JP2021508557A - State estimation of ultrasonic end effector and control system for it - Google Patents

Abstract

Various aspects of generators, ultrasonic devices, and methods for estimating the state of the end effector of an ultrasonic device are disclosed. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, including an ultrasonic transducer connected to an ultrasonic blade. The control circuit measures the complex impedance of the ultrasonic transducer, and the complex impedance is defined as Eq. (1). The control circuit receives the complex impedance measurement data points and compares the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern. The control circuit then classifies the complex impedance measurement data points based on the results of the comparative analysis and assigns the end effector state or status based on the results of the comparative analysis.

Description

(Cross-reference of related applications)
This application is filed August 28, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THE REFOR", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the US Patent Act. Claims interests in US non-provisional patent application Nos. 16 / 115,214.

This application is filed on August 23, 2018, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the US Patent Act. Claims priority over US Provisional Patent Application No. 62 / 721,995.

This application is a US provisional patent application filed on August 23, 2018, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the US Patent Act. Claim priority over 62 / 721,998.

This application is filed in the United States on August 23, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACTIVE COUPLING", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the U.S. Patent Act. Claim priority over Provisional Patent Application No. 62 / 721,999.

This application is entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESS PRESS ON ENERGY MODALITY", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the US Patent Act, August 23, 2018. Claim priority over US Provisional Patent Application No. 62 / 721,994.

This application is filed on August 23, 2018, entitled "RADIO FREENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRIC SIGNALS", the entire disclosure of which is incorporated herein by reference under Article 119 (e) of the US Patent Act. Claims priority over US Provisional Patent Application No. 62 / 721,996.

This application is further entitled "SMART ACTIVE OF AN ENERGY DEVICE BY ANOTHER DEVICE", which is incorporated herein by reference in its entirety under Article 119 (e) of the US Patent Act, June 30, 2018. US Provisional Patent Application No. 62 / 692,747 filed in Japan, US Provisional Patent Application No. 62 / 692,748, filed June 30, 2018, entitled "SMART ENERGY ARCHITECTURE", and "SMART ENERGY DEVICES" Claims priority over US Provisional Patent Application No. 62 / 692,768 filed June 30, 2018.

This application is further under Article 119 (e) of the United States Patent Act, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR", the entire disclosure of which is incorporated herein by reference. U.S. Provisional Patent Application Nos. 62 / 640,417 of the Japanese filing, and U.S. Provisional Patent Application No. 62 / 640,415 of the March 8, 2018 application entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTOR SYSTEM THEREFOR" Claim the interests of priority.

This application is further under Article 119 (e) of the US Patent Act, entitled "CAPACITIIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS", the entire disclosure of which is incorporated herein by reference. US Provisional Patent Application No. 62 / 650,898 filed in Japan, US Provisional Patent Application No. 62 / 650,887 filed on March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES", "SMOKE EVACUATIONMO US Provisional Patent Application No. 62 / 650,882, filed March 30, 2018, entitled "INTERACTIVE SURGICAL PLATFORM", and US Provisional Patent, March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS" Claim the benefit of the priority of 62 / 650,877.

This application is also a US provisional patent filed on December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," in which the entire disclosure is incorporated herein by reference under Section 119 (e) of the US Patent Act. Application No. 62 / 611,341, U.S. Provisional Patent Application No. 62 / 611,340, filed December 28, 2017, entitled "CLOUD-BASED MEDICAL ANALYTICS", and December 2017, entitled "ROBOT ASSISTED SURGICAL PLATFORM". Claims the priority benefit of US Provisional Patent Application No. 62 / 611,339 filed on 28th May.

Surgical environments may require smart energy devices within a smart energy architecture environment. Ultrasound surgical devices, such as scalpels, are being found in increasingly widespread use in surgical procedures due to their unique performance characteristics. With specific device configurations and operating parameters, ultrasonic surgical devices can provide homeostasis by substantially simultaneous transverse incision and coagulation of tissue, preferably minimizing patient trauma. The ultrasonic surgical device was coupled to a handpiece containing an ultrasonic transducer, as well as an ultrasonic transducer having a distally attached end effector (eg, blade tip) for cutting and sealing tissue. May include instruments. In some cases, the device can be permanently attached to the handpiece. In other cases, the device can be removable from the handpiece, as in the case of disposable or replaceable devices. The end effector transfers ultrasonic energy to the tissue in contact with the end effector to achieve cutting and sealing action. Such ultrasonic surgical devices can be configured for open surgery applications, laparoscopic or endoscopic surgery including robot-assisted surgery.

Ultrasonic energy can be transferred to the end effector by an ultrasonic generator that cuts and coagulates tissue using lower temperatures than those used in electrosurgical procedures and communicates with the handpiece. The ultrasonic blade vibrates at high frequencies (eg, 55,500 cycles per second) to denature proteins in tissue to form sticky clots. When pressure is applied to the tissue by the blade surface, the blood vessels collapse, allowing the clot to form a hemostatic seal. The surgeon can control the cutting rate and coagulation due to the force applied to the tissue by the end effector, the time the force is applied, and the execution level of the end effector selected.

The ultrasonic transducer is modeled as an equivalent circuit that includes a first branch with capacitance, a second "working" branch with series-connected inductance, resistance, and capacitance that defines the electromechanical properties of the resonator. Can be done. Known ultrasonic generators may include a tuning inductor for tuning out the capacitance at a resonant frequency so that substantially all of the generator drive signal current flows within the operating branch. Therefore, by using a tuning inductor, the drive signal current of the generator represents the operating branch current, so the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuned inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency fixation capability of the generator. However, the tuning inductor must be compatible with the particular capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different capacitances require different tuning inductors.

In addition, in some ultrasonic generator structures, the generator drive signal exhibits asymmetric harmonic distortion that complicates impedance scale and phase measurements. For example, the accuracy of impedance phase measurements can be reduced by harmonic distortion of current and voltage signals.

Moreover, electromagnetic interference in a noisy environment reduces the ability of the generator to maintain a fixed resonant frequency of the ultrasonic transducer and increases the possibility of invalid control algorithm inputs.

Electrosurgical devices for applying electrical energy to tissue to treat and / or destroy tissue have also been found in increasingly widespread use in surgical procedures. Electrosurgical instruments can include instruments with handpieces and distally attached end effectors (eg, one or more electrodes). The end effector can be positioned relative to the tissue so that current is introduced into the tissue. The electrosurgical device can be configured for bipolar or unipolar operation. During bipolar operation, each current is introduced into the tissue by the working electrode of the end effector and returned from the tissue by the return electrode of the end effector. During unipolar operation, current is introduced into the tissue by the active electrode of the end effector and is returned via a return electrode (eg, ground pad) that is located separately on the patient's body. The heat generated by the current flowing through the tissue may form a hemostatic seal within and / or between the tissues, and thus may be particularly useful, for example, to seal a blood vessel. The end effector of the electrosurgical device may also include a cutting member that is movable with respect to the tissue and electrodes for making a transverse incision in the tissue.

The electrical energy applied by the electrosurgical device can be transferred to the instrument by a generator that communicates with the handpiece. Electrical energy may be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that can be in the frequency range of 300 kHz to 1 MHz, as described in EN60601-2-2: 2009 + A11: 2011, Definition 2011.3.218-HIGH FREENCY. For example, frequencies in unipolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, the frequency can be of almost any value. Frequencies above 200 kHz are typically used in unipolar applications to avoid unnecessary nerve and muscle irritation resulting from the use of low frequency currents. Lower frequencies can be used for bipolar techniques if risk analysis shows that the potential for neuromuscular stimulation has been mitigated to acceptable levels. Frequencies above 5 MHz are typically not used to minimize problems associated with high frequency leakage currents. Generally, 10 mA is recognized as the lower threshold of thermal effect on tissue.

During its operation, the electrosurgical device can transfer low frequency RF energy through the tissue, which causes ionic agitation or friction, or resistance heating, which raises the temperature of the tissue. A clear boundary can be formed between the tissue to be treated and the surrounding tissue, allowing the surgeon to perform surgery with a high level of accuracy and control without sacrificing adjacent non-target tissue. The low operating temperature of RF energy can be useful in simultaneously sealing blood vessels while removing, contracting, or engraving soft tissue. RF energy can work particularly well on connective tissue, which is composed primarily of collagen and contracts when in contact with heat.

Due to the need for these unique drive signals, sensing and feedback, ultrasonic and electrosurgical devices generally required different generators. In addition, if the instruments are disposable or compatible with handpieces, ultrasonic and electrosurgical generators recognize the particular instrument configuration used and thus optimize those for control and diagnostic processes. Ability is limited. Moreover, the capacitive coupling between the generator's non-insulated circuit and the patient's insulated circuit can result in exposing the patient to unacceptable levels of leakage current, especially when higher voltages and frequencies are used.

Moreover, due to the need for these unique drive signals, sensing and feedback, ultrasonic and electrosurgical devices have generally required different user interfaces for different generators. In these conventional ultrasonic and electrosurgical devices, one user interface may be configured for use with an ultrasonic instrument, while another user interface may be configured for use with an electrosurgical instrument. is there. Such user interfaces include hand and / or foot-activated user interfaces such as hand-activated switches and / or foot-activated switches. Various aspects of combined generators for use with both ultrasound and electrosurgical instruments are conceived in subsequent disclosures and thus work with both ultrasound and / or electrosurgical instrument generators. Additional user interfaces configured as such are also considered.

An additional user interface for providing feedback to either the user or any other machine to provide feedback indicating the mode or state of operation of any of the ultrasound and / or electrosurgical instruments will be provided in the subsequent disclosure. Will be considered. Providing user and / or mechanical feedback for manipulating a combination of ultrasound and / or electrosurgical instruments provides sensory feedback to the user and provides electrical / mechanical / electromechanical feedback to the machine. Need to do. A visual feedback device (eg, LCD display screen, LED indicator), an audible feedback device (eg, speaker, buzzer), or a tactile feedback device (eg, eg, for use with combined ultrasonic and / or electrosurgical instruments). Feedback devices incorporating tactile actuators) will be considered in subsequent disclosures.

Other electrosurgical instruments include, but are not limited to, irreversible and / or reversible electroporation and / or microwave technology. Therefore, the techniques disclosed herein apply, among other things, to ultrasound, bipolar or unipolar RF (electrosurgical), irreversible and / or reversible electroperforation, and / or microwave-based surgical instruments. It is possible.

In one general aspect, a method of estimating the state of the end effector of an ultrasonic device is provided. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system includes an ultrasonic transducer connected to an ultrasonic blade. The method is to measure the complex impedance of the ultrasonic transducer by the control circuit, and the composite impedance is

として定義される、測定することと、
制御回路によって、複素インピーダンス測定データ点を受信することと、制御回路によって、複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、制御回路によって、比較解析の結果に基づいて、複素インピーダンス測定データ点を分類することと、制御回路によって、比較解析の結果に基づいて、エンドエフェクタの状態又は状況を割り当てることと、を含む。

Defined as, measuring and
The control circuit receives the complex impedance measurement data points, the control circuit compares the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern, and the control circuit results in comparative analysis. Includes classifying complex impedance measurement data points based on, and assigning end effector states or situations by control circuitry based on the results of comparative analysis.

Another Asspec provides a generator for estimating the state of the end effector of an ultrasonic device. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, the electromechanical ultrasonic system includes an ultrasonic transducer connected to an ultrasonic blade, and a generator is connected to a memory. Including the control circuit, the control circuit is to measure the complex impedance of the ultrasonic transducer, and the complex impedance is

として定義される、測定することと、複素インピーダンス測定データ点を受信することと、複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、比較解析の結果に基づいて、複素インピーダンス測定データ点を分類することと、比較解析の結果に基づいて、エンドエフェクタの状態又は状況を割り当てることと、を行うように構成されている。

Based on the measurement, receiving the complex impedance measurement data points, comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern, and the results of the comparative analysis. , Complex impedance measurement data points are classified and the state or status of the end effector is assigned based on the result of the comparative analysis.

In yet another aspect, an ultrasonic device for estimating the state of the end effector is provided. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system includes an electromechanical ultrasonic system including an ultrasonic transducer connected to an ultrasonic blade. A control circuit connected to a memory is provided, and the control circuit measures the complex impedance of the ultrasonic transducer.

として定義される、測定することと、複素インピーダンス測定データ点を受信することと、複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、比較解析の結果に基づいて、複素インピーダンス測定データ点を分類することと、比較解析の結果に基づいて、エンドエフェクタの状態又は状況を割り当てることと、を行うように構成されている。

Based on the measurement, receiving the complex impedance measurement data points, comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern, and the results of the comparative analysis. , Complex impedance measurement data points are classified and the state or status of the end effector is assigned based on the result of the comparative analysis.

In yet another aspect, a method of estimating the state of the end effector of the ultrasonic device is provided. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system includes an ultrasonic transducer connected to an ultrasonic blade. The method is to apply a drive signal to the ultrasonic transducer by a drive circuit, the drive signal is a periodic signal defined by magnitude and frequency.
Sweeping the frequency of the drive signal from less than the resonance to above the resonance of the electromagnetic ultrasonic system by a processor or control circuit.
By a processor or control circuit, the impedance / admittance circle variables _{R e, G e, X e} , and that the _{B e} measuring and recording, by a processor or controller, the measured impedance / admittance circle variables _{R e, G} e, X _e, and _{B e,} the reference impedance / admittance circle variables _{R ref, G ref, X ref} , and comparing the _{B ref,} by a processor or controller, state or condition of the end effector on the basis of the result of the comparative analysis To determine and include.

The features of the various aspects are described in detail within the appended claims. However, various aspects of both the mechanism and the method of operation, along with their further objectives and advantages, can be best understood by reference to the following description, in conjunction with the accompanying drawings below.
FIG. 6 is a block diagram of a computer-mounted interactive surgical system according to at least one aspect of the present disclosure. A surgical system used to perform a surgical procedure in an operating room according to at least one aspect of the present disclosure. 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. FIG. 3 is a partial perspective view of a surgical hub housing and a combination generator module slidably acceptable in the drawer of the surgical hub housing according to at least one aspect of the present disclosure. FIG. 3 is a perspective view of a combination generator module with bipolar, ultrasonic, and unipolar contacts, as well as smoke exhaust components, according to at least one aspect of the present disclosure. Demonstrates the individual power bus attachments of a plurality of lateral docking ports of a laterally modular housing configured to accept a plurality of modules according to at least one aspect of the present disclosure. Demonstrates a vertically modular housing configured to accept multiple modules according to at least one aspect of the present disclosure. A modular device located in one or more operating rooms of a medical facility, or any room in a medical facility equipped with specialized equipment for surgical procedures, according to at least one aspect of the present disclosure. Shown is a surgical data network with a modular communication hub configured to connect. A computer-mounted interactive surgical system according to at least one aspect of the present disclosure is shown. Demonstrates a surgical hub with a plurality of modules connected to a modular control tower according to at least one aspect of the present disclosure. An aspect of a universal serial bus (USB) network hub device according to at least one aspect of the present disclosure is shown. A logical diagram of a control system for a surgical instrument or tool according to at least one aspect of the present disclosure is shown. Demonstrates a control circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates a combination logic circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates an order logic circuit configured to control aspects of a surgical instrument or tool according to at least one aspect of the present disclosure. Demonstrates 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. FIG. 6 is a circuit diagram of a robotic surgical instrument configured to operate the surgical tools described herein, according to at least one aspect of the present disclosure. FIG. 3 shows a block diagram of a surgical instrument programmed to control the distal translation of a displacement member according to at least one aspect of the present disclosure. It is a circuit diagram of a surgical instrument configured to control various functions according to at least one aspect of the present disclosure. A system configured to perform an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communication hub according to at least one aspect of the present disclosure. An embodiment of a generator according to at least one aspect of the present disclosure is shown. A surgical system comprising a generator and various surgical instruments that can be used with the generator according to at least one aspect of the present disclosure. An end effector according to at least one aspect of the present disclosure. FIG. 2 is a diagram of the surgical system of FIG. 22 according to at least one aspect of the present disclosure. It is a model showing an operating branch current according to at least one aspect of the present disclosure. It is a structural diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a functional diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a functional diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a functional diagram of the architecture of the generator according to at least one aspect of the present disclosure. It is a structural and functional aspect of the generator according to at least one aspect of the present disclosure. It is a structural and functional aspect of the generator according to at least one aspect of the present disclosure. It is a circuit diagram of one aspect of an ultrasonic drive circuit. It is a circuit diagram of the transformer connected to the ultrasonic drive circuit shown in FIG. 29 according to at least one aspect of the present disclosure. FIG. 30 is a circuit diagram of a transformer shown in FIG. 30 connected to a test circuit according to at least one aspect of the present disclosure. It is a circuit diagram of the control circuit according to at least one aspect of this disclosure. Shown is a simplified block schematic illustrating another electrical circuit housed within a modular ultrasonic surgical instrument according to at least one aspect of the present disclosure. A generator circuit divided into a plurality of stages according to at least one aspect of the present disclosure is shown. Shown is a generator circuit divided into a plurality of stages in which the first stage circuit is common to the second stage circuit according to at least one aspect of the present disclosure. It is a circuit diagram of one aspect of a drive circuit configured to drive a radio frequency current (RF) according to at least one aspect of the present disclosure. It is a circuit diagram of the transformer connected to the RF drive circuit shown in FIG. 34 according to at least one aspect of the present disclosure. FIG. 6 is a schematic of a circuit with separate power supplies for high power energy / drive circuits and low power circuits, according to one aspect of resent disclosure. For surgical instruments, we show a control circuit that allows a dual generator system to switch between RF generator energy modality and ultrasonic generator energy modality. FIG. 5 shows a diagram of one aspect of a surgical instrument comprising a feedback system for use with the surgical instrument, according to one aspect of the retransmitted disclosure. Digital synthesis, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms for electrical signal waveforms for use in surgical instruments, according to at least one aspect of the present disclosure. An aspect of the basic architecture of the circuit is shown. Shown is an aspect of a direct digital compositing (DDS) circuit configured to generate multiple waveforms of electrical signal waveforms for use in surgical instruments, according to at least one aspect of the present disclosure. Analog Waveforms According to At least One Aspect of the Disclosure One cycle of a discrete-time digital electrical signal waveform according to at least one aspect of the present disclosure (shown superimposed on a discrete-time digital electrical signal waveform for comparison purposes). Shown. Control according to one aspect of the present disclosure to provide gradual closure of the closing member as the closing member advances distally to close the clamp arm and apply a closing force load at a desired speed. It is a diagram of the system. A proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure is shown. Elevation disassembly of a modular handheld ultrasonic surgical instrument according to an aspect of the present disclosure, in which the left shell half is removed from the handle assembly to expose the device identifier communicatively linked to the multilead handle terminal assembly. It is a figure. FIG. 6 is a detailed view of a trigger portion and a switch of the ultrasonic surgical instrument shown in FIG. 46 according to at least one aspect of the present disclosure. It is a fragmentary enlarged perspective view of the end effector from the distal end where the jaw member is in the open position according to at least one aspect of the present disclosure. FIG. 5 is a system diagram of a segmented circuit comprising a plurality of independently operating circuit segments according to at least one aspect of the present disclosure. It is a circuit diagram of various components of a surgical instrument having a motor control function according to at least one aspect of the present disclosure. An aspect of an end effector with an RF data sensor located on a jaw member is shown according to at least one aspect of the present disclosure. Shown is one aspect of the flexible circuit shown in FIG. 51, according to at least one aspect of the present disclosure, wherein the sensor can be attached to or integrally formed with the flexible circuit. An alternative system for controlling the frequency of an ultrasonic electromechanical system and detecting its impedance, according to at least one aspect of the present disclosure. It is a spectrum of the same ultrasonic apparatus having various different states and situations of end effectors, in which the phase and magnitude of the impedance of the ultrasonic transducer are plotted as a function of frequency according to at least one aspect of the present disclosure. FIG. 5 is a graph of a plot of a set of 3D training data S in which the magnitude and phase of ultrasonic transducer impedances are plotted as a function of frequency according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for determining a jaw situation based on a complex impedance characteristic pattern (fingerprint) according to at least one aspect of the present disclosure. It is a circle plot of complex impedance plotted as an imaginary component with respect to the real component of the piezoelectric oscillator according to at least one aspect of the present disclosure. It is a circle plot of complex admittance plotted as an imaginary component with respect to the real component of the piezoelectric oscillator according to at least one aspect of the present disclosure. A circular plot of complex admittance for a 55.5 kHz ultrasonic piezoelectric transducer. A graph representation of an impedance analyzer showing an impedance / admittance circle plot of an open, unloaded ultrasonic device according to at least one aspect of the present disclosure, where red indicates admittance and blue indicates impedance. ing. A graph representation of an impedance analyzer showing an impedance / admittance circle plot of an ultrasonic device with jaws clamped on dry chamois leather according to at least one aspect of the present disclosure, with red indicating admittance and blue indicating impedance. ing. A graph representation of an impedance analyzer showing an impedance / admittance circle plot of an ultrasonic device with a jaw tip clamped onto a wet chamois according to at least one aspect of the present disclosure, with red indicating admittance and blue indicating impedance. Shown. A graph representation of an impedance analyzer showing an impedance / admittance circle plot of an ultrasonic device with jaws fully clamped on a wet chamois, according to at least one aspect of the present disclosure, where red indicates admittance and blue indicates impedance. Shown. Frequencies are swept from 48 kHz to 62 kHz to capture multiple resonances of the ultrasonic device that Joe is open to help see the circle in the gray overlap according to at least one aspect of the present disclosure. It is a graph display of an impedance analyzer showing an impedance / admittance plot. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for determining a jaw situation based on an estimation of the radius and offset of an impedance / admittance circle according to at least one aspect of the present disclosure. It is a graph figure of the ultrasonic transducer current hemostasis algorithm. FIG. 5 is a graph of the percentage of maximum current to an ultrasonic transducer as a function of time. It is a graph figure of the ultrasonic transducer current hemostasis algorithm. FIG. 5 is a graph of ultrasonic blade temperature as a function of time and tissue type according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for controlling the temperature of an ultrasonic blade based on a tissue type according to at least one aspect of the present disclosure. A logical flow diagram of a process according to an aspect of the present disclosure showing a control program or logical configuration for monitoring the impedance of an ultrasonic transducer in order to profile the ultrasonic blade and deliver power to the ultrasonic blade on the profile. Is. FIG. 5 is a series of graphs according to one aspect of the present disclosure, in which an ultrasonic blade is profiled and the impedance of the ultrasonic transducer is monitored in order to deliver power to the ultrasonic blade on the profile. It is a graph figure of the initial impedance of an ultrasonic transducer as a function of time. FIG. 5 is a series of graphs according to one aspect of the present disclosure, in which an ultrasonic blade is profiled and the impedance of the ultrasonic transducer is monitored in order to deliver power to the ultrasonic blade on the profile. FIG. 5 is a graph of power delivered to an ultrasonic blade as a function of time based on initial impedance. FIG. 5 is a series of graphs according to one aspect of the present disclosure, in which an ultrasonic blade is profiled and the impedance of the ultrasonic transducer is monitored in order to deliver power to the ultrasonic blade on the profile. It is a graph of the new impedance of an ultrasonic transducer as a function of time. FIG. 5 is a series of graphs according to one aspect of the present disclosure, in which an ultrasonic blade is profiled and the impedance of the ultrasonic transducer is monitored in order to deliver power to the ultrasonic blade on the profile. FIG. 5 is a graph of the tuned power delivered to the ultrasonic blades based on the new impedance. A system for adjusting the complex impedance of an ultrasonic transducer in order to compensate for power loss when the ultrasonic blade is in joint motion, according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for compensating for output power as a function of joint angle according to at least one aspect of the present disclosure. A system for measuring the complex impedance of an ultrasonic transducer in real time to determine the operation performed by the ultrasonic blade according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for determining an operation performed by an ultrasonic blade based on a complex impedance pattern according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram of an adaptive process showing a control program or logical configuration for identifying hemostatic vessels according to at least one aspect of the present disclosure. FIG. 5 is a graph of an ultrasonic transducer current profile as a function of time for venous and arterial vessel types according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram of an adaptive process showing a control program or logical configuration for identifying hemostatic vessels according to at least one aspect of the present disclosure. FIG. 5 is a graph of an ultrasonic transducer frequency profile as a function of time for venous and arterial vessel types according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram of a process showing a control program or logical configuration for identifying calcified blood vessels according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram of a process showing a control program or logical configuration for identifying calcified blood vessels according to at least one aspect of the present disclosure. FIG. 6 is a logical flow diagram of a process showing a control program or logical configuration for identifying calcified blood vessels according to at least one aspect of the present disclosure. FIG. 5 is a view of liver resection with blood vessels buried in parenchymal tissue according to at least one aspect of the present disclosure. FIG. 5 is a diagram of an ultrasonic blade in parenchymal tissue but not in contact with blood vessels, according to at least one aspect of the present disclosure. It is a magnitude / phase plot of the ultrasonic transducer impedance having a curve of parenchymal tissue shown in red according to at least one aspect of the present disclosure. It is a magnitude / phase plot of the ultrasonic transducer impedance having a curve of parenchymal tissue shown in red according to at least one aspect of the present disclosure. FIG. 5 is a diagram of an ultrasonic blade located in parenchymal tissue and in contact with large blood vessels. A magnitude / phase plot of an ultrasonic transducer impedance having a large vascular curve shown in blue, according to at least one aspect of the present disclosure. A magnitude / phase plot of an ultrasonic transducer impedance having a large vascular curve shown in blue, according to at least one aspect of the present disclosure. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for treating tissue in parenchymal tissue when a blood vessel is detected, according to at least one aspect of the present disclosure. To determine if the disposable portion of the reusable and disposable ultrasonic device according to at least one aspect of the present disclosure is properly installed, the status of the ultrasonic blade is identified and the clocked clamp arm status is determined. It is an ultrasonic device configured to judge. It is an end effector part of the ultrasonic apparatus shown in FIG. 87. To determine if the disposable portion of the reusable and disposable ultrasonic device according to at least one aspect of the present disclosure is properly installed, the status of the ultrasonic blade is identified and the clamp arm is fully distal. It is an ultrasonic device configured to determine whether or not it is. FIG. 5 is a logical flow diagram of a process showing a control program or logical configuration for identifying the status of reusable and disposable device components according to at least one aspect of the present disclosure. FIG. 3 is a three-dimensional graph of tissue radio frequency (RF) impedance classification according to at least one aspect of the present disclosure. FIG. 3 is a three-dimensional graph of tissue radio frequency (RF) impedance analysis according to at least one aspect of the present disclosure. FIG. 5 is a graph of carotid technology sensitivity in which a time impedance (Z) derivative as a function of initial radio frequency (RF) impedance is plotted according to at least one aspect of the present disclosure. FIG. 5 is a graph of the relationship between an initial frequency and a frequency change required to achieve a temperature of about 340 ° C. according to at least one aspect of the present disclosure. Setting the current (i) applied to the ultrasonic transducer of an ultrasonic electromechanical system to prevent the frequency (f) of the ultrasonic transducer from dropping below a predetermined threshold according to at least one aspect of the present disclosure. A feedback control system with an ultrasonic generator that adjusts the value is shown. FIG. 5 is a process logical flow diagram illustrating a control program or logical configuration of a controlled thermal management process for protecting an end effector pad according to at least one aspect of the present disclosure. FIG. 5 is a temperature vs. time graph comparing a desired temperature of an ultrasonic blade with a smart ultrasonic blade and a conventional ultrasonic blade according to at least one aspect of the present disclosure. It is a timeline showing the situational awareness of the surgical hub according to at least one aspect of the present disclosure.

The applicant of the present application owns the following US patent application filed on August 28, 2018, the entire disclosure of which is incorporated herein by reference.
-US Patent Application Reference No. END8560USNP2 / 180106-2, entitled "TEMPERATURE CONTORO OF ULTRASONIC END EFFECTOR AND CONTORL SYSTEM THEREFOR",
-US Patent Application Reference No. END8561USNP 1/180144-1, entitled "RADIO FREENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRIC SIGNALS",
-US Patent Application Reference No. END8563USNP 1/180139-1, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCRDING TO TISSUE LOCATION",
-US Patent Application Reference No. END8563USNP2 / 180139-2, entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE",
U.S. Patent Application Reference No. END8563USNP3 / 180139-3, entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM",
-US Patent Application Reference No. END8563USNP4 / 180139-4, entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT",
-US Patent Application Reference No. END8563USNP5 / 180139-5, entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR",
-US Patent Application Reference No. END8564USNP 1/1801401, entitled "Situational AWARENSS OF ELECTROSURGICAL SYSTEMS",
-US Patent Application Reference No. END8564USNP2 / 180140-2, entitled "MECHANIMSS FOR CONTROLLING DIFFERENT ELECTROMECANICAL SYSTEM SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT",
U.S. Patent Application Reference No. END8564USNP3 / 180140-3, entitled "DECTION OF END EFFECTOR IMMERSION IN LIQUID",
-US Patent Application Reference No. END8565USNP 1/1801421-1, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACTIVE COUPLING",
-US Patent Application Reference No. END8565USNP2 / 180142-2, entitled "INCREASING RADIO FREENCY TO CREATE PAD-LESS MONOPOLAR LOOP",
U.S. Patent Application Reference No. END8566USNP1 / 180143-1 and ・ "ACTIVATION NO.

The applicant of the present application owns the following US patent application filed on August 23, 2018, the entire disclosure of which is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 721,995, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCRDING TO TISSUE LOCATION",
-US Provisional Patent Application No. 62 / 721,998, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS",
-US Provisional Patent Application No. 62 / 721,999, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACTIVE COUPLING",
・ US provisional patent application No. 62 / 721,994 entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESS PRESS ON ENERGY MODALITY", and ・ "RADIO FREQUEEN SIGN" No. 721,996.

The applicant of the present application owns the following US patent application filed June 30, 2018, the entire disclosure of which is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 692,747, entitled "SMART ACTIVE OF AN ENERGY DEVICE BY ANOTHER DEVICE",
-US Provisional Patent Application No. 62 / 692,748 entitled "SMART ENERGY ARCHITECTURE" and-US Provisional Patent Application No. 62 / 692,768 entitled "SMART ENERGY DEVICES".

The applicant of the present application owns the following US patent application filed June 29, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application No. 16 / 024,090, entitled "CAPATICIVE COUPLED RETURN PATH PAD WITH Separable ARRAY ELEMENTS",
U.S. Patent Application No. 16 / 024,057, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCRDING TO SENSED CLOSED CLOSEP PARAMETERS",
U.S. Patent Application No. 16 / 024,067, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATION 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 ASSEMBLES",
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 PRIORIZED 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 GENERATION CONTROLL",
U.S. Patent Application No. 16 / 024,180 entitled "SURGICAL EVACUATION SENSING AND DISPLAY",
・ US Pat. No. 16, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODEL FOR FOR INTERACTIVE SURGICAL PLATFORM", US Pat.
U.S. Patent Application No. 16 / 024,258, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM",
・ "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEEN A FILTER AND A SMOKE EVACUATION DEVICE" Application No. 16 / 024,273.

The applicant of the present application owns the following US provisional patent application filed June 28, 2018, the entire disclosure of which is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES",
-US Provisional Patent Application No. 62 / 691,227, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCRDING TO SENSED CLOSED CLOSE PARAMETERS",
-US Provisional Patent Application No. 62 / 691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE",
-US Provisional Patent Application No. 62 / 691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL",
・ US title "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODEL FOR FOR INTERACTIVE SURGICAL PLATFORM"
・ "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEEN A FILTER AND A SMOKE EVACUATION DEVILE Provisional Patent Application No. 62 / 691,251.

The applicant of the present application owns the following US provisional patent application filed on April 19, 2018, of which the entire disclosure is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 659,900 entitled "METHOD OF HUB COMMUNICATION".

The applicant of the present application owns the following US provisional patent application filed on March 30, 2018, the entire disclosure of which is incorporated herein by reference.
-US Provisional Patent Application No. 62 / 650,898, filed on March 30, 2018, entitled "CAPATICIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS",
US Provisional Patent Application No. 62 / 650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES",
-US provisional patent application Nos. 62 / 650,882 entitled "SMOKE EVACUATION MODEL FOR INTERACTIVE SURGICAL PLATFORM", and- "SURGICAL SMOKE EVACUATION SENSING AND CONTRO" US patent No. 62 / 650, 882.

The applicant of the present application owns the following US patent application filed March 29, 2018, the entire disclosure of which is incorporated herein by reference.
U.S. Patent Application No. 15 / 940, 641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENGRYPTED COMMUNICATION CAPABILITIES",
U.S. Patent Application No. 15 / 940,648 entitled "INTERACTIVE SURGICAL SYSTEM SYSTEM 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 OPERATION ROOM DEVICES",
U.S. Patent Application No. 15 / 940,666 entitled "SPATIAL AWARENSS OF SURGICAL HUBS IN OPERATING ROOMS",
U.S. Patent Application No. 15 / 940,670, entitled "COOPERATION UTILIZETION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS",
U.S. Patent Application No. 15 / 940,677, entitled "SURGICAL HUB CONTOROL ARRANGEMENTS",
U.S. Patent Application No. 15 / 940, 632, entitled "DATA STRIPPING METHOD TO INTERROGATE PAIENT RECORDS AND CREATE ANONYMIZED RECORD",
・ "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS US Pat.
US Patent Application No. 15 / 940,645, entitled "SELF DESCRIBING DATA PACKETS GENELATED 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 AWARENSS",
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 SPARC 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 Nos. 15 / 940, 722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFACTIVITY", and U.S. Patent Application Nos. 15 / 940, 722, and "DUAL CMOS ARRAY
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 CUSTOMIZETION AND RECOMMENDATIONS TO A USER",
-US Patent Application No. 15/9
U.S. Patent Application No. 15 / 940,694 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY 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 Nos. 15 / 940, 706 entitled "DATA HANDLING AND PRIORIZATION IN A CLOUD ANALYTICS NETWORK" and-U.S. Patent Application No. 15 / 940, 706 entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICE".
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 "COOPERATION SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
U.S. Patent Application Nos. 15/940, 690 entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and-"SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL

The applicant of the present application owns the following US provisional patent application filed March 28, 2018, the entire disclosure of which is incorporated herein by reference.
US Provisional Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENGRYPTED COMMUNICATION CAPABILITIES",
-US Provisional Patent Application Publication No. 62 / 649,294 entitled "DATA STRIPPING METHOD TO INTERROGATE PAIENT RECORDS AND CREATE ANONYMIZED RECORD",
-US Provisional Patent Application Publication No. 62 / 649,300 entitled "SURGICAL HUB Situational AWARENSS",
-US Provisional Patent Application Publication No. 62 / 649,309 entitled "SURGICAL HUB SPARC AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER",
-US Provisional Patent Application Publication No. 62 / 649,310 entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS",
-US Provisional Patent Application Publication No. 62 / 649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT",
-US Provisional Patent Application Publication No. 62 / 649,296 entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES",
-US Provisional Patent Application Publication No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZETION AND RECOMMENDATIONS TO A USER",
-US Provisional Patent Application Publication No. 62 / 649,327 entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES",
-US Provisional Patent Application Publication No. 62 / 649,315 entitled "DATA HANDLING AND PRIORIZATION IN A CLOUD ANALYTICS NETWORK",
-US Provisional Patent Application Publication No. 62 / 649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES",
-US Provisional Patent Application Publication No. 62 / 649,320 entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS",
・ US provisional patent application publication No. 62 / 649,307 entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and ・ "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED US provisional patent No. 323.

The applicant of the present application owns the following US provisional patent application filed March 8, 2018, of which the entire disclosure is incorporated herein by reference.
-US provisional patent application No. 62 / 640,417 entitled "TEMPERATURE CONTOROL IN ULTRASONIC DEVICE AND CONTROLL SYSTEM THEREFOR", and- "ESTIMATING STATE OF ULTRASONIC END EFFECT" US provisional patent application No. 62 / 640, 417 , 415.

The applicant of the present application owns the following US provisional patent application filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.
US Provisional Patent Application No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM", US Provisional Patent Application No. 62 / 611,341,
-US Provisional Patent Application No. 62 / 611,340 entitled "CLOUD-BASED MEDICAL ANALYTICS" and-US Provisional Patent Application No. 62 / 611,339 entitled "ROBOT ASSISTED SURGICAL PLATFORM".

