Determining tissue composition via ultrasound systems
The ultrasonic electromechanical system with frequency and infrared detection capabilities addresses the challenge of determining tissue composition during surgery, enhancing precision and safety in surgical procedures.
Patent Information
- Application Number
- JP2023158325
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2018-08-28
- Filing Date
- 2023-09-22
- Publication Date
- 2025-01-17
- Estimated Expiration
- 2038-10-12
AI Technical Summary
Existing surgical instruments lack the ability to accurately determine tissue composition during procedures, which can affect the efficacy and safety of tissue transection and coagulation.
An ultrasonic electromechanical system with an ultrasonic blade and control circuit that determines tissue composition by comparing resonant frequencies before and during tissue interaction, and an ultrasound generator that uses infrared detection to assess tissue properties.
Enhances the precision and safety of tissue transection and coagulation by providing real-time tissue composition analysis, improving surgical outcomes.
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 / 721,995, filed August 23, 2018, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION," the entire disclosure of which is incorporated herein by reference.
[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 721,998, filed August 23, 2018, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS," the entire disclosure of which is incorporated herein by reference.
[0003] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 721,999, filed August 23, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING," the entire disclosure of which is incorporated herein by reference.
[0004] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 721,994, filed August 23, 2018, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," the entire disclosure of which is incorporated herein by reference.
[0005] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 721,996, filed August 23, 2018, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS," the entire disclosure of which is incorporated herein by reference.
[0006] This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 692,747, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE," filed June 30, 2018; U.S. Provisional Patent Application No. 62 / 692,748, entitled "SMART ENERGY ARCHITECTURE," filed June 30, 2018; and U.S. Provisional Patent Application No. 62 / 692,768, entitled "SMART ENERGY DEVICES," filed June 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.
[0007] 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 entireties.
[0008] This application further relates to U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," 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 / 650,882, 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 "SURGICAL SMOKE EVACUATION SENSING AND INTERACTIVE SURGICAL PLATFORM," 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 / 650,877, filed March 30, 2018, entitled "CONTROLS."
[0009] 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. [Background technology]
[0010] In a surgical environment, smart energy devices within a smart energy architecture environment may be required. Summary of the Invention [Means for solving the problem]
[0011] In one general aspect, an ultrasonic electromechanical system for an ultrasonic surgical instrument includes an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, and a control circuit coupled to the ultrasonic transducer. The ultrasonic transducer is configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal. The control circuit is configured to determine a first resonant frequency of the ultrasonic electromechanical system, determine a second resonant frequency of the ultrasonic electromechanical system when the ultrasonic blade vibrates against tissue, and determine a tissue composition of the tissue according to a comparison between the first resonant frequency and the second resonant frequency.
[0012] In another general aspect, an ultrasonic generator connectable to an ultrasonic electromechanical system includes an ultrasonic blade and an ultrasonic transducer acoustically coupled to the ultrasonic blade, the ultrasonic generator including a control circuit connectable to the ultrasonic transducer, the control circuit configured to apply a drive signal to the ultrasonic transducer to cause the ultrasonic transducer to vibrate the ultrasonic blade, determine a first resonant frequency of the ultrasonic electromechanical system, determine a second resonant frequency of the ultrasonic electromechanical system when the ultrasonic blade vibrates against tissue, and determine a tissue composition of the tissue according to a comparison between the first resonant frequency and the second resonant frequency.
[0013] In another general aspect, an ultrasonic surgical instrument includes an end effector including an ultrasonic blade, an ultrasonic transducer acoustically coupled to the ultrasonic blade, an infrared source configured to emit infrared energy at tissue within the end effector, an infrared detector, and control circuitry coupled to the ultrasonic transducer and the infrared detector, the ultrasonic transducer configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal, the control circuitry configured to receive infrared energy reflected by the tissue via the infrared detector, and determine a tissue composition of the tissue according to the reflected infrared energy. [Brief explanation of the drawings]
[0014] 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 facilities for surgical procedures, to a cloud, in accordance with at least one embodiment of the present disclosure. [Figure 9] 1 illustrates a computer-implemented interactive surgical system according to at least one aspect of the present disclosure. [Figure 10]1 illustrates a surgical hub comprising a plurality of modules coupled to a modular control tower, 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] 1 is a system configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communications hub, according to at least one aspect of the present disclosure. [Figure 21] 1 illustrates an example of a generator according to at least one aspect of the present disclosure. [Figure 22]1 is a surgical system including a generator and various surgical instruments usable with the generator, according to at least one aspect of the present disclosure. [Figure 23] 1 is an end effector according to at least one aspect of the present disclosure. [Figure 24] FIG. 23 is a diagram of the surgical system of FIG. 22, according to at least one embodiment of the present disclosure. [Figure 25] 1 is a model illustrating motional branch currents, in accordance with at least one embodiment of the present disclosure. [Figure 26] FIG. 1 is a structural diagram of a generator architecture, in accordance with at least one aspect of the present disclosure. [Figure 27A] FIG. 1 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure. [Figure 27B] FIG. 1 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure. [Figure 27C] FIG. 1 is a functional diagram of a generator architecture, in accordance with at least one aspect of the present disclosure. [Figure 28A] 1 illustrates structural and functional aspects of a generator according to at least one embodiment of the present disclosure. [Figure 28B] 1 illustrates structural and functional aspects of a generator according to at least one embodiment of the present disclosure. [Figure 29] FIG. 1 is a circuit diagram of one embodiment of an ultrasonic drive circuit. [Figure 30] FIG. 2 is a circuit diagram of a control circuit according to at least one aspect of the present disclosure. [Figure 31] FIG. 10 shows a simplified block circuit diagram illustrating another electrical circuit housed within a modular ultrasonic surgical instrument, in accordance with at least one embodiment of the present disclosure. [Figure 32] 1 illustrates a generator circuit divided into multiple stages, in accordance with at least one embodiment of the present disclosure. [Figure 33] 1 illustrates a generator circuit divided into multiple stages, where the first stage circuit is common with the second stage circuit, according to at least one embodiment of the present disclosure. [Figure 34]FIG. 1 is a circuit diagram of one embodiment of a drive circuit configured to drive radio frequency (RF) current, in accordance with at least one embodiment of the present disclosure. [Figure 35] 1 illustrates one embodiment of a basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms of electrical signal waveforms for use in a surgical instrument, in accordance with at least one embodiment of the present disclosure. [Figure 36] 1 illustrates one embodiment of a direct digital synthesis (DDS) circuit configured to generate multiple waveforms of an electrical signal waveform for use in a surgical instrument, in accordance with at least one embodiment of the present disclosure. [Figure 37] 1 illustrates one cycle of an analog waveform (shown superimposed on a discrete-time digital electrical signal waveform for comparison purposes) according to at least one embodiment of the present disclosure; [Figure 38] FIG. 10 is a diagram of a control system configured to provide progressive closure of a closure member as it advances distally to close the clamp arms and apply a closure force load at a desired rate, according to one aspect of the present disclosure. [Figure 39] 1 illustrates a proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure. [Figure 40] FIG. 1 is a system diagram of a segmented circuit comprising multiple independently operating circuit segments, in accordance with at least one aspect of the present disclosure. [Figure 41] FIG. 1 is a circuit diagram of various components of a surgical instrument with motor control functionality, according to at least one aspect of the present disclosure. [Figure 42] 1 is an alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system, according to at least one aspect of the present disclosure. [Figure 43A]1 is a graphical representation of impedance phase angle as a function of resonant frequency for the same ultrasonic device with a cold (blue) and a hot (red) ultrasonic blade. [Figure 43B] 1 is a graphical representation of impedance magnitude as a function of resonant frequency for the same ultrasonic device with a cold (blue) and hot (red) ultrasonic blade. [Figure 44] FIG. 10 is a diagram of a Kalman filter that improves a temperature estimator and a state-space model based on impedance across an ultrasonic transducer measured at various frequencies, in accordance with at least one aspect of the present disclosure. [Figure 45] 45A-45C are three probability distributions employed by the state estimator of the Kalman filter shown in FIG. 44 to maximize estimation, in accordance with at least one aspect of the present disclosure. [Figure 46A] 1 is a graphical representation of temperature versus time for an ultrasonic device without temperature control reaching a maximum temperature of 490° C. [Figure 46B] 1 is a graphical representation of temperature versus time for an ultrasonic device having temperature control reaching a maximum temperature of 320° C., in accordance with at least one embodiment of the present disclosure. [Figure 47A] 10 is a graphical representation of a feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a sudden temperature drop of the ultrasonic blade is detected; and FIG. 11 is a graphical representation of ultrasonic power as a function of time. [Figure 47B] 1 is a graphical representation of a feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a sudden temperature drop of the ultrasonic blade is detected; and FIG. 2 is a plot of ultrasonic blade temperature as a function of time, according to at least one embodiment of the present disclosure. [Figure 48] FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for controlling the temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. [Figure 49] 1 is a graphical representation of ultrasound blade temperature as a function of time during a vessel firing, according to at least one embodiment of the present disclosure. [Figure 50]FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for controlling the temperature of an ultrasonic blade between two temperature setpoints, in accordance with at least one aspect of the present disclosure. [Figure 51] FIG. 1 is a logic flow diagram of a process illustrating a control program or logic configuration for determining an initial temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. [Figure 52] FIG. 10 is a logic flow diagram illustrating a process for determining when an ultrasonic blade is approaching instability and subsequently adjusting power to the ultrasonic transducer to prevent instability in accordance with at least one aspect of the present disclosure. [Figure 53] FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for providing ultrasonic sealing with temperature control, according to at least one aspect of the present disclosure. [Figure 54] 1 is a graphical representation of ultrasonic transducer current and ultrasonic blade temperature as a function of time, according to at least one embodiment of the present disclosure. [Figure 55] FIG. 10 is a bottom view of an ultrasonic end effector showing a clamp arm and an ultrasonic blade depicting the positioning of tissue within the ultrasonic end effector, in accordance with at least one aspect of the present disclosure. [Figure 56] 10 is a graphical representation illustrating the change in ultrasonic transducer impedance as a function of tissue position within an ultrasonic end effector over a range of increasing predetermined ultrasonic generator power levels, in accordance with at least one embodiment of the present disclosure. [Figure 57] 10 is a graphical representation illustrating change in ultrasonic transducer impedance as a function of time relative to tissue position within an ultrasonic end effector, in accordance with at least one embodiment of the present disclosure. [Figure 58] FIG. 10 is a logic flow diagram of a process illustrating a control program or logic configuration for specifying operation in a non-therapeutic range of power applied to an ultrasound transducer to determine tissue positioning, in accordance with at least one aspect of the present disclosure. [Figure 59]1 illustrates one embodiment of an end effector of an ultrasonic surgical instrument with an infrared (IR) sensor located on a jaw member, in accordance with at least one embodiment of the present disclosure. [Figure 60] 59 shows one embodiment of a flexible circuit to which the IR sensor shown in FIG. 59 may be integrally attached or formed, according to one embodiment of the present disclosure. [Figure 61] FIG. 1 is a cross-sectional view of an ultrasonic end effector including a clamp arm and an ultrasonic blade, according to at least one embodiment of the present disclosure. [Figure 62] 1 illustrates an IR refraction detection sensor circuit mounted on a flexible circuit board shown in plan view, according to at least one embodiment of the present disclosure. [Figure 63] FIG. 1 is a logic flow diagram of a process illustrating a control program or logic configuration for measuring IR reflectivity to determine tissue composition and adjust ultrasound transducer amplitude, according to at least one embodiment of the present disclosure. [Figure 64A] 1 is a graphical representation of clamp arm closure rate versus time for identifying a collagen transformation point according to various embodiments of the present disclosure, with time shown along the horizontal axis and change in clamp arm position shown along the vertical axis, in accordance with at least one embodiment of the present disclosure. [Figure 64B] FIG. 64B is an enlarged portion of the graphical representation shown in FIG. 64A. [Figure 65] FIG. 10 is a logic flow diagram of a process illustrating a control program or logic configuration for detecting a collagen transformation point and controlling the rate of closure of a clamp arm or the amplitude of an ultrasonic transducer, according to at least one embodiment of the present disclosure. [Figure 66] 1 is a graphical representation of identifying collagen transformation temperature points for determining collagen / elastin ratios according to various embodiments of the present disclosure, with tissue temperature shown along the horizontal axis and ultrasound transducer impedance shown along the vertical axis, in accordance with at least one embodiment of the present disclosure. [Figure 67] FIG. 1 is a logic flow diagram of a process illustrating a control program or logic configuration for determining a collagen transformation temperature to determine a collagen / elastin ratio, according to at least one embodiment of the present disclosure. [Figure 68] 1 is a graphical representation of a distribution of compressive load across an ultrasonic blade, according to at least one embodiment of the present disclosure. [Figure 69] 1 is a graphical representation of pressure applied to tissue versus time, according to at least one embodiment of the present disclosure. [Figure 70] 1 illustrates an end effector including a single jaw electrode array for detecting tissue location, according to at least one embodiment of the present disclosure. [Figure 71] 71 is an activation matrix of the single-jaw electrode array of FIG. 70 according to at least one embodiment of the present disclosure. [Figure 72] 1 illustrates an end effector including a dual-jaw electrode array for detecting tissue location, according to at least one embodiment of the present disclosure. [Figure 73] FIG. 73 is an activation matrix of the dual-jaw electrode array of FIG. 72, according to at least one embodiment of the present disclosure. [Figure 74] 74 illustrates opposing sets of electrodes superimposed on tissue grasped by an end effector corresponding to the activation matrix of FIG. 73, in accordance with at least one embodiment of the present disclosure. [Figure 75] 1 illustrates an end effector including a dual-jaw segmented electrode array in accordance with at least one embodiment of the present disclosure. [Figure 76] 1 illustrates tissue superimposed on a jaw including a segmented electrode array, according to at least one embodiment of the present disclosure. [Figure 77] FIG. 1 is a circuit diagram of a segmented electrode array circuit including a bandpass filter, according to at least one embodiment of the present disclosure. [Figure 78] 77 is a graphical representation of a frequency response corresponding to the tissue grasped in FIG. 76, in accordance with at least one embodiment of the present disclosure. [Figure 79] 1 is a graphical representation of the frequency of an ultrasonic transducer system as a function of drive frequency and ultrasonic blade temperature drift, in accordance with at least one embodiment of the present disclosure. [Figure 80]1 is a graphical representation of the temperature of an ultrasonic transducer as a function of time, according to at least one embodiment of the present disclosure. [Figure 81] 1 is a graphical representation of a modal shift in resonant frequency based on ultrasonic blade temperature, which shifts the resonant frequency as a function of ultrasonic blade temperature, in accordance with at least one embodiment of the present disclosure. [Figure 82] 10A-10C are spectra of an ultrasonic surgical instrument having various different states and conditions of the end effector, in which the phase and magnitude of the impedance of the ultrasonic transducer are plotted as a function of frequency, in accordance with at least one embodiment of the present disclosure. [Figure 83] 1 is a methodology for data classification based on a set of training data S, in which the magnitude and phase of ultrasonic transducer impedance are plotted as a function of frequency, according to at least one embodiment of the present disclosure. [Figure 84] FIG. 10 is a logic flow diagram illustrating a control program or logic configuration for determining jaw status based on a complex impedance signature pattern (fingerprint) in accordance with at least one aspect of the present disclosure. [Figure 85] 10 is a timeline illustrating situational awareness of a surgical hub, according to at least one aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION
[0015] The applicant of this application owns the following U.S. patent applications, filed August 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety: U.S. Patent Application Docket No. END8536USNP2 / 180107-2, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR"; U.S. Patent Application Docket No. END8560USNP2 / 180106-2, entitled "TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR"; U.S. Patent Application Docket No. END8561USNP1 / 180144-1, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS"; U.S. Patent Application Docket No. END8563USNP1 / 180139-1, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION"; U.S. Patent Application Docket No. END8563USNP2 / 180139-2, entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE"; U.S. Patent Application Docket No. END8563USNP4 / 180139-4, entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT"; U.S. Patent Application Docket No. END8563USNP5 / 180139-5, entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR"; U.S. Patent Application Docket No. END8564USNP1 / 180140-1, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS"; U.S. Patent Application Docket No. END8564USNP2 / 180140-2, entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT"; U.S. Patent Application Docket No. END8564USNP3 / 180140-3, entitled "DETECTION OF END EFFECTOR IMMERSION IN LIQUID"; U.S. Patent Application Docket No. END8565USNP1 / 180142-1, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING"; U.S. Patent Application Docket No. END8565USNP2 / 180142-2, entitled "Increasing Radio Frequency to Create a Pad-Lesse Monopolar Loop"; U.S. Patent Application Serial No. END8566USNP1 / 180143-1, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," and · U.S. Patent Application Docket No. END8573USNP1 / 180145-1 entitled "ACTIVATION OF ENERGY DEVICES."
