-described communication methods and / or variations thereof may also be used to transmit data other than generator data to the cloud-based system 205 and / or to transmit generator data and / or other data from the surgical hub 206 to systems and / or devices other than the cloud-based system 205. For example, according to various aspects, generator data and / or other data may be transmitted from the surgical hub 206 to a handheld surgical device / instrument (e.g., wireless device / instrument 235), to a robotic interface of a surgical device / instrument (e.g., robotic hub 222), and / or other servers, including servers (e.g., similar to server 213) associated with other cloud-based systems (e.g., similar to cloud-based system 205) according to the above-described communication methods. For example, in some cases, the EEPROM chip of a given surgical instrument may initially be set with only the electronic chip device ID. When a given surgical instrument is connected to the combination generator 3700, data may be downloaded from the cloud-based system 205 to the surgical hub 206 and subsequently to the EEPROM of the surgical instrument according to the above-described communication methods.

[0371] In addition to transmitting the generator data to the cloud-based system 205, the surgical hub 206 may also utilize the above-described communication methods and / or variations thereof to transmit data other than the generator data to the cloud-based system 205. For example, the surgical hub 206 may also transmit other information associated with the surgical procedure to the cloud-based system 205. Such other information may include, for example, the type of surgical procedure being performed, the name of the facility where the surgical procedure is being performed, the location of the facility where the surgical procedure is being performed, the identification of the operating room within the facility where the surgical procedure is being performed, the name of the surgeon performing the surgical procedure, the age of the patient, and data associated with the patient's condition (e.g., blood pressure, heart rate, current medications). According to various aspects, all information that may identify a particular surgical procedure, patient, or surgeon may be stripped from such other information such that the information is substantially anonymized for further processing and analysis by the cloud-based system 205. In other words, the stripped data is not associated with a particular surgical procedure, patient, or surgeon. The stripped information may be transmitted to the cloud-based system 205 along with the transmitted generator data or separately from the transmitted generator data.

[0372] For situations where the stripped / other data is to be transmitted separately from the generator data, the stripped / other data may be time stamped, compressed, and / or encrypted in the same or different manner as described above with respect to the generator data, and the surgical hub 206 may be programmed / configured to generate a datagram that includes the encrypted stripped / other information in place of the encrypted generator data. The datagram may then be transmitted from the surgical hub 206 to the cloud-based system 205 over the Internet following an IP that: (1) defines a datagram that encapsulates the encrypted stripped / other data to be delivered, and (2) defines an addressing method for tagging the datagram with source and destination information.

[0373] In the event that the stripped / other information is to be transmitted along with the generator data, the stripped / other data may be timestamped, compressed, and / or encrypted in the same or different manner as described above with respect to the generator data, and the surgical hub 206 may be programmed / configured to generate a datagram that includes both the encrypted generator data and the encrypted stripped / other information. Fig.30 An example of such a datagram is shown, where the payload 3804 of the datagram 3800 is divided into two or more different payload data portions (e.g., a portion for encrypted generator data 3834, and a portion for encrypted stripped / other information 3836), where each portion has identification bits (e.g., generator data (GD) 3806, other data (OD) 3812), associated encrypted data 3808, 3814, and associated padding 3810, 3816, respectively, if desired. In addition, as shown in FIG. Fig.30 As shown, header 3802 can be used with reference Fig.29 The header 3782 of the datagram 3780 shown may be the same (e.g., IP address source 3818, IP address destination 3820, header length 3822) or different. For example, the header 3802 may differ in that the header 3802 also includes a field that specifies the number of payload data portions 3824 (e.g., 2) included in the payload 3804 of the datagram 3800. The header 3802 may also differ in that it may include fields that specify the payload length 3826, 3830 and checksum values ​​3828, 2832 of each payload data portion 3834, 3836, respectively. Although Fig.30Only two payload data portions are shown in FIG. 3 , but it should be understood that the payload 3804 of the datagram 3800 may include any amount / number of payload data portions (e.g., 1, 2, 3, 4, 5), wherein each payload data portion includes data associated with a different aspect of the surgical procedure. The datagram 3800 may then be transmitted from the surgical hub 206 to the cloud-based system 205 over the Internet following an IP that: (1) defines a datagram that encapsulates the encrypted generator data and encrypted stripped / other data to be delivered, and (2) defines an addressing method for marking the datagram with source information and destination information.

[0374] As described above, the unfortunate fact is that not all surgical procedures are always optimal and / or successful in their outcomes. For situations where a failure event is detected and / or identified, surgical data associated with the failure event (e.g., failure event surgical data) and surgical data not associated with the failure event (e.g., non-failure event surgical data) may be isolated using variations of the above-described communication methods, and surgical data associated with the failure event (e.g., failure event data) may be preferentially transmitted from the surgical hub 206 to the cloud-based system 205 for analysis. According to one aspect of the present disclosure, the failure event surgical data is preferentially transmitted from the surgical hub 206 to the cloud-based system 205 relative to the non-failure event surgical data.