Prior to elaborating on the various aspects of surgical devices and generators, the illustrated examples are not limited in application or application to the details of the structure and arrangement of the parts shown in the accompanying drawings and description. It should be noted. The exemplary examples may be implemented in or incorporated into other embodiments, variants, and modifications, and may be implemented or implemented in a variety of ways. Furthermore, unless otherwise stated, the terms and expressions used herein have been selected for the convenience of the reader to illustrate exemplary examples and are not intended to limit them. .. In addition, one or more of the embodiments, embodiments, and / or examples described below, and any of the other embodiments, embodiments, and / or examples described below. It should be understood that it can be combined with one or more.

Various aspects are intended for improved ultrasonic surgical equipment, electrosurgical equipment, and generators for use with them. Aspects of ultrasonic surgical devices can be configured, for example, to transversely incis and / or coagulate tissue during a surgical procedure. Aspects of electrosurgical devices can be configured, for example, to transversely incis, coagulate, scale, weld and / or dry tissue during a surgical procedure.

Referring to FIG. 1, a computer-mounted interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (eg, a cloud 104 that may include a remote server 113 attached to a storage device 105). ,including. Each surgical system 102 includes at least one surgical hub 106 that communicates with a cloud 104 that may include a remote server 113. In one embodiment, as shown in FIG. 1, the surgical system 102 is configured to communicate with each other and / or with the hub 106, a visualization system 108, a robot system 110, and a handheld intelligent surgical instrument 112. And, including. In some embodiments, the surgical system 102 may include M hubs 106, N visualization systems 108, O robot systems 110, and P handheld intelligent surgical instruments 112. , Where M, N, O, and P are integers greater than or equal to 1.

FIG. 3 shows an example of a surgical system 102 used to perform a surgical procedure on a patient lying on an operating table 114 in an operating room 116. The robot system 110 is used as part of the surgical system 102 in a surgical procedure. The robot 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 operate at least one detachably coupled surgical tool 117 during a minimally invasive incision in the patient's body while the surgeon views the surgical site through the surgeon's console 118. .. An image of the surgical site can be obtained by the medical imaging device 124, which can be manipulated by the patient-side cart 120 to orient the imaging device 124. The robot hub 122 can be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

Other types of robot systems can be easily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with this disclosure are entitled "ROBOT ASSISTED SURGICAL PLATFORM" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in US Provisional Patent Application Publication No. 62 / 611,339.

Various examples of cloud-based analyzes performed by Cloud 104 and suitable for use with this disclosure are described in "CLOUD-BASED MEDICAL" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is described in US Provisional Patent Application Publication No. 62 / 611,340 entitled "ANALYTICS".

In various aspects, the imaging device 124 comprises 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.

The optical components of the imaging device 124 may include one or more illumination sources and / or one or more lenses. One or more illumination sources may be oriented to illuminate part of the surgical field. One or more image sensors may receive reflected or refracted light from the surgical field, including light reflected or refracted from tissues and / or surgical instruments.

One or more illumination sources may be configured to radiate electromagnetic energy within the visible and invisible spectra. The visible spectrum, sometimes referred to as the optical spectrum or emission spectrum, is a portion of the electromagnetic spectrum visible to the human eye (ie, detectable by the human eye) and is sometimes referred to as visible light, or simply light. The typical human eye responds to wavelengths in the air from about 380 nm to about 750 nm.

The invisible spectrum (ie, the non-emissive spectrum) is a portion of the electromagnetic spectrum located below and above the visible spectrum (ie, 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 results in invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, which results in invisible UV, X-ray, and gamma-ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in minimally invasive procedures. Examples of imaging devices suitable for use with the present disclosure include arthroscopy, vasoscope, bronchoscope, biliary tract, colonoscope, cytoscope, duodenalscope, endoscopy, esophagogastroduodenalscope (gastroscope). , Endoscope, laryngoscope, nasopharyngo-neproscope, sigmoid colonoscope, thoracoscope, and cystoscope, but not limited to these.

In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlayer structure. A multispectral image captures image data within a specific wavelength range over an electromagnetic spectrum. Wavelengths can be separated by filters or by using devices that are sensitive to light from frequencies beyond the visible light range, such as IR and ultraviolet light. Spectral imaging can allow the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is "Advanced" in US Provisional Patent Application Publication No. 62 / 611,341 entitled "INTERACTIVE SURGICAL PLATFORM" filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is explained in detail in the section "Imaging Acquisition Module". Multispectral monitoring can be a useful tool for rearranging surgical fields to perform one or more of the above tests on treated tissue after one surgical operation has been completed.

It is self-evident that any surgery requires strict sterilization of the operating room and surgical instruments. The "surgical theater", that is, the strict hygiene and sterilization conditions required for operating rooms or treatment rooms, require the highest degree of sterilization of all medical devices and equipment. Part of the sterilization process is the need to sterilize anything that comes into contact with the patient or invades the sterilization field, including the imaging device 124 and its accessories and components. The sterile field can be considered as a specific area considered to be free of microorganisms, such as in a tray or on a sterile towel, or the sterile field is seen as the area immediately surrounding the patient prepared for the surgical procedure. It will be understood that it can be done. The sterile field may include washed team members wearing appropriate clothing, as well as all fixtures and fixtures within the area.

In various aspects, the visualization system 108 comprises one or more imaging sensors strategically placed relative to the sterile field and one or more image processing units, as shown in FIG. And one or more storage arrays and one or more displays. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. For the various components of the visualization system 108, US Provisional Patent Application Publication No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM", filed December 28, 2017, the entire disclosure of which is incorporated herein by reference. It is explained in the section of "Advanced Imaging Acquisition System".

As shown in FIG. 2, the primary display 119 is arranged in a sterile field so that it is visible to the operator located on the operating table 114. In addition, the visualization tower 111 is located outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. The visualization system 108 guided by the hub 106 is configured to use displays 107, 109, and 119 to coordinate the flow of information to operators inside and outside the sterile field. For example, the hub 106 causes the visualization system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109 while maintaining a live image of the surgical site on the primary display 119. Can be done. Snapshots on the non-sterile display 107 or 109 can allow, for example, a non-sterile operator to perform surgical steps related to the surgical procedure.

In one aspect, the hub 106 sends diagnostic input or feedback input by a non-sterile operator located at the visualization tower 111 to the primary display 119 within the sterilization area in the sterilization field, which is a sterilization operation located on the operating table. It is also configured so that one can see it. In one embodiment, the input may be in the form of a modification to the snapshot displayed on the non-sterile display 107 or 109, which can be sent by the hub 106 to the primary display 119.

With reference to FIG. 2, the surgical instrument 112 is used as part of the surgical system 102 in the surgical procedure. The hub 106 is also configured to coordinate the flow of information to the display of the surgical instrument 112. For example, in US Provisional Patent Application Publication 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 input by the non-sterile operator at the location of the visualization tower 111 may be sent to the surgical instrument display 115 by the hub 106 in the sterile field, where the diagnostic input or feedback is on the surgical instrument 112. It may be seen by the operator. For exemplary surgical instruments suitable for use with the surgical system 102, for example, the section "Surgical Instrument Hardware", the entire disclosure of which is incorporated herein by reference, and the year 2017 entitled "INTERACTIVE SURGICAL PLATFORM". It is described in US Provisional Patent Application Publication No. 62 / 611,341 filed December 28.

With reference to FIG. 3, the hub 106 is shown communicating with the visualization system 108, the robot system 110, and the handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In a particular embodiment, as shown in FIG. 3, the hub 106 further includes a smoke exhaust module 126 and / or a suction / irrigation module 128.

During the surgical procedure, applying energy to the tissue for sealing and / or cutting generally involves flue gas, aspiration of excess fluid, and / or irrigation of the tissue. Fluids, power, and / or data lines from different sources are often entangled during the surgical procedure. Addressing this issue during a surgical procedure can result in the loss of valuable time. Untangling the lines may require pulling the lines out of their corresponding modules, which may require resetting the modules. The modular housing 136 of the hub provides a unified environment for managing power, data, and fluid lines, reducing the frequency of such line entanglements.

Aspects of the present disclosure present a surgical hub for use in surgical procedures involving application of energy to tissue at a surgical site. The surgical hub comprises a hub housing and a combination generator module that is slidably acceptable within the docking station of the hub housing. The docking station includes data and power contacts. The combination generator module comprises two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a unipolar RF energy generator component housed in a single unit. In one aspect, the combination generator module further comprises a smoke exhaust component, at least one energy supply cable for connecting the combination generator module to the surgical instrument, and smoke generated by the application of therapeutic energy to the tissue. , A fluid, and / or at least one flue gas component configured to expel fine particles, and a fluid line extending from the remote surgery site to the flue gas component.

In one aspect, the fluid line is the first fluid line and the second fluid line extends from the remote surgery site to the suction and irrigation module slidably received within the hub housing. In one aspect, the hub housing comprises a fluid interface.

Certain surgical procedures may require the application of more than one energy type to the tissue. One energy type can be more beneficial for cutting tissue, while another different energy type can be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal the tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which a modular enclosure 136 of a hub is configured to accommodate various generators and facilitate two-way communication between them. One of the advantages of the modular housing 136 of the hub is that it allows for rapid removal and / or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure comprises a first energy generator module configured to generate a first energy to be applied to the tissue and a first docking port containing first data and power contacts. A first docking station, including a first docking station, the first energy generator module is slidably movable to electrically engage with power and data contacts, and the first energy generator module is: It is slidable and movable so as to disengage from the electrical engagement with the first power and data contacts.

In addition to the above, the modular surgical enclosure has a second energy generator module configured to generate a second energy to be applied to the tissue, which is different from the first energy, and a second. A second docking station with a second docking port containing the data and power contacts of the second energy generator module is slidably moved to electrically engage the power and data contacts. It is possible and the second energy generator module is slidably movable so as to disengage from the electrical engagement with the second power and data contacts.

In addition, the modular surgical enclosure is configured to facilitate communication between the first energy generator module and the second energy generator module, with a first docking port and a second docking. It also includes a communication bus to and from the port.

Referring to FIGS. 3-7, aspects of the present disclosure relating to a modular housing 136 of a hub that allows modular integration of a generator module 140, a smoke exhaust module 126, and a suction / irrigation module 128 are presented. Will be done. The modular housing 136 of the hub further facilitates bidirectional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 is integrated into a single housing unit 139 that is slidably insertable into the modular housing 136 of the hub. It may be a generator module with sound wave components. As shown in FIG. 5, the generator module 140 may be configured to connect to a unipolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of unipolar, bipolar, and / or ultrasonic generator modules that interact via the modular housing 136 of the hub. The modular housing 136 of the hub allows multiple generators to be inserted and bidirectional between the generators docked in the modular housing 136 of the hub so that the multiple generators function as a single generator. It may be configured to facilitate communication.

In one aspect, the modular enclosure 136 of the hub comprises modular power and with external and wireless communication headers to allow removable mounting of modules 140, 126, 128 and bidirectional communication between them. A communication backplane 149 is provided.

In one aspect, the modular housing 136 of the hub includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and the combination generator module 145 slidably acceptable to the docking station 151 of the surgical hub housing 136. The docking port 152, which has power and data contacts on the rear side of the combination generator module 145, is configured when the combination generator module 145 is slid into a position within the corresponding docking station 151 of the modular housing 136 of the hub. The corresponding docking port 150 is configured to engage the power and data contacts of the corresponding docking station 151 of the modular enclosure 136 of the hub. In one aspect, the combination generator module 145 includes a bipolar, ultrasonic, and unipolar module, as well as a smoke exhaust module integrated with a single housing unit 139, as shown in FIG.

In various aspects, the smoke exhaust module 126 includes a fluid line 154 that transports captured / recovered smoke and / or fluid away from the surgical site, eg, to the smoke exhaust module 126. The vacuum suction generated from the smoke exhaust module 126 can draw smoke into the opening of the utility conduit at the surgical site. The utility conduit connected to the fluid line may be in the form of a flexible tube terminated by a smoke exhaust module 126. Utility conduits and fluid lines define a fluid path extending towards the smoke exhaust module 126 received within the hub housing 136.

In various aspects, the suction / irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one embodiment, the suction and suction fluid line is in the form of a flexible tube extending from the surgical site towards the suction / irrigation module 128. One or more drive systems may be configured to cause fluid irrigation and inhalation into and from the surgical site.

In one aspect, the surgical tool comprises a shaft having an end effector at its distal end, at least one energy treatment section 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 can have an inlet port in close proximity to the energy delivery device. The energy delivery device is configured to deliver ultrasonic and / or RF energy to the surgical site and is first connected to the generator module 140 by a cable that extends through the shaft.

The irrigation pipe can communicate with the fluid source, and the suction pipe can communicate with the vacuum source. The fluid source and / or vacuum source may be housed in the suction / irrigation module 128. In one embodiment, the fluid source and / or vacuum source may be housed in the hub housing 136 separately from the suction / irrigation module 128. In such an embodiment, the fluid interface may be configured to connect the suction / irrigation module 128 to a fluid source and / or a vacuum source.

In one aspect, their corresponding docking stations on modules 140, 126, 128 and / or the modular housing 136 of the hub align the docking ports of the modules to the docking stations of the modular housing 136 of the hub. It may include an alignment mechanism configured to engage these corresponding components within. For example, as shown in FIG. 4, the combination generator module 145 is configured to slidably engage the corresponding bracket 156 of the corresponding docking station 151 of the modular housing 136 of the hub. Includes 155. The brackets work together to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the modular housing 136 of the hub.

In some embodiments, the drawer 151 of the modular housing 136 of the hub is the same or substantially the same size, and the module is adjusted to a size that is acceptable within the drawer 151. For example, the side brackets 155 and / or 156 may be larger or smaller depending on the size of the module. In another aspect, the drawer 151 is of different size and is designed to accommodate a particular module.

In addition, the contacts of a particular module may be locked to engage the contacts of a particular drawer to avoid inserting the module into a drawer with incompatible contacts.

As shown in FIG. 4, the docking port 150 of one drawer 151 is connected to the docking port 150 of another drawer 151 via a communication link 157, and the module is housed in the modular housing 136 of the hub. Two-way communication between them can be facilitated. Alternatively, or further, the docking port 150 of the modular housing 136 of the hub may facilitate wireless bidirectional communication between the modules housed in the modular housing 136 of the hub. For example, any suitable wireless communication such as Air Titan-Bluetooth may be used.

FIG. 6 shows the individual power bus attachments of the plurality of lateral docking ports of the laterally modular housing 160 configured to receive the plurality of modules of the surgical hub 206. The laterally modular housing 160 is configured to laterally receive and interconnect the modules 161. The module 161 is slidably inserted into the docking station 162 of the lateral modular housing 160, which includes a backplane for interconnecting the modules 161. As shown in FIG. 6, the module 161 is arranged laterally within the laterally modular housing 160. Alternatively, the module 161 may be arranged vertically within the laterally modular housing.

FIG. 7 shows a vertical modular housing 164 configured to receive multiple modules 165 of the surgical hub 106. The module 165 is slidably inserted into the docking station or drawer 167 of the vertical modular housing 164 including the backplane for interconnecting the modules 165. Although the drawer 167 of the vertical modular housing 164 is arranged vertically, in certain cases the vertical modular housing 164 may include a drawer arranged laterally. Further, the modules 165 can interact with each other via the docking port of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 for displaying data related to the operation of module 165 is provided. In addition, the vertical modular housing 164 includes a master module 178 that houses a plurality of submodules that are slidably received within the master module 178.

In various aspects, the imaging module 138 comprises a built-in video processor and modular light source and is adapted for use with a variety of imaging devices. In one aspect, the imaging device comprises 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 detachably coupled with a reusable controller, light source module, and camera module. The light source module and / or the camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module comprises a CMOS sensor. In another aspect, the camera module is configured for imaging the scanned beam. Similarly, the light source module can be configured to deliver white light or different light depending on the surgical procedure.

During the surgical procedure, it may be inefficient to remove the surgical device from the surgical field and replace it with another surgical device containing a different camera or different light source. Temporary loss of field of view in the surgical field can have undesired consequences. The modular imaging device of the present disclosure is configured to allow replacement of a light source module or camera module intermediate (midstream) during a surgical procedure without the need to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing that includes a plurality of channels. The first channel is configured to slidably accept a camera module that may be configured to snap fit and engage with the first channel. The second channel is configured to slidably accept a light source module that may be configured to snap fit and engage with the second channel. In another embodiment, the camera module and / or light source module can be rotated to its final position within these corresponding channels. Screw engagement may be employed instead of snap fit engagement.

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 imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from different imaging devices.

Various image processors and imaging devices suitable for use with the present disclosure are US Pat. Nos. 6, 2011, entitled "COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR," which are incorporated herein by reference in their entirety. It is described in No. 7,995,045. In addition, US Pat. 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, removes motion artifacts from image data. Describes various systems for doing so. Such a system can be integrated with the imaging module 138. In addition, the US Patent Application Publication No. 2011/0306840 published on December 15, 2011, entitled "CONTROLLABLE MAGNETIC SOURCE TO FIXTURE TO FIXTURE INTRACORPORTAL APPARATUS", and "SYSTEM FOR PERFORMING A MEMRAL 2014" Published US Patent Application Publication No. 2014/0243597, each of which is incorporated herein by reference in its entirety.

FIG. 8 shows a cloud-based system (eg, storage) of modular equipment located in one or more operating rooms of a medical facility, or in any room within a medical facility equipped with specialized equipment for surgical procedures. FIG. 6 shows a surgical data network 201 with a modular communication hub 203 configured to connect to a cloud 204) that may include a remote server 213 connected to device 205. In one aspect, the modular communication hub 203 comprises a network hub 207 and / or a network switch 209 that communicates with a network router. The modular communication hub 203 can also be coupled to the local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switchable. Passive surgical data networks act as conduits for data, allowing data to travel from one device (or segment) to another (or segment) and to cloud computing resources. The intelligent surgical data network allows traffic to pass through the monitored surgical data network and includes additional mechanisms that make up each port in the network hub 207 or network switch 209. Intelligent surgical data networks can be referred to as manageable hubs or switches. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.

The modular devices 1a to 1n arranged in the operating room may be connected to the modular communication hub 203. The network hub 207 and / or the network switch 209 can be connected to the network router 211 to connect the devices 1a to 1n to the cloud 204 or the local computer system 210. The data associated with the devices 1a-1n may be transferred to a cloud-based computer via a router for remote data processing and operation. The data associated with the devices 1a-1n may also be transferred to the local computer system 210 for local data processing and operation. Modular devices 2a-2m located in the same operating room may also be connected to the network switch 209. The network switch 209 can be connected to the network hub 207 and / or the network router 211 to connect the devices 2a to 2m to the cloud 204. The data associated with the devices 2a-2n may be transferred to the cloud 204 via the network router 211 for data processing and operation. The data associated with the devices 2a-2m may also be transferred to the local computer system 210 for local data processing and operation.

It will be appreciated that the surgical data network 201 can be extended by interconnecting the plurality of network hubs 207 and / or the plurality of network switches 209 with the plurality of network routers 211. The modular communication hub 203 may be housed in a modular control tower configured to receive a plurality of devices 1a-1n / 2a-2m. The local computer system 210 may also be housed in a modular control tower. The modular communication hub 203 is connected to the display 212 to display images acquired by some of the devices 1a-1n / 2a-2m, for example during a surgical procedure. In various aspects, the devices 1a-1n / 2a-2m include, among other modular devices that can be connected to the modular communication hub 203 of the surgical data network 201, for example, an imaging module 138 connected to an endoscope. , Generator module 140 connected to energy-based surgical equipment, smoke exhaust module 126, suction / irrigation module 128, communication module 130, processor module 132, storage array 134, surgical equipment connected to display, and / Alternatively, various modules such as non-contact sensor modules may be mentioned.

In one aspect, the surgical data network 201 combines a network hub (s), a network switch (s), and a network router (s) that connect the devices 1a-1n / 2a-2m to the cloud. It may be included. Any one or all of the devices 1a-1n / 2a-2m connected 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 operation. .. It will be appreciated that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. The term "cloud" can be used as a metaphor for the "Internet," but the term is not so limited. Therefore, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing," in which various services such as servers, storage, and applications are referred to as surgical sites. Modular communication hub 203 and / or computer system 210 located (eg, fixed, mobile, temporary, or field operating room or space) and / or modular communication hub 203 and / or computer via the Internet. Delivered to a device connected to system 210. The cloud infrastructure can be maintained by the cloud service provider. In this context, a cloud service provider can be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services can perform a number of 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 computers that communicate with cloud computing resources and storage.

By applying cloud computer data processing technology to the data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. After the tissue sealing and cutting procedure, at least some of the devices 1a-1n / 2a-2m can be used to observe the condition of the tissue and assess leakage or perfusion of the sealed tissue. .. At least one of the devices 1a-1n / 2a-2m to use cloud-based computing to examine data, including images of body tissue samples, for diagnostic purposes to identify medical conditions such as the effects of disease. Some can be used. This includes tissue and phenotypic localization and margin confirmation. Devices 1a-1n / 2a to identify the anatomical structure of the body using techniques such as overlaying images captured by multiple imaging devices and various sensors integrated with the imaging device. At least some of ~ 2 m can be used. Data collected by devices 1a-1n / 2a-2m, including image data, may be transferred to cloud 204 and / or local computer system 210 for data processing and operation, including image processing and operation. .. The data of surgical procedures by determining whether further treatments such as endoscopic interventions for tissue-specific sites and conditions, emerging technologies, targeted radiation, targeted interventions, and the application of precision robots can be performed. It can be analyzed to improve the results. Such data analysis may further employ prognostic processing, and whether using a standardized approach confirms surgical treatment and surgeon behavior or suggests modifications to surgical treatment and surgeon behavior. Can provide useful feedback for any of the above.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via a wired or wireless channel, depending on the configuration of the devices 1a-1n with respect to the network hub. In one aspect, the network hub 207 may be implemented as a local network broadcaster acting 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. Network hub 207 collects data in packet form and sends them to the router in half-duplex mode. The network hub 207 does not store any medium access control / internet protocol (MAC / IP) for transferring device data. Only one of the devices 1a-1n can transmit data at a time via the network hub 207. The network hub 207 does not have a routing table or intelligence regarding the destination of information, and broadcasts all network data to the entire connection and to the remote server 213 (FIG. 9) on the cloud 204. The network hub 207 can detect basic network errors such as collisions, but broadcasting all the information to a plurality of ports poses a security risk and may cause a bottleneck.

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 devices 2a to 2m located in the same operating room to the network. The network switch 209 transmits data in the form of a frame to the network router 211 and functions in full-duplex mode. The plurality of devices 2a to 2m can simultaneously transmit data via the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a to 2m to transfer data.

The network hub 207 and / or network switch 209 is connected to the 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 cloud the data packets received from the network hub 207 and / or the network switch 211 in order to further process and manipulate the data collected by any one or all of the devices 1a-1n / 2a-2m. Create a route to send to the base computer resource. The network router 211 is used to connect two or more different networks located at different locations, for example, different operating rooms in the same medical facility or different networks located in different operating rooms in different medical facilities. May be good. The network router 211 transmits packet form data to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data at the same time. The network router 211 uses an IP address to transfer data.

In one embodiment, the network hub 207 may be implemented as a USB hub that allows a plurality of USB devices to be connected to a host computer. A USB hub can extend a single USB port into several layers so that more ports are available to connect the device to the host system computer. The network hub 207 may include a wired or wireless capability for receiving information via a wired or wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in the operating room.

In another embodiment, operating room devices 1a-1n / 2a-2m exchange data over short distances from fixed and mobile devices (using short wavelength UHF radio waves in the ISM band 2.4-2.485 GHz). ), And can communicate with the modular communication hub 203 via the Bluetooth radio technology standard to build a personal area network (PAN). In another aspect, the operating room devices 1a-1n / 2a-2m are Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, Long Term Evolution (LTE), and Ev. -DO, HSPA +, HSDPA +, HSUPA +, LTE, GSM, GPRS, CDMA, TDMA, DECT, and their Ethernet derivatives, as well as any other radio designated as 3G, 4G, 5G, and beyond It is possible to communicate with the modular communication hub 203 via a number of wireless or wired communication standards or protocols, including but not limited to wired protocols. The computing module may include a plurality of 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 GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc. It may be dedicated to long-distance wireless communication.

The modular communication hub 203 can function as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles a data type known as a frame. The frame carries the data generated by the devices 1a-1n / 2a-2m. When the frame is received by the modular communication hub 203, the frame is amplified and transmitted to the network router 211, which uses a number of wireless or wired communication standards or protocols described herein. Transfer this data to your cloud computing resources.

The modular communication 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 communication hub 203 is generally easy to install, configure, and maintain, making the modular communication hub 203 a good choice for networking operating room devices 1a-1n / 2a-2m.

FIG. 9 shows a computer-mounted interactive surgical system 200. The computer-mounted interactive surgical system 200 is, in many respects, similar to the computer-mounted interactive surgical system 100. For example, the computer-mounted interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204 that may include a remote server 213. In one aspect, the computer-mounted interactive surgical system 200 comprises 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 connected to the computer system 210. As illustrated in the embodiment of FIG. 9, the modular control tower 236 includes an imaging module 238 connected to an endoscope 239, a generator module 240 connected to an energy device 241, a smoke evacuator module 226, and suction / It is coupled to the irrigation module 228, the communication module 230, the processor module 232, the storage array 234, the smart device / appliance 235 optionally coupled to the display 237, and the non-contact sensor module 242. The operating room equipment is connected to cloud computing resources and data storage via a modular control tower 236. Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. Above all, the device / appliance 235, visualization system 208 may be connected to the modular control tower 236 via a wired or wireless communication standard or protocol described herein. The modular control tower 236 may be coupled to a hub display 215 (eg, monitor, screen) to display and overlay images received from the imaging module, device / instrument display, and / or other visualization system 208. .. The hub display may also display data received from a device connected to the modular control tower along with images and overlay images.

FIG. 10 shows a surgical hub 206 with a plurality of modules connected to a modular control tower 236. The modular control tower 236 includes, for example, a modular communication hub 203 such as a network connection device and a computer system 210 for providing, for example, local processing, visualization, and imaging. As shown in FIG. 10, the modular communication hub 203 is connected in a hierarchical configuration in order to expand the number of modules (for example, devices) that can be connected to the modular communication hub 203, and the data associated with the modules is displayed. It can be transferred to computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs / switches in the modular communication hub 203 includes three downstream ports and one upstream port. Upstream network hubs / switches are connected to processors to provide communication connections to cloud computing resources and local displays 217. Communication to the cloud 204 can be done via either a wired or wireless communication channel.

The surgical hub 206 uses the non-contact sensor module 242 to measure the dimensions of the operating room and uses either an ultrasonic or laser non-contact measuring device to generate a map of the surgical site. "Surgical Hub Spatial Awarens With Operating Room" in US Provisional Patent Application Publication No. 62 / 611,341 filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM", which is incorporated herein by reference in its entirety. As described in the section, the ultrasound-based non-contact sensor module scans the operating room by transmitting a burst of ultrasound and receiving an echo as the burst of ultrasound reflects off the outer wall of the operating room. Here, the sensor module is configured to determine the size of the operating room and adjust the distance limit of the Bluetooth pairing. A laser-based non-contact sensor module, for example, transmits a laser light pulse, receives a laser light pulse reflected on the outer wall of the operating room, and compares the phase of the transmitted pulse to the received pulse in the operating room. The operating room is scanned by determining the size and adjusting the Bluetooth pairing distance limit.

The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is connected to the communication module 247, the storage 248, the memory 249, the non-volatile memory 250, and the input / output interface 251 via the system bus. The system bus is a 9-bit bus, industry standard architecture (ISA), microchannel architecture (MSA), extended ISA (EISA), intelligent drive electronics (IDE), VESA local bus (VLB), peripheral device interconnection (PCI), Any, but not limited to, USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association Bus (PCMCIA), Small Computer System Interface (SCSI), or any other proprietary bus. It may be any of several types of bus structures (s), including memory buses or memory controllers, peripheral or external buses, and / or local buses that use different bus architectures.

The processor 244 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In one aspect, the processor, for example, on-chip memory of up to 40 MHz 256 KB single cycle flash memory or other non-volatile memory, the details of which are available in the product data sheet, to improve performance to over 40 MHz. Prefetch buffer, 32KB single-cycle serial random access memory (SRAM), internal read-only memory with StaticrisWare® software (ROM), 2KB electrically erasable programmable read-only memory (EEPROM), and / or One or more pulse width modulation (PWM) modules, one or more orthogonal encoder input (QEI) analogs, one or more 12 with 12 analog input channels It may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including a bit analog-to-digital converter (ADC).

In one aspect, the processor 244 may include a safety controller that includes two controller families such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory choices. Good.

Examples of the system memory include volatile memory and non-volatile memory. A basic input / output system (BIOS) that includes a basic routine for transferring information between elements in a computer system, such as during startup, is stored in non-volatile memory. For example, the non-volatile memory may include a ROM, a programmable ROM (PROM), an electrically programmable ROM (EPROM), an EEPROM, or a flash memory. Examples of the volatile memory include a random access memory (RAM) that functions as an external cache memory. Further, the RAM includes SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESRAM), synclink DRAM (SLRAM), direct rambus RAM (DRRAM), and the like. It is available in many forms of.

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, the disk storage can be a storage medium independently, or a compact disc ROM device (CD-ROM), a compact disc recordable drive (CD-R drive), a compact disc rewritable drive (CD-RW drive), and the like. Alternatively, an optical disk drive such as a digital versatile disk ROM drive (DVD-ROM) can be mentioned, but the present invention can be included in combination with other storage media not limited thereto. A removable or non-removable interface may be used to facilitate the connection of the disk storage device to the system bus.

It should be understood that the computer system 210 includes software that acts as an intermediary between the user and the basic computer resources described in the preferred operating environment. Examples of such software include operating systems. An operating system that can be stored on disk storage functions to control and allocate resources for the computer system. System applications take advantage of resource management by the operating system via 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 in different operating systems or combinations of operating systems.

The user inputs a command or information to the computer system 210 via an input device (s) connected to the I / O interface 251. Input devices include pointing devices such as mice, trackballs, stylus, and touchpads, keyboards, microphones, joysticks, gamepads, satellite dishes, scanners, TV tuner cards, digital cameras, digital video cameras, and webcams. However, it is not limited to these. These and other input devices connect to the processor through the system bus via the interface port (s). Examples of the interface port (s) include a serial port, a parallel port, a game port, and USB. The output device (s) use some of the same types of ports as the input device (s). Thus, for example, the USB port may be used to provide input to the computer system and output information from the computer system to the output device. Output adapters are provided to indicate the presence of some output devices, such as monitors, displays, speakers, and printers, among other output devices that require special adapters. Output adapters include, for example, but not limited to, video and sound cards that provide a means of connection between the output device and the system bus. Note that other devices and / or systems of devices, such as remote computers (s), provide both input and output functions.

The computer system 210 can operate in a networked environment that uses a logical connection to one or more remote computers or local computers, such as a cloud computer (s). The remote cloud computer (s) can be a personal computer, server, router, network PC, workstation, microprocessor-based device, peer device, or other common network node, typically a computer. Contains many or all of the elements described for the system. For brevity, only the memory storage device is shown along with the remote computer (s). The remote computer (s) are logically connected to the computer system via a network interface and then physically connected via a communication connection. Network interfaces include communication networks such as local area networks (LANs) and wide area networks (WANs). Examples of LAN technology include an optical fiber distributed data interface (FDDI), a copper wire distributed data interface (CDDI), Ethernet / IEEE802.3, Token Ring / IEEE802.5, and the like. WAN technology includes, but is not limited to, point-to-point links, integrated services digital networks (ISDN) and circuit switching networks such as and variants thereof, packet switching networks, and digital subscriber lines (DSL).

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 are image processors, image processing engines, media processors, or digital images. It may include any dedicated digital signal processor (DSP) used in the processing of. Image processors can increase speed and efficiency by using single-instruction multiple data (SIMD) or parallel computing with multiple instruction multiple data (MIMD) technology. Digital image processing engines can perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

Communication connection (s) refers to the hardware / software used to connect the network interface to the bus. The communication connection is shown inside the computer system for the sake of illustration clarity, but the communication connection may be outside the computer system 210. For illustrative purposes only, the hardware / software required to connect to a network interface includes conventional telephone grade modems, cable modems, modems including DSL modems, ISDN adapters, and internal and external technologies such as Ethernet cards. Can be mentioned.

FIG. 11 shows a functional block diagram of one aspect of the USB network hub 300 device according to at least one aspect 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 provides upstream USB transmission / reception ports 302 and up to three downstream USB transmission / reception ports 304, 306, and 308 that comply with the USB 2.0 standard. The upstream USB transmit / receive port 302 is a differential root data port that includes a differential data plus (DP0) input and a paired differential data minus (DM0) input. The three downstream USB transmit / receive ports 304, 306, 308 are differential data ports each containing a differential data plus (DP1 to DP3) output paired with a differential data minus (DM1 to DM3) output.

The USB network hub 300 device is implemented with a digital state machine instead of a microcontroller and does not require firmware programming. A fully compliant USB transmitter / receiver is integrated into the circuits of the upstream USB transmit / receive port 302 and all downstream USB transmit / receive ports 304, 306, 308. Downstream USB transmit and receive ports 304, 306, 308 support both maximum and slow speed devices by automatically setting the slew rate according to the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered mode or self-powered mode and includes hub-powered logic 312 for managing power.

The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE310 is the front end of the USB network hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. The SIE310 typically understands signaling down to the transaction level. Functions covered by this include packet recognition, transaction reordering, SOP, EOP, SETET, and RESTUME signal detection / generation, clock / data separation, non-return-to-zero reversal (NRZI) data coding / decoding and bit stuffing, CRC Generation and check (tokens and data), packet ID (PID) generation, and check / decryption, and / or serial parallel / parallel serial conversion can be mentioned. 310 receives clock input 314 and suspend / resume logic as well to control communication between upstream USB transmit / receive ports 302 and downstream USB transmit / receive ports 304, 306, 308 via port logic circuits 320, 322, 324. It is connected to the frame timer 316 circuit and the hub repeater circuit 318. The SIE 310 is connected to the command decoder 326 via an interface logic for controlling commands from the serial EEPROM via the serial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functions configured in up to 6 logical layers (hierarchies) to a single computer. In addition, the USB network hub 300 can be connected to all peripherals using four standardized wire cables that provide both communication and power distribution. The power configuration is a bus-powered mode and a self-powered mode. The USB network hub 300 is a bus power hub having either individual port power management or interlocking port power management, and a self-powered hub having either individual port power management or interlocking port power management. It may be configured to support one mode. In one aspect, using a USB cable, a 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, 308 connect a USB compatible device. It is exposed because of it.

Hardware for Surgical Instruments FIG. 12 shows a logical diagram of a surgical instrument or tool control system 470 according to one or more aspects of the present disclosure. System 470 includes a control circuit. The control circuit includes a microprocessor 461 with a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, and 476 provide real-time feedback to the processor 462. The motor 482, driven by the motor drive 492, operably connects displacement members that are movable in the longitudinal direction to drive the clamp arm closing member. The tracking system 480 is configured to determine the position of a displacement member that is movable in the longitudinal direction. The position information is provided to the processor 462 which can be programmed or configured to determine the position of the drive member and the position of the closing member which are movable in the longitudinal direction. Additional motors may be provided in the tool driver interface to control the movement of the closure tube, rotation of the shaft, joint movement, or closure of the clamp arm, or any combination of the above. The display 473 may display various operating conditions of the appliance and may include a touch screen function for data entry. The information displayed on the display 473 can be overlaid with the image acquired via the endoscopic imaging module.

In one aspect, the microcontroller 461 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In one aspect, the main microcontroller 461 improves performance to over 40 MHz, for example, on-chip memory of 256 KB single cycle flash memory up to 40 MHz or other non-volatile memory, the details of which are available in the product datasheet. Prefetch buffer for, 32KB single cycle SRAM, internal ROM with NonvolatilesWare® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs, and / Alternatively, it may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including one or more 12-bit ADCs with 12 analog input channels.

In one aspect, the microcontroller 461 may include a safety controller that includes two controller families such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory choices. Good.

The microcontroller 461 may be programmed to perform various functions such as a knife, joint movement system, clamp arm, or precise control of speed and position of the combination described above. In one aspect, 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 a mechanical connection to a joint movement or knife system. In one aspect, the motor drive 492 may be A3941 available from Allegro Microsystems, Inc. Other motor drives can be easily replaced for use in the tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system, which is incorporated herein by reference in its entirety, is entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT" published October 19, 2017 in the United States Patent Application Publication No. 2017/2017. It is described in 0296213.

The microcontroller 461 may be programmed to provide precise control over the speed and position of the displacement member and joint movement system. Microcontroller 461 may be configured to calculate the response within the software of microcontroller 461. The calculated response is compared to the measured response of the actual system to give an "observed" response, which is used to determine the actual feedback. The observed response is a suitable adjusted value that balances the smooth and continuous nature of the simulated response with the measured response, which can detect external effects on the system.