[0016] The applicant of this application owns the following U.S. patent applications, filed August 23, 2018, the disclosures of which are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 62 / 721,995, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION"; · U.S. Provisional Patent Application No. 62 / 721,998, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS"; U.S. Provisional Patent Application No. 62 / 721,999, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING"; U.S. Provisional Patent Application No. 62 / 721,994, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," and · U.S. Provisional Patent Application No. 62 / 721,996, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS."
[0017] The applicant of this application owns the following U.S. patent applications, filed June 30, 2018, the disclosures of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 62 / 692,747, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE"; U.S. Provisional Patent Application No. 62 / 692,748, entitled "SMART ENERGY ARCHITECTURE," and · U.S. Provisional Patent Application No. 62 / 692,768, entitled "SMART ENERGY DEVICES."
[0018] 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. 16 / 024,090, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS"; U.S. Patent Application No. 16 / 024,057, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS"; U.S. Patent Application No. 16 / 024,067, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION"; · U.S. Patent Application No. 16 / 024,075, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING"; · U.S. Patent Application No. 16 / 024,083, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING"; · U.S. Patent Application No. 16 / 024,094, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES"; U.S. Patent Application No. 16 / 024,138, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE"; · U.S. Patent Application No. 16 / 024,150, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES"; · U.S. Patent Application No. 16 / 024,160, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY"; U.S. Patent Application No. 16 / 024,124, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE"; U.S. Patent Application No. 16 / 024,132, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT"; · U.S. Patent Application No. 16 / 024,141, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY"; U.S. Patent Application No. 16 / 024,162, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES"; · U.S. Patent Application No. 16 / 024,066, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL"; · U.S. Patent Application No. 16 / 024,096, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS"; · U.S. Patent Application No. 16 / 024,116, entitled "SURGICAL EVACUATION FLOW PATHS"; · U.S. Patent Application No. 16 / 024,149, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL"; · U.S. Patent Application No. 16 / 024,180, entitled "SURGICAL EVACUATION SENSING AND DISPLAY"; U.S. Patent Application No. 16 / 024,245, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Patent Application No. 16 / 024,258, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Patent Application No. 16 / 024,265, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE," and · U.S. Patent Application No. 16 / 024,273, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS"
[0019] 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 / 691,227, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS"; · 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."
[0020] 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."
[0021] The applicant of this application owns the following U.S. provisional patent applications, filed March 30, 2018, the disclosures of which are incorporated herein by reference in their entirety: U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS"; · U.S. Provisional Patent Application No. 62 / 650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES"; U.S. Provisional Patent Application No. 62 / 650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM," and · U.S. Provisional Patent Application No. 62 / 650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS."
[0022] 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." · 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." · 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."
[0023] The applicant of this application owns the following U.S. provisional patent applications, filed March 28, 2018, the disclosures 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."
[0024] The applicant of this application owns the following U.S. provisional patent applications, filed March 8, 2018, the disclosures of each 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."
[0025] The applicant of this application owns the following U.S. provisional patent applications, filed December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety: · U.S. Provisional Patent Application No. 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."
[0026] 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.
[0027] Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical devices can be configured, for example, to transect and / or coagulate tissue during a surgical procedure. Aspects of the electrosurgical devices can be configured, for example, to transect, coagulate, scale, weld, and / or desiccate tissue during a surgical procedure.
[0028] 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.
[0029] 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.
[0030] 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.
[0031] 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.
[0032] In various embodiments, 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.
[0033] 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.
[0034] 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.
[0035] 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.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] 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.
[0042] 2 , a surgical instrument 112 is used as part of a 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.
[0043] 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.
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] Aspects of the present disclosure present 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.
[0049] 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.
[0050] 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.
[0051] 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.
[0052] 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.
[0053] 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.
[0054] 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.
[0055] 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.
[0056] 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.
[0057] 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.
[0058] 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.
[0059] 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.
[0060] Additionally, to prevent inserting a module into a drawer with incompatible contacts, the contacts on a particular module may be keyed to engage with the contacts on a particular drawer.
[0061] 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.
[0062] 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.
[0063] 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.
[0064] 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.
[0065] 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.
[0066] 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.
[0067] 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.
[0068] 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," are each incorporated herein by reference in their entirety.
[0069] 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 of a medical facility, or any room within a medical facility equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204, which 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.
[0070] 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.
[0071] 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.
[0072] 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 the 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, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. The cloud computing service may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0073] 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.
[0074] 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.
[0075] 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.
[0076] The network hub 207 and / or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 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.
[0077] 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.
[0078] 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.
[0079] 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.
[0080] 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.
[0081] 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.
[0082] 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.
[0083] 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" of U.S. Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, 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.
[0084] 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.
[0085] Processor 244 may be any single-core or multi-core processor, such as those known by the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be 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) analog, 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.
[0086] 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.
[0087] 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).
[0088] 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.
[0089] 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.
[0090] 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; and webcams. 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.
[0091] 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, which is then physically connected via a communications connection. The network interface encompasses communications 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).
[0092] 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.
[0093] 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.
[0094] 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.
[0095] 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.
[0096] The USB network hub 300 device includes a serial interface engine (SIE) 310. The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in Chapter 8 of the USB Specification. The SIE 310 typically understands signaling down to the transaction level. Functions it handles may include packet recognition, transaction reordering, SOP, EOP, RESET, and RESUME signal detection / generation, clock / data separation, non-return-to-zero invert (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. 310 receives a clock input 314 and is coupled to a suspend / resume logic and frame timer 316 circuit and a hub repeater circuit 318 for controlling communication between the upstream USB transmit / receive port 302 and the downstream USB transmit / receive ports 304, 306, 308 via port logic circuits 320, 322, 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.
[0097] 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.
[0098] 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, operably couples a longitudinally movable displacement member to drive a clamp arm closure member. 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 can be programmed or configured to determine the position of the longitudinally movable drive member and the position of the closure member. Additional motors may be provided at the tool driver interface to control movement of the closure tube, shaft rotation, articulation, or clamp arm closure, or a combination thereof. A display 473 displays various operating conditions of the instrument and may include touchscreen functionality for data entry. Information displayed on the display 473 can be overlaid with images acquired via the endoscopic imaging module.
[0099] 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.
[0100] 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.
[0101] The microcontroller 461 may be programmed to perform various functions, such as precisely controlling the speed and position of the knife, articulation system, clamp arm, or a combination of the above. 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 available from Allegro Microsystems, Inc. Other motor drivers can 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.
[0102] The microcontroller 461 may be programmed to provide precise control over the velocity and position of the displacement members and articulation system. The microcontroller 461 may be configured to calculate a response within the microcontroller 461 software. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used to determine the actual feedback. The observed response is a suitably adjusted value that balances the smooth, continuous nature of the simulated response with the measured response, which can detect external influences on the system.
[0103] 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 another configuration, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including field-effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery, which may include multiple battery cells connected in series, that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and / or rechargeable battery cells. In at least one example, the battery cells may be lithium-ion batteries, which may be coupleable to and separable from the power supply assembly.
[0104] 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 above the N-channel MOSFET. 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.
[0105] The tracking system 480 includes controlled motor drive circuitry including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In another aspect, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinal displacement member for opening and closing a clamp arm, which may be adapted and configured to include a rack of drive teeth. In another aspect, the displacement member represents a clamp arm closure member configured to open and close a clamp arm of a stapler, ultrasonic, or electrosurgical device, or a combination of the above. Thus, as used herein, the term displacement member is used generally to refer to any movable member of a surgical instrument or tool, such as a drive member, a clamp arm, or any element that can be displaced. Thus, an absolute positioning system can, in effect, track the displacement of a clamp arm by tracking the linear displacement of a longitudinally movable drive member.
[0106] In other aspects, the absolute positioning system may be configured to track the position of the clamp arm during the opening and closing process. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, or the clamp arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor. The linear displacement sensor may include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), slide potentiometers, a magnetic sensing system with a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system with a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical detection system with a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical detection system with a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
[0107] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly mounted in meshing engagement with a set or rack of drive teeth on the displacement member. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to a certain 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 represents a longitudinally movable firing member that opens and closes the clamp arm.
[0108] 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 one revolution of the sensor element coupled to the displacement member. 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.
[0109] A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of the position sensor 472. The state of the switches is fed back to the microcontroller 461, which applies logic to calculate the longitudinal linear displacement d1+d2+...d of the displacement member. n 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.
[0110] 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.
[0111] In one aspect, the position sensor 472 of the tracking system 480 with an absolute positioning system comprises a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single-chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 472 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. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface, such as a serial peripheral interface (SPI) interface. The position sensor 472 provides 12-bit or 14-bit resolution. The position sensor 472 may be an AS5055 chip, which comes in a small QFN 16-pin 4x4x0.85mm package.
[0112] 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 a signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by position sensor 472, other 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.
[0113] 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.
[0114] Sensor 474, such as a strain gauge or micro-strain 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 additionally to sensor 474, a sensor 476, such as a load sensor, can measure the closure force applied by a closure drive system to the anvil in a stapler or clamp arm within an ultrasonic or electrosurgical instrument. For example, sensor 476, such as a load sensor, can measure the firing force applied to a closure member coupled to a clamp arm of a surgical instrument or tool, or the force applied by the clamp arm to tissue positioned within the jaws of an ultrasonic or electrosurgical instrument. Alternatively, a current sensor 478 can be used to measure the current draw by motor 482. The displacement member may also be configured to engage and open / close the clamp arm. A force sensor may be configured to measure the clamping force on the tissue. The force required to advance the displacement member can correspond to the current drawn by motor 482, for example. The measured force is converted to a digital signal and provided to processor 462 .
[0115] 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 clamping operation, which can indicate 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 manipulate a knife element, for example, to cut tissue captured between an anvil and a staple cartridge. The load sensor 476 can measure the force used to manipulate a clamp arm element, for example, to capture tissue between a clamp arm and an ultrasonic blade or between a clamp arm and the jaws of an electrosurgical instrument. The magnetic field sensor can be used to measure the thickness of the captured tissue. The magnetic field sensor measurements can also be converted to digital signals and provided to the processor 462.
[0116] 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.
[0117] 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.
[0118] FIG. 13 illustrates a control circuit 500 configured to control aspects of a surgical instrument or tool according to one embodiment of the present disclosure. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 can comprise a microcontroller 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 comprise volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present disclosure.
[0119] 14 illustrates a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 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.
[0120] FIG. 15 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool according to one embodiment of the present disclosure. The sequential logic circuit 520 or the combinatorial logic 522 can be configured to implement the various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, 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 the various processes described 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.
[0121] 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.
[0122] In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transfer the firing motion generated by the motor 602 to the end effector, specifically to displace a clamp arm closure member. The closure member may be retracted by reversing the direction of the motor 602, which also causes the clamp arm to open.
[0123] In certain examples, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operably 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 motor 603 may be operably 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 clamp arm and compress tissue between the clamp arm and either the ultrasonic blade or jaw member of the electrosurgical device. The closure motion may, for example, transition the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.
[0124] 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.
[0125] As described above, a surgical instrument or tool may include multiple motors that can be configured to perform various independent functions. In certain examples, the 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 or member, as described in more detail herein below.
[0126] 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.
[0127] 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.
[0128] 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.
[0129] 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 based on input from, for example, a microcontroller 620 ("controller"). In certain examples, as described above, for example, microcontroller 620 may be used to determine the current drawn by a motor while the motor is coupled to common control module 610.
[0130] 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. In various aspects, microcontroller 620 may communicate via wired or wireless channels, or a combination thereof.
[0131] 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.
[0132] 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. The processor 622 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. The processor operates on numbers and symbols represented in the binary system.
[0133] 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.
[0134] In certain examples, memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that are coupleable 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.
[0135] In certain examples, one or more mechanisms and / or sensors, such as, for example, sensor 630, can be used to alert processor 622 to program instructions to use in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closure, and articulation of the end effector. In certain examples, sensor 630 can include, 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 a closure member coupled to a clamp arm of the end effector when it detects, for example, via sensor 630, that switch 614 is in first position 616; processor 622 can use program instructions associated with closing 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 articulation of the end effector when it detects, for example, via sensor 630, that switch 614 is in third position 618a or fourth position 618b.
[0136] 17 is a circuit diagram of a robotic surgical instrument 700 configured to operate a surgical tool described herein, according to one embodiment of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of an obturator tube, shaft rotation, and articulation using either single or multiple articulation drive linkages. In one embodiment, the surgical instrument 700 may be programmed or configured to individually control a firing member, a closure member, a shaft member, or one or more articulating members, or a combination thereof. The surgical instrument 700 includes a control circuit 710 configured to control a motor-driven firing member, a closure member, a shaft member, or one or more articulating members, or a combination thereof.
[0137] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control a clamp arm 716 and closure member 714 portion of the end effector 702 via a plurality of motors 704a-704e, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721, a shaft 740, and one or more articulating members 742a, 742b. A position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. Another sensor 738 may be configured to provide feedback to the control circuit 710. A timer / counter 731 provides timing and counting information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e can be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.
[0138] In one aspect, the control circuitry 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor or processors to perform one or more tasks. In one aspect, the timer / counter 731 provides an output signal, such as an elapsed time or a digital count, to the control circuitry 710 to correlate the position of the closure member 714 determined by the position sensor 734 with the output of the timer / counter 731 so that the control circuitry 710 can determine the position of the closure member 714 at a particular time (t) relative to a starting position or time (t) when the closure member 714 is at a particular position relative to the starting position. The timer / counter 731 may be configured to measure elapsed time, count an external event, or time an external event.
[0139] 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 closing 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 closing control program may control the closing force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and articulating members 742a, 742b.
[0140] 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 directly generate the motor drive signals.
[0141] 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.
[0142] In one aspect, the motors 704a-704e can receive power from an energy source 712. The energy source 712 can be a DC power supply driven by a mains AC power supply, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e can be mechanically coupled to respective movable mechanical elements, such as the closure member 714, the clamp arm 716, the shaft 740, the joint 742a, and the joint 742b, via respective transmissions 706a-706e. The transmissions 706a-706e can include one or more gears or other linking components for coupling the motors 704a-704e to the movable mechanical elements. The position sensor 734 can sense the position of the closure member 714. The position sensor 734 can be or include any type of sensor capable of generating position data indicative of the position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuitry 710 as the closure member 714 translates distally and proximally. The control circuitry 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some 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 closure member 714 by summing the number and direction of steps the motor 704 is commanded to take. The position sensor 734 may be located within the end effector 702 or 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.