[0375] Fig.31 Various aspects of a system-implemented method of identifying surgical data associated with a failure event (e.g., failure event surgical data) and prioritizing transmission of the identified surgical data to a cloud-based system 205 are shown. The method includes (1) receiving 3838 surgical data at a surgical hub 206, wherein the surgical data is associated with a surgical procedure; (2) time-stamping 3840 the surgical data; (3) identifying 3842 a failure event associated with the surgical procedure; (4) determining 3844 which of the surgical data is associated with the failure event (e.g., failure event surgical data); (5) separating 3846 the surgical data associated with the failure event from all other surgical data received at the surgical hub 206 (e.g., non-failure event surgical data); (6) chronologically sorting 3848 the surgical data associated with the failure event; (7) encrypting 3850 the surgical data associated with the failure event; and (8) prioritizing transmission 3852 of the encrypted surgical data to the cloud-based system 205.

[0376] More specifically, various surgical data may be captured during a surgical procedure, and the captured surgical data, as well as other surgical data associated with the surgical procedure, may be transmitted to the surgical hub 206. The surgical data may include, for example, surgical devices / instruments used during the surgical procedure (e.g., Fig. 9, surgical devices / instruments 235), data associated with the patient, data associated with the facility where the surgical procedure was performed, and data associated with the surgeon. Before or after the surgical data is transmitted to and received by the surgical hub 206, the surgical data may be time stamped and / or stripped of all information that may identify a specific surgical procedure, patient, or surgeon so that the information is substantially anonymized for further processing and analysis by the cloud-based system 205.

[0377] Once a fault event is detected and / or identified (e.g., which may be during or after a surgical procedure), the surgical hub 206 may determine which of the surgical data is associated with the fault event (e.g., fault event surgical data) and which of the surgical data is not associated with the surgical event (e.g., non-fault event surgical data). According to one aspect of the present disclosure, a fault event may include, for example, the detection of one or more unfired staples during a stapling portion of a surgical procedure. For example, in one aspect, see Fig. 9 , the endoscope 239 may take a snapshot while the surgical device / instrument 235 including an end effector with a staple cartridge performs the stapling portion of the surgical procedure. In such aspects, the imaging module 238 may compare the snapshot to stored images expressing properly fired staples and / or images downloaded from the cloud-based system 205 to detect unfired staples and / or evidence of unfired staples (e.g., leaks). On the other hand, the imaging module 238 may analyze the snapshot itself to detect unfired staples and / or evidence of unfired staples. In an alternative aspect, the surgical hub 206 may transmit the snapshot to the cloud-based system 205, and components of the cloud-based system 205 may perform the various imaging module functions described above to detect unfired staples and / or evidence of unfired staples and report the detection results to the surgical hub 206. According to another aspect of the present disclosure, a fault event may include detecting a tissue temperature that is lower than an expected temperature during the tissue sealing portion of the surgical procedure and / or a visual indication of excessive bleeding or oozing after the surgical procedure (e.g., Fig. 9 , via endoscope 239). For example, in one aspect, see Fig. 9, the surgical device / instrument 235 may include an end effector that includes a temperature sensor and the surgical hub 206, and / or the cloud-based system may compare at least one temperature detected by the temperature sensor (e.g., during the tissue sealing portion of the surgical procedure) to a stored temperature and / or an expected temperature range and / or a temperature range associated with the surgical procedure to detect an insufficient / low sealing temperature. In another aspect, the endoscope 239 may take snapshots during the surgical procedure. In such aspects, the imaging module 238 may compare the snapshots to stored images that express tissue properly sealed at the expected temperature and / or images downloaded from the cloud-based system 205 to detect evidence of inappropriate / inadequate sealing temperature (e.g., charring, bleeding / bleeding). Further, in such aspects, the imaging module 238 may analyze the snapshots themselves to detect evidence of inappropriate / inadequate sealing temperature (e.g., charring, bleeding / bleeding). In an alternative aspect, the surgical hub 206 may transmit the snapshot to the cloud-based system 205, and components of the cloud-based system 205 may perform the various imaging module functions described above to detect evidence of improper / inadequate sealing temperature and report the detection results to the surgical hub 206. According to various aspects described above, in response to the detected and / or identified fault event, the surgical hub 206 may download a program from the cloud-based system 205 for execution by the surgical device / instrument 235 that corrects the detected problem (i.e., a program to change surgical device / instrument parameters to prevent unfired staples, a program to change surgical device / instrument parameters to ensure correct sealing temperature).