In one aspect, the motor 482 may be controlled by a motor drive 492 and may be used by a surgical instrument or tool launch system. In various forms, the motor 482 may be, for example, a brushed DC drive motor having a maximum rotational speed of about 25,000 RPM. In another arrangement, the motor 482 may include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may include, for example, an H-bridge driver including a field-effect transistor (FET). The motor 482 may be powered by a power assembly that is detachably mounted on the handle assembly or tool housing to supply control power to the surgical instrument or tool. The power assembly may include a battery that may include a large number of battery cells connected in series, which can be used as a power source to power a surgical instrument or tool. Under certain circumstances, the battery cells in the power assembly may be replaceable and / or rechargeable battery cells. In at least one example, the battery cell can be a lithium ion battery that can be coupled to and separable from the power assembly.

The motor drive 492 may be A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full bridge controller for use with an external N-channel power metal oxide semiconductor field effect transistor (MOSFET) specifically designed for inductive loads such as brushed DC motors. The drive 492 is equipped with a unique charge pump regulator, which provides full (> 10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive up to 5.5V. To do. A bootstrap capacitor may be used to provide the above-mentioned battery supply voltage required for the N-channel MOSFET. The internal charge pump for high-side drive enables DC (100% duty cycle) operation. The full bridge can be driven in fast or slow decay mode using diodes or synchronous rectification. In slow decay mode, current recirculation is possible with both high-side and low-side FETs. The power FET is protected from shoot-through by a register-adjustable dead time. The integrated diagnostics indicate low voltage, overtemperature, and power bridge anomalies and can be configured to protect the power MOSFET under most short circuit conditions. Other motor drives can be easily replaced for use in the tracking system 480 with an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuit configuration with 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 comprising a rack of drive teeth for meshing and engaging with the corresponding drive gear of the gear reducer assembly. In another aspect, the displacement member represents a launching member that can 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 the 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 of a stapler, ultrasound, or electrosurgical device, or a clamp arm closing member configured to open and close the combination described above. Therefore, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, clamp arm, or any element that can be displaced. Will be done. Therefore, the absolute positioning system can actually track the displacement of the clamp arm by tracking the linear displacement of the drive member that is movable in the longitudinal direction.

In another aspect, the absolute positioning system may be configured to track the position of the clamp arm in 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. Therefore, a drive member or clamp arm that is movable in the longitudinal direction, or a combination thereof, may be connected to any suitable linear displacement sensor. The linear displacement sensor may include a contact or non-contact displacement sensor. Linear displacement sensors are placed on a series of linear variable differential transformers (LVDT), differential variable reluctance transducers (DVRT), slide potentiometers, movable magnets and a series of straight lines. Magnetic sensing system with Hall effect sensors, fixed magnets and magnetic sensing system with Hall effect sensors arranged on a series of movable straight lines, movable light sources and light arranged on a series of linear lines It may include an optical detection system with a diode or photodetector, an optical detection system with a fixed light source and a set of movable linear light diodes or photodetectors, or any combination thereof.

The electric motor 482 may include a rotary shaft operably interfaced with a gear assembly mounted in mesh engagement with a set of drive teeth on the displacement member or rack. The sensor element may be operably coupled to the gear assembly such that one rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. Gearing and sensor mechanisms can be connected to linear actuators by rack and pinion mechanisms, or to rotary actuators by spur gears or other connections. The power supply powers the absolute positioning system and the output indicator can display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed on it to mesh and engage with the corresponding drive gear of the gear reducer assembly. The displacement member represents a launching member that can move in the longitudinal direction to open and close the clamp arm.

One rotation of the sensor element attached to the position sensor 472 corresponds to a linear displacement di in the longitudinal direction of the displacement member, which means that the displacement member moves from the point "a" after one rotation of the sensor element connected to the displacement member. It is a linear distance in the longitudinal direction to move to the point "b". The sensor mechanism may be connected via gear deceleration resulting in the position sensor 472 completing one or more rotations for the full stroke of the displacement member. The position sensor 472 can complete a plurality of rotations with respect to the full stroke of the displacement member.

A series of switches (where n is an integer greater than 1), even when used alone, in combination with gear deceleration to provide a unique position signal for two or more rotations of the position sensor 472. May be used in. The state of the switch is fed back to the microcontroller 461, which applies the logic to the longitudinal displacement of the displacement member d ₁ + d ₂ +. .. .. Determine the unique position signal corresponding to d _n. The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor mechanism may include an analog rotation sensor such as a magnetic sensor, a potential difference meter, or an array of analog Hall effect elements that output a unique combination of position signals or values.

The position sensor 472 may include any number of magnetic sensing elements, such as magnetic sensors that are classified based on whether or not they measure the total magnetic field or vector component of the magnetic field. The technology used to produce both types of magnetic sensors involves many aspects of physics and electronics. Techniques used for magnetic field sensing include, among other things, probe coils, flux gates, optical pumping, nuclear precession, SQUID, Hall effect, anisotropic magnetic resistance, giant magnetic resistance, magnetic tunnel junctions, giant magnetic impedance. , Magnetic strain / piezoelectric composites, magnetic diodes, magnetic transistors, optical fibers, magnetic optics, and magnetic sensors based on microelectromechanical systems.

In one aspect, the position sensor 472 of the tracking system 480 with the absolute positioning system comprises a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055 EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. The position sensor 472 is interfaced with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the region of the position sensor 472 located above the magnet. In addition, a high resolution ADC and smart power management controller are provided on the chip. Digit-by-digit method and boulder to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. A coordinate rotation digital computer (CORDIC) processor, also known as a Volder's algorithm, is provided. 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 a 12-bit or 14-bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85 mm package.

The tracking system 480 with an absolute positioning system may include and / or may be programmed to implement a feedback controller such as a PID, state feedback, and adaptive controller. The power supply converts the signal from the feedback controller into a physical input to the system, in this case a voltage. Other examples include voltage, current, and force PWM. In addition to the position measured by the position sensor 472, other sensors (s) may be provided to measure the physical parameters of the physical system. In some embodiments, as the other sensor (s), the US Pat. No. 9, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety. , 345, 481, the United States Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE TISSUE TISSUE SENSOR SYSTEM," which is incorporated herein by reference in its entirety, and in its entirety. U.S. Patent Application Publication No. 17/6, 2017 Examples of sensor mechanisms such as those that are present. 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. Absolute positioning systems use algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response to combine the calculated response with the measured response. Can be equipped. In order to predict what the state and output of the physical system will be by knowing the inputs, the calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, and induced resistance.

The absolute positioning system resets the displacement members, which may be required in conventional rotary encoders where the motor 482 simply counts the number of steps taken forward or backward to estimate the position of device actuators, drive bars, knives, etc. Provides the absolute position of the displacement member when the appliance is powered on, without retracting or advancing to the zero or home) position.

A sensor 474, such as a strain gauge or microstrain gauge, can indicate, for example, one or more end effectors such as the amplitude of strain exerted on the anvil during clamping operation, which can indicate the closing force applied to the anvil. It is configured to measure the parameters of. The measured distortion is converted into a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, for example, a sensor 476, such as a load sensor, measures the closure force that the closure drive system exerts on a stapler in an ultrasound or electrosurgical instrument or an anvil in a clamp arm. Can be done. For example, a sensor 476, such as a load sensor, may be applied to a firing force applied to a closing member connected to a clamp arm of a surgical instrument or tool, or to tissue located within a jaw of an ultrasonic or electrosurgical instrument by the clamp arm. It is possible to measure the force to be applied. Alternatively, a current sensor 478 can be used to measure the current draw by the motor 482. The displacement member may also be configured to engage the clamp arm to open and close the clamp arm. The force sensor may be configured to measure the clamping force on the tissue. The force required to advance the displacement member may correspond, for example, to the current drawn by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.

In one form, the strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector. A strain gauge can be attached to the end effector to measure the force of the end effector on the tissue to be treated. The system for measuring the force applied to the tissue gripped by the end effector is, for example, a strain gauge sensor 474, such as a micro strain gauge configured to measure one or more parameters of the end effector. To be equipped. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of strain exerted on the end effector jaw member during clamping operation, which can indicate tissue compression. The measured distortion is converted into a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to manipulate the knife element, for example, to cut the tissue trapped between the anvil and the staple cartridge. The load sensor 476 operates the clamp arm element, for example, to capture tissue between the clamp arm and the ultrasonic blade, or to capture tissue between the clamp arm and the jaws of an electrosurgical instrument. The force used to do this can be measured. Magnetic field sensors can be used to measure the thickness of captured tissue. The magnetic field sensor measurements can also be converted to digital signals and provided to the processor 462.

Measures of tissue compression, tissue thickness, and / or force required to close the end effector on the tissue, measured by sensors 474 and 476, respectively, are the selected position of the launching member and /. Alternatively, it can be used by the microcontroller 461 to characterize the corresponding value of the velocity of the launching member. In one example, memory 468 can store techniques, equations and / or look-up tables that can be used by microcontroller 461 during evaluation.

The surgical instrument or tool control system 470 may also include a wired or wireless communication circuit for communicating with a modular communication hub as shown in FIGS. 8-11.

FIG. 13 shows a control circuit 500 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 can be configured to implement the various processes described herein. The control circuit 500 can include a microcontroller having one or more processors 502 (eg, microprocessor, microcontroller) coupled to at least one memory circuit 504. The memory circuit 504 stores machine executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions for implementing the various processes described herein. The processor 502 may be any one of a number of single or multi-core processors known in the art. The memory circuit 504 may include volatile and non-volatile storage media. The processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

FIG. 14 shows a combination logic circuit 510 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The combination logic circuit 510 can be configured to implement the various processes described herein. The combination logic circuit 510 is a finite state machine containing the combination logic 512 configured to receive data associated with a surgical instrument or tool at input 514, process the data by combination logic 512, and provide output 516. May include.

FIG. 15 shows a sequence logic circuit 520 configured to control aspects of a surgical instrument or tool according to one aspect of the present disclosure. The order logic circuit 520 or combination logic 522 can be configured to implement the various processes described herein. The order logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, a combination logic 522, at least one memory circuit 524, and a clock 529. At least one memory circuit 524 can store the current state of the finite state machine. In a particular example, the order logic circuit 520 may be synchronous or asynchronous. Combination logic 522 is configured to receive data associated with a surgical instrument or tool from input 526, process the data by combination logic 522, and provide output 528. In another aspect, the circuit may include a combination of a processor (eg, processor 502 in FIG. 13) and a finite state machine that implements the various processes herein. In another aspect, the finite state machine can include a combination of a combination logic circuit (eg, combination logic circuit 510 in FIG. 14) and a sequence logic circuit 520.

FIG. 16 shows a surgical instrument or tool with multiple motors that can be activated to perform various functions. In a particular example, the first motor can be started to perform the first function, the second motor can be started to perform the second function, and the third motor can be started. The third function can be executed, the fourth motor can be started to execute the fourth function, and so on. In certain examples, multiple motors of the robotic surgical instrument 600 can be individually activated to produce launching, closing, and / or jointing motions in the end effector. Launching motion, closing motion, and / or joint motion can be transmitted to the end effector, for example, via a shaft assembly.

In certain examples, the surgical instrument system or tool may include a launch motor 602. The launch motor 602 can be made operational to the launch motor drive assembly 604, which can be configured to transmit the launch motion generated by the motor 602 to the end effector, specifically to displace the clamp arm closing member. It may be concatenated. The closing member may be retracted by reversing the direction of the motor 602, thereby further opening the clamp arm.

In certain examples, the surgical instrument or tool may include a closure motor 603. The closing motor 603 specifically displaces the closing tube to close the anvil and transmits the closing motion generated by the motor 603 to the end effector to compress the tissue between the anvil and the staple cartridge. It may be operably coupled with a closed motor drive assembly 605 that may be configured. The closure motor 603 specifically displaces the closure tube to close the clamp arm and compresses the tissue between the clamp arm and either the ultrasonic blade or jaw member of the electrosurgical device. It may be operably coupled with a closure motor drive assembly 605, which may be configured to transmit the closure motion generated by 603 to the end effector. The closing motion allows, for example, the end effector to transition from an open configuration to an approaching configuration to capture tissue. The end effector can be transitioned to the open position by reversing the direction of the motor 603.

In certain examples, the surgical instrument or tool may include, for example, one or more joint motion motors 606a, 606b. The motors 606a, 606b may be operably coupled to the corresponding joint motion motor drive assemblies 608a, 608b, which may be configured to transmit the joint motion generated by the motors 606a, 606b to the end effector. In certain examples, articulation allows, for example, end effectors to articulate with respect to the shaft.

As mentioned above, a surgical instrument or tool may include multiple motors that may be configured to perform a variety of independent functions. In certain examples, multiple motors of a surgical instrument or tool can be activated independently or separately to perform one or more functions while the other motors remain stationary. Can be carried out. For example, the joint movement motors 606a and 606b can be activated to jointly move the end effector while the launch motor 602 is maintained in a stopped state. Alternatively, the launch motor 602 can be activated to launch a plurality of staples and / or advance the cutting edge while the joint motion motor 606 is stopped. Further, the closure motor 603 may be activated at the same time as the launch motor 602 in order to advance the closure tube or closing member distally, as described in more detail below.

In certain examples, the 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 a particular example, the common control module 610 can accommodate one of a plurality of motors at a time. For example, the common control module 610 may be individually connectable and detachable to multiple motors of the robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, multiple motors of a surgical instrument or tool can be independently and selectively engaged with a common control module 610. In a particular example, the common control module 610 selectively switches from working with one of the motors of the surgical instrument or tool to working with the other of the motors of the surgical tool or tool. be able to.

In at least one example, the common control module 610 selects between an operable engagement with the joint motion motors 606a, 606b and an operable engagement with either the launch motor 602 or the closure motor 603. Can be switched. In at least one embodiment, as shown in FIG. 16, switch 614 can move or transition between multiple positions and / or states. For example, at the first position 616, the switch 614 may electrically connect the common control module 610 to the launch motor 602, and at the second position 617, the switch 614 closes the common control module 610. It may be electrically connected to the motor 603, and at the third position 618a, the switch 614 may electrically connect the common control module 610 to the first joint motion motor 606a, at the fourth position. At 618b, the switch 614 may electrically connect the common control module 610 to the second joint motion motor 606b. In certain examples, separate common control modules 610 may be electrically connected to launch motors 602, closure motors 603, and joint motion motors 606a, 606b at the same time. In a particular example, the switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may be provided with a torque sensor for measuring the output torque on the shaft of the motor. The force on the end effector may be sensed by any conventional method, such as by a force sensor on the outside of the jaw, or by a torque sensor on the motor that actuates the jaw.

In various examples, as shown in FIG. 16, the common control module 610 may include a motor drive 626, which may include one or more H-bridge FETs. The motor drive 626 may modulate the power transmitted from the power supply 628 to the motor connected to the common control module 610, for example, based on the input from the microcontroller 620 (“controller”). In a particular example, as described above, for example, a microcontroller 620 can be used while the motor is connected to a common control module 610 to determine the current drawn by the motor.

In certain examples, the microcontroller 620 may include a microprocessor 622 (“processor”) and one or more non-transitory computer-readable media or memory units 624 (“memory”). In a particular example, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform multiple functions and / or calculations described herein. it can. In a particular example, one or more of the memory units 624 may be attached to, for example, processor 622. In various aspects, the microcontroller 620 may communicate via a wired or wireless channel, or a combination thereof.

In certain examples, the power supply 628 may be used to power, for example, the microcontroller 620. In certain examples, the power supply 628 may include batteries (or "battery packs" or "power packs"), such as lithium-ion batteries. In certain examples, the battery pack may be configured to be detachably attached to the handle to power the surgical instrument 600. A large number of battery cells connected in series may be used as the power source 628. In certain examples, the power supply 628 may be, for example, replaceable and / or rechargeable.

In various examples, the processor 622 can control the motor drive 626 to control the position, direction of rotation, and / or speed of the motor coupled to the common control module 610. In a particular example, the processor 622 can signal the motor drive 626 to stop and / or disable the motor coupled to the common control module 610. The term "processor", as used herein, is the function of any suitable microprocessor, microcontroller, or computer central processing unit (CPU) in one integrated circuit or up to several integrated circuits. It should be understood to include other basic computing devices integrated above. Processor 622 is a versatile programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides the results as output. This is an example of sequential digital logic because it has internal memory. The processor operates on numbers and symbols represented in binary notation.

In one example, the processor 622 may be any single-core or multi-core processor, such as that known by the Texas Instruments ARM Cortex trade name. In a particular example, the microcontroller 620 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR features on-chip memory of up to 40 MHz 256 KB single-cycle flash memory or other non-volatile memory, with 40 MHz performance, among other characteristics readily available in the product datasheet. Prefetch buffer for super-improvement, 32KB single cycle SRAM, internal ROM with Non-volatile Memory® software, 2KB EEPROM, one or more PWM modules, one or more QEI analogs , ARM Cortex-M4F processor core containing one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with the module 4410. Therefore, this disclosure should not be limited to this context.

In a particular example, the memory 624 may include program instructions for controlling each motor of a surgical instrument 600 that can be connected to a common control module 610. For example, the memory 624 may include program instructions for controlling the launch motor 602, the closure motor 603, and the joint motion motors 606a, 606b. Such program instructions can cause the processor 622 to control firing, closing, and joint motor functions according to input from an algorithm or control program of a surgical instrument or tool.

In certain examples, one or more mechanisms and / or sensors, such as the sensor 630, can be used to warn the processor 622 of program instructions to be used in a particular setting. For example, sensor 630 can warn processor 622 to use program instructions related to end effector firing, closing, and joint movement. In certain examples, the sensor 630 may include, for example, a position sensor that can be used to sense the position of the switch 614. Therefore, when the processor 622 detects, for example, through the sensor 630 that the switch 614 is in the first position 616, it uses a program instruction associated with the firing of the closing member coupled to the clamp arm of the end effector. The processor 622 can use the program instructions associated with the closure of the anvil when it detects, for example, through the sensor 630 that the switch 614 is in the second position 617. For example, if the switch 614 is detected at the third position 618a or the fourth position 618b via the sensor 630, the program instruction associated with the joint movement of the end effector can be used.

FIG. 17 is a circuit diagram of a robotic surgical instrument 700 configured to operate the surgical tools described herein according to an aspect of the present disclosure. The robotic surgical instrument 700 uses either a single or multiple joint motion drive joints to provide distal / proximal translation of displacement members, distal / proximal displacement of closed tubes, shaft rotation, and joints. It may be programmed or configured to control movement. In one aspect, the surgical instrument 700 may be programmed or configured to individually control a launching member, a closing member, a shaft member, or one or more joint motion members, or a combination thereof. The surgical instrument 700 includes a motor-driven launching member, a closing member, a shaft member, or a control circuit 710 configured to control one or more joint motion members, or a combination thereof.

In one aspect, the robotic surgical instrument 700 is coupled to the clamp arm 716 and closing member 714 portion of the end effector 702 and the ultrasonic transducer 719 excited by the ultrasonic generator 721 via a plurality of motors 704a-704e. It is provided with a control circuit 710 configured to control the ultrasonic blade 718, the shaft 740, and one or more joint movement members 742a, 742b. The position sensor 734 may be configured to provide position feedback for the closing member 714 to the control circuit 710. The other sensor 738 may be configured to provide feedback to the control circuit 710. The timer / counter 731 provides timing and count information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and the 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.

In one aspect, the control circuit 710 is one or more microcontrollers, microprocessors, or other suitable instructions for causing a processor or multiple processors to perform one or more tasks. It may be equipped with a processor. In one aspect, the timer / counter 731 provides an output signal such as elapsed time or digital count to the control circuit 710 to correlate the position of the closing member 714 determined by the position sensor 734 with the output of the timer / counter 731. As a result, the control circuit 710 can determine the position of the closing member 714 at a specific time (t) with respect to the starting position or time (t) when the closing member 714 is at a specific position with respect to the starting position. it can. The timer / counter 731 may be configured to measure elapsed time, count external events, or measure the time of external events.

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 states. 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 launch control program or a closure control program based on tissue conditions. The launch control program can describe the distal motion of the displacement member. Various launch control programs can be selected to better handle different tissue conditions. For example, in the presence of thicker tissue, the control circuit 710 may be programmed to translate the displacement member at a slower speed and / or at a lower power. In the presence of thinner tissue, the control circuit 710 may be programmed to translate the displacement member faster and / or at higher power. The closure control program can control the closure force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and the joint motion members 742a, 742b.

In one aspect, the control circuit 710 can generate a motor setpoint signal. Motor set value signals may be provided to various motor controllers 708a-708e. Motor controllers 708a-708e include one or more circuits configured to provide motor drive signals to motors 704a-704e to drive motors 704a-704e, as described herein. You may. In some embodiments, the motors 704a-704e may be brushed DC electric motors. For example, the speeds of the motors 704a to 704e may be proportional to the respective motor drive signals. In some embodiments, the motors 704a-704e may be brushless DC electric motors, the respective motor drive signal being PWM provided to one or more stator windings of the motors 704a-704e. It may include a signal. Further, in some embodiments, the motor controllers 708a to 708e may be omitted, and the control circuit 710 may directly generate a motor drive signal.

In one aspect, the control circuit 710 may first operate each of the motors 704a-704e in an open-loop configuration at the first open-loop portion of the displacement member stroke. Based on the response of the robotic surgical instrument 700 during the open loop portion of the stroke, the control circuit 710 may select a launch control program with a closed loop configuration. The response of the instrument is the translational distance of the displacement member between the open loop portions, the time elapsed between the open loop portions, the energy provided to one of the motors 704a-704e during the open loop portions, the motor. The total pulse width of the drive signal may be mentioned. After the open loop portion, the control circuit 710 may implement the selected launch control program for the second portion of the displacement member stroke. For example, during the closed loop portion of the stroke, the control circuit 710 modulates one of the motors 704a to 704e in a closed loop manner based on translational data describing the position of the displacement member to translate the displacement member at a constant speed. You may let me.

In one aspect, the motors 704a-704e can receive power from the energy source 712. The energy source 712 may be a main AC power source, a battery, a supercapacitor, or a DC power source driven by any other suitable energy source. The motors 704a-704e may be mechanically coupled to individual movable mechanical elements such as the closing member 714, clamp arm 716, shaft 740, joint 742a, and joint 742b via the respective transmission devices 706a-706e. Good. Transmission devices 706a-706e may include one or more gears or other connecting components for connecting motors 704a-704e to mobile mechanical elements. The position sensor 734 can sense the position of the closing member 714. The position sensor 734 may be any type of sensor capable of generating position data indicating the position of the closing member 714, or may include it. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the closure member 714 translates distally and proximally. The control circuit 710 may track the pulse to determine the position of the closing member 714. Other suitable position sensors, including, for example, proximity sensors may be used. Other types of position sensors can provide other signals indicating the movement of the closing member 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a-704e is a step motor, the control circuit 710 may track the position of the closing member 714 by summing the number and directions of steps instructed by the motor 704 to perform. it can. The position sensor 734 can be located within the end effector 702 or at any other part of the instrument. Each output of the motors 704a-704e includes torque sensors 744a-744e for sensing force and has an encoder that senses the rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a launching member, such as a closing member 714 portion of the end effector 702. The control circuit 710 provides the motor control unit 708a with a motor set value, and the motor control unit 708a provides a drive signal to the motor 704a. The output shaft of the motor 704a is connected to the torque sensor 744a. The torque sensor 744a is connected to the transmission device 706a connected to the closing member 714. The transmission device 706a includes movable mechanical elements such as a rotating element and a launching member for controlling the movement of the closing member 714 in the distal and proximal directions along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that includes a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to launch or displace the closing member 714. The position sensor 734 may be configured to provide the position of the closing member 714 or the position of the firing member along the firing stroke to the control circuit 710 as a feedback signal. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 can provide a firing signal to the motor control unit 708a. In response to the launch signal, the motor 704a drives the launch member distally along the longitudinal axis of the end effector 702 from the proximal stroke start position to the stroke end position distal to the stroke start position. be able to. As the closing member 714 translates distally, the clamp arm 716 closes towards the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to drive a closing member such as the clamp arm 716 of the end effector 702. The control circuit 710 provides a motor setting point to the motor control unit 708b that provides a drive signal to the motor 704b. The output shaft of the motor 704b is connected to the torque sensor 744b. The torque sensor 744b is connected to the transmission device 706b connected to the clamp arm 716. The transmission device 706b includes movable mechanical elements such as a rotating element and a closing member for controlling the movement of the clamp arm 716 from the open position and the closed position. In one aspect, the motor 704b is coupled to a closed gear assembly that includes a closed reduction gear set that is meshed with and supported by the closed spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal represents the closing force applied to the clamp arm 716. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 can provide a closing force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned on the opposite side of the ultrasonic blade 718. When ready for use, the control circuit 710 can provide a closure signal to the motor control unit 708b. In response to the closure signal, the motor 704b advances the closure member to grip the tissue between the clamp arm 716 and the ultrasonic blade 718.

In one aspect, the control circuit 710 is configured to rotate a shaft member, such as a shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor setting point to the motor control unit 708c that provides a drive signal to the motor 704c. The output shaft of the motor 704c is connected to the torque sensor 744c. The torque sensor 744c is connected to the transmission device 706c connected to the shaft 740. The transmission device 706c includes a movable mechanical element such as a rotating element to control the clockwise or counterclockwise rotation of the shaft 740 up to and beyond 360 degrees. In one aspect, the motor 704c is formed (or to) on the proximal end of the proximal closure tube so that it is operably engaged by a rotating gear assembly operably supported on a tool mounting plate. It is connected to a rotation transmission assembly that includes a tubular gear segment (attached). The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the rotation position of the shaft 740 to the control circuit 710.

In one aspect, the control circuit 710 is configured to jointly move the end effector 702. The control circuit 710 provides a motor setting point to the motor control unit 708d that provides a drive signal to the motor 704d. The output shaft of the motor 704d is connected to the torque sensor 744d. The torque sensor 744d is connected to a transmission device 706d connected to the joint movement member 742a. The transmission device 706d includes a movable mechanical element such as a joint movement element for controlling the ± 65 ° joint movement of the end effector 702. In one aspect, the motor 704d is connected to a joint motion nut, which is rotatably pivoted on the proximal end portion of the distal spine portion and joints on the proximal end portion of the distal spine portion. It is rotatably driven by the kinetic gear assembly. The torque sensor 744d provides a joint kinetic force feedback signal to the control circuit 710. The joint kinetic force feedback signal represents the joint kinetic force applied to the end effector 702. A sensor 738, such as a joint motion encoder, may provide the joint motion position of the end effector 702 to the control circuit 710.

In another aspect, the joint motor function of the robotic surgical system 700 may include two joint motor members, or joints 742a, 742b. These joint motion members 742a, 742b are driven by separate discs on a robot interface (rack) driven by two motors 708d, 708e. A separate launch motor 704a is provided to provide resistance-holding motion and load to the head when the head is not in motion, and to provide joint motion when the head is in joint motion. Each of the joint motion connecting portions 742a and 742b can be driven antagonistically with respect to the other connecting portions. The joint movement members 742a and 742b are attached to the head with a fixed radius when the head rotates. Therefore, as the head rotates, the mechanical efficiency of the push-pull connection changes. This change in mechanical efficiency can be more pronounced in the drive system of other joint motion connections.

In one aspect, one or more motors 704a-704e may include a gearbox and a brushed DC motor with a mechanical connection to a launching member, closing member, or articulating member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, joint motion connections, closure tubes, and shafts. External effects are unmeasured and unpredictable effects, such as friction on tissues, surrounding bodies, and physical systems. Such external influences are sometimes referred to as drags that act against one of the electric motors 704a-704e. External influences, such as failures, can deviate the behavior of the physical system from the desired behavior of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a gyromagnetic absolute positioning system implemented as an AS5055 EQFT single-chip gyromagnetic position sensor available from Austria Microsystems, AG. The position sensor 734 can be interfaced with the control circuit 710 to provide an absolute positioning system. The position is located above the magnet and is provided to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. It may include multiple Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the boulder algorithm.

In one aspect, the control circuit 710 may communicate with one or more sensors 738. The sensor 738 is positioned on the end effector 702 and is adapted to work with the robotic surgical instrument 700 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. You may. The sensor 738 is one of a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an induction sensor such as a vortex current sensor, a resistance sensor, a capacitance sensor, an optical sensor, and / or an end effector 702. Alternatively, any other suitable sensor for measuring two or more parameters may be provided. Sensor 738 may include one or more sensors. The sensor 738 may be placed on the clamp arm 716 to determine the position of the tissue using the divided electrodes. Torque sensors 744a-744e may be configured to sense, among other things, forces such as firing force, closing force, and / or joint kinetic force. Therefore, the control circuit 710 has (1) the closure load experienced by the distal closure tube and its position, (2) the launching member and its position in the rack, and (3) which part of the ultrasonic blade 718 is on it. It has tissue and can (4) sense loads and positions on both articular motion rods.

In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain on the clamp arm 716 during the clamped state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. The sensor 738 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the clamp arm 716 and the ultrasonic blade 718. The sensor 738 may be configured to detect the impedance of the tissue portion located between the clamp arm 716 and the ultrasonic blade 718, which impedance is the thickness of the tissue located between them and / or Indicates the degree of filling.

In one aspect, the sensor 738 is mounted as, among other things, one or more limit switches, electromechanical devices, solid switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers. May be done. In other embodiments, the sensor 738 may be mounted as a solid-state switch that operates under the influence of light, such as light sensors, IR sensors, and UV sensors, among others. Further, the switch may be a solid-state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.

In one aspect, the sensor 738 may be configured to measure the force exerted on the clamp arm 716 by the closed drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the clamp arm 716 to detect the closing force applied to the clamp arm 716 by the closure tube. .. The force exerted on the clamp arm 716 may represent the tissue compression experienced by the tissue section captured between the clamp arm 716 and the ultrasonic blade 718. One or more sensors 738 can be located at various points of interaction along the closure drive system to detect the closure force applied to the clamp arm 716 by the closure drive system. One or more sensors 738 may be sampled in real time during the clamping operation by the processor of control circuit 710. The control circuit 710 receives real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the clamp arm 716 in real time.

In one aspect, the 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 closing member 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted into a digital signal and provided to the control circuit 710. The control circuit 710 may be configured to simulate the response of the actual system of the instrument with the software of the controller. The displacement member can be actuated to move the closing member 714 in the end effector 702 at or near the target speed. The robotic surgical instrument 700 can include a feedback controller, the feedback controller being any feedback controller including, but not limited to, PID, state feedback, linear quadratic (LQR), and / or adaptive controllers. It may be any one of them. The robotic surgical instrument 700 can include a power source for converting signals from the feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force. .. Further details are provided in US Patent Application Publication No. 15 / 636,829, entitled "CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT", filed June 29, 2017, which is incorporated herein by reference in its entirety. It is disclosed.

FIG. 18 shows a circuit diagram of a surgical instrument 750 configured to control the distal translation of a displacement member according to one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control the distal translation of the displacement member, such as the closing member 764. The surgical instrument 750 comprises an end effector 752 that may include a clamp arm 766, a closing member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.

The position, movement, displacement, and / or translation of a linear displacement member, such as the closing member 764, can be measured by an absolute positioning system, sensor mechanism, and position sensor 784. Since the closing member 764 is connected to a drive member that is movable in the longitudinal direction, the position of the closing member 764 is determined by measuring the position of the drive member that is movable in the longitudinal direction using the position sensor 784. Can be done. Therefore, in the following description, the position, displacement, and / or translation of the closing member 764 can be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of the displacement member, such as the closing member 764. In some embodiments, the control circuit 760 commands one or more microcontrollers, microprocessors, or processors or multiple processors to control a displacement member, eg, a closure member 764, in the manner described. Other suitable processors for execution may be provided. In one aspect, the timer / counter 781 provides an output signal such as elapsed time or digital count to the control circuit 760 to correlate the position of the closing member 764 determined by the position sensor 784 with the output of the timer / counter 781. As a result, the control circuit 760 can determine the position of the closing member 764 at a specific time (t) with respect to the starting position. The timer / counter 781 may be configured to measure elapsed time, count external events, or measure the time of external events.

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

The motor 754 can receive power from the energy source 762. The energy source 762 may be a battery, a supercapacitor, or any other suitable energy source, or may include it. The motor 754 may be mechanically connected to the closing member 764 via the transmission device 756. The transmission device 756 may include one or more gears or other connecting components for connecting the motor 754 to the closing member 764. The position sensor 784 can sense the position of the closing member 764. The position sensor 784 may be any type of sensor capable of generating position data indicating the position of the closing member 764, or may include it. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the closure member 764 translates distally and proximally. The control circuit 760 may track the pulse to determine the position of the closing member 764. Other suitable position sensors, including, for example, proximity sensors may be used. Other types of position sensors can provide other signals indicating the movement of the closing member 764. Further, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuit 760 can track the position of the closing member 764 by summing the number and directions of steps instructed by the motor 754 to perform. The position sensor 784 can be located within the end effector 752 or at any other part of the instrument.

The control circuit 760 can communicate with one or more sensors 788. The sensor 788 may be positioned on the end effector 752 and work with the surgical instrument 750 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. .. The sensor 788 is one or more of induction sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or end effectors 752. Any other suitable sensor for measuring parameters may be provided. Sensor 788 may include one or more sensors.

One or more sensors 788 may include a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain on the clamp arm 766 during the clamped state. The strain gauge provides an electrical signal whose amplitude fluctuates with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect the impedance of the tissue portion located between the clamp arm 766 and the ultrasonic blade 768, which impedance is the thickness of the tissue located between them and / or Indicates the degree of filling.

The sensor 788 may be configured to measure the force exerted on the clamp arm 766 by the closed drive system. For example, one or more sensors 788 may be located at the point of interaction between the closure tube and the clamp arm 766 to detect the closing force applied to the clamp arm 766 by the closure tube. .. The force exerted on the clamp arm 766 may represent the tissue compression experienced by the tissue section captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 can be positioned at various points of interaction along the closure drive system to detect the closure force applied to the clamp arm 766 by the closure drive system. One or more sensors 788 may be sampled in real time during the clamping operation by the processor of control circuit 760. The control circuit 760 receives real-time sample measurements, provides and analyzes time-based information, and evaluates the closing force applied to the clamp arm 766 in real time.

A current sensor 786 can be used to measure the current drawn by the motor 754. The force required to advance the closing member 764 corresponds to the current drawn by the motor 754. The force is converted into a digital signal and provided to the control circuit 760.

The control circuit 760 may be configured to simulate the response of the actual system of the instrument with the software of the controller. The displacement member can be actuated to move the closing member 764 in the end effector 752 at or near the target speed. The surgical instrument 750 can include a feedback controller, the feedback controller being any one of any feedback controllers including, but not limited to, for example, PID, state feedback, LQR, and / or adaptive controllers. It may be one. The surgical instrument 750 can include a power source for converting signals from the feedback controller into physical inputs such as case voltage, PWM voltage, frequency modulation voltage, current, torque, and / or force.

The actual drive system for the surgical instrument 750 is such that a displacement member, cutting member, or closing member 764 is driven by a brushed DC motor with a gearbox and a mechanical connection to the joint movement and / or knife system. It is configured in. Another example is an electric motor 754 that operates a displacement member and a joint motion driver of a replaceable shaft assembly. External effects are unmeasured and unpredictable effects, such as friction on tissues, surrounding bodies, and physical systems. Such external influences are sometimes referred to as failures acting against the electric motor 754. External influences, such as failures, can deviate the behavior of the physical system from the desired behavior of the physical system.

Various exemplary embodiments relate to a surgical instrument 750 with an end effector 752 having a motor-driven surgical encapsulation and cutting instrument. For example, the motor 754 may drive the displacement members distally and proximally along the 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 located on the opposite side of the clamp arm 766. The clinician may grip the tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When ready to use the instrument 750, the clinician may provide a firing signal, for example by pressing the trigger on the instrument 750. In response to the firing signal, the motor 754 drives the displacement member distally along the longitudinal axis of the end effector 752 from the proximal stroke start position to the stroke end position distal to the stroke start position. be able to. As the displacement member translates distally, the closing member 764 with the cutting element located at the distal end can cut the tissue between the ultrasonic blade 768 and the clamp arm 766.

In various embodiments, the surgical instrument 750 comprises a control circuit 760 programmed to control the distal translation of a displacement member, such as a closure member 764, based on one or more tissue conditions. You may. 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 state. The control program can describe the distal movement of the displacement member. Different control programs can be selected to better handle different tissue conditions. For example, in the presence of thicker tissue, control circuit 760 may be programmed to translate the displacement member at a slower speed and / or at a lower power. In the presence of thinner tissue, control circuit 760 may be programmed to translate the displacement member faster and / or at higher power.

