System for adjusting end effector parameters based on perioperative information - Patents.com
By designing a surgical tool-end effector and control circuit with adjustable motion parameters, the problem of low surgical efficiency and accuracy of existing surgical systems is solved, and more efficient and accurate surgical operations are achieved.
Patent Information
- Application Number
- JP2023085281
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-06-29
- Filing Date
- 2023-05-24
- Publication Date
- 2025-04-30
- Estimated Expiration
- 2038-09-21
AI Technical Summary
When performing surgery, it is difficult to adjust and optimize the movement parameters of surgical tools in real time, resulting in low surgical efficiency and accuracy.
A surgical system is designed, which includes an end effector of a surgical tool, with a first and second fixtures and is equipped with a motor to adjust the movement of the fixture according to the closing rate change and threshold parameters. The system also contains sensors that can transmit signals about fixture shutdown parameters. The control circuit is connected to the sensor and can adjust the motion parameters according to the surgical information and sensor signals.
By adjusting the movement parameters of surgical tools in real time, the efficiency and accuracy of the surgery are improved and the control ability of the surgical process is enhanced.
Smart Images

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Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 691,227, filed June 28, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING," the entire disclosure of which is incorporated herein by reference.
[0002] This application further relates to U.S. Provisional Patent Application No. 62 / 650,887, filed March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," U.S. Provisional Patent Application No. 62 / 650,877, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS," U.S. Provisional Patent Application No. 62 / 650,882, filed March 30, 2018, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," and U.S. Provisional Patent Application No. 62 / 650,882, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY," the disclosures of each of which are incorporated herein by reference in their entirety under 35 U.S.C. §119(e). This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled "PATENT ELEMENTS."
[0003] This application further claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," and U.S. Provisional Patent Application No. 62 / 640,415, filed March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR," the disclosures of each of which are incorporated herein by reference in their entirety.
[0004] This application further claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017; U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017; and U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety.
[0005] FIELD OF THE INVENTION The present disclosure relates to various surgical systems. Summary of the Invention [Means for solving the problem]
[0006] The surgical system includes a surgical instrument. The surgical instrument includes an end effector including a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The surgical instrument further includes a motor configured to move the first jaw relative to the second jaw according to a closure change rate parameter and a closure threshold parameter. The surgical instrument further includes a sensor configured to transmit a sensor signal indicative of the closure parameter of the end effector. The surgical system further includes control circuitry communicatively coupled to the sensor. The control circuitry is configured to receive perioperative information including one or more of a perioperative disease, a perioperative treatment, and a type of surgical procedure. The control circuitry is further configured to receive the sensor signal from the sensor and determine adjustments to the closure change rate parameter and the closure threshold parameter based on the perioperative information and the sensor signal.
[0007] The surgical system includes a surgical hub configured to receive perioperative information transmitted from a remote database of a cloud computing system. The surgical hub is communicatively coupled to the cloud computing system. The surgical system further includes a surgical instrument communicatively coupled to the surgical hub. The surgical instrument includes an end effector including a first jaw and a second jaw. The first jaw is configured to move relative to the second jaw. The end effector further includes a motor configured to move the first jaw relative to the second jaw in accordance with a closure rate parameter and a closure threshold parameter of a closure control program received from the surgical hub. The end effector further includes a sensor configured to transmit a sensor signal indicative of the closure parameter of the end effector. The surgical hub is further configured to receive the sensor signal from the sensor and determine adjustments to the closure rate parameter and the closure threshold parameter based on the perioperative information and the sensor signal. [Brief explanation of the drawings]
[0008] While the features of the various aspects are set forth with particularity in the appended claims, the various aspects, both as to organization and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings in which: [Figure 1] FIG. 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 2] 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. [Figure 3] 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. [Figure 4] FIG. 12 is a partial perspective view of a surgical hub housing and a combination generator module slidably receivable within a drawer of the surgical hub housing, according to at least one aspect of the present disclosure. [Figure 5] FIG. 1 is a perspective view of a combination generator module including bipolar, ultrasonic, and monopolar contacts and smoke evacuation components according to at least one embodiment of the present disclosure. [Figure 6] 10 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, according to at least one embodiment of the present disclosure. [Figure 7] 1 illustrates a vertical modular housing configured to receive multiple modules, according to at least one embodiment of the present disclosure. [Figure 8] 1 illustrates a surgical data network comprising a modular communications hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room within a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one aspect of the present disclosure. [Figure 9] 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 10]1 illustrates a surgical hub comprising multiple modules coupled to a modular control tower, according to at least one embodiment of the present disclosure. [Figure 11] 1 illustrates one embodiment of a Universal Serial Bus (USB) network hub device in accordance with at least one embodiment of the present disclosure. [Figure 12] 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 13] 1 illustrates a control circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 14] 1 illustrates a combinational logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 15] 1 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 16] 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, according to at least one aspect of the present disclosure. [Figure 17] FIG. 1 is a circuit diagram of a robotic surgical instrument configured to manipulate a surgical tool described herein, in accordance with at least one aspect of the present disclosure. [Figure 18] FIG. 1 shows a block diagram of a surgical instrument programmed to control distal translation of a displacement member, according to at least one aspect of the present disclosure. [Figure 19] FIG. 1 is a circuit diagram of a surgical instrument configured to control various functions, according to at least one aspect of the present disclosure. [Figure 20] 10 is a stroke length graph illustrating an example of a control system that modifies the stroke length of a gripper assembly based on articulation angle. [Figure 21] 10 is a closure tube assembly positioning graph illustrating an example of a control system that modifies the longitudinal position of the closure tube assembly based on the articulation angle. [Figure 22]10A-10C are diagrams comparing stapling methods with and without controlled tissue compression. [Figure 23] A force graph shown in section A and an associated displacement graph shown in section B, the force graph and displacement graph having an x-axis defining time, the y-axis of the displacement graph defining the travel displacement of the firing rod, and the y-axis of the force graph defining the sensed torsional force on a motor configured to advance the firing rod. [Figure 24] FIG. 10 is a schematic diagram of a tissue contact circuit showing completion of the circuit upon contact with a pair of spaced apart contact plates. [Figure 25] FIG. 1 is a perspective view of a surgical instrument having an interchangeable shaft assembly operatively coupled thereto, according to at least one embodiment of the present disclosure. [Figure 26] FIG. 26 is an exploded assembly view of a portion of the surgical instrument of FIG. 25, in accordance with at least one embodiment of the present disclosure. [Figure 27] FIG. 1 is an exploded view of a portion of an interchangeable shaft assembly according to at least one embodiment of the present disclosure. [Figure 28] FIG. 26 is an exploded view of an end effector of the surgical instrument of FIG. 25, in accordance with at least one embodiment of the present disclosure. [Figure 29A] FIG. 26 is a block diagram of a control circuit for the surgical instrument of FIG. 25 spanning two views, in accordance with at least one embodiment of the present disclosure. [Figure 29B] FIG. 26 is a block diagram of a control circuit for the surgical instrument of FIG. 25 spanning two views, in accordance with at least one embodiment of the present disclosure. [Figure 30] FIG. 26 is a block diagram of a control circuit of the surgical instrument of FIG. 25, showing the interface between the handle assembly and the power supply assembly, and between the handle assembly and the interchangeable shaft assembly, according to at least one embodiment of the present disclosure. [Figure 31] 1 depicts an example medical device that may include one or more aspects of the present disclosure. [Figure 32]1 depicts an example end effector of a medical device encircling tissue, according to one or more aspects of the present disclosure. [Figure 33] 1 depicts an end effector of an example medical device for compressing tissue, according to one or more aspects of the present disclosure. [Figure 34] 10A-10C depict an example force exerted by an end effector of a medical device compressing tissue, according to one or more aspects of the present disclosure. [Figure 35] FIG. 10 depicts an example force exerted by an end effector of a medical device compressing tissue, also in accordance with one or more aspects of the present disclosure. [Figure 36] FIG. 1 depicts an example tissue compression sensor system according to one or more aspects of the present disclosure. [Figure 37] 10, which also depicts an example tissue compression sensor system according to one or more aspects of the present disclosure. [Figure 38] 10, which also depicts an example tissue compression sensor system according to one or more aspects of the present disclosure. [Figure 39] 1, which also depicts an example circuit diagram according to one or more aspects of the present disclosure. [Figure 40] 1, which also depicts an example circuit diagram according to one or more aspects of the present disclosure. [Figure 41] 1 is a graph depicting an example frequency modulation in accordance with one or more aspects of the present disclosure. [Figure 42] 1 is a graph depicting a combined RF signal in accordance with one or more aspects of the present disclosure. [Figure 43] 1 is a graph depicting a filtered RF signal in accordance with one or more aspects of the present disclosure. [Figure 44] FIG. 1 is a perspective view of a surgical instrument with an articulatable interchangeable shaft. [Figure 45] FIG. 1 is a side view of the tip of a surgical instrument. [Figure 46]Graphs plotting gap size over time (FIG. 46), firing current over time (FIG. 47), tissue compression over time (FIG. 48), anvil strain over time (FIG. 49), and trigger force over time (FIG. 50). [Figure 47] Graphs plotting gap size over time (FIG. 46), firing current over time (FIG. 47), tissue compression over time (FIG. 48), anvil strain over time (FIG. 49), and trigger force over time (FIG. 50). [Figure 48] Graphs plotting gap size over time (FIG. 46), firing current over time (FIG. 47), tissue compression over time (FIG. 48), anvil strain over time (FIG. 49), and trigger force over time (FIG. 50). [Figure 49] Graphs plotting gap size over time (FIG. 46), firing current over time (FIG. 47), tissue compression over time (FIG. 48), anvil strain over time (FIG. 49), and trigger force over time (FIG. 50). [Figure 50] Graphs plotting gap size over time (FIG. 46), firing current over time (FIG. 47), tissue compression over time (FIG. 48), anvil strain over time (FIG. 49), and trigger force over time (FIG. 50). [Figure 51] 1 is a graph plotting tissue displacement as a function of tissue compression for normal tissue. [Figure 52] 1 is a graph plotting tissue displacement as a function of tissue compression to distinguish between normal and diseased tissue. [Figure 53] FIG. 1 illustrates an embodiment of an end effector comprising a first sensor and a second sensor. [Figure 54] FIG. 54 is a logic diagram illustrating one embodiment of a process for adjusting a first sensor measurement based on input from a second sensor of the end effector shown in FIG. 53. [Figure 55] FIG. 10 is a logic diagram illustrating one embodiment of a process for determining a lookup table for a first sensor based on input from a second sensor. [Figure 56] FIG. 10 is a logic diagram illustrating one embodiment of a process for calibrating a first sensor in response to input from a second sensor. [Figure 57] FIG. 10 is a logic diagram illustrating one embodiment of a process for determining and displaying the thickness of a portion of tissue grasped between an anvil and staple cartridge of an end effector. [Figure 58] FIG. 10 is a logic diagram illustrating one embodiment of a process for determining and displaying the thickness of a portion of tissue grasped between an anvil and staple cartridge of an end effector. [Figure 59] 10 is a graph showing a comparison of adjusted and uncorrected Hall Effect thickness measurements. [Figure 60] FIG. 1 illustrates an embodiment of an end effector comprising a first sensor and a second sensor. [Figure 61] FIG. 1 illustrates an embodiment of an end effector comprising a first sensor and a plurality of second sensors. [Figure 62] FIG. 10 is a logic diagram illustrating one embodiment of a process for adjusting a first sensor measurement in response to multiple secondary sensors. [Figure 63] FIG. 2 illustrates one embodiment of a circuit configured to convert signals from a first sensor and a plurality of secondary sensors into digital signals that can be received by a processor. [Figure 64] FIG. 1 illustrates an embodiment of an end effector with multiple sensors. [Figure 65] FIG. 1 is a logic diagram illustrating one embodiment of a process for determining one or more tissue properties based on multiple sensors. [Figure 66] 10 illustrates an embodiment of an end effector comprising multiple sensors coupled to a second jaw member. [Figure 67] 10A-10C illustrate an embodiment of a staple cartridge having multiple sensors integrally formed therein. [Figure 68]FIG. 10 is a logic diagram illustrating one embodiment of a process for determining one or more parameters of a portion of tissue grasped in an end effector. [Figure 69] FIG. 10 illustrates another end effector embodiment with multiple redundant sensors. [Figure 70] FIG. 1 is a logic diagram illustrating one embodiment of a process for selecting the most reliable output from multiple redundant sensors. [Figure 71] FIG. 1 illustrates an embodiment of an end effector with a sensor that includes a specific sampling rate to limit or eliminate spurious signals. [Figure 72] FIG. 10 is a logic diagram illustrating one embodiment of a process for generating a thickness measurement of a portion of tissue located between an anvil and a staple cartridge of an end effector. [Figure 73] 10A-10C illustrate an embodiment of an end effector including sensors for distinguishing between different types of staple cartridges. [Figure 74] 10A-10C illustrate an embodiment of an end effector including sensors for distinguishing between different types of staple cartridges. [Figure 75] 1A-1C illustrate an embodiment of a segmented flexible circuit configured to be fixedly attached to a jaw member of an end effector, according to at least one embodiment of the present disclosure. [Figure 76] 1A-1C illustrate an embodiment of a segmented flexible circuit configured to be attached to a jaw member of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 77] FIG. 10 illustrates one embodiment of an end effector configured to measure tissue gap GT, in accordance with at least one embodiment of the present disclosure. [Figure 78] FIG. 1 illustrates one embodiment of an end effector comprising a segmented flexible circuit, according to at least one embodiment of the present disclosure. [Figure 79]FIG. 79 illustrates the end effector shown in FIG. 78 with jaw members grasping tissue between the jaw members and a staple cartridge in accordance with at least one embodiment of the present disclosure. [Figure 80] FIG. 10 is a diagram of an absolute positioning system for a surgical instrument comprising controlled motor drive circuitry with a sensor mechanism, according to at least one aspect of the present disclosure. [Figure 81] 1 is a diagram of a position sensor comprising a magnetic rotary absolute positioning system according to at least one aspect of the present disclosure. [Figure 82] FIG. 10 is a cross-sectional view of an end effector of a surgical instrument illustrating a firing member stroke against tissue grasped within the end effector, in accordance with at least one aspect of the present disclosure. [Figure 83] 1 is a first graph of two closing force (FTC) plots depicting the force applied to the closing member to close on thick and thin tissue during the closing phase, and a second graph of two firing force (FTF) plots illustrating the force applied to the firing member to fire through thick and thin tissue during the firing phase. [Figure 84] 10 is a graph of a control system configured to provide progressive closure of a closure member during a firing stroke in which the firing member advances distally and engages within a gripper arm, thereby reducing the closure force load on the closure member at a desired rate and decreasing the firing force load on the firing member, in accordance with at least one embodiment of the present disclosure. [Figure 85] FIG. 1 illustrates a proportional-integral-derivative (PID) controller feedback control system in accordance with at least one aspect of the present disclosure. [Figure 86] FIG. 10 is a logic flow diagram illustrating the process of a control program or logic configuration for determining the velocity of a closure member, according to at least one aspect of the present disclosure. [Figure 87] 10 is a timeline illustrating situational awareness of a surgical hub, according to at least one aspect of the present disclosure. [Figure 88] FIG. 1 is a block diagram of a surgical system configured to control surgical functions, according to at least one aspect of the present disclosure. [Figure 89] FIG. 1 is a block diagram of a context-aware surgical system configured to control surgical functions, according to at least one aspect of the present disclosure. [Figure 90] FIG. 10 is a logic flow diagram depicting algorithm-based situational awareness for controlling surgical functions, in accordance with at least one aspect of the present disclosure. [Figure 91] FIG. 10 is a logic flow diagram depicting an algorithm for controlling surgical functions, according to at least one aspect of the present disclosure. [Figure 92] 1 illustrates a portion of a patient's tissue including a tumor and defined surgical margins for the tumor, in accordance with at least one embodiment of the present disclosure. [Figure 93] FIG. 1 is a logic flow diagram illustrating the process flow of a control program or logic configuration for addressing a device selection problem, in accordance with at least one aspect of the present disclosure. [Figure 94] FIG. 1 is a block diagram of a surgical system configured to determine the adequacy of a surgical instrument based on device parameters and sensed parameters, in accordance with at least one aspect of the present disclosure. [Figure 95] FIG. 1 is a block diagram of a surgical instrument according to at least one embodiment of the present disclosure. [Figure 96] FIG. 10 is a logic flow diagram of a process for controlling a surgical instrument according to the consistency of grasped tissue, according to at least one aspect of the present disclosure. [Figure 97] 1 is a first graph depicting end effector force versus time to closure for an exemplary firing of a surgical instrument, in accordance with at least one embodiment of the present disclosure. [Figure 98] 10 is a second graph depicting end effector force versus time for an exemplary firing of a surgical instrument, in accordance with at least one embodiment of the present disclosure. [Figure 99] FIG. 10 is a logical flow diagram of a process for controlling a surgical instrument according to the physiological type of grasped tissue, according to at least one aspect of the present disclosure. [Figure 100A]FIG. 10 is a side elevation view of an end effector grasping soft tissue, with the end effector in an initial contact position with the soft tissue, in accordance with at least one aspect of the present disclosure. [Figure 100B] FIG. 10 is a side elevation view of an end effector grasping soft tissue, with the end effector closed, in accordance with at least one aspect of the present disclosure. [Figure 101A] FIG. 10 is a side elevation view of an end effector grasping a vessel, with the end effector in an initial contact position with the vessel, in accordance with at least one aspect of the present disclosure. [Figure 101B] FIG. 10 is a side view of an end effector grasping a vessel, with the end effector closed, in accordance with at least one aspect of the present disclosure. [Figure 102] 10A-10C are first and second graphs depicting end effector force to close and closure velocity, respectively, versus time for an exemplary firing of a surgical instrument that grasps soft tissue, in accordance with at least one aspect of the present disclosure; [Figure 103] 10A-10D are third and fourth graphs depicting end effector force to close and closure velocity, respectively, versus time for an exemplary firing of a surgical instrument that grasps a vessel, in accordance with at least one embodiment of the present disclosure. [Figure 104] FIG. 10 shows a fifth graph depicting end effector force to close and closure speed versus time for an exemplary firing of a surgical instrument in accordance with at least one embodiment of the present disclosure. [Figure 105] 10 is a fifth graph illustrating end effector force to close and closing velocity, respectively, versus time for an exemplary firing of a surgical instrument in accordance with at least one embodiment of the present disclosure. [Figure 106] 10 is a fifth graph illustrating end effector force to close and closing velocity, respectively, versus time for an exemplary firing of a surgical instrument in accordance with at least one embodiment of the present disclosure. [Figure 107] 10 is a graph depicting impedance versus time for determining when the jaws of a surgical instrument contact tissue and / or staples, in accordance with at least one embodiment of the present disclosure. [Figure 108] 10 is a first graph depicting various tissue closure thresholds for controlling closure of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 109] 10 is a second graph depicting various tissue closure thresholds for controlling closure of an end effector, in accordance with at least one embodiment of the present disclosure. [Figure 110] FIG. 10 is a logic flow diagram illustrating the process of a control program or logic configuration for adjusting a closing rate algorithm, according to at least one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0009] The applicant of this application owns the following U.S. patent applications, filed June 29, 2018, the disclosures of which are incorporated herein by reference in their entirety: U.S. Patent Application No. __________, Attorney Docket No. END8542USNP / 170755, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP / 170760, entitled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP1 / 170760-1, entitled SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP2 / 170760-2, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP3 / 170760-3, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP4 / 170760-4, entitled SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP5 / 170760-5, entitled SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP6 / 170760-6, entitled SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES; U.S. Patent Application No. __________, Attorney Docket No. END8543USNP7 / 170760-7-7, entitled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY; U.S. Patent Application No. __________, Attorney Docket No. END8544USNP / 170761, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE; U.S. Patent Application No. __________, Attorney Docket No. END8544USNP1 / 170761-1, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT; U.S. Patent Application No. __________, Attorney Docket No. END8544USNP2 / 170761-2, entitled SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY; U.S. Patent Application No. __________, Attorney Docket No. END8544USNP3 / 170761-3, entitled SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES; U.S. Patent Application No. __________, Attorney Docket No. END8545USNP / 170762, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL; U.S. Patent Application No. __________, Attorney Docket No. END8545USNP1 / 170762-1, entitled SURGICAL EVACUATION SENSOR ARRANGEMENTS; U.S. Patent Application No. __________, Attorney Docket No. END8545USNP2 / 170762-2, entitled SURGICAL EVACUATION FLOW PATHS; U.S. Patent Application No. __________, Attorney Docket No. END8545USNP3 / 170762-3, entitled SURGICAL EVACUATION SENSING AND GENERATOR CONTROL; U.S. Patent Application No. __________, Attorney Docket No. END8545USNP4 / 170762-4, entitled SURGICAL EVACUATION SENSING AND DISPLAY; U.S. Patent Application No. __________, Attorney Docket No. END8546USNP / 170763, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Patent Application No. __________, Attorney Docket No. END8546USNP1 / 170763-1, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Patent Application No. __________, Attorney Docket No. END8547USNP / 170764, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE," and U.S. Patent Application No. __________, Attorney Docket No. END8548USNP / 170765, entitled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[0010] The applicant of this application owns the following U.S. provisional patent applications, filed June 28, 2018, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES"; · U.S. Provisional Patent Application No. 62 / 691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE"; · U.S. Provisional Patent Application No. 62 / 691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL"; U.S. Provisional Patent Application No. 62 / 691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Provisional Patent Application No. 62 / 691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE," and · U.S. Provisional Patent Application No. 62 / 691,251, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS."
[0011] The applicant of this application owns the following U.S. patent applications, filed March 29, 2018, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Patent Application No. 15 / 940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES"; · U.S. Patent Application No. 15 / 940,648, entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES"; · U.S. Patent Application No. 15 / 940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES"; · U.S. Patent Application No. 15 / 940,666, entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS"; U.S. Patent Application No. 15 / 940,670, entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS"; · U.S. Patent Application No. 15 / 940,677, entitled "SURGICAL HUB CONTROL ARRANGEMENTS"; · U.S. Patent Application No. 15 / 940,632, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD"; U.S. Patent Application No. 15 / 940,640, entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS"; U.S. Patent Application No. 15 / 940,645, entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT"; U.S. Patent Application No. 15 / 940,649, entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME"; · U.S. Patent Application No. 15 / 940,654, entitled "SURGICAL HUB SITUATIONAL AWARENESS"; · U.S. Patent Application No. 15 / 940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING"; · U.S. Patent Application No. 15 / 940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA"; · U.S. Patent Application No. 15 / 940,671, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER"; U.S. Patent Application No. 15 / 940,686, entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE"; · U.S. Patent Application No. 15 / 940,700, entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS"; · U.S. Patent Application No. 15 / 940,629, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS"; U.S. Patent Application No. 15 / 940,704, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT"; U.S. Patent Application No. 15 / 940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY," and · U.S. Patent Application No. 15 / 940,742 entitled "DUAL CMOS ARRAY IMAGING."