[0378] In some aspects, a fault event is considered to cover a particular time period, and all surgical data associated with the particular time period may be considered to be associated with the fault event.

[0379] After surgical data associated with a failure event has been identified, the identified surgical data (e.g., failure event surgical data) can be separated or isolated from all of the other surgical data associated with the surgical procedure (e.g., non-failure event surgical data). The separation can be achieved, for example, by tagging or marking the identified surgical data, by storing the identified surgical data separately from all of the other surgical data associated with the surgical procedure, or by storing only the other surgical data while continuing to process the identified surgical data for subsequent priority transmission to the cloud-based system 205. According to various aspects, tagging or marking the identified surgical data can occur during the communication process when a datagram is generated, as described in more detail below.

[0380] The components of the surgical hub 206 may utilize all timestamps in the surgical data (e.g., before or after the surgical data was received at the surgical hub) to chronologically sort the identified surgical data associated with the failure event. The components of the surgical hub 206 that utilize timestamps to chronologically sort the identified surgical data may be, for example, the processor module 232, the processor 244 of the computer system 210, and / or a combination thereof. By chronologically sorting the identified surgical data, the cloud-based system 205 and / or other interested parties may subsequently better understand the conditions that existed that led to the failure event, and may identify the exact cause of the failure event, thereby providing knowledge to potentially reduce the occurrence of similar failure events during similar surgical procedures performed at a future date.

[0381] Once the identified surgical data has been chronologically ordered, the chronologically ordered surgical data may be encrypted in a manner similar to that described above with respect to encrypting the generator data. Thus, the identified surgical data may be encrypted to help ensure the confidentiality of the identified surgical data, both when it is stored at the surgical hub 206 and when it is transmitted to the cloud-based system 205 using the Internet or other computer network. According to various aspects, components of the surgical hub 206 utilize an encryption algorithm to convert the identified surgical data from a readable version to an encoded version, thereby forming encrypted surgical data associated with the fault event (e.g., Figure 25 to Figure 27 ). The component of the surgical hub that utilizes the encryption algorithm may be, for example, the processor module 232, the processor 244 of the computer system 210, and / or a combination thereof. The encryption algorithm utilized may be a symmetric encryption algorithm or an asymmetric encryption algorithm.

[0382] After the identified surgical data has been encrypted, a component of the surgical hub may transmit the encrypted surgical data associated with the fault event (e.g., encrypted fault event surgical data) to the cloud-based system 205. The component of the surgical hub that transmits the encrypted surgical data to the cloud-based system 205 may be, for example, a processor module 232, a hub 207 / switch 209 of the modular communication hub 203, a router 211 of the modular communication hub 203, or a communication module 247 of the computer system 210. According to various aspects, communication of encrypted surgical data (e.g., encrypted fault event surgical data) over the Internet may follow IP, which: (1) defines a datagram that encapsulates the encrypted surgical data to be delivered, and (2) defines an addressing method for marking the datagram with source information and destination information. The datagram may be similar to Fig.29 The datagram shown or Fig.30The datagrams shown may differ in that either the header or the payload of the datagram may include a field including a tag or label that prioritizes the encrypted surgical data (e.g., encrypted failure event surgical data) relative to other non-priority surgical data (e.g., encrypted non-failure event surgical data). Examples of such datagrams are shown in Fig.32 , where the payload 3864 of the datagram 3860 includes a field indicating (e.g., the priority name 3834) that the payload 3864 includes priority surgical data (e.g., the combined generator data 3868). According to various aspects, the payload 3864 of the datagram 3860 may also include untagged / unlabeled / unprioritized surgical data 3836 (e.g., other surgical data 3874), such as Fig.32 shown.

[0383] According to various aspects, before the identified surgical data (e.g., failure event surgical data) is encrypted, the identified surgical data may be compressed (if not already compressed by one or more sources of the associated surgical data). Compression allows a smaller representation of the surgical data associated with the failure event to be subsequently encrypted and transmitted to the cloud-based system 205. For compression, components of the surgical hub 206 may utilize a compression algorithm to convert the representation of the identified surgical data into a smaller representation of the identified surgical data, thereby allowing more efficient and economical encryption of the identified surgical data (less data for encryption utilizes less processing resources) and allowing more efficient and economical transmission of the encrypted surgical data (a smaller representation of the surgical data within the payload of a datagram allows more identified surgical data to be included in a given datagram, allows more identified surgical data to be transmitted in a given time period, and / or allows the identified surgical data to be transmitted with fewer communication resources). The component of the surgical hub 206 that utilizes the compression algorithm may be, for example, the processor module 232, the processor 244 of the computer system 210, and / or a combination thereof. The compression algorithm utilized may be a lossless compression algorithm or a lossy compression algorithm.