In some embodiments, the control circuit 760 may first operate the motor 754 in an open loop configuration with respect to the 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 launch control program. The response of the instrument is the sum of the translational distance of the displacement member between the open loop portions, the time elapsed between the open loop portions, the energy provided to the motor 754 during the open loop portions, and the pulse width of the motor drive signal. And so on. After the open loop portion, the control circuit 760 may implement the selected launch control program for the 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 translational data describing the position of the displacement member to translate the displacement member at a constant speed. Further details are incorporated herein by reference in their entirety, US Patent Application Publication No. 15 / 720, 852, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT", filed September 29, 2017. It is disclosed in the issue.

FIG. 19 is a schematic view of a surgical instrument 790 configured to control various functions according to one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of the displacement member, such as the closing member 764. The surgical instrument 790 can be replaced with or interlocked with a clamp arm 766, a closing member 764, and one or more RF electrodes 796 (shown by dashed lines), an ultrasonic blade 768. It is provided with an end effector 792 which can be provided with. The ultrasonic blade 768 is connected to an ultrasonic transducer 769 driven by an ultrasonic generator 771.

In one aspect, the sensor 788 may be implemented, among other things, as a limit switch, electromechanical device, solid switch, Hall effect device, MR device, GMR device, magnetometer. In other embodiments, the sensor 638 may be a solid-state switch that operates under the influence of light, especially light sensors, IR sensors, UV sensors, and the like. Further, the switch may be a solid-state device such as a transistor (eg, FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include, among other things, a conductor-free switch, an ultrasonic switch, an accelerometer, and an inertial sensor.

In one aspect, the position sensor 784 may be implemented as an absolute positioning system comprising a magnetic rotation absolute positioning system implemented as an AS5055EQFT single chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 784 can be interfaced with the control circuit 760 to provide an absolute positioning system. The position is located above the magnet and is provided to implement a concise and efficient algorithm for computing hyperbolic and trigonometric functions that requires only addition, subtraction, bitshift, and table reference operations. It may include multiple Hall effect elements coupled to a CORDIC processor, also known as the digit-by-digit method and the boulder algorithm.

In some embodiments, the position sensor 784 may be omitted. If the motor 754 is a step motor, the control circuit 760 can track the position of the closing member 764 by summing the number and directions of steps instructed by the motor to perform. The position sensor 784 can be located within the end effector 792 or at any other part of the instrument.

The control circuit 760 can communicate with one or more sensors 788. The sensor 788 may be positioned on the end effector 792 and work with the surgical instrument 790 to measure various derived parameters such as clearance distance vs. time, tissue compression vs. time, and anvil strain vs. time. .. The sensor 788 is one or more of induction sensors such as magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, eddy current sensors, resistance sensors, capacitance sensors, optical sensors, and / or end effectors 792. Any other suitable sensor for measuring parameters may be provided. Sensor 788 may include one or more sensors.

The RF energy source 794 is coupled to the end effector 792 and is provided to operate when the RF electrode 796 is provided within the end effector 792 instead of the ultrasonic blade 768 or in conjunction with the ultrasonic blade 768. When applied to the RF electrode 796. For example, the ultrasonic blade may be made of conductive metal and used as a return path for electrosurgical RF currents. The control circuit 760 controls the delivery of RF energy to the RF electrode 796.

Further details are incorporated herein by reference in their entirety, "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING US Pat. It is disclosed in No. 15 / 636,096.

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 the following sections of this disclosure. Various aspects of the smart ultrasonic energy device are described herein in connection with, for example, FIGS. 1-94. Therefore, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with FIGS. 1-94 and related descriptions.

Identification of tissue type and adjustment of device parameters For certain surgical procedures, it is desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust the parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device may be adjusted based on the position of the tissue within the jaws of the ultrasonic end effector, eg, the position of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasonic transducer may be used to identify which proportion of tissue is located at the distal or proximal end of the end effector. The reaction of the ultrasonic device may be based on the type of tissue or the compressibility of the tissue. In another aspect, the parameters of the ultrasound device may be adjusted based on the type or parameterization of the identified tissue. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be adjusted based on the ratio of collagen to the elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue can be detected using a variety of techniques, including infrared (IR) surface reflectance and emissivity. The force exerted on the tissue by the clamp arm and / or the stroke of the clamp arm to create a gap and compression. The electrical conduction of the entire jaw with electrodes can be used to determine which proportion of the jaw is covered with tissue.

FIG. 20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communication hub according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute the adaptive ultrasonic blade control algorithm (s) 802 described herein with reference to FIGS. 53-105. In another aspect, the device / appliance 235 is configured to perform the adaptive ultrasonic blade control algorithm (s) 804 described herein with reference to FIGS. 53-105. In another aspect, both device / appliance 235 and apparatus / appliance 235 are configured to execute the adaptive ultrasonic blade control algorithms 802,804 described herein with reference to FIGS. 53-105. Will be done.

The generator module 240 may include a patient isolation stage that communicates with the non-isolated stage via a power transformer. The secondary windings of the power transformer are housed in an isolation stage and include, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multifunctional surgery including ultrasonic and RF energy modes that can be delivered independently or simultaneously. It may include a tap configuration (eg, center tap or non-center tap configuration) for defining a drive signal output to deliver the drive signal to various surgical instruments such as instruments. Specifically, the drive signal output unit can output an ultrasonic drive signal (for example, a 420 V root mean square (RMS) drive signal) to the ultrasonic surgical instrument 241 and drives the signal. The signal output unit can output an RF electrosurgical drive signal (for example, a 100 V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 will be described herein with reference to FIGS. 21-28B.

The generator module 240, and / or device / instrument 235, are described, for example, with reference to FIGS. 8-11, eg, intelligent surgical instruments, robots, and other computers located in the operating room. It is connected to a modular control tower 236 connected to a plurality of operating room devices such as a computer.

FIG. 21 is configured to be coupled to an ultrasonic instrument and further configured to perform an adaptive ultrasound blade control algorithm within a surgical data network with the modular communication hub shown in FIG. 20. An embodiment of the generator 900, which is a form of the vessel, is shown. The generator 900 is configured to deliver multiple energy modality to the surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, to deliver energy to the surgical instrument. The RF signal and the ultrasonic signal may be provided alone or in combination, or may be provided at the same time. As mentioned above, at least one generator output unit has multiple energy modalities (eg, ultrasound, bipolar or unipolar RF, irreversible and / or reversible electroporation, and / or microwaves, among others, through a single port. Energy) can be delivered and these signals can be delivered to the end effector individually or simultaneously to treat the tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and the waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory connected to the processor 902 (not shown for clarity of disclosure). The digital information associated with the waveform is provided to the waveform generator 904, which includes one or more DAC circuits to convert the digital input to an analog output. The analog output is supplied to amplifier 1106 for signal conditioning and amplification. The regulated and amplified output of the amplifier 906 is coupled to the power transformer 908. The signal is coupled across the power transformer 908 to the secondary side on the patient isolated side. The first signal of the first energy modality is provided between the terminals labeled _{ENERGY 1 and RETURN of the surgical instrument.} The second signal of the second energy modality is coupled over the capacitor 910 and provided between the terminals labeled _{ENERGY 2 and RETURN of the surgical instrument.} More than two energy modality may be output, so the subscript "n" _{can be used to indicate that up to n ENERGY n} terminals can be provided, where n is greater than one. It will be understood that it is a positive integer of. It will also be appreciated that a maximum of "n" return paths (RETURN _n ) may be provided without departing from the scope of the present disclosure.

The first voltage sensing circuit 912 is _{connected over the terminals labeled ENERGY 1} and RETURN path and measures the output voltage between them. A second voltage sensing circuit 924 is _{connected over the terminals labeled ENERGY 2} and RETURN paths and measures the output voltage between them. The current sensing circuit 914 is arranged in series with the RETURN section on 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 sensing circuit must be provided for each return interval. The output of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 is provided to the corresponding insulated transformers 916, 922, and the output of the current sensing circuit 914 is provided to another insulated transformer 918. The output of the insulated transformers 916, 928, 922 on the primary side (non-patient isolated side) of the power transformer 908 is provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to processor 902 for further processing and computation. The output voltage and output feedback information can be used to adjust the output voltage and current provided to the surgical instrument and to calculate the output impedance among several parameters. Input / output communication between the processor 902 and the patient isolation circuit is provided through the interface circuit 920. The sensor may also telecommunications with the processor 902 via the interface circuit 920.

In one aspect, the impedance is either a first voltage sensing circuit 912 coupled over a terminal labeled _{ENERGY 1} / RETURN or a second voltage sensing circuit 924 coupled over a terminal labeled _{ENERGY 2 / RETURN.} The output can be determined by the processor 902 by dividing the output by the output of the current sensing circuit 914 arranged in series with the RETURN section on the secondary side of the power transformer 908. The output of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 is provided to the separate insulated transformers 916, 922, and the output of the current sensing circuit 914 is provided to another insulated transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to processor 902 to calculate the impedance. As an example, the first energy modality ENERGY ₁ may be ultrasonic energy and the second energy modality ENERGY ₂ may be RF energy. Nevertheless, in addition to ultrasonic energy modality and bipolar or unipolar RF energy modality, other energy modality includes irreversible and / or reversible electropiercing and / or radiofrequency energy, among others. Also, the example illustrated in FIG. 21 shows that a single return path (RETURN) can be provided for more than one energy modality, but in other embodiments, multiple return paths RETURN _n can be provided. It may be provided to each energy modality ENERGY _n. Therefore, as described herein, the impedance of the ultrasonic transducer may be measured by dividing the output of the first voltage sensing circuit 912 by the current sensing circuit 914, and the tissue impedance is the second. The output of the voltage sensing circuit 924 may be measured by dividing the output of the voltage sensing circuit 924 by the current sensing circuit 914.

As shown in FIG. 21, a generator 900 containing at least one output port can power, for example, ultrasound, bipolar or unipolar RF, irreversible and /, depending on the type of tissue treatment performed. Or a power transformer having a single output and having multiple taps to provide to the end effector in the form of one or more energy modalities such as reversible electropiercing and / or microwave energy. A vessel 908 can be included. For example, the generator 900 uses either a unipolar or bipolar RF electrosurgical electrode to drive an RF electrode for tissue encapsulation at high voltage and low current to drive an ultrasonic transducer. Energy can be delivered at low voltage and high current, or with a solidification waveform for spot solidification. The output waveform from the generator 900 can be guided, switched, or filtered to provide frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the generator 900 output will preferably be located between the output labeled _{ENERGY 1 and RETURN as shown in FIG.} In one embodiment, the connection of the RF bipolar electrode to the output of the generator 900 would preferably be located between the output labeled _{ENERGY 2 and RETURN.} For unipolar outputs, a preferred connection would be an active electrode (eg, pencil type or other probe) to a suitable return pad connected to the _{ENERGY 2 output and the RETURN output.}

Further details are incorporated herein by reference in their entirety, entitled "TECHNIQUES FOR OPERATING GENERATIONOR FOR DIGITALLY GENERATION ELECTRIC SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS 2017 U.S.A. It is disclosed in the issue.

As used throughout this description, the term "radio" and its derivatives describe circuits, devices, systems, methods, techniques, communication channels, etc. that can communicate data through the use of modulated electromagnetic radiation over non-solid media. May be used for. The term does not mean that the devices involved do not include any wires, but in some embodiments they may not exist. Communication modules include Wi-Fi (IEEE802.11 family), WiMAX (IEEE802.16 family), IEEE802.20, Long Term Evolution (LTE), Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS. , CDMA, TDMA, DECT, Bluetooth, their Ethernet derivatives, as well as any other radio and wired protocols designated as 3G, 4G, 5G, and beyond, but not limited to many radios. Alternatively, either a wired communication standard or a protocol may be implemented. The computing module may include a plurality of 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 GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc. It may be dedicated to long-distance wireless communication.

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 central processor (central processing unit) within a system or computer system (particularly a system-on-chip (SoC)) that combines many dedicated "processors".

As used herein, a system or system-on-chip (SoC or SOC) on a chip is also known as an integrated circuit (also known as an "IC" or "chip") that integrates all components of a computer or other electronic system. Is). It can include digital, analog, mixed signals, and often radio frequency functions, all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with modern peripherals such as graphics processing units (GPUs), Wi-Fi modules, or coprocessors. The SoC may or may not include a built-in memory.

As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to the SoC, which may include a microcontroller as one of its components. The microcontroller can accommodate memory and programmable input / output peripherals along with one or more core processing units (CPUs). Program memory in the form of ferroelectric RAM, NOR flash, or OTP ROM, and small amounts of RAM are also often included on the chip. Microcontrollers can be employed for embedded applications, as opposed to personal computers or other general purpose microprocessors composed of various individual chips.

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

Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those known by the Texas Instruments ARM Cortex trade name. In one aspect, the processor, for example, on-chip memory of up to 40 MHz 256 KB single cycle flash memory or other non-volatile memory, the details of which are available in the product data sheet, for improving performance above 40 MHz. Prefetch buffer, 32KB single-cycle serial random access memory (SRAM), internal read-only memory with StaticrisWare® software (ROM), 2KB electrically erasable programmable read-only memory (EEPROM), one or two One or more pulse width modulation (PWM) modules, one or more orthogonal encoder input (QEI) analogs, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels ), Which may be the LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments.

In one aspect, the processor may include a safety controller that includes two controller family families, such as the TMS570 and RM4x, also known by the Texas Instruments Hercules ARM Cortex R4 trade name. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety limit applications to provide a highly integrated safety mechanism while providing scalable performance, connectivity, and memory choices. Good.

The modular device is connected to a module that is acceptable within the surgical hub (eg, described in connection with FIGS. 3 and 9) and to various modules to connect or pair with the corresponding surgical hub. Includes surgical equipment or instruments to obtain. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, inhalers, and displays. The modular devices described herein can be controlled by control algorithms. The control algorithm is 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 (eg, via a distributed computing architecture). ), Can be executed. In some examples, the control algorithm of a modular device is to the data sensed by the modular device itself (ie, by a sensor in the modular device, on the modular device, or by a sensor connected to the modular device). Control the device based on. This data may be related to the patient undergoing surgery (eg, tissue characteristics or injection pressure) or the modular device itself (eg, the speed of the knife moving forward, the motor current, or the energy level). For example, a surgical staple fastening and cutting instrument control algorithm can control the speed at which the instrument motor penetrates tissue and drives the knife based on the resistance the knife encounters as the knife advances.

FIG. 22 shows a form of a surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106, 1108 that can be used with it, wherein the surgical instrument 1104 is an ultrasonic surgical instrument. The surgical instrument 1106 is an RF electrosurgical instrument and the multifunctional surgical instrument 1108 is a combined ultrasonic / RF electrosurgical instrument. Generator 1100 can be configured for use with a variety of surgical instruments. According to various forms, the generator 1100 integrates, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instrument 1106, and the RF energy and ultrasonic energy simultaneously delivered from the generator 1100. It may be configured for use with a variety of surgical devices of various types, including the instrument 1108. In the form of FIG. 22, the generator 1100 is shown separately from the surgical instruments 1104, 1106, 1108, but in one form, the generator 1100 is any of the surgical instruments 1104, 1106, 1108. It may be formed integrally with the heel 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 can include any suitable device that produces a signal suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.

The generator 1100 is configured to drive a plurality of 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 and a clamp arm 1140 that are acoustically coupled to the ultrasonic transducer 1120. The handpiece 1105 includes a trigger 1143 that operates the clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c for energizing and driving the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, and 1134c can be configured to energize the ultrasonic transducer 1120 using the generator 1100.

The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument, comprising a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamp arms 1142a and 1142b and returns through the conductor portion of the shaft 1127. The electrodes are connected to a bipolar energy source in the generator 1100 and are energized by the bipolar energy source.

The handpiece 1107 includes a trigger 1145 for operating the clamp arms 1142a and 1142b and an energy button 1135 for operating an energy switch for energizing the electrodes in the end effector 1124.

The generator 1100 is also configured to drive a multifunctional surgical instrument 1108. The multifunctional surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 that operates the clamp arm 1146 and a combination of toggle buttons 1137a, 1137b, 1137c for energizing and driving the ultrasonic blade 1149 or other function. The toggle buttons 1137a, 1137b, 1137c are configured to energize the ultrasonic transducer 1120 using the generator 1100 and also energize the ultrasonic blade 1149 using a bipolar energy source housed in the generator 1100. can do.

Generator 1100 can be configured for use with a variety of surgical instruments. According to various forms, the generator 1100 integrates, for example, the ultrasonic surgical instrument 1104, the RF electrosurgical instrument 1106, and the RF energy and ultrasonic energy simultaneously delivered from the generator 1100. It may be configured for use with a variety of surgical devices of various types, including the instrument 1108. In the form of FIG. 22, the generator 1100 is shown separately from the surgical instruments 1104, 1106, 1108, but in another form, the generator 1100 is of the surgical instruments 1104, 1106, 1108. It may be integrally formed with any one 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 can include any suitable device that produces a signal suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Further embodiments of generators for digitally generating electrical signal waveforms, and surgical instruments, are described in US Patent Application Publication No. 2017-0086914-A1, which is incorporated herein by reference in its entirety. There is.

FIG. 23 is an end effector 1122 of an exemplary ultrasonic device 1104 according to at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128 that may be coupled to the ultrasonic transducer 1120 via a waveguide. As described herein, the blade 1128 can vibrate when driven by the ultrasonic transducer 1120 and can cut and / or solidify the tissue when in contact with the tissue. According to various aspects 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. Along with the blade 1128, the clamp arm 1140 may include a series of jaws. Clamp arm 1140 may be pivotally connected to the distal end of shaft 1126 of instrument portion 1104. Clamp arm 1140 may include clamp arm tissue pads 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 the pivotal motion of the clamp arm 1140 positions the clamp pad 1163 in a substantially parallel relationship with and in contact with the blade 1128. Can be done. With this configuration, the piece of tissue to be clamped can be gripped between the tissue pad 1163 and the blade 1128. The tissue pad 1163 may comprise a serrated configuration that includes a plurality of gripping teeth 1161s that are axially spaced apart and extend proximally to improve tissue grip in cooperation with the blade 1128. The clamp arm 1140 can transition from the open position shown in FIG. 23 to the closed position (where the clamp arm 1140 is in contact with or close to the blade 1128) in any suitable manner. For example, handpiece 1105 may include a jaw closing trigger. When activated by a clinician, the jaw closure trigger can pivot the clamp arm 1140 in any suitable manner.

The generator 1100 can be activated to provide the drive signal to the ultrasonic transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 (FIG. 24) connected to the generator 1100 via a foot switch cable 1432. The clinician may activate the ultrasonic transducer 1120 by depressing the footswitch 1430, thereby activating the ultrasonic transducer 1120 and the blade 1128. In addition to, or instead of, the footswitch 1430, some embodiments of the device 1104 may use one or more switches located on the handpiece 1105, which when activated. , The ultrasonic transducer 1120 can be actuated on the generator 1100. In one aspect, for example, one or more switches may include, for example, a pair of toggle buttons 1134a, 1134b, 1134c to determine the mode of operation of device 1104 (FIG. 22). For example, when the toggle button 1134a is pressed down, the ultrasonic generator 1100 can provide a maximum drive signal to the ultrasonic transducer 1120 to cause the ultrasonic transducer 1120 to generate a maximum ultrasonic energy output. By pressing the toggle button 1134b, the ultrasonic generator 1100 can provide a user-selectable drive signal to the ultrasonic transducer 1120 to cause the ultrasonic transducer 1120 to generate less than maximum ultrasonic energy output. The device 1104 may additionally or alternatively include a second switch for indicating the position of the jaw closing trigger in order to operate the jaws, for example, via the clamp arm 1140 of the end effector 1122. Also, in some embodiments, the ultrasonic generator 1100 can be activated based on the position of the jaw closure trigger (eg, when the clinician pushes down on the jaw closure trigger to close the jaws via the clamp arm 1140). , Ultrasonic energy can be applied).

Further or / or one or more switches may include a toggle button 1134c that causes the generator 1100 to provide a pulse output when pressed down (FIG. 22). The pulses may be provided, for example, at any suitable frequency and classification. In certain embodiments, the power level of the pulse may be, for example, the power level (maximum, less than maximum) associated with the toggle buttons 1134a, 1134b.

It will be appreciated that device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c (FIG. 22). For example, device 1104 has only two toggle buttons, a toggle button 1134a for generating the maximum ultrasonic energy output and a toggle button 1134c for generating a pulse output at either the maximum or less power level each time. Can be configured to have. Thus, the drive signal output configuration of the generator 1100 may be five continuous signals, or any individual number of individual pulse signals (1, 2, 3, 4, or 5 times). In certain embodiments, the particular drive signal configuration may be controlled, for example, based on the EEPROM settings of the generator 1100 and / or the user's power level selection (s).

In certain embodiments, a two-position switch may be provided as an alternative to the toggle button 1134c (FIG. 22). For example, device 1104 may include a toggle button 1134a for generating continuous output at maximum power level and a two-position toggle button 1134b. In the first detent position, the toggle button 1134b may generate continuous output below the maximum power level, and in the second detent position, the toggle button 1134b (eg, maximum or maximum, depending on the EEPROM setting). A pulsed output may be generated (at any output level less than or equal to).

In some embodiments, the RF electrosurgical end effector 1124, 1125 (FIG. 22) may also include a pair of electrodes. The electrodes may communicate with the generator 1100, for example via a cable. Electrodes can be used, for example, to measure the impedance of tissue pieces present between the clamp arms 1142a, 1146 and the blades 1142b, 1149. The generator 1100 may provide a signal (eg, a non-therapeutic signal) to the electrodes. The impedance of the tissue piece can be found, for example, by monitoring the current, voltage, etc. of the signal.

In various aspects, the generator 1100 may include several distinct functional elements such as the modules and / or blocks shown in FIG. 24, which is a schematic representation of the surgical system 1000 of FIG. Various functional elements or modules may be configured to drive different types of surgical devices 1104, 1106, 1108. For example, the ultrasonic generator module can drive an ultrasonic device such as the ultrasonic device 1104. The electrosurgical / RF generator module can drive the electrosurgical device 1106. The module can generate the corresponding drive signal to drive the surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and / or the electrosurgery / RF generator module may each be formed integrally with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (Modules are shown with virtual lines to illustrate this option). Also, in some embodiments, the electrosurgery / RF generator module may be formed integrally with the ultrasound generator module and vice versa.

According to the described embodiment, the ultrasonic generator module may generate a drive signal or a plurality of drive signals of a specific voltage, current, and frequency (eg, 55,500 cycles / second, or Hz). The drive signal or the plurality of drive signals may be provided to the ultrasonic device 1104, in particular the transducer 1120 which may operate as described above, for example. In one aspect, the generator 1100 can be configured to generate a drive signal for a particular voltage, current, and / or frequency output signal that can be stepped with high resolution, accuracy, and reproducibility.

According to the aspects described, the electrosurgery / RF generator module uses radio frequency (RF) energy to deliver a drive signal or multiple drive signals with sufficient output power to perform a bipolar electrosurgery procedure. Can be generated. In bipolar electrosurgery applications, for example, the drive signal may be provided, for example, to the electrodes of electrosurgical device 1106, as described above. Thus, the generator 1100 can be configured for therapeutic purposes by applying sufficient electrical energy to the tissue to treat the tissue (eg, coagulation, ablation, tissue welding, etc.).

The generator 1100 may include, for example, an input device 2150 (FIG. 27B) located on the front panel of the console of the generator 1100. The input device 2150 can include any suitable device that produces a signal suitable for programming the operation of the generator 1100. During operation, the user can use the input device 2150 to program the operation of the generator 1100 or otherwise control it. The input device 2150 is housed by the generator (eg, in the generator) to control the operation of the generator 1100 (eg, the operation of the ultrasonic generator module and / or the electrosurgery / RF generator module). It may include any suitable device that produces a signal that can be used (by one or more processors). In various aspects, the input device 2150 includes one or more of buttons, switches, thumbwheels, keyboards, keypads, touch screen monitors, pointing devices, remote connections to general purpose or dedicated computers. In another aspect, the input device 2150 may include a suitable user interface, such as, for example, one or more user interface screens displayed on a touch screen monitor. Thus, with the input device 2150, the user can use, for example, the current (I), voltage (V), of the drive signal or plurality of drive signals generated by the ultrasonic generator module and / or the electrosurgical / RF generator module. Various operating parameters of the generator, such as frequency (f) and / or duration (T), can be set or programmed.

The generator 1100 may also include, for example, an output device 2140 (FIG. 27B) located on the front panel of the generator 1100 console. The output device 2140 includes one or more devices for providing sensory feedback to the user. Such devices may include, for example, a visual feedback device (eg, LCD display screen, LED indicator), an audible feedback device (eg, speaker, buzzer) or a tactile feedback device (eg, tactile activator).

Specific modules and / or blocks of generator 1100 may be described as examples, but more or less numbers of modules and / or blocks may be used, which may still be within the scope of the embodiment. Let's understand. Further, for ease of description, various aspects may be described with respect to the module and / or block, such module and / or block being one or more hardware components such as a processor. Digital signal processors (DSPs), programmable logic mechanisms (PLDs), application-specific integrated circuits (ASICs), circuits, registers and / or software components such as programs, subroutines, logic and / or hardware components. And software components may be implemented in combination.

In one aspect, the ultrasound generator drive module and the electrosurgery / RF drive module 1110 (FIG. 22) are one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. May include. Modules can include various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and so on. The firmware can be stored in bitmasked read-only memory (ROM) or non-volatile memory (NVM) such as flash memory. In various implementations, the flash memory can be stored by storing the firmware in ROM. NVMs are, for example, programmable ROMs (PROMs), erasable programmable ROMs (EPROMs), electrically erasable programmable ROMs (EEPROMs), or dynamic RAMs (DRAMs), double data rate DRAMs (DDRAMs), and / or synchronous DRAMs. Other types of memory may be included, including a battery-backed random access memory (RAM) such as a DRAM).

In one aspect, the module executes program instructions for monitoring various measurable characteristics of devices 1104, 1106, 1108 and corresponds output drive signals or plurality for operating devices 1104, 1106, 1108. Includes hardware components implemented as a processor for producing output drive signals. In an embodiment in which the generator 1100 is used with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in cutting and / or coagulation mode. The electrical properties of the device 1104 and / or tissue may be measured and used to control the mode of operation of the generator 1100 and / or may be provided as feedback to the user. In an embodiment in which the generator 1100 is used with the device 1106, the drive signal may supply electrical energy (eg, RF energy) to the end effector 1124 in cutting, solidifying and / or drying modes. The electrical properties of the device 1106 and / or tissue may be measured and used to control the mode of operation of the generator 1100 and / or may be provided as feedback to the user. In various aspects, as mentioned above, the hardware components can be implemented as DSPs, PLDs, ASICs, circuits, and / or registers. In one aspect, the processor stores and executes computer software program instructions to drive various components of devices 1104, 1106, 1108, such as ultrasonic transducers 1120 and end effectors 1122, 1124, 1125. It may be configured to generate an output signal.

Electromechanical ultrasonic systems include ultrasonic transducers, waveguides, and ultrasonic blades. Electromechanical ultrasonic systems have an initial resonance frequency defined by the physical properties of ultrasonic transducers, waveguides, and ultrasonic blades. Ultrasonic transducers are excited by an electromechanical AC voltage V _{g (t)} and the current l _{g (t)} signal is equal to the resonant frequency of the ultrasound system. When electromechanical ultrasound system resonates, the phase difference between the voltage V _{g (t)} signal and the current l _{g (t)} signal is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, compliance with the ultrasonic blade (modeled as 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. Here the system operates "off-resonance". Mismatch between the drive frequency and the resonant frequency appears as a phase difference between the voltage V _{g (t)} signal and the current l _{g (t)} signal applied to the ultrasonic transducer. The generator electronics _{can easily monitor the phase difference between the voltage V g} (t) signal and the current l _g (t) signal and continuously keep the drive frequency until the phase difference becomes zero again. Can be adjusted. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. Phase and / or frequency changes can be used as indirect measurements of ultrasonic blade temperature.

As shown in FIG. 25, the electromechanical properties of the ultrasonic transducer are a first branch with capacitance and a second “series” with inductance, resistance, and capacitance that defines the electromechanical properties of the resonator. It may be modeled as an equivalent circuit that includes the "behavior" branch. Known ultrasonic generators may include an adjusting inductor to tune out the capacitance at a resonant frequency so that substantially all of the generator drive signal current flows within the operating branch. Therefore, by using a tuning inductor, the drive signal current of the generator represents the operating branch current, so the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuned inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency fixation capability of the generator. However, the tuning inductor must be compatible with the particular capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different capacitances require different tuning inductors.

FIG. 25 shows an equivalent circuit 1500 of an ultrasonic transducer such as the ultrasonic transducer 1120 according to one aspect. Circuit 1500 has a first "working" branch with _{series-connected inductance L s} , resistance R _s , and capacitance C _s , and a second with _{capacitance C 0} , which defines the electromechanical properties of the resonator. Includes a capacitive branch of. Flows through the operating current _I m (t) is the first branch, with the current _{I g (t) ~I m (} t) flows through the capacitive branch, the driving current _I g (t) is the generator It may be received from the drive voltage V _g (t). Control of the electromechanical properties of the ultrasonic transducer may be achieved by suitably controlling _Ig (t) and V _{g (t).} As mentioned above, the known generator architecture has a _{capacitance C 0} at the resonant frequency within the parallel resonant circuit so that substantially all of the _{generator's current output Ig (t) flows through the operating branch. Can include an adjusting inductor Lt} (shown by a virtual line in FIG. 25) for tune-out. In this method, control of the operating branch current _Im (t) _{is achieved by controlling the current output Ig} (t) of the generator. The tuning inductor L _t is unique to the capacitance C ₀ of the ultrasonic transducer, but different ultrasonic transducers with different static capacitances require _{different tuning inductor L t.} Further, since the adjusting inductor L _t matches the nominal value of the _{capacitance C 0} at a single resonance frequency, _{accurate control of the operating branch current Im} (t) is guaranteed only at that frequency. Precise control of the operating branch current is compromised when the frequency drops due to the temperature of the transducer.

Various aspects of the generator 1100 may monitor the operation branch current I _{m (t)} without resorting to adjust inductor L _t. Rather, the generator 1100 is during the application of power for a particular ultrasonic surgical device 1104 to determine the value of the operating branch current Im (t) on a dynamic and ongoing basis (eg, in real time). Capacitance C ₀ measurements can be used (along with drive signal voltage and current feedback data). Thus, these aspects of the generator 1100, not only in a single resonant frequency determined by the nominal value of the capacitance C _0, or is adjusted to any value of the capacitance C ₀ at an arbitrary frequency It is possible to provide virtual tuning to simulate a resonating system.

FIG. 26 is a simplified block diagram of one aspect of the generator 1100 to provide the inductorless adjustment described above, among other advantages. 27A-27C show the architecture of the generator 1100 of FIG. 26 in one aspect. Referring to FIG. 26, the generator 1100 may include a patient insulation stage 1520 communicating with a non-insulation stage 1540 via a power transformer 1560. The secondary winding 1580 of the power transformer 1560 is included in the insulation stage 1520 and may include a tap configuration (eg, center tap or non-center tap configuration), eg, for ultrasonic surgical equipment 1104 and electrosurgery. A drive signal output unit 1600a, 1600b, 1600c for outputting a drive signal to various surgical devices such as the device 1106 is defined. In particular, the drive signal output units 1600a, 1600b, 1600c may output a drive signal (for example, a 420V RMS drive signal) to the ultrasonic surgical apparatus 1104, and the drive signal output units 1600a, 1600b, 1600c are electric. A drive signal (eg, a 100 V RMS drive signal) may be output to the surgical device 1106, where the output unit 1600b corresponds to the center tap of the power transformer 1560. The non-insulated stage 1540 can include a power amplifier 1620 having an output section connected to the primary winding 1640 of the power transformer 1560. In certain embodiments, the power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may further include a programmable logic mechanism 1660 for supplying digital output to the digital-to-analog converter (DAC) 1680, followed by the digital-to-analog converter. (DAC) 1680 supplies the corresponding analog signal to the input section of the power amplifier 1620. In certain embodiments, the programmable logic mechanism 1660 can include, for example, a field programmable gate array (FPGA). The programmable logic mechanism 1660 controls the input of the power amplifier 1620 via the DAC1680, resulting in a number of parameters (eg, frequency, waveform shape) of the drive signal appearing in the drive signal output units 1600a, 1600b, 1600c. , Waveform amplitude) can be controlled. In certain embodiments, and as described below, along with a programmable logic mechanism 1660, a processor (eg, a processor 1740 described below), many digital signal processing (DSP) -based and / or other control algorithms. Can be executed to control the parameters of the drive signal output by the generator 1100.

Power can be supplied to the bus of the power amplifier 1620 by the switch mode regulator 1700. In certain embodiments, the switch mode regulator 1700 may include, for example, an adjustable back regulator. As mentioned above, the non-insulated stage 1540 can further include a processor 1740, which, in one aspect, includes a DSP processor such as the ADSP-21469 SHARC DSP available from Analog Devices (Norwood, Mass.), For example. Can include. In certain embodiments, the processor 1740 may control the operation of the switch mode power converter 1700 in response to voltage feedback data received by the processor 1740 from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. it can. For example, in one aspect, the processor 1740 can receive the waveform envelope of a signal (eg, an RF signal) amplified by the power amplifier 1620 as an input via the ADC 1760. Processor 1740 can then control the switch mode regulator 1700 (eg, via pulse width modulation (PWM) output) so that the rail voltage supplied to the power amplifier 1620 tracks the waveform envelope of the amplified signal. it can. By dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved compared to a fixed rail voltage amplifier scheme. Processor 1740 may be configured for wired or wireless communication.

In a particular embodiment and as described in more detail in connection with FIGS. 28A-28B, the programmable logic mechanism 1660, along with the processor 1740, directly executes a digital synthesizer (DDS) control scheme to generate. The waveform shape, frequency, and / or amplitude of the drive signal output by the device 1100 can be controlled. In one aspect, for example, the programmable logic mechanism 1660 controls the DDS by calling a waveform sample stored in a dynamically updated look-up table (LUT), such as a RAM LUT, which may be built into the FPGA. Algorithm 2680 (FIG. 28A) can be executed. This control algorithm is particularly useful in ultrasonic applications where an ultrasonic transducer, such as the ultrasonic transducer 1120, can be driven by a distinct sinusoidal current at its resonant frequency. Minimization or reduction of the total distortion of the operating branch current can correspondingly minimize or reduce the undesired resonance effect, as other frequencies can excite the parasitic resonance. The waveform shape of the drive signal output by the generator 1100 can be influenced by various distortion sources present in the output drive circuit (eg, power transformer 1560, power amplifier 1620), and thus the voltage and current based on the drive signal. Feedback data can be input to algorithms such as the error control algorithm executed by the processor 1740, which is a dynamic, ongoing-based (eg, in real-time), LUT-stored waveform sample. Distortion is compensated by suitably pre-distorting or correcting. In one aspect, the amount or degree of pre-strain applied to the LUT sample may be based on the error between the calculated operating branch current and the desired current waveform shape, the error being determined on a sample-by-sample basis. In this way, the pre-distorted LUT sample, when processed by the drive circuit, produces an operating branch drive signal with the desired waveform shape (eg, sinusoidal) in order to optimally drive the ultrasonic transducer. obtain. Therefore, in such an embodiment, the LUT waveform sample is required to finally generate an operating branch drive signal of the desired waveform, taking into account the distortion effect rather than the desired waveform shape of the drive signal. Represents the waveform shape.

The non-insulated stage 1540 is connected to the output of the power transformer 1560 via the insulated transformers 1820 and 1840, respectively, in order to sample the voltage and current of the drive signal output by the generator 1100. ADC 1800 can be further included. In certain embodiments, the ADC 1780 and 1800 can be configured to sample at high speeds (eg, 80 Mbps) to allow oversampling of drive signals. In one aspect, for example, the sampling rate of ADC1780, 1800 can allow oversampling of about 200 times the drive signal (depending on the drive frequency). In certain embodiments, the sampling operation of the ADC 1780 and 1800 can be performed by a single ADC that receives the input voltage and current signals via a bidirectional multiplexer. The use of fast sampling in the aspect of the generator 1100 is, among other things, the calculation of complex currents flowing through the operating branch, which can be used in certain embodiments to perform the DDS-based waveform shape control described above), sampled. It is possible to enable accurate digital filtering of the signal and highly accurate calculation of actual power consumption. The voltage and current feedback data output by the ADC 1780 and 1800 may be received and processed by the programmable logic mechanism 1660 (eg, FIFO buffering, multiplexing), eg for subsequent reads by the processor 1740. In addition, it may be stored in the data memory. As mentioned above, the voltage and current feedback data can be used as input to the algorithm to pre-distort or modify the LUT waveform sample on a dynamic and progressive basis. In a particular aspect, this is in the corresponding LUT sample where each stored voltage and current feedback data pair was output by the programmable logic mechanism 1660 when the voltage and current feedback data pair was acquired. It may need to be indexed based on or otherwise associated with it. The synchronization of the LUT sample with the voltage and current feedback data in this way contributes to the accurate timing and stability of the pre-distortion algorithm.