[0012] The applicant of this application owns the following U.S. patent applications, filed March 29, 2018, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Patent Application No. 15 / 940,636, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES"; · U.S. Patent Application No. 15 / 940,653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS"; U.S. Patent Application No. 15 / 940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"; U.S. Patent Application No. 15 / 940,679, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET"; · U.S. Patent Application No. 15 / 940,694, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION"; U.S. Patent Application No. 15 / 940,634, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"; U.S. Patent Application No. 15 / 940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK," and · U.S. Patent Application No. 15 / 940,675, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES."
[0013] The applicant of this application owns the following U.S. patent applications, filed March 29, 2018, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Patent Application No. 15 / 940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application No. 15 / 940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application No. 15 / 940,642, entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application No. 15 / 940,676, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application No. 15 / 940,680, entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; · U.S. Patent Application No. 15 / 940,683, entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Patent Application No. 15 / 940,690, entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and · U.S. Patent Application No. 15 / 940,711, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS."
[0014] The applicant of this application owns the following U.S. provisional patent applications, filed March 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES"; · U.S. Provisional Patent Application No. 62 / 649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD"; · U.S. Provisional Patent Application No. 62 / 649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS"; · U.S. Provisional Patent Application No. 62 / 649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER"; · U.S. Provisional Patent Application No. 62 / 649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS"; · U.S. Provisional Patent Application No. 62 / 649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT"; · U.S. Provisional Patent Application No. 62 / 649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES"; U.S. Provisional Patent Application No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"; · U.S. Provisional Patent Application No. 62 / 649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"; · U.S. Provisional Patent Application No. 62 / 649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; · U.S. Provisional Patent Application No. 62 / 649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES"; · U.S. Provisional Patent Application No. 62 / 649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Provisional Patent Application No. 62 / 649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and · U.S. Provisional Patent Application No. 62 / 649,323, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS."
[0015] The applicant of this application owns the following U.S. provisional patent applications, filed April 19, 2018, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 659,900, entitled "METHOD OF HUB COMMUNICATION."
[0016] The applicant of this application owns the following U.S. provisional patent applications, filed March 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES"; · U.S. Provisional Patent Application No. 62 / 650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS"; U.S. Provisional Patent Application No. 62 / 650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," and · U.S. Patent Application No. 62 / 650,898, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS."
[0017] The applicant of this application owns the following U.S. provisional patent applications, filed March 8, 2018, the disclosures of which are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 62 / 640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," and · U.S. Provisional Patent Application No. 62 / 640,415, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR."
[0018] The applicant of this application owns the following U.S. provisional patent applications, filed December 28, 2017, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM"; U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," and · U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM."
[0019] Before describing various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The illustrative embodiments may be embodied in or incorporated into other aspects, variations, and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise specified, the terms and phrases used herein have been chosen for the convenience of the reader for the purpose of describing the illustrative embodiments, and not for the purpose of limiting them. Furthermore, it should be understood that one or more of the aspects, embodiment(s), and / or embodiments described below can be combined with any one or more of the other aspects, embodiment(s), and / or embodiments described below.
[0020] Before describing various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The illustrative embodiments may be embodied in or incorporated into other aspects, variations, and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise specified, the terms and phrases used herein have been chosen for the convenience of the reader for the purpose of describing the illustrative embodiments, and not for the purpose of limiting them. Furthermore, it should be understood that one or more of the aspects, embodiment(s), and / or embodiments described below can be combined with any one or more of the other aspects, embodiment(s), and / or embodiments described below.
[0021] Certain exemplary embodiments will be described below to provide a thorough understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of various embodiments is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the claims.
[0022] 1 , a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104, which may include the remote server 113. In one example, as shown in FIG. 1 , the surgical systems 102 include a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 configured to communicate with each other and / or with the hub 106. In some aspects, the surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to 1.
[0023] FIG. 3 illustrates an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in a surgical operating room 116. A robotic system 110 is used as part of the surgical system 102 in the surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 during minimally invasive incisions in the patient's body while the surgeon views the surgical site via the surgeon's console 118. Images of the surgical site can be acquired by 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 the images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
[0024] Other types of robotic systems can be readily adapted for use with surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,339, filed December 28, 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference.
[0025] Various examples of cloud-based analytics performed by the cloud 104 and suitable for use with the present disclosure are described in U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.
[0026] In various embodiments, the image capture device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.
[0027] The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. The one or more illumination sources may be directed to illuminate a portion of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.
[0028] The one or more illumination sources can be configured to emit electromagnetic energy within the visible and invisible spectrum. The visible spectrum, sometimes called the optical spectrum or luminous spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and is sometimes called visible light, or simply light. The typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.
[0029] The invisible spectrum (i.e., non-radiative spectrum) is the portion of the electromagnetic spectrum located below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths above about 750 nm are longer than the red visible spectrum, which constitutes invisible infrared (IR), microwave, and radio electromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, which constitutes invisible ultraviolet, X-ray, and gamma-ray electromagnetic radiation.
[0030] In various aspects, the imaging device 124 is configured for use in minimally invasive surgery. Examples of imaging devices suitable for use with the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.
[0031] In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. Wavelengths can be separated by filters or by using instruments sensitive to specific wavelengths of light, including frequencies beyond the visible light range, e.g., IR and ultraviolet light. Spectral imaging can enable the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is described in detail in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. Multispectral monitoring can be a useful tool for repositioning the surgical field after a surgical procedure is completed to perform one or more of the above-mentioned tests on the treated tissue.
[0032] It is self-evident that any surgical procedure requires rigorous sterilization of the operating room and surgical instruments. The strict hygiene and sterilization conditions required in the "surgical theater," i.e., operating room or procedure room, require the utmost sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It will be understood that the sterile field may be considered a specific area deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field may be considered the area immediately surrounding the patient as he or she is prepared for the surgical procedure. The sterile field may include cleaned team members in appropriate clothing and all equipment and fixtures within the area.
[0033] In various aspects, the visualization system 108 includes one or more imaging sensors strategically positioned relative to the sterile field, one or more image processing units, one or more storage arrays, and one or more displays, as shown in FIGURE 2. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. The various components of the visualization system 108 are described in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.
[0034] As shown in FIG. 2 , primary display 119 is positioned within the sterile field so as to be visible to an operator positioned at operating table 114. In addition, visualization tower 111 is positioned outside the sterile field. Visualization tower 111 includes first non-sterile display 107 and second non-sterile display 109 facing away from each other. Visualization system 108, guided by hub 106, is configured to coordinate information flow to operators inside and outside the sterile field using displays 107, 109, and 119. For example, hub 106 can cause visualization system 108 to maintain a live video of the surgical site on primary display 119 while displaying snapshots of the surgical site recorded by imager 124 on non-sterile display 107 or 109. The snapshots on non-sterile display 107 or 109 can, for example, enable a non-sterile operator to perform diagnostic steps related to the surgical procedure.
[0035] In one aspect, the hub 106 is also configured to send diagnostic input or feedback entered by a non-sterile operator located in the sterile field at the visualization tower 111 to the primary display 119 in the sterile field for viewing by a sterile operator located at the operating table. In one example, the input may be in the form of a correction to a snapshot displayed on the non-sterile display 107 or 109 that can be sent by the hub 106 to the primary display 119.
[0036] 2 , a surgical instrument 112 is used as part of the surgical system 102 in a surgical procedure. The hub 106 is also configured to coordinate information flow to the display of the surgical instrument 112, as described, for example, in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 may be sent by the hub 106 to the surgical instrument display 115 within the sterile field, where the diagnostic input or feedback may be viewed by the operator of the surgical instrument 112. Exemplary surgical instruments suitable for use with the surgical system 102 are described, for example, in the section entitled "Surgical Instrument Hardware" and in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," the entire disclosure of which is incorporated herein by reference.
[0037] 3, hub 106 is shown in communication with visualization system 108, robotic system 110, and handheld intelligent surgical instrument 112. Hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communications module 130, a processor module 132, and a storage array 134. In certain embodiments, as shown in FIG. 3, hub 106 further includes a smoke evacuation module 126 and / or a suction / irrigation module 128.
[0038] During a surgical procedure, the application of energy to tissue for sealing and / or cutting is commonly accompanied by smoke evacuation, aspiration of excess fluid, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become tangled during a surgical procedure. Addressing this issue can result in valuable time being lost during a surgical procedure. Untangling the lines may require unplugging them from their corresponding modules, which may require resetting the modules. The hub's modular housing 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of such line tangles.
[0039] Aspects of the present disclosure present a surgical hub for use in a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably receivable within a docking station of the hub housing. The docking station includes data and power contacts. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module further includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.
[0040] In one aspect, the fluid line is a first fluid line and a second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received within the hub housing. In one aspect, the hub housing comprises a fluid interface.
[0041] Certain surgical procedures may require the application of two or more energy types to tissue. One energy type may be more beneficial for cutting tissue, while another, different energy type may be more beneficial for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular housing 136 is configured to house various generators and facilitate bidirectional communication between them. One advantage of the hub's modular housing 136 is that it allows for quick removal and / or replacement of various modules.
[0042] Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving the application of energy to tissue, the modular surgical housing including a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port including first data and power contacts, the first energy generator module slidably movable into electrical engagement with the power and data contacts, and the first energy generator module slidably movable out of electrical engagement with the first power and data contacts.
[0043] Further to the above, the modular surgical housing further includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts and the second energy generator module is slidably movable out of electrical engagement with the second power and data contacts.
[0044] Additionally, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.
[0045] 3-7, aspects of the present disclosure are presented relating to a hub modular housing 136 that allows for modular integration of a generator module 140, a smoke evacuation module 126, and a suction / irrigation module 128. The hub modular housing 136 further facilitates bidirectional communication between the modules 140, 126, and 128. As shown in FIG. 5, the generator module 140 may be a generator module that includes integrated monopolar, bipolar, and ultrasonic components supported within a single housing unit 139 that is slidably insertable into the hub modular housing 136. As shown in FIG. 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of monopolar, bipolar, and / or ultrasonic generator modules that interact via the hub modular housing 136. The hub modular housing 136 may be configured to facilitate the insertion of multiple generators and bidirectional communication between the generators docked to the hub modular housing 136 so that the multiple generators function as a single generator.
[0046] In one aspect, the hub's modular housing 136 includes a modular power and communication backplane 149 with external and wireless communication headers to allow removable attachment of the modules 140, 126, 128 and bidirectional communication therebetween.
[0047] In one aspect, the hub modular housing 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. Figure 4 shows a partial perspective view of the surgical hub housing 136 and a combination generator module 145 slidably receiveable in the docking station 151 of the surgical hub housing 136. A docking port 152 having power and data contacts on the rear side of the combination generator module 145 is configured to engage the corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the hub modular housing 136 when the combination generator module 145 is slid into position 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 with a single housing unit 139, as shown in Figure 5.
[0048] In various aspects, the smoke evacuation module 126 includes fluid lines 154 that transport captured / collected smoke and / or fluids away from the surgical site, for example, to the smoke evacuation module 126. Vacuum suction generated from the smoke evacuation module 126 can draw the smoke into openings in utility conduits at the surgical site. Utility conduits coupled to the fluid lines may be in the form of flexible tubing that terminates at the smoke evacuation module 126. The utility conduits and fluid lines define a fluid pathway that extends toward the smoke evacuation module 126, which is received within the hub housing 136.
[0049] In various aspects, the aspiration / irrigation module 128 is coupled to a surgical tool that includes aspiration and suction fluid lines. In one embodiment, the aspiration and suction fluid lines are in the form of flexible tubing that extends from the surgical site toward the aspiration / irrigation module 128. One or more drive systems can be configured to drive the irrigation and suction of fluids to and from the surgical site.
[0050] In one aspect, the surgical tool includes a shaft having an end effector at its distal end, at least one energy treatment unit associated with the end effector, a suction tube, and an irrigation tube. The suction tube can have an inlet port at its distal end, and the suction tube extends through the shaft. Similarly, the irrigation tube can extend through the shaft and have an inlet port proximate to the energy delivery instrument. The energy delivery instrument is configured to deliver ultrasonic and / or RF energy to the surgical site and is initially coupled to the generator module 140 by a cable extending through the shaft.
[0051] The irrigation tubing can be in fluid communication with a fluid source, and the suction tubing can be in fluid communication with a vacuum source. The fluid source and / or vacuum source can be housed within aspiration / irrigation module 128. In one embodiment, the fluid source and / or vacuum source can be housed within hub housing 136 separate from aspiration / irrigation module 128. In such an embodiment, a fluid interface can be configured to connect aspiration / irrigation module 128 to the fluid source and / or vacuum source.
[0052] 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 into engagement with their counterparts in the docking stations of the hub modular housing 136. For example, as shown in FIG. 4 , the combination generator module 145 includes side brackets 155 configured to slidably engage with corresponding brackets 156 of the corresponding docking stations 151 of the hub modular housing 136. The brackets cooperate to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub modular housing 136.
[0053] In some embodiments, the drawers 151 of the hub's modular housing 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In other embodiments, the drawers 151 are different sizes, each designed to accommodate a specific module.
[0054] Additionally, to prevent inserting a module into a drawer with incompatible contacts, the contacts of a particular module may be keyed to engage with the contacts of a particular drawer.
[0055] 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate two-way communication between modules housed within the hub modular housing 136. Alternatively, or in addition, the docking port 150 of the hub modular housing 136 may facilitate wireless two-way communication between modules housed within the hub modular housing 136. Any suitable wireless communication may be used, such as, for example, Air Titan-Bluetooth.
[0056] FIG. 6 illustrates individual power bus attachments of multiple lateral docking ports of a lateral modular housing 160 configured to receive multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect modules 161. The modules 161 are slidably inserted into docking stations 162 of the lateral modular housing 160, which include a backplane for interconnecting the modules 161. As shown in FIG. 6, the modules 161 are arranged laterally within the lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically within the lateral modular housing.
[0057] FIG. 7 illustrates a vertical modular housing 164 configured to receive multiple 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 backplane for interconnecting the modules 165. While the drawer 167 of the vertical modular housing 164 is vertically oriented, in certain cases the vertical modular housing 164 may include a horizontally oriented drawer. Additionally, the modules 165 may interact with each other via docking ports in the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of the modules 165. Additionally, the vertical modular housing 164 includes a master module 178 that houses multiple sub-modules that are slidably received within the master module 178.
[0058] In various aspects, the imaging module 138 includes a built-in video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is configured with a modular housing that can be assembled with a light source module and a camera module. The housing may be a disposable housing. In at least one embodiment, 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 depending on the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for imaging of a scanned beam. Similarly, the light source module can be configured to deliver white light or a different light depending on the surgical procedure.
[0059] During a surgical procedure, it can be inefficient to remove a surgical device from the surgical field and replace it with another surgical device containing a different camera or a different light source. Temporarily losing view of the surgical field can have undesirable consequences. The modular imaging device of the present disclosure is configured to allow for replacement of a light source module or camera module midstream during a surgical procedure without having to remove the imaging device from the surgical field.
[0060] In one aspect, the imaging device includes a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module that can be configured for snap-fit engagement with the first channel. A second channel is configured to slidably receive a light source module that can be configured for snap-fit engagement with the second channel. In another embodiment, the camera module and / or the light source module can be rotated to a final position within their corresponding channels. A threaded engagement may be employed instead of a snap-fit engagement.
[0061] In various embodiments, multiple imaging devices are positioned at different locations within the surgical field to provide multiple fields of view. The imaging module 138 can be configured to switch between the imaging devices to provide the optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from the different imaging devices.
[0062] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Patent No. 7,995,045, issued August 9, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which is incorporated herein by reference in its entirety. Additionally, U.S. Patent No. 7,982,776, issued July 19, 2011, entitled "SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD," which is incorporated herein by reference in its entirety, describes various systems for removing motion artifacts from image data. Such systems may be integrated with imaging module 138. Additionally, U.S. Patent Application Publication No. 2011 / 0306840, published December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE INTRACORPOREAL APPARATUS," and U.S. Patent Application Publication No. 2014 / 0243597, published August 28, 2014, entitled "SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE," the disclosures of each of which are incorporated herein by reference in their entireties.
[0063] FIG. 8 illustrates a surgical data network 201 comprising a modular communications hub 203 configured to connect modular devices located in one or more operating rooms in a medical facility, or any room within a medical facility equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communications hub 203 comprises a network hub 207 and / or a network switch 209 in communication with a network router. The modular communications hub 203 can further be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to travel from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features that allow traffic to pass through the monitored surgical data network, configuring each port in the network hub 207 or network switch 209. An intelligent surgical data network can be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.
[0064] Modular devices 1a-1n located in an operating room may be coupled to a modular communication hub 203. A network hub 207 and / or a network switch 209 may be coupled to a network router 211 to connect devices 1a-1n to the cloud 204 or a local computer system 210. Data associated with devices 1a-1n may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transferred to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to the network switch 209. The network switch 209 may be coupled to the network hub 207 and / or a network router 211 to connect devices 2a-2m to the cloud 204. Data associated with devices 2a-2n may be transferred to the cloud 204 via the network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transferred to the local computer system 210 for local data processing and manipulation.
[0065] It will be appreciated that surgical data network 201 may be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. Modular communications hub 203 may be housed within a modular control tower configured to receive multiple devices 1a-1n / 2a-2m. A local computer system 210 may also be housed in the modular control tower. Modular communications hub 203 is connected to a display 212 to display images acquired by some of devices 1a-1n / 2a-2m, for example, during a surgical procedure. In various embodiments, devices 1a-1n / 2a-2m may include various modules such as, for example, an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communications module 130, a processor module 132, a storage array 134, a surgical device coupled to a display, and / or a non-contact sensor module, among other modular devices that may be connected to a modular communications hub 203 of a surgical data network 201.
[0066] In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es), and network router(s) that connect the devices 1a-1n / 2a-2m to the cloud. Any one or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. While the term "cloud" may be used as a metaphor for the "Internet," the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to a type of internet-based computing in which various services, such as servers, storage, and applications, are delivered to a modular communications hub 203 and / or computer system 210 located at a surgical site (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and / or computer system 210 via the internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. The cloud computing service may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0067] By applying cloud computer data processing technology to data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status and evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. Using cloud-based computing, at least some of the devices 1a-1n / 2a-2m can be used to diagnostically examine data, including images of bodily tissue samples, to identify pathologies, such as the effects of disease. This includes tissue and phenotypic localization and margin confirmation. At least some of the devices 1a-1n / 2a-2m can be used to identify bodily anatomical structures using various sensors integrated with the imaging devices and techniques such as overlaying images captured by multiple imaging devices. Data collected by the devices 1a-1n / 2a-2m, including image data, can be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve the outcome of the surgical procedure by determining whether further treatments can be performed, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and using a standardized approach can provide useful feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.
[0068] In one implementation, operating room devices 1a-1n may be connected to the modular communications hub 203 via wired or wireless channels, depending on the configuration of the devices 1a-1n relative to the network hub. In one embodiment, the network hub 207 may be implemented as a local network broadcasting device operating on the physical layer of the Open Systems Interconnection (OSI) model. The network hub provides connectivity to devices 1a-1n located within the same operating room network. The network hub 207 collects data in the form of packets and sends them to a router in half-duplex mode. The network hub 207 does not store any Media Access Control / Internet Protocol (MAC / IP) protocols for transferring device data. Only one of the devices 1a-1n can transmit data through the network hub 207 at a time. The network hub 207 does not have a routing table or intelligence regarding where to send the information; it broadcasts all network data across each connection and to a remote server 213 (FIG. 9) on the cloud 204. Although network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.
[0069] In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via a wired or wireless channel. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and functions in full-duplex mode. Multiple devices 2a-2m can transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.
[0070] The network hub 207 and / or the network switch 209 are coupled to a network router 211 for connection to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n / 2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as different operating rooms in the same medical facility or different operating rooms in different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.
[0071] In one embodiment, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub can expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information via wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between the devices 1a-1n and 2a-2m located in the operating room.
[0072] In another embodiment, the operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via the Bluetooth wireless technology standard to exchange data over short distances from fixed and mobile devices (using short-wavelength UHF radio waves in the 2.4-2.485 GHz ISM band) and to establish a personal area network (PAN). In another aspect, the operating room devices 1a-1n / 2a-2m can communicate with the modular communications hub 203 via numerous wireless or wired communications standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any other wireless or wired protocols designated 3G, 4G, 5G, and beyond. The computing module may include multiple communication modules, for example, a first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and a second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.
[0073] The modular communications hub 203 can act as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles data types known as frames. Frames carry data generated by the devices 1a-1n / 2a-2m. Once the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211, which forwards this data to cloud computing resources using any number of wireless or wired communications standards or protocols described herein.
[0074] The modular communications hub 203 may be used as a stand-alone device or may be connected to compatible network hubs and network switches to form a larger network. The modular communications hub 203 is generally easy to install, configure, and maintain, making the modular communications hub 203 a good choice for networking the operating room devices 1a-1n / 2a-2m.
[0075] FIG. 9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210. As illustrated in the embodiment of FIG. 9 , modular control tower 236 is coupled to imaging module 238 coupled to endoscope 239, generator module 240 coupled to energy device 241, smoke evacuation module 226, suction / irrigation module 228, communications module 230, processor module 232, storage array 234, smart device / instrument 235 optionally coupled to display 237, and non-contact sensor module 242. Operating room equipment is coupled to cloud computing resources and data storage via modular control tower 236. Robotic hub 222 may also be connected to modular control tower 236 and cloud computing resources. Device / instrument 235, visualization system 208, among other devices, may be coupled to modular control tower 236 via wired or wireless communication standards or protocols described herein. Modular control tower 236 may be coupled to hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from imaging module, device / instrument display, and / or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with images and overlay images.
[0076] FIG. 10 illustrates a surgical hub 206 comprising multiple modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for providing local processing, visualization, and imaging. As shown in FIG. 10, the modular communications hubs 203 can be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communications hub 203 and transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches in the modular communications hub 203 includes three downstream ports and one upstream port. The upstream network hub / switch is connected to a processor to provide communications connectivity to cloud computing resources and a local display 217. Communications to the cloud 204 can occur via either wired or wireless communication channels.