[0384] In the event that other non-priority surgical data (e.g., non-failure event surgical data) is to be transmitted with priority surgical data (e.g., failure event surgical data), the other non-priority surgical data may be timestamped, compressed, and / or encrypted in the same or different manner as described above with respect to surgical data identified as being associated with a failure event (e.g., failure event surgical data), and the surgical hub 206 may be programmed / configured to generate a datagram that includes both the encrypted priority surgical data (e.g., encrypted failure event surgical data) and the encrypted other non-priority surgical data (e.g., encrypted non-failure event surgical data). For example, in accordance with Fig.32, the payload 3864 of the datagram 3860 may be divided into two or more different payload data portions (e.g., one portion for priority surgical data 3834 and one portion for non-priority surgical data 3836), wherein each portion has identification bits (e.g., generator data (GD) 3866, other data (OD) 3872), associated encrypted data (e.g., encrypted priority surgical data 3868, encrypted non-priority surgical data 3874), and associated padding 3870, 3876, if desired. In addition, similar to Fig.30 , header 3862 can be referenced with Fig.29 The header 3782 of the datagram 3780 shown may be the same (e.g., IP address source 3878, IP address destination 3880, header length 3882) or different. For example, the header 3862 may differ in that the header 3862 also includes a field that specifies the number of payload data portions 3884 (e.g., 2) included in the payload 3864 of the datagram 3860. The header 3862 may also differ in that it may include fields that specify the payload length 3886, 3890 and checksum values ​​3888, 2892 of each payload data portion 3834, 3836, respectively. Although Fig.32 Only two payload data portions are shown in FIG. 3 , but it should be understood that the payload 3864 of the datagram 3860 may include any amount / number of payload data portions (e.g., 1, 2, 3, 4, 5), wherein each payload data portion includes data associated with a different aspect of the surgical procedure. The datagram 3860 may then be transmitted from the surgical hub 206 to the cloud-based system 205 over the Internet following an IP that: (1) defines a datagram that encapsulates the encrypted generator data and encrypted stripped / other data to be delivered, and (2) defines an addressing method for marking the datagram with source information and destination information.

[0385] In some aspects, once a failure event associated with a surgical procedure has been identified, the surgical hub 206 and / or cloud-based system 205 may subsequently mark or tag the surgical device / instrument 235 used during the surgical procedure as inoperable and / or removable. For example, in one aspect, information associated with the surgical device / instrument 235 and stored at the surgical hub 206 and / or cloud-based system 205 (e.g., serial number, ID) may be used to effectively prevent the surgical device / instrument 235 from being used again (e.g., blacklisted). In another aspect, information associated with the surgical device / instrument (e.g., serial number, ID) may initiate the printing of a shipping order and shipping instructions to return the surgical device / instrument 235 to the manufacturer or other designated party so that a thorough analysis / inspection of the surgical device / instrument 235 may be performed (e.g., to determine the cause of the failure). According to various aspects described herein, once the cause of a failure is determined (e.g., via the surgical hub 206 and / or the cloud-based system 205), the surgical hub 206 may download a program from the cloud-based system 205 for execution by the surgical device / instrument 235 that corrects the determined cause of the failure (i.e., a program that changes the surgical device / instrument parameters to prevent the failure from recurring).

[0386] According to some aspects, the surgical hub 206 and / or cloud-based system 205 may also provide / display a prompt (e.g., via the hub display 215 and / or surgical device / instrument display 237) to an administrator, staff, and / or other personnel to physically remove the surgical device / instrument 235 from the operating room (e.g., if detected to still be present in the operating room) and / or send the surgical device / instrument 235 to the manufacturer or other designated party. In one aspect, the prompt may be configured to be provided / displayed periodically until the administrator is able to remove the tag or label of the surgical device / instrument 235 from the surgical hub 206 and / or cloud-based system 205. According to various aspects, once the administrator can confirm (e.g., via system tracking of the surgical device / instrument 235 by its serial number / ID) that the surgical device / instrument 235 has been received by the manufacturer or another designated party, the administrator may remove the tag or label. By tagging and / or tracking surgical data associated with a fault event using the above-described methods, closed-loop control of surgical data associated with the fault event and / or with the surgical device / instrument 235 may be achieved. Additionally, in view of the above, it should be appreciated that the surgical hub 206 may be used to effectively manage the utilization (or non-utilization) of surgical devices / instruments 235 that have been utilized or have the potential to be utilized during a surgical procedure.