In certain embodiments, the voltage and current feedback data can be used to control the frequency and / or amplitude (eg, current amplitude) of the drive signal. In one aspect, for example, voltage and current feedback data can be used to determine the impedance phase, eg, the phase difference between the voltage-driven signal and the current-driven signal. The frequency of the drive signal is then controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set value (eg 0 °), thereby minimizing or reducing the effects of harmonic distortion. It can be reduced and the impedance phase measurement accuracy can be improved accordingly. The determination of the phase impedance and the frequency control signal may be performed, for example, in the processor 1740, and the frequency control signal is supplied as an input to the DDS control algorithm executed by the programmable logic mechanism 1660.

The impedance phase can be determined by Fourier analysis. In one aspect, _{the phase difference between the generator voltage V g} (t) drive signal and the generator current _Ig (t) drive signal is as follows: Fast Fourier Transform, FFT) or Discrete Fourier Transform, DFT). Can be determined using.

By evaluating the Fourier transform at the frequency of the sinusoidal wave, the following can be obtained.

Other approaches include weighted least squares estimation, Kalman filtering, and space vector-based techniques. Virtually all of the processing in the FFT or DFT technology may be performed within the digital domain using, for example, a two-channel fast ADC 1780, 1800. In one technique, digital signal samples of voltage and current signals are Fourier transformed by FFT or DFT. The phase angle φ at any time point can be calculated by the following formula:

In the equation, f is the phase angle, φ is the frequency, t is the time, and φ ₀ is the phase at t = 0.

Another technique for determining the phase difference between a voltage V _g (t) signal and a current _Ig (t) signal is the zero crossing method, which produces accurate results. If voltage V _{g (t)} signal and the current I _{g (t)} signal having the same frequency, the zero crossing of the positive from the negative voltage signal V _{g (t)} triggers the beginning of the pulse, while the current signal _{Each negative to positive zero intersection of Ig} (t) triggers the end of the 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 phase difference measurement. In addition, positive to negative zero intersections are used in a similar manner and the results can be averaged to reduce any effects of DC and harmonic components. In one embodiment, the analog voltage V _g (t) signal and the current _Ig (t) signal are converted to a high digital signal if the analog signal is positive and a low digital signal if the analog signal is negative. .. High-precision phase evaluation requires a rapid transition between high and low. In one aspect, a Schmitt trigger can be used with an RC stabilized network to convert an analog signal to a digital signal. In other embodiments, edge-triggered RS flip-flops and auxiliary circuits may be used. In yet another aspect, the zero crossing technique may use an eXcrusive OR (XOR) gate.

Other techniques for determining the phase difference between a voltage signal and a current signal include monitoring lithage figures and images, a three-voltmeter method, a cross-coil method, a vector voltmeter, and a vector impedance method. The method, as well as the phase standard instrument, the use of a phase lock loop, and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC, <http: // www. engagebase. Other techniques described in com> are mentioned, and this article is incorporated herein by reference.

In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at the current amplitude set value. The current amplitude set value may be directly specified, or may be indirectly determined based on the specified voltage amplitude and power set value. In certain embodiments, control of the current amplitude can be performed by a control algorithm, such as a proportional calculus (PID) control algorithm within the processor 1740. Variables controlled by the control algorithm to suitably control the current amplitude of the drive signal include, for example, scaling of the LUT waveform sample stored in the programmable logic mechanism 1660 and / or DAC1680 via DAC1860 (which). Can supply the input to the power amplifier 1620).

The non-isolated stage 1540 may further include a processor 1900, among other things, to provide user interface (UI) functionality. In one aspect, the processor 1900 can include, for example, an Atmel AT91 SAM9263 processor having an ARM926EJ-S core available from Atmel Corporation (San Jose, California). Examples of UI features supported by processor 1900 include auditory and visual user feedback, communication with peripherals (eg, via a universal serial bus (USB) interface), communication with footswitch 1430, and input. Communication with the device 2150 (eg, touch screen display) and communication with the output device 2140 (eg, speaker) can be mentioned. Processor 1900 can communicate with Processor 1740 and programmable logic mechanisms (eg, via the Serial Peripheral Interface (SPI) bus). Processor 1900 can primarily support UI functionality, but it can also work with processor 1740 to achieve risk mitigation in certain embodiments. For example, processor 1900 may be programmed to monitor various aspects of user input and / or other inputs (eg, touch screen input 2150, footswitch 1430 input, temperature sensor input 2160) and is erroneous. When the state is detected, the drive output of the generator 1100 can be invalidated.

In certain embodiments, both processor 1740 (FIGS. 26, 27A) and processor 1900 (FIGS. 26, 27B) can determine and monitor the operating state of the generator 1100. For processor 1740, the operating state of generator 1100 can determine, for example, which control and / or diagnostic process is performed by processor 1740. For the processor 1900, the operating state of the generator 1100 can determine, for example, which element of the user interface (eg, display screen, sound) is provided to the user. Processors 1740 and 1900 maintain the current operating state of the generator 1100 separately and recognize and evaluate possible transitions from the current operating state. Processor 1740 can act as a master in this relationship and determine when transitions between operating states occur. Processor 1900 can recognize valid transitions between operating 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 confirm that the requested transition is valid. If the transition between states requested by processor 1900 is determined to be invalid, processor 1900 may put generator 1100 into failure mode.

The non-insulated stage 1540 is a controller 1960 for monitoring the input device 2150 (eg, a capacitive touch sensor used to turn the generator 1100 on and off, a capacitive touch screen) (FIG. 26, FIG. FIG. 27B) can be further included. In certain embodiments, the controller 1960 may include at least one processor and / or other controller device that communicates with the processor 1900. In one aspect, for example, controller 1960 is a processor configured to monitor user input provided via one or more capacitive touch sensors (eg, Mega168 8 available from Atmel). A bit controller) can be provided. In one aspect, the controller 1960 can include a touch screen controller (eg, a QT5480 touch screen controller available from Atmel) for controlling and managing the acquisition of touch data from a capacitive touch screen.

In a particular embodiment, when the generator 1100 is in the "power off" state, the controller 1960 delivers operating power (eg, via a line from the power source of the generator 1100, such as power supply 2110 (FIG. 26) described below). You can continue to receive. In this way, the controller 1960 can continue to monitor the input device 2150 for turning the generator 1100 on and off (eg, a capacitive touch sensor located on the front panel of the generator 1100). When the generator 1100 is in the "power off" state, the controller 1960 can power up when it detects that the user has activated the "on / off" input device 2150 (eg, 1 of power supply 2110). Enable the operation of one or more DC / DC voltage converters 2130 (FIG. 26). As a result, the controller 1960 can initiate a sequence for transitioning the generator 1100 to the "powered 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 is a sequence for transitioning the generator 1100 to the "power off" state. Can be started. In certain embodiments, for example, the controller 1960 can report the activation of the "on / off" input device 2150 to the processor 1900, which in turn causes the generator 1100 to transition to the "power off" state. Executes the processing sequence required for. In such an embodiment, the controller 1960 may not have an independent capability to cause power removal from the generator 1100 after its "powered on" state has been established.

In certain embodiments, the controller 1960 can cause the generator 1100 to provide auditory or other sensory feedback to warn the user that a "power on" or "power off" sequence has begun. Such warnings may be provided at the beginning of a "power on" or "power off" sequence, and before the start of other processes associated with the sequence.

In certain embodiments, the insulating step 1520 comprises, for example, a control circuit of a surgical device (eg, a control circuit with a handpiece switch) and components of the non-isolated step 1540 (eg, programmable logic mechanism 1660, processor 1740). , And / or a device interface circuit 1980 to provide a communication interface with (such as processor 1900). The instrument interface circuit 1980 provides the components and information of the non-insulated stage 1540 via a communication link that maintains a suitable degree of electrical insulation between stages 1520 and 1540, such as an infrared (IR) based communication link. Can be exchanged. For example, a low dropout voltage regulator powered by an insulated transformer driven from the non-isolated stage 1540 can be used to power the appliance interface circuit 1980.

In one aspect, the instrument interface circuit 1980 can include a programmable logic mechanism 2000 (eg FPGA) that communicates with the signal conditioning circuit 2020 (FIGS. 26 and 27C). The signal conditioning circuit 2020 can be configured to receive a periodic signal (eg, a 2 kHz square wave) from the programmable logic mechanism 2000 to generate a bipolar call signal having the same frequency. The call signal can be generated using, for example, a bipolar current source supplied by a differential amplifier. The call signal is transmitted to the surgical device control circuit (eg, by using a conductive pair in a cable that connects the generator 1100 to the surgical device) and the state or configuration of the control circuit. Can be monitored to determine. For example, a control circuit may have one or more characteristics of the calling signal (eg, amplitude, etc.) such that the state or configuration of the control circuit can be individually identified based on one or more characteristics. A large number of switches, registers, and / or diodes may be included to modify the rectification. For example, in one aspect, the signal conditioning circuit 2020 may include an ADC for generating a sample of the voltage signal that appears between the inputs of the control circuit generated by the passage of the call signal. The programmable logic mechanism 2000 (or one component of the non-insulated step 1540) can then determine the state or configuration of the control circuit based on the ADC sample.

In one aspect, the instrument interface circuit 1980 is associated with a programmable logic mechanism 2000 (or other element of the instrument interface circuit 1980), located inside the surgical device, or otherwise associated with the surgical device. A first data circuit interface 2040 can be provided that enables information exchange with the first data circuit. In certain embodiments, for example, the first data circuit 2060 is in a cable integrally attached to the handpiece of the surgical device, or an adapter for interfacing a particular surgical device type or model with the generator 1100. It may be placed inside. In certain embodiments, the first data circuit may include a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device. In a particular embodiment and again with reference to FIG. 26, the first data circuit interface 2040 can be implemented separately from the programmable logic mechanism 2000, with the programmable logic mechanism 2000 and the first data circuit. Suitable circuits (eg, individual logic mechanisms, processors) that allow communication between them can be provided. In another aspect, the first data circuit interface 2040 may be integral with the programmable logic mechanism 2000.

In certain embodiments, the first data circuit 2060 can store information about the particular surgical device with which the first data circuit 2060 is associated. Such information can include, for example, model numbers, serial numbers, number of operations in which the surgical device has been used, and / or other types of information. This information is read by the instrument interface circuit 1980 (eg, by the programmable logic mechanism 2000) and presented to the user via the output device 2140 and / or controls the function or operation of the generator 1100. For this purpose, it may be transferred to the components of non-isolated stage 1540 (eg, programmable logic mechanism 1660, processor 1740, and / or processor 1900). Further, any kind of information can be transmitted to the first data circuit 2060 via the first data circuit interface 2040 for storage in the first data circuit 2060 (eg, programmable). (Using Logic Mechanism 2000). Such information can include, for example, the latest number of operations in which the surgical device has been used, and / or the date and / or time of its use.

As mentioned above, the surgical instrument may be removable from the handpiece to facilitate instrument compatibility and / or disposability (eg, instrument 1106 may be removable from handpiece 1107. May be). In such cases, known generators may have limited ability to recognize the particular instrument configuration being used and to optimize control and diagnostic processes accordingly. However, adding a readable data circuit to the surgical instrument to address this issue is problematic from a compatibility standpoint. For example, designing a surgical device to maintain backward compatibility with a generator that lacks the required data reading capabilities is impractical, for example, due to different signal schemes, design complexity, and cost. In some cases. Other aspects of the instrument economically use data circuits that can be implemented in existing surgical instruments and minimize design changes to maintain compatibility between surgical instruments and modern generator platforms. Address these concerns by doing so.

Further, aspects of the generator 1100 can allow communication with instrument-based data circuits. For example, the generator 1100 may be configured to communicate with a second data circuit (eg, a data circuit) housed within a surgical instrument instrument (eg, instrument 1104, 1106, or 1108). The instrument interface circuit 1980 can include a second data circuit interface 2100 that enables this communication. In one aspect, the second data circuit interface 2100 can include a tristate digital interface, but other interfaces can also be used. In certain embodiments, the second data circuit can be generally any circuit for transmitting and / or receiving data. In one aspect, for example, a second data circuit may store information about the particular surgical instrument to which this circuit is associated. Such information can include, for example, model numbers, serial numbers, number of movements in which surgical instruments have been used, and / or any other type of information. Further or / or any kind of information can be transmitted to the second data circuit via the second data circuit interface 2100 for storage in the second data circuit (eg, programmable). Using logic mechanism 2000). Such information may include, for example, the latest number of movements in which the instrument has been used, and / or the date and / or time of its use. In certain embodiments, the second data circuit can transmit data acquired by one or more sensors (eg, appliance-based temperature sensors). In certain embodiments, the second data circuit can receive data from the generator 1100 and provide the user with a display (eg, LED display or other visible display) based on the received data.

In certain embodiments, the second data circuit and the second data circuit interface 2100 do not need to be provided with additional conductors for this purpose (eg, dedicated conductors of the cable connecting the handpiece to the generator 1100). It can be configured to achieve communication between the programmable logic mechanism 2000 and the second data circuit. In one aspect, a one-wire bus communication scheme implemented on existing cabling, for example, one of the conductors used transmits a call signal from the signal conditioning circuit 2020 to the control circuit in the handpiece. Can be used to transfer information to and from a second data circuit. In this way, the originally necessary design changes or modifications of the surgical device are minimized or reduced. Moreover, the presence of a second data circuit is a necessary data read, as various types of communication can be performed over common physical channels (with or without frequency band separation). It is "invisible" to the non-functional generator and can therefore allow backward compatibility of surgical instruments.

In certain embodiments, the isolation step 1520 can include at least one blocking capacitor 2960-1 (FIG. 27C) connected to the drive signal output section 1600b to prevent the patient from being energized with DC current. A single blocking capacitor may be required to comply with, for example, medical regulations or standards. Although failures in single capacitor designs are relatively rare, such failures can nevertheless have negative consequences. In one aspect, a second blocking capacitor 2960-2 is provided in series with the blocking capacitor 2960-1, and a current leak from a point between the blocking capacitors 2960-1 and 2960-2 is induced, for example, by a leakage current. It can be monitored by an ADC 2980 for sampling the current voltage. The sample may be received, for example, by the programmable logic mechanism 2000. Based on the change in leakage current (shown by the voltage sample in the aspect of FIG. 26), the generator 1100 can determine when at least one of the blocking capacitors 2960-1 and 2960-2 has failed. Therefore, the aspect of FIG. 26 can provide benefits for a single capacitor design with a single failure point.

In certain embodiments, the non-insulated stage 1540 may include a power source 2110 for outputting DC power at suitable voltages and currents. The power supply may include, for example, a 400 W power supply for outputting a 48 VDC system voltage. As mentioned above, the power supply 2110 receives the output of the power supply and produces one or more DCs at the voltage and current required by the various components of the generator 1100. A / DC voltage converter 2130 can be further provided. As mentioned above in connection with controller 1960, one or more of the DC / DC voltage converters 2130 are when the controller 1960 detects the activation of the "on / off" input device 2150 by the user. An input may be received from the controller 1960 to enable the operation or activation of the DC / DC voltage converter 2130.

28A-28B show specific functional and structural aspects of one aspect of the generator 1100. Feedback indicating the current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by the ADC 1780 and 1800, respectively. As shown, the ADC 1780 and 1800 can be implemented as a 2-channel ADC and at high speed (eg 80 mps) to allow oversampling of the drive signal (eg approximately 200 times oversampling) The feedback signal can be sampled. The current and voltage feedback signals can be suitably tuned in the analog region prior to processing by ADC1780 and 1800 (eg, amplification, filtering). Current and voltage feedback samples from ADC1780 and 1800 can be individually buffered and then multiplexed or interleaved within a single data stream within block 2120 of programmable logic mechanism 1660. In the aspects of FIGS. 28A-28B, the programmable logic mechanism 1660 comprises an FPGA.

The multiplexed current and voltage feedback samples can be received by a parallel data acquisition port (PDAP) implemented within block 2144 of processor 1740. The PDAP can include a packing unit for performing any of the many methods for correlating a multiplexed feedback sample with a memory address. In one aspect, for example, the feedback sample corresponding to a particular LUT sample output by the programmable logic mechanism 1660 is one or more memory addresses associated with or indexed by the LUT address of the LUT sample. Can be remembered at. In another aspect, the feedback sample corresponding to a particular LUT sample output by the programmable logic mechanism 1660 can be stored in a common storage location along with the LUT address of the LUT sample. In any case, the feedback sample can be stored so that the address of the LUT sample from which a particular set of feedback samples is derived can then be confirmed. As mentioned above, synchronization of the LUT sample address and feedback sample thus contributes to the accurate timing and stability of the pre-distortion algorithm. A direct memory access (DMA) controller implemented in block 2166 of processor 1740 is a feedback sample (and arbitrary LUT sample address data where applicable) at a designated storage location 2180 (eg, internal RAM) of processor 1740. Can be memorized.

Block 2200 of processor 1740 can perform a pre-distortion algorithm to pre-distort or modify a LUT sample stored in a programmable logic device 1660 on a dynamic ongoing basis. As mentioned above, the pre-distortion of the LUT sample can compensate for the various distortion sources present in the output drive circuit of the generator 1100. The pre-distorted LUT sample therefore, when processed by the drive circuit, produces a drive signal with the desired waveform shape (eg, sinusoidal) in order to optimally drive the ultrasonic transducer.

In block 2220 of the pre-distortion algorithm, the current flowing through the operating branch of the ultrasonic transducer is determined. The operating branch current can be, for example, a current and voltage feedback sample stored in storage location 2180, which, when scaled appropriately, can represent _Ig and V _{g of the model of FIG.} Based on _{the value of capacitance C 0} (measured or a priori known), and known values of drive frequency, it can be determined using Kirchhoff's current law. An operating branch current sample in each set of stored current and voltage feedback samples associated with the LUT sample can be determined.

In block 2240 of the pre-distortion algorithm, each operating branch current sample determined in block 2220 is compared with a sample of the desired current waveform shape to determine the difference between the samples being compared or the sample amplitude error. For this determination, a sample of the current waveform shape may be supplied from, for example, a waveform shape LUT2260 containing an amplitude sample for one cycle of the desired current waveform shape. A particular sample of the desired current waveform shape from the LUT 2260 used for comparison can be determined by the LUT sample address associated with the operating branch current sample used for comparison. Therefore, the input of the operating branch current to block 2240 can be synchronized with the input of its associated LUT sample address to block 2240. Therefore, the LUT sample stored in the programmable logic mechanism 1660 and the LUT sample stored in the waveform shape LUT2260 can have equivalent numerical values. In certain embodiments, the desired current waveform shape represented by the LUT sample stored in the waveform shape LUT2260 can be a fundamental sinusoidal wave. Other waveform shapes may be desirable. Overlapped with one or more other drive signals at other wavelengths, such as third harmonics to drive at least two mechanical resonances, for example due to lateral or other modes of beneficial vibration. It is conceivable that a basic sine wave can be used to drive the major longitudinal motion of the ultrasonic transducer.

Each value of the sample amplitude error determined at block 2240, along with an index of its associated LUT address, can be transmitted to the LUT of the programmable logic mechanism 1660 (shown in block 2280 of FIG. 28A). LUT2280 (or other control block of programmable logic mechanism 1660) based on the value of the sample amplitude error and its associated address (and optionally the value of the sample amplitude error for the same LUT address received earlier). ) Can pre-distort or modify the value of the LUT sample stored in the LUT address, thereby reducing or minimizing the sample amplitude error. Such pre-distortion or correction of each LUT sample in an iterative manner over the entire range of LUT addresses will cause the output current waveform shape of the generator to be the desired current waveform shape represented by the waveform shape LUT2260 sample. It will be understood to match or match.

Current and voltage amplitude measurements, power measurements, and impedance measurements can be determined at block 2300 of processor 1740 based on current and voltage feedback samples stored in storage location 2180. Prior to determining these numbers, the feedback sample is suitably scaled and, in certain embodiments, processed through a suitable filter 2320 to remove, for example, noise and induced harmonic components generated by the data acquisition process. be able to. The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal. In certain embodiments, the filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such an embodiment can use the Fast Fourier Transform (FFT) of the output drive signal current and voltage signals. In certain embodiments, the resulting frequency spectrum can be used to provide additional generator function. In one aspect, for example, the ratio of the second and / or third harmonic components to the fundamental frequency component can be used as a diagnostic index.

At block 2340 (FIG. 28B), a root mean square (RMS) calculation is applied to the sample size of the current feedback sample, which represents an integer of the drive signal cycle, to generate a _{measurement Irms that represents the drive signal output current.} obtain. At block 2360, a root mean square (RMS) calculation can be applied to the sample size of the voltage feedback sample, which represents an integer of the drive signal cycle, to determine the _{measured value Vrms} , which represents the drive signal output voltage.

In block 2380, the current and voltage feedback samples may be one by one multiplied, average calculation is applied to samples representing the integer number of cycles of the drive signal, the measured value P _r of the actual output power of the generator is determined ..

In block 2400, the measured value _{P a} of apparent output power of the generator may be determined as the product _{V rms · I} rms.

At block 2420, the measured value Z _m of the magnitude of the load impedance can be determined as the quotient V _rms / _Irms.

In certain embodiments, blocks 2340,2360,2380,2400, and numerical _I rms is determined in _{2420, V rms, P r,} P a, and _{Z m} is any of a number of control and / or diagnostic process Can be used by generator 1100 to implement. In a particular aspect, any of these numbers may be placed in a suitable communication interface (eg, a USB interface) via, for example, an output device 2140 integrated with the generator 1100 or an output device 2140 connected to the generator 1100. Can be communicated to the user through. Various diagnostic processes include, for example, handpiece integration, equipment integration, equipment mounting integration, equipment overload, equipment overload approach, poor frequency fixation, overvoltage condition, overcurrent condition, overpower condition, poor voltage sensing. , Current sensing failure, audible index failure, visual index failure, short circuit state, power supply failure, or blocking capacitor failure, but is not limited to these.

Block 2440 of processor 1740 can implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (eg, an ultrasonic transducer) driven by the generator 1100. As described above, the effect of harmonic distortion is affected by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase set value (eg 0 °). It can be minimized or reduced to improve the accuracy of phase measurement.

The phase control algorithm receives the current and voltage feedback samples stored in storage location 2180 as inputs. Prior to using them in phase control algorithms, the feedback samples are suitably scaled and, in certain embodiments, suitable filters 2460 (to remove noise resulting from, for example, the data acquisition process and induced harmonic components). It may be processed through the same filter 2320). The filtered voltage and current samples can therefore substantially represent the fundamental frequency of the generator drive output signal.

Block 2480 of the phase control algorithm determines the current through the operating branch of the ultrasonic transducer. This determination may be the same as that described above in connection with block 2220 of the pre-distortion algorithm. Therefore, the output of block 2480 can be an operating branch current sample for each set of stored current and voltage feedback samples associated with the LUT sample.

In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized inputs of the operating branch current sample and the corresponding voltage feedback sample determined in block 2480. In a particular aspect, 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.

In block 2520 of the phase control algorithm, the impedance phase value determined in block 2220 is compared with the phase set value 2540 to determine the difference or phase error between the values to be compared.

In the phase control algorithm block 2560 (FIG. 28A), the frequency output for controlling the frequency of the drive signal is based on the value of the phase error determined by the block 2520 and the magnitude of the impedance determined by the block 2420. It is judged. In order to maintain the impedance phase determined in block 2500 at the phase set value (eg, zero phase error), the frequency output value can be continuously adjusted by block 2560 and transferred to the DDS control block 2680 (discussed below). In certain embodiments, the impedance phase can be adjusted to a 0 ° phase setting. In this way, any amount of harmonic distortion is centered around the top of the voltage waveform, improving the accuracy of phase impedance determination.

Block 2580 of processor 1740 is driven to control drive signal current, voltage, and power according to user-specified settings or requirements specified by other processes or algorithms performed by generator 1100. An algorithm for modulating the current amplitude of the signal can be implemented. Control of these numbers can be achieved, for example, by scaling the LUT sample of the LUT2280 and / or by adjusting the full-scale output voltage of the DAC1680 (which supplies the input to the power amplifier 1620) via the DAC1860. it can. Block 2600 (which, in certain embodiments, can be implemented as a PID controller) can receive current feedback samples (which can be optionally scaled and filtered) as input from storage location 2180. The current feedback sample is compared _{to the "current demand" Id} value determined by a controlled variable (eg, current, voltage, or power) to determine if the drive signal is supplying the required current. Can be done. In embodiments the drive signal current is controlled variables, current demand _{I d} can be designated directly by the current setpoint 2620A _{(I sp).} For example, the RMS value of the current feedback data (determined by block 2340) can be compared to _{a user-specified RMS current set value I sp to determine the appropriate controller action.} For example, if the current feedback data _{shows an RMS value lower than the current set value I sp} , the LUT scaling and / or the full scale output voltage of the DAC1680 may be adjusted by the block 2600 to increase the drive signal current. Conversely, if the current feedback data _{shows an RMS value higher than the current set value I sp} , the block 2600 may adjust the LUT scaling and / or the DAC1680 full scale output voltage to reduce the drive signal current. Good.

In embodiments the driving signal voltage is the control variable, current demand I _d, for example, maintain the desired voltage set value 2620B (V _sp) when the magnitude Z _m of the measured load impedance at block 2420 is given It can be specified indirectly based on the current required to do so (eg, _Id = _Vsp / Zm). Similarly, in an embodiment the drive signal power is controlled variables, current demand _{I d,} for example to maintain a desired power setting 2620C to _{(P sp)} when given a voltage _{V rms} measured in block 2360 Can be specified indirectly based on the current required for (eg _Id = P _sp / V _rms ).

Block 2680 (FIG. 28A) can implement a DDS control algorithm to control the drive signal by recalling the LUT sample stored in the LUT 2280. In certain embodiments, the DDS control algorithm may be a Numerically Controlled Oscillator (NCO) algorithm for generating waveform samples at a fixed clock rate using point (storage location) skipping techniques. The NCO algorithm can implement a phase accumulator, or frequency / phase converter, that acts as an address pointer for recalling the LUT sample from the 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 a frequency control value and N is the number of LUT samples in the LUT2280. For example, a frequency control value of D = 1 can cause, for example, a phase accumulator to continuously specify all addresses of the LUT 2280 to produce a waveform output that duplicates the waveform stored in the LUT 2280. If D> 1, the phase accumulator can skip the address of the LUT2280 to produce a waveform output with a higher frequency. Thereby, the frequency of the waveform generated by the DDS control algorithm can therefore be controlled by suitably changing the frequency control value. In certain embodiments, the frequency control value can be determined based on the output of the phase control algorithm implemented in block 2440. The output of block 2680 can supply the input of DAC1680, which then supplies the corresponding analog signal to the input of power amplifier 1620.

Block 2700 of processor 1740 dynamically modulates the rail voltage of the power amplifier 1620 based on the waveform envelope of the amplified signal, thereby improving the efficiency of the power amplifier 1620, a switch mode converter control algorithm. Can be carried out. In certain embodiments, the characteristics of the waveform envelope can be determined by monitoring one or more signals contained in the power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope can be determined by monitoring the minimum value of the drain voltage (eg 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 linked to the drain voltage. The minimum voltage signal is sampled by the ADC 1760 and the output minimum voltage sample may be received in block 2720 of the switch mode converter control algorithm. Based on the value of the minimum voltage sample, the block 2740 may control the PWM signal output by the PWM generator 2760, which in turn controls the rail voltage supplied to the power amplifier 1620 by the switch mode regulator 1700. .. In certain embodiments, the rail voltage can 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 exhibits a low envelope power level, block 2740 supplies a low rail voltage to the power amplifier 1620, and the full rail voltage is supplied only when the minimum voltage sample exhibits a maximum envelope power level. You may. When the minimum voltage sample is below the minimum target 2780, the block 2740 may keep the rail voltage at a minimum value suitable to ensure suitable operation of the power amplifier 1620.

FIG. 29 is a circuit diagram of one aspect of the electrical circuit 2900 suitable for driving an ultrasonic transducer such as the ultrasonic transducer 1120 according to at least one aspect of the present disclosure. The electric circuit 2900 includes an analog multiplexer 2980. The analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A such as ultrasonic waves, batteries, and power control circuits. The current sensor 2982 is connected in series with the return or ground section of the power supply circuit and measures the current supplied by the power supply. The field effect transistor (FET) temperature sensor 2984 provides an ambient temperature. The pulse width modulation (PWM) watchdog timer 2988 automatically causes a system reset if the main program fails to provide a periodic system reset. It 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 can 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. Therefore, referring again to FIG. 29, the electric circuit 2900 can be used to alternately drive both the ultrasonic transducer and the RF electrode. When driven at the same time, a filter circuit may be provided in the corresponding first stage circuit 3404 (FIG. 34) to select either an ultrasonic waveform or an RF waveform. Such filtering techniques are described in co-owned US Patent Application Publication No. 2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATION", which is incorporated herein by reference in its entirety.

Drive circuit 2896 provides left and right ultrasonic energy outputs. The digital signal representing the signal waveform is supplied to the SCL-A and SDA-A inputs of the analog multiplexer 2980 from a control circuit such as the control circuit 3200 (FIG. 32). The digital / analog converter 2990 (DAC) converts a digital input into an analog output and drives a PWM circuit 2992 connected to an oscillator 2994. The PWM circuit 2992 provides a first signal to the first gate drive circuit 2996a connected to the first transistor output step 2998a to drive the first ultrasonic (left) energy output. The PWM circuit 2992 also provides a second signal to the second gate drive circuit 2996b coupled to the second transistor output step 2998b to drive the second ultrasonic (right) energy output. The voltage sensor 2999 is connected between the ultrasonic left / right output terminals to measure the output voltage. The drive circuit 2896, the first drive circuit 2996a and the second drive circuit 2996b, and the first transistor output stage 2998a and the second transistor output stage 2998b define a first stage amplifier circuit. During operation, the control circuit 3200 (FIG. 32) generates a digital waveform 4300 (FIG. 43) using circuits such as the direct digital compositing (DDS) circuits 4100 and 4200 (FIGS. 41 and 42). The DAC2990 receives the digital waveform 4300, converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

FIG. 30 is a circuit diagram of a transformer 3000 connected to the electrical circuit 2900 shown in FIG. 29 according to at least one aspect of the present disclosure. The ultrasonic left / right input terminal (primary winding) of the transformer 3000 is electrically connected to the ultrasonic left / right output terminal of the electric circuit 2900. The secondary winding of the transformer 3000 is connected to the positive electrode 3074a and the negative electrode 3074b. The positive and negative electrodes 3074a and 3074b of the transformer 3000 are connected to the positive terminals (stack 1) and the negative terminals (stack 2) of the ultrasonic transducer. In one aspect, the transformer 3000 has a 1:50 n ₁ : n ₂ turns ratio.

FIG. 31 is a circuit diagram of the transformer 3000 shown in FIG. 30 connected to the test circuit 3165 according to at least one aspect of the present disclosure. The test circuit 3165 is connected to the positive and negative electrodes 3074a and 3074b. Switch 3167 is arranged in series with an inductor / capacitor / register (LCR) load device that simulates the load of an ultrasonic transducer.

FIG. 32 is a circuit diagram of a control circuit 3200 such as a control circuit 3212 according to at least one aspect of the present disclosure. The control circuit 3200 is located within the housing of the battery assembly. The battery assembly is an energy source for various local power sources 3215. The control circuit includes, for example, the main processor 3214 connected to various downstream circuits via the interface master 3218 by the outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. Be prepared. In one embodiment, the interface master 3218 is a universal serial interface such as ^{I 2} C serial interface. The main processor 3214 is also configured to drive a switch 3224 via general purpose input / output (GPIO) 3220, a display 3226 (eg, an LCD display), and various indicators 3228 via GPIO 3222. The watchdog processor 3216 is provided to control the main processor 3214. The 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.

In one aspect, the main processor 3214 is connected to the electrical circuit 2900 (FIG. 29) by output terminals SCL-A, SDA-A. The main processor 3214 includes, for example, a memory for storing a table of digitized drive signals or waveforms transmitted to the electrical circuit 2900 to drive the ultrasonic transducer 1120. In another aspect, the main processor 3214 may generate a digital waveform and transmit it to electrical circuit 2900, or it may store the digital waveform for later transmission to electrical circuit 2900. The main processor 3214 is also RF driven by the output terminals SCL-B, SDA-B, and various sensors by the output terminals SCL-C, SDA-C (eg, Hall effect sensor, ferrofluid (MRF) sensor, etc.). May be provided. 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 suitable software and user interface functions.

In one aspect, the main processor 3214 may be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one example, Texas Instruments' LM4F230H5QR improves on-chip memory, performance of 256KB single-cycle flash memory up to 40MHz or other non-volatile memory, among other mechanisms readily available from product datasheets. Prefetch buffer, 32KB single-cycle serial random access memory (SRAM), internal read-only memory with StaticrisWare® software (ROM), 2KB electrically erasable programmable read-only memory (EEPROM), 1 One or more pulse width modulation (PWM) modules, one or more orthogonal encoder input (QED) analogs, one or more 12-bit analog-to-digital converters with 12 analog input channels An ARM Cortex-M4F processor core that includes an ADC. Other processors may be readily substituted, and therefore this disclosure should not be limited to this context.

FIG. 33 shows a simplified block schematic showing another electrical circuit 3300 housed within a modular ultrasonic surgical instrument 3334, according to at least one aspect of the present disclosure. The electric circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power supply 3304 (for example, 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, and a signal. Ultrasonic blades (eg, ultrasonic blades 1128), which may also be referred to as smoothing circuits 3312 (also referred to as matching circuits, eg tank circuits), sensing circuits 3314, transducers 1120, and simply waveguides herein. , 1149), including shaft assemblies (eg, shaft assemblies 1126, 1129) with an ultrasonic transmission waveguide.

Breaking Dependence on High Voltage (120VAC) Input Power (Characteristics of Common Ultrasonic Disconnectors) One feature of the disclosure is the use of low voltage switching throughout the wave forming process and just before the transformer stage. It is the amplification of the drive signal limited to. For this reason, in one aspect of the present disclosure, power is derived only from batteries or groups of batteries that are small enough to fit either within the handle assembly. State-of-the-art battery technology provides powerful batteries with a height and width of a few centimeters and a depth of a few millimeters. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasonic device, a reduction in manufacturing cost can be achieved.

The output of the power supply 3304 is supplied to the processor 3302 to supply power. The processor 3302 receives and outputs signals and also functions according to the custom logic executed by the processor 3302 or according to a computer program, as described below. As mentioned above, the electrical circuit 3300 can also include a memory 3326, preferably a random access memory (RAM), for storing computer-readable instructions and data.

The output of power supply 3304 is also directed to switch 3306, which has a duty cycle controlled by processor 3302. By controlling the on-time of switch 3306, processor 3302 can determine the total amount of power ultimately delivered to transducer 1120. In one aspect, the switch 3306 is a MOSFET, but other switches and switching configurations are similarly adaptable. The output of switch 3306 is supplied to a drive circuit 3308 that includes, for example, a phase detection phase-locked loop (PLL) and / or a lowpass filter and / or a voltage controlled oscillator. The output of switch 3306 is sampled by processor 3302 to determine _{the voltage and current (V IN} and I _{IN, respectively) of the output signal.} These values are used in the feedback architecture to tune 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 actual output from switch 3306.

The drive circuit 3308 that receives the signal from the switch 3306 includes an oscillator circuit that converts the output of the switch 3306 into an electrical signal with an ultrasonic frequency, for example 55 kHz (VCO). As mentioned above, a smoothed version of this ultrasonic waveform is finally fed to the ultrasonic transducer 1120 to generate a resonant sine wave along the ultrasonic transmission waveguide.