[0077] The surgical hub 206 uses a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the surgical site using either an ultrasound or laser-based non-contact measurement device. As described in the section titled "Surgical Hub Spatial Awareness Within an Operating Room" in U.S. Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety, an ultrasound-based non-contact sensor module scans the operating room by transmitting bursts of ultrasound and receiving echoes when the bursts of ultrasound reflect off the exterior walls of the operating room, where the sensor module is configured to determine the size of the operating room and adjust the Bluetooth pairing distance limit. A laser-based non-contact sensor module scans the operating room by, for example, transmitting laser light pulses, receiving laser light pulses that reflect off the exterior walls of the operating room, and comparing the phase of the transmitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.
[0078] Computer system 210 includes a processor 244 and a network interface 245. Processor 244 is coupled to a communications module 247, storage 248, memory 249, non-volatile memory 250, and input / output interface 251 via a system bus. The system bus may be any of several types of bus structure(s), including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus using any of a variety of bus architectures, including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), Micro Channel Architecture (MSA), Enhanced ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus.
[0079] Processor 244 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including, for example, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product data sheet.
[0080] In one embodiment, processor 244 may include a safety controller, including two controller families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.
[0081] System memory includes both volatile and nonvolatile memory. The basic input / output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. RAM is available in many forms, including static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), sync link DRAM (SLDRAM), and direct RAM (DRRAM).
[0082] The computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage can include storage media independently or in combination with other storage media, including, but not limited to, optical disk drives such as compact disk read-only memory drives (CD-ROMs), compact disk recordable drives (CD-R drives), compact disk rewritable drives (CD-RW drives), or digital versatile disk read-only memory drives (DVD-ROMs). Removable or non-removable interfaces may be used to facilitate connection of disk storage devices to the system bus.
[0083] It should be understood that computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in a suitable operating environment. Such software includes an operating system. The operating system, which may be stored on disk storage, functions to control and allocate resources of the computer system. System applications leverage resource management by the operating system through program modules and program data stored either in system memory or on disk storage. It should be understood that the various components described herein can be implemented with various operating systems or combinations of operating systems.
[0084] A user inputs commands or information into the computer system 210 through input device(s) coupled to the I / O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, trackball, stylus, or touchpad; keyboards; microphones; joysticks; gamepads; satellite dishes; scanners; TV tuner cards; digital cameras; digital video cameras; webcams; and the like. These and other input devices connect to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial ports, parallel ports, game ports, and USB. Output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to the computer system and to output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices, such as monitors, displays, speakers, and printers, among other output devices, that require special adapters. Output adapters include, by way of example and not limitation, video and sound cards, which provide a means of connection between an output device and the system bus. It should be noted that other devices and / or systems of devices, such as remote computer(s), provide both input and output capabilities.
[0085] The computer system 210 can operate in a networked environment using logical connections to one or more remote or local computers, such as cloud computer(s). The remote cloud computer(s) may be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices, or other common network nodes, and typically include many or all of the elements described with respect to a computer system. For simplicity, only memory storage devices are shown along with the remote computer(s). The remote computer(s) are logically connected to the computer system through a network interface and are subsequently physically connected via a communications connection. Network interfaces encompass communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet / IEEE 802.3, Token Ring / IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and its variants, packet-switched networks, and Digital Subscriber Lines (DSL).
[0086] In various embodiments, the computer system 210 of FIG. 10, the imaging module 238 of FIGS. 9-10, and / or the visualization system 208, and / or the processor module 232 may include an image processor, an image processing engine, a media processor, or any specialized digital signal processor (DSP) used to process digital images. The image processor may use parallel computing using single instruction, multiple data (SIMD) or multiple instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.
[0087] The communications connection(s) refer to the hardware / software used to connect the network interface to the bus. While the communications connections are shown internal to the computer system for clarity of illustration, the communications connections may also be external to computer system 210. By way of example only, the hardware / software required to connect to the network interface may include internal and external technologies such as modems, including regular telephone-grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards.
[0088] FIG. 11 shows a functional block diagram of one embodiment of a USB network hub 300 device in accordance with at least one embodiment of the present disclosure. In the illustrated embodiment, the USB network hub device 300 employs a Texas Instruments TUSB2036 integrated circuit hub. The USB network hub 300 is a CMOS device that conforms to the USB 2.0 standard and provides an upstream USB transmit / receive port 302 and up to three downstream USB transmit / receive ports 304, 306, and 308. The upstream USB transmit / receive port 302 is a differential routed data port that includes a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transmit / receive ports 304, 306, and 308 are differential data ports, each including a differential data plus (DP1-DP3) output paired with a differential data minus (DM1-DM3) output.
[0089] The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. Fully compliant USB transceivers are integrated into the circuitry of the upstream USB transmit / receive port 302 and all downstream USB transmit / receive ports 304, 306, and 308. The downstream USB transmit / receive ports 304, 306, and 308 support both full-speed and low-speed devices by automatically setting the slew rate depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes hub power logic 312 to manage power.
[0090] The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in Chapter 8 of the USB Specification. The SIE 310 typically understands signaling down to the transaction level. Its functions may include packet recognition, transaction reordering, SOP, EOP, RESET, and RESUME signal detection / generation, clock / data separation, non-return-to-zero inverted (NRZI) data encoding / decoding and bit stuffing, CRC generation and checking (token and data), Packet ID (PID) generation and checking / decoding, and / or serial-to-parallel / parallel-to-serial conversion. The SIE 310 receives a clock input 314 and is coupled to a suspend / resume logic and frame timer 316 circuit and a hub repeater circuit 318 to control communication between the upstream USB transmit / receive port 302 and the downstream USB transmit / receive ports 304, 306, and 308 via port logic circuits 320, 322, and 324. The SIE 310 is coupled to a command decoder 326 via interface logic for controlling commands from a serial EEPROM via a serial EEPROM interface 330 .
[0091] In various embodiments, the USB network hub 300 can connect 127 functions organized into up to six logical layers (hierarchies) to a single computer. Furthermore, the USB network hub 300 can connect to all peripheral devices using a standardized four-wire cable that provides both communication and power distribution. Power configurations include bus-powered mode and self-powered mode. The USB network hub 300 may be configured to support four modes of power management: a bus-powered hub with either individual or ganged port power management, and a self-powered hub with either individual or ganged port power management. In one embodiment, using a USB cable, the USB network hub 300, the upstream USB transmit / receive port 302 is plugged into a USB host controller, and the downstream USB transmit / receive ports 304, 306, and 308 are exposed for connecting USB-compatible devices.
[0092] Surgical Instrument Hardware FIG. 12 shows a logic diagram of a surgical instrument or tool control system 470 according to one or more embodiments of the present disclosure. The system 470 comprises a control circuit. The control circuit includes a microcontroller 461 with a processor 462 and a memory 468. For example, one or more of sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482, driven by a motor driver 492, is operatively coupled to the longitudinally movable displacement member to drive the I-beam knife element. A 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 may be programmed or configured to determine the position of the longitudinally movable drive member, as well as the positions of the firing member, firing bar, and I-beam knife element. Additional motors may be provided to the tool driver interface to control the firing of the I-beam, the movement of the closure tube, the rotation of the shaft, and the articulation. The display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on the display 473 can be overlaid with images acquired via the endoscopic imaging module.
[0093] In one embodiment, microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and / or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product datasheet.
[0094] In one embodiment, the microcontroller 461 may include a safety controller, which includes two controller families such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.
[0095] The microcontroller 461 may be programmed to perform various functions, such as providing precise control over the speed and position of the knife and articulation system. In one embodiment, the microcontroller 461 includes a processor 462 and memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical linkage to the articulation or knife system. In one embodiment, the motor driver 492 may be an A3941 motor available from Allegro Microsystems, Inc. Other motor drivers may be easily substituted for use in the tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system is provided in U.S. Patent Application Publication No. 2017 / 0296213, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety.
[0096] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate a response within the microcontroller 461 software. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used to determine the actual feedback. The observed response is a suitable adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.
[0097] In one aspect, the motor 482 may be controlled by a motor driver 492 and may be used by the surgical instrument or tool firing system. In various configurations, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In other configurations, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may comprise, for example, an H-bridge driver including field effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery, which may include multiple battery cells connected in series, that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable. In at least one example, the battery cells may be a lithium-ion battery, which may be connectable to and separable from the power supply assembly.
[0098] The motor driver 492 may be the A3941, available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller for use with external N-channel power metal-oxide semiconductor field-effect transistors (MOSFETs), specifically designed for inductive loads such as brushed DC motors. The driver 492 includes an intrinsic charge pump regulator that provides full (>10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the required battery supply voltage for the N-channel MOSFETs. An internal charge pump for the high-side drive allows DC (100% duty cycle) operation. The full-bridge can be driven in fast or slow decay mode using diode or synchronous rectification. In slow decay mode, current recirculation is possible through either the high-side or low-side FET. The power FETs are protected from shoot-through by a resistor-adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.
[0099] The tracking system 480 includes controlled motor drive circuitry including a position sensor 472 according to at least one embodiment 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 embodiment, the displacement member represents a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In another embodiment, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another embodiment, the displacement member represents a firing bar or an I-beam, each of which may be adapted and configured to include a rack of drive teeth. Accordingly, as used herein, the term displacement member is used to collectively refer to any movable member of a surgical instrument, such as a drive member, firing member, firing bar, I-beam, or any element that can be displaced. In one embodiment, the longitudinally movable drive member is coupled to the firing member, firing bar, and I-beam. Thus, the absolute positioning system can, in effect, 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 suitable position sensor 472 for measuring linear displacement. Thus, the longitudinally movable drive member, firing member, firing bar, or I-beam, or combinations thereof, may be coupled to any suitable displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor.The linear displacement sensors may include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), slide potentiometers, magnetic sensing systems with a movable magnet and a series of linearly arranged Hall effect sensors, magnetic sensing systems with a fixed magnet and a series of movable linearly arranged Hall effect sensors, optical detection systems with a movable light source and a series of linearly arranged photodiodes or photodetectors, optical detection systems with a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
[0100] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly mounted in meshing engagement with a set of drive teeth or a rack on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor mechanism may be connected to a linear actuator by a rack and pinion mechanism or to a rotary actuator by a spur gear or other connection. A power source provides power to the absolute positioning system, and an output indicator may display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member may represent a longitudinally movable firing member, a firing bar, an I-beam, or a combination thereof.
[0101] One revolution of the sensor element associated with position sensor 472 corresponds to a linear longitudinal displacement d1 of the displacement member, where d1 is the linear longitudinal distance traveled by the displacement member from point "a" to point "b" after the sensor element coupled to the displacement member rotates one revolution. The sensor mechanism may be connected via a gear reduction that results in the position sensor 472 completing one or more revolutions relative to the full stroke of the displacement member. The position sensor 472 may complete multiple revolutions relative to the full stroke of the displacement member.
[0102] A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of the position sensor 472. The states of the switches are fed back to the microcontroller 461, which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement d1+d2+...dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may comprise a magnetic sensor, an analog rotation sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.
[0103] Position sensor 472 may comprise any number of magnetic sensing elements, such as magnetic sensors classified based on whether they measure the total magnetic field or vector components of a magnetic field. The technologies used to produce both types of magnetic sensors involve many aspects of physics and electronics. Technologies used to sense magnetic fields include search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetodiodes, magnetotransistors, fiber optics, magneto-optics, and microelectromechanical systems-based magnetic sensors, among others.
[0104] In one embodiment, the position sensor 472 of the tracking system 480 with an absolute positioning system comprises a magnetic rotary absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 472 works in conjunction with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 is a low-voltage, low-power component and includes four Hall-effect elements in the area of the position sensor 472 located above the magnet. Additionally, a high-resolution ADC and a smart power management controller are provided on-chip. A Coordinate Rotation Digital Computer (CORDIC) processor, also known as the digit-by-digit method and Volder's algorithm, is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. Angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 via a standard serial communications interface, such as a serial peripheral interface (SPI) interface. The position sensor 472 provides 12-bit or 14-bit resolution and may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.
[0105] A tracking system 480 comprising an absolute positioning system may comprise and / or be programmed to implement a feedback controller, such as a PID, state feedback, and adaptive controller. A power supply 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 position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some embodiments, the other sensor(s) may include sensor mechanisms such as those described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014 / 0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, and induced resistance in order to predict what the state and output of the physical system will be given knowledge of the input.
[0106] The absolute positioning system provides the absolute position of the displacement member upon powering up of the instrument without retracting or advancing the displacement member to a reset (zero or home) position, as may be required with conventional rotary encoders that simply count the number of steps taken by the motor 482 forward or backward to estimate the position of the device actuator, drive bar, knife, etc.
[0107] Sensor 474, such as a strain gauge or microstrain gauge, is configured to measure one or more parameters of the end effector, such as the amplitude of strain exerted on the anvil during clamping, which can be indicative of the closure force applied to the anvil. The measured strain is converted to a digital signal and provided to processor 462. Alternatively or in addition to sensor 474, a sensor 476, such as a load sensor, can measure the closure force applied to the anvil by the closure drive system. For example, sensor 476, such as a load sensor, can measure the firing force applied to the I-beam during the firing stroke of the surgical instrument. The I-beam is configured to engage a wedge-shaped sled, which is configured to cam the staple driver upward and drive the staples into deforming contact with the anvil. The I-beam also includes a sharp cutting edge that can be used to cut tissue as the I-beam is advanced distally by the firing bar. Alternatively, a current sensor 478 can be used to measure current draw by motor 482. The force required to advance the firing member may correspond, for example, to the current drawn by motor 482. The measured force is converted to a digital signal and provided to processor 462.
[0108] In one form, a strain gauge sensor 474 can be used to measure the force applied to tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force applied by the end effector to the tissue being treated. A system for measuring the force applied to tissue grasped by the end effector includes a strain gauge sensor 474, such as a micro-strain gauge configured to measure one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the jaw members of the end effector during a grasping operation, which can be an indication of tissue compression. The measured strain is converted to a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to operate the knife element, for example, to cut tissue captured between the anvil and the staple cartridge. A magnetic field sensor can be used to measure the thickness of the captured tissue. The magnetic field sensor measurements can also be converted to a digital signal and provided to the processor 462.
[0109] Measurements of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474, 476, respectively, can be used by microcontroller 461 to characterize a selected position of the firing member and / or a corresponding value of firing member velocity. In one example, memory 468 can store techniques, equations, and / or look-up tables that can be used by microcontroller 461 during the evaluation.
[0110] The surgical instrument or tool control system 470 may also include wired or wireless communication circuitry for communicating with a modular communications hub as shown in Figures 8-11.
[0111] FIG. 13 illustrates a control circuit 500 configured to control aspects of a surgical instrument or tool according to at least one embodiment of the present disclosure. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 can include a microcontroller including one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute the machine instructions to implement the various processes described herein. The processor 502 can be any one of a number of single- or multi-core processors known in the art. The memory circuit 504 can include volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present disclosure.
[0112] 14 illustrates a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool in accordance with at least one embodiment of the present disclosure. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 can include a finite state machine including combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data through the combinational logic 512, and provide an output 516.
[0113] FIG. 15 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool in accordance with at least one embodiment of the present disclosure. The sequential logic circuit 520 or the combinatorial logic 522 can be configured to implement various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 can store the current state of the finite state machine. In certain examples, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data through the combinatorial logic 522, and provide an output 528. In other embodiments, a circuit may include a combination of a processor (e.g., processor 502 of FIG. 13 ) and a finite state machine that implements various processes herein. In other aspects, the finite state machine may include a combination of combinational logic (eg, combinational logic 510 of FIG. 14) and sequential logic 520.
[0114] 16 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions. In certain examples, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In certain examples, the motors of the robotic surgical instrument 600 can be individually activated to produce firing, closing, and / or articulation motions in the end effector. The firing, closing, and / or articulation motions can be transmitted to the end effector via, for example, a shaft assembly.
[0115] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transfer a firing motion generated by the motor 602 to an end effector, particularly to displace an I-beam element. In certain examples, the firing motion generated by the motor 602 may, for example, deploy staples from a staple cartridge into tissue captured by the end effector and / or advance a cutting blade of the I-beam element to cut the captured tissue. The I-beam element may also be retracted by reversing the direction of the motor 602.
[0116] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, which may be configured to transmit the closure motion generated by the motor 603 to the end effector, specifically to displace a closure tube to close the anvil and compress tissue between the anvil and the staple cartridge. The closure motion may, for example, transition the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.
[0117] In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606 a, 606 b. The motors 606 a, 606 b may be operatively coupled to corresponding articulation motor drive assemblies 608 a, 608 b, which may be configured to transfer articulation motion generated by the motors 606 a, 606 b to an end effector. In certain examples, the articulation motion may, for example, cause the end effector to articulate relative to the shaft.
[0118] As described above, a surgical instrument or tool may include multiple motors that can be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool can be independently or separately activated to perform one or more functions while other motors remain stopped. For example, articulation motors 606 a, 606 b can be activated to articulate the end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 can be activated to fire multiple staples and / or advance a cutting edge while articulation motor 606 is stopped. Additionally, closure motor 603 can be activated simultaneously with firing motor 602 to distally advance a closure tube and I-beam element, as described in more detail herein below.
[0119] In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can accommodate one of the multiple motors at a time. For example, the common control module 610 may be capable of individually coupling and decoupling multiple motors of a robotic surgical instrument. In certain examples, the multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, the multiple motors of a surgical instrument or tool can be independently and selectively engaged with the common control module 610. In certain examples, the common control module 610 can be selectively switched from coupling with one of the multiple motors of the surgical instrument or tool to coupling with another of the multiple motors of the surgical instrument or tool.
[0120] In at least one example, the common control module 610 can be selectively switched between operative engagement with the articulation motors 606 a, 606 b and operative engagement with either the firing motor 602 or the closure motor 603. In at least one embodiment, as shown in FIGURE 16 , the switch 614 can be moved or transitioned between multiple positions and / or states. For example, in a first position 616, the switch 614 can electrically couple the common control module 610 to the firing motor 602, in a second position 617, the switch 614 can electrically couple the common control module 610 to the closure motor 603, in a third position 618 a, the switch 614 can electrically couple the common control module 610 to the first articulation motor 606 a, and in a fourth position 618 b, the switch 614 can electrically couple the common control module 610 to the second articulation motor 606 b. In certain examples, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b at the same time. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.
[0121] Each of the motors 602, 603, 606a, 606b may be equipped with a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaws or by a torque sensor on the motor that actuates the jaws.
[0122] 16, common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. Motor driver 626 may modulate power transferred from a power supply 628 to a motor coupled to common control module 610, for example, based on input from a microcontroller 620 ("controller"). In particular examples, as described above, for example, microcontroller 620 may be used to determine the current drawn by a motor while the motor is coupled to common control module 610.
[0123] In particular examples, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or memory units 624 ("memory"). In particular examples, memory 624 may store various program instructions that, when executed, cause processor 622 to perform multiple functions and / or calculations described herein. In particular examples, one or more of memory units 624 may be coupled to processor 622, for example.
[0124] In certain examples, power supply 628 may be used to, for example, power microcontroller 620. In certain examples, power supply 628 may include a battery (or "battery pack" or "power pack"), such as, for example, a lithium-ion battery. In certain examples, the battery pack may be configured to releasably attach to the handle to power surgical instrument 600. Multiple battery cells connected in series may be used as power supply 628. In certain examples, power supply 628 may be, for example, replaceable and / or rechargeable.
[0125] In various examples, the processor 622 can control the motor drivers 626 to control the position, direction of rotation, and / or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor drivers 626 to stop and / or disable the motors coupled to the common control module 610. The term "processor," as used herein, should be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to a few integrated circuits. A processor is a general-purpose, programmable device that accepts digital data as input, processes that data according to instructions stored in memory, and provides a result as output. Because it has internal memory, it is an example of sequential digital logic. A processor operates on numbers and symbols represented in the binary system.
[0126] In one example, processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In a particular example, microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other characteristics readily available in the product datasheet, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with module 4410. Accordingly, the present disclosure should not be limited in this context.
[0127] In certain examples, memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are connectable to the common control module 610. For example, memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606 a, 606 b. Such program instructions may cause processor 622 to control the firing, closing, and articulation functions according to inputs from algorithms or control programs of the surgical instruments or tools.
[0128] In certain examples, one or more mechanisms and / or sensors, such as, for example, sensor 630, can be used to alert processor 622 to use program instructions that should be used in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In certain examples, sensor 630 can include, for example, a position sensor that can be used to sense the position of switch 614. Thus, for example, processor 622 can use program instructions associated with firing an I-beam of the end effector when it detects, for example, via sensor 630, that switch 614 is in first position 616; processor 622 can use program instructions associated with closing an anvil when it detects, for example, that switch 614 is in second position 617 via sensor 630; and processor 622 can use program instructions associated with articulating the end effector when it detects, for example, via sensor 630, that switch 614 is in third position 618a or fourth position 618b.
[0129] 17 is a schematic diagram of a robotic surgical instrument 700 configured to manipulate a surgical tool described herein, according to at least one embodiment of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of an obturator tube, shaft rotation, and articulation using either single or multiple articulation drive couplings. In one embodiment, the surgical instrument 700 may be programmed or configured to individually control a firing member, a closure member, a shaft member, and / or one or more articulating members. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, or one or more articulating members.
[0130] 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 blade) portions of the end effector 702, a removable staple cartridge 718, a shaft 740, and one or more articulating members 742a, 742b via multiple motors 704a-704e. 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 can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.
[0131] In one aspect, control circuitry 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to perform one or more tasks. In one aspect, timer / counter circuitry 731 provides an output signal, such as an elapsed time or a digital count, to control circuitry 710 to correlate the position of I-beam 714 determined by position sensor 734 with the output of timer / counter circuitry 731 so that control circuitry 710 can determine the position of I-beam 714 at a particular time (t) relative to a starting position or time (t) when I-beam 714 is at a particular position relative to the starting position. Timer / counter 731 may be configured to measure elapsed time, count external events, or time an external event.
[0132] In one aspect, the control circuit 710 may be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuit 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or a closure control program based on the tissue condition. The firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 710 may be programmed to translate the displacement member at a slower speed and / or with lower power. When thinner tissue is present, the control circuit 710 may be programmed to translate the displacement member at a higher speed and / or with higher power. The closure control program may control the closure force applied to the tissue by the anvil 716. Other control programs control the rotation of the shaft 740 and articulating members 742a, 742b.
[0133] In one aspect, the control circuit 710 may generate motor setpoint signals. The motor setpoint signals may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e, as described herein. In some embodiments, the motors 704a-704e may be brushed DC electric motors. For example, the speed of the motors 704a-704e may be proportional to the respective motor drive signals. In some embodiments, the motors 704a-704e may be brushless DC electric motors, and the respective motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Also, in some embodiments, the motor controllers 708a-708e may be omitted, and the control circuit 710 may generate the motor drive signals directly.