[0387] In various aspects of the present disclosure, the surgical hub 206 and / or cloud-based system 205 may want to control which components (e.g., surgical devices / instruments 235, energy devices 241) are being used in their interactive surgical system 100 / 200 to perform a surgical procedure (e.g., to minimize future failure events, to avoid the use of unauthorized or counterfeit components).

[0388] Thus, in various aspects of the present disclosure, since the interactive surgical system 100 may include multiple surgical hubs 106, the cloud-based system 105 and / or each surgical hub 106 of the interactive surgical system 100 may wish to track the component-surgical hub combinations used over time. In one aspect, in the case of a component (see Fig. 9, e.g., a surgical device / instrument 235, an energy device 241) is connected to / used with a particular surgical hub 106 (e.g., the surgical device / instrument 235 is wired / wirelessly connected to a particular surgical hub 106, the energy device 241 is connected to a particular surgical hub 106 via a generator module 240), the particular surgical hub 106 may transmit a record / block of the connection / use (e.g., linking the respective unique identifiers of the connected devices) to the cloud-based system 105 and / or other surgical hubs 106 in the interactive surgical system 100. For example, when / after the energy device 241 is connected / used, the particular surgical hub 106 may transmit a record / block (e.g., linking the unique identifier of the energy device 241 to the unique identifier of the generator module 240, to the unique identifier of the particular surgical hub 106) to the cloud-based system 105 and / or other surgical hubs 106 in the interactive surgical system 100. In such aspects, if this is the first time that a component (e.g., an energy device) is connected to / used with a surgical hub 106 in an interactive surgical system 100, the cloud-based system 105 and / or each surgical hub 106 of the interactive surgical system 100 may store the record / block as a provenance record / block. In such aspects, the provenance record / block stored at the cloud-based system 105 and / or each surgical hub 106 may include a timestamp. However, in such aspects, if this is not the first time that a component (e.g., an energy device 241) is connected to / used with a surgical hub 106 in an interactive surgical system 100, the cloud-based system 105 and / or each surgical hub 106 of the interactive surgical system may store the record / block as a new record / block in a chain of records / blocks associated with the component. In such aspects, the new record / block may include a cryptographic hash of the most recently transmitted record / block stored at the cloud-based system 105 and / or each surgical hub 106, the transmitted link data, and a timestamp. In such aspects, each cryptographic hash links each new record / block (e.g., each use of a component) to its previous record / block to form a chain that confirms the integrity of each previous record / block back to the original origin record / block (e.g., the first use of the component). According to such aspects, this block chain of records / blocks may be developed at the cloud-based system 105 and / or each surgical hub 106 of the interactive surgical system 100 to permanently and verifiably bind the use of a particular component to one or more surgical hubs 106 in the interactive surgical system 100 over time. Here, according to another aspect, the method may be similarly applied to sub-components of a component (e.g., handle, shaft, end effector, cartridge) when / after the component is connected to / used with a particular surgical hub 106 of the interactive surgical system 100.

[0389] According to various aspects of the present disclosure, the cloud-based system 105 and / or each surgical hub 106 may utilize such records / blocks to trace the use of a particular component and / or sub-component back to its initial use in the interactive surgical system 100. For example, if a particular component (e.g., a surgical device / instrument 235) is tagged / labeled as being associated with a failure event, the cloud-based system 105 and / or surgical hub 106 may analyze such records / blocks to determine whether past use of the component and / or sub-components of the component contributed to or caused the failure event (e.g., overuse). In one example, the cloud-based system 105 may determine that a sub-component of the component (e.g., an end effector) may actually be contributing to / causing a failure event and then label / mark the component as inoperable and / or removed based on that determination.