At the output of drive circuit 3308, there is a transformer 3310 that can boost from a low voltage signal (s) to a higher voltage. Note that upstream switching is performed at low (eg, battery-powered) voltage prior to transformer 3310, which until now was not possible with ultrasonic cutting and cauterizing equipment. This is due, at least in part, to the fact that the device favorably uses low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they generate lower switching loss and less heat than conventional MOSFET devices and can pass higher currents. Therefore, 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 MOSFETs (s) are operated at, for example, 10V. In such cases, a separate 10 VDC power supply can be used to supply the MOSFET gate, ensuring that the MOSFET is completely on and a reasonably low on-resistance is achieved. In one aspect of the disclosure, the transformer 3310 boosts the battery voltage to a root mean square (RMS) of 120V. Transformers are not described in detail here as they are known in the art.

In the described circuit configuration, deterioration of circuit components can have a negative effect on the circuit performance of the circuit. One factor that directly affects the performance of components is heat. Known circuits generally monitor switching temperatures (eg MOSFET temperatures). However, due to technological advances in MOSFET design and corresponding reductions in size, MOSFET temperature is no longer a valid 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. The additional temperature will destroy the core material, such as ferrite, which can cause permanent damage. The present disclosure of the transformer 3310, for example, by reducing the drive power in the transformer 3310, signaling the user, turning off the power, pulsing the power, or other suitable response. Can respond to the highest temperature.

In one aspect of the disclosure, the processor 3302 is communicatively coupled to an end effector (eg 1122, 1125), which arranges the material so that it is in physical contact with an ultrasonic blade (eg 1128, 1149). Used to do. The end-effector, there is provided a sensor for measuring the clamping force value (present within a known range), based on the received clamping force value, the processor 3302 changes the operating voltage V _M. The temperature sensor 3332 may be communicably coupled to the processor 3302, where the processor 3302 is from the temperature sensor 3336 to the blade, because a high force value combined with a set operating speed can result in a high blade temperature. It can operate to receive and interpret a signal indicating the current temperature and to determine the target frequency of blade motion based on the received temperature. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to a trigger (eg, 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch button so that the displacement strength corresponds to the force applied to the switch button by the user.

According to at least one aspect of the present disclosure, the PLL portion of the drive circuit 3308 coupled to the processor 3302 can determine the frequency of waveguide motion and transmit that frequency to the processor 3302. 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, read the last frequency of the waveguide motion. .. The device can then be started at the last frequency, which is presumably the optimum frequency for the current load.

Modular Battery-powered Handheld Surgical Instruments with Multi-Stage Generator Circuits In another aspect, the present disclosure provides modular battery-powered handheld surgical instruments with multi-stage generator circuits. Surgical instruments including battery assemblies, handle assemblies, and shaft assemblies are disclosed, which are 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 a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The shaft assembly includes a second stage circuit coupled with a first stage circuit for receiving, amplifying and applying the analog waveform to the load device.

In one aspect, the present disclosure comprises a control circuit including a battery, a memory coupled to the battery, and a memory and a processor coupled to the battery, the processor being configured to generate a digital waveform; The first stage circuit includes a first stage circuit connected to a processor, the first stage circuit includes a digital / analog (DAC) converter and a first stage amplifier circuit, and the DAC receives a digital waveform and converts the digital waveform into an analog waveform. The first stage amplifier circuit is configured to receive and amplify the analog waveform; as well as to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to the load device. Provides a surgical instrument comprising a shaft assembly comprising a second stage circuit connected to a first stage amplifier circuit, the battery assembly and the shaft assembly being configured to be mechanically and electrically connected to the handle assembly. To do.

The loading 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 be connected to the second-stage ultrasonic drive circuit. The second stage ultrasonic drive circuit may be configured to be coupled with an ultrasonic transducer. The first-stage high-frequency current drive circuit may be configured to be connected to the second-stage high-frequency drive circuit. The second stage high frequency drive circuit may be configured to be connected to the electrodes.

The first-stage circuit may include a first-stage sensor drive circuit. The first-stage sensor drive circuit may be configured with respect to the second-stage sensor drive circuit. The second stage sensor drive circuit may be configured to be connected to the sensor.

In another aspect, the present disclosure comprises a control circuit including a battery, a memory coupled to the battery, and a memory and a processor coupled to the battery, the processor being configured to generate a digital waveform. Includes a common first-stage circuit connected to the processor, a common first-stage circuit contains a digital-to-analog (DAC) converter and a common first-stage amplifier circuit, and the DAC receives the digital waveform and digital waveform. A common first-stage amplifier circuit configured to receive and amplify the analog waveform; as well as a handle assembly; as well as receive the analog waveform, amplify the analog waveform, and analog In order to apply the waveform to the load device, a shaft assembly including a second stage circuit connected to a common first stage amplifier circuit is provided, and the battery assembly and the shaft assembly are mechanically and electrically connected to the handle assembly. Provides surgical instruments that are configured in.

The loading device may include any one of an ultrasonic transducer, an electrode, or a sensor, or any combination thereof. Common first-stage circuits may be configured to drive ultrasonic, high frequency current, or sensor circuits. The common first-stage drive circuit may be configured to be connected 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 be connected to an ultrasonic transducer, the second-stage high-frequency drive circuit may be configured to be connected to an electrode, and the second-stage sensor drive circuit may be configured to be connected to a sensor. It is configured in.

In another aspect, the present disclosure is a control circuit comprising a memory coupled with a processor, wherein the processor is configured to generate a digital waveform; a common first stage circuit coupled with the processor. Including, a common first stage circuit is configured to receive a digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform; and to receive and amplify the analog waveform. Provided with a shaft assembly that includes a second stage circuit coupled with a common first stage circuit, the shaft assembly provides a surgical instrument that is configured to be mechanically and electrically connected to the handle assembly.

Common first-stage circuits may be configured to drive ultrasonic, high frequency current, or sensor circuits. The common first-stage drive circuit may be configured to be connected 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 be connected to an ultrasonic transducer, the second-stage high-frequency drive circuit may be configured to be connected to an electrode, and the second-stage sensor drive circuit may be configured to be connected to a sensor. It is configured in.

FIG. 34 shows a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 according to at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein may include a generator circuit 3400 divided into multiple stages. For example, the surgical instrument of the surgical system 1000 is a first stage circuit of amplification that allows the operation of at least two circuits, namely RF energy only, ultrasonic energy only, and / or a combination of RF energy and ultrasonic energy. A generator circuit 3400 divided into 3404 and a second stage circuit 3406 may be provided. The 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 integrated with the modular shaft assembly 3414. As described 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 mechanically and electrically connected to the handle assembly 3412. The end effector assembly is configured to be mechanically and electrically connected to the shaft assembly 3414.

With reference to FIG. 34, the generator circuit 3400 is divided into a plurality of stages located within a plurality of modular assemblies of surgical instruments such as the surgical instruments 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 a control circuit 3200 described in connection with FIG. The control circuit 3200 includes a processor 3214 including an internal memory 3217 (FIG. 34) (eg, volatile and non-volatile memory) and is electrically connected to the battery 3211. The battery 3211 supplies electric power to the first stage circuit 3404, the second stage circuit 3406, and the third stage circuit 3408, respectively. As mentioned above, the control circuit 3200 produces a digital waveform 4300 (FIG. 43) using the circuits and techniques described in connection with FIGS. 41 and 42. With reference to FIG. 34 again, the digital waveform 4300 may be configured to drive ultrasonic transducers, radio frequency (eg, RF) electrodes, or a combination thereof, either individually or simultaneously. When driven at the same time, a filter circuit may be provided in the corresponding first stage circuit 3404 to select either an ultrasonic waveform or an RF waveform. Such filtering techniques are described in co-owned US Patent Application Publication No. 2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATION", which is incorporated herein by reference in its entirety.

The first stage circuit 3404 (eg, 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 the outputs SCL-A and SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 will be 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 the outputs SCL-B and SDA-B of the control circuit 3200. The first stage RF drive circuit 3422 will be described in detail in connection with FIG. The control circuit 3200 provides a sensor drive signal to the first-stage sensor drive circuit 3424 via the outputs SCL-C and SDA-C of the control circuit 3200. In general, each of the first stage circuits 3404 includes a digital / analog (DAC) converter and a first stage amplifier 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.

The control circuit 3200 is configured to detect which module is plugged into the control circuit 3200. For example, the control circuit 3200 determines 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. It is configured to detect. Similarly, each of the first-stage circuits 3404 can detect which second-stage circuit 3406 is connected to it, and that information is used to determine the type of signal waveform to generate in the control circuit 3200. Returned to. 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 used to determine the type of signal waveform to generate. It is returned to the control circuit 3200.

In one aspect, the second stage circuit 3406 (eg, ultrasonic driven second stage circuit 3430, RF driven second stage circuit 3432, and sensor driven second stage circuit 3434) is located within the shaft assembly 3414 of the surgical instrument. To do. The first stage ultrasonic drive circuit 3420 provides a signal to the second stage ultrasonic drive circuit 3430 via the output US left / US right. The second stage ultrasonic drive circuit 3430 will be described in detail in relation to FIGS. 30 and 31. In addition to the transformers (FIGS. 30 and 31), the second stage ultrasonic drive circuit 3430 may further include a filter, an amplifier, and a signal conditioning circuit. The first stage radio frequency (RF) current drive circuit 3422 provides a signal to the second stage RF drive circuit 3432 via the output RF left / RF right. In addition to transformers and blocking capacitors, the second stage RF drive circuit 3432 may further include filters, amplifiers, and signal conditioning circuits. The first-stage sensor drive circuit 3424 provides a signal to the second-stage sensor drive circuit 3434 via the output sensor 1 / sensor 2. The second stage sensor drive circuit 3434 may include a filter, an amplifier, and a signal conditioning circuit 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.

In one aspect, the third stage circuit 3408 (eg, ultrasonic transducers 1120, RF electrodes 3074a, 3074b, and sensor 3440) may be located within 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 embodiments, the ultrasonic transducer 1120 may be located within the handle assembly 3412, shaft assembly 3414, or end effector. In one aspect, the second stage RF drive circuit 3432 provides drive signals to the RF electrodes 3074a, 3074b, which are located approximately within the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides drive signals to various sensors 3440 located throughout the surgical instrument.

FIG. 35 shows a generator circuit 3500 divided into a plurality of stages, in which the first stage circuit 3504 is common to the second stage circuit 3506, according to at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein may include a generator circuit 3500 divided into multiple stages. For example, the surgical instruments of the surgical system 1000 have at least two circuits, namely radio frequency (RF) energy only, ultrasonic energy only, and / or amplifications that allow the operation of a combination of RF energy and ultrasonic energy. A generator circuit 3500 divided into a first-stage circuit 3504 and a second-stage circuit 3506 may be provided. The 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 integrated with the modular shaft assembly 3514. As mentioned above throughout this description in connection with the surgical instruments of the surgical system 1000, the battery assembly 3510 and the shaft assembly 3514 are configured to be mechanically and electrically connected to the handle assembly 3512. The end effector assembly is configured to be mechanically and electrically connected to the shaft assembly 3514.

As shown in the embodiment of FIG. 35, the battery assembly 3510 portion of the surgical instrument comprises a first control circuit 3502 including the control circuit 3200 described above. The handle assembly 3512 connected to the battery assembly 3510 includes a common first stage drive circuit 3420. As mentioned above, the first stage drive circuit 3420 is configured to drive ultrasonic waves, radio frequency (RF) currents, and sensor loads. The output of the common first-stage drive circuit 3420 is a second-stage circuit 3506 such as a second-stage ultrasonic drive circuit 3430, a second-stage radio frequency (RF) current drive circuit 3432, and / or a second-stage sensor drive circuit 3434. Any one of them can be driven. 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 is replaced by a second stage circuit 3506 (eg, second stage ultrasonic drive circuit 3430, second stage RF drive circuit 3432, and / Alternatively, it is determined which one of the second stage sensor drive circuits 3434) is located in the shaft assembly 3514. This information is located within the handle assembly 3512 to supply a suitable digital waveform 4300 (FIG. 43) to the second stage circuit 3506 to drive the appropriate load (eg ultrasound, RF, or sensor). Provided to the control circuit 3200. It will be appreciated that various assemblies 3516 within the third stage circuit 3508, such as the ultrasonic transducer 1120, electrodes 3074a, 3074b, or sensor 3440, may include identification circuits. Therefore, 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.

FIG. 36 is a circuit diagram of one aspect of an electrical circuit 3600 configured to drive a radio frequency current (RF) according to at least one aspect of the present disclosure. The electric circuit 3600 includes an analog multiplexer 3680. The analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A such as RF, batteries, and power control circuits. The current sensor 3682 is connected in series with the return or ground section of the power supply circuit and measures the current supplied by the power supply. The field effect transistor (FET) temperature sensor 3864 provides the ambient temperature. The pulse width modulation (PWM) watchdog timer 3688 automatically causes a system reset if the main program fails to provide a periodic system reset. It 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, for example, to drive the RF electrodes or to drive the ultrasonic transducer 1120, as described with respect to FIG. 29. Therefore, referring again to FIG. 36, the electrical circuit 3600 can be used to drive both the ultrasonic waves and the RF electrodes alternately.

Drive circuit 3686 provides left and right RF energy outputs. The digital signal representing the signal waveform is supplied to the SCL-A and SDA-A inputs of the analog multiplexer 3680 from a control circuit such as the control circuit 3200 (FIG. 32). The digital-to-analog converter 3690 (DAC) converts a digital input into an analog output and drives a PWM circuit 3692 connected to an oscillator 3694. The PWM circuit 3692 provides a first signal to the first gate drive circuit 3696a connected to the first transistor output step 3698a to drive the first RF + (left side) energy output. The PWM circuit 3692 also provides a second signal to the second gate drive circuit 3696b coupled to the second transistor output step 3698b to drive the second RF (right) energy output. The voltage sensor 3699 is connected between the RF left / RF output terminals to measure the output voltage. The drive circuit 3686, the first drive circuit 3696a and the second drive circuit 3696a, and the first transistor output stage 3698a and the second transistor output stage 3698b define a first stage amplifier circuit. During operation, the control circuit 3200 (FIG. 32) generates a digital waveform 4300 (FIG. 43) using circuits such as the direct digital compositing (DDS) circuits 4100 and 4200 (FIGS. 41 and 42). The DAC3690 receives the digital waveform 4300, converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

FIG. 37 is a schematic view of a transformer 3700 coupled to the electrical circuit 3600 shown in FIG. 36 according to at least one aspect of the present disclosure. The RF + / RF input terminal (primary winding) of the transformer 3700 is electrically connected to the RF left / RF output terminal of the electric circuit 3600. One side of the secondary winding is connected in series with a first blocking capacitor 3706 and a second blocking capacitor 3708. The second blocking capacitor is connected to the positive terminal of the second stage RF drive circuit 3774a. The other side of the secondary winding is connected to the negative terminal of the second stage RF drive circuit 3774b. The positive output of the second stage RF drive circuit 3774a is connected to the ultrasonic blade, and the negative ground terminal of the second stage RF drive circuit 3774b is connected to the outer tube. In one aspect, the transformer has a turn ratio of _{1:50 n 1} : n _2.

FIG. 38 is a schematic of circuit 3800 with separate power supplies for high power energy / drive circuits and low power circuits according to at least one aspect of the present disclosure. The power supply 3812 is a primary battery pack that includes a first primary battery 3815 and a second primary battery 3817 (eg, a Li ion battery) that are connected to the circuit 3800 by a switch 3818 when the power source 3812 is inserted into the battery assembly. And a secondary battery pack containing the secondary battery 3820 connected to the circuit by the switch 3823. The secondary battery 3820 is an anti-sag battery having components resistant to gamma or other radiation sterilization. For example, a switch mode power source 3827 and any charging circuit in the battery assembly may be incorporated to allow the secondary battery 3820 to reduce the voltage sag of the primary batteries 3815, 3817. This guarantees a fully charged cell at the start of surgery for easy introduction into sterile fields. The primary batteries 3815 and 3817 can be used to directly power the motor control circuit 3826 and the energy circuit 3832. The motor control circuit 3826 is configured to control a motor such as a motor 3829. The power / battery pack 3812 comprises a primary Li-ion battery 3815 comprising a dedicated energy cell 3820 for controlling the handle electronics circuit 3830 from the dedicated energy cells 3815, 3817 for operating the motor control circuit 3826 and the energy circuit 3832. , 3817 and a secondary NiMH battery 3820, may include a dual type battery assembly. In this case, when the primary batteries 3815, 3817 involved in driving the energy circuit 3832 and / or the motor control circuit 3826 drop low, the circuit 3810 is withdrawn from the secondary battery 3820 involved in driving the handle electronics circuit 3830. In various aspects, the circuit 3810 is a unidirectional diode that does not allow current to flow in the opposite direction (eg, from the battery involved in driving the energy and / or motor control circuit to the battery involved in driving the electronics circuit). May include.

In addition, a gamma-friendly charging circuit can be provided that includes a switch mode power supply 3827 that uses diodes and tube components to minimize voltage sag at predetermined levels. The switch mode power supply 3827 can be eliminated by including the minimum sag voltage, which is a division of the NiMH voltage (three NiMH cells). In addition, a module system in which the radiation-cured components are located within the module can be provided, making the module sterilizable by radiation sterilization. Other non-radiation-cured components may be included in other module components and connections made between the module components, thereby as if the components were co-located on the same circuit board. In addition, the components work together. If only two NiMH cells are desired, a diode and tube based switch mode power supply 3827 enables sterilizable electronics in disposable primary battery packs.

With reference to FIG. 39, a control circuit 3900 for operating an RF generator circuit 3902 powered by a battery 3901 for use with a surgical instrument is shown according to at least one aspect of the present disclosure. Surgical instruments are configured to perform surgical coagulation / cutting on biological tissue using both ultrasonic vibration and high frequency current, and surgical coagulation on biological tissue using high frequency current. ..

FIG. 39 is a control that allows the dual generator system to switch between the energy modality of the RF generator circuit 3902 and the energy modality of the ultrasonic generator circuit 3920 for the surgical instruments of the surgical system 1000. The circuit 3900 is shown. In one aspect, the current threshold in the RF signal is detected. When the tissue impedance is low, the high frequency current through the tissue is high when RF energy is used as a treatment source for the tissue. According to one aspect, the visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 may be configured to be turned on during this high current period. When the current falls below the threshold, the visual indicator 3912 is turned off. Therefore, as shown in the control circuit 3900 shown in FIG. 39, the phototransistor 3914 can be configured to detect the transition from the on state to the off state and release the RF energy. Therefore, when the energy button is released and the energy switch 3926 is opened, the control circuit 3900 is reset and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are kept off.

With reference to FIG. 39, in one aspect, a method of managing the RF generator circuit 3902 and the ultrasonic generator circuit 3920 is provided. The RF generator circuit 3902 and / or the ultrasonic generator circuit 3920 may include, for example, the handle assembly 1109 of the multifunctional electrosurgical instrument 1108, the ultrasonic transducer / RF generator assembly 1120, the battery assembly, the shaft assembly 1129 and / or. It may be located in the nozzle. The control circuit 3900 is kept in the reset state when the energy switch 3926 is off (eg, open). Therefore, when the energy switch 3926 is opened, the control circuit 3900 is reset and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are turned off. When the energy switch 3926 is pressed and the energy switch 3926 is engaged (eg, closed), RF energy is delivered to the tissue and the visual indicator 3912 operated by the current sensing step-up transformer 3904 has a tissue impedance. Lights up while low. The light from the visual indicator 3912 provides a logical signal to keep the ultrasonic generator circuit 3920 off. Once the tissue impedance increases above the threshold and the high frequency current through the tissue decreases below the threshold, the visual indicator 3912 turns off and the light shifts to the off state. The logic signal generated by this transition turns off the relay 3908, which turns off the RF generator circuit 3902 and turns on the ultrasonic generator circuit 3920 to complete the solidification and disconnect cycle.

Continuing with reference to FIG. 39, in one aspect, the dual generator circuit configuration is an onboard RF generator circuit 3902 powered by a battery 3901 for one modality and, for example, a multifunctional electrosurgical instrument. A second onboard ultrasonic generator circuit 3920, which may be onboard within the handle assembly 1109, battery assembly, shaft assembly 1129, nozzle, and / or ultrasonic transducer / RF generator assembly 1120 of the 1108, and Is used. The ultrasonic generator circuit 3920 is also powered by battery 3901. In various aspects, the RF generator circuit 3902 and the ultrasonic generator circuit 3920 may be integrated or separable components of the handle assembly 1109. According to various aspects, having dual RF / ultrasonic generator circuits 3902, 3920 as part of the handle assembly 1109 can eliminate the need for complex wiring. The RF / ultrasonic generator circuits 3902, 3920 may be configured to provide the full capabilities of an existing generator while simultaneously utilizing the capabilities of the cordless generator system.

Either type of system can have separate control over modality that is not communicating with each other. The surgeon activates RF and ultrasound separately and optionally. Another approach is to provide a fully integrated communication scheme that shares algorithms for managing buttons, tissue status, instrument operating parameters (eg jaw closure, force, etc.) and tissue treatment. .. Various combinations of this integration can be implemented to provide the appropriate level of functionality and performance.

As described above, in one aspect, the control circuit 3900 includes an RF generator circuit 3902 powered by a battery 3901, comprising a battery as an energy source. As shown, the RF generator circuit 3902 is coupled to two conductive surfaces referred to herein as electrodes 3906a, 3906b (ie, active electrode 3906a and return electrode 3906b), and the electrodes 3906a, 3906b are connected to RF energy (ie, RF energy (ie, active electrode 3906a and return electrode 3906b)). For example, it is configured to be driven by a high frequency current). The first winding 3910a of the step-up transformer 3904 is connected in series to one pole of the bipolar RF generator circuit 3902 and the return electrode 3906b. In one aspect, the first winding 3910a and the return electrode 3906b are connected to the negative electrode of the bipolar RF generator circuit 3902. The other pole of the bipolar RF generator circuit 3902 is connected to the active electrode 3906a through the switch contact 3909 of the relay 3908 or is moved by an electromagnet 3936 to operate the switch contact 3909 any suitable electromagnetic. It is connected to the switching device. When the electromagnet 3936 is energized, the switch contact 3909 closes, and when the electromagnet 3936 is de-energized, the switch contact 3909 opens. When the switch contacts are closed, RF current flows through a conductive tissue (not shown) located between the electrodes 3906a and 3906b. In one aspect, it will be appreciated that the active electrode 3906a is connected to the positive electrode of the bipolar RF generator circuit 3902.

The visual indicator circuit 3905 includes a step-up transformer 3904, a series register R2, and a visual indicator 3912. The visual indicator 3912 may be adapted for use with surgical instruments 1108 and other electrosurgical systems and tools such as those described herein. The first winding 3910a of the step-up transformer 3904 is connected in series with the return electrode 3906b, and the second winding 3910b of the step-up transformer 3904 is a visual indicator containing a register R2 and, for example, a NE-2 neon valve. It is connected in series with the 3912.

During operation, when the switch contact 3909 of the relay 3908 opens, the active electrode 3906a is separated from the positive electrode of the bipolar RF generator circuit 3902 and passes through the tissue, the return electrode 3906b, and the first winding 3910a of the step-up transformer 3904. No current flows. Therefore, the visual indicator 3912 is not energized and does not emit light. When the switch contact 3909 of the relay 3908 is closed, the active electrode 3906a is connected to the positive electrode of the bipolar RF generator circuit 3902, thereby passing through the tissue, the return electrode 3906b, and the first winding 3910a of the step-up transformer 3904. An electric current can flow to operate on the tissue, for example, to cut and cauterize the tissue.

The first current flows through the first winding 3910a as a function of the impedance of the tissue located between the active electrode 3906a and the return electrode 3906b, and flows through the first winding 3910a of the step-up transformer 3904. Provides a voltage of 1. The boosted second voltage is induced throughout the second winding 3910b of the step-up transformer 3904. The secondary voltage appears throughout the register R2, and when the current through the tissue is greater than a predetermined threshold, the visual indicator 3912 is energized to light the neon bulb. It will be appreciated that circuit and component values are exemplary and not limited. When the switch contact 3909 of relay 3908 closes, current flows through the tissue and the visual indicator 3912 is turned on.

Referring here to the energy switch 3926 portion of the control circuit 3900, when the energy switch 3926 is in the open position, the logic high is applied to the input of the first inverter 3928 and the logic low is of the two inputs of the AND gate 3932. Applies to one of. Therefore, the output of the AND gate 3932 is low and the transistor 3934 is off, preventing current from flowing through the windings of the electromagnet 3936. When the electromagnet 3936 is in the non-energized state, the switch contact 3909 of the relay 3908 remains open, preventing current from flowing through the electrodes 3906a and 3906b. The logical low output of the first inverter 3928 is also applied to the second inverter 3930 to raise the output and reset the flip-flop 3918 (eg, D-type flip-flop). At this time, the Q output becomes low, the ultrasonic generator circuit 3920 circuit is turned off, and

出力は高くなり、ＡＮＤゲート３９３２の他の入力に適用される。

The output will be higher and will be applied to the other inputs of AND Gate 3932.

When the user presses the energy switch 3926 on the instrument handle to apply energy to the tissue between the electrodes 3906a and 3906b, the energy switch 3926 closes and applies a logic row to the input of the first inverter 3928, which is A logic high is applied to the other inputs of the AND gate 3932 to raise the output of the AND gate 3932 and turn on the transistor 3934. In the on state, the transistor 3934 conducts and sinks a current through the winding of the electromagnet 3936 to energize the electromagnet 3936 and closes the switch contact 3909 of the relay 3908. As mentioned above, when the switch contact 3909 is closed, when the tissue is located between the electrodes 3906a and 3906b, the current passes through the electrodes 3906a, 3906b and the first winding 3910a of the step-up transformer 3904. Can flow.

As described above, the magnitude of the current flowing through the electrodes 3906a and 3906b depends on the impedance of the tissue located between the electrodes 3906a and 3906b. First, the impedance of the tissue is low and the magnitude of the current through the structure and the first winding 3910a is high. Therefore, the voltage applied to the second winding 3910b is high enough to turn on the visual indicator 3912. The light emitted by the visual indicator 3912 turns on the phototransistor 3914, which pulls the input of the inverter 3916 low and makes the output of the inverter 3916 high. The high input applied to the CLK of the flip-flop 3918 is the Q of the flip-flop 3918 or

出力に影響を与えず、Ｑ出力は低いままであり、

Does not affect the output, the Q output remains low,

出力は高いままである。したがって、視覚インジケータ３９１２は通電されたままであり、超音波発生器回路３９２０はオフとなり、多機能型電気外科用器具の超音波トランスデューサ３９２２及び超音波ブレード３９２４は起動しなくなる。

The output remains high. Therefore, the visual indicator 3912 remains energized, the ultrasonic generator circuit 3920 is turned off, and the ultrasonic transducer 3922 and ultrasonic blade 3924 of the multifunctional electrosurgical instrument are not activated.

When the tissue between the electrodes 3906a and 3906b dries due to the heat generated by the current flowing through the tissue, the impedance of the tissue increases and the current through it decreases. As the current through the first winding 3910a decreases, so does the voltage across the second winding 3910b, and when the voltage falls below the minimum threshold required to operate the visual indicator 3912, the visual indicator 3912 and the phototransistor 3914 Is turned off. When the phototransistor 3914 is turned off, the logic high is applied to the input of the inverter 3916, the logic low is applied to the CLK input of the flip-flop 3918, the logic high is clocked to the Q output, and the logic low is

出力に適用される。Ｑ出力における論理ハイによって、超音波発生器回路３９２０がオンになり、超音波トランスデューサ３９２２及び超音波ブレード３９２４を起動させて電極３９０６ａと電極３９０６ａとの間に位置する組織の切断を開始させる。超音波発生器回路３９２０がオンになるのと同時に又はほぼ同時に、フリップ・フロップ３９１８の

Applies to output. The logic high in the Q output turns on the ultrasonic generator circuit 3920 and activates the ultrasonic transducer 3922 and the ultrasonic blade 3924 to start cutting the tissue located between the electrodes 3906a and 3906a. At the same time as or approximately at the same time that the ultrasonic generator circuit 3920 is turned on, the flip-flop 3918

出力は低くなり、ＡＮＤゲート３９３２の出力を低くして、トランジスタ３９３４をオフにすることにより、電磁石３９３６を非通電し、リレー３９０８のスイッチ接点３９０９を開いて電極３９０６ａ、３９０６ｂを通る電流の流れを遮断する。

The output is low, the output of the AND gate 3932 is low, and the transistor 3934 is turned off, so that the electromagnet 3936 is de-energized and the switch contact 3909 of the relay 3908 is opened to allow the current flow through the electrodes 3906a and 3906b. Cut off.

While the switch contact 3909 of the relay 3908 is open, no current flows through the electrodes 3906a, 3906b, the tissue, and the first winding 3910a of the step-up transformer 3904. Therefore, no voltage is generated over the second winding 3910b and no current flows through the visual indicator 3912.

Q of flip-flop 3918 and while the user grasps the energy switch 3926 on the instrument handle and keeps the energy switch 3926 closed.

出力の状態は同じままである。したがって、双極ＲＦ発生器回路３９０２から電極３９０６ａ、３９０６ｂを通って電流が流れていない間は、超音波ブレード３９２４は起動した状態を維持してエンドエフェクタのジョーの間の組織を切断し続ける。ユーザが器具ハンドルのエネルギースイッチ３９２６を解放すると、エネルギースイッチ３９２６が開いて、第１のインバータ３９２８の出力はローになり、第２のインバータ３９３０の出力はハイになってフリップフロップ３９１８をリセットし、Ｑ出力をローにして超音波発生器回路３９２０をオフにする。同時に、この

The state of the output remains the same. Therefore, while no current is flowing from the bipolar RF generator circuit 3902 through the electrodes 3906a and 3906b, the ultrasonic blade 3924 remains activated and continues to cut tissue between the end effector jaws. When the user releases the energy switch 3926 on the instrument handle, the energy switch 3926 opens, the output of the first inverter 3928 goes low, the output of the second inverter 3930 goes high and resets the flip-flop 3918. Set the Q output to low and turn off the ultrasonic generator circuit 3920. At the same time, this

出力は高くなり、ここで回路はオフ状態になり、ユーザが器具ハンドル上のエネルギースイッチ３９２６を作動させて、エネルギースイッチ３９２６を閉じ、電極３９０６ａ、３９０６ｂの間に位置する組織に電流を印加し、上述のように組織にＲＦエネルギーを印加し、組織に超音波エネルギーを印加するサイクルを繰り返す準備ができる。

The output is high, where the circuit is turned off and the user activates the energy switch 3926 on the instrument handle, closes the energy switch 3926 and applies current to the tissue located between the electrodes 3906a and 3906b. It is ready to repeat the cycle of applying RF energy to the tissue and applying ultrasonic energy to the tissue as described above.

FIG. 40 includes a surgical system 1000 including a feedback system for use with any one of the surgical instruments of the surgical system 1000, which may include or implement many of the features described herein. It is a figure of the surgical system 4000 which represents one aspect. The surgical system 4000 may include a generator 4002 coupled to a surgical instrument that includes an end effector 4006 that can be activated when the clinician operates the trigger 4010. In various aspects, the end effector 4006 can include an ultrasonic blade for delivering ultrasonic vibrations to perform a surgical coagulation / cutting procedure on living tissue. In another aspect, the end effector 4006 performs a cutting procedure on the living tissue with a conductive element connected to a high frequency current energy source for electrosurgery to perform a surgical coagulation or cauterization on the living tissue. It may include either a mechanical knife or an ultrasonic blade, which has a sharp edge for the purpose. When the trigger 4010 is activated, the force sensor 4012 can generate a signal indicating the amount of force applied to the trigger 4010. In addition to, or instead of, the force sensor 4012, the surgical instrument may generate a signal indicating the position of the trigger 4010 (eg, how deeply the trigger was pressed or otherwise actuated). The position sensor 4013 can be included. In one aspect, the position sensor 4013 may be a sensor positioned with the outer tubular sheath or a reciprocating tubular actuating member located within the outer tubular sheath of the surgical instrument. In one aspect, the sensor may be a Hall effect sensor or any suitable transducer that changes its output voltage in response to a magnetic field. Hall effect sensors can be used in proximity switching, positioning, velocity sensing and current sensing applications. In one aspect, the Hall effect sensor acts as an analog transducer and returns the voltage directly. A known magnetic field can be used to determine the distance from the hole plate.

The control circuit 4008 can receive a signal from the sensor 4012 and / or 4013. The control circuit 4008 may include any suitable analog or digital circuit components. The control circuit 4008 further communicates with the generator 4002 and / or the transducer 4004 to provide a force applied to the trigger 4010 and / or the position of the trigger 4010 and / or a reciprocating tubular actuating member located within the outer tubular sheath. Power delivered to the end effector 4006 and / or generator level or ultrasound of the end effector 4006 based on the position of the outer tubular sheath with respect to (eg, measured by a combination of a Hall effect sensor and a magnet). The blade amplitude can be modulated. For example, when a greater force is applied to the trigger 4010, more power and / or higher ultrasonic blade amplitude can be delivered to the end effector 4006. According to various aspects, the force sensor 4012 may be replaced by a multi-position switch.

According to various aspects, the end effector 4006 may include a clamp or a clamp mechanism. When the trigger 4010 is first actuated, the clamping mechanism can be closed to clamp the tissue between the clamp arm and the end effector 4006. As the force applied to the trigger increases (eg, as sensed by the force sensor 4012), the control circuit 4008 brings about the power delivered to the end effector 4006 by the transducer 4004 and / or around the end effector 4006. Instrument level or ultrasonic blade amplitude can be increased. In one aspect, the trigger position sensed by the position sensor 4013 or the clamp or clamp arm position sensed by the position sensor 4013 (eg, using a Hall effect sensor) sets the power and / or amplitude of the end effector 4006. Can be used by the control circuit 4008 to do so. For example, if the trigger is further moved towards the fully actuated position, or if the clamp or clamp arm is further moved towards the ultrasonic blade (or end effector 4006), the power and / or amplitude of the end effector 4006 will increase. obtain.

According to various aspects, the surgical instrument of the surgical system 4000 can also include one or more feedback devices to indicate the amount of power delivered to the end effector 4006. For example, the speaker 4014 can emit a signal indicating the power of the end effector. According to various aspects, the speaker 4014 can emit a series of pulsed sounds, the frequency of which indicates power. In addition to or instead of the speaker 4014, the surgical instrument can include a visual display 4016. The visual display 4016 can show the power of the end effector according to any suitable method. For example, the visual display 4016 may include a series of LEDs, where the power of the end effector is indicated by the number of illuminated LEDs. The speaker 4014 and / or the visual display 4016 may be driven by the control circuit 4008. According to various aspects, the surgical instrument can include a ratchet device connected to a trigger 4010. When a stronger force is applied to the trigger 4010, the ratchet device can generate an audible sound to provide an indirect indicator of the power of the end effector. Surgical instruments can include other mechanisms that can enhance safety. For example, the control circuit 4008 may be configured to prevent power from being delivered to the end effector 4006 beyond a predetermined threshold. The control circuit 4008 also provides a delay between the time when the end effector power change is indicated (eg, by the speaker 4014 or the visual display 4016) and the time when the end effector power change is delivered. Can be done. In this way, the clinician can afford to warn that the level of ultrasonic output delivered to the end effector 4006 is about to change.

In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 digitally digitizes the electrical signal waveform so that it digitizes the waveform using a predetermined number of phase points stored in the lookup table. It can be configured to occur. Phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 41 shows an aspect of a basic architecture for a digital compositing circuit such as the direct digital compositing (DDS) circuit 4100, which is configured to generate multiple waveforms for an electrical signal waveform. The generator software and digital control can instruct the FPGA to scan the address in the look-up table 4104, which in turn provides various digital input values to the DAC circuit 4108 that feeds the power amplifier. The address may be scanned according to the desired frequency. The use of such a look-up table 4104 can be supplied within the tissue, or within a transducer, RF electrode, multiple transducers, simultaneously within multiple RF electrodes, or within a combination of RF and ultrasonic instruments. It is possible to generate various types of waveforms. In addition, a plurality of look-up tables 4104 representing the plurality of waveforms can be created, stored, and applied from the generator to the tissue.

The waveform signal is the output current, output voltage, or output of the ultrasonic transducer and / or RF electrode, or multiple of them (eg, two or more ultrasonic transducers and / or two or more RF electrodes). It may be configured to control at least one of the power sources. Further, if the surgical instrument comprises an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Thus, the generator may be configured to provide the waveform signal to at least one surgical instrument, which responds to at least one of the plurality of waveforms in the table. Note that the waveform signals provided to the two surgical instruments may include two or more waveforms. The table may contain information related to multiple waveforms, and the table may be stored in the generator. In one embodiment or embodiment, the table may be a direct digital compositing table and may be stored in the FPGA of the generator. The table may be addressed by any method that is convenient for categorizing waveforms. According to one aspect, the table, which can be a direct digital compositing table, is addressed according to the frequency of the waveform signal. Further, the information related to the plurality of waveforms may be stored in the table as digital information.