[0134] In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program for a closed-loop configuration. The instrument response may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, the total pulse width of the motor drive signal, etc. After the open-loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the displacement member's stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity.
[0135] In one aspect, motors 704a-704e can receive power from an energy source 712. Energy source 712 may be a DC power supply driven by a mains AC power supply, a battery, a supercapacitor, or any other suitable energy source. Motors 704a-704e may be mechanically coupled to respective movable mechanical elements, such as I-beam 714, anvil 716, shaft 740, articulating member 742a, and articulating member 742b, via respective transmissions 706a-706e. Transmissions 706a-706e may include one or more gears or other coupling components for coupling motors 704a-704e to the movable mechanical elements. Position sensor 734 may sense the position of I-beam 714. Position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of I-beam 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuitry 710 as the I-beam 714 translates distally and proximally. The control circuitry 710 may track the pulses to determine the position of the I-beam 714. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the I-beam 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a-704e are stepper motors, the control circuitry 710 may track the position of the I-beam 714 by summing the number and direction of steps the motor 704 is commanded to take. The position sensor 734 may be located within the end effector 702 or any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.
[0136] In one aspect, the control circuit 710 is configured to drive a firing member, such as the I-beam 714 portion of the end effector 702. The control circuit 710 provides motor settings to a motor controller 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a, which is coupled to the I-beam 714. The transmission 706a includes a moving mechanical element, such as a rotating element and a firing member, to control the distal and proximal movement of the I-beam 714 along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly including a knife gear reduction set including a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to fire or displace the I-beam 714. The position sensor 734 can be configured to provide a feedback signal to the control circuit 710 regarding the position of the I-beam 714 or the firing member along the firing stroke. The end effector 702 can include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor controller 708a. In response to the firing signal, the motor 704a can drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the firing member translates distally, the I-beam 714, with a cutting element positioned at its distal end, advances distally to cut tissue located between the staple cartridge 718 and the anvil 716.
[0137] In one aspect, the control circuit 710 is configured to drive a closure member, such as the anvil 716 of the end effector 702. The control circuit 710 provides motor settings to a motor controller 708b, which provides a drive signal to a 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, which is coupled to the anvil 716. The transmission 706b includes a moving mechanical element, such as a rotating element and a closure member, for controlling movement of the anvil 716 from open and closed positions. In one aspect, the motor 704b is coupled to a closure gear assembly including a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closure force feedback signal to the control circuit 710. The closure force feedback signal is indicative of the closure force applied to the anvil 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 can provide a closure force feedback signal to the control circuit 710. The pivotable anvil 716 is positioned opposite the staple cartridge 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control 708b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the anvil 716 and the staple cartridge 718.
[0138] In one aspect, the control circuit 710 is configured to rotate a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides motor settings to a motor controller 708c, which in turn provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c, which is coupled to the shaft 740. The transmission 706c includes a movable mechanical element, such as a rotating element, to control the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is coupled to a rotational transmission assembly including a tubular gear segment formed on (or attached to) the proximal end of the proximal closure tube for operably engaging with a rotary gear assembly operably supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.
[0139] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides motor settings to a motor controller 708d, which provides a drive signal to the motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d, which is coupled to the articulation member 742a. The transmission 706d comprises a movable mechanical element, such as an articulation element, for controlling ±65° of articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut, which is rotatably journaled on a proximal end portion of the distal spine portion and rotatably driven by an articulation gear assembly on the proximal end portion of the distal spine portion. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal is indicative of 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 .
[0140] In another embodiment, the articulation function of the robotic surgical system 700 may include two articulation members, or linkages, 742a, 742b. These articulation members 742a, 742b are driven by separate disks on a robot interface (rack) driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the articulation linkages 742a, 742b may be driven antagonistically relative to the other linkage to provide resistive holding motion and load to the head when the head is not moving, and to provide articulation motion when the head is articulating. The articulation members 742a, 742b are attached to the head at a fixed radius as the head rotates. Therefore, as the head rotates, the mechanical efficiency of the push-pull linkage changes. This change in mechanical efficiency may be more pronounced with other articulation linkage drive systems.
[0141] In one aspect, one or more of the motors 704a-704e may comprise a brushed DC motor with a gearbox and a mechanical linkage to the firing member, closure member, or articulation member. Another example includes electric motors 704a-704e that operate moving mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are the unmeasured and unpredictable effects of things like tissue, surroundings, and friction on a physical system. Such external influences are sometimes referred to as drags that act against one of the electric motors 704a-704e. External influences, such as drag, can cause the operation of a physical system to deviate from the desired operation of the physical system.
[0142] In one aspect, position sensor 734 may be implemented as an absolute positioning system. In one aspect, position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. Position sensor 734 can cooperate with control circuit 710 to provide an absolute positioning system. The position sensor may include multiple Hall effect elements positioned above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and Boulder algorithm, which implements simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.
[0143] In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensor 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensor 738 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. The sensor 738 may be positioned on the deck of the staple cartridge 718 to determine the position of the tissue using split electrodes. The torque sensors 744a-744e may be configured to sense forces, such as firing force, closure force, and / or articulation force, among others. Thus, the control circuit 710 can sense (1) the closure load and position experienced by the distal closure tube, (2) the firing member in the rack and its position, (3) which portion of the staple cartridge 718 has tissue thereon, and (4) the load and position on both articulation rods.
[0144] In one aspect, the one or more sensors 738 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of strain in the anvil 716 during the clamping state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of strain. The sensor 738 may comprise a pressure sensor configured to detect pressure caused by the presence of tissue compressed between the anvil 716 and the staple cartridge 718. The sensor 738 may be configured to detect the impedance of a portion of the tissue located between the anvil 716 and the staple cartridge 718, which impedance is indicative of the thickness and / or integrity of the tissue located therebetween.
[0145] In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, among others. In other implementations, the sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, or an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include a non-conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.
[0146] In one aspect, the sensor 738 may be configured to measure the force exerted by the closure drive system on the anvil 716. For example, one or more sensors 738 may be located at an interaction point between a closure tube and the anvil 716 to detect the closure force applied to the anvil 716 by the closure tube. The force exerted on the anvil 716 may be representative of tissue compression experienced by a portion of tissue 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 closure force applied to the anvil 716 by the closure drive system. The one or more sensors 738 may be sampled in real time during the clamping operation by a processor in the control circuitry 710. The control circuitry 710 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force applied to the anvil 716 in real time.
[0147] In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the moving mechanical elements, such as the I-beam 714, corresponds to the current drawn by one of the motors 704a-704e. This 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 controller software. The displacement member can be actuated to move the I-beam 714 in the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be any one of any feedback controllers, including, but not limited to, a PID, a state feedback, a linear quadratic (LQR), and / or an adaptive controller. The robotic surgical instrument 700 can include a power supply for converting a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force. Further details are disclosed in U.S. Patent Application No. 15 / 636,829, filed June 29, 2017, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT," which is incorporated herein by reference in its entirety.
[0148] 18 shows a block diagram of a surgical instrument 750 programmed to control the distal translation of a displacement member, in accordance with at least one embodiment of the present disclosure. In one embodiment, the surgical instrument 750 is programmed to control the distal translation of a displacement member, such as an I-beam 764. The surgical instrument 750 includes an anvil 766, an I-beam 764 (including a sharp cutting blade), and an end effector 752 that may include a removable staple cartridge 768.
[0149] The position, movement, displacement, and / or translation of a linear displacement member, such as I-beam 764, can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Because I-beam 764 is coupled to a longitudinally movable drive member, the position of I-beam 764 can be determined by measuring the position of the longitudinally movable drive member utilizing position sensor 784. Accordingly, in the following description, the position, displacement, and / or translation of I-beam 764 can be achieved by position sensor 784 as described herein. Control circuitry 760 can be programmed to control the translation of a displacement member, such as I-beam 764. In some embodiments, control circuitry 760 can comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to control a displacement member, e.g., I-beam 764, in the manner described. In one aspect, timer / counter 781 provides an output signal, such as elapsed time or a digital count, to control circuitry 760 so that the position of I-beam 764 determined by position sensor 784 can be correlated with the output of timer / counter 781, allowing control circuitry 760 to determine the position of I-beam 764 at a particular time (t) relative to a starting position. Timer / counter 781 may be configured to measure elapsed time, count external events, or time external events.
[0150] Control circuit 760 may generate a motor setpoint signal 772. Motor setpoint signal 772 may be provided to motor controller 758. Motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to motor 754 to drive motor 754, as described herein. In some embodiments, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774. In some examples, motor 754 may be a brushless DC electric motor, and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754. Also, in some embodiments, motor controller 758 may be omitted, and control circuit 760 may directly generate motor drive signal 774.
[0151] The motor 754 may receive power from an energy source 762. The energy source 762 may be or may include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other coupling components for coupling 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 may include any type of sensor capable of generating position data indicative of 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 circuitry 760 as the I-beam 764 translates distally and proximally. The control circuitry 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the I-beam 764. Also, in some embodiments, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 may track the position of I-beam 764 by summing the number and direction of steps motor 754 is commanded to take. Position sensor 784 may be located in end effector 752 or any other part of the instrument.
[0152] The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may comprise magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensors 788 may include one or more sensors.
[0153] The one or more sensors 788 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of strain in the anvil 766 during the clamping state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of strain. The sensor 788 may comprise a pressure sensor configured to detect pressure caused by the presence of tissue compressed between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of a portion of the tissue located between the anvil 766 and the staple cartridge 768, which is indicative of the thickness and / or integrity of the tissue located therebetween.
[0154] The sensor 788 may be configured to measure the force exerted on the anvil 766 by the closure drive system. For example, one or more sensors 788 may be located at an interaction point between a closure tube and the anvil 766 to detect the closure force applied to the anvil 766 by the closure tube. The force exerted on the anvil 766 may be representative of tissue compression experienced by tissue portions 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 closure force applied to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time during clamping by a processor in the control circuitry 760. The control circuitry 760 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force applied to the anvil 766 in real time.
[0155] A current sensor 786 can be used to measure the current drawn by motor 754. The force required to advance I-beam 764 corresponds to the current drawn by motor 754. The force is converted to a digital signal and provided to control circuit 760.
[0156] The control circuitry 760 can be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the I-beam 764 in the end effector 752 at or about a target velocity. The surgical instrument 750 can include a feedback controller, which can be any one of any feedback controllers, including, but not limited to, a PID, a state feedback, an LQR, and / or an adaptive controller. The surgical instrument 750 can include a power supply for converting a signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and / or a force.
[0157] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or I-beam 764 via a brushed DC motor with a gearbox and mechanical linkage to the articulation and / or knife system. Another example is an electric motor 754 operating the displacement member and articulation driver, for example, an interchangeable shaft assembly. External influences are the unmeasured and unpredictable effects of things like tissue, surroundings, and friction on a physical system. These external influences are sometimes referred to as obstacles that act against the electric motor 754. External influences, such as obstacles, can cause the operation of a physical system to deviate from the desired operation of the physical system.
[0158] Various exemplary embodiments are directed to a surgical instrument 750 including an end effector 752 having a motor-driven surgical stapling and cutting means. For example, a motor 754 can drive a displacement member distally and proximally along a 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 positioned opposite the anvil 766. A clinician can grasp 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 depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 can drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the displacement member translates distally, an I-beam 764 having a cutting element positioned at its distal end can cut tissue between the staple cartridge 768 and the anvil 766 .
[0159] In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as 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, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a firing control program based on the tissue condition. The firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and / or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or with higher power.
[0160] In some embodiments, the control circuit 760 may initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's stroke. Based on the response of the instrument 750 during the open-loop portion of the stroke, the control circuit 760 may select a firing control program. The instrument response may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to the motor 754 during the open-loop portion, the total pulse width of the motor drive signal, etc. After the open-loop portion, the control circuit 760 may implement the selected firing control program for a second portion of the displacement member's stroke. For example, during the closed-loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Further details are disclosed in U.S. Patent Application No. 15 / 720,852, filed September 29, 2017, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," which is incorporated herein by reference in its entirety.
[0161] 19 is a schematic illustration of a surgical instrument 790 configured to control various functions, in accordance with at least one embodiment of the present disclosure. In one embodiment, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as an I-beam 764. The surgical instrument 790 includes an end effector 792 that may include an anvil 766, an I-beam 764, and a removable staple cartridge 768 that may be replaced with an RF cartridge 796 (shown in dashed lines).
[0162] In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid-state switch, a Hall effect device, an MR device, a GMR device, a magnetometer, among others. In other implementations, the sensor 638 may be a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include a non-conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.
[0163] In one aspect, position sensor 784 may be implemented as an absolute positioning system comprising a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. Position sensor 784 can provide an absolute positioning system in conjunction with control circuit 760. The position sensor may include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit method and Boulder algorithm, which implements simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.
[0164] In one aspect, I-beam 764 may be implemented as a knife member comprising a knife body operably supporting a tissue-cutting blade thereon and may further include an anvil engagement tab or mechanism and a track engagement mechanism or foot. In one aspect, staple cartridge 768 may be implemented as a standard (mechanical) surgical fastener cartridge. In one aspect, RF cartridge 796 may be implemented as an RF cartridge. These and other sensor configurations are described in commonly owned U.S. patent application Ser. No. 15 / 628,175, filed June 20, 2017, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated by reference herein in its entirety.
[0165] The position, movement, displacement, and / or translation of a linear displacement member, such as I-beam 764, can be measured by an absolute positioning system, sensor arrangement, and position sensor, represented as position sensor 784. Because I-beam 764 is coupled to a longitudinally movable drive member, the position of I-beam 764 can be determined by measuring the position of the longitudinally movable drive member using position sensor 784. Accordingly, in the following description, the position, displacement, and / or translation of I-beam 764 can be achieved by position sensor 784 as described herein. Control circuitry 760 can be programmed to control the translation of a displacement member, such as I-beam 764, as described herein. In some embodiments, control circuitry 760 can comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to control a displacement member, e.g., I-beam 764, in the manner described. In one aspect, timer / counter 781 provides an output signal, such as elapsed time or a digital count, to control circuitry 760 so that the position of I-beam 764 determined by position sensor 784 can be correlated with the output of timer / counter 781, allowing control circuitry 760 to determine the position of I-beam 764 at a particular time (t) relative to a starting position. Timer / counter 781 may be configured to measure elapsed time, count external events, or time external events.
[0166] Control circuit 760 may generate a motor setpoint signal 772. Motor setpoint signal 772 may be provided to motor controller 758. Motor controller 758 may include one or more circuits configured to provide a motor drive signal 774 to motor 754 to drive motor 754, as described herein. In some embodiments, motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to motor drive signal 774. In some examples, motor 754 may be a brushless DC electric motor, and motor drive signal 774 may include a PWM signal provided to one or more stator windings of motor 754. Also, in some embodiments, motor controller 758 may be omitted, and control circuit 760 may directly generate motor drive signal 774.
[0167] The motor 754 can receive power from an energy source 762. The energy source 762 may be or may include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the I-beam 764 via a transmission 756. The transmission 756 may include one or more gears or other coupling components for coupling 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 indicative of 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 circuitry 760 as the I-beam 764 translates distally and proximally. The control circuitry 760 may track the pulses to determine the position of the I-beam 764. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may also provide other signals indicative of the movement of the I-beam 764. Also, in some embodiments, position sensor 784 may be omitted. If motor 754 is a stepper motor, control circuit 760 may track the position of I-beam 764 by summing the number and direction of steps the motor is commanded to take. Position sensor 784 may be located in end effector 792 or any other part of the instrument.
[0168] The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 may comprise magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors for measuring one or more parameters of the end effector 792. The sensors 788 may include one or more sensors.
[0169] The one or more sensors 788 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of strain in the anvil 766 during the clamping state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of strain. The sensor 788 may comprise a pressure sensor configured to detect pressure caused by the presence of tissue compressed between the anvil 766 and the staple cartridge 768. The sensor 788 may be configured to detect the impedance of a portion of the tissue located between the anvil 766 and the staple cartridge 768, which is indicative of the thickness and / or integrity of the tissue located therebetween.
[0170] The sensor 788 may be configured to measure the force exerted on the anvil 766 by the closure drive system. For example, one or more sensors 788 may be located at an interaction point between a closure tube and the anvil 766 to detect the closure force applied to the anvil 766 by the closure tube. The force exerted on the anvil 766 may be representative of tissue compression experienced by a portion of tissue 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 closure force applied to the anvil 766 by the closure drive system. The one or more sensors 788 may be sampled in real time during the gripping operation by a processor portion of the control circuitry 760. The control circuitry 760 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force applied to the anvil 766 in real time.
[0171] A current sensor 786 can be used to measure the current drawn by motor 754. The force required to advance I-beam 764 corresponds to the current drawn by motor 754. The force is converted to a digital signal and provided to control circuit 760.
[0172] An RF energy source 794 is coupled to the end effector 792 and is applied to the RF cartridge 796 when the RF cartridge 796 is loaded into the end effector 792 in place of the staple cartridge 768. The control circuit 760 controls the delivery of RF energy to the RF cartridge 796.
[0173] Further details are disclosed in U.S. Patent Application No. 15 / 636,096, filed June 28, 2017, entitled "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME," which is incorporated herein by reference in its entirety.
[0174] 20 shows a stroke length graph 20740 illustrating how the control system can modify the stroke length of the closure tube assembly based on the articulation angle θ. Such stroke length modification includes reducing the stroke length as the articulation angle θ increases (e.g., defined along the x-axis) to a compensated stroke length (e.g., defined along the y-axis). The compensated stroke length defines the length of distal travel of the closure tube assembly to close the jaws of the end effector, which is dependent on the articulation angle θ, and prevents the closure tube assembly from over-traveling and causing damage to the surgical device.
[0175] For example, as shown in stroke length graph 20740, the stroke length of the closure tube assembly is approximately 0.250 inches when the end effector is not articulated, and the corrected stroke length is approximately 0.242 inches when the articulation angle θ is approximately 60 degrees. Such measurements are provided by way of example only, and any of a variety of angles and corresponding stroke lengths and corrected stroke lengths may be included without departing from the scope of this disclosure. Furthermore, the relationship between articulation angle θ and corrected stroke length is non-linear, such that as the articulation angle increases, the rate at which the corrected stroke length decreases also increases. For example, the reduction in corrected stroke length for articulation between 45 degrees and 60 degrees is greater than the reduction in corrected stroke length for articulation between zero degrees and 15 degrees. In this approach, although the control system adjusts the stroke length based on the articulation angle θ to prevent damage to the surgical instrument (e.g., jamming the distal end of the closure tube assembly in a distal position), the distal closure tube may still be able to advance during articulation, potentially at least partially closing the jaws.
[0176] 21 shows a closure tube assembly positioning graph 20750 illustrating one manner in which the control system modifies the longitudinal position of the closure tube assembly based on the articulation angle θ. Such modification of the longitudinal position of the closure tube assembly includes retracting the closure tube assembly proximally a correction distance (e.g., defined along the y-axis) based on the articulation angle θ (e.g., defined along the x-axis) as the end effector is articulated. The correction distance the closure tube assembly is retracted proximally prevents distal advancement of the distal closure tube, thereby maintaining the jaws in an open position during articulation. By retracting the closure tube assembly proximally a correction distance during articulation, the closure tube assembly can progress a stroke length starting from a proximally retracted position to close the jaws when the closure assembly is actuated.
[0177] For example, as shown in closure tube assembly positioning graph 20750, the compensation distance is zero when the end effector is not articulated, and is approximately 0.008 inches when the articulation angle θ is approximately 60 degrees. In this example, the closure tube assembly is retracted a compensation distance of 0.008 inches during articulation. Therefore, to close the jaws, the closure tube assembly can be advanced a stroke length starting from this retracted position. Such measurements are provided for example purposes only and may include any of a variety of angles and corresponding compensation distances without departing from the scope of the present disclosure. As shown in FIG. 21 , the relationship between articulation angle θ and compensation distance is non-linear, such that as articulation angle θ increases, the rate at which compensation distance increases also increases. For example, the increase in compensation distance from 45 degrees to 60 degrees is greater than the increase in compensation distance from zero degrees to 15 degrees.
[0178] When gripping a patient's tissue, the force exerted via a gripping device (e.g., a linear stapler) can reach unacceptably high levels. For example, if a constant closure speed is employed, the force may be great enough to cause excessive trauma to the gripped tissue and may cause deformation of the gripping device such that an acceptable tissue gap is not maintained across the stapling path. FIG. 22 is a graph showing the power applied to tissue during compression at a constant anvil closure speed (i.e., without utilizing controlled tissue compression (CTC)) and a variable anvil closure speed (i.e., with CTC). The closure speed may be adjusted to control tissue compression so that the power applied to the tissue remains constant over a portion of the compression. The peak power applied to the tissue according to FIG. 22 is much lower when a variable anvil closure speed is utilized. Based on the applied power, the force (a parameter related to or proportional to force) exerted by the surgical device can be calculated. In this regard, power may be limited so that the force exerted through a surgical device, such as the jaws of a linear stapler, does not exceed a yield force or pressure that would cause the jaws to splay out, resulting in a tissue gap that is not within an acceptable range along the entire length of stapling when in a fully closed position. For example, the jaws should be parallel or close enough so that the tissue gap remains within an acceptable or target range for all staple positions along the entire length of the jaws. Furthermore, limiting the applied power avoids or at least minimizes trauma or damage to the tissue.
[0179] In Figure 22, the total energy exerted in the method without a CTC is the same as the total energy exerted in the method with a CTC, i.e., the area under the power curve in Figure 22 is the same or substantially the same. However, the difference in the power profile utilized is significant since the peak power is much lower in the example with a CTC compared to the example with a CTC.
[0180] Power limitation is achieved in embodiments using CTC by slowing down the closure speed, as shown by line 20760. Note that compression time B' is longer than closure time B. As shown in FIG. 22 , devices and methods providing a constant closure speed (i.e., without CTC) achieve the same 50 lb compression force in the same 1 mm tissue gap as devices and methods providing a variable closure speed (i.e., with CTC). While devices and methods providing a constant closure speed can achieve the desired tissue gap compression force in a shorter period of time compared to devices and methods using a variable closure speed, this results in a spike in the power applied to the tissue, as shown in FIG. 22 . In contrast, the exemplary embodiment shown with CTC slows down the closure speed to limit the amount of power applied to the tissue so that it does not exceed a certain level. By limiting the power applied to the tissue, tissue trauma can be minimized relative to systems and methods not using CTC.
[0181] Figure 22 and additional examples are further described in U.S. Patent No. 8,499,992, filed June 1, 2012, entitled "DEVICE AND METHOD FOR CONTROLLING COMPRESSION OF TISSUE," issued August 6, 2013, the entire disclosure of which is incorporated herein by reference.