[0143] In one aspect, the control circuit 710 is configured to drive a firing member, such as the closure member 714 portion of the end effector 702. The control circuit 710 provides 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 closure member 714. The transmission 706a includes a moving mechanical element, such as a rotating element and a firing member, for controlling the movement of the closure member 714 distally and proximally along the longitudinal axis of the end effector 702. In one aspect, the motor 704a 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 closure member 714. The position sensor 734 may be configured to provide the position of the closure member 714 or the firing member along the firing stroke as a feedback signal to the control circuit 710. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor controller 708a. In response to the firing signal, the motor 704a can drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the closure member 714 translates distally, the clamp arm 716 closes against the ultrasonic blade 718.
[0144] In one aspect, the control circuit 710 is configured to drive a closure member, such as a clamp arm 716 of the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708b, which provides a drive signal to 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 clamp arm 716. The transmission 706b includes a movable mechanical element, such as a rotating element and a closure member, for controlling movement of the clamp arm 716 from open and closed positions. In one aspect, the motor 704b is coupled to a closure gear assembly including a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closure force feedback signal to the control circuit 710. The closure force feedback signal is indicative of the closure force applied to the clamp arm 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 can provide a closure force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control 708b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.
[0145] In one aspect, the control circuit 710 is configured to rotate a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor setpoint to a motor controller 708c, which provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c, which is coupled to the shaft 740. The transmission 706c comprises a movable mechanical element, such as a rotating element, to control the rotation of the shaft 740 up to and beyond 360 degrees clockwise or counterclockwise. 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 to be operably engaged by 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 is indicative of the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotational position of the shaft 740 to the control circuit 710.
[0146] In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708d, which provides a drive signal to the motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 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 .
[0147] 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.
[0148] 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.
[0149] In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as an AS5055EQFT single-chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 734 may interface with the control circuit 710 to provide the absolute positioning system. 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 the Boulder algorithm, which implements simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.
[0150] 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 clamp arm 716 to determine the position of the tissue using split electrodes. The torque sensors 744a-744e may be configured to sense forces, such as firing force, closure force, and / or articulation force, among others. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member in the rack and its position, (3) which portion of the ultrasonic blade 718 has tissue on it, and (4) the load and position on both articulation rods.
[0151] In one aspect, the one or more sensors 738 may comprise strain gauges, such as micro-strain gauges, configured to measure the magnitude of strain in the clamp arm 716 during clamping. The strain gauges provide an electrical signal whose amplitude varies with the magnitude of strain. The sensors 738 may comprise pressure sensors configured to detect pressure created by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718. The sensors 738 may be configured to detect the impedance of the tissue portion located between the clamp arm 716 and the ultrasonic blade 718, which impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0152] In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magneto-resistive (MR) devices, giant magneto-resistive (GMR) devices, magnetometers, among others. In other implementations, the 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.
[0153] In one aspect, the sensor 738 may be configured to measure the force exerted by the closure drive system on the clamp arm 716. For example, one or more sensors 738 may be located at the interaction point between a closure tube and the clamp arm 716 to detect the closure force applied to the clamp arm 716 by the closure tube. The force exerted on the clamp arm 716 may be representative of tissue compression experienced by a tissue section captured between the clamp arm 716 and the ultrasonic blade 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closure force applied to the clamp arm 716 by the closure drive system. The one or more sensors 738 may be sampled in real time during clamping operation by a processor in the control circuit 710. The control circuit 710 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force applied to the clamp arm 716 in real time.
[0154] In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted to a digital signal and provided to the control circuit 710. The control circuit 710 can be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the closure member 714 in the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be any one of any feedback controllers, including, but not limited to, a PID, 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.
[0155] 18 shows a circuit diagram of a surgical instrument 750 configured to control the distal translation of a displacement member, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 750 is programmed to control the distal translation of a displacement member, such as a closure member 764. The surgical instrument 750 includes an end effector 752, which may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
[0156] The position, movement, displacement, and / or translation of a linear displacement member, such as closure member 764, can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Because closure member 764 is coupled to a longitudinally movable drive member, the position of closure member 764 can be determined by measuring the position of the longitudinally movable drive member using position sensor 784. Accordingly, in the following description, the position, displacement, and / or translation of closure member 764 can be achieved by position sensor 784 as described herein. Control circuitry 760 may be programmed to control the translation of a displacement member, such as closure member 764. In some embodiments, control circuitry 760 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to control a displacement member, such as closure member 764, in the manner described. In one aspect, the timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuitry 760 to correlate the position of the closure member 764 determined by the position sensor 784 with the output of the timer / counter 781 so that the control circuitry 760 can determine the position of the closure member 764 at a particular time (t) relative to a starting position. The timer / counter 781 may be configured to measure elapsed time, count an external event, or time an external event.
[0157] 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.
[0158] The motor 754 may receive power from an energy source 762. The energy source 762 may be or may include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closure member 764 via a transmission 756. The transmission 756 may include one or more gears or other linking components to couple the motor 754 to the closure member 764. The position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuitry 760 as the closure member 764 translates distally and proximally. The control circuitry 760 may track the pulses to determine the position of the closure member 764. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the closure member 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuitry 760 may track the position of the closure member 764 by summing the number and direction of steps that the motor 754 is commanded to take. The position sensor 784 may be located in the end effector 752 or in any other portion of the instrument.
[0159] 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.
[0160] The one or more sensors 788 may comprise strain gauges, such as micro-strain gauges, configured to measure the magnitude of strain in the clamp arm 766 during clamping. The strain gauges provide an electrical signal whose amplitude varies with the magnitude of strain. The sensors 788 may comprise pressure sensors configured to detect pressure created by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensors 788 may be configured to detect the impedance of a tissue section located between the clamp arm 766 and the ultrasonic blade 768, which impedance indicates the thickness and / or fullness of the tissue located therebetween.
[0161] The sensor 788 may be configured to measure the force exerted on the clamp arm 766 by the closure drive system. For example, one or more sensors 788 may be located at the interaction point between the closure tube and the clamp arm 766 to detect the closure force applied to the clamp arm 766 by the closure tube. The force exerted on the clamp arm 766 may be representative of tissue compression experienced by a tissue section captured between the clamp arm 766 and the ultrasonic blade 768. 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 clamp arm 766 by the closure drive system. The one or more sensors 788 may be sampled in real time during clamping operation by a processor in the control circuit 760. The control circuit 760 receives the real-time sampled measurements to provide and analyze time-based information to assess the closure force applied to the clamp arm 766 in real time.
[0162] A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the closure member 764 corresponds to the current drawn by the motor 754. The force is converted to a digital signal and provided to the control circuit 760.
[0163] The control circuitry 760 can be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the closure member 764 in the end effector 752 at or near a target velocity. The surgical instrument 750 can include a feedback controller, which can be any one of any feedback controller, 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.
[0164] The actual drive system of the surgical instrument 750 is configured to drive the displacement member, cutting member, or closure member 764 via a brushed DC motor with a gearbox and mechanical linkage to the articulation and / or knife system. Another example is an electric motor 754 operating, for example, a displacement member and articulation driver of an interchangeable shaft assembly. External influences are the unmeasured and unpredictable effects of things like tissue, surroundings, and friction on a physical system. These external influences can be 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.
[0165] Various exemplary embodiments relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, a motor 754 may drive a displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 positioned opposite the clamp arm 766. A clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When the instrument 750 is ready to be used, the clinician may provide a firing signal, for example, by pressing a trigger on the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the displacement member translates distally, the closure member 764 with a cutting element positioned at its distal end can cut tissue between the ultrasonic blade 768 and the clamp arm 766 .
[0166] In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as the closure member 764, based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on the tissue condition. The control program may dictate the distal movement of the displacement member. Different control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and / or with lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or with higher power.
[0167] 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 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 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.
[0168] 19 is a circuit diagram of a surgical instrument 790 configured to control various functions, according to one embodiment of the present disclosure. In one embodiment, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as a closure member 764. The surgical instrument 790 includes an end effector 792 that may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 that may replace or operate in conjunction with one or more RF electrodes 796 (shown in dashed lines). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 that is driven by an ultrasonic generator 771.
[0169] 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.
[0170] 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 may interface with control circuit 760 to provide an absolute positioning system. 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 is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.
[0171] In some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuit 760 can track the position of the closure member 764 by summing the number and direction of steps the motor is commanded to take. The position sensor 784 can be located in the end effector 792 or in any other portion of the instrument.
[0172] 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 in conjunction 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.
[0173] An RF energy source 794 is coupled to the end effector 792 and is applied to the RF electrode 796 when the RF electrode 796 is provided within the end effector 792 in place of the ultrasonic blade 768 or when the RF electrode 796 is provided to operate in conjunction with the ultrasonic blade 768. For example, the ultrasonic blade may be made of a conductive metal and used as a return path for the electrosurgical RF current. A control circuit 760 controls the delivery of RF energy to the RF electrode 796.
[0174] 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.
[0175] Generator Hardware Adaptive ultrasonic blade control algorithm In various aspects, the smart ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize the tissue type. Algorithms for detecting the collagen / elasticity ratio of tissue to adjust the amplitude of the distal tip of the ultrasonic blade are described in subsequent sections of this disclosure. Various aspects of smart ultrasonic energy devices are described herein, for example, with reference to FIGS. 1-85. Thus, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with FIGS. 1-85 and their associated descriptions.
[0176] Identifying tissue types and adjusting device parameters In certain surgical procedures, it may be desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust ultrasonic device parameters based on the type of tissue in contact with the ultrasonic blade. In one aspect, ultrasonic device parameters may be adjusted based on the location of the tissue within the jaws of the ultrasonic end effector, for example, the location of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasonic transducer may be used to identify which percentage of tissue is located at the distal or proximal end of the end effector. The response of the ultrasonic device may be based on the tissue type or tissue compressibility. In another aspect, ultrasonic device parameters may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be adjusted based on the ration of collagen to elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue may be detected using various techniques, including infrared (IR) surface reflectance and elastance. The force applied to the tissue by the clamp arm and / or clamp arm stroke to create gap and compression. Electrical continuity across the jaw with the electrodes can be used to determine what percentage of the jaw is covered with tissue.
[0177] 20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communications hub, according to at least one embodiment of the present disclosure. In one embodiment, the generator module 240 is configured to execute the adaptive ultrasonic blade control algorithm(s) 802 described herein with reference to FIGS. 43A-54. In another embodiment, the device / instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 described herein with reference to FIGS. 43A-54. In another embodiment, both the device / instrument 235 and the device / instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 described herein with reference to FIGS. 43A-54.
[0178] The generator module 240 may include a patient-isolated stage that communicates with a non-isolated stage via a power transformer. The secondary winding of the power transformer is housed within the isolated stage and may include a tap configuration (e.g., center-tapped or non-center-tapped) to define a drive signal output for delivering drive signals to various surgical instruments, such as ultrasonic surgical instruments, RF electrosurgical instruments, and multifunction surgical instruments including ultrasonic and RF energy modes that can be delivered singly or simultaneously. Specifically, the drive signal output can output an ultrasonic drive signal (e.g., a 420 V root-mean-square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output can output an RF electrosurgical drive signal (e.g., a 100 V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to FIGS. 21-28B.
[0179] The generator module 240, or the device / instrument 235, or both, are coupled to a modular control tower 236, e.g., as described with reference to Figures 8-11, which is connected to a plurality of operating room devices, such as intelligent surgical instruments, robots, and other computerized devices located in the operating room.
[0180] FIG. 21 illustrates an example of a generator 900, a form of generator configured to couple with an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network comprising the modular communications hub shown in FIG. 20 . The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, for delivering energy to the surgical instrument. The RF and ultrasonic signals may be provided alone, in combination, or simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be delivered individually or simultaneously to an end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory (not shown for clarity of disclosure) coupled to the processor 902. Digital information related to the waveforms is provided to the waveform generator 904, which includes one or more DAC circuits for converting the digital input to an analog output. The analog output is provided to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled across the power transformer 908 to a secondary side on the patient-isolated side. A first signal of a first energy modality is provided between terminals labeled ENERGY1 and RETURN on the surgical instrument. A second signal of a second energy modality is coupled across a capacitor 910 and provided between terminals labeled ENERGY2 and RETURN on the surgical instrument. More than two energy modalities may be output, thus the subscript "n" refers to up to n ENERGY nIt will be understood that n is a positive integer greater than 1. A maximum of "n" return paths (RETURN n ) may be provided without departing from the scope of the present disclosure.
[0181] A first voltage sense circuit 912 is coupled across the terminals labeled ENERGY1 and RETURN paths and measures the output voltage therebetween. A second voltage sense circuit 924 is coupled across the terminals labeled ENERGY2 and RETURN paths and measures the output voltage therebetween. A current sense circuit 914 is disposed in series with the RETURN section of the secondary side of the illustrated power transformer 908 to measure the output current of either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit must be provided in each return section. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to corresponding isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side (non-patient-isolated side) of the power transformer 908 are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculations. Feedback information of the output voltage and output current can be used to adjust the output voltage and current provided to the surgical instrument and to calculate output impedance, among other parameters. Input / output communication between the processor 902 and the patient-isolated circuitry is provided through an interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.
[0182] In one aspect, the impedance may be determined by the processor 902 by dividing the output of either a first voltage sense circuit 912 coupled across the terminals labeled ENERGY1 / RETURN or a second voltage sense circuit 924 coupled across the terminals labeled ENERGY2 / RETURN by the output of a current sense circuit 914 placed in series with the RETURN section of the secondary side of the power transformer 908. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 916. Digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 to calculate the impedance. As an example, the first energy modality ENERGY1 may be ultrasound energy and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to ultrasound energy modalities and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. Also, while the example illustrated in FIG. 21 shows that a single return path (RETURN) may be provided for two or more energy modalities, in other embodiments, multiple return paths (RETURN) may be provided. n However, each energy modality n Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the impedance of the tissue may be measured by dividing the output of the second voltage sensing circuit 924 by the current sensing circuit 914.
[0183] As shown in FIG. 21 , a generator 900 including at least one output port may include a power transformer 908 with a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities, such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy at high voltage and low current to drive an ultrasonic transducer, at low voltage and high current to drive an RF electrode for tissue sealing, or in a coagulation waveform for spot coagulation, using either monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be steered, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the generator 900 output would preferably be located between the output labeled ENERGY1 and RETURN, as shown in FIG. 21 . In one embodiment, the connection to the output of the RF bipolar electrode generator 900 would preferably be located between the output labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be the active electrode (e.g., a pencil or other probe) to a suitable return pad connected to the ENERGY2 and RETURN outputs.
[0184] Further details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published March 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety.
[0185] As used throughout this description, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that may communicate data through the use of modulated electromagnetic radiation over a non-solid medium. This term does not imply that the associated devices do not include any wires, although in some aspects they may not be present. A communication module may implement any of a number of wireless or wired communication standards or protocols, including, but not limited to, Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and beyond. A computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.
[0186] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually memory or some other data stream. The term is used herein to refer to a system that combines many dedicated "processors" or the central processor (central processing unit) within a computer system (especially a system on a chip (SoC)).
[0187] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also known as an "integrated circuit, IC" or "chip") that integrates all the components of a computer or other electronic system. It can include digital, analog, mixed-signal, and often high-frequency functions, all on a single substrate. An SoC integrates a microcontroller (or microprocessor) with modern peripherals such as a graphics processing unit (GPU), Wi-Fi module, or coprocessor. An SoC may or may not include built-in memory.
[0188] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to an SoC, which may include a microcontroller as one of its components. A microcontroller can house one or more core processing units (CPUs) along with memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM, and a small amount of RAM are also often included on the chip. Microcontrollers may be employed for embedded applications, as opposed to microprocessors used in personal computers or other general-purpose applications, which are composed of various individual chips.
[0189] As used herein, the term controller or microcontroller may be a standalone IC or chip device that interfaces with a peripheral device, or it may be the link between two parts: a computer or controller on an external device that manages the operation of (and connections with) that device.