[0390] According to another aspect, the cloud-based system 205 and / or the surgical hub 206 can control which components (e.g., surgical devices / instruments 235, energy devices 241) are being used in the interactive surgical system 200 to perform a surgical procedure by authenticating the components and / or their suppliers / manufacturers. In one aspect, the supplier / manufacturer of the component can associate a serial number and a source ID with the component. In such aspects, the supplier / manufacturer can create / generate a private key for the serial number, encrypt the serial number with the private key, and store the encrypted serial number and source ID on an electronic chip (e.g., memory) in the component before shipping to the surgical site. Here, upon / after the component is connected to the surgical hub 206, the surgical hub 206 can read the encrypted serial number and source ID from the electronic chip. In response, the surgical hub 206 can send a message (i.e., including the encrypted serial number) to the server of the supplier / manufacturer associated with the source ID (e.g., directly or via the cloud-based system 205). In such aspects, the surgical hub 206 can encrypt the message using a public key associated with the supplier / manufacturer. In response, the surgical hub 206 may receive a message (i.e., including a private key generated by the supplier / manufacturer for / associated with the encrypted serial number) from a supplier / manufacturer server (e.g., directly or via the cloud-based system 205). In such aspects, the supplier / manufacturer server may encrypt the message using a public key associated with the surgical hub 206. Further, in such aspects, the surgical hub 206 may then decrypt the message (e.g., using a private key paired with the public key used to encrypt the message) to reveal the private key associated with the encrypted serial number. The surgical hub 206 may then decrypt the encrypted serial number using the private key to reveal the serial number. Further, in such aspects, the surgical hub 206 may then compare the decrypted serial number with a comprehensive list of authorized serial numbers (e.g., stored at the surgical hub 206 and / or the cloud-based system and / or downloaded from the cloud-based system, e.g., received separately from the supplier / manufacturer), and if the decrypted serial number matches the authorized serial number, then use of the connected component is permitted. Initially, such methods allow the surgical hub 206 to authenticate the supplier / manufacturer. Specifically, the surgical hub 206 uses a public key associated with the supplier / manufacturer to encrypt a message including an encrypted serial number. Thus, receiving a response message (i.e., including a private key) authenticates the supplier / manufacturer to the surgical hub 206 (i.e., otherwise the supplier / manufacturer would not have access to the private key paired with the public key used by the surgical hub 206 to encrypt the message, and the supplier / manufacturer would not be able to associate the encrypted serial number received in the message with the private key it had generated). In addition, such methods allow the surgical hub 206 to authenticate the connected component / device itself.Specifically, the supplier / manufacturer (e.g., just authenticated) encrypts the serial number of the component using the delivered private key. Upon securely receiving the private key, the surgical hub 206 is able to decrypt the encrypted serial number (i.e., read from the connected component), which authenticates the component and / or its association with the supplier / manufacturer (i.e., only the private key received from the supplier / manufacturer will decrypt the encrypted serial number). Nevertheless, the surgical hub 206 also authenticates the component as authentic (e.g., comparing the decrypted serial number to a comprehensive list of authorized serial numbers received separately from the supplier / manufacturer). It is noteworthy that such aspects as described above may alternatively be performed by the cloud-based system 205 and / or a combination of the cloud-based system 205 and the surgical hub 206 by authenticating the component and / or its supplier / manufacturer to control which components (e.g., surgical devices / instruments 235, energy devices 241) are being used in the interactive surgical system 200 (e.g., to perform a surgical procedure). In one aspect, such described methods may prevent the use of one or more replica components within the interactive surgical system 200 and ensure the safety and well-being of the surgical patient.

[0391] According to another aspect, the electronic chip of a component (e.g., surgical device / instrument 235, energy device 241) may store (e.g., in memory) data associated with the use of the component (i.e., usage data, such as the number of uses of a limited-use device, the number of uses remaining, the firing algorithm executed, the designation of a single-use component). In such aspects, upon / after the component is connected to the interactive surgical system, the surgical hub 206 and / or the cloud-based system 205 may read such usage data from the memory of the component and write back at least a portion of the usage data for storage (e.g., in memory 249) at the surgical hub 206 and / or for storage at the cloud-based system 205 (e.g., individually and / or in a block chain manner as described herein). According to such aspects, upon / after the component is subsequently connected to the interactive surgical system, the surgical hub 206 and / or the cloud-based system 205 may read such usage data again and compare the usage with the previously stored usage data. Here, if there is a discrepancy or if a predetermined / authorized use has been satisfied, the surgical hub 206 and / or cloud-based system 205 may prevent the use of the component on the interactive surgical system 200 (e.g., blacklist, render inoperable, mark for removal). In various aspects, such methods prevent bypassing of the encrypted chip system. If the electronic chip / memory of a component has been tampered with (e.g., memory has been reset, use count has been changed, firing algorithm has been changed, single use device was designated as a multiple use device), then there will be a discrepancy and use of the component will be controlled / prevented.

[0392] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, entitled “TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS,” which is incorporated herein by reference in its entirety.

[0393] Surgical Hub coordination of device pairing in the operating room

[0394] One of the functions of the surgical hub 106 is to pair (also referred to herein as "connect" or "couple") with other components of the surgical system 102 to control, collect information from, or coordinate interactions between components of the surgical system 102. Because operating rooms in a hospital may be in close physical proximity to one another, the surgical hub 106 of a surgical system 102 may inadvertently pair with components of the surgical system 102 in an adjacent operating room, which would significantly interfere with the function of the surgical hub 106. For example, the surgical hub 106 may inadvertently activate surgical instruments in a different operating room, or record information from a different ongoing surgical procedure in an adjacent operating room.

[0395] Aspects of the present disclosure provide a solution in which the surgical hub 106 only pairs with detected devices of the surgical system 102 that are located within the boundaries of the surgical hub operating room.