[0182] In some aspects, the control system can include a plurality of predefined force thresholds that assist the control system in determining the position of the E-beam and / or articulation of the firing shaft and appropriately controlling at least one motor based on such determination. For example, the force threshold can vary depending on the length of travel of a firing bar configured to translate the firing shaft, and such force threshold can be compared to a measured torsional force of one or more motors in communication with the control system. Comparing the measured torsional force to the force threshold can provide a method the control system can rely on to determine the position of the E-beam and / or articulation of the end effector. This allows the control system to appropriately control one or more motors (e.g., reduce or stop torsional loads) to ensure proper firing of the firing assembly and articulation of the end effector and prevent damage to the system.
[0183] FIG. 23 shows a force versus displacement graph 20800, including a measured force in section A relative to a measured displacement in section B. Both sections A and B have an x-axis that defines time (e.g., seconds). The y-axis of section B defines the firing rod travel displacement (e.g., in millimeters), and the y-axis of section A defines the force applied to the firing bar, thereby advancing the firing shaft. As shown in section A, movement of the firing bar within a first range of articulation 20902 (e.g., approximately the first 12 mm of travel) articulates the end effector. For example, at the 12 mm displacement position, the end effector is fully articulated to the right and is mechanically unable to articulate further. As a result of full articulation, a torsional force on the motor increases, and the control system can sense an articulation force peak 20802 that exceeds a predefined articulation threshold 20804, as shown in section A. The control system may include two or more predefined joint motion thresholds 20804 for sensing two or more maximum joint motion directions (e.g., left joint motion and right joint motion). After the control system detects a joint motion force peak 20802 that exceeds a predetermined joint motion threshold 20804, the control system may reduce or stop activation of the motor, thereby at least protecting the motor from damage.
[0184] After the firing bar advances beyond the articulation range 20902, a shift mechanism within the surgical stapler can cause further distal movement of the firing bar, thereby causing distal movement of the firing shaft. For example, as shown in section B, a travel displacement of approximately 12 mm to 70 mm can advance the E-beam along the firing stroke 20904 and cut tissue captured between the jaws, although other lengths of travel are within the scope of this disclosure. In this example, the E-beam's maximum firing stroke position 20906 occurs at 70 mm of travel. At this point, the E-beam or knife abuts the distal end of the cartridge or jaws, thereby increasing the torsional force on the motor and causing the knife travel force peak 20806, as shown in section A, to be sensed by the control system. As shown in section A, the control system can include a motor threshold 20808 and a knife travel threshold 20810 that diverges from the motor threshold 20808 and decreases (e.g., non-linearly) as the E-beam approaches the maximum firing stroke position 20906.
[0185] The control system can be configured to monitor the motor torsional force sensed during at least the last portion 20907 of the E-beam's distal travel (e.g., the last 10 percent of the firing stroke 904) before reaching the maximum firing stroke position 20906. While monitoring along such last portion 20907 of the distal travel, the control system can cause the motor to reduce the torsional force, thereby reducing the load on the E-beam. This can prevent damage to a surgical stapler including the E-beam by reducing the load on the E-beam as it approaches the maximum firing stroke position 20906, thereby reducing the impact of the E-beam on the cartridge or distal end of the jaws. As described above, such an impact can cause a knife movement force peak 20806, which may exceed the knife movement threshold 20810, but will not exceed the motor threshold 20808 and therefore will not damage the motor. Therefore, the control system stops the motor from operating when the knife movement force peak 20806 exceeds the knife movement threshold 20810 and before the knife movement force peak 20806 exceeds the motor threshold 20808, thereby protecting the motor from damage. Furthermore, increasing the reduction in the knife movement threshold 20810 prevents the control system from inferring in advance that the E-beam has reached the maximum firing stroke position 20906.
[0186] After the control system detects a knife movement force peak 20806 that exceeds the knife movement threshold 20810, the control system can ascertain the position of the E-beam (e.g., 70 mm displacement and / or end of firing stroke 20904) and, based on knowing the displacement position, can retract the firing bar and reset the E-beam at the most proximal position 20908 (e.g., 0 mm displacement). At the most proximal position 20908, a knife retraction force peak 20812 that exceeds a predefined knife retraction threshold 20814 as shown in section A can be sensed by the control system. At this point, the control system can be recalibrated, if necessary, to correlate the position of the E-beam such that a subsequent distal advancement of the firing rod (e.g., approximately 12 mm in length) will cause the shifter to disengage the E-beam from the firing bar, resulting in re-articulation of the end effector.
[0187] Thus, the control system can control the movement of the firing bar and compare such sensed torsional forces to multiple thresholds to determine the position of the E-beam or the angle of articulation of the end effector, thereby appropriately controlling the motors to prevent damage to the motors, and also verify the positioning of the firing bar and / or E-beam.
[0188] As described above, the tissue contact or pressure sensor determines when the jaw members first contact the tissue "T." This allows the surgeon to determine the initial thickness of the tissue "T" and / or the thickness of the tissue "T" prior to grasping. In any of the embodiments of the surgical instrument described above, contact of the jaw members with the tissue "T" closes an otherwise open sensing circuit "SC" by establishing contact with a pair of opposing plates "P1, P2" provided on the jaw members, as shown in FIG. 24. The contact sensor may also include a force-sensitive transducer that determines the amount of force applied to the sensor, which can be assumed to be the same as the amount of force applied to the tissue "T." After such force is applied to the tissue, it may be converted into an amount of tissue compression. The force sensor measures the amount of compression the tissue experiences and provides the surgeon with information regarding the force applied to the tissue "T." Excessive tissue compression can have adverse effects on the tissue "T" being operated on. For example, excessive compression of the tissue "T" can result in tissue necrosis and, in certain procedures, staple line failure. Information regarding the pressure applied to tissue "T" allows the surgeon to better determine that excessive pressure is not being applied to tissue "T."
[0189] Any contact sensor disclosed herein may include, but is not limited to, electrical contacts located on the inner surface of the jaws that, when in contact with tissue, close an otherwise open sensing circuit. Contact sensors may also include force-sensitive transducers that detect when grasped tissue resists compression. Force transducers may include, but are not limited to, piezoelectric elements, piezoresistive elements, metal film or semiconductor strain gauges, inductive pressure sensors, capacitive pressure sensors, and potentiometric pressure transducers that use a Bourdon tube, capsule, or bellows to drive a wiper arm on a resistive element.
[0190] In one aspect, any one of the aforementioned surgical instruments may include one or more piezoelectric elements for detecting changes in pressure generated on the jaw members. The piezoelectric element is a bidirectional transducer that converts stress into electrical potential. The element may be composed of metallized quartz or ceramic. During operation, when stress is applied to the crystal, the charge distribution in the material changes, generating a voltage across the material. The piezoelectric element may be used to indicate the amount of pressure exerted on tissue "T" after one or both of the jaw members contact and establish contact with tissue "T."
[0191] In one aspect, any one of the aforementioned surgical instruments may include or be equipped with one or more metallic strain gauges disposed within or on a portion of its body. Metallic strain gauges operate on the principle that the resistance of a material depends on its length, width, and thickness. Thus, when the material of the metallic strain gauge is subjected to strain, the resistance of the material changes. A resistor made of this material and incorporated into a circuit therefore converts the strain into a change in an electrical signal. Desirably, the strain gauge may be positioned on the surgical instrument such that pressure applied to tissue affects the strain gauge.
[0192] Alternatively, in another embodiment, one or more semiconductor strain gauges may be used in a manner similar to the metallic strain gauges described above, but with a different mode of transduction. During operation, deformation of the crystalline lattice structure of the semiconductor strain gauge as a result of applied stress causes a change in the resistance of the material. The observed phenomenon is sometimes referred to as the "piezoresistive effect."
[0193] In yet another aspect, any one of the aforementioned surgical instruments may include or be equipped with one or more inductive pressure sensors to convert pressure or force into movement of inductive elements relative to one another, which changes the overall inductance or inductive coupling. Capacitive pressure transducers similarly convert pressure or force into movement of capacitive elements that change the overall capacitance.
[0194] In yet another aspect, any one of the aforementioned surgical instruments may include or be equipped with one or more capacitive pressure transducers to convert pressure or force into movement of a capacitive element that changes the overall capacitance.
[0195] In one aspect, any one of the aforementioned surgical instruments may include or be equipped with one or more mechanical pressure transducers for converting pressure or force into motion. During use, motion of the mechanical element is used to deflect a pointer or dial on the gauge. This movement of the pointer or dial can represent the pressure or force being applied to the tissue "T." Examples of mechanical elements include, but are not limited to, a Bourdon tube, a capsule, or a bellows. By way of example, the mechanical element may be coupled with other measuring and / or sensing elements, such as a potentiometer pressure transducer. In this example, the mechanical element is coupled with a wiper on a variable resistor. During use, pressure or force may be converted into mechanical motion that deflects the wiper on the potentiometer to reflect the applied pressure or force, thereby changing resistance to reflect the applied pressure or force.
[0196] The combination of the above aspects, particularly the combination of the gap and tissue contact sensor, provides the surgeon with feedback and / or real-time information regarding the condition of the surgical site and / or target tissue "T." For example, information regarding the initial thickness of the tissue "T" can guide the surgeon in selecting an appropriate staple size, information regarding the clamped thickness of the tissue "T" can inform the surgeon whether the selected staples are properly formed, information regarding the initial and clamped thickness of the tissue "T" may be used to determine the amount of compression or strain on the tissue "T," and information related to strain on the tissue "T" can also be used to avoid stapling excessive strain values and / or tissue that has undergone excessive strain.
[0197] Additionally, a force sensor may be used to provide the surgeon with the amount of pressure being applied to the tissue, which the surgeon may use to avoid applying excessive pressure to tissue "T" that is experiencing excessive strain.
[0198] Figure 24 and additional examples are further described in U.S. Patent Application No. 8,181,839, filed June 27, 2011, entitled "SURGICAL INSTRUMENT EMPLOYING SENSORS," and published May 5, 2012, the entire disclosure of which is incorporated herein by reference.
[0199] Certain embodiments are shown and described to provide an understanding of the structure, function, manufacture, and use of the disclosed devices and methods. Features shown or described in one embodiment may be combined with features of other embodiments, and such modifications and variations are within the scope of the present disclosure.
[0200] The terms "proximal" and "distal" are terms relative to a clinician manipulating the handle of a surgical instrument, with "proximal" referring to the portion closer to the clinician and "distal" referring to the portion further from the clinician. Because surgical instruments may be used in a variety of orientations and positions, for convenience, the spatial terms "vertical," "horizontal," "up," and "down" used with respect to the drawings are not intended to be limiting and / or absolute.
[0201] Exemplary apparatus and methods are provided for performing laparoscopic and minimally invasive surgical procedures. However, such apparatus and methods can be used in other surgical procedures and applications, including, for example, open surgery. Surgical instruments can be inserted through natural orifices or through incisions or punctures formed in tissue. The working portions, or end effector portions, of the instruments can be inserted directly into the body or through an access device having a working channel through which the end effector and elongate shaft of the surgical instrument can be advanced.
[0202] 25-28 depict a motorized surgical instrument 150010 for cutting and fastening, which may or may not be reusable. In the illustrated embodiment, the surgical instrument 150010 includes a housing 150012 with a handle assembly 150014 configured to be grasped, manipulated, and actuated by a clinician. The housing 150012 is configured to be operably attached to an interchangeable shaft assembly 150200 to which an end effector 150300 configured to perform one or more surgical tasks or procedures is operably coupled. In accordance with the present disclosure, various forms of interchangeable shaft assemblies may be effectively used in connection with robotically controlled surgical systems. Accordingly, the term "housing" can encompass a housing or similar portion of a robotic system that houses or operably supports at least one drive system configured to generate and apply at least one control motion that can be utilized to actuate the interchangeable shaft assembly. The term "frame" may also refer to a portion of a handheld surgical instrument. The term "frame" may also refer to a portion of a robotically controlled surgical instrument and / or a portion of a robotic system that may be used to operatively control a surgical instrument. The interchangeable shaft assembly may be used with various robotic systems, instruments, components, and methods disclosed in U.S. Patent No. 9,072,535, entitled "SURGICAL STAPLING INSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS," which is incorporated herein by reference in its entirety.
[0203] 25 is a perspective view of a surgical instrument 150010 having an operably coupled interchangeable shaft assembly 150200 according to at least one embodiment of the present disclosure. The housing 150012 includes an end effector 150300 with a surgical cutting and fastening device configured to operably support a surgical staple cartridge 150304 therein. The housing 150012 may be configured for use in connection with interchangeable shaft assemblies having various shaft lengths, sizes, and types, including end effectors adapted to support various sizes and types of staple cartridges. The housing 150012 may be used with a variety of interchangeable shaft assemblies, including assemblies configured to apply other motions and other forms of energy, such as radio frequency (RF) energy, ultrasonic energy, and / or motion, to end effector configurations adapted for use in connection with various surgical applications and procedures. The end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system may utilize any suitable fasteners to fasten tissue. For example, a fastener cartridge having a plurality of fasteners removably stored therein may be removably inserted into and / or attached to the end effector of the shaft assembly.
[0204] The handle assembly 150014 may include a pair of interconnectable handle housing segments 150016, 150018, which may be interconnected by screws, snap mechanisms, adhesives, etc. The handle housing segments 150016, 150018 cooperate to form a pistol grip portion 150019 that may be grasped and manipulated by a clinician. The handle assembly 150014 operably supports a plurality of drive systems configured to generate and apply controlled motions to corresponding portions of an interchangeable shaft assembly operably attached to the handle assembly. A display may be provided below the cover 150045.
[0205] 26 is an exploded assembly view of a portion of the surgical instrument 150010 of FIG. 25 in accordance with at least one embodiment of the present disclosure. The handle assembly 150014 may include a frame 150020 that operably supports multiple drive systems. The frame 150020 may operably support a "first," or closure drive system 150030, which can apply closing and opening motions to the interchangeable shaft assembly 150200. The closure drive system 150030 may include an actuator, such as a closure trigger 150032, pivotally supported by the frame 150020. The closure trigger 150032 is pivotally coupled to the handle assembly 150014 by a pivot pin 150033, allowing the closure trigger 150032 to be operated by a clinician. When a clinician grasps the pistol grip portion 150019 of the handle assembly 150014, the closure trigger 150032 can pivot from a starting position or "unactivated" position to an "activated" position, more specifically, a fully compressed position or a fully activated position.
[0206] The handle assembly 150014 and frame 150020 may operably support a firing drive system 150080 configured to apply a firing motion to a corresponding portion of an interchangeable shaft assembly attached thereto. The firing drive system 150080 may utilize an electric motor 150082 mounted in the pistol grip portion 150019 of the handle assembly 150014. The electric motor 150082 may be a brushed DC motor having a maximum rotational speed of, for example, approximately 25,000 RPM. In other configurations, the motor may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The electric motor 150082 may be powered by a power source 150090, which may include a removable power pack 150092. The removable power pack 150092 may include a proximal housing portion 150094 configured to attach to a distal housing portion 150096. The proximal housing portion 150094 and the distal housing portion 150096 are configured to operably support a plurality of batteries 150098 therein. Each of the batteries 150098 may include, for example, lithium ion (LI) or other suitable batteries. The distal housing portion 150096 is configured to be removably and operably attached to a control circuit board 150100, which is operably coupled to the electric motor 150082. Several batteries 150098 connected in series can power the surgical instrument 150010. The power source 150090 may be replaceable and / or rechargeable. A display 150043, located below a cover 150045, is electrically coupled to the control circuit board 150100. The cover 150045 may be removed to expose the display 150043.
[0207] The electric motor 150082 may include a rotatable shaft (not shown) in operative association with a gear reducer assembly 150084 that is mounted in meshing engagement with a set or rack of drive teeth 150122 on a longitudinally movable drive member 150120. The longitudinally movable drive member 150120 has a rack of drive teeth 150122 formed thereon for meshing engagement with a corresponding drive gear 150086 of the gear reducer assembly 150084.
[0208] In use, the voltage polarity provided by the power source 150090 causes the electric motor 150082 to operate in a clockwise direction, although the voltage polarity applied to the electric motor by the battery can be reversed to cause the electric motor 150082 to operate in a counterclockwise direction. When the electric motor 150082 is rotated in one direction, the longitudinally movable drive member 150120 is driven axially in a distal direction "DD." When the electric motor 150082 is driven in the opposite rotational direction, the longitudinally movable drive member 150120 is driven axially in a proximal direction "PD." The handle assembly 150014 can include a switch that can be configured to reverse the polarity applied to the electric motor 150082 by the power source 150090. The handle assembly 150014 can include a sensor configured to detect the position of the longitudinally movable drive member 150120 and / or the direction in which the longitudinally movable drive member 150120 is moved.
[0209] Operation of the electric motor 150082 may be controlled by a firing trigger 150130 that is pivotally supported on the handle assembly 150014. The firing trigger 150130 may be pivoted between an inactivated position and an activated position.
[0210] 25 , the interchangeable shaft assembly 150200 includes an end effector 150300 having an elongated channel 150302 configured to operably support a surgical staple cartridge 150304 therein. The end effector 150300 may include an anvil 150306 pivotally supported relative to the elongated channel 150302. The interchangeable shaft assembly 150200 may include an articulation joint 150270. The configuration and operation of the end effector 150300 and the articulation joint 150270 are described in U.S. Patent Application Publication No. 2014 / 0263541, entitled "ARTICULATABLE SURGICAL INSTRUMENT COMPRISING AN ARTICULATION LOCK," which is incorporated herein by reference in its entirety. The interchangeable shaft assembly 150200 may include a proximal housing or nozzle 150201 comprised of nozzle portions 150202, 150203. The interchangeable shaft assembly 150200 may include a closure tube 150260 extending along the shaft axis SA, which may be utilized to close and / or open the anvil 150306 of the end effector 150300.
[0211] 25 , in the manner described in the above-referenced U.S. Patent Application Publication No. 2014 / 0263541, for example, the closure tube 150260 is translated in a distal direction (direction “DD”) in response to actuation of the closure trigger 150032 to close the anvil 150306. The anvil 150306 is opened by translating the closure tube 150260 in a proximal direction. In the anvil open position, the closure tube 150260 is moved to its proximal position.
[0212] 27 is another exploded assembly view of a portion of the interchangeable shaft assembly 150200 in accordance with at least one embodiment of the present disclosure. The interchangeable shaft assembly 150200 may include a firing member 150220 supported for axial movement within the spine 150210. The firing member 150220 includes an intermediate firing shaft 150222 configured to attach to a distal cutting portion or knife bar 150280. The firing member 150220 may also be referred to as a "second shaft" or "second shaft assembly." The intermediate firing shaft 150222 may include a longitudinal slot 150223 at its distal end configured to receive a tab 150284 on the proximal end 150282 of the knife bar 150280. The longitudinal slot 150223 and the proximal end 150282 can be configured to allow relative movement therebetween and can include a slip joint 150286. The slip joint 150286 can allow the intermediate firing shaft 150222 of the firing member 150220 to articulate the end effector 150300 about the articulation joint 150270 without moving, or at least substantially moving, the knife bar 150280. Once the end effector 150300 is properly oriented, the intermediate firing shaft 150222 can be advanced distally until the proximal sidewall of the longitudinal slot 150223 contacts the tab 150284 to advance the knife bar 150280 and fire a staple cartridge located within the channel 150302. The spine 150210 has an elongated opening or window 150213 therein to facilitate assembly and insertion of the intermediate firing shaft 150222 into the spine 150210. Once the intermediate firing shaft 150222 is inserted therein, the top frame segment 150215 may be engaged with the shaft frame 150212 to enclose the intermediate firing shaft 150222 and knife bar 150280. Operation of the firing member 150220 can be found in U.S. Patent Application Publication No. 2014 / 0263541. The spine 150210 may be configured to slidably support the firing member 150220 and a closure tube 150260 that extends around the spine 150210.The spine 150210 may slidably support an articulation driver 150230 .
[0213] The interchangeable shaft assembly 150200 may include a clutch assembly 150400 configured to selectively and removably couple the articulation driver 150230 to the firing member 150220. The clutch assembly 150400 includes a locking collar or locking sleeve 150402 positioned about the firing member 150220, the locking sleeve 150402 being rotatable between an engaged position, in which the locking sleeve 150402 couples the articulation driver 150230 to the firing member 150220, and a disengaged position, in which the articulation driver 150230 is not operably coupled to the firing member 150220. When the locking sleeve 150402 is in its engaged position, distal movement of the firing member 150220 can cause distal movement of the articulation driver 150230, and correspondingly, proximal movement of the firing member 150220 can cause proximal movement of the articulation driver 150230. When the locking sleeve 150402 is in its disengaged position, movement of the firing member 150220 is not transmitted to the articulation driver 150230, such that the firing member 150220 can be moved independently of the articulation driver 150230. The nozzle 150201 can be used to operatively engage and disengage the articulation drive system and firing drive system in various manners described in U.S. Patent Application Publication No. 2014 / 0263541.
[0214] The interchangeable shaft assembly 150200 can include a slip ring assembly 150600, which can be configured, for example, to transfer power to / from the end effector 150300 and / or communicate signals to / from the end effector 150300. The slip ring assembly 150600 can include a proximal connector flange 150604 and a distal connector flange 150601 disposed within slots defined in the nozzle portions 150202, 150203. The proximal connector flange 150604 can include a first surface, and the distal connector flange 150601 can include a second surface disposed adjacent to and movable relative to the first surface. The distal connector flange 150601 can rotate relative to the proximal connector flange 150604 about the shaft axis SA-SA (FIG. 25). The proximal connector flange 150604 can include a plurality of concentric, or at least substantially concentric, conductors 150602 defined on a first surface thereof. The connector 150607 can be mounted proximally to the distal connector flange 150601 and can have a plurality of contacts, each contact corresponding to and in electrical contact with one of the conductors 150602. Such a configuration allows the proximal connector flange 150604 and the distal connector flange 150601 to rotate relative to each other while maintaining electrical contact therebetween. The proximal connector flange 150604 can include an electrical connector 150606 that can, for example, place the conductors 150602 in communication with a shaft circuit board. In at least one instance, a wiring harness comprising multiple conductors may extend between the electrical connector 150606 and the shaft circuit board. The electrical connector 150606 may extend proximally through a connector opening defined in the chassis mounting flange. U.S. Patent Application Publication No. 2014 / 0263551, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," is incorporated herein by reference in its entirety.U.S. Patent Application Publication No. 2014 / 0263552, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," is incorporated herein by reference in its entirety. Further details regarding the slip ring assembly 150600 may be found in U.S. Patent Application Publication No. 2014 / 0263541.
[0215] The interchangeable shaft assembly 150200 may include a proximal portion fixably attached to the handle assembly 150014 and a distal portion rotatable about a longitudinal axis. The rotatable distal shaft portion may be rotated relative to the proximal portion about a slip ring assembly 150600. A distal connector flange 150601 of the slip ring assembly 150600 may be positioned within the rotatable distal shaft portion.