The analog electrical signal waveform is the output current, output voltage, of the ultrasonic transducer and / or RF electrodes, or multiple of them (eg, two or more ultrasonic transducers and / or two or more RF electrodes). Alternatively, it may be configured to control at least one of the output powers. Further, if the surgical instrument comprises an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Therefore, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, the analog electrical signal waveform being at least one of the plurality of waveforms stored in the look-up table 4104. Corresponds to one waveform. Note that the analog electrical signal waveforms provided for the two surgical instruments may include two or more waveforms. The look-up table 4104 may contain information related to a plurality of waveforms, and the look-up table 4104 may be stored in either the generator circuit or the surgical instrument. In one embodiment or embodiment, the lookup table 4104 may be a direct digital compositing table, which may be stored in the FPGA of the generator circuit or surgical instrument. The look-up table 4104 may be addressed by any method that is convenient for categorizing waveforms. According to one aspect, the lookup table 4104, which may be a direct digital compositing table, is addressed according to the frequency of the desired analog electrical signal waveform. Further, the information related to the plurality of waveforms may be stored in the lookup table 4104 as digital information.

With the widespread use of digital technology in instrumentation systems and communication systems, digital control methods that generate multiple frequencies from a reference frequency have evolved and are called direct digital compositing. The basic architecture is shown in FIG. In this simplified block diagram, the DDS circuit is connected to the processor, controller, or logic mechanism of the generator circuit, and a memory circuit located within the generator circuit of the surgical system 1000. The DDS circuit 4100 includes an address counter 4102, a look-up table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. Stable clock f _c is received by the address counter 4102, a register 4106, a programmable read-only storing one or more integer number of cycles of a sine wave (or any other waveform) in the look-up table 4104 Drives a memory (PROM). When the address counter 4102 steps through the storage location, the value stored in the lookup table 4104 is written to the register 4106 connected to the DAC circuit 4108. The corresponding digital amplitude of the signal at the storage location of the look-up table 4104 subsequently drives the DAC circuit 4108 to generate the analog output signal 4110. The spectral purity of the analog output signal 4110 is mainly determined by the DAC circuit 4108. Phase noise is of basically the reference clock f _c. The first analog output signal 4110 output from the DAC circuit 4108 is filtered by the filter 4112, and the second analog output signal 4114 output by the filter 4112 is an amplifier having an output coupled to the output of the generator circuit. Will be provided to. The second analog output signal has a frequency of _out .

Since the DDS circuit 4100 is a sampled data system, problems associated with sampling such as quantization noise, aliasing, and filtering must be taken into consideration. For example, the higher harmonics at the output of a phase-locked loop (PLL) -based synthesizer can be filtered, while the higher harmonics at the DAC circuit 4108 output frequency wrap to the Nyquist bandwidth, making them unfilterable. To do. Look-up table 4104 contains signal data for integers of cycles. The final output frequency f _out, by changing the reference clock frequency f _c, or PROM may be changed by reprogramming.

The DDS circuit 4100 may include a plurality of look-up tables 4104, which stores a waveform represented by a predetermined number of samples, and the samples define a predetermined waveform shape. Therefore, a plurality of waveforms having a unique shape can be stored in a plurality of look-up tables 4104 to provide various tissue treatments based on instrument settings or tissue feedback. Examples of waveforms are high crested RF electrical signal waveforms for surface tissue coagulation, low crested RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. Can be mentioned. In one aspect, the DDS circuit 4100 can create multiple waveform look-up tables 4104, which is desired during tissue treatment procedures (eg, "on the fly" based on user or sensor inputs or in real time). Switching between the various waveforms stored in the individual look-up table 4104 can be made based on the tissue effect and / or tissue feedback of.

Therefore, switching between waveforms can be based on, for example, tissue impedance and other factors. In another aspect, the look-up table 4104 can store electrical signal waveforms (ie, trapezoidal or square waves) that are formed to maximize the power delivered into the tissue each cycle. In another aspect, the look-up table 4104 can store a synchronized waveform so that the waveform delivers RF and ultrasonic drive signals while the multifunctional surgical instrument of the surgical system 1000. Maximize power delivery by. In yet another aspect, the look-up table 4104 can store an electrical signal waveform that simultaneously drives ultrasonic and RF therapeutic and / or sub-therapeutic energy while maintaining a lock on the ultrasonic frequency. Custom waveforms specific to the various instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory of the surgical system 1000 (eg EEPROM) and are also multifunctional surgical instruments. Is fetched when connecting to the generator circuit. An example of an exponentially decaying sinusoidal curve used in many high wave high rate "solidification" waveforms is shown in FIG.

A more flexible and effective implementation of the DDS circuit 4100 uses a digital circuit called a Numerically Controlled Oscillator (NCO). A block diagram of a more flexible and effective digital compositing circuit, such as the DDS circuit 4200, is shown in FIG. In this simplified block diagram, the DDS circuit 4200 is connected to a processor, controller, or logic mechanism of the generator, and to a memory circuit located in either the generator or the surgical instrument of the surgical system 1000. ing. The DDS circuit 4200 includes a load register 4202, a parallel delta phase register 4204, an adder circuit 4216, a phase register 4208, a look-up table 4210 (phase-amplitude converter), a DAC circuit 4212, and a filter 4214. The adder circuit 4216 and the phase register 4208 form part of the phase accumulator 4206. Clock frequency _{f c} is applied to the phase register 4208 and the DAC circuit 4212. Load register 4202 receives an adjustment word which specifies the output frequency as a fraction of the reference clock frequency signal f _c. The output of the load register 4202 is provided to the parallel delta phase register 4204 along with the adjustment word M.

DDS circuit 4200, a sample clock for generating a clock frequency _{f c,} the phase accumulator 4206, and the look-up table 4210 (e.g., a phase - amplitude converter) including. The contents of the phase accumulator 4206, is updated once every clock cycle _{f c.} When the phase accumulator 4206 is updated, the digital number M stored in the parallel delta phase register 4204 is added to the number in the phase register 4208 by the adder circuit 4216. The number in the parallel delta phase register 4204 is 00. .. .. 01, and the initial content of the phase accumulator 4206 is 00. .. .. Assume that it is 00. The phase accumulator 4206 has a clock cycle of 00. .. .. Updated as 01. If the phase accumulator 4206 is 32-bit wide, then the phase accumulator 4206 is 00. .. .. 232 clock cycles (more than 4 billion) are required to return to 00, and the cycles are repeated.

The truncated output 4218 of the phase accumulator 4206 is provided to the lookup table 4210 of the phase-amplitude converter, and the output of the lookup table 4210 is coupled to the DAC circuit 4212. The truncated output 4218 of the phase accumulator 4206 serves as an address to a sinusoidal (or cosine) look-up table. The addresses in the look-up table correspond to the 0 ° to 360 ° phase points in the sine wave. Look-up table 4210 contains the corresponding digital amplitude information for one complete cycle of the sine wave. Therefore, the look-up table 4210 maps the phase information from the phase accumulator 4206 to the digital amplitude word, which in turn drives the DAC circuit 4212. The output of the DAC circuit is the first analog signal 4220, which is filtered by the filter 4214. The output of the filter 4214 is a second analog signal 4222 provided to the power amplifier connected to the output of the generator circuit.

In one aspect, any suitable waveform in which the digitizable waveform is in the range 256 (28) to 281, 474, 976, 710, 656 (248) (where n is a positive integer, as shown in Table 1). Despite the number of 2n phase points, the electrical signal waveform may be digitized to 1024 (210) phase points. Electrical signal waveform may be represented as A _{n (theta n),} the amplitude A _n which is normalized at point n is represented by the phase angle theta _n, called phase point at point n. The number of individual phase points n determines the adjustment resolution of the DDS circuit 4200 (and the DDS circuit 4100 shown in FIG. 41).

Table 1 identifies the digitized electrical signal waveforms at a number of phase points.

The generator circuit algorithm and digital control circuit scan the addresses in the look-up table 4210, which in turn provides various digital input values to the filter 4214 and the DAC circuit 4212 that feeds the power amplifier. The address may be scanned according to the desired frequency. By using the lookup table, it is converted into an analog output signal by the DAC circuit 4212, filtered by the filter 4214, amplified by the power amplifier connected to the output of the generator circuit, and supplied to the tissue in the form of RF energy. It is possible to generate various types of shapes that can be applied to the tissue in the form of ultrasonic vibrations that are supplied to the or ultrasonic transducer and deliver energy to the tissue in the form of heat. The output of the amplifier can be applied, for example, to a single RF electrode, multiple RF electrodes at the same time, a single ultrasonic transducer, multiple ultrasonic transducers at the same time or a combination of RF transducers and ultrasonic transducers. In addition, multiple waveform tables can be created, stored and applied to tissue from the generator circuit.

Referring again to FIG. 41, for n = 32 and M = 1, the phase accumulator 4206 steps through 232 possible outputs before overflowing and restarting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. When M = 2, the phase register 1708 "rolls over" at twice the speed and the output frequency doubles. This can be generalized as follows:

In the case of a phase accumulator 4206 configured to store n-bits (n is generally in the range 24-32 in most DDS systems, but as mentioned above, n may be selected from a wide range of choices. ), There are 2 ⁿ possible phase points. The digital word M in the delta phase register represents the amount by which the phase accumulator increments with each clock cycle. If f _c is the clock frequency, the frequency of the output sine wave is equal to or less.

The above equation is known as the DDS "adjustment equation". The frequency resolution of the system

と等しいことに留意されたい。ｎ＝３２では、分解能は４億分の１よりも大きい。ＤＤＳ回路４２００の一態様では、位相アキュムレータ４２０６外の全てのビットがルックアップテーブル４２１０に伝えられるわけではなく、切り捨てられて、例えば、最初の１３〜１５個の最上位ビット（ＭＳＢ）のみが残される。これはルックアップテーブル４２１０のサイズを低減し、かつ周波数分解能に影響を及ぼさない。位相の切り捨ては、少量だが許容できる位相雑音の量のみを最終出力に追加する。

Note that is equal to. At n = 32, the resolution is greater than 1/400 million. In one aspect of the DDS circuit 4200, not all bits outside the phase accumulator 4206 are transmitted to the look-up table 4210 and are truncated, leaving, for example, only the first 13 to 15 most significant bits (MSB). Is done. This reduces the size of the look-up table 4210 and does not affect the frequency resolution. Phase truncation adds only a small but acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by current, voltage, or power at a given frequency. Further, if the surgical instrument of the surgical system 1000 comprises an ultrasonic component, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Therefore, the generator circuit may be configured to provide the electrical signal waveform to at least one surgical instrument, which is stored in the look-up table 4210 (or the look-up table 4104 of FIG. 41). It is characterized by a predetermined waveform. The electrical signal waveform may be a combination of two or more waveforms. The look-up table 4210 may include information related to a plurality of waveforms. In one embodiment or embodiment, the look-up table 4210 may be generated by the DDS circuit 4200 and may also be referred to directly as a digital compositing table. The DDS operates by the first storage operation of a large repetitive waveform in the onboard memory. The cycle of the waveform (sine, triangle, square, arbitrary) is represented by a predetermined number of phase points and can be stored in memory, as shown in Table 1. Once the waveform is stored in memory, it can be generated at a very accurate frequency. The direct digital synthesis table can be stored in the non-volatile memory of the generator circuit and / or implemented with the FPGA circuit in the generator circuit. The look-up table 4210 may be addressed by any suitable technique that is convenient for categorizing waveforms. According to one aspect, the look-up table 4210 is addressed according to the frequency of the electrical signal waveform. Further, the information related to the plurality of waveforms may be stored as digital information in the memory or as a part of the look-up table 4210.

In one aspect, the generator circuit may be configured to simultaneously deliver electrical signal waveforms to at least two surgical instruments. The generator circuit is also configured to provide electrical signal waveforms (which can be characterized by two or more waveforms) simultaneously to two surgical instruments via a single output channel of the generator circuit. May be done. For example, in one aspect, the electrical signal waveform includes a first electrical signal (eg, an ultrasonic drive signal) that drives an ultrasonic transducer, a second RF drive signal, and / or a combination thereof. Further, the electrical signal waveform may include a plurality of ultrasonic drive signals, a plurality of RF drive signals, and / or a combination of a plurality of ultrasonic drive signals and RF drive signals.

Further, the method of operating the generator circuit according to the present disclosure includes generating an electrical signal waveform and providing the generated electrical signal waveform to any one of the surgical instruments of the surgical system 1000. Generating an electrical signal waveform involves receiving information related to the electrical signal waveform from a memory. The generated electrical signal waveform includes at least one waveform. Further, providing the generated electrical signal waveform to at least one surgical instrument includes simultaneously providing the electrical signal waveform to at least two surgical instruments.

The generator circuits described herein may allow the generation of various types of direct digital compositing tables. Examples of RF / electrosurgical signal waveforms generated by generator circuits that are suitable for treating various tissues include RF signals with high frequency (which can be used for surface coagulation in RF mode) and low frequency. RF signals with (which can be used for deeper tissue penetration) and waveforms that promote efficient modified coagulation can be mentioned. The generator circuit can also generate multiple waveforms directly using the digitally synthesized look-up table 4210 and can switch between specific waveforms based on the desired tissue effect on the fly. Switching may be based on tissue impedance and / or other factors.

In addition to the traditional sinusoidal / cosine waveform, the generator circuit may be configured to generate a waveform (s) (ie, trapezoidal or square wave) that maximizes power to the tissue at each cycle. If the generator circuit contains a circuit topology that allows the RF and ultrasonic signals to be driven simultaneously, then the generator circuit will be loaded when driving the RF and ultrasonic signals simultaneously. It is possible to provide a waveform (s) that are synchronized to maximize the power delivered and to maintain the ultrasonic frequency lock. In addition, custom waveforms specific to the instrument and its tissue effects can be stored in non-volatile memory (NVM) or in the EEPROM of the instrument, and any one of the surgical instruments of the surgical system 1000 is generated in the generator circuit. Can be fetched when connecting to.

The DDS circuit 4200 may include a plurality of look-up tables 4104, and the look-up table 4210 stores a waveform represented by a predetermined number of phase points (sometimes called a sample), and the phase points are predetermined waveforms. Define the shape of. Therefore, a plurality of waveforms having a unique shape can be stored in a plurality of look-up tables 4210 to provide various tissue treatments based on instrument settings or tissue feedback. Examples of waveforms are high crested RF electrical signal waveforms for surface tissue coagulation, low crested RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. Can be mentioned. In one aspect, the DDS circuit 4200 can create multiple waveform look-up tables 4210 as desired during tissue treatment procedures (eg, "on the fly" based on user or sensor inputs or in real time). Switching between the various waveforms stored in the various look-up tables 4210 can be made based on the tissue effect and / or tissue feedback of.

Therefore, switching between waveforms can be based on, for example, tissue impedance and other factors. In another aspect, the look-up table 4210 can store electrical signal waveforms (ie, trapezoidal or square waves) that are formed to maximize the power delivered into the tissue each cycle. In another aspect, the lookup table 4210 can store synchronized waveforms, so that when this waveform delivers RF and ultrasonic drive signals, it is among the surgical instruments of the surgical system 1000. Maximize power delivery by any one. In yet another aspect, the look-up table 4210 can store an electrical signal waveform that simultaneously drives ultrasonic and RF therapeutic and / or sub-therapeutic energy while maintaining a lock on the ultrasonic frequency. In general, the output waveform may be in the form of a sine wave, a cosine wave, a pulse wave, a square wave, or the like. Nevertheless, more complex custom waveforms specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory of the surgical instrument (eg EEPROM). It can also be fetched when connecting surgical instruments to the generator circuit. An example of a custom waveform is an exponentially decaying sinusoidal waveform used in many high wave height "solidification" waveforms, as shown in FIG.

FIG. 43 shows one cycle of the discrete-time digital electrical signal waveform 4300 according to at least one aspect of the present disclosure of the analog waveform 4304 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison purposes). The horizontal axis represents time (t) and the vertical axis represents digital phase points. The digital-electric signal waveform 4300 is, for example, a digital discrete-time version of the desired analog waveform 4304. Digital electrical signal waveform 4300, representing the amplitude of each clock cycle _{T L} over one cycle or period _{T o,} is generated by storing the amplitude and phase point 4302. Digital electrical signal waveform 4300, by any suitable digital processing circuitry, is generated over one period T _o. The amplitude phase point is a digital word stored in the memory circuit. In the embodiment shown in FIGS. 41 and 42, the digital word is a 6-bit word capable of storing amplitude phase points with a resolution of 26 or 64 bits. It will be appreciated that the examples shown in FIGS. 41 and 42 are for illustration purposes and the resolution can be much higher in a practical implementation. Digital amplitude phase point 4302 over one cycle _{T o} is, for example, as described with respect to FIGS. 41 and 42, are stored in memory as a string of a string word in the look-up table 4104,4210. Also Figure 41, as described with respect to FIG. 42, in order to generate an analog waveform 4304 of the analog version, amplitude phase point 4302 is read sequentially from memory at 0 to T _o for each clock cycle _{T clk,} And it is converted by DAC circuits 4108 and 4212. Additional cycles may be generated by reading in desired and may 0~T over cycle or period of only _o, repeated amplitude phase point 4302 of the digital electric signal waveform 4300. The smooth analog version of the analog waveform 4304 is achieved by filtering the output of DAC circuits 4108, 4212 with filters 4112, 4214 (FIGS. 41 and 42). The filtered analog output signals 4114, 4222 (FIGS. 41 and 42) are applied to the input of the power amplifier.

FIG. 44 provides a gradual closure of the closing member (eg, closing tube) when the displacement member advances distally and is connected to a clamp arm (eg, anvil) according to one aspect of the present disclosure. FIG. 5 is a diagram of a control system 12950 configured to reduce the closing force load on the closing member at a desired rate and reduce the firing force load on the launching member. In one aspect, the control system 12950 may be implemented as a nested PID feedback controller. The PID controller is a control loop feedback mechanism (controller) for continuously calculating the error value as the difference between the desired set point and the measured process variable, and is a proportional, integral, and derivative term (P, respectively). , I, and D). The nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12965. The primary controller 12952 may be the PID controller 12972 as shown in FIG. 45, and the secondary controller 12955 may also be the PID controller 12972 as shown in FIG. 45. The primary controller 12952 controls the primary process 12985 and the secondary controller 12955 controls the secondary process 12960. The output 12966 of the primary process 12985 is subtracted from the primary set value SPi by the first adder 12962. The first adder 12962 produces a single sum output signal applied to the primary controller 12952. The output of the primary controller 12952 is the secondary setting point SP ₂ . The output 12966 of the secondary process 12960 is subtracted from the _{secondary set point SP 2 by the second adder 12964.}

In the situation of controlling the displacement of the closing tube, the control system 12950 receives the closing force from the torque sensor connected to the output of the closing motor, with the primary set value SPi being the desired closing force value and the primary controller 12952. It may be configured to determine the motor speed of the closed motor set value SP _2. In other embodiments, the closing force can be measured with a strain gauge, load cell, or other suitable force sensor. The closed motor speed set value SP ₂ is compared with the actual speed of the closed tube as determined by the secondary controller 12955. The actual velocity of the closed tube can be measured by comparing the measurement of the displacement of the closed tube with a position sensor to the measurement of the elapsed time with a timer / counter. Other techniques, such as linear encoders or rotary encoders, can be used to measure the displacement of the closed tube. The output 12868 of the secondary process 12960 is the actual speed of the closed tube. This closed tube velocity output 12868 is provided to the primary process 12985, which determines the force acting on the closed tube, and is fed back to the adder 12962, which subtracts the _{measured closing force from the primary set value SP 1.} The primary set value SP ₁ may be an upper threshold value or a lower limit threshold value. Based on the output of the adder 12962, the primary controller 12952 controls the speed and direction of the closed motor. The secondary controller 12955 closes based on the actual velocity of the closed tube measured by the secondary process 12960 and the secondary set value SP _{2 based on the comparison of the actual firing force with the upper and lower thresholds of the firing force.} Control the speed of the motor.

FIG. 45 illustrates a PID feedback control system 12970 according to an aspect of the present disclosure. The primary controller 12952, the secondary controller 12955, or both may be implemented as the PID controller 12972. In one aspect, the PID controller 12972 may include a proportional element 12974 (P), an integrating element 12996 (I), and a differential element 12978 (D). The outputs of the P element 12974, the I element 12976, and the D element 12978 are added by the adder 12986, which provides the control variable μ (t) to process 12980. The output of process 12980 is the process variable y (t). The adder 12984 calculates the difference between the desired set value r (t) and the measured process variable y (t). The PID controller 12972 sets the error value e (eg, the closing force threshold) as the difference between the desired set point r (t) and the measured process variable y (t) (eg, the velocity and direction of the closing tube). t) (eg, the difference between the closing force threshold and the measured closing force) is continuously calculated and calculated by the proportional element 12974 (P), the integrating element 12996 (I), and the differential element 12978 (D), respectively. Apply corrections based on proportional, integral, and derivative terms. The PID controller 12972 attempts to minimize the error e (t) over time by adjusting the control variable μ (t) (eg, velocity and direction of the closed tube).

According to the PID algorithm, the "P" element 12974 causes the current value of the error. For example, when the error is large and positive, the control output is also large and positive. According to the present disclosure, the error term eft differs between the desired closing force of the closed tube and the measured closing force. The "I" element 12976 causes a historical value of error. For example, if the current output is not strong enough, the error integral accumulates over time and the controller responds by applying stronger motion. The "D" element 12978 is responsible for future trends in possible error, based on its current rate of change. For example, returning to the example of P above, if a large positive control output succeeds in bringing the error close to zero, it also puts the process on the path to a large negative error in the near future. In this case, the derivative becomes negative and the D module reduces the strength of motion to prevent this overshoot.

It will be appreciated that other variables and setpoints may be monitored and controlled according to the feedback control system 12950, 12970. For example, the adaptive closure member velocity control algorithms described herein include, among other things, the parameters of launch member stroke position, launch member load, cutting element displacement, cutting element velocity, closure tube stroke position, closure tube load. At least two of them can be measured.

Various aspects are intended for improved ultrasonic surgical equipment, electrosurgical equipment, and generators for use with them. Aspects of ultrasonic surgical devices can be configured, for example, to transversely incis and / or coagulate tissue during a surgical procedure. Aspects of electrosurgical devices can be configured, for example, to transversely incis, coagulate, scale, weld and / or dry tissue during a surgical procedure.

The generator aspect uses fast analog-digital sampling of the generator drive signal current and voltage (eg, oversampling about 200x depending on the frequency) along with digital signal processing, and has many advantages over known generator structures. And provide benefits. In one aspect, the generator may determine the operating branch current of the ultrasonic transducer, for example, based on current and voltage feedback data, the capacitance value of the ultrasonic transducer, and the drive signal frequency value. This provides the benefit of a substantially tuned system and simulates the presence of a system that is tuned or resonates with any value of capacitance (eg, CO in FIG. 4) at any frequency. .. Therefore, control of the operating branch current can be achieved by tune out the capacitance effect without the need for a regulating inductor. In addition, the elimination of the regulating inductor may not impair the frequency fixing capability of the generator, as frequency fixing can be achieved by appropriately processing the current and voltage feedback data.

Fast analog-digital sampling of generator drive signal currents and voltages with digital signal processing can also allow accurate digital filtering of samples. For example, a generator aspect uses a low-pass digital filter (eg, a finite impulse response (FIR) filter) that rolls off between the fundamental drive signal frequency and the second harmonic of the current and voltage feedback sample. Asymmetric harmonic distortion and EMI induction noise may be reduced. The filtered current and voltage feedback samples effectively represent the fundamental drive signal frequency, thus allowing for more accurate impedance phase measurements with respect to the fundamental drive signal frequency and an improvement in the generator's ability to maintain a fixed resonant frequency. To. The accuracy of the impedance phase measurement can be further improved by averaging the falling edge and rising edge phase measurements and adjusting the measured impedance phase to 0 °.

Various aspects of the generator can also use high-speed analog-digital sampling of the generator drive signal current and voltage, along with digital signal processing, to determine actual power consumption and other quantities with high accuracy. This is useful in many ways, such as controlling the amount of power that the generator supplies to the tissue as the tissue impedance changes, and controlling the power supply to maintain a constant rate of increase in tissue impedance. It may be possible to execute various algorithms. Some of these algorithms are used to determine the phase difference between the generator drive signal current and the voltage signal. At resonance, the phase difference between the current signal and the voltage signal is zero. The phase changes when the ultrasonic system goes off-resonance. Various algorithms may be used to detect the phase difference and adjust the drive frequency until the ultrasonic system returns to resonance, i.e., the phase difference between the current and voltage signals is zero. The phase information may also be used to estimate the state of the ultrasonic blade. In particular, as described in detail below, the phase changes as a function of the temperature of the ultrasonic blade. Therefore, the phase information may be used to control the temperature of the ultrasonic blade. This, for example, reduces the power delivered to the ultrasonic blade when the ultrasonic blade is operating at an excessively high temperature, and delivers it to the ultrasonic blade when the ultrasonic blade is operating at an excessively low temperature. It can be done by increasing the power generated.

Various aspects of the generator may have a wide frequency range and increased output power required to drive both ultrasonic and electrosurgical devices. The lower voltage, higher current demands of electrosurgical equipment may be met by dedicated taps on wideband power transformers, thus eliminating the need for separate power amplifiers and output transducers. In addition, the generator sensing and feedback circuitry can support a large dynamic range to meet the needs of both minimal distortion ultrasound and electrosurgical applications.

Various aspects are known by the generator being a data circuit (eg, trade name "1-Wire") placed within the instrument attached to the handpiece using an existing multi-conductor generator / handpiece cable. It may provide a simple and economical means for reading from and optionally writing to a single wire bus device, such as a 1-wire protocol EEPROM. In this way, the generator can read and process data specific to the device from the device attached to the handpiece. This may allow the generator to provide better control and improved diagnostic and error detection. In addition, the ability of the generator to write data to the instrument gives rise to possible new functionality, for example, in tracking instrument use and capturing motion data. In addition, the use of frequency bands allows backward compatibility of equipment, including the bus equipment of existing generators.

The disclosed aspects of the generator provide active elimination of leakage current caused by unintended capacitive coupling between the generator's non-insulated circuit and the patient's insulated circuit. In addition to reducing patient risk, reducing leakage current can also reduce electromagnetic radiation. These and other benefits of aspects of this disclosure will be apparent from the statements below.

It will be appreciated that the terms "proximal" and "distal" are used herein in accordance with the clinician holding the handpiece. Therefore, the end effector is distal to the more proximal handpiece. Further, for convenience and clarity, it is understood that spatial terms such as "upper" and "lower" can also be used herein with reference to the clinician holding the handpiece. However, surgical devices are used in many orientations and positions, and these terms are not intended to be limited and absolute.

FIG. 46 shows, according to one aspect of the present disclosure, for modular handheld ultrasound surgery, in which the left shell half is removed from the handle assembly 6482 to expose the device identifier communicatively coupled to the multi-reed handle terminal assembly. It is an elevation exploded view of the instrument 6480. In an additional aspect of the disclosure, an intelligent or smart battery is used to energize a modular handheld ultrasonic surgical instrument 6480. However, smart batteries are not limited to modular handheld ultrasonic surgical instruments 6480 and may or may not have different power requirements (eg, current and voltage) as described below. It can be used in various devices. The smart battery assembly 6486 according to one aspect of the present disclosure can advantageously identify specific devices that are electrically connected. This is done by an encrypted or unencrypted identification method. For example, the smart battery assembly 6486 may have a connection portion such as a connection portion 6488. The handle assembly 6482 may also be communicably coupled to the multi-reed handle terminal assembly 6491 and provided with a device identifier capable of communicating at least one piece of information about the handle assembly 6482. This information includes the number of times the handle assembly 6482 was used, the number of times the ultrasonic transducer / generator assembly 6484 (currently disconnected from the handle assembly 6482) was used, and the waveguide shaft assembly 6490 (currently the handle assembly). Number of times (Connected to 6482) was used, Type of waveguide shaft assembly 6490 currently connected to handle assembly 6482, Type of ultrasonic transducer / generator assembly 6484 currently connected to handle assembly 6482 Or it may be related to identifying information and / or many other properties. When the smart battery assembly 6486 is inserted into the handle assembly 6482, the connecting portion 6488 within the smart battery assembly 6486 communicates with the device identifier of the handle assembly 6482. The handle assembly 6482 can transmit information to the smart battery assembly 6486 via hardware, software, or a combination thereof (either by self-launch or in response to a request from the smart battery assembly 6486). This communicated identifier is received by the connecting portion 6488 of the smart battery assembly 6486. In one aspect, once the smart battery assembly 6486 receives the information, the communication portion can control the output of the smart battery assembly 6486 and operate to comply with the specific power requirements of the device.

In one aspect, the communication portion includes a processor 6493 and a memory 6497, which can be separate or single components. Processor 6493, in combination with memory, can provide intelligent power management for modular handheld ultrasonic surgical instruments 6480. This embodiment is particularly advantageous because ultrasonic devices such as the modular handheld ultrasonic surgical instrument 6480 have power requirements (frequency, current and voltage) that can be unique to the modular handheld ultrasonic surgical instrument 6480. .. In fact, the modular handheld ultrasonic surgical instrument 6480 has a specific power requirement or limitation for one dimension or type of outer tube 6494, as well as a second type of waveguide having different dimensions, shapes and / or configurations. Can have a second different power requirement for.

Therefore, the smart battery assembly 6486 according to at least one aspect of the present disclosure allows the battery assembly to be used among several surgical instruments. Since the smart battery assembly 6486 can identify the device to which it is attached and can change its output accordingly, operators of various different surgical instruments utilizing the smart battery assembly 6486 can use it. You no longer have to worry about which power source you are trying to install in the electronics used. This is especially advantageous in operating environments where the battery assembly needs to be replaced or replaced with another surgical instrument during a complex surgical procedure.

In a further aspect of the present disclosure, the smart battery assembly 6486 stores a record in memory 6497 each time a particular device is used. This record can be useful for assessing the useful or permissible end of life of the device. For example, if a device has been used 20 times, it is defined as a "no more reliable" surgical instrument, so such batteries in the smart battery assembly 6486 connected to this device are this device. Refuse to power. Reliability is determined on the basis of many factors. One factor can be wear, which can be estimated in many ways, including the number of times the device has been used or activated. After a certain number of uses, the parts of the device may wear out and exceed the tolerances between the parts. For example, the smart battery assembly 6486 can sense the number of button presses received by the handle assembly 6482 and determine when the maximum number of button presses has been reached or exceeded. The smart battery assembly 6486 can also monitor the impedance of the button mechanism, which can change, for example, if the handle is contaminated with, for example, salt water.

This wear can lead to unacceptable failure during the procedure. In some aspects, the smart battery assembly 6486 can recognize which parts are integrally combined in the device and even how many times the parts have been used. For example, if the smart battery assembly 6486 is a smart battery according to the present disclosure, the handle assembly 6482, waveguide shaft assembly 6490, and ultrasonic transducer / generator assembly 6484 are identified long before the user attempts to use the composite device. can do. The memory 6497 in the smart battery assembly 6486 can record, for example, the time the ultrasonic transducer / generator assembly 6484 has been operating, as well as how, when, and for how long it has been operating. it can. If the ultrasonic transducer / generator assembly 6484 has an individual identifier, the smart battery assembly 6486 tracks the use of the ultrasonic transducer / generator assembly 6484, and once the handle assembly 6482 or the ultrasonic transducer / generator assembly 6484 If the maximum number of uses is exceeded, the power supply to the ultrasonic transducer / generator assembly 6484 can be cut off. The ultrasonic transducer / generator assembly 6484, handle assembly 6482, waveguide shaft assembly 6490, or other component may include a memory chip that records this information as well. In this way, any number of smart batteries in the smart battery assembly 6486 can be used with any number of ultrasonic transducer / generator assemblies 6484, staplers, vascular sealers, etc. and still ultrasonic transducers / generators. The total number of uses of the transducer assembly 6484, stapler, vascular sealer, etc., or the total usage time (through the use of the clock), the total number of operations, etc., or the charge or discharge cycle can be determined. The smart function may reside outside the battery assembly 6486, for example, within the handle assembly 6482, the ultrasonic transducer / generator assembly 6484, and / or the shaft assembly 6490.

When counting the use of the ultrasonic transducer / generator assembly 6484 and intelligently ending the life of the ultrasonic transducer / generator assembly 6484, the surgical instrument is the actual ultrasonic transducer / generator assembly 6484 in the surgical procedure. Accurately distinguish between the completion of use of the ultrasonic transducer / generator assembly 6484, for example due to a temporary delay in battery replacement or surgical procedure. Therefore, as an alternative to easily count the number of activations of the ultrasonic transducer / generator assembly 6484, a real-time clock (RTC) circuit is implemented for the time when the ultrasonic transducer / generator assembly 6484 was actually shut down. The amount can be tracked. From the length of time measured, was the shutdown significant enough to be considered an actual single-use end, or was the shutdown too short to be considered a single-use end? Can be determined by an appropriate theory. Thus, in some applications, this method should indicate, for example, that if 10 "activations" occur during a surgical procedure, 10 activations should indicate that the counter is incremented by one. The useful life of the ultrasonic transducer / generator assembly 6484 can be determined more accurately than a simple "startup based" algorithm. In general, this type of internal clocking and system prevents misuse of equipment designed to deceive simple "startup-based" algorithms, and is required for good reason ultrasonic transducer / generator assembly 6484 or Prevents accidental logging as completed use if only a simple disconnection of the smart battery assembly 6486 was present.

The ultrasonic transducer / generator assembly 6484 of the surgical instrument 6480 is reusable, but in one aspect, a finite number of uses is set because the surgical instrument 6480 is exposed to harsh conditions during cleaning and sterilization. May be done. More specifically, the battery pack is configured to be sterilized. Regardless of the material used for the outer surface, there is a limited expected life for the actual material used. This lifetime is determined by a variety of properties that can include, for example, the amount of time the pack was actually sterilized, the time since the pack was manufactured, and the number of times the pack was refilled, to name a few. To. In addition, the life of the battery cell itself is finite. The software of the present invention validates the number of uses of the ultrasonic transducer / generator assembly 6484 and the smart battery assembly 6486 and disables the device when this number of uses is reached or exceeded. Is incorporated. Analysis of the outside of the battery pack can be performed in each of the possible sterilization methods. Based on the most demanding sterilization procedure, the maximum number of sterilizations allowed can be defined and that number can be stored in the memory of the smart battery assembly 6486. If the charger is non-sterile and the smart battery assembly 6486 is assumed to be used after its charging, the charge count can be defined as equal to the number of sterilizations encountered by a particular pack.

In one aspect, the hardware in the battery pack can be disabled to minimize or eliminate safety concerns due to continuous drainage from the battery cells after the pack has been disabled by software. There may be situations where the internal hardware of the battery is unable to disable the battery under certain low voltage conditions. In such situations, in one aspect, a charger can be used to "stop" the battery. Due to the fact that the battery microcontroller is off while the battery is in its charger, it uses a non-volatile system management bus (SMB) based electrically erasable programmable read-only memory (EEPROM). Information can be exchanged between the battery microcontroller and the charger. Therefore, a series of EEPROMs can be used to store writable and readable information even when the battery microcontroller is off, which is very important when trying to exchange information with a charger or other peripherals. It is beneficial to. The EEPROM of this example is at least (a) the usage count limit at the time the battery should be disabled (battery usage count), and (b) the number of procedures the battery experiences (battery usage count), to name just a few. And / or (c) may be configured to include sufficient memory registers to store the number of charges (charge count) experienced by the battery. Some of the information stored in the EEPROM, such as the usage count register and the charge count register, is stored in the write-protected portion of the EEPROM to prevent the user from modifying the information. In one aspect, the use and counter are stored with the corresponding bit inverting small registers to detect data corruption.

Any residual voltage in the SMBus line can damage the microcontroller and destroy the SMBus signal. Therefore, a relay is provided between the external SMBus line and the battery microcontroller substrate to ensure that the SMBus line of the battery controller does not carry voltage while the microcontroller is off.

During charging of the smart battery assembly 6486, for example, when using a constant current / constant voltage charging scheme, if the inflow of current into the battery gradually falls below a given threshold, the battery in the smart battery assembly 6486 will be "charged". The "finished" state is determined. To accurately detect this "end of charge" state, the battery microcontroller and back board can be powered down and turned off during battery charging, which can be triggered by the board and interfere with tapering current detection. Reduce the current drain of the. In addition, the microcontroller and backboard are powered down during charging to prevent the resulting destruction of any SMBus signals.