[0396] In addition, the surgical hub 106 relies on its knowledge of the locations of other components of the surgical system 102 within its operating room to make decisions about, for example, which surgical instruments should be paired or activated with each other. Changes in the location of the surgical hub 106 or another component of the surgical system 102 may be problematic.

[0397] Aspects of the present disclosure also provide a solution in which the surgical hub 106 is configured to reassess or redefine the boundaries of its operating room upon detecting that the surgical hub 106 has been moved. Aspects of the present disclosure also provide a solution in which the surgical hub 106 is configured to redefine the boundaries of its operating room upon detecting a potential installation of a surgical system 102, which may be an indication that the surgical hub 106 has been moved.

[0398] In various aspects, the surgical hub 106 is used with the surgical system 102 during a surgical procedure performed in an operating room. The surgical hub 106 includes control circuitry configured to determine the boundaries of the operating room, determine the devices of the surgical system 102 that are within the boundaries of the operating room, and pair the surgical hub 106 with the devices of the surgical system 102 that are within the boundaries of the operating room.

[0399] In one aspect, the control circuitry is configured to determine the boundaries of the operating room upon activation of the surgical hub 106. In one aspect, the surgical hub 106 includes communication circuitry configured to detect and pair with a device of the surgical system that is within the boundaries of the operating room. In one aspect, the control circuitry is configured to re-determine the boundaries of the operating room upon detection of a potential device of the surgical system 102. In one aspect, the control circuitry is configured to periodically determine the boundaries of the operating room.

[0400] In one aspect, the surgical hub 106 includes an operating room mapping circuit comprising a plurality of contactless sensors configured to measure the boundaries of the operating room.

[0401] In various aspects, the surgical hub 106 includes a processor and a memory coupled to the processor. The memory stores instructions that are executable by the processor to pair the surgical hub with a device of the surgical system 102 that is located within the boundaries of the operating room, as described above. In various aspects, the present disclosure provides a non-transitory computer-readable medium storing computer-readable instructions that, when executed, cause a machine to pair the surgical hub 106 with a device of the surgical system 102 that is located within the boundaries of the operating room, as described above.

[0402] Fig.35 and Fig.36 is a logic flow diagram of the method as described above, which depicts a control program or logic configuration for pairing the surgical hub 106 with devices of the surgical system 102 located within the boundaries of the operating room.

[0403] The surgical hub 106 performs a wide range of functions that require short-range and long-range communications, such as assisting in surgical procedures, coordinating between devices of the surgical system 102, and collecting and transmitting data to the cloud 104. In order to properly perform its functions, the surgical hub 106 is equipped with a communication module 130 that enables short-range communications with other devices of the surgical system 102. The communication module 130 is also capable of long-range communications with the cloud 104.

[0404] The surgical hub 106 is also equipped with an operating room mapping module 133 that is capable of identifying the boundaries of the operating room and identifying devices of the surgical system 102 within the operating room. The surgical hub 106 is configured to identify the boundaries of the operating room and only pair or connect with potential devices of the surgical system 102 that are detected within the operating room.

[0405] In one aspect, the pairing includes establishing a communication link or path. In another aspect, the pairing includes establishing a control link or path.

[0406] An initial mapping or assessment of the boundaries of the operating room is performed during initial activation of the surgical hub 106. In addition, the surgical hub 106 is configured to maintain spatial awareness during operations by periodically mapping its operating room, which may help determine if the surgical hub 106 has been moved. Reassessment 3017 may be performed periodically, or it may be triggered by an event, such as observing a change in the devices of the surgical system 102 that are considered to be within the operating room. In one aspect, a change is the detection 3010 of a new device that was not previously considered to be within the boundaries of the operating room, such as Fig.37 In another aspect, the change is the disappearance, disconnection, or unpairing of a paired device previously considered resident in the operating room, such as Fig.38 The surgical hub 106 may continuously monitor 3035 the connection with the paired device to detect 3034 the disappearance, disconnection, or unpairing of the paired device.

[0407] In other aspects, the triggering event for re-evaluation may be, for example, a change in the surgeon's position, an instrument exchange, or sensing a new set of tasks being performed by the surgical hub 106.

[0408] In one aspect, the surgical hub 106's assessment of the boundaries of the room is accomplished by activating a sensor array of an operating room mapping module 133 within the surgical hub 106 that enables it to detect the walls of the operating room.

[0409] Other components of the surgical system 102 may be made spatially aware in the same or similar manner as the surgical hub 106. For example, the robotic hub 122 may also be equipped with an operating room mapping module 133.