[0216] FIG. 28 is an exploded view of one embodiment of the end effector 150300 of the surgical instrument 150010 of FIG. 25 , in accordance with at least one embodiment of the present disclosure. The end effector 150300 can include an anvil 150306 and a surgical staple cartridge 150304. The anvil 150306 can be coupled to an elongated channel 150302. An opening 150199 can be defined in the elongated channel 150302 to receive a pin 150152 extending from the anvil 150306, allowing the anvil 150306 to pivot relative to the elongated channel 150302 and the surgical staple cartridge 150304 from an open position to a closed position. A firing bar 150172 is configured to translate longitudinally within the end effector 150300. The firing bar 150172 may be constructed from one solid piece or may comprise a laminate material, including a stack of steel plates. The firing bar 150172 includes an I-beam 150178 and a cutting blade 150182 at its distal end. The distally protruding end of the firing bar 150172 may be attached to the I-beam 150178 to assist in spacing the anvil 150306 away from the surgical staple cartridge 150304 positioned within the elongated channel 150302 when the anvil 150306 is in the closed position. The I-beam 150178 may include a sharp cutting blade 150182 to cut tissue as the I-beam 150178 is advanced distally by the firing bar 150172. In operation, the I-beam 150178 may, or does, fire the surgical staple cartridge 150304. The surgical staple cartridge 150304 can include a shaped cartridge body 150194 that holds a plurality of staples 150191 mounted on staple drivers 150192, each in an upwardly opening staple recess 150195. A wedge-shaped sled 150190 is driven distally by the I-beam 150178 and slides over a cartridge tray 150196 of the surgical staple cartridge 150304.The wedge-shaped sled 150190 cams the staple driver 150192 upward, pushing the staples 150191 into deforming contact with the anvil 150306 while the cutting blades 150182 of the I-beam 150178 sever the grasped tissue.
[0217] The I-beam 150178 can include an upper pin 150180 that engages the anvil 150306 during firing. The I-beam 150178 can include a center pin 150184 and a bottom foot 150186 to engage the cartridge body 150194, the cartridge tray 150196, and a portion of the elongated channel 150302. When the surgical staple cartridge 150304 is positioned within the elongated channel 150302, the slot 150193 defined in the cartridge body 150194 can be aligned with the longitudinal slot 150197 defined in the cartridge tray 150196 and the slot 150189 defined in the elongated channel 150302. In use, the I-beam 150178 can slide through the aligned longitudinal slots 150193, 150197, and 150189, and as shown in FIG. 28, the bottom foot 150186 of the I-beam 150178 can engage with a groove running along the bottom surface of the elongated channel 150302 along the length of the slot 150189, the central pin 150184 can engage with the top surface of the cartridge tray 150196 along the length of the longitudinal slot 150197, and the upper pin 150180 can engage with the anvil 150306. As the firing bar 150172 advances distally to fire staples from the surgical staple cartridge 150304 and / or cut tissue captured between the anvil 150306 and the surgical staple cartridge 150304, the I-beam 150178 can space or limit the relative movement between the anvil 150306 and the surgical staple cartridge 150304. The firing bar 150172 and I-beam 150178 are retracted proximally, which allows the anvil 150306 to open and release the two stapled and severed tissue portions.
[0218] 29A and 29B are block diagrams of the control circuit 150700 of the surgical instrument 150010 of FIG. 25 spanning two views, in accordance with at least one embodiment of the present disclosure. Referring primarily to FIGS. 29A and 29B, the handle assembly 150702 can include a motor 150714, which can be controlled by a motor driver 150715 and utilized by the firing system of the surgical instrument 150010. In various forms, the motor 150714 can be a brushed DC drive motor having a maximum rotational speed of approximately 25,000 RPM. In other configurations, the motor 150714 can include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 150715 can include, for example, an H-bridge driver including a field effect transistor (FET) 150719. The motor 150714 may be powered by a power supply assembly 150706 releasably attached to the handle assembly 150200 to provide control power to the surgical instrument 150010. The power supply assembly 150706 may include multiple batteries connected in series that may be used as a power source to power the surgical instrument 150010. Under certain circumstances, the battery cells of the power supply assembly 150706 may be replaceable and / or rechargeable. In at least one example, the battery cells may be lithium ion batteries that may be separately connectable to the power supply assembly 150706.
[0219] The shaft assembly 150704 may include a shaft assembly controller 150722 that is capable of communicating with the safety controller and power management controller 150716 via the interface while the shaft assembly 150704 and the power supply assembly 150706 are coupled to the handle assembly 150702. For example, the interface may include a first interface portion 150725 that may include one or more electrical connectors for mating engagement with corresponding shaft assembly electrical connectors, and a second interface portion 150727 that may include one or more electrical connectors for mating engagement with corresponding power supply assembly electrical connectors, to enable electrical communication between the shaft assembly controller 150722 and the power management controller 150716 while the shaft assembly 150704 and the power supply assembly 150706 are coupled to the handle assembly 150702. One or more communication signals may be sent via the interface to communicate one or more power requirements of the installed interchangeable shaft assembly 150704 to the power management controller 150716. In response, the power management controller may modulate the power output of the battery of the power supply assembly 150706, as described in further detail below, according to the power requirements of the installed shaft assembly 150704. The connector includes a switch that may be actuated following mechanical coupling engagement of the handle assembly 150702 to the shaft assembly 150704 and / or power supply assembly 150706 to enable electrical communication between the shaft assembly controller 150722 and the power management controller 150716.
[0220] The interface may facilitate the transmission of one or more communication signals between the power management controller 150716 and the shaft assembly controller 150722, for example, by routing the communication signals through a main controller 150717 located within the handle assembly 150702. In other circumstances, the interface may facilitate a direct line of communication between the power management controller 150716 and the shaft assembly controller 150722 via the handle assembly 150702 while the shaft assembly 150704 and power supply assembly 150706 are coupled to the handle assembly 150702.
[0221] The main controller 150717 may be any single-core or multi-core processor, such as that known under the trademark ARM Cortex by Texas Instruments. In one aspect, the main controller 150717 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory up to 40 MHz, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QEI) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product datasheet.
[0222] The safety controller may be a safety controller platform with two controller base families, such as the TMS570 and RM4x, also known by Texas Instruments under the trademark Hercules ARM Cortex R4. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.
[0223] The power supply assembly 150706 may include a power management circuit, which may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. The power management circuit may be configured to modulate the power output of the battery based on the power requirements of the shaft assembly 150704 while the shaft assembly 150704 and power supply assembly 150706 are coupled to the handle assembly 150702. The power management controller 150716 may be programmed to control the power modulator 150738 of the power output of the power supply assembly 150706 and may utilize the current sensing circuit 150736 to monitor the power output of the power supply assembly 150706 and provide feedback to the power management controller 150716 regarding the power output of the battery so that the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. The power management controller 150716 and / or the shaft assembly controller 150722 may each include one or more processors and / or memory units capable of storing multiple software modules.
[0224] The surgical instrument 150010 (FIGS. 25-28) may include an output device 150742, which may include a device for providing sensory feedback to the user. Such devices may include, for example, a visual feedback device (e.g., an LCD display screen, an LED indicator), an audible feedback device (e.g., a speaker, a buzzer), or a tactile feedback device (e.g., a tactile actuator). Under certain circumstances, the output device 150742 may include a display 150743, which may be included in the handle assembly 150702. The shaft assembly controller 150722 and / or the power management controller 150716 can provide feedback to a user of the surgical instrument 150010 via the output device 150742. An interface can be configured to connect the shaft assembly controller 150722 and / or the power management controller 150716 to the output device 150742. The output device 150742 may alternatively be integrated with the power supply assembly 150706. In such a situation, the shaft assembly 150704 may be coupled to the handle assembly 150702, while communication between the output device 150742 and the shaft assembly controller 150722 may be achieved via an interface.
[0225] The control circuit 150700 includes circuit segments configured to control the operation of the powered surgical tool 150010. The safety controller segment (segment 1) includes a safety controller and a main controller 150717 segment (segment 2). The safety controller and / or main controller 150717 are configured to interact with one or more additional circuit segments, such as an acceleration segment, a display segment, a shaft segment, an encoder segment, a motor segment, and a power segment. Each of the circuit segments may be coupled to the safety controller and / or main controller 150717. The main controller 150717 is also coupled to flash memory. The main controller 150717 also includes a serial communication interface. The main controller 150717 includes multiple inputs coupled to, for example, one or more circuit segments, a battery, and / or multiple switches. The segmented circuits may be implemented by any suitable circuitry, such as, for example, a printed circuit board assembly (PCBA) within the powered surgical tool 150010. The term processor, as used herein, should be understood to include any microprocessor, processor, one or more controllers, or other basic computing device that incorporates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to several integrated circuits. Main controller 150717 is a general-purpose programmable device that accepts digital data as input, processes that data according to instructions stored in memory, and provides the results as output. Because it has internal memory, it is an example of sequential digital logic. Control circuit 150700 may be configured to implement one or more processes described herein.
[0226] The acceleration segment (segment 3) comprises an accelerometer. The accelerometer is configured to detect movement or acceleration of the powered surgical tool 150010. Input from the accelerometer may be used to transition in and out of sleep mode, identify the orientation of the powered surgical tool, and / or identify when the surgical tool has been dropped. In some examples, the acceleration segment is coupled to the safety controller and / or the main controller 150717.
[0227] The display segment (segment 4) includes a display connector coupled to the main controller 150717. The display connector couples the main controller 150717 to a display through one or more integrated circuit drivers for the display. The integrated circuit drivers for the display may be integrated with the display and / or located separately from the display. The display may include any suitable display, such as, for example, an organic light emitting diode (OLED) display, a liquid crystal display (LCD), and / or any other suitable display. In some examples, the display segment is coupled to a safety controller.
[0228] The shaft segment (segment 5) includes controls for an interchangeable shaft assembly 150200 ( FIGS. 25 and 27 ) coupled to the surgical instrument 150010 ( FIGS. 25-28 ) and / or one or more controls for an end effector 150300 coupled to the interchangeable shaft assembly 150200. The shaft segment includes a shaft connector configured to couple the main controller 150717 to a shaft PCBA. The shaft PCBA includes a low-power microcontroller having ferroelectric random access memory (FRAM), an articulation switch, a shaft release Hall effect switch, and a shaft PCBA EEPROM. The shaft PCBA EEPROM contains one or more parameters, routines, and / or programs specific to the interchangeable shaft assembly 150200 and / or the shaft PCBA. The shaft PCBA may be coupled to the interchangeable shaft assembly 150200 and / or may be integral to the surgical instrument 150010. In some examples, the shaft segment includes a second shaft EEPROM that contains a plurality of algorithms, routines, parameters, and / or other data corresponding to one or more shaft assemblies 150200 and / or end effectors 150300 that may be associated with the powered surgical instrument 150010.
[0229] The position encoder segment (segment 6) comprises one or more magnetic angular rotary position encoders configured to identify the rotational position of the motor 150714, interchangeable shaft assembly 150200 ( FIGS. 25 and 27 ), and / or end effector 150300 of the surgical instrument 150010 ( FIGS. 25-28 ). In some examples, the magnetic angular rotary position encoders may be coupled to the safety controller and / or the main controller 150717.
[0230] The motor circuit segment (segment 7) comprises a motor 150714 configured to control the movement of the powered surgical tool 150010 (FIGS. 25-28). The motor 150714 is coupled to the main microcontroller processor 150717 by an H-bridge driver comprising one or more H-bridge field effect transistors (FETs) and a motor controller. The H-bridge driver is also coupled to a safety controller. A motor current sensor is coupled in series with the motor to measure the motor's current draw. The motor current sensor is in signal communication with the main controller 150717 and / or the safety controller. In some examples, the motor 150714 is coupled to a motor electromagnetic interference (EMI) filter.
[0231] The motor controller controls the first motor flag and the second motor flag to indicate the status and position of the motor 150714 to the main controller 150717. The main controller 150717 provides a pulse width modulation (PWM) high signal, a PWM low signal, a direction signal, a synchronization signal, and a motor reset signal to the motor controller via a buffer. The power segments are configured to provide segment voltages to each of the circuit segments.
[0232] The power segment (segment 8) includes a battery coupled to the safety controller, the main controller 150717, and an additional circuit segment. The battery is coupled to the segmented circuitry by a battery connector and a current sensor. The current sensor is configured to measure the total current drawn by the segmented circuitry. In some examples, one or more voltage converters are configured to provide a predetermined voltage value to one or more circuit segments. For example, in some examples, the segmented circuitry may include a 3.3V voltage converter and / or a 5V voltage converter. The boost converter is configured to provide a boost voltage up to a predetermined amount, such as up to 13V. The boost converter is configured to provide additional voltage and / or current during power-intensive operations and prevent brownouts or low-power conditions.
[0233] A plurality of switches are coupled to the safety controller and / or main controller 150717. The switches may be configured to control the operation of the segmented circuit, the surgical instrument 150010 (FIGS. 25-28), and / or indicate the status of the surgical instrument 150010. An emergency escape door switch and an emergency escape Hall effect switch are configured to indicate the status of the emergency escape door. A plurality of articulation switches, for example, a left articulation left switch, a left articulation right switch, a left articulation center switch, a right articulation left switch, a right articulation right switch, and a right articulation center switch, are configured to control the articulation of the interchangeable shaft assembly 150200 (FIGS. 25 and 27) and / or the end effector 150300 (FIGS. 25 and 28). A left reversal switch and a right reversal switch are coupled to the main controller 150717. The left side switches, including a left side articulation left switch, a left side articulation right switch, a left side articulation center switch, and a left side reversing switch, are coupled by a left side flexible connector to the main controller 150717. The right side switches, including a right side articulation left switch, a right side articulation right switch, a right side articulation center switch, and a right side reversing switch, are coupled by a right side flexible connector to the main controller 150717. A fire switch, a grip release switch, and a shaft engage switch are coupled to the main controller 150717.
[0234] The switches may be implemented using any suitable mechanical, electromechanical, or solid-state switches in any combination. For example, the switches may be limit switches activated by the movement of a component associated with the surgical instrument 150010 (FIGS. 25-28) or the presence of an object. Such switches may be used to control various functions associated with the surgical instrument 150010. A limit switch is an electromechanical device consisting of an actuator mechanically coupled to a set of contacts. When an object contacts the actuator, the device manipulates the contacts to create or break an electrical connection. Due to their ruggedness, ease of installation, and reliable operation, limit switches are used in a variety of applications and environments. Limit switches can determine the presence, absence, passage, placement, and end of movement of an object. In other implementations, the switches may be solid-state switches that operate under the influence of a magnetic field, such as Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, among others. In other implementations, the switch may be a solid-state switch that operates under the influence of light, such as a light sensor, an infrared sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device, such as a transistor (e.g., a FET, a junction FET, a metal-oxide semiconductor FET (MOSFET), a bipolar, etc.). Other switches may include wireless switches, ultrasonic switches, accelerometers, inertial sensors, among others.
[0235] 30 is another block diagram of the control circuit 150700 of the surgical instrument of FIG. 25 illustrating the interface between the handle assembly 150702 and the power supply assembly 150706, and the interface between the handle assembly 150702 and the interchangeable shaft assembly 150704, in accordance with at least one aspect of the present disclosure. The handle assembly 150702 may include a main controller 150717, a shaft assembly connector 150726, and a power supply assembly connector 150730. The power supply assembly 150706 may include a power supply assembly connector 150732 and a power management circuit 150734 that may include a power management controller 150716, a power modulator 150738, and a current sensing circuit 150736. The shaft assembly connectors 150730, 150732 form an interface 150727. While the interchangeable shaft assembly 150704 and the power supply assembly 150706 are coupled to the handle assembly 150702, the power management circuit 150734 can be configured to modulate the power output of the battery 150707 based on the power requirements of the interchangeable shaft assembly 150704. For example, the power management controller 150716 can be programmed to control a power modulator 150738 of the power output of the power supply assembly 150706, and the current sense circuit 150736 can be utilized to monitor the power output of the power supply assembly 150706 and provide feedback to the power management controller 150716 regarding the power output of the battery 150707 so that the power management controller 150716 can adjust the power output of the power supply assembly 150706 to maintain the desired output. The shaft assembly 150704 includes a shaft processor 150720 coupled to a non-volatile memory 150721 and a shaft assembly connector 150728 to electrically couple the shaft assembly 150704 to the handle assembly 150702. The shaft assembly connectors 150726, 150728 form an interface 150725. The main controller 150717, the shaft processor 150720 and / or the power management controller 150716 can be configured to implement one or more of the processes described herein.
[0236] The surgical instrument 150010 (FIGS. 25-28) may include an output device 150742 that provides sensory feedback to the user. Such devices may include visual feedback devices (e.g., LCD display screen, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators). Under certain circumstances, the output device 150742 may include a display 150743 that may be included in the handle assembly 150702. The shaft assembly controller 150722 and / or the power management controller 150716 may provide feedback to a user of the surgical instrument 150010 via the output device 150742. The interface 150727 may be configured to connect the shaft assembly controller 150722 and / or the power management controller 150716 to the output device 150742. The output device 150742 may also be integrated with the power supply assembly 150706. While the interchangeable shaft assembly 150704 is coupled to the handle assembly 150702, communication between the output device 150742 and the shaft assembly controller 150722 can be achieved via the interface 150725. Having described a control circuit 150700 (FIGS. 29A and 29B and FIG. 6) for controlling the operation of the surgical instrument 150010 (FIGS. 25-28), the disclosure now turns to various configurations of the surgical instrument 150010 (FIGS. 25-28) and the control circuit 150700.
[0237] Referring to FIG. 31 , the surgical stapler 151000 may include a handle component 151002, a shaft component 151004, and an end effector component 151006. The surgical stapler 151000 is constructed and equipped similarly to the motorized surgical cutting and fastening instrument 150010 described in connection with FIG. 25 . Therefore, for the sake of brevity and clarity, details of operation and construction will not be repeated here. The end effector 151006 may be used to compress, cut, or staple tissue. Referring now to FIG. 32 , the end effector 151030 may be positioned by a physician to surround tissue 151032 prior to compressing, cutting, or stapling. As shown in FIG. 32 , no compression may be applied to the tissue while preparing the end effector for use. 33, by engaging the handle of a surgical stapler (e.g., handle 151002), a physician may use the end effector 151030 to compress tissue 151032. In one aspect, the tissue 151032 may be compressed to its maximum threshold, as shown in FIG.
[0238] 34, various forces may be applied to the tissue 151032 by the end effector 151030. For example, as the tissue 151032 is compressed between the anvil 151034 and the channel frame 151036 of the end effector 151030, normal forces F1 and F2 may be applied to the anvil 151034 and the channel frame 151036. Now, referring to FIG. 35, various diagonal and / or lateral forces may also be applied to the tissue 151032 as it is compressed by the end effector 151030. For example, a force F3 may be applied. For purposes of operating a medical device such as the surgical stapler 151000, it may be desirable to sense or calculate the various forms of compression being applied to the tissue by the end effector. For example, knowing the vertical or lateral compression may allow the end effector to apply the staple action more precisely or accurately, or may inform the operator of the surgical stapler so that it can be used more appropriately or safely.
[0239] Compression in a direction through the tissue 151032 may be determined from the impedance of the tissue 151032. At various levels of compression, the impedance Z of the tissue 151032 may increase or decrease. By applying a voltage V and a current I to the tissue 151032, the impedance Z of the tissue 151032 may be determined at various levels of compression. For example, the impedance Z may be calculated by dividing the applied voltage V by the current I.
[0240] 36 , in one aspect, an RF electrode 151038 may be positioned on the end effector 151030 (e.g., on a staple cartridge, knife, or channel frame of the end effector 151030). Additionally, an electrical contact 151040 may be positioned on the anvil 151034 of the end effector 151030. In one aspect, the electrical contact may be positioned on the channel frame of the end effector. When tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. The vertical tissue compression 151042 caused by the end effector 151030 may be measured as a function of the impedance Z of the tissue 151032.
[0241] 37 , in one aspect, when the RF electrode 151038 is positioned, the electrical contact 151044 may be positioned at an opposite end of the anvil 151034 of the end effector 151030. When the tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. The lateral tissue compression 151046 caused by the end effector 151030 may be measured as a function of the impedance Z of the tissue 151032.
[0242] 38 , in one aspect, the electrical contacts 151050 may be positioned on the anvil 151034 and the electrical contacts 151052 may be positioned on the opposite end of the end effector 151030 at the channel frame 151036. The RF electrodes 151048 may be positioned laterally in a central portion of the end effector 151030. When the tissue 151032 is compressed between the anvil 151034 of the end effector 151030 and, for example, the channel frame 151036, the impedance Z of the tissue 151032 changes. Lateral compression 151054 or angular compression 151056 on either side of the RF electrode 151048 may be produced by the end effector 151030 and may be measured as a function of the varying impedance Z of the tissue 151032 based on the relative positioning of the RF electrode 151048, the electrical contacts 151050 and 151052.
[0243] As shown in FIG. 39 , the frequency generator 151222 may receive power or current from the power source 151221 and may supply one or more RF signals to one or more RF electrodes 151224. As discussed above, the one or more RF electrodes may be positioned at various locations or components on the end effector or surgical stapler, such as the staple cartridge or channel frame. One or more electrical contacts, such as electrical contacts 151226 or 151228, may be positioned on the channel frame or anvil of the end effector. Additionally, one or more filters, such as filter 151230 or 151232, may be communicatively coupled to the electrical contacts 151226 or 151228. The filters 151230 and 151232 may filter the one or more RF signals supplied by the frequency generator 151222 before combining into a single return path 151234. The voltage V and current I associated with one or more RF signals may be used to calculate an impedance Z associated with tissue that may be compressed and / or communicatively coupled between one or more RF electrodes 151224 and electrical contacts 151226 or 151228.
[0244] 39 , various components of the tissue compression sensor system described herein may be disposed within the handle 151236 of a surgical stapler. For example, as shown in circuit diagram 151220a, a frequency generator 151222 may be disposed within the handle 151236 and receive power from a power source 151221. Additionally, currents I1 and I2 may be measured on return paths corresponding to electrical contacts 151228 and 151226. Impedances Z1 and Z2 may be calculated using a voltage V applied between the supply and return paths. Z1 may correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151224 and the electrical contacts 151228. Furthermore, Z2 may correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151224 and the electrical contacts 151226. Applying the equations Z1=V / I1 and Z2=V / I2, the impedances Z1 and Z2 corresponding to various compression levels of tissue compressed by the end effector can be calculated.