[0190] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor may be 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), 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.
[0191] In one aspect, the processor 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.
[0192] 0282 Modular devices include modules (e.g., as described in connection with FIGS. 3 and 9 ) that are receivable within a surgical hub, and surgical devices or instruments that can be connected to various modules to connect or pair with corresponding surgical hubs. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, aspirators, and displays. The modular devices described herein can be controlled by control algorithms. The control algorithms can execute on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the modular device's control algorithm controls the device based on data sensed by the modular device itself (i.e., by sensors within, on, or connected to the modular device). This data can relate to the patient during surgery (e.g., tissue characteristics or infusion pressure) or the modular device itself (e.g., advancing knife speed, motor current, or energy level). For example, a control algorithm for a surgical stapling and severing instrument may control the speed at which the instrument's motor drives the knife through tissue based on the resistance the knife encounters as it advances.
[0193] 0283 22 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunction surgical instrument 1108 is a combination ultrasonic / RF electrosurgical instrument. The generator 1100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1100 may be configurable for use with a variety of different surgical devices, including, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instrument 1106, and the multifunction surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108; however, in one form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. The input device 1110 may include any suitable device for generating signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.
[0194] The generator 1100 is configured to drive multiple surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104, which includes a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 acoustically coupled to the ultrasonic transducer 1120 and a clamp arm 1140. The handpiece 1105 includes a trigger 1143 for actuating the clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c for energizing and actuating the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, 1134c can be configured to energize the ultrasonic transducer 1120 using the generator 1100.
[0195] The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in clamp arms 1142 a, 1142 b and return through a conductor portion of the shaft 1127. The electrodes are coupled to and energized by a bipolar energy source within the generator 1100. The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1142 a, 1142 b and an energy button 1135 for actuating an energy switch to energize the electrodes in the end effector 1124.
[0196] The generator 1100 is also configured to drive a multifunction surgical instrument 1108. The multifunction surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to an ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 that operates the clamp arm 1146 and a combination of toggle buttons 1137a, 1137b, and 1137c for energizing and driving the ultrasonic blade 1149 or other functions. The toggle buttons 1137a, 1137b, and 1137c can be configured to energize the ultrasonic transducer 1120 using the generator 1100 and also energize the ultrasonic blade 1149 using a bipolar energy source housed within the generator 1100.
[0197] The generator 1100 is configurable for use with a variety of surgical instruments. According to various configurations, the generator 1100 may be configurable for use with a variety of different surgical devices, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunction surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. In the configuration of FIG. 22 , the generator 1100 is shown separate from the surgical instruments 1104, 1106, and 1108; however, in other configurations, the generator 1100 may be integrally formed with any one of the surgical instruments 1104, 1106, and 1108 to form an integrated surgical system. As mentioned above, the generator 1100 includes an input device 1110 located on the front panel of the console of the generator 1100. The input device 1110 may comprise any suitable device that generates signals suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Further aspects of generators for digitally generating electrical signal waveforms and surgical instruments are described in U.S. Patent Application Publication No. 2017-0086914-A1, which is incorporated herein by reference in its entirety.
[0198] FIG. 23 illustrates an end effector 1122 of an exemplary ultrasonic device 1104, according to at least one embodiment of the present disclosure. The end effector 1122 may include a blade 1128 that may be coupled to an ultrasonic transducer 1120 via a waveguide. As described herein, the blade 1128 may vibrate when driven by the ultrasonic transducer 1120 and, upon contact with tissue, may cut and / or coagulate the tissue. According to various embodiments, and as illustrated in FIG. 23 , the end effector 1122 may further include a clamp arm 1140 that may be configured to cooperate with the blade 1128 of the end effector 1122. Together with the blade 1128, the clamp arm 1140 may include a series of jaws. The clamp arm 1140 may be pivotally connected to a distal end of the shaft 1126 of the instrument portion 1104. The clamp arm 1140 may include a clamp arm tissue pad 1163 that may be formed from TEFLON® or other suitable low-friction material. The pad 1163 is mounted to cooperate with the blade 1128 so that pivotal movement of the clamp arm 1140 can position the clamp pad 1163 in a substantially parallel relationship with and in contact with the blade 1128. With this configuration, a piece of clamped tissue can be grasped between the tissue pad 1163 and the blade 1128. The tissue pad 1163 may include a sawtooth-like configuration including a plurality of axially spaced, proximally extending grasping teeth 1161 to cooperate with the blade 1128 to improve the grip of the tissue. The clamp arm 1140 can transition from the open position shown in FIG. 23 to a closed position (where the clamp arm 1140 contacts or is proximate to the blade 1128) in any suitable manner. For example, the handpiece 1105 can include a jaw closure trigger. When actuated by the clinician, the jaw closure trigger can pivot the clamp arm 1140 in any suitable manner.
[0199] The generator 1100 may be activated to provide a drive signal to the ultrasonic transducer 1120 in any suitable manner. For example, the generator 1100 may include a footswitch 1430 ( FIG. 24 ) coupled to the generator 1100 via a footswitch cable 1432. A clinician may activate the ultrasonic transducer 1120, and thereby the ultrasonic transducer 1120 and blade 1128, by depressing the footswitch 1430. In addition to or instead of the footswitch 1430, some embodiments of the device 1104 may use one or more switches positioned on the handpiece 1105 that, when activated, can cause the generator 1100 to operate the ultrasonic transducer 1120. In one embodiment, for example, the one or more switches may include a pair of toggle buttons 1134 a, 1134 b, 1134 c ( FIG. 22 ), for example, to determine the operating mode of the device 1104. For example, when toggle button 1134a is depressed, the ultrasonic generator 1100 provides a maximum drive signal to the ultrasonic transducer 1120, causing the ultrasonic transducer 1120 to generate a maximum ultrasonic energy output. Pressing toggle button 1134b causes the ultrasonic generator 1100 to provide a user-selectable drive signal to the ultrasonic transducer 1120, causing the ultrasonic transducer 1120 to generate a less-than-maximum ultrasonic energy output. The device 1104 may additionally or alternatively include a second switch to indicate the position of a jaw closure trigger, for example, to operate the jaws via the clamp arm 1140 of the end effector 1122. Also, in some aspects, the ultrasonic generator 1100 can be activated based on the position of the jaw closure trigger (e.g., ultrasonic energy can be applied when a clinician depresses the jaw closure trigger to close the jaws via the clamp arm 1140).
[0200] Additionally or alternatively, one or more switches may include a toggle button 1134c that, when depressed, causes the generator 1100 to provide a pulsed output (FIG. 22). The pulses may be provided, for example, at any suitable frequency and frequency. In certain aspects, the power level of the pulses may be, for example, a power level (maximum, less than maximum) associated with the toggle buttons 1134a, 1134b.
[0201] It will be appreciated that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c (FIG. 22). For example, the device 1104 may be configured with only two toggle buttons: toggle button 1134a for generating maximum ultrasonic energy output, and toggle button 1134c for generating pulsed outputs at either maximum or less-than-maximum power levels, one at a time. In this manner, the drive signal output configuration of the generator 1100 may be five consecutive signals, or any discrete number of individual pulse signals (1, 2, 3, 4, or 5). In certain aspects, the particular drive signal configuration may be controlled based on, for example, the EEPROM settings of the generator 1100 and / or the user's power level selection(s).
[0202] In certain embodiments, a two-position switch may be provided as an alternative to toggle button 1134c (FIG. 22). For example, device 1104 may include toggle button 1134a for generating a continuous output at a maximum power level and two-position toggle button 1134b. In a first detent position, toggle button 1134b may generate a continuous output at less than the maximum power level, and in a second detent position, toggle button 1134b may generate a pulsed output (e.g., at either the maximum or less than maximum power level, depending on EEPROM settings).
[0203] In some embodiments, the RF electrosurgical end effectors 1124, 1125 (FIG. 22) may also include a pair of electrodes. The electrodes may be in communication with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of a tissue fragment present between the clamp arms 1142a, 1146 and the blades 1142b, 1149. The generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. The impedance of the tissue fragment may be found, for example, by monitoring the signal's current, voltage, etc.
[0204] In various aspects, the generator 1100 may comprise several separate functional elements, such as the modules and / or blocks shown in FIG. 24, which is a schematic illustration of the surgical system 1000 of FIG. 22. The various functional elements or modules may be configured to drive various types of surgical devices 1104, 1106, 1108. For example, an ultrasonic generator module may drive an ultrasonic device, such as the ultrasonic device 1104. An electrosurgical / RF generator module may drive the electrosurgical device 1106. The modules may generate corresponding drive signals to drive the surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and / or the electrosurgical / RF generator module may each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (The modules are shown in phantom to illustrate this option.) Also, in some embodiments, the electrosurgical / RF generator module may be integrally formed with the ultrasonic generator module, or vice versa.
[0205] According to the described embodiment, the ultrasonic generator module may generate a drive signal or signals at a specific voltage, current, and frequency (e.g., 55,500 cycles per second, or Hz). The drive signal or signals may be provided to the ultrasonic device 1104, and in particular to the transducer 1120, which may operate, for example, as described above. In one embodiment, the generator 1100 may be configured to generate drive signals of specific voltage, current, and / or frequency output signals that may be stepped with high resolution, precision, and repeatability.
[0206] According to the described embodiment, the electrosurgical / RF generator module can use radio frequency (RF) energy to generate a drive signal or multiple drive signals at an output power sufficient to perform a bipolar electrosurgical procedure. In a bipolar electrosurgical application, for example, the drive signal may be provided to, for example, the electrodes of the electrosurgical device 1106, as described above. Thus, the generator 1100 can be configured for therapeutic purposes by applying electrical energy to tissue sufficient to treat the tissue (e.g., coagulation, cauterization, tissue welding, etc.).
[0207] The generator 1100 can include an input device 2150 (FIG. 27B) located, for example, on a front panel of the console of the generator 1100. The input device 2150 can include any suitable device that generates signals suitable for programming the operation of the generator 1100. During operation, a user can program or otherwise control the operation of the generator 1100 using the input device 2150. The input device 2150 can include any suitable device that generates signals that can be used by the generator (e.g., by one or more processors housed within the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasonic generator module and / or the electrosurgical / RF generator module). In various embodiments, the input device 2150 includes one or more of a button, a switch, a thumbwheel, a keyboard, a keypad, a touchscreen monitor, a pointing device, or a remote connection to a general-purpose or dedicated computer. In other aspects, the input device 2150 may include a suitable user interface, such as, for example, one or more user interface screens displayed on a touchscreen monitor. The input device 2150 thus enables a user to set or program various operating parameters of the generator, such as, for example, the current (I), voltage (V), frequency (f), and / or duration (T) of the drive signal or signals generated by the ultrasonic generator module and / or the electrosurgical / RF generator module.
[0208] The generator 1100 may also include output devices 2140 (FIG. 27B), located, for example, on the front panel of the generator 1100 console. The output devices 2140 include one or more devices for providing sensory feedback to the user. Such devices may include, for example, visual feedback devices (e.g., LCD display screen, LED indicators), audible feedback devices (e.g., speaker, buzzer), or tactile feedback devices (e.g., haptic actuators).
[0209] While particular modules and / or blocks of generator 1100 may be described as examples, it will be understood that a greater or lesser number of modules and / or blocks may be used and still fall within the scope of the aspects. Furthermore, while various aspects may be described in terms of modules and / or blocks for ease of explanation, such modules and / or blocks may be implemented by one or more hardware components, e.g., processors, digital signal processors (DSPs), programmable logic devices (PLDs), application specific integrated circuits (ASICs), circuits, registers, and / or software components, e.g., programs, subroutines, logic, and / or combinations of hardware and software components.
[0210] In one aspect, the ultrasonic generator drive module and electrosurgical / RF drive module 1110 (FIG. 22) may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), etc. The firmware may be stored in bit-masked read-only memory (ROM) or nonvolatile memory (NVM) such as flash memory. In various implementations, storing the firmware in ROM may preserve flash memory. The NVM may include other types of memory, including, for example, programmable ROM (PROM), erasable programmable ROM (EPROM), electrically erasable programmable ROM (EEPROM), or battery-backed random access memory (RAM) such as dynamic RAM (DRAM), double data rate DRAM (DDRAM), and / or synchronous DRAM (SDRAM).
[0211] In one aspect, the module includes hardware components embodied as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1104, 1106, 1108 and generating a corresponding output drive signal or signals for operating the devices 1104, 1106, 1108. In aspects where the generator 1100 is used with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in a cutting and / or coagulation mode of operation. The electrical characteristics of the device 1104 and / or tissue may be measured and used to control aspects of operation of the generator 1100 and / or provided as feedback to the user. In aspects where the generator 1100 is used with the device 1106, the drive signal may supply electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation, and / or desiccation mode. The electrical characteristics of the device 1106 and / or tissue may be measured and used to control aspects of operation of the generator 1100 and / or provided as feedback to the user. In various aspects, the hardware components may be implemented as DSPs, PLDs, ASICs, circuits, and / or registers, as described above. In one aspect, the processor may be configured to store and execute computer software program instructions to generate step function output signals for driving various components of the devices 1104, 1106, 1108, such as the ultrasonic transducer 1120 and end effectors 1122, 1124, 1125.
[0212] The electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic blade. The electromechanical ultrasonic system has an initial resonant frequency defined by the physical properties of the ultrasonic transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is driven by an AC voltage V equal to the resonant frequency of the electromechanical ultrasonic system. g (t) and current I g (t) signal. When the electromechanical ultrasonic system resonates, the voltage V g (t) Signal and current I gThe phase difference between the (t) signal and the (t) signal is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, the compliance of the ultrasonic blade (modeled as an equivalent capacitance) changes the resonant frequency of the electromechanical ultrasonic system. Therefore, the inductive impedance is no longer equal to the capacitive impedance, which causes a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasonic system. The system is now operating "off-resonance." The mismatch between the drive frequency and the resonant frequency is due to the voltage V applied to the ultrasonic transducer. g (t) Signal and current I g (t) appears as a phase difference between the signal and the generator electronics. g (t) Signal and current I g The phase difference between the (t) signal can be easily monitored, and the drive frequency can be continuously adjusted until the phase difference is again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. The change in phase and / or frequency can be used as an indirect measure of the ultrasonic blade temperature.
[0213] As shown in Figure 25, the electromechanical characteristics of an ultrasonic transducer may be modeled as an equivalent circuit including a first branch with capacitance and a second "operational" branch with series-connected inductance, resistance, and capacitance that define the electromechanical characteristics of the resonator. Known ultrasonic generators may include a tuning inductor to tune out the capacitance at a certain resonant frequency so that substantially all of the generator drive signal current flows in the operational branch. Thus, by using the tuning inductor, the generator's drive signal current represents the operational branch current, and the generator can therefore control its drive signal to maintain the ultrasonic transducer's resonant frequency. The tuning inductor can also transform the ultrasonic transducer's phase impedance plot to improve the generator's frequency locking capability. However, the tuning inductor must be matched to the specific capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different capacitances require different tuning inductors.
[0214] 25 illustrates an equivalent circuit 1500 of an ultrasonic transducer, such as ultrasonic transducer 1120, according to one embodiment. Circuit 1500 includes a series-connected inductance L that defines the electromechanical properties of the resonator. s , resistance R s , and capacitance C s and a second capacitive branch with capacitance C0. The operating current I m (t) flows through the first branch, and the current I g (t)~I m With (t) flowing through the capacitive branch, the drive current I g (t) is the driving voltage V g (t) may be received. The control of the electromechanical properties of the ultrasonic transducer may be performed by I g (t) and V g This may be achieved by suitably controlling the current output I of the generator. ga tuning inductor L for tuning out the capacitance C0 at the resonant frequency in a parallel resonant circuit so that substantially all of (t) flows through the operating branch; t (shown in phantom in FIG. 25). In this way, the motional branch current I m The control of (t) is the generator current output I g This is achieved by controlling the regulating inductor L t is specific to the static capacitance C0 of the ultrasonic transducer, but different ultrasonic transducers with different static capacitances will require different tuning inductors L t In addition, the adjustment inductor L t coincides with the nominal value of the capacitance C0 at a single resonant frequency, so that the operating branch current I m Accurate control of (t) is only guaranteed at that frequency. If the frequency decreases due to converter temperature, accurate control of the working branch current is lost.