[0410] The spatial awareness of the surgical hub 106 and its ability to map the operating room for potential components of the surgical system 102 allows the surgical hub 106 to make autonomous decisions regarding whether to include or exclude such potential components as part of the surgical system 102, which relieves the surgical staff from handling such tasks. In addition, the surgical hub 106 is configured to infer information about, for example, the type of surgical procedure to be performed in the operating room based on information collected before, during, and / or after the performance of the surgical procedure. Examples of the information collected include the type of device introduced into the operating room, the time such device was introduced into the operating room, and / or the device activation sequence.

[0411] In one aspect, the surgical hub 106 employs an operating room mapping module 133 to determine the boundaries of a surgical room (eg, a fixed, mobile, or temporary o...

Claims

1. A surgical hub configured to authenticate a surgical device coupled to the surgical hub, the surgical hub comprising: processor; as well as a memory coupled to the processor, the memory storing instructions executable by the processor to: detecting a surgical device communicatively coupled to the surgical hub; receiving an encrypted identifier and a source ID from the surgical device; transmitting a first message from the surgical hub to a server of a surgical device manufacturer associated with the source ID, wherein the first message includes the encrypted identifier, and wherein the first message is encrypted using a public key associated with the surgical device manufacturer; receiving a second message from the server of the surgical device manufacturer, wherein the second message is encrypted using a public key associated with the surgical hub, and wherein the encrypted second message includes a shared key associated with the encrypted identifier of the surgical device; decrypting the encrypted second message using a private key associated with the public key used to encrypt the second message to reveal the shared key associated with the encrypted identifier of the surgical device; decrypting the encrypted identifier of the surgical device using the shared key to reveal the identifier for authenticating the surgical device and its manufacturer; comparing the decrypted identifier to a list of authorized identifiers; as well as Use of the surgical device is permitted based on a match between the decrypted identifier and authorized identifiers in the list.

2. A surgical hub according to claim 1, wherein the identifier comprises a unique serial number of the surgical device.

3. The surgical hub of claim 1 or 2, wherein the instructions are further executable by the processor to: The list of authorized identifiers is downloaded from a cloud-based system communicatively coupled to a plurality of surgical hubs.

4. The surgical hub of claim 1 or 2, wherein receiving the encrypted identifier and the source ID from the surgical device comprises: The encrypted identifier and the source ID are read from a memory device of the surgical device.

5. The surgical hub of claim 1 or 2, wherein the instructions are further executable by the processor to: reading usage data from a memory device of the coupled surgical device, wherein the usage data comprises one or more of: a number of uses of the surgical device, a number of remaining uses, a firing algorithm executed, and a designation of a single-use component when the surgical device is a limited-use device; storing at least a portion of the read usage data each time the surgical device is coupled to the surgical hub; comparing the read usage data with previously stored usage data to identify differences in the usage data; as well as The surgical device is prevented from being used with the surgical hub based on the identified differences.

6. The surgical hub of claim 1 or 2, wherein the instructions are further executable by the processor to: Transmitting a record of the coupling of the surgical device and the surgical hub to a cloud-based system or at least one of a plurality of other surgical hubs in a surgical system that are communicatively coupled to the cloud-based system, wherein the record links a unique identifier assigned to the surgical device to a unique identifier assigned to the surgical hub.

7. The surgical hub of claim 6, wherein the unique identifier assigned to the surgical device comprises a serial number.

8. The surgical hub of claim 6, wherein the instructions are further executable by the processor to: The record of the coupling of the surgical device and the surgical hub is stored as a provenance record, wherein the provenance record includes a timestamp.

9. The surgical hub of claim 8, wherein the instructions are further executable by the processor to: storing a new record of each subsequent coupling of the surgical device to the surgical hub, wherein each new record in the chain of records associated with the surgical device comprises a cryptographic hash of the most recent record, the link from the unique identifier assigned to the surgical device to the unique identifier assigned to the surgical hub, and a timestamp.

10. The surgical hub of claim 9, wherein the instructions are further executable by the processor to: receiving a record of coupling of the surgical device to one of the plurality of other surgical hubs communicatively coupled to the cloud-based system; and storing a new record of the coupling of the surgical device to the one of the plurality of other surgical hubs, wherein the new record in the chain of records associated with the surgical device comprises a cryptographic hash of a most recent record, a link between the unique identifier assigned to the surgical device and the unique identifier assigned to the one of the plurality of other surgical hubs, and a timestamp.

11. The surgical hub of claim 10, wherein the instructions are further executable by the processor to: The coupling of the surgical device to the surgical hub and the plurality of other surgical hubs in the surgical system is traced back to the origin record.

12. The surgical hub of claim 11, wherein the instructions are further executable by the processor to: The traced coupling is analyzed to determine whether past use of the surgical device contributed to or caused the failure event.

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