[0245] 40 , one or more aspects of the present disclosure are described in a circuit diagram 151250. In one implementation, a power source in the handle 151252 of the surgical stapler can provide power to a frequency generator 151254. The frequency generator 151254 can generate one or more RF signals. The one or more RF signals can be multiplexed or superimposed in a multiplexer 151256, which can be within the shaft 151258 of the surgical stapler. In this manner, two or more RF signals can be superimposed (or, for example, nested or modulated together) and transmitted to the end effector. The one or more RF signals can energize one or more RF electrodes 151260 in the end effector 151262 of the surgical stapler (e.g., positioned within a staple cartridge). Tissue (not shown) may be compressed and / or communicatively coupled between one or more RF electrodes 151260 and one or more electrical contacts. For example, tissue may be compressed and / or communicatively coupled between one or more RF electrodes 151260 and electrical contacts 151264 positioned in a channel frame of the end effector 151262 or electrical contacts 151266 positioned in an anvil of the end effector 151262. A filter 151268 may be communicatively coupled to the electrical contacts 151264, and a filter 151270 may be communicatively coupled to the electrical contacts 151266.
[0246] The voltage V and current I associated with one or more RF signals can be used to calculate the impedance Z associated with tissue that can be compressed between the staple cartridge (and can be communicatively coupled to one or more RF electrodes 151260) and the channel frame or anvil (which can be communicatively coupled to one or more of the electrical contacts 151264 or 151266).
[0247] In one aspect, various components of the tissue compression sensor system described herein can be disposed within the shaft 151258 of the surgical stapler. For example, as shown in circuit diagram 151250 (and in addition to frequency generator 151254), impedance calculator 151272, controller 151274, non-volatile memory 151276, and communication channel 151278 can be disposed within the shaft 151258. In one example, frequency generator 151254, impedance calculator 151272, controller 151274, non-volatile memory 151276, and communication channel 151278 can be located on a circuit board within the shaft 151258.
[0248] The two or more RF signals may be returned on a common path via the electrical contacts. Furthermore, to differentiate between the different tissue impedances represented by the two or more RF signals, the two or more RF signals may be filtered before joining the RF signals on the common path. Current I1 and current I2 may be measured on the return paths corresponding to electrical contacts 151264 and 151266. Impedances Z1 and Z2 may be calculated using the voltage V applied between the supply and return paths. Z1 may correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151260 and the electrical contact 151264. Furthermore, Z2 may correspond to the impedance of tissue compressed and / or communicatively coupled between one or more of the RF electrodes 151260 and the electrical contact 151266. Applying the equations Z1=V / I1 and Z2=V / I2, impedances Z1 and Z2 corresponding to various compressions of tissue compressed by the end effector 151262 can be calculated. In an embodiment, impedances Z1 and Z2 can be calculated by the impedance calculator 151272. Impedances Z1 and Z2 can be used to calculate various compression levels of tissue.
[0249] Referring now to FIG. 41 , frequency graph 151290 is shown. Frequency graph 151290 illustrates frequency modulation of nesting two RF signals. As described above, two RF signals can be nested before reaching the RF electrode at the end effector. For example, an RF signal having frequency 1 and an RF signal having frequency 2 can be nested together. Referring now to FIG. 42 , the resulting nested RF signal is shown in frequency graph 151300. The combined signal shown in frequency graph 151300 includes the two RF signals of frequency graph 151290 combined. Referring now to FIG. 43 , frequency graph 151400 is shown. Frequency graph 151400 illustrates the RF signals having frequency 1 and frequency 2 after being filtered (e.g., by filters 151268 and 151270). The resulting RF signal can be used to perform separate impedance calculations or measurements on the return path, as described above.
[0250] In one aspect, filters 151268 and 151270 may be high-Q filters, such that the filter range may be narrow (e.g., Q=10). Q may be defined by center frequency (Wo) / bandwidth (BW), where Q=Wo / BW. In one embodiment, frequency 1 may be 150 kHz and frequency 2 may be 300 kHz. The feasible impedance measurement range may be 100 kHz to 20 MHz. In various embodiments, other advanced techniques, such as correlation, quadrature detection, etc., may be used to separate the RF signals.
[0251] Using one or more of the techniques and features described herein, a single energized electrode on the staple cartridge or isolated knife of an end effector can be used to simultaneously perform multiple tissue compression measurements. When two or more RF signals are superimposed or multiplexed (or nested or modulated), they can be transmitted to a single power supply side of the end effector and looped back on either the channel frame or anvil of the end effector. If a filter is incorporated at the junction of the anvil and channel before they join the common return path, the tissue impedance represented by both paths can be differentiated. This can provide a measurement of vertical versus lateral tissue compression. This method can also provide proximal and distal tissue compression depending on the placement of the filter and the location of the metal return path. The frequency generator and signal processor can be located on one or more chips on a circuit board or sub-board (which may already be present in the surgical stapler).
[0252] In one aspect, the present disclosure provides an instrument 150010 (described in connection with FIGS. 25-30 ) configured with various sensing systems. Therefore, for the sake of brevity and clarity, details of operation and construction will not be repeated here. In one aspect, the detection system includes a viscoelastic / rate of change detection system to monitor knife acceleration, rate of change of impedance, and rate of change of tissue contact. In one example, rate of change of knife acceleration can be used as a measure of tissue type. In another example, rate of change of impedance can be measured with a pulse sensor and used as a measure of compressibility. Finally, rate of change of tissue contact can be measured with a sensor that measures tissue flow based on knife firing rate.
[0253] The rate of change of a detected parameter, or how long it takes for an otherwise defined tissue parameter to reach an asymptotic steady-state value, is itself a separate measurement that may be more valuable than the detected parameter from which it is derived. To improve tissue parameter measurements, such as waiting a predetermined time before taking a measurement, the present disclosure provides novel techniques for using derivatives of measurements, such as the rate of change of a tissue parameter.
[0254] Differential techniques or rate of change measurements are most useful with the understanding that there is no single measurement that can be used alone to dramatically improve staple formation. It is the combination of multiple measurements that makes the measurement valid. In the case of tissue gap, it is helpful to know how much of the jaws are covered by tissue in order to make a relevant gap measurement. Impedance rate of change measurements may be combined with strain measurements at the anvil to relate the force and compression applied to tissue grasped between the jaw members of an end effector, such as an anvil and staple cartridge. Rate of change measurements can be used by intra-surgical devices to determine tissue compression as well as tissue type. Although stomach tissue and lung tissue sometimes have similar thicknesses and even similar compressive characteristics when lung tissue is calcified, instruments may be able to distinguish between these tissue types by using a combination of measurements such as gap, compression, applied force, tissue contact area, and rate of change of compression or rate of change of gap. If any of these measurements were used alone, it may be difficult for an intra-surgical device to distinguish between tissue types. The rate of change of compression may also serve to enable the device to determine whether the tissue is "normal" or whether an abnormality exists. Measuring not only the elapsed time but also the variation in the sensor signal and determining the derivative of the signal would provide another measurement that would allow the intra-surgical device to measure the signal. The rate of change information may also be used to determine when a steady state has been reached and to signal the next step in the process. For example, after grasping tissue between the jaw members of an end effector, such as an anvil and staple cartridge, once a steady state of tissue compression has been reached (e.g., approximately 15 seconds), an indicator or trigger may be enabled to initiate firing of the device.
[0255] Also provided herein are methods, devices, and systems for the time-dependent evaluation of sensor data to determine the stability, creep, and viscoelastic properties of tissue during surgical instrument operation. A surgical instrument, such as the stapler shown in FIG. 25, can include various sensors to measure operating parameters such as jaw gap size or distance, firing current, tissue compression, amount of jaws covered by tissue, anvil strain, and trigger force. These detected measurements are important for automated control of the surgical instrument and for providing feedback to the clinician.
[0256] 30-49 can be used to measure various derived parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. Motor current may be monitored using a current sensor in series with the battery 2308.
[0257] Turning now to FIGURE 44, a motorized surgical cutting and fastening instrument 151310 is depicted, which may or may not be reusable. The motorized surgical cutting and fastening instrument 151310 is constructed and equipped similarly to the motorized surgical cutting and fastening instrument 150010 described in connection with FIGURES 25-30. In the embodiment shown in FIGURE 44, the instrument 151310 includes a housing 151312 with a handle assembly 151314 configured to be grasped, manipulated, and actuated by a clinician. The housing 151312 is configured to be operably attached to an interchangeable shaft assembly 151500 having a surgical end effector 151600 operably coupled thereto, the shaft assembly 151312 being configured to perform one or more surgical tasks or procedures. The motor-driven surgical cutting and fastening instrument 151310 is constructed and equipped similarly to the motor-driven surgical cutting and fastening instrument 150010 described in connection with Figures 25-30, and therefore, for the sake of brevity and clarity, details of operation and construction will not be repeated here.
[0258] The housing 151312 depicted in FIG. 44 is shown connected to an interchangeable shaft assembly 151500 including an end effector 151600 with a surgical cutting and fastening device configured to operably support a surgical staple cartridge 151304 therein. The housing 151312 may be configured for use in connection with interchangeable shaft assemblies having various shaft lengths, sizes, and types, including end effectors adapted to support staple cartridges of various sizes and types. Additionally, the housing 151312 may also be used with a variety of other interchangeable shaft assemblies, including assemblies configured to apply other motions and other forms of energy, such as radio frequency (RF) energy, ultrasonic energy, and / or motion, to end effector configurations adapted for use in connection with various surgical applications and procedures. Furthermore, the end effector, shaft assembly, handle, surgical instrument, and / or surgical instrument system may utilize any suitable fasteners to fasten tissue. For example, a fastener cartridge having a plurality of fasteners removably stored therein may be removably inserted into and / or attached to the end effector of the shaft assembly.
[0259] 44 illustrates a surgical instrument 151310 having an interchangeable shaft assembly 151500 operably coupled thereto. In the illustrated configuration, the handle housing forms a pistol grip portion 151319 that can be grasped and manipulated by a clinician. The handle assembly 151314 operably supports therein a plurality of drive systems configured to generate and apply various control motions to corresponding portions of the interchangeable shaft assembly operably attached to the handle assembly. A trigger 151332 is operably associated with the pistol grip for controlling various of these control motions.
[0260] 44 , the interchangeable shaft assembly 151500 includes a surgical end effector 151600 having an elongated channel 151302 configured to operably support a staple cartridge 151304 therein. The end effector 151600 may further include an anvil 151306 pivotally supported relative to the elongated channel 151302.
[0261] The inventors have discovered that derived parameters can be more useful in controlling surgical instruments, such as the instrument illustrated in FIG. 44 , than the sensed parameters on which they are based. Non-limiting examples of derived parameters include the rate of change of a sensed parameter (e.g., jaw gap distance) and the elapsed time until a tissue parameter reaches an asymptotic steady-state value (e.g., 15 seconds). Derived parameters, such as rate of change, are particularly useful because they dramatically improve measurement accuracy and also provide information not otherwise directly apparent from the sensed parameter. For example, the rate of change of impedance (e.g., tissue compression) can be combined with anvil strain to relate compression and force, allowing a microcontroller to determine the amount of tissue compression as well as tissue type. This example is by way of example only; any derived parameter can be combined with one or more sensed parameters to provide more accurate information regarding tissue type (e.g., stomach vs. lung), tissue health (calcified vs. normal), and the operating status of the surgical device (e.g., grasp complete). Different tissues have unique viscoelastic properties and unique rates of change, and therefore these and other parameters described herein provide useful indications for monitoring and automatically adjusting surgical procedures.
[0262] FIG. 46 is an exemplary graph showing the change in gap distance over time, where the gap is the space occupied by grasped tissue between the jaws. The vertical (y) axis is distance, and the horizontal (x) axis is time. Specifically, with reference to FIGS. 44 and 45 , the gap distance 151340 is the distance between the anvil 151306 and the elongated channel 151302 of the end effector. In the open jaw position, at time 0, the gap 151340 between the anvil 151306 and the elongated member is at its maximum distance. The width of the gap 151340 decreases as the anvil 151306 closes, such as while grasping tissue. Because tissue has non-uniform elasticity, the rate of gap distance change can vary. For example, some tissue types initially exhibit rapid compression, resulting in a faster rate of change. However, as the tissue is continuously compressed, the viscoelastic properties of the tissue may decrease the rate of change until the tissue can no longer be compressed, at which point the gap distance remains substantially constant. The gap decreases over time as the tissue is compressed between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. One or more sensors described in connection with FIGS. 31-43 , such as, for example, 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, may be adapted and configured to measure the gap distance “d” between the anvil 151306 and the staple cartridge 151304 over time “t,” as graphically represented in FIG. 46 . The rate of change of the gap distance “d” over time “t” is the slope of the curve shown in FIG. 46 , where slope = Δd / Δt.
[0263] FIG. 47 is an exemplary graph showing the firing current of the jaws of an end effector. The vertical (y) axis is current, and the horizontal (x) axis is time. As discussed herein, a surgical instrument and / or its microcontroller, such as that shown and described in connection with FIG. 25 , may include a current sensor to detect the current utilized during various operations, such as grasping, cutting, and / or stapling tissue. For example, as tissue resistance increases, the instrument's electric motor may require more current to grasp, cut, and / or staple the tissue. Conversely, as resistance decreases, the electric motor may require less current to grasp, cut, and / or staple the tissue. As a result, the firing current can be used as an approximation of the tissue resistance. The detected current can be used alone, or more preferably in combination with other measurements, to provide feedback regarding the target tissue. Still referring to FIG. 47 , during some operations, such as stapling, the firing current is initially high at time zero but decreases over time. During operation of other devices, if the motor draws more current to overcome increasing mechanical loads, the current may increase over time. Additionally, the rate of change of firing current can be used as an indicator that tissue is transitioning from one state to another. Thus, firing current, and in particular, the rate of change of firing current, can be used to monitor device operation. As the knife cuts through tissue, the firing current decreases over time. If the tissue being cut offers greater or less resistance due to tissue properties or the sharpness of the knife 151305 (FIG. 45), the rate of change of firing current may vary. As cutting conditions vary, the work done by the motor varies, resulting in a fluctuation in firing current over time. A current sensor may be used to measure the firing current over time while the knife 151305 is firing, as depicted graphically in FIG. 47. For example, the motor current may be monitored using a current sensor. The current sensor may be adapted and configured to measure the motor firing current "i" over time "t," as depicted graphically in FIG. 47.The rate of change of firing current "i" over time "t" is the slope of the curve shown in Figure 47, where slope = Δi / Δt.
[0264] FIG. 48 is an exemplary graph of impedance change over time. The vertical (y) axis is impedance and the horizontal (x) axis is time. At time 0, impedance is low and increases over time as tissue pressure increases upon manipulation (e.g., gripping and stapling). The rate of change varies over time as tissue between the anvil 151306 of the end effector 151340 and the staple cartridge 151304 is cut by a knife or sealed using RF energy between electrodes located between the anvil 151306 of the end effector 151340 and the staple cartridge 151304. For example, as the tissue is cut, the electrical impedance increases and reaches infinity when the tissue is completely severed by the knife. Also, when the end effector 151340 includes electrodes coupled to an RF energy source, the electrical impedance of the tissue increases when energy is delivered through the tissue between the anvil 151306 and staple cartridge 151304 of the end effector 151340. The electrical impedance increases as energy passing through the tissue dries the tissue by evaporating water within the tissue. Eventually, when a suitable amount of energy is delivered to the tissue, the impedance increases to a very high value, or to infinity if the tissue is severed. Additionally, as shown in FIG. 48 , different tissues may have unique compressive properties, such as compressibility, that distinguish them. Tissue impedance may be measured by driving a sub-therapeutic RF current through tissue grasped between the first jaw member 9014 and the second jaw member 9016. One or more electrodes may be positioned on either or both of the anvil 151306 and the staple cartridge 151304. The tissue compression / impedance of the tissue between the anvil 151306 and the staple cartridge 151304 can be measured over time as graphically depicted in FIG 48. The sensors described in connection with FIGs. 31-43, such as, for example, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors, can be adapted and configured to measure tissue compression / impedance.The sensor may be adapted and configured to measure tissue impedance "Z" over time "t", as represented graphically in FIG.
[0265] FIG. 49 is an exemplary graph of the strain of the anvil 151306 (FIGS. 44, 45) over time. The vertical (y) axis is strain and the horizontal (x) axis is time. For example, during stapling, the strain of the anvil 151306 is initially high but decreases as the tissue reaches a steady state and less pressure is exerted on the anvil 151306. The rate of change of strain of the anvil 151306 can be measured by a pressure sensor or strain gauge positioned on either or both of the anvil 151306 and the staple cartridge 151304 (FIGS. 44, 45) to measure the pressure or strain applied to the tissue clamped between the anvil 151306 and the staple cartridge 151304. The strain of the anvil 151306 can be measured over time as graphically represented in FIG. 49. The rate of change of strain "S" over time "t" is the slope of the curve shown in FIG. 49, where slope = ΔS / Δt.
[0266] FIG. 50 is an exemplary graph of trigger force over time. The vertical (y) axis is trigger force and the horizontal (x) axis is time. In certain embodiments, the trigger force is progressive, providing tactile feedback to the clinician. Thus, at time 0, the pressure on the trigger 151320 ( FIG. 44 ) may be at its lowest value, and the trigger pressure may increase until the operation (e.g., grasping, cutting, or stapling) is completed. The rate of change of trigger force can be measured by a pressure sensor or strain gauge positioned on the trigger 151302 of the handle 151319 of the instrument 151310 ( FIG. 44 ) to measure the force required to drive the knife 151305 ( FIG. 45 ) through tissue grasped between the anvil 151306 and the staple cartridge 151304. The trigger 151332 force can be measured over time as represented graphically in FIG. 50 . The rate of change of strain trigger force "F" over time "t" is the slope of the curve shown in Figure 50, where slope = ΔF / Δt.
[0267] For example, stomach tissue and lung tissue can be distinguished even though these tissues may have similar thicknesses and, when calcified, lung tissue may have similar compressive properties. Stomach tissue and lung tissue can be distinguished by analyzing jaw gap distance, tissue compression, applied force, tissue contact area, rate of change of compression, and rate of change of jaw gap. For example, FIG. 51 shows a graph of tissue pressure "P" for various tissues versus tissue displacement for various tissues. The vertical (y) axis is tissue pressure, and the horizontal (x) axis is tissue displacement. When tissue pressure reaches a predetermined threshold, such as 0.50 to 100 pounds per square inch (psi), the amount of tissue displacement, as well as the rate of tissue displacement before the threshold, can be used to distinguish the tissues. For example, vascular tissue reaches the predetermined pressure threshold with less tissue displacement and a faster rate of change than colon, lung, or stomach tissue. Additionally, the rate of change (tissue pressure versus displacement) for vascular tissue is approximately asymptotic at a threshold of 50-100 psi, while the colon, lung, and stomach are not asymptotic at a threshold of 50-100 psi. As will be appreciated, any pressure threshold may be used, for example, 1-1000 psi, more preferably 10-500 psi, and even more preferably 50-100 psi. Additionally, multiple thresholds or gradual thresholds may be used to provide further resolution for tissue types with similar viscoelastic properties.
[0268] The rate of change of compression may also allow the microcontroller to determine whether the tissue is "normal" or whether an abnormality, such as calcification, is present. For example, referring to Figure 52, the compression of calcified lung tissue follows a different curve than the compression of normal lung tissue. Thus, tissue displacement and the rate of change of tissue displacement can be used to diagnose calcified lung tissue and / or distinguish it from normal lung tissue.
[0269] Additionally, certain detected measurements may benefit from additional sensory input. For example, in the case of jaw gap, knowing how much of the jaw is covered by tissue can make the gap measurement more useful and accurate. If a small portion of the jaw is covered by tissue, tissue compression may appear less than if the entire jaw is covered by tissue. Thus, the amount of jaw coverage may be taken into account by the microcontroller when analyzing tissue compression and other detected parameters.
[0270] In certain circumstances, elapsed time may also be an important parameter. Measuring elapsed time along with the sensed parameter and derivative parameter (e.g., rate of change) provides additional useful information. For example, if the rate of change of the jaw gap remains constant after a set period of time (e.g., 5 seconds), this parameter may have reached an asymptotic value.
[0271] The rate of change information is also useful for determining when a steady state has been reached and signaling the next step in the process. For example, during a grasp, once tissue compression reaches a steady state, e.g., no significant rate of change occurs after a set period of time, the microcontroller may send a signal to a display alerting the clinician to initiate the next step in the operation, such as firing staples. Alternatively, the microcontroller may be programmed to automatically initiate the next step in the operation (e.g., firing staples) once a steady state has been reached.
[0272] Similarly, the rate of change of impedance, combined with the strain of the anvil, can relate force and compression. The rate of change would allow the device to determine tissue type rather than simply measure compression values. For example, the stomach and lungs sometimes have similar thicknesses and even similar compression characteristics when the lungs are calcified.
[0273] The combination of one or more detected and derived parameters provides a more reliable and accurate assessment of tissue type and tissue health, enabling more effective device monitoring, control, and feedback to the clinician.
[0274] 53 illustrates one embodiment of an end effector 152000 including a first sensor 152008a and a second sensor 152008b. The end effector 152000 is similar to the end effector 150300 described above. The end effector 152000 includes a first jaw member, or anvil 152002, pivotally coupled to a second jaw member 152004. The second jaw member 152004 is configured to receive a staple cartridge 152006 therein. The staple cartridge 152006 includes a plurality of staples (not shown). The plurality of staples can be deployed from the staple cartridge 152006 during a surgical procedure. The end effector 152000 includes a first sensor 152008a. The first sensor 152008a is configured to measure one or more parameters of the end effector 152000. For example, in one embodiment, the first sensor 152008a is configured to measure the gap 152010 between the anvil 152002 and the second jaw member 152004. The first sensor 152008a may comprise a Hall Effect sensor configured to detect a magnetic field generated by, for example, a magnet 152012 embedded in the second jaw member 152004 and / or the staple cartridge 152006. As another example, in one embodiment, the first sensor 152008a is configured to measure one or more forces exerted on the anvil 152002 by the second jaw member 152004 and / or by tissue grasped between the anvil 152002 and the second jaw member 152004.
[0275] The end effector 152000 includes a second sensor 152008b. The second sensor 152008b is configured to measure one or more parameters of the end effector 152000. For example, in various embodiments, the second sensor 152008b may include a strain gauge configured to measure the magnitude of strain of the anvil 152002 during a gripped state. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of strain. In various embodiments, for example, the first sensor 152008a and / or the second sensor 152008b may include a magnetic sensor, such as a Hall effect 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 152000. The first sensor 152008a and the second sensor 152008b may be arranged in a series configuration and / or a parallel configuration. In a series configuration, the second sensor 152008b may be configured to directly affect the output of the first sensor 152008a. In a parallel configuration, the second sensor 152008b may be configured to indirectly affect the output of the first sensor 152008a.