[0215] Various aspects of the generator 1100 include a tuning inductor L t Operating without relying on branch current I m Rather, the generator 1100 may monitor the operating branch current I(t) on a dynamic and ongoing basis (e.g., in real time). m Measurements of capacitance C0 during application of power for a particular ultrasonic surgical device 1104 may be used (along with drive signal voltage and current feedback data) to determine the value of (t). Thus, such aspects of the generator 1100 can provide virtual tuning to simulate a system tuned or resonating with any value of capacitance C0 at any frequency, rather than only at a single resonant frequency determined by a nominal value of capacitance C0.
[0216] FIG. 26 is a simplified block diagram of one embodiment of a generator 1100 for providing, among other advantages, the inductorless regulation described above. FIGS. 27A-27C illustrate the architecture of the generator 1100 of FIG. 26 according to one embodiment. Referring to FIG. 26, the generator 1100 may include a patient-isolated stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is included in the isolated stage 1520 and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to various surgical devices, such as the ultrasonic surgical device 1104 and the electrosurgical device 1106. In particular, drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to ultrasonic surgical device 1104, and drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to electrosurgical device 1106, where output 1600b corresponds to the center tap of power transformer 1560. Non-isolated stage 1540 may include a power amplifier 1620 having an output connected to primary winding 1640 of power transformer 1560. In certain embodiments, power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may further include a programmable logic 1660 for providing a digital output to a digital-to-analog converter (DAC) 1680, which in turn provides a corresponding analog signal to the input of the power amplifier 1620. In certain embodiments, the programmable logic 1660 may include, for example, a field-programmable gate array (FPGA). The programmable logic 1660 may control the input of the power amplifier 1620 via the DAC 1680, thereby controlling any of a number of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signals appearing at the drive signal outputs 1600a, 1600b, 1600c.In certain embodiments, and as described below, the programmable logic 1660, in conjunction with a processor (e.g., processor 1740, described below), can execute a number of digital signal processing (DSP)-based and / or other control algorithms to control parameters of the drive signal output by the generator 1100.
[0217] Power can be supplied to the bus of the power amplifier 1620 by a switch-mode regulator 1700. In particular aspects, the switch-mode regulator 1700 can include, for example, an adjustable buck regulator. As mentioned above, the non-isolated stage 1540 can further include a processor 1740, which in one aspect can include, for example, a DSP processor such as an ADSP-21469 SHARC DSP available from Analog Devices (Norwood, Mass.). In particular aspects, the processor 1740 can control the operation of the switch-mode power converter 1700 in response to voltage feedback data that the processor 1740 receives from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. For example, in one aspect, the processor 1740 can receive as an input via the ADC 1760 the waveform envelope of a signal (e.g., an RF signal) being amplified by the power amplifier 1620. The processor 1740 can then control the switch-mode regulator 1700 (e.g., via a pulse-width modulated (PWM) output) so that the rail voltages supplied to the power amplifier 1620 track the waveform envelope of the amplified signal. By dynamically modulating the rail voltages of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved compared to fixed rail voltage amplifier schemes. The processor 1740 may be configured for wired or wireless communication.
[0218] In certain aspects, and as described in further detail in connection with FIGS. 28A-28B , the programmable logic 1660, in conjunction with the processor 1740, may implement a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency, and / or amplitude of the drive signal output by the generator 1100. In one aspect, for example, the programmable logic 1660 may execute a DDS control algorithm 2680 ( FIG. 28A ) by recalling waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT, which may be embedded in an FPGA. This control algorithm is particularly useful in ultrasound applications where an ultrasonic transducer, such as the ultrasonic transducer 1120, may be driven by a well-defined sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the overall distortion of the operating branch current can correspondingly minimize or reduce undesirable resonant effects. Because the waveform shape of the drive signal output by generator 1100 can be affected by various distortion sources present in the output drive circuitry (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal can be input to an algorithm, such as an error control algorithm executed by processor 1740, which compensates for the distortion by appropriately pre-distorting or modifying the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated motional branch current and the desired current waveform shape, the error being determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuitry, can produce a motional branch drive signal having a desired waveform shape (e.g., a sinusoidal wave) to optimally drive the ultrasonic transducer. Thus, in such an aspect, the LUT waveform samples represent not the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately produce the motional branch drive signal of the desired waveform, taking distortion effects into account.
[0219] The non-isolated stage 1540 may further include an ADC 1780 and an ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for sampling the voltage and current, respectively, of the drive signal output by the generator 1100. In certain aspects, the ADCs 1780, 1800 may be configured to sample at a high speed (e.g., 80 Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling rate of the ADCs 1780, 1800 may enable oversampling of the drive signal by approximately 200 times (depending on the drive frequency). In certain aspects, the sampling operation of the ADCs 1780, 1800 may be performed by a single ADC that receives the input voltage and current signals via a bidirectional multiplexer. The use of high-speed sampling in embodiments of generator 1100 can enable, among other things, calculation of complex currents flowing in the motional branch (which may be used in certain embodiments to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and highly accurate calculation of actual power consumption. The voltage and current feedback data output by ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering, multiplexing) by programmable logic 1660 and stored in data memory for subsequent retrieval, such as by processor 1740. As noted above, the voltage and current feedback data may be used as input to algorithms for pre-distorting or modifying LUT waveform samples on a dynamic and ongoing basis. In certain embodiments, this may require each stored voltage and current feedback data pair to be indexed or otherwise associated with the corresponding LUT sample output by programmable logic 1660 as the voltage and current feedback data pair is acquired. Synchronizing the LUT samples with the voltage and current feedback data in this manner contributes to the precise timing and stability of the predistortion algorithm.
[0220] In certain aspects, the voltage and current feedback data can be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, the voltage and current feedback data can be used to determine the impedance phase, e.g., the phase difference between the voltage drive signal and the current drive signal. The frequency of the drive signal can then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase setpoint (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the accuracy of the impedance phase measurement. The determination of the phase impedance and frequency control signal can be performed, for example, by processor 1740, with the frequency control signal provided as an input to a DDS control algorithm executed by programmable logic 1660.
[0221] The impedance phase can be determined by Fourier analysis. In one embodiment, the generator voltage V g (t) Drive signal and generator current I g The phase difference between the (t) drive signal can be determined using a fast fourier transform (FFT) or a discrete fourier transform (DFT) as follows:
[0222]
number
[0223] Evaluating the Fourier transform at the frequency of the sine wave gives:
[0224]
number
[0225] Other approaches include weighted least squares estimation, Kalman filtering, and space vector-based techniques. Substantially all of the processing in the FFT or DFT techniques may be performed in the digital domain using, for example, a two-channel high-speed ADC 1780, 1800. In one technique, digital signal samples of the voltage and current signals are Fourier transformed with an FFT or DFT. The phase angle φ at any time can be calculated by the following formula: φ=2πft+φ0 where φ is the phase angle, f is the frequency, t is the time, and φ 0 is the phase at t=0.
[0226] Voltage V g (t) Signal and current I g Another technique for determining the phase difference between a (t) signal and a voltage V with the same frequency is the zero-crossing method, which produces highly accurate results. g (t) Signal and current I g In the case of the (t) signal, the voltage signal V g Each negative to positive zero crossing of (t) triggers the start of a pulse, while the current signal I g Each negative-to-positive zero crossing of (t) triggers the end of a pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train can be passed through an averaging filter to obtain a measure of the phase difference. Additionally, positive-to-negative zero crossings can be used in a similar manner, and the result can be averaged to reduce any effects of DC and harmonic content. In one implementation, the analog voltage V g (t) Signal and current I g The (t) signal is converted to a digital signal that is high when the analog signal is positive and low when the analog signal is negative. High accuracy phase estimation requires a sharp transition between high and low. In one embodiment, a Schmitt trigger can be used in conjunction with an RC stabilization network to convert the analog signal to a digital signal. In another embodiment, an edge-triggered RS flip-flop and supporting circuitry can be used. In yet another embodiment, the zero-crossing technique can use an eXclusive OR (XOR) gate.
[0227] Other techniques for determining the phase difference between voltage and current signals include Lissajous figures and image monitoring, methods such as the three-voltmeter method, the crossed coil method, the vector voltmeter and vector impedance method, as well as phase standard instruments, phase-locked loops, and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http: / / www.engnetbase.com> and the use of other techniques such as those described in, which are incorporated herein by reference.
[0228] In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at a current amplitude setpoint. The current amplitude setpoint can be directly specified or indirectly determined based on specified voltage amplitude and power setpoints. In certain aspects, control of the current amplitude can be performed by a control algorithm, such as, for example, a proportional-integral-derivative (PID) control algorithm in processor 1740. Variables controlled by the control algorithm to appropriately control the current amplitude of the drive signal can include, for example, scaling of LUT waveform samples stored in programmable logic 1660 and / or the full-scale output voltage of DAC 1680 (which provides an input to power amplifier 1620) via DAC 1860.
[0229] The non-isolated stage 1540 may further include a processor 1900 to provide, among other things, user interface (UI) functions. In one embodiment, the processor 1900 may include, for example, an Atmel AT91 SAM9263 processor with an ARM926EJ-S core, available from Atmel Corporation (San Jose, Calif.). Examples of UI functions supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with a foot switch 1430, communication with an input device 2150 (e.g., a touchscreen display), and communication with an output device 2140 (e.g., a speaker). The processor 1900 may communicate with the processor 1740 and the programmable logic (e.g., via a serial peripheral interface (SPI) bus). While the processor 1900 may primarily support UI functions, it may also cooperate with the processor 1740 in certain embodiments to provide hazard mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user input and / or other input (e.g., touchscreen input 2150, footswitch 1430 input, temperature sensor input 2160) and can disable the drive output of the generator 1100 if an erroneous condition is detected.
[0230] In certain aspects, both processor 1740 (FIGS. 26, 27A) and processor 1900 (FIGS. 26, 27B) can determine and monitor the operational state of generator 1100. In the case of processor 1740, the operational state of generator 1100 can determine, for example, which control and / or diagnostic processes are executed by processor 1740. In the case of processor 1900, the operational state of generator 1100 can determine, for example, which elements of the user interface (e.g., display screen, sound) are presented to the user. Processors 1740, 1900 can independently maintain the current operational state of generator 1100 and recognize and evaluate possible transitions from the current operational state. Processor 1740 acts as a master in this relationship and can determine when transitions between operational states occur. Processor 1900 can recognize valid transitions between operational states and can verify that a particular transition is appropriate. For example, when processor 1740 commands processor 1900 to transition to a particular state, processor 1900 can verify that the requested transition is valid. If the requested transition between states is determined by processor 1900 to be invalid, processor 1900 can place generator 1100 in a failure mode.
[0231] The non-isolated stage 1540 may further include a controller 1960 (FIGS. 26, 27B) for monitoring the input device 2150 (e.g., capacitive touch sensors used to turn the generator 1100 on and off, capacitive touch screen). In certain aspects, the controller 1960 may comprise at least one processor and / or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 may comprise a processor (e.g., a Mega168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 may comprise a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) for controlling and managing the acquisition of touch data from a capacitive touch screen.
[0232] In certain aspects, when the generator 1100 is in the “power off” state, the controller 1960 may continue to receive operating power (e.g., via a line from a power source of the generator 1100, such as the power supply 2110 (FIG. 26) described below). In this manner, the controller 1960 may continue to monitor an input device 2150 (e.g., a capacitive touch sensor located on the front panel of the generator 1100) for turning the generator 1100 on and off. When the generator 1100 is in the “power off” state, the controller 1960 may activate the power supply (e.g., enable operation of one or more DC / DC voltage converters 2130 (FIG. 26) of the power supply 2110) upon detecting user activation of the “on / off” input device 2150. As a result, the controller 1960 may initiate a sequence to transition the generator 1100 to the “power on” state. Conversely, if activation of the "on / off" input device 2150 is detected while the generator 1100 is in the "power on" state, the controller 1960 can initiate a sequence to transition the generator 1100 to the "power off" state. In certain aspects, for example, the controller 1960 can report activation of the "on / off" input device 2150 to the processor 1900, which then executes the processing sequence necessary to transition the generator 1100 to the "power off" state. In such aspects, the controller 1960 may not have the independent capability to cause the removal of power from the generator 1100 after its "power on" state has been established.
[0233] In certain aspects, the controller 1960 may cause the generator 1100 to provide auditory or other sensory feedback to alert the user that a "power on" or "power off" sequence has begun. Such an alert may be provided at the start of the "power on" or "power off" sequence and prior to the start of other processes associated with the sequence.
[0234] In certain embodiments, isolated stage 1520 may include an instrument interface circuit 1980 to provide a communications interface between, for example, the surgical device's control circuitry (e.g., control circuitry including the handpiece switches) and components of non-isolated stage 1540 (e.g., programmable logic 1660, processor 1740, and / or processor 1900, etc.). Instrument interface circuit 1980 may exchange information with components of non-isolated stage 1540 via a communications link that maintains an appropriate degree of electrical isolation between stages 1520, 1540, such as, for example, an infrared (IR)-based communications link. For example, instrument interface circuit 1980 may be powered using a low-dropout voltage regulator powered by an isolation transformer driven from non-isolated stage 1540.
[0235] In one aspect, the instrument interface circuit 1980 can include a programmable logic 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (FIGS. 26 and 27C). The signal conditioning circuit 2020 can be configured to receive a periodic signal (e.g., a 2 kHz square wave) from the programmable logic 2000 and generate a bipolar interrogation signal having the same frequency. The interrogation signal can be generated, for example, using a bipolar current source fed by a differential amplifier. The interrogation signal can be communicated to a surgical device control circuit (e.g., by using a conductive pair in a cable connecting the generator 1100 to the surgical device) and monitored to determine the state or configuration of the control circuit. For example, the control circuit can include a number of switches, resistors, and / or diodes to modify one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that the state or configuration of the control circuit is individually identifiable based on the one or more characteristics. For example, in one aspect, the signal conditioning circuit 2020 may include an ADC for generating samples of the voltage signal appearing across the input of the control circuit caused by the interrogation signal passing through it. The programmable logic 2000 (or a component of the non-isolated stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.
[0236] In one aspect, the instrument interface circuit 1980 can include a first data circuit interface 2040 that enables the exchange of information between the programmable logic 2000 (or other elements of the instrument interface circuit 1980) and a first data circuit disposed within or otherwise associated with the surgical device. In certain aspects, for example, the first data circuit 2060 may be disposed in a cable integrally attached to a handpiece of the surgical device or in an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit can include non-volatile storage, such as an electrically erasable programmable read-only memory (EEPROM) device. In certain aspects, and referring again to FIG. 26 , the first data circuit interface 2040 can be implemented separately from the programmable logic 2000 and can include suitable circuitry (e.g., discrete logic, processor) that enables communication between the programmable logic 2000 and the first data circuit. In other embodiments, the first data circuit interface 2040 may be integral to the programmable logic 2000 .
[0237] In certain aspects, the first data circuit 2060 can store information regarding the particular surgical device with which it is associated. Such information can include, for example, a model number, a serial number, the number of operations the surgical device has been used in, and / or other types of information. This information can be read by the instrument interface circuit 1980 (e.g., by the programmable logic 2000) and forwarded to components of the non-isolated stage 1540 (e.g., the programmable logic 1660, the processor 1740, and / or the processor 1900) for presentation to a user via the output device 2140 and / or for controlling the functions or operations of the generator 1100. Additionally, any type of information can be communicated to the first data circuit 2060 via the first data circuit interface 2040 (e.g., using the programmable logic 2000) for storage within the first data circuit 2060. Such information can include, for example, the most recent number of operations the surgical device has been used in and / or the date and / or time of its use.