[0276] In one embodiment, one or more parameters measured by the first sensor 152008a are related to one or more parameters measured by the second sensor 152008b. For example, in one embodiment, the first sensor 152008a is configured to measure a gap 152010 between the anvil 152002 and the second jaw member 152004. The gap 152010 represents the thickness and / or compressibility of a portion of tissue grasped between the anvil 152002 and the staple cartridge 152006. The first sensor 152008a may comprise, for example, a Hall Effect sensor configured to detect a magnetic field generated by a magnet 152012 coupled to the second jaw member 152004 and / or the staple cartridge 152006. While a single point measurement accurately represents the compressed tissue thickness in the case of a calibrated full engagement of the tissue, it may produce inaccurate results when a partial engagement of the tissue is located between the anvil 152002 and the second jaw member 152004. The partial engagement of the tissue, whether a proximal partial engagement or a distal partial engagement, changes the gripping geometry of the anvil 152002.
[0277] In some embodiments, the second sensor 152008b is configured to detect one or more parameters indicative of the type of tissue engagement, e.g., full engagement, partial proximal engagement, and / or partial distal engagement. The measurement of the second sensor 152008b may be used to adjust the measurement of the first sensor 152008a to accurately represent the true compressed tissue thickness at either the proximal or distally positioned partial engagement. For example, in one embodiment, the second sensor 152008b comprises a strain gauge, e.g., a micro strain gauge, configured to monitor the magnitude of strain in the anvil 152002 during the gripping state. The magnitude of strain in the anvil 152002 is used to modify the output of the first sensor 152008a, e.g., a Hall Effect sensor, to accurately represent the true compressed tissue thickness at either the proximal or distally positioned partial engagement. The first sensor 152008a and the second sensor 152008b may be measured in real time during the gripping operation. Real-time measurements allow time-based information to be analyzed, for example, by a primary processor (e.g., processor 462 (FIG. 12)) and used to select one or more algorithms and / or lookup tables to dynamically adjust tissue thickness measurements in recognition of tissue characteristics and grip positioning.
[0278] In some embodiments, the thickness measurement of the first sensor 152008a may be provided to an output device of the surgical instrument 150010 coupled to the end effector 152000. For example, in one embodiment, the end effector 152000 is coupled to the surgical instrument 150010 that includes a display, such as display 473 (FIG. 12). The measurement of the first sensor 152008a is provided to a processor, such as the primary processor. The primary processor adjusts the measurement of the first sensor 152008a based on the measurement of the second sensor 152008b to reflect the true tissue thickness of the portion of tissue grasped between the anvil 152002 and the staple cartridge 152006. The primary processor outputs the adjusted tissue thickness measurement and an indication of full engagement or partial engagement to the display. An operator may determine whether to deploy staples in the staple cartridge 152006 based on the displayed value.
[0279] In some embodiments, the first sensor 152008a and the second sensor 152008b may be located in different environments, e.g., the first sensor 152008a may be located at a treatment site inside the patient's body and the second sensor 152008b may be located outside the patient's body. The second sensor 152008b may be configured to calibrate and / or correct the output of the first sensor 152008a. The first sensor 152008a and / or the second sensor 152008b may comprise, for example, an environmental sensor. The environmental sensor may comprise, for example, a temperature sensor, a humidity sensor, a pressure sensor, and / or any other suitable environmental sensor.
[0280] 54 is a logic diagram illustrating one embodiment of a process 152020 for adjusting a measurement value of a first sensor 152008a based on input from a second sensor 152008b. A first signal 152022a is captured by the first sensor 152008a. The first signal 152022a may be adjusted based on one or more predetermined parameters, such as, for example, a smoothing function, a lookup table, and / or any other suitable adjustment parameters. A second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as, for example, a primary processor. The processor adjusts the measurement of the first sensor 152008a, as represented by the first signal 152022a, based on the second signal 152022b from the second sensor. For example, in one embodiment, the first sensor 152008a comprises a Hall Effect sensor and the second sensor 152008b comprises a strain gauge. The distance measurement of the first sensor 152008a is adjusted by the magnitude of the strain measured by the second sensor 152008b to determine the completeness of the tissue engagement at the end effector 152000. The adjusted measurement is displayed 152026 to the operator, for example, by a display embedded in the surgical instrument 150010.
[0281] 55 is a logic diagram illustrating one embodiment of a process 152030 for determining a lookup table for a first sensor 152008a based on input from a second sensor 152008b. The first sensor 152008a captures a signal 152022a indicative of one or more parameters of the end effector 152000. The first signal 152022a may be adjusted based on one or more predetermined parameters, such as, for example, a smoothing function, a lookup table, and / or any other suitable adjustment parameters. A second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as, for example, a primary processor. The processor selects a lookup table from one or more available lookup tables 152034a, 152034b based on the value of the second signal. The selected lookup table is used to convert the first signal into a measurement of the thickness of the tissue located between the anvil 152002 and the staple cartridge 152006. The adjusted measurement is displayed 152026 to the operator, for example, by a display embedded in the surgical instrument 150010.
[0282] 56 is a logic diagram illustrating one embodiment of a process 152040 for calibrating a first sensor 152008a in response to input from a second sensor 152008b. The first sensor 152008a is configured to capture a signal 152022a indicative of one or more parameters of the end effector 152000. The first signal 152022a may be adjusted based on one or more predetermined parameters, such as, for example, a smoothing function, a lookup table, and / or any other suitable adjustment parameters. A second signal 152022b is captured by the second sensor 152008b. The second signal 152022b may be adjusted based on one or more predetermined adjustment parameters. The first signal 152022a and the second signal 152022b are provided to a processor, such as, for example, a primary processor. The primary processor calibrates 152042 the first signal 152022a in response to the second signal 152022b. The first signal 152022a is calibrated 152042 to reflect the integrity of tissue engagement at the end effector 152000. The calibrated signal is displayed 152026 to the operator, for example, by a display embedded in the surgical instrument 150010.
[0283] 57 is a logic diagram illustrating one embodiment of a process 152050 for determining and displaying the thickness of a portion of tissue grasped between the anvil 152002 and staple cartridge 152006 of the end effector 152000. The process 152050 includes obtaining a Hall effect voltage 152052, for example, through a Hall effect sensor located at the distal tip of the anvil 152002. The Hall effect voltage 152052 is provided to an analog-to-digital converter 152054 and converted to a digital signal. The digital signal is provided to a processor, such as a primary processor. The primary processor calibrates 152056 the curve input of the Hall effect voltage 152052 signal. A strain gauge 152058, for example, a micro-strain gauge, is configured to measure one or more parameters of the end effector 152000, such as, for example, the magnitude of strain exerted on the anvil 152002 during the grasping operation. The measured strain is converted to a digital signal 152060 and provided to a processor, such as a primary processor. The primary processor uses one or more algorithms and / or lookup tables to adjust the Hall effect voltage 152052 in response to the strain measured by the strain gauges 152058 to reflect the true thickness and integrity of engagement of the tissue grasped by the anvil 152002 and staple cartridge 152006. The adjusted thickness is displayed 152026 to the operator, for example, by a display embedded in the surgical instrument 150010.
[0284] In some embodiments, the surgical instrument can further include a load cell or load sensor 152082. The load sensor 152082 can be located, for example, in the shaft assembly 150200, as described above, or in the housing 150012, also described above. FIG. 58 is a logic diagram illustrating one embodiment of a process 152070 for determining and displaying the thickness of a portion of tissue grasped between the anvil 152002 and staple cartridge 152006 of the end effector 152000. The process includes obtaining a Hall effect voltage 152072, for example, through a Hall effect sensor located at the distal tip of the anvil 152002. The Hall effect voltage 152072 is provided to an analog-to-digital converter 152074 and converted to a digital signal. The digital signal is provided to a processor, such as, for example, a primary processor. The primary processor calibrates 152076 a curve input of the Hall effect voltage 152072 signal. The strain gauge 152078, e.g., a micro-strain gauge, is configured to measure one or more parameters of the end effector 152000, e.g., the magnitude of strain exerted on the anvil 152002 during a gripping operation. The measured strain is converted to a digital signal and provided to a processor, e.g., a primary processor 152080. The load sensor 152082 measures the gripping force of the anvil 152002 against the staple cartridge 152006. The measured gripping force is converted to a digital signal and provided to a processor, e.g., a primary processor 152084. The primary processor adjusts the Hall effect voltage 152072 in response to the strain measured by the strain gauge 152078 and the gripping force measured by the load sensor 152082 using one or more algorithms and / or lookup tables to reflect the true thickness of the tissue gripped by the anvil 152002 and staple cartridge 152006 and the integrity of their engagement. The adjusted thickness is displayed 152026 to the operator, for example, by a display embedded in the surgical instrument 150010.
[0285] FIG. 59 is a graph 152090 illustrating a comparison of an adjusted Hall effect thickness measurement 152092 and an uncorrected Hall effect thickness measurement 152094. As shown in FIG. 59, the uncorrected Hall effect thickness measurement 152094 indicates a thicker tissue measurement because a single sensor cannot compensate for distal / proximal partial interlocking, resulting in an inaccurate thickness measurement. The adjusted thickness measurement 152092 is generated, for example, by the process 152050 shown in FIG. 57. The Hall effect thickness measurement 152092 is calibrated based on input from one or more additional sensors, such as, for example, a strain gauge. The adjusted Hall effect thickness 152092 reflects the true thickness of the tissue located between the anvil 152002 and the staple cartridge 152006.
[0286] FIG. 60 illustrates one embodiment of an end effector 152100 including a first sensor 152108a and a second sensor 152108b. The end effector 152100 is similar to the end effector 152000 shown in FIG. 53. The end effector 152100 includes a first jaw member, or anvil 152102, pivotally coupled to a second jaw member 152104. The second jaw member 152104 is configured to receive a staple cartridge 152106 therein. The end effector 152100 includes a first sensor 152108a coupled to the anvil 152102. The first sensor 152108a is configured to measure one or more parameters of the end effector 152100, such as, for example, a gap 152110 between the anvil 152102 and the staple cartridge 152106. The gap 152110 can correspond to, for example, a thickness of tissue grasped between the anvil 152102 and the staple cartridge 152106. The first sensor 152108a may comprise any suitable sensor that measures one or more parameters of the end effector. For example, in various embodiments, the first sensor 152108a may comprise a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure 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.
[0287] In some embodiments, the end effector 152100 includes a second sensor 152108b. The second sensor 152108b is coupled to the second jaw member 152104 and / or the staple cartridge 152106. The second sensor 152108b is configured to detect one or more parameters of the end effector 152100. For example, in some embodiments, the second sensor 152108b is configured to detect one or more instrument conditions, such as, for example, the color of the staple cartridge 152106 coupled to the second jaw member 152104, the length of the staple cartridge 152106, the gripping condition of the end effector 152100 and / or the staple cartridge 152106, the number of uses / remaining uses, and / or any other suitable instrument condition. The second sensor 152108b may comprise any suitable sensor for detecting one or more instrument conditions, such as a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure 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.
[0288] The end effector 152100 may be used in conjunction with any of the processes shown in FIGS. 54-57. For example, in one embodiment, input from the second sensor 152108b may be used to calibrate the input of the first sensor 152108a. The second sensor 152108b may be configured to detect one or more parameters of the staple cartridge 152106, such as, for example, the color and / or length of the staple cartridge 152106. The detected parameters, such as the color and / or length of the staple cartridge 152106, may correspond to one or more characteristics of the cartridge, such as, for example, the height of the cartridge deck, the usable / optimal tissue thickness for the staple cartridge, and / or the pattern of staples within the staple cartridge 152106. The known parameters of the staple cartridge 152106 may be used to adjust the thickness measurement provided by the first sensor 152108a. For example, if the staple cartridge 152106 has a higher deck height, the thickness measurement provided by the first sensor 152108a may be reduced to compensate for the additional deck height. The adjusted thickness may be displayed to the operator, for example, through a display coupled to the surgical instrument 150010.
[0289] 61 illustrates one embodiment of an end effector 152150 including a first sensor 152158 and a plurality of second sensors 152160a, 152160b. The end effector 152150 includes a first jaw member, or anvil 152152, and a second jaw member 152154. The second jaw member 152154 is configured to receive a staple cartridge 152156. The anvil 152152 is pivotally movable relative to the second jaw member 152154 to grasp tissue between the anvil 152152 and the staple cartridge 152156. The anvil includes the first sensor 152158. The first sensor 152158 is configured to detect one or more parameters of the end effector 152150, such as, for example, a gap 152110 between the anvil 152152 and the staple cartridge 152156. The gap 152110 can correspond to, for example, a thickness of tissue grasped between the anvil 152152 and the staple cartridge 152156. The first sensor 152158 may comprise any suitable sensor that measures one or more parameters of the end effector. For example, in various embodiments, the first sensor 152158 may comprise a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure 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.
[0290] In some embodiments, the end effector 152150 includes multiple secondary sensors 152160a, 152160b. The secondary sensors 152160a, 152160b are configured to detect one or more parameters of the end effector 152150. For example, in some embodiments, the secondary sensors 152160a, 152160b are configured to measure the amount of strain exerted on the anvil 152152 during the grasping procedure. In various embodiments, the secondary sensors 152160a, 152160b may include a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure 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. The secondary sensors 152160a, 152160b may be configured to measure one or more of the same parameters at different positions on the anvil 152152, different parameters at the same position on the anvil 152152, and / or different parameters at different positions on the anvil 152152.
[0291] FIG. 62 is a logic diagram illustrating one embodiment of a process 152170 for adjusting the measurements of the first sensor 152158 in response to the plurality of secondary sensors 152160a, 152160b. In one embodiment, a Hall effect voltage is obtained 152172, for example, by a Hall effect sensor. The Hall effect voltage is converted 152174 by an analog-to-digital converter. The converted Hall effect voltage signal is calibrated 152176. The calibrated curve represents the thickness of a portion of tissue located between the anvil 152152 and the staple cartridge 152156. A plurality of secondary measurements are obtained 152178a, 152178b by a plurality of secondary sensors, for example, a plurality of strain gauges. The strain gauge inputs are converted 152180a, 152180b to one or more digital signals, for example, by a plurality of electronic μ-strain conversion circuits. The calibrated Hall effect voltage and the plurality of secondary measurements are provided to a processor, for example, a primary processor. The primary processor utilizes the secondary measurements to adjust the Hall effect voltage 152182, for example, by applying an algorithm and / or one or more lookup tables. The adjusted Hall effect voltage represents the true thickness of the tissue grasped between the anvil 152152 and the staple cartridge 152156 and the completeness of that engagement. The adjusted thickness is displayed 152026 to the operator, for example, by a display embedded in the surgical instrument 150010.
[0292] FIG. 63 illustrates one embodiment of a circuit 152190 configured to convert signals from a first sensor 152158 and multiple secondary sensors 152160a, 152160b into digital signals that can be received by a processor, such as a primary processor. The circuit 152190 includes an analog-to-digital converter 152194. In some embodiments, the analog-to-digital converter 152194 includes a four-channel, 18-bit analog-to-digital converter. Those skilled in the art will recognize that the analog-to-digital converter 152194 may include any suitable number of channels and / or bits to convert one or more inputs from analog to digital. The circuit 152190 includes one or more level-shifting resistors 152196 configured to accept input from the first sensor 152158, such as a Hall-effect sensor. The level-shifting resistor 152196 conditions the input from the first sensor to shift the value to a higher or lower voltage depending on the input. The level shift resistor 152196 provides a level shifted input from the first sensor 152158 to the analog-to-digital converter.
[0293] In some embodiments, the multiple secondary sensors 152160a, 152160b are coupled to multiple bridges 152192a, 152192b in the circuit 152190. The multiple bridges 152192a, 152192b may provide filtering of the input from the multiple secondary sensors 152160a, 152160b. After filtering the input signals, the multiple bridges 152192a, 152192b provide the input from the multiple secondary sensors 152160a, 152160b to an analog-to-digital converter 152194. In some embodiments, a switch 152198 coupled to one or more level-shifting resistors may be coupled to the analog-to-digital converter 152194. The switch 152198 is configured to calibrate one or more input signals, such as input from a Hall effect sensor. The switch 152198 may be engaged to provide one or more level shift signals to adjust one or more input signals of the sensors, such as to calibrate the input of a Hall effect sensor. In some embodiments, adjustment is not required and the switch 152198 is left in an open position to disconnect the level shift resistor. The switch 152198 is coupled to the analog-to-digital converter 152194. The analog-to-digital converter 152194 provides an output to one or more processors, such as a primary processor. The primary processor calculates one or more parameters of the end effector 152150 based on input from the analog-to-digital converter 152194. For example, in one embodiment, the primary processor calculates the thickness of the tissue located between the anvil 152152 and the staple cartridge 152156 based on input from one or more sensors 152158, 152160a, 152160b.
[0294] 64 illustrates one embodiment of an end effector 152200 including multiple sensors 152208a-152208d. The end effector 152200 includes an anvil 152202 pivotally coupled to a second jaw member 152204. The second jaw member 152204 is configured to receive a staple cartridge 152206 therein. The anvil 152202 includes multiple sensors 152208a-152208d thereon. The multiple sensors 152208a-152208d are configured to detect one or more parameters of the end effector 152200, such as the anvil 152202. The multiple sensors 152208a-152208d may include one or more of the same sensors and / or different sensors. The plurality of sensors 152208a-152208d may comprise, for example, magnetic sensors such as Hall effect sensors, strain gauges, pressure sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors or combinations thereof. For example, in one embodiment, the plurality of sensors 152208a-152208d may comprise a plurality of strain gauges.
[0295] In one embodiment, the multiple sensors 152208a-152208d enable a robust tissue thickness sensing process. By detecting various parameters along the length of the anvil 152202, the multiple sensors 152208a-152208d enable a surgical instrument, such as the surgical instrument 150010, to calculate tissue thickness within the jaws regardless of engagement, e.g., partial or full engagement. In some embodiments, the multiple sensors 152208a-152208d comprise multiple strain gauges. The multiple strain gauges are configured to measure strain at various points on the anvil 152202. The magnitude and / or gradient of the strain at each of the various points on the anvil 152202 can be used to determine tissue thickness between the anvil 152202 and the staple cartridge 152206. The multiple strain gauges may be configured to optimize a maximum difference in magnitude and / or gradient based on the mechanics of the grasp to determine tissue thickness, tissue placement, and / or material properties. Time-based monitoring of the multiple sensors 152208a-152208d during grasping allows a processor, such as a primary processor, to utilize algorithms and lookup tables to recognize tissue characteristics and grasping positions and dynamically adjust the end effector 152200 and / or the tissue grasped between the anvil 152202 and the staple cartridge 152206.
[0296] FIG. 65 is a logic diagram illustrating one embodiment of a process 152220 for determining one or more tissue characteristics based on a plurality of sensors 152208a-152208d. In one embodiment, the plurality of sensors 152208a-152208d generate a plurality of signals 152222a-152222d indicative of one or more parameters of the end effector 152200. The plurality of generated signals are converted to digital signals 152224a-152224d and provided to a processor. For example, in an embodiment including a plurality of strain gauges, a plurality of electronic μ-strain (microstrain) conversion circuits convert the strain gauge signals to digital signals 152224a-152224d. The digital signals are provided to a processor, such as a primary processor. The primary processor determines one or more tissue characteristics 152226 based on the plurality of signals. The processor may determine the one or more tissue characteristics by applying an algorithm and / or a lookup table. The one or more tissue features are displayed 152026 to the operator, for example, by a display embedded in the surgical instrument 150010.
[0297] FIG. 66 illustrates one embodiment of an end effector 152250 including multiple sensors 152260a-152260d coupled to a second jaw member 3254. The end effector 152250 includes an anvil 152252 pivotally coupled to the second jaw member 152254. The anvil 152252 is movable relative to the second jaw member 152254 to grasp one or more substances, such as, for example, a portion of tissue 152264, therebetween. The second jaw member 152254 is configured to receive a staple cartridge 152256. A first sensor 152258 is coupled to the anvil 152252. The first sensor is configured to detect one or more parameters of the end effector 152150, such as, for example, a gap 152110 between the anvil 152252 and the staple cartridge 152256. The gap 152110 can correspond to, for example, the thickness of tissue grasped between the anvil 152252 and the staple cartridge 152256. The first sensor 152258 can comprise any suitable sensor that measures one or more parameters of the end effector. For example, in various embodiments, the first sensor 152258 can comprise a magnetic sensor such as a Hall effect sensor, a strain gauge, a pressure 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.
[0298] A plurality of secondary sensors 152260a-152260d are coupled to the second jaw member 152254. The plurality of secondary sensors 152260a-152260d may be integrally formed with the second jaw member 152254 and / or the staple cartridge 152256. For example, in one embodiment, the plurality of secondary sensors 152260a-152260d are disposed on the outer rows of the staple cartridge 152256 (see FIG. 67 ). The plurality of secondary sensors 152260a-152260d are configured to detect one or more parameters of the end effector 152250 and / or a portion of tissue 152264 grasped between the anvil 152252 and the staple cartridge 152256. The multiple secondary sensors 152260a-152260d may comprise any suitable sensors that detect one or more parameters of the end effector 152250 and / or tissue portion 152264, such as, for example, magnetic sensors such as Hall effect sensors, strain gauges, pressure sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and / or any other suitable sensors, or combinations thereof. The multiple secondary sensors 152260a-152260d may comprise the same sensors and / or different sensors.
[0299] In some embodiments, the plurality of secondary sensors 152260a-152260d comprise dual-purp...
Claims
1. 1. A surgical system comprising:
1. A surgical instrument comprising: An end effector, A first jaw; and an end effector comprising: a first jaw configured to move closed relative to the second jaw; and a second jaw configured to move closed relative to the first jaw. a motor configured to move the first jaw relative to the second jaw according to a closing force rate of change parameter and a closing force threshold parameter; a sensor configured to transmit a sensor signal indicative of a closure parameter of the end effector; and a control circuit communicatively connected to the sensor, receiving information including at least preoperative information of a patient; receiving the sensor signal from the sensor; and a control circuit configured to perform adjustments to the closure force change rate parameter and the closure force threshold parameter over time based at least on the pre-operative information and the sensor signal included in the information.
2. The surgical system of claim 1 , wherein the control circuitry is further configured to vary a speed of the motor based on the determined adjustments to the closure force rate of change parameter and the closure force threshold parameter.
3. 10. The surgical system of claim 1, wherein the information further includes one or more of a type of tissue to be treated by the surgical instrument, tissue characteristics, a clinician history, and a type of staple cartridge for use with the surgical instrument.
4. the closure force threshold parameter is a maximum closure force threshold; The surgical system of claim 1 , wherein the control circuitry is further configured to disable the motor for a predetermined period of time based on reaching the maximum closure force threshold.
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