[0238] As noted above, surgical instruments may be detachable from handpieces to facilitate instrument interchangeability and / or disposability (e.g., instrument 1106 may be detachable from handpiece 1107). In such cases, known generators may be limited in their ability to recognize the particular instrument configuration being used and correspondingly optimize their control and diagnostic processes. However, adding readable data circuitry to surgical instruments to address this issue presents compatibility challenges. For example, designing a surgical instrument to be backward compatible with generators lacking the necessary data read functionality may be impractical due to, for example, different signaling schemes, design complexity, and expense. Other instrument aspects address these concerns by economically using data circuitry that can be implemented in existing surgical instruments and minimizing design changes to maintain compatibility of the surgical instrument with modern generator platforms.
[0239] Additionally, embodiments of the generator 1100 may enable communication with an instrument-based data circuit. For example, the generator 1100 may be configured to communicate with a second data circuit (e.g., a data circuit) housed within an instrument (e.g., instrument 1104, 1106, or 1108) of a surgical device. The instrument interface circuit 1980 may include a second data circuit interface 2100 that enables this communication. In one embodiment, the second data circuit interface 2100 may include a tri-state digital interface, although other interfaces may be used. In certain embodiments, the second data circuit may generally be any circuit for transmitting and / or receiving data. In one embodiment, for example, the second data circuit may store information regarding the particular surgical instrument with which it is associated. Such information may include, for example, a model number, a serial number, the number of operations the surgical instrument has been used in, and / or any other type of information. Additionally or alternatively, any type of information can be communicated to the second data circuit via the second data circuit interface 2100 (e.g., using the programmable logic 2000) for storage within the second data circuit. Such information may include, for example, the most recent number of operations the appliance was used for and / or the date and / or time of its use. In certain aspects, the second data circuit can transmit data obtained by one or more sensors (e.g., appliance-based temperature sensors). In certain aspects, the second data circuit can receive data from the generator 1100 and provide an indication (e.g., an LED indication or other visual indication) to the user based on the received data.
[0240] In certain aspects, the second data circuit and second data circuit interface 2100 can be configured to enable communication between the programmable logic 2000 and the second data circuit without the need to provide additional conductors for this purpose (e.g., dedicated conductors in the cable connecting the handpiece to the generator 1100). In one aspect, information can be conveyed to and from the second data circuit using a one-wire bus communication scheme implemented on existing cabling, for example, where one of the conductors used transmits an interrogation signal from the signal conditioning circuit 2020 to the control circuitry in the handpiece. In this manner, design changes or modifications to the surgical device that might otherwise be required are minimized or reduced. Furthermore, because various types of communications can be conducted over a common physical channel (either with or without frequency band separation), the presence of the second data circuit is “invisible” to generators that do not have the necessary data reading capabilities, thus enabling backward compatibility of surgical device instruments.
[0241] In certain embodiments, the isolation stage 1520 can include at least one blocking capacitor 2960-1 (FIG. 27C) connected to the drive signal output 1600b to prevent DC current from passing through the patient. A single blocking capacitor may be required, for example, to comply with medical regulations or standards. While failure in a single capacitor design is relatively rare, such failure may still have negative consequences. In one embodiment, a second blocking capacitor 2960-2 can be provided in series with the blocking capacitor 2960-1 to monitor current leakage from a point between the blocking capacitors 2960-1, 2960-2, for example, by an ADC 2980 for sampling the voltage induced by the leakage current. The samples can be received, for example, by the programmable logic 2000. Based on changes in the leakage current (represented by voltage samples in the embodiment of FIG. 26), the generator 1100 can determine when at least one of the blocking capacitors 2960-1, 2960-2 has failed. Thus, the embodiment of FIG. 26 can provide benefits over single capacitor designs with a single point of failure.
[0242] In certain aspects, the non-isolated stage 1540 may include a power supply 2110 for outputting DC power at a suitable voltage and current. The power supply may comprise, for example, a 400 W power supply for outputting a 48 VDC system voltage. As mentioned above, the power supply 2110 may further include one or more DC / DC voltage converters 2130 for receiving the output of the power supply and generating a DC output at the voltage and current required by the various components of the generator 1100. As discussed above in connection with the controller 1960, one or more of the DC / DC voltage converters 2130 may receive input from the controller 1960 when activation of an “on / off” input device 2150 by a user is detected by the controller 1960, allowing operation or activation of the DC / DC voltage converter 2130.
[0243] 28A-28B illustrate certain functional and structural aspects of one embodiment of generator 1100. Feedback indicative of the current and voltage output from secondary winding 1580 of power transformer 1560 is received by ADCs 1780, 1800, respectively. As shown, ADCs 1780, 1800 may be implemented as two-channel ADCs and may sample the feedback signal at a high rate (e.g., 80 Msps) to allow oversampling of the drive signal (e.g., approximately 200x oversampling). The current and voltage feedback signals may be appropriately conditioned (e.g., amplified, filtered) in the analog domain prior to processing by ADCs 1780, 1800. The current and voltage feedback samples from ADCs 1780, 1800 may be individually buffered and then multiplexed or interleaved into a single data stream within block 2120 of programmable logic 1660. In the embodiment of Figures 28A-28B, programmable logic 1660 comprises an FPGA.
[0244] The multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented in block 2144 of processor 1740. The PDAP may include a packing unit for implementing any of a number of methods for correlating the multiplexed feedback samples with memory addresses. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by programmable logic 1660 may be stored at one or more memory addresses associated with or indexed to the LUT address of the LUT sample. In another aspect, feedback samples corresponding to a particular LUT sample output by programmable logic 1660 may be stored in a common memory location along with the LUT address of the LUT sample. In either case, the feedback samples may be stored such that the address of the LUT sample from which a particular set of feedback samples originates can subsequently be ascertained. As noted above, synchronization of the LUT sample addresses and feedback samples thus contributes to the precise timing and stability of the predistortion algorithm. A direct memory access (DMA) controller implemented in block 2166 of processor 1740 can store the feedback samples (and any LUT sample address data, if applicable) in a specified memory location 2180 (e.g., internal RAM) of processor 1740.
[0245] Block 2200 of processor 1740 can implement a pre-distortion algorithm to pre-distort or modify, on a dynamic, ongoing basis, the LUT samples stored in programmable logic 1660. As described above, pre-distortion of the LUT samples can compensate for various sources of distortion present in the output drive circuitry of generator 1100. The pre-distorted LUT samples, when processed by the drive circuitry, therefore, produce a drive signal having a desired waveform shape (e.g., a sine wave) for optimally driving the ultrasonic transducer.
[0246] In block 2220 of the pre-distortion algorithm, the current flowing through the motional branch of the ultrasonic transducer is determined. The motional branch current may be determined, for example, from the current and voltage feedback samples stored in memory location 2180 (which, when appropriately scaled, may correspond to the I g and V g Based on the LUT sample's associated voltage and current feedback signal, the amplitude of the LUT can be determined using Kirchhoff's current law based on the amplitude of the ultrasonic transducer capacitance C (which may represent C), the value of the ultrasonic transducer capacitance C (measured or known a priori), and the known value of the drive frequency. The motional branch current sample in each set of stored current and voltage feedback samples associated with the LUT sample can be determined.
[0247] In block 2240 of the predistortion algorithm, each motional branch current sample determined in block 2220 is compared to a sample of the desired current waveform shape to determine the difference, or sample amplitude error, between the compared samples. For this determination, the current waveform shape sample may be provided, for example, from waveform shape LUT 2260, which contains amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 used for the comparison may be determined by the LUT sample address associated with the motional branch current sample used for the comparison. Thus, the input of the motional branch current to block 2240 may be synchronized with the input of its associated LUT sample address to block 2240. Thus, the LUT samples stored in programmable logic 1660 and the LUT samples stored in waveform shape LUT 2260 may be numerically equivalent. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT 2260 may be a fundamental sine wave. Other waveform shapes may be desirable. For example, it is contemplated that a fundamental sine wave may be used to drive the primary longitudinal motion of the ultrasonic transducer superimposed with one or more other drive signals at other wavelengths, such as third harmonics, to drive at least two mechanical resonances for beneficial vibration in the lateral or other modes.
[0248] Each value of sample amplitude error determined in block 2240 can be communicated to a LUT (shown in block 2280 of FIG. 28A ) of programmable logic 1660, along with an index of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and, optionally, a previously received value of sample amplitude error for the same LUT address), LUT 2280 (or other control block of programmable logic 1660) can pre-distort or modify the value of the LUT sample stored at the LUT address, thereby reducing or minimizing the sample amplitude error. It will be appreciated that such pre-distortion or modification of each LUT sample in an iterative manner across the range of LUT addresses causes the waveform shape of the generator's output current to match or adapt to the desired current waveform shape represented by the samples of waveform shape LUT 2260.
[0249] Current and voltage amplitude measurements, power measurements, and impedance measurements may be determined in block 2300 of processor 1740 based on the current and voltage feedback samples stored in memory location 2180. Prior to determining these values, the feedback samples may be appropriately scaled and, in certain embodiments, processed through a suitable filter 2320 to remove, for example, noise and induced harmonic components caused by the data acquisition process. The filtered voltage and current samples may therefore substantially represent the fundamental frequency of the generator's drive output signal. In certain embodiments, filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such embodiments may use a fast Fourier transform (FFT) of the output drive signal current and voltage signals. In certain embodiments, the resulting frequency spectrum may be used to provide additional generator functions. In one embodiment, for example, the ratio of second and / or third harmonic components to the fundamental frequency component may be used as a diagnostic indicator.
[0250] At block 2340 (FIG. 28B), a measurement I representing the drive signal output current is obtained.rms A root mean square (RMS) calculation may be applied to a sample size of the current feedback samples that represents an integer number of cycles of the drive signal to generate .times. ...
[0251] At block 2360, a measurement V representing the drive signal output voltage is calculated. rms To determine √{square root over (RMS)}, a root mean square (RMS) calculation may be applied to a sample size of voltage feedback samples that represents an integer number of cycles of the drive signal.
[0252] In block 2380, the current and voltage feedback samples may be multiplied point by point and an averaging calculation applied to samples representing an integer number of cycles of the drive signal to obtain a measure of the actual output power of the generator, P r is determined.
[0253] In block 2400, the measured apparent output power of the generator, P a is the product V rms I rms It can be determined as:
[0254] At block 2420, the measured magnitude of the load impedance Z m is the quotient V rms / I rms It can be determined as:
[0255] In certain embodiments, the values I determined in blocks 2340, 2360, 2380, 2400, and 2420 rms , V rms , P r , P a , and Z mmay be used by the generator 1100 to implement any of a number of control and / or diagnostic processes. In certain aspects, any of these values may be communicated to a user through a suitable communications interface (e.g., a USB interface), for example, via an output device 2140 integral with or connected to the generator 1100. The various diagnostic processes may include, but are not limited to, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, overvoltage condition, overcurrent condition, overpower condition, voltage sense failure, current sense failure, audible indicator failure, visual indicator failure, short circuit condition, power supply failure, or blocking capacitor failure.
[0256] Block 2440 of processor 1740 may implement a phase control algorithm to determine and control the impedance phase of an electrical load (e.g., an ultrasonic transducer) driven by generator 1100. As described above, controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°) may minimize or reduce the effects of harmonic distortion and improve the accuracy of the phase measurement.
[0257] The phase control algorithm receives as input the current and voltage feedback samples stored in memory location 2180. Before using them in the phase control algorithm, the feedback samples may be appropriately scaled and, in certain aspects, processed through a suitable filter 2460 (which may be the same as filter 2320) to remove noise resulting from, for example, the data acquisition process and induced harmonic components. The filtered voltage and current samples may thus substantially represent the fundamental frequency of the generator's drive output signal.
[0258] At block 2480 of the phase control algorithm, the current through the motional branch of the ultrasonic transducer is determined. This determination may be the same as that described above in connection with block 2220 of the predistortion algorithm. Thus, the output of block 2480 may be a motional branch current sample for each set of stored current and voltage feedback samples associated with a LUT sample.
[0259] In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized input of the motional branch current samples and corresponding voltage feedback samples determined in block 2480. In certain aspects, the impedance phase is determined as the average of the impedance phase measured at the rising edge of the waveform and the impedance phase measured at the falling edge of the waveform.
[0260] In block 2520 of the phase control algorithm, the impedance phase value determined in block 2220 is compared to a phase set point 2540 to determine the difference or phase error between the compared values.
[0261] In block 2560 (FIG. 28A) of the phase control algorithm, a frequency output is determined for controlling the frequency of the drive signal based on the value of the phase error determined in block 2520 and the magnitude of the impedance determined in block 2420. The frequency output value may be continuously adjusted by block 2560 and forwarded to DDS control block 2680 (described below) to maintain the impedance phase determined in block 2500 at a phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0° phase set point. In this way, any amount of harmonic distortion is centered around the top of the voltage waveform, improving the accuracy of the phase impedance determination.
[0262] Block 2580 of processor 1740 can implement an algorithm for modulating the current amplitude of the drive signal to control the drive signal current, voltage, and power according to user-specified set points or requirements specified by other processes or algorithms implemented by generator 1100. Control of these values can be achieved, for example, by scaling LUT samples in LUT 2280 and / or by adjusting the full-scale output voltage of DAC 1680 (which provides input to power amplifier 1620) via DAC 1860. Block 2600 (which in certain aspects may be implemented as a PID controller) can receive as input from memory location 2180 a current feedback sample (which may be appropriately scaled and filtered). The current feedback sample is used to calculate a "current demand" I, determined by the controlled variable (e.g., current, voltage, or power), to determine whether the drive signal is supplying the required current. d In embodiments where drive signal current is the controlled variable, the current demand I d The current setting is 2620A (I sp ) directly. For example, the RMS value of the current feedback data (determined in block 2340) may be used in conjunction with the user-specified RMS current setpoint I to determine the appropriate controller action. sp For example, the current feedback data can be compared to the current setpoint I sp If the current feedback data indicates an RMS value lower than the current setpoint I, then the LUT scaling and / or the full-scale output voltage of the DAC 1680 may be adjusted by block 2600 such that the drive signal current is increased. sp If the RMS value is higher than 1, block 2600 may adjust the LUT scaling and / or the full-scale output voltage of the DAC 1680 to reduce the drive signal current.
[0263] In embodiments where the drive signal voltage is the controlled variable, the current demand I d is, for example, the magnitude of the load impedance Z measured in block 2420. mWhen the desired voltage setting value 2620B (V sp ) can be indirectly specified based on the current required to maintain the d =V sp / Z m Similarly, in embodiments where drive signal power is the controlled variable, the current demand I d is the voltage V measured in block 2360, for example. rms Given the desired power setting 2620C(P sp ) can be indirectly specified based on the current required to maintain d =P sp / V rms ).
[0264] Block 2680 (FIG. 28A) can implement a DDS control algorithm to control the drive signal by recalling the LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm can be a numerically-controlled oscillator (NCO) algorithm for generating waveform samples at a fixed clock rate using a point (memory location) skip technique. The NCO algorithm can implement a phase accumulator or frequency-to-phase converter that acts as an address pointer for recalling LUT samples from LUT 2280. In one aspect, the phase accumulator can be a D-step size, modulo-N phase accumulator, where D is a positive integer representing the frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D=1 can cause the phase accumulator to sequentially address all of LUT 2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. If D>1, the phase accumulator may skip addresses in the LUT 2280, resulting in a waveform output having a higher frequency. This allows the frequency of the waveform generated by the DDS control algorithm to be controlled accordingly by appropriately changing the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented in block 2440. The output of block 2680 may provide the input of the DAC 1680, which in turn provides a corresponding analog signal to the input of the power amplifier 1620.
[0265] Block 2700 of processor 1740 can implement a switch-mode converter control algorithm to dynamically modulate the rail voltage of power amplifier 1620 based on the waveform envelope of the signal being amplified, thereby improving the efficiency of power amplifier 1620. In certain aspects, characteristics of the waveform envelope can be determined by monitoring one or more signals included in power amplifier 1620. In one aspect, for example, characteristics of the waveform envelope can be determined by monitoring a minimum value of a drain voltage (e.g., a MOSFET drain voltage) modulated according to the envelope of the amplified signal. The minimum voltage signal can be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal can be sampled by ADC 1760, and the output minimum voltage sample can be received by block 2720 of the switch-mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 can control the PWM signal output by PWM generator 2760, which in turn controls the rail voltage supplied to power amplifier 1620 by switch-mode regulator 1700. In certain aspects, the rail voltages may be modulated according to the waveform envelope characterized by the minimum voltage sample as long as the value of the minimum voltage sample is less than the minimum target 2780 input to block 2720. For example, when the minimum voltage sample indicates a low envelope power level, a low rail voltage may be supplied to the power amplifier 1620 by block 2740, and full rail voltage may be supplied only when the minimum voltage sample indicates a maximum envelope power level. When the minimum voltage sample is below the minimum target 2780, the rail voltages may be maintained by block 2740 at a minimum value suitable to ensure proper operation of the power amplifier 1620.
[0266] FIG. 29 is a circuit diagram of one embodiment of an electrical circuit 2900 suitable for driving an ultrasonic transducer, such as the ultrasonic transducer 1120, in accordance with at least one embodiment of the present disclosure. The electrical circuit 2900 includes an analog multiplexer 2980. The analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A, such as ultrasonic, battery, and power control circuits. A current sensor 2982 is coupled in series with the return or ground section of the power supply circuit and measures the current supplied by the power supply. A field-effect transistor (FET) temperature sensor 2984 provides the ambient temperature. A pulse-width modulation (PWM) watchdog timer 2988 automatically generates a system reset if the main program neglects to provide a periodic system reset. This is provided to automatically reset the electrical circuit 2900 if it hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 2900 may be configured as an RF driver circuit for driving an ultrasonic transducer or for driving an RF electrode, such as, for example, the electrical circuit 3600 shown in FIG. 34. Thus, referring again now to FIG. 29, the electrical circuit 2900 may be used to alternately drive both an ultrasonic transducer and an RF electrode. A filter circuit may be provided within the corresponding first stage circuit 3404 (FIG. 32) to select either the ultrasonic waveform or the RF waveform when driven simultaneously. Such filtering techniques are described in commonly owned U.S. Patent Application Publication No. US-2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR," which is incorporated herein by reference in its entirety.
[0267] A driver circuit 2986 provides left and right ultrasonic energy outputs. Digital signals representing signal waveforms are provided to the SCL-A and SDA-A inputs of the analog multiplexer 2980 from a control circuit, such as control circuit 3200 (FIG. 30). A digital-to-analog converter 2990 (DAC) converts the digital input to an analog output to drive a PWM circuit 2992 coupled to an oscillator 2994. The PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to a first transistor output stage 2998a to drive the first ultrasonic (left) energy output. The PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to a second transistor output stage 2998b to drive the second ultrasonic (right) energy output. A voltage sensor 2999 is coupled between the ultrasonic left / right output terminals to measure the output voltage. The driver circuit 2986, the first and second driver circuits 2996a, 2996b, and the first and second transistor output stages 2998a, 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 30) generates a digital waveform 4300 (FIG. 37) using circuitry such as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 35 and 36). The DAC 2990 receives the digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.
[0268] 30 is a circuit diagram of a control circuit 3200, such as control circuit 3212, in accordance with at least one embodiment of the present disclosure. Control circuit 3200 is located within the housing of a battery assembly. The battery assembly is the energy source for various local power sources 3215. The control circuit comprises a main processor 3214 coupled to various downstream circuits via an interface master 3218, for example, by outputs SCL-A and SDA-A, SCL-B and SDA-B, and SCL-C and SDA-C. In one embodiment, interface master 3218 is connected to an I / O bus 3216. 2The main processor 3214 is also configured to drive a switch 3224 via a general purposes input / output (GPIO) 3220, a display 3226 (e.g., an LCD display), and various indicators 3228 via a GPIO 3222. A watchdog processor 3216 is provided to control the main processor 3214. A switch 3230 is provided in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.
[0269] In one aspect, the main processor 3214 is coupled to the electrical circuit 2900 (FIG. 29) by output terminals SCL-A, SDA-A. The main processor 3214 includes memory for storing, for example, a table of digitized drive signals or waveforms that are transmitted to the electrical circuit 2900 to drive the ultrasonic transducer 1120. In other aspects, the main processor 3214 may generate and transmit digital waveforms to the electrical circuit 2900 or store digital waveforms for later transmission to the electrical circuit 2900. The main processor 3214 may also provide RF drive by output terminals SCL-B, SDA-B and various sensors (e.g., Hall effect sensors, magnetorheological fluid (MRF) sensors, etc.) by output terminals SCL-C, SDA-C. In one aspect, the main processor 3214 is configured to sense the presence of an ultrasonic drive circuit and / or an RF drive circuit to enable appropriate software and user interface functionality.
[0270] In one aspect, main processor 3214 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other features readily available from 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 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 (QED) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels. Other processors may be readily substituted, and therefore the present disclosure should not be limited in this context.
[0271] 31 shows a simplified block circuit diagram illustrating another electrical circuit 3300 housed within a modular ultrasonic surgical instrument 3334, in accordance with at least one embodiment of the present disclosure. The electrical circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power source 3304 (e.g., a battery), a switch 3306, such as a metal oxide semiconductor field effect transistor (MOSFET) power switch, a drive circuit 3308 (PLL), a transformer 3310, a signal smoothing circuit 3312 (also referred to as a matching circuit, which may be, for example, a tank circuit), a sensing circuit 3314, a transducer 1120, and a shaft assembly (e.g., shaft assembly 1126, 1129) comprising an ultrasonic transmission waveguide that terminates in an ultrasonic blade (e.g., ultrasonic blade 1128, 1149), which may also be referred to herein simply as a waveguide.
[0272] One feature of the present disclosure that breaks the dependency on high voltage (120 VAC) input power (a characteristic of typical ultrasonic cutting devices) is the use of low voltage switching throughout the wave formation process and amplification of the drive signal only just prior to the transformer stage. For this reason, in one aspect of the present disclosure, power is derived solely from a battery or battery group small enough to fit either within the handle assembly. State-of-the-art battery technology provides powerful batteries that are a few centimeters in height and width and a few millimeters in depth. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasonic device, reduced manufacturing costs can be achieved.
[0273] The output of the power supply 3304 is provided to the processor 3302 to provide power. The processor 3302 receives and outputs signals and functions according to custom logic or according to a computer program executed by the processor 3302, as described below. As mentioned above, the electrical circuitry 3300 can also include memory 3326, preferably random access memory (RAM), for storing computer-readable instructions and data.
[0274] The output of the power supply 3304 is also directed to a switch 3306, which has a duty cycle controlled by the processor 3302. By controlling the on-time of the switch 3306, the processor 3302 can determine the total amount of power that is ultimately delivered to the converter 1120. In one aspect, the switch 3306 is a MOSFET, although other switch and switching configurations are equally applicable. The output of the switch 3306 is provided to a drive circuit 3308, which may include, for example, a phase detector phase-locked loop (PLL) and / or a low-pass filter and / or a voltage-controlled oscillator. The output of the switch 3306 is sampled by the processor 3302 to obtain the voltage and current (V IN and I IN) These values are used in a feedback architecture to adjust the pulse width modulation of switch 3306. For example, the duty cycle of switch 3306 can vary from about 20% to about 80% depending on the desired and actual output from switch 3306.
[0275] A driver circuit 3308 receives the signal from the switch 3306 and includes an oscillator circuit that converts the output of the switch 3306 into an electrical signal having an ultrasonic frequency, e.g., 55 kHz (VCO). As described above, a smoothed version of this ultrasonic waveform is ultimately fed to the ultrasonic transducer 1120 to generate a resonant sine wave along the ultrasonic transmission waveguide.
[0276] At the output of the driver circuit 3308 is a transformer 3310 that can step up the low-voltage signal(s) to a higher voltage. Note that upstream switching is performed at a low (e.g., battery-powered) voltage before the transformer 3310, something that has not been possible in ultrasonic cutting and cauterization devices to date. This is at least partially due to the fact that the device advantageously uses low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they produce lower switching losses and less heat than conventional MOSFET devices and can pass higher currents. Thus, the switching stage (pre-transformer) can be characterized as low voltage / high current. To ensure a lower on-resistance of the amplifier MOSFET(s), the MOSFET(s) are operated at, for example, 10 V. In such a case, a separate 10 V DC power supply can be used to supply the MOSFET gates, ensuring that the MOSFETs are fully on and achieving a reasonably low on-resistance. In one aspect of the present disclosure, the transformer 3310 steps up the battery voltage to 120 V root mean square (RMS). Transformers are known in the art and therefore will not be described in detail here.
[0277] In the described circuit configuration, degradation of circuit components can negatively impact the circuit's performance. One factor that directly affects component performance is heat. Known circuits typically monitor switching temperatures (e.g., MOSFET temperature). However, due to technological advances in MOSFET design and corresponding size reductions, MOSFET temperature is no longer an effective indicator of circuit load and heat. Therefore, according to at least one aspect of the present disclosure, the sensing circuit 3314 senses the temperature of the transformer 3310. This temperature sensing is advantageous because the transformer 3310 operates at or near its maximum temperature during use of the device. Additional temperature can break down the core material, e.g., ferrite, causing permanent damage. The present disclosure can respond to the maximum temperature of the transformer 3310 by, for example, reducing the drive power in the transformer 3310, signaling the user, turning off the power supply, pulsing the power, or other appropriate response.
[0278] In one aspect of the present disclosure, the processor 3302 is communicatively coupled to an end effector (e.g., 1122, 1125) used to place a material into physical contact with an ultrasonic blade (e.g., 1128, 1149). A sensor is provided in the end effector to measure a clamping force value (within a known range), and based on the received clamping force value, the processor 3302 controls an operating voltage V M. Because a high force value combined with a set operating speed may result in a high blade temperature, a temperature sensor 3332 may be communicatively coupled to the processor 3302, where the processor 3302 is operable to receive and interpret a signal indicative of the current temperature of the blade from the temperature sensor 3336 and determine a target frequency of blade movement based on the received temperature. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the trigger (e.g., 1143, 1147) to measure the force applied to the trigger by a user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch button such that a displacement magnitude corresponds to the force applied to the switch button by the user.
[0279] According to at least one aspect of the present disclosure, a PLL portion of the drive circuit 3308 coupled to the processor 3302 can determine the frequency of the waveguide motion and communicate that frequency to the processor 3302. The processor 3302 stores this frequency value in memory 3326 when the device is turned off. By reading the clock 3330, the processor 3302 can determine the elapsed time since the device was shut off and, if the elapsed time is less than a predetermined value, retrieve the last frequency of the waveguide motion. The device can then start at the last frequency, which is presumably the optimal frequency for the current load.
[0280] Modular battery-powered handheld surgical instrument with multi-stage generator circuit In another aspect, the present disclosure provides a modular, battery-powered, handheld surgical instrument including a multi-stage generator circuit. The surgical instrument includes a battery assembly, a handle assembly, and a shaft assembly, the battery assembly and the shaft assembly configured to be mechanically and electrically connected to the handle assembly. The battery assembly includes a control circuit configured to generate a digital waveform. The handle assembly includes a first-stage circuit configured to receive the digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The shaft assembly includes a second-stage circuit coupled to the first-stage circuit for receiving, amplifying, and applying the analog waveform to a load device.
[0281] In one aspect, the present disclosure provides a surgical instrument comprising: a battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured to generate a digital waveform; a handle assembly including a first stage circuit coupled to the processor, the first stage circuit including a digital-to-analog (DAC) converter and a first stage amplifier circuit, the DAC configured to receive the digital waveform and convert the digital waveform to an analog waveform, and the first stage amplifier circuit configured to receive and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the first stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load device, wherein the battery assembly and the shaft assembly are configured to be in mechanical and electrical communication with the handle assembly.
[0282] The load device may include any one of an ultrasonic transducer, an electrode, or a sensor, or any combination thereof. The first stage circuit may include a first stage ultrasonic drive circuit and a first stage high frequency current drive circuit. The control circuit may be configured to drive the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit individually or simultaneously. The first stage ultrasonic drive circuit may be configured to couple to a second stage ultrasonic drive circuit. The second stage ultrasonic drive circuit may be configured to couple to an ultrasonic transducer. The first stage high frequency current drive circuit may be configured to couple to a second stage high frequency drive circuit. The second stage high frequency drive circuit may be configured to couple to an electrode.
[0283] The first stage circuitry may comprise a first stage sensor drive circuitry. The first stage sensor drive circuitry may be configured with a second stage sensor drive circuitry. The second stage sensor drive circuitry may be configured to couple to the sensor.
[0284] In another aspect, the present disclosure provides a surgical instrument comprising: a battery assembly including control circuitry including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured to generate a digital waveform; a handle assembly including a common first stage circuit coupled to the processor, the common first stage circuit including a digital-to-analog (DAC) converter and a common first stage amplifier circuit, the DAC configured to receive the digital waveform and convert the digital waveform to an analog waveform, and the common first stage amplifier circuit configured to receive and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the common first stage amplifier circuit for receiving the analog waveform, amplifying the analog waveform, and applying the analog waveform to a load device, wherein the battery assembly and the shaft assembly are configured to be in mechanical and electrical communication with the handle assembly.
[0285] The load device may include any one of an ultrasonic transducer, an electrode, or a sensor, or any combination thereof. A common first stage circuit may be configured to drive the ultrasonic, high frequency current, or sensor circuit. The common first stage drive circuit may be configured to couple to a second stage ultrasonic drive circuit, a second stage high frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to couple to the ultrasonic transducer, the second stage high frequency drive circuit configured to couple to the electrode, and the second stage sensor drive circuit configured to couple to the sensor.
[0286] In another aspect, the present disclosure provides a surgical instrument comprising: a control circuit including a memory coupled to a processor, the processor configured to generate a digital waveform; a handle assembly including a common first stage circuit coupled to the processor, the common first stage circuit configured to receive the digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the common first stage circuit to receive and amplify the analog waveform, the shaft assembly configured to be in mechanical and electrical communication with the handle assembly.
[0287] The common first stage circuit may be configured to drive an ultrasonic, high frequency current, or sensor circuit. The common first stage drive circuit may be configured to couple to a second stage ultrasonic drive circuit, a second stage high frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to couple to an ultrasonic transducer, the second stage high frequency drive circuit configured to couple to an electrode, and the second stage sensor drive circuit configured to couple to a sensor.
[0288] 32 illustrates a generator circuit 3400 split into a first stage circuit 3404 and a second stage circuit 3406 according to at least one embodiment of the present disclosure. In one embodiment, a surgical instrument of a surgical system 1000 described herein may include a generator circuit 3400 split into multiple stages. For example, a surgical instrument of a surgical system 1000 may include a generator circuit 3400 split into at least two circuits, a first stage circuit 3404 and a second stage circuit 3406 of amplification that allow operation with RF energy only, ultrasonic energy only, and / or a combination of RF and ultrasonic energy. A combination modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within the handle assembly 3412 and a modular second stage circuit 3406 integral with the modular shaft assembly 3414. As discussed above throughout this description in connection with the surgical instruments of the surgical system 1000, the battery assembly 3410 and the shaft assembly 3414 are configured to be in mechanical and electrical communication with the handle assembly 3412. The end effector assembly is configured to be in mechanical and electrical communication with the shaft assembly 3414.
[0289] Referring now to FIG. 32 , the generator circuit 3400 is divided into multiple stages located within multiple modular assemblies of a surgical instrument, such as the surgical instrument of the surgical system 1000 described herein. In one aspect, the control stage circuit 3402 may be located within the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is the control circuit 3200 described in connection with FIG. 30 . The control circuit 3200 comprises a processor 3214 including internal memory 3217 ( FIG. 32 ) (e.g., volatile and non-volatile memory) and is electrically coupled to a battery 3211. The battery 3211 provides power to the first stage circuit 3404, the second stage circuit 3406, and the third stage circuit 3408, respectively. As previously mentioned, the control circuit 3200 generates the digital waveform 4300 ( FIG. 37 ) using the circuits and techniques described in connection with FIGS. 35 and 36 . 32, the digital waveform 4300 can be configured to drive an ultrasonic transducer, a radio frequency (e.g., RF) electrode, or a combination thereof, either individually or simultaneously. If driven simultaneously, a filter circuit may be provided within the corresponding first stage circuit 3404 to select either the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned U.S. Patent Application Publication No. US-2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR," which is incorporated herein by reference in its entirety.
[0290] The first stage circuitry 3404 (e.g., first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, and first stage sensor drive circuit 3424) is located within the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic drive signal to the first stage ultrasonic drive circuit 3420 via outputs SCL-A, SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 is described in detail in connection with FIG. 29. The control circuit 3200 provides an RF drive signal to the first stage RF drive circuit 3422 via outputs SCL-B, SDA-B of the control circuit 3200. The first stage RF drive circuit 3422 is described in detail in connection with FIG. 34. The control circuit 3200 provides a sensor drive signal to the first stage sensor drive circuit 3424 via outputs SCL-C, SDA-C of the control circuit 3200. Generally, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section for driving the second stage circuit 3406. The output of the first stage circuit 3404 is provided to the input of the second stage circuit 3406.
[0291] The control circuit 3200 is configured to detect which modules are plugged into the control circuit 3200. For example, the control circuit 3200 is configured to detect whether the first stage ultrasonic drive circuit 3420, the first stage RF drive circuit 3422, or the first stage sensor drive circuit 3424 located in the handle assembly 3412 is connected to the battery assembly 3410. Similarly, each of the first stage circuits 3404 can detect which second stage circuit 3406 is connected to it, and that information is returned to the control circuit 3200 to determine the type of signal waveform to generate. Similarly, each of the second stage circuits 3406 can detect which third stage circuit 3408 or component is connected to it, and that information is returned to the control circuit 3200 to determine the type of signal waveform to generate.
[0292] In one aspect, the second stage circuit 3406 (e.g., ultrasonic drive second stage circuit 3430, RF drive second stage circuit 3432, and sensor drive second stage circuit 3434) is located within the shaft assembly 3414 of the surgical instrument. The first stage ultrasonic drive circuit 3420 provides a signal to the second stage ultrasonic drive circuit 3430 via outputs US Left / US Right. The second stage ultrasonic drive circuit 3430 may include, for example, a transformer, a filter, an amplifier, and / or signal conditioning circuitry. The first stage radio frequency (RF) current drive circuit 3422 provides a signal to the second stage RF drive circuit 3432 via outputs RF Left / RF Right. In addition to a transformer and blocking capacitors, the second stage RF drive circuit 3432 may further include a filter, an amplifier, and signal conditioning circuitry. The first stage sensor drive circuit 3424 provides a signal to the second stage sensor drive circuit 3434 via outputs Sensor 1 / Sensor 2. The second stage sensor driver circuit 3434 may include filters, amplifiers, and signal conditioning circuitry depending on the type of sensor. The output of the second stage circuit 3406 is provided to the input of the third stage circuit 3408.
[0293] In one aspect, the third stage circuit 3408 (e.g., the ultrasonic transducer 1120, the RF electrodes 3074a, 3074b, and the sensor 3440) may be located within the various assemblies 3416 of the surgical instrument. In one aspect, the second stage ultrasonic drive circuit 3430 provides a drive signal to the piezoelectric stack of the ultrasonic transducer 1120. In one aspect, the ultrasonic transducer 1120 is located within the ultrasonic transducer assembly of the surgical instrument. However, in other aspects, the ultrasonic transducer 1120 may be located within the handle assembly 3412, the shaft assembly 3414, or the end effector. In one aspect, the second stage RF drive circuit 3432 provides a drive signal to the RF electrodes 3074a, 3074b, which are located generally within the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides a drive signal to the various sensors 3440 located throughout the surgical instrument.
[0294] 33 illustrates a generator circuit 3500 split into multiple stages, with a first stage circuit 3504 common to a second stage circuit 3506, according to at least one embodiment of the present disclosure. In one embodiment, a surgical instrument of a surgical system 1000 described herein may include a generator circuit 3500 split into multiple stages. For example, a surgical instrument of a surgical system 1000 may include a generator circuit 3500 split into at least two circuits, a first stage circuit 3504 and a second stage circuit 3506 of amplification that allow operation with radio frequency (RF) energy only, ultrasonic energy only, and / or a combination of RF and ultrasonic energy. A combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integral with the modular shaft assembly 3514. As previously described throughout this description in connection with the surgical instruments of the surgical system 1000, the battery assembly 3510 and shaft assembly 3514 are configured to mechanically and electrically connect with the handle assembly 3512. The end effector assembly is configured to mechanically and electrically connect with the shaft assembly 3514.
[0295] As shown in the embodiment of FIG. 33 , the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the control circuit 3200 described above. The handle assembly 3512 that connects to the battery assembly 3510 includes a common first stage drive circuit 3420. As described above, the first stage drive circuit 3420 is configured to drive ultrasonic, radio frequency (RF) current, and sensor loads. The output of the common first stage drive circuit 3420 can drive any one of the second stage circuits 3506, such as the second stage ultrasonic drive circuit 3430, the second stage radio frequency (RF) current drive circuit 3432, and / or the second stage sensor drive circuit 3434. The common first stage drive circuit 3420 detects which second stage circuit 3506 is located within the shaft assembly 3514 when the shaft assembly 3514 is connected to the handle assembly 3512. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 determines which one of the second stage circuits 3506 (e.g., second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and / or second stage sensor drive circuit 3434) is located within the shaft assembly 3514. This information is provided to the control circuit 3200 located within the handle assembly 3512 to supply the appropriate digital waveform 4300 ( FIG. 37 ) to the second stage circuit 3506 to drive the appropriate load, e.g., ultrasonic, RF, or sensor. It will be appreciated that identification circuitry may be included in the various assemblies 3516 within the third stage circuit 3508, such as the ultrasonic transducer 1120, the electrodes 3074 a, 3074 b, or the sensor 3440. Thus, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.
[0296] FIG. 34 is a circuit diagram of one embodiment of an electrical circuit 3600 configured to drive radio frequency (RF) current, in accordance with at least one embodiment of the present disclosure. The electrical circuit 3600 includes an analog multiplexer 3680. The analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A, such as RF, battery, and power control circuits. A current sensor 3682 is coupled in series with the return or ground section of the power supply circuit and measures the current provided by the power supply. A field-effect transistor (FET) temperature sensor 3684 provides ambient temperature. A pulse-width modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program neglects to provide a periodic system reset. This is provided to automatically reset the electrical circuit 3600 if it hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 3600 can be configured to drive an RF electrode or an ultrasonic transducer 1120, for example, as described with respect to FIG. 29 . Thus, referring again now to FIG. 34, electrical circuitry 3600 can be used to alternately drive both ultrasound and RF electrodes.
[0297] The driver circuit 3686 provides left and right RF energy outputs. Digital signals representing signal waveforms are provided to the SCL-A and SDA-A inputs of the analog multiplexer 3680 from a control circuit, such as the control circuit 3200 (FIG. 30). A digital-to-analog converter 3690 (DAC) converts the digital input to an analog output to drive a PWM circuit 3692 coupled to an oscillator 3694. The PWM circuit 3692 provides a first signal to a first gate driver circuit 3696a coupled to a first transistor output stage 3698a to drive the first RF+ (left) energy output. The PWM circuit 3692 also provides a second signal to a second gate driver circuit 3696b coupled to a second transistor output stage 3698b to drive the second RF (right) energy output. A voltage sensor 3699 is coupled between the RF-Left / RF-Output terminals to measure the output voltage. The driver circuit 3686, the first and second driver circuits 3696a, 3696b, and the first and second transistor output stages 3698a, 3698b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 30) generates a digital waveform 4300 (FIG. 37) using circuitry such as direct digital synthesis (DDS) circuits 4100, 4200 (FIGS. 35 and 36). The DAC 3690 receives the digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.
[0298] In one aspect, the ultrasonic or radio frequency current generator of the surgical system 1000 can be configured to digitally generate the electrical signal waveform, desirably using a predetermined number of phase points stored in a lookup table to digitize the waveform. The phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 35 shows one aspect of a basic architecture for a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 4100, configured to generate multiple waveforms for the electrical signal waveform. The generator software and digital control can instruct the FPGA to scan addresses in the lookup table 4104, which in turn provides various digital input values to a DAC circuit 4108 that feeds the power amplifier. The addresses may be scanned according to the desired frequency. Using such a lookup table 4104 allows for the generation of various types of waveforms that can be delivered into tissue, or into a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasonic instruments. Additionally, multiple lookup tables 4104 representing multiple waveforms can be created, stored, and applied to the tissue from the generator.
[0299] The waveform signal may be configured to control at least one of the output current, output voltage, or output power of an ultrasonic transducer and / or RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). Furthermore, if the surgical instruments include ultrasonic components, the waveform signal may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Thus, the generator may be configured to provide a waveform signal to at least one surgical instrument, the waveform signal responsive to at least one waveform of a plurality of waveforms in a table. Note that the waveform signals provided to the two surgical instruments may include two or more waveforms. The table may include information related to the plurality of waveforms, and the table may be stored within the generator. In one aspect or embodiment, the table may be a direct digital synthesis table and may be stored within the generator's FPGA. The table may be addressed by any method that is convenient for categorizing waveforms. According to one aspect, the table, which may be a direct digital synthesis table, is addressed according to the frequency of the waveform signal. Additionally, information relating to multiple waveforms may be stored as digital information in a table.
[0300] The analog electrical signal waveform may be configured to control at least one of the output current, output voltage, or output power of an ultrasonic transducer and / or RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). Furthermore, if the surgical instrument includes an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Thus, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, where the analog electrical signal waveform corresponds to at least one waveform of a plurality of waveforms stored in the lookup table 4104. Note that the analog electrical signal waveforms provided to the two surgical instruments may include two or more waveforms. The lookup table 4104 may include information related to a plurality of waveforms, and the lookup table 4104 may be stored in either the generator circuit or the surgical instrument. In one aspect or embodiment, the lookup table 4104 may be a direct digital synthesis table, which may be stored in the generator circuitry or FPGA of the surgical instrument. The lookup table 4104 may be addressed by any convenient method for categorizing waveforms. According to one aspect, the lookup table 4104, which may be a direct digital synthesis table, is addressed according to the frequency of the desired analog electrical signal waveform. Furthermore, information related to multiple waveforms may be stored in the lookup table 4104 as digital information.
[0301] With the widespread use of digital technology in instrumentation and communication systems, a digitally controlled method for generating multiple frequencies from a reference frequency has evolved and is called direct digital synthesis. The basic architecture is shown in Figure 35. In this simplified block diagram, the DDS circuitry is coupled to a processor, controller, or logic of the generator circuitry and to memory circuitry located within the generator circuitry of the surgical system 1000. The DDS circuitry 4100 includes an address counter 4102, a look-up table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. A stable clock f c is received by an address counter 4102, and a register 4106 drives a programmable read-only memory (PROM) that stores one or more integer numbers of cycles of a sine wave (or any other waveform) in a look-up table 4104. As the address counter 4102 steps through the memory locations, the values stored in the look-up table 4104 are written to a register 4106 that is coupled to a DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location of the look-up table 4104 drives the DAC circuit 4108, which in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. Phase noise is essentially a function of the phase of a reference clock f c The first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has a frequency f out It has.
[0302] Because the DDS circuit 4100 is a sampled data system, it must consider issues associated with sampling, such as quantization noise, aliasing, and filtering. For example, whereas the higher harmonics of a phase-locked-loop (PLL)-based synthesizer's output can be filtered, the higher harmonics of the DAC circuit 4108 output frequency fold back into the Nyquist bandwidth, making them unfilterable. The lookup table 4104 contains signal data for an integer number of cycles. The final output frequency f out is the reference clock frequency f c or by reprogramming the PROM.
[0303] The DDS circuit 4100 may include multiple lookup tables 4104, which store waveforms represented by a predetermined number of samples, where the samples define a predetermined waveform shape. Thus, multiple waveforms with unique shapes can be stored in the multiple lookup tables 4104 to provide various tissue treatments based on instrument settings or tissue feedback. Example waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuit 4100 can create multiple waveform lookup tables 4104 and switch between the various waveforms stored in the individual lookup tables 4104 during a tissue treatment procedure (e.g., “on the fly” or in substantial real time based on user or sensor input) based on the desired tissue effect and / or tissue feedback.
[0304] Thus, switching between waveforms can be based on, for example, tissue impedance and other factors. In other embodiments, the lookup table 4104 can store an electrical signal waveform (i.e., a trapezoidal or square wave) shaped to maximize the power delivered into the tissue per cycle. In other embodiments, the lookup table 4104 can store synchronized waveforms that maximize power delivery by the multifunction surgical instrument of the surgical system 1000 while delivering RF and ultrasonic drive signals. In still other embodiments, the lookup table 4104 can store electrical signal waveforms that simultaneously drive ultrasoni...
Claims
1. 1. An ultrasonic surgical instrument comprising: an end effector comprising an ultrasonic blade; an ultrasonic transducer acoustically coupled to the ultrasonic blade and configured to ultrasonically vibrate the ultrasonic blade in response to a drive signal; an infrared source configured to radiate infrared energy to tissue within the end effector; An infrared detector; a control circuit coupled to the ultrasonic transducer and the infrared detector, the control circuit comprising: receiving infrared energy reflected by the tissue via the infrared detector; determining a tissue composition of the tissue according to the reflected infrared energy; and An ultrasonic surgical instrument configured to adjust operating parameters of the ultrasonic surgical instrument according to the tissue composition.
2. The ultrasonic surgical instrument of claim 1 , wherein the operating parameters include at least one of a warm-up time of the ultrasonic blade or an ultrasonic blade temperature threshold.
3. a memory coupled to the control circuit, the memory storing a plurality of tissue compositions according to the reflected infrared energy; 10. The ultrasonic surgical instrument of claim 1, wherein the control circuitry is configured to determine the tissue composition of the tissue by retrieving from the memory which of the plurality of tissue compositions corresponds to the reflected infrared energy.
4. the end effector further comprising a clamp arm pivotally moveable relative to the ultrasonic blade; The ultrasonic surgical instrument of claim 1 , wherein at least one of the infrared source and the infrared detector is disposed on the clamp arm.
Citation Information
Patent Citations
Surgical instruments with sensors and power control
JP2014500063A
Frequency Shifting Multi Mode Ultrasonic Dissector
US20110213397A1
Medical Tool With Electromechanical Control and Feedback
US20160374723A1
Circuits for supplying isolated direct current (DC) voltage to surgical instruments
US20170086911A1
Measurement device, measurement system, measurement method, control program, and recording medium
WO2012033139A1