With respect to the charger, in one aspect, the smart battery assembly 6486 is prevented from being inserted into the charger in any way other than the correct insertion position. Therefore, a mechanism for holding the charger is provided outside the smart battery assembly 6486. The cup to securely hold the smart battery assembly 6486 inside the charger matches the contour to prevent the smart battery assembly 6486 from being accidentally inserted in any way other than the correct (intended) way. It is composed of a tapered shape. It is further expected that the presence of the smart battery assembly 6486 may be detectable by the charger itself. For example, the charger may be configured to detect the presence of SMBus transmission from the battery protection circuit, as well as registers located within the protection board. In such cases, the charger will be able to control the voltage exposed at the charger pins until the smart battery assembly 6486 is properly seated or placed in place on the charger. This is because the exposure voltage at the pins of the charger indicates the danger and risk of an electrical short circuit across the pins and the charger unintentionally starting charging.

In some embodiments, the smart battery assembly 6486 can communicate with the user through audio and / or visual feedback. For example, the smart battery assembly 6486 can turn on the LEDs in a preset way. In such a case, even if the microcontroller in the ultrasonic transducer / generator assembly 6484 controls the LED, the microcontroller directly receives the instructions executed from the smart battery assembly 6486.

In yet a further aspect of the present disclosure, the microcontroller in the ultrasonic transducer / generator assembly 6484 goes into sleep mode when not in use for a predetermined period of time. Advantageously, when in sleep mode, the clock speed of the microcontroller is reduced and the current drain is significantly reduced. The processor continues to ping and waits to sense the input, so some current continues to be consumed. Advantageously, when the microcontroller is in this power saving sleep mode, the microcontroller and battery controller can directly control the LEDs. For example, a decoder circuit may be built into the ultrasonic transducer / generator assembly 6484 and connected to a communication line, thereby while the microcontroller of the ultrasonic transducer / generator assembly 6484 is in "off" or "sleep mode". , LEDs can be controlled independently by processor 6493. This is a power saving mechanism that eliminates the need to activate the microcontroller in the ultrasonic transducer / generator assembly 6484. Power is still conserved by turning off the generator while still actively controlling the user interface indicators.

Another aspect is to slow down one or more of the microcontrollers to save power when not in use. For example, the clock frequencies of both microcontrollers can be reduced to save power. To maintain synchronous operation, the microcontroller adjusts for both changes in each clock frequency that occur at about the same time, a reduction when full-speed operation is required, and then an increase in frequency thereafter. For example, when entering idle mode, the clock frequency decreases, and when exiting idle mode, the frequency increases.

In an additional aspect, the smart battery assembly 6486 can determine the amount of available power remaining in its cell and has sufficient battery power to operate the device as expected throughout the expected procedure. It is programmed to operate the attached surgical instrument only if it determines that it remains. For example, the smart battery assembly 6486 can remain inactive if there is not enough power in the cell to operate the surgical instrument for 20 seconds. According to one aspect, the smart battery assembly 6486 determines the amount of power remaining in the cell at the end of its recent preceding function, eg surgical cutting. In this aspect, therefore, the smart battery assembly 6486 does not allow subsequent functions to be performed, for example, if the cell determines to be underpowered during the procedure. Alternatively, if the smart battery assembly 6486 determines that there is sufficient power for the subsequent procedure during and below that threshold, it will complete the ongoing procedure without interruption. , Prevents additional procedures from occurring afterwards.

The following describes the benefits of maximizing the use of devices with the smart battery assembly 6486 of the present disclosure. In this example, different sets of devices have different ultrasonic transmission waveguides. By definition, a waveguide may have its own maximum permissible power limit, beyond which it overstresses the waveguide and eventually breaks it. One waveguide from a set of waveguides inherently has a minimum maximum power tolerance. Because prior art batteries lack intelligent battery power management, the output of prior art batteries is the smallest / thinnest / most fragile waveguide of a set intended to be used with equipment / batteries. It must be limited by the minimum value of the maximum allowable power input for the tube. This is true even though a larger and thicker waveguide is later attached to its handle, allowing greater force to be applied by definition. This limitation is also true for maximum battery power. For example, if a battery is designed to be used in multiple devices, its maximum output power is limited to the minimum and maximum power ratings of any of the devices in which it is used. With such a configuration, one or more devices or device configurations cannot maximize battery use because the battery is unaware of the particular limitations of a particular device.

In one aspect, the smart battery assembly 6486 can be used to intelligently circumvent the limitations of the ultrasonic device described above. The smart battery assembly 6486 can generate one output for one device or specific device configuration, and the same smart battery assembly 6486 will later produce different outputs for a second device or device configuration. be able to. This universal smart battery surgery system is suitable for modern operating rooms where space and time are important. By operating many different devices on smart battery packs, nurses can easily manage the storage, retrieval and inventory of these packs. Advantageously, in one aspect, the smart battery according to the present disclosure can use one type of charging station, thus increasing ease of use and efficiency and reducing the cost of operating room charging equipment.

In addition, other surgical instruments, such as electric staplers, may have different power requirements than those of the modular handheld ultrasonic surgical instrument 6480. According to various aspects of the disclosure, the smart battery assembly 6486 can be used with any one of a series of surgical instruments and is powered by itself for the particular device in which it is installed. Can be manufactured to regulate output. In one aspect, this power regulation is a switch such as a back, back boost, boost, or other configuration that is integrated with or otherwise coupled to the smart battery assembly 6486 and controlled by the smart battery assembly 6486. It is carried out by controlling the duty cycle of the mode power supply. In another aspect, the smart battery assembly 6486 can dynamically change its power output during device operation. For example, in a vascular encapsulation device, power management provides improved tissue encapsulation. These devices require a large constant current value. When the tissue is sealed, its impedance changes and the total power output needs to be dynamically adjusted. Aspects of the present disclosure provide a variable maximum current limit for the smart battery assembly 6486. Current limits may vary from application to application (or device) based on the requirements of the application or device.

FIG. 47 is a detailed view of the trigger 6843 portion and switch of the ultrasonic surgical instrument 6480 shown in FIG. 46 according to at least one aspect of the present disclosure. The trigger 6483 is operably coupled to the jaw member 6495 of the end effector 6492. The ultrasonic blade 6494 is energized by the ultrasonic transducer / generator assembly 6484 when the start switch 6485 is activated. With reference to FIG. 46 and also with reference to FIG. 47, the trigger 6483 and the start switch 6485 are shown as components of the handle assembly 6482. The trigger 6843 activates the end effector 6492, which has a collaborative relationship with the ultrasonic blade 6494 of the waveguide shaft assembly 6490, and various types of end effector jaw member 6495 and ultrasonic blade 6494 with tissue and / or other materials. Allows contact. The jaw member 6495 of the end effector 6492 is usually a pivot jaw that acts to grip or clamp the tissue disposed between the jaw and the ultrasonic blade 6494. In one aspect, audible feedback is provided within the trigger that clicks when the trigger is fully pressed. Noise can be generated by thin metal parts that snap as the trigger closes. This feature informs the user that the jaws are completely compressed against the waveguide and that sufficient clamping pressure is applied to achieve vascular sealing of the audible component. Add to user feedback. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the trigger 6483 to measure the force applied to the trigger 6483 by the user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch 6485 button so that the displacement strength corresponds to the force applied by the user to the switch 6485 button.

When pressed, the activation switch 6485 puts the modular handheld ultrasonic surgical instrument 6480 into ultrasonic operating mode, causing the waveguide shaft assembly 6490 to undergo ultrasonic motion. In one aspect, pressing the start switch 6485 closes the electrical contacts in the switch, thereby completing the circuit between the smart battery assembly 6486 and the ultrasonic transducer / generator assembly 6484, as described above. Power is applied to the transducer. In another aspect, pressing the start switch 6485 closes the electrical contacts to the smart battery assembly 6486. As a matter of course, the description of closing the electrical contacts in the circuit is merely an exemplary general description of switch operation. There are many alternative embodiments that can include open contacts or processor-controlled power delivery that receives information from a switch and directs the corresponding circuit response based on that information.

FIG. 48 is a fragmentary enlarged perspective view of the end effector 6492 from the distal end with the jaw member 6495 in the open position, according to at least one aspect of the present disclosure. Referring to FIG. 48, a perspective view of the distal end 6498 of the waveguide shaft assembly 6490 is shown. The waveguide shaft assembly 6490 includes an outer tube 6494 that surrounds a portion of the waveguide. The ultrasonic blade 6494 portion of the waveguide 6499 projects from the distal end 6498 of the outer tube 6494. This is the ultrasonic blade 6494 portion that contacts the tissue during a medical procedure and transfers its ultrasonic energy to the tissue. The waveguide shaft assembly 6490 also includes a jaw member 6495 connected to an outer tube 6494 and an inner tube (not visible in this figure). The jaw member 6495, along with the inner and outer tubes, and the ultrasonic blade 6494 portion of the waveguide 6499, may be referred to as an end effector 6492. As described below, the outer tube 6494 and the inner tube (not shown) slide longitudinally relative to each other. When relative movement between the outer tube 6494 and the inner tube (not shown) occurs, the jaw member 6495 turns on a fixed point, thereby opening and closing the jaw member 6495. When closed, the jaw member 6495 exerts a pinching force on the tissue located between the jaw member 6495 and the ultrasonic blade 6494 to ensure positive and efficient blade-tissue contact.

FIG. 49 is a system diagram 7400 of a segmented circuit 7401 with a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 according to at least one aspect of the present disclosure. The circuit segment of the plurality of circuit segments of the segmented circuit 7401 is a set of one or more circuits and one or more machine-executable instructions stored in one or more memory devices. And, including. One or more circuits in a circuit segment are connected for telecommunications through one or more wired or wireless connection media. The plurality of circuit segments are configured to transition between three modes, including sleep mode, standby mode and operation mode.

In one aspect shown, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 first start in standby mode, secondly enter sleep mode, and thirdly operate mode. Move to. However, in other embodiments, the plurality of circuit segments can transition from any one of the three modes to any other one of the three modes. For example, a plurality of circuit segments can directly transition from standby mode to operating mode. The individual circuit segments may be placed in a particular state by the voltage control circuit 7408 based on the processor execution of machine executable instructions. These states include a non-energized state, a low energy state and an energized state. The non-energized state corresponds to the sleep mode, the low energy state corresponds to the standby mode, and the energized state corresponds to the operation mode. The transition to the low energy state can be achieved, for example, by using a potentiometer.

In one aspect, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 can transition from sleep mode or standby mode to operation mode according to the energization sequence. The plurality of circuit segments can also transition from the operating mode to the standby mode or the sleep mode according to the non-energized sequence. The energized sequence and the non-energized sequence may be different. In some embodiments, the energization sequence comprises energizing only a subset of the circuit segments of the plurality of circuit segments. In some embodiments, the non-energized sequence comprises stopping energization of only a subset of the circuit segments of the plurality of circuit segments.

With reference to system FIG. 7400 of FIG. 49 again, the segmented circuit 7401 has a transition circuit segment 7402, a processor circuit segment 7414, a handle circuit segment 7416, a communication circuit segment 7420, a display circuit segment 7424, a motor control circuit segment 7428, and energy treatment. It comprises a plurality of circuit segments, including a circuit segment 7434 and a shaft circuit segment 7440. The transition circuit segment comprises a wakeup circuit 7404, a boost current circuit 7406, a voltage control circuit 7408, a safety controller 7410, and a POST controller 7412. Transitional circuit segment 7402 is configured to implement de-energized and energized sequences, safety detection protocols, and POST.

In some embodiments, the wakeup circuit 7404 includes an accelerometer button sensor 7405. In aspects, the transition circuit segment 7402 is configured to be energized, while the other circuit segments of the plurality of circuit segments of the segmented circuit 7401 are in a low energy state, non-energized state, or energized state. It is composed of. The accelerometer button sensor 7405 may monitor the movement or acceleration of the surgical instrument 6480 described herein. For example, the movement can be a change in orientation or rotation of the surgical instrument. The surgical instrument can be moved in any direction with respect to the three-dimensional Euclidean space, for example, by the user of the surgical instrument. When the accelerometer button sensor 7405 senses movement or acceleration, the accelerometer button sensor 7405 signals the voltage control circuit 7408 and causes the voltage control circuit 7408 to apply voltage to the processor circuit segment 7414 to provide the processor and volatile memory. To the energized state. In the embodiment, the processor and the volatile memory are energized before the voltage control circuit 7409 applies a voltage to the processor and the volatile memory. In operating mode, the processor can initiate an energized or de-energized sequence. In various aspects, the accelerometer button sensor 7405 can also signal the processor to initiate an energized or de-energized sequence. In some embodiments, the processor initiates an energization sequence when most of the individual circuit segments are in a low energy or non-energized state. In another aspect, the processor initiates a non-energized sequence when most of the individual circuit segments are energized.

Further or / or, the accelerometer button sensor 7405 can detect external movement within a predetermined neighborhood of the surgical instrument. For example, the accelerometer button sensor 7405 can sense the user of the surgical instrument 6480 described herein moving the user's hand within a predetermined neighborhood. When the accelerometer button sensor 7405 senses this external movement, the accelerometer button sensor 7405 can send a signal to the voltage control circuit 7408 and a signal to the processor, as described above. After receiving the transmitted signal, the processor can initiate an energized or de-energized sequence to shift one or more circuit segments between the three modes. In aspects, the signal sent to the voltage control circuit 7408 is sent to verify that the processor is in operating mode. In some embodiments, the accelerometer button sensor 7405 can sense when a surgical instrument has fallen and signal the processor based on the sensed fall. For example, the signal can indicate an error in the operation of individual circuit segments. One or more sensors can detect damage or malfunction of individual affected circuit segments. Based on the detected damage or malfunction, the POST controller 7412 can perform POST on the corresponding individual circuit segment.

The energized or de-energized sequence may be defined based on the accelerometer button sensor 7405. For example, the accelerometer button sensor 7405 can sense a particular motion or sequence of motions indicating the selection of a particular circuit segment for a plurality of circuit segments. Based on the sensed motion or series of sensed motions, the accelerometer button sensor 7405 gives indications for one or more of the circuit segments when the processor is energized. The including signal can be transmitted to the processor. Based on this signal, the processor determines an energization sequence that includes one or more selected circuit segments. Further or / or, the user of the surgical instrument 6480 described herein chooses the number and order of circuit segments and uses an energization sequence or based on interaction with the surgical instrument's graphical user interface (GUI). A non-energized sequence can be defined.

In various embodiments, the accelerometer button sensor 7405 detects when the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein, or external movement within a predetermined neighborhood above a predetermined threshold. Can only send a signal to the voltage control circuit 7408 and a signal to the processor. For example, a signal can only be sent if the movement is detected for more than 5 seconds, or if the surgical instrument has been moved more than 5 inches. In another aspect, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and the processor only when the accelerometer button sensor 7405 detects the vibrational movement of the surgical instrument. .. Predetermined thresholds reduce inadvertent transitions in the circuit segments of surgical instruments. As described above, the transition can include a transition to an operating mode following an energized sequence, a transition to a low energy mode following a non-energized sequence, or a transition to a sleep mode following a non-energized sequence. In some embodiments, the surgical instrument comprises an actuator that can be actuated by the user of the surgical instrument. This operation is sensed by the accelerometer button sensor 7405. The actuator may be a slider, a toggle switch, or an instantaneous contact switch. Based on the sensed operation, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and also the processor.

The boost current circuit 7406 is connected to the battery. The boost current circuit 7406 is a current amplifier such as a relay or transistor and is configured to amplify the magnitude of the current in each circuit segment. The initial magnitude of the current corresponds to the supply voltage provided by the battery to the segmented circuit 7401. Suitable relays include solenoids. Suitable transistors include field effect transistors (FETs), MOSFETs and bipolar junction transistors (BJTs). The boost current circuit 7406 can amplify the magnitude of the current corresponding to an individual circuit segment or circuit that requires more current draw during the operation of the surgical instrument 6480 described herein. For example, an increase in current with respect to the motor control circuit segment 7428 can be provided when the motor of the surgical instrument requires more input power. The increase in current provided to an individual circuit segment can cause a corresponding decrease in current in another circuit segment or multiple circuit segments. Further or / or the increase in current may correspond to the voltage provided by an additional voltage source operating with the battery.

The voltage control circuit 7408 is connected to the battery. The voltage control circuit 7408 is configured to provide or remove voltage from a plurality of circuit segments. The voltage control circuit 7408 is also configured to increase or decrease the voltage provided to the plurality of circuit segments of the segmented circuit 7401. In various aspects, the voltage control circuit 7408 comprises a combination logic circuit such as a multiplexer (MUX) that selects an input, a plurality of electronic switches, and a plurality of voltage converters. The electronic switch of the plurality of electronic switches may be configured to switch between an open configuration and a closed configuration to disconnect individual circuit segments from the battery or connect to the battery. The plurality of electronic switches may be solid-state devices such as transistors, or, among other things, other types of switches such as wireless switches, ultrasonic switches, accelerometers, inertial sensors and the like. Combination logic circuits are configured to select individual electronic switches to allow voltage application to the corresponding circuit segments by switching to an open configuration. Combination logic circuits are also configured to switch to a closed configuration and select individual electronic switches to allow the removal of voltage from the corresponding circuit segment. By selecting a plurality of individual electronic switches, the combinatorial logic circuit can implement a non-energized sequence or an energized sequence. The plurality of voltage converters can provide a boosted voltage or a bucked voltage to a plurality of circuit segments. The voltage control circuit 7408 may also include a microprocessor and a memory device.

The safety controller 7410 is configured to perform a safety check of the circuit segment. In some embodiments, the safety controller 7410 performs a safety check when one or more individual circuit segments are in operating mode. Safety checks may be performed to determine if there are any errors or defects in the function or operation of the circuit segment. The safety controller 7410 can monitor one or more parameters of a plurality of circuit segments. The safety controller 7410 can verify the identification information and operation of a plurality of circuit segments by comparing one or more parameters with the default parameters. For example, when the RF energy modality is selected, the safety controller 7410 verifies that the joint motion parameters of the shaft match the predetermined joint motion parameters of the surgical instrument 6480 described herein. The operation of the RF energy modality can be verified. In some embodiments, the safety controller 7410 may, by means of a sensor, monitor a predetermined relationship between one or more characteristics of the surgical instrument to detect a failure. Failure can occur when one or more properties do not match a given relationship. If the safety controller 7410 determines that there is a failure, an error, or the operation of some of the circuit segments has not been verified, the safety controller 7410 will fail the failure, error, or verification. Prevents or disables the operation of a particular circuit segment that occurs.

The POST controller 7412 performs POST to verify the proper operation of the plurality of circuit segments. In some embodiments, POST is an individual circuit of multiple circuit segments before the voltage control circuit 7408 applies voltage to the individual circuit segments to transition the individual circuit segments from standby or sleep mode to operating mode. Implemented for the segment. If individual circuit segments do not pass through POST, then no particular circuit segment transitions from standby or sleep mode to operating mode. The POST of the handle circuit segment 7416 may include, for example, testing whether the handle control sensor 7418 senses the operation of the handle control of the surgical instrument 6480 described herein. In some embodiments, the POST controller 7412 can signal the accelerometer button sensor 7405 to verify the operation of individual circuit segments as part of POST. For example, after receiving a signal, the accelerometer button sensor 7405 can prompt the user of the surgical instrument to move the surgical instrument to multiple different positions and check the operation of the surgical instrument. .. The accelerometer button sensor 7405 may also monitor the output of the circuit segment or the circuit of the circuit segment as part of the POST. For example, the accelerometer button sensor 7405 can sense the incremental motor pulse generated by the motor 7432 and verify its operation. The motor controller of the motor control circuit 7430 can be used to control the motor 7432 to generate incremental motor pulses.

In various aspects, the surgical instrument 6480 described herein may include an additional accelerometer button sensor. The POST controller 7412 may also execute a control program stored in the memory device of the voltage control circuit 7408. The control program can cause the POST controller 7412 to transmit signals requesting matching encryption parameters from a plurality of circuit segments. Failure to receive matching encryption parameters from individual circuit segments indicates to POST controller 7412 that the corresponding circuit segment is corrupted or malfunctioning. In some embodiments, if the POST controller 7412 determines that the processor is corrupted or malfunctioning based on POST, the POST controller 7412 signals one or more secondary processors, one. Alternatively, two or more secondary processors can be made to perform limit functions that the processor cannot perform. In some embodiments, if the POST controller 7412 determines that one or more circuit segments are not working properly based on POST, then the POST controller 7412 fails or properly POSTs. It is possible to start a low performance mode of a properly operating circuit segment while locking out a non-operating circuit segment. The locked out circuit segment can function in the same way as a circuit segment in standby mode or sleep mode.

Processor circuit segment 7414 includes a processor and volatile memory. The processor is configured to initiate an energized or de-energized sequence. To initiate an energization sequence, the processor sends an energization signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to apply voltage to a plurality of circuit segments or a subset of the circuit segments according to the energization sequence. To initiate a de-energized sequence, the processor sends a de-energized signal to the voltage control circuit 7408 to remove voltage from the voltage control circuit 7408 from multiple circuit segments or subsets of the circuit segments according to the de-energized sequence. Let me.

The handle circuit segment 7416 comprises a handle control sensor 7418. The handle control sensor 7418 may sense the operation of one or more handle controls of the surgical instrument 6480 described herein. In various aspects, one or more steering wheel controls include clamp control, release button, articulation switch, energy activation button, and / or any other suitable steering wheel control. The user can activate the energy activation button to select RF energy mode, ultrasonic energy mode, or a combination of RF energy mode and ultrasonic energy mode. The handle control sensor 7418 can also facilitate the attachment of modular handles to surgical instruments. For example, the handle control sensor 7418 can sense the proper attachment of the modular handle to the surgical instrument and indicate the perceived attachment to the user of the surgical instrument. The LCD display 7426 can provide a sensed mounting graphic display. In some embodiments, the steering wheel control sensor 7418 senses the activation of one or more steering wheel controls. Based on the sensed operation, the processor can initiate either an energized sequence or a non-energized sequence.

The communication circuit segment 7420 includes a communication circuit 7422. Communication circuit 7422 includes a communication interface for facilitating signal communication between individual circuit segments of a plurality of circuit segments. In some embodiments, the communication circuit 7422 provides a path for the modular components of the surgical instrument 6480 described herein for electrical communication. For example, when the module shaft and module transducer are integrally attached to the handle of a surgical instrument, the control program can be uploaded to the handle via the communication circuit 7422.

The display circuit segment 7424 comprises an LCD display 7426. The LCD display 7426 may include a liquid crystal display screen, an LED indicator, and the like. In some embodiments, the LCD display 7426 is an organic light emitting diode (OLED) screen. The display may be placed on, embedded, or remotely placed on the surgical instrument 6480 described herein. For example, the display may be placed on the handle of a surgical instrument.

The display is configured to provide sensory feedback to the user. In various aspects, the LCD display 7426 further comprises a backlight. In some embodiments, the surgical instrument can also include an audible feedback device such as a speaker or buzzer and a haptic feedback device such as a tactile actuator.

The motor control circuit segment 7428 comprises a motor control circuit 7430 coupled to the motor 7432. The motor 7432 is connected to the processor by transistors such as drivers and FETs. In various aspects, the motor control circuit 7430 includes a motor current sensor that signals and communicates with the processor to provide the processor with a signal indicating a measurement of the current draw of the motor. The processor sends a signal to the display. The display receives this signal and displays the measured value of the current draw of the motor 7432. The processor uses signals to monitor, for example, that the current draw of motor 7432 is within acceptable limits, compare the current draw with one or more parameters of multiple circuit segments, and patient. One or more parameters of the treatment site can be determined. In various aspects, the motor control circuit 7430 comprises a motor controller that controls the operation of the motor. For example, the motor control circuit 7430 controls various motor parameters, for example by adjusting the speed, torque, and acceleration of the motor 7432. This adjustment is based on the current through the motor 7432 measured by the motor current sensor.

In various aspects, the motor control circuit 7430 comprises a force sensor that measures the force and torque generated by the motor 7432. Motor 7432 is configured to activate the mechanism of the surgical instrument 6480 described herein. For example, the motor 7432 is configured to control the operation of the shaft of a surgical instrument to provide clamping, rotation, and joint motor functions. For example, the motor 7432 can actuate the shaft to provide a clamping motion with the jaws of the surgical instrument. The motor controller can determine whether the material clamped by the jaws is tissue or metal. The motor controller may also determine how much the jaw clamps the material. For example, the motor controller can determine the degree of opening and closing of the jaws based on the sensed motor current or derivative of the motor voltage. In some embodiments, the motor 7432 is configured to actuate the transducer to apply torque to the transducer or to control the joint movement of the surgical instrument. The motor current sensor can interact with the motor controller to set the motor current limit. If the current meets a predetermined threshold limit, the motor controller initiates a corresponding change in motor control operation. For example, when the motor current limit is exceeded, the motor controller reduces the current draw of the motor.

The energy treatment circuit segment 7434 includes an RF amplifier and safety circuit 7436, as well as an ultrasonic signal generator circuit 7438 to implement the energy module functionality of the surgical instruments 6480 described herein. In various aspects, the RF amplifier and safety circuit 7436 are configured to control the RF modality of the surgical instrument by generating an RF signal. The ultrasonic signal generator circuit 7438 is configured to control the ultrasonic energy modality by generating an ultrasonic signal. The RF amplifier and safety circuit 7436, as well as the ultrasonic signal generator circuit 7438, can jointly operate to control the combined RF and ultrasonic energy modality.

The shaft circuit segment 7440 comprises a shaft module controller 7442, a module control actuator 7444, one or more end effector sensors 7446, and a non-volatile memory 7448. The shaft module controller 7442 is configured to control a plurality of shaft modules, including a control program executed by the processor. Multiple shaft modules implement shaft modality such as ultrasound, combined ultrasound and RF, RF I-blades and RF facing jaws. The shaft module controller 7442 can select the shaft modality by selecting the corresponding shaft module executed by the processor. Modular control actuator 7444 is configured to actuate the shaft according to the selected shaft modality. After activation is initiated, the shaft articulates the end effectors according to one or more parameters, routines or programs specific to the selected shaft modality and the selected end effector modality. One or more end effector sensors 7446 located on the end effector may include a force sensor, a temperature sensor, a current sensor, or a motion sensor. The one or more end effector sensors 7446 transmit data about the operation of one or more end effectors based on the energy modality performed by the end effectors. In various aspects, the energy model comprises a combination of ultrasonic energy modality, RF energy modality or ultrasonic energy modality and RF energy modality. The non-volatile memory 7448 stores a shaft control program. The control program includes one or more shaft-specific parameters, routines or programs. In various embodiments, the non-volatile memory 7448 may be a ROM, EPROM, EEPROM, or flash memory. The non-volatile memory 7448 stores the shaft module corresponding to the selected shaft of the surgical instrument 6480 described herein. The shaft module may be modified or upgraded in the non-volatile memory 7448 by the shaft module controller 7442, depending on the surgical instrument shaft used during operation.

FIG. 50 is a schematic of a circuit 7925 of various components of a surgical instrument having a motor control function, according to at least one aspect of the present disclosure. In various aspects, the surgical instrument 6480 described herein is configured to drive a shaft and / or gear component to perform various movements associated with the surgical instrument 6480. The drive mechanism 7930 may be included. In one aspect, the drive mechanism 7930 includes, for example, a rotary drive train 7932 configured to rotate the end effector about a longitudinal axis with respect to the handle housing. The drive mechanism 7930 further includes a closed drive train 7934 configured to close the jaw member and grip the tissue with an end effector. Further, the drive mechanism 7930 includes a launch drive train 7936 configured to open and close the clamp arm portion of the end effector to grip the tissue with the end effector.

The drive mechanism 7930 includes a selector gearbox assembly 7938 that can be located within the handle assembly of the surgical instrument. Proximal to the selector gearbox assembly 7938, any second motor 7944 and motor drive circuit 7946 (second motor 7944 and motor) with one of the drive trains 7932, 7934, 7936 selectively positioned. Functions to selectively move the gear element within the selector gearbox assembly 7938 to engage with the input drive component (indicated by a broken line to indicate that the drive circuit 7946 is any component). , There is a function selection module including a first motor 7942.

With reference to FIG. 50, the motors 7942, 7944 are connected to the motor control circuits 7946, 7948, respectively, and the motor control circuits 7946, 7948 include the flow of electrical energy from the power supply 7950 to the motors 7942, 7944, respectively. It is configured to control the operation of the 7944. The power source 7950 may be a DC battery (eg, a rechargeable lead-based, nickel-based, lithium-ion-based battery, etc.) or any other power source suitable for providing electrical energy to surgical instruments.

Surgical instruments further include a microcontroller 7952 (“controller”). In certain examples, the controller 7952 may include a microprocessor 7954 (“processor”) and one or more computer-readable media or memory units 7965 (“memory”). In a particular example, memory 7965 may store various program instructions that, when executed, may cause processor 7954 to perform multiple functions and / or calculations described herein. it can. The power supply 7950 can be configured to, for example, supply power to the controller 7952.

Processor 7954 may communicate with motor control circuit 7946. Further, when the memory 7965 is executed by the processor 7954 in response to the user input 7985 or the feedback element 7960, the motor control circuit 7946 stimulates the motor 7942 to generate at least one rotational motion, the selector gearbox assembly 7938. The gear elements within can be selectively moved to selectively position one of the drive trains 7932, 7934, 7936 to engage the input drive component of the second motor 7944. Can store program instructions. Further, the processor 7954 may communicate with the motor control circuit 7948. The memory 7965 also causes the motor control circuit 7948 to stimulate the motor 7944 to generate at least one rotational motion when executed by the processor 7954 in response to user input 7985, eg, driving the input of a second motor 7948. It can store program instructions that can drive a drive train that is engaged with a component.

Controllers 7952 and / or other controllers of the present disclosure may be implemented using integrated and / or discrete hardware, software, and / or combinations of both. Examples of integrated hardware elements include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor elements, chips, microchips, chipsets, microcontrollers, system-on-a-chips. Chips (SoCs) and / or single inline packages (SIPs) can be mentioned. Examples of discrete hardware components may include circuits and / or circuit elements such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and / or relays. In certain examples, the controller 7952 may include, for example, a hybrid circuit having discrete and integrated circuit elements or components on one or more substrates.

In certain examples, the controller 7952 and / or other controller of the present disclosure may be, for example, the LM 4F230H5QR available from Texas Instruments. In certain examples, Texas Instruments' LM4F230H5QR improves performance over 40MHz, among other readily available characteristics, up to 40MHz, 256KB single-cycle flash memory or other non-volatile memory on-chip memory. Prefetch buffer, 32KB single-cycle SRAM, internal ROM with Non-volatile Memory® software, 2KB EEPROM, 1 or more PWM modules, 1 or 2 or more QEI analogs, 12 An ARM Cortex-M4F processor core that includes one or more 12-bit ADCs with analog input channels. Other microcontrollers can be readily substituted for use with this disclosure. Therefore, this disclosure should not be limited to this context.

In various examples, one or more of the various steps described herein can be performed by a finite state machine that includes either a combination logic circuit or an ordinal logic circuit. Alternatively, any of the sequential logic circuits is connected to at least one memory circuit. At least one memory circuit stores the current state of the finite state machine. The combination or order logic circuit is configured to provide a finite state machine for these steps. The sequential logic circuit may be synchronous or asynchronous. In other cases, one or more of the various steps described herein can be performed, for example, by a circuit that includes a combination of processor 7985 and a finite state machine.

In various cases, it may be advantageous to be able to assess the functional state of the surgical instrument to ensure proper functioning. For example, a drive mechanism configured to include various motors, drive trains and / or gear components to perform various movements of a surgical instrument, as described above, wears over time. Can be considered. This can occur through normal use, but in some cases the drive mechanism can wear faster due to overuse conditions. In certain examples, the surgical instrument can be configured to perform a self-assessment to determine the condition of the drive mechanism and its various components, eg, health.

For example, using self-diagnosis to determine if a surgical instrument is capable of performing its function prior to resterilization, or if some of its components should be replaced and / or repaired. Can be done. Evaluation of drive mechanisms and their components, including but not limited to rotary drive train 7932, closed drive train 7934, and / or launch drive train 7936, can be achieved in a variety of ways. The magnitude of the deviation from the predicted performance can be used to determine the likelihood of a detected failure and the severity of such failure. Several metrics may be used, including periodic analysis of repeatably predictable events, peaks or drops above the expected threshold and width of failure.

In various examples, one or more characteristic waveforms of a properly functioning drive mechanism or its components are used to create one or more states of the drive mechanism or its components. Can be evaluated. One or more vibration sensors may be placed with respect to one or more of the properly functioning drive mechanisms or components thereof and among the properly functioning drive mechanisms or components thereof. Various vibrations that occur during one or more operations can be recorded. The recorded vibrations can be used to generate characteristic waveforms. The state of the drive mechanism and its components can be evaluated by comparing future waveforms with characteristic waveforms.

Continuing with reference to FIG. 50, the surgical instrument 7930 was configured to record and analyze one or more of the drive trains 7932, 7934, 7936, one or more audible outputs. Includes drive train failure detection module 7962. Processor 7954 can communicate with module 7962 or can be controlled in other ways. As described in more detail below, module 7962 comprises a computer-readable medium (eg, memory 7965) that stores computer-readable program instructions that can be executed by a circuit, hardware, processor (eg, processor 7954). It can be embodied as various means such as computer program products, or some combinations thereof. In some embodiments, the processor 36 may include module 7962 or may be controlled in other ways.

Referring here to FIG. 51, the end effector 8400 includes RF data sensors 8406, 8408a, 8408b located on the jaw member 8402. The end effector 8400 includes a jaw member 8402 and an ultrasonic blade 8404. The jaw member 8402 is shown with the tissue 8410 located between the jaw member 8402 and the ultrasonic blade 8404 clamped. The first sensor 8406 is located at the center of the jaw member 8402. The second sensor 8408a and the third sensor 8408b are located on the outer portion of the jaw member 8402. The sensors 8406, 8408a, 8408b are attached to or integrally formed with a flexible circuit 8412 (more specifically shown in FIG. 52) configured to be fixedly attached to the jaw member 8402.

The end effector 8400 is an exemplary end effector for surgical instruments. The sensors 8406, 8408a, and 8408b are electrically connected to a control circuit such as the control circuit 7400 (FIG. 63) via an interface circuit. The sensors 8406, 8408a, 8408b are battery powered and the signals generated by the sensors 8406, 8408a, 8408b are provided to the analog and / or digital processing circuits of the control circuit.

In one aspect, the first sensor 8406 is a force sensor for measuring the normal force F3 applied to the tissue 8410 by the jaw member 8402. The second sensor 8408a and the third sensor 8408b apply RF energy to the tissue 8410 and, among other parameters, one or one for measuring tissue impedance, downward force F1, lateral force F2, and temperature. Contains two or more elements. Electrodes 8409a, 8409b are electrically connected to an energy source to apply RF energy to the tissue 8410. In one aspect, the first sensor 8406 and the second sensor 8408a and the third sensor 8408b are strain gauges for measuring force or force per unit area. It will be appreciated that the measurements of the downward force F1, the lateral force F2, and the normal force F3 can be easily converted to pressure by determining the surface area on which the force sensors 8406, 8408a, 8408b act. Further, as described in detail herein, the flexible circuit 8412 may include temperature sensors embedded in one or more layers of the flexible circuit 8412. The one or more temperature sensors may be arranged symmetrically or asymmetrically to provide temperature feedback of tissue 8410 to the control circuits of the ultrasonic drive circuit and the RF drive circuit.

FIG. 52 shows an aspect of the flexible circuit 8412 shown in FIG. 51 in which the sensors 8406, 8408a, 8408b can be attached to the flexible circuit 8412 or formed integrally with the flexible circuit 8412. The flexible circuit 8412 is configured to be fixedly attached to the jaw member 8402. As specifically shown in FIG. 52, the asymmetric temperature sensors 8414a, 8414b are attached to the flexible circuit 8412 to allow the temperature of the tissue 8410 (FIG. 51) to be measured.

FIG. 53 is an alternative system 132000 for controlling the frequency of the ultrasonic electromechanical system 132002 and detecting its impedance according to at least one aspect of the present disclosure. System 132000 may be incorporated into the generator. Processor 132 004 which is coupled to a memory 132 026 programs the programmable counter 132006, is tuned to the output frequency _{f o} of the ultrasound electromechanical systems 132,002. The input frequency is generated by the crystal oscillator 132008 and is input to the fixed counter 132010 to scale the frequency to a suitable value. The outputs of the fixed counter 132010 and the programmable counter 132006 are applied to the phase / frequency detector 132012. The output of the phase / frequency detector 132012 may be applied to the amplifier / active filter circuit 132014 generates a regulated voltage _{V t} that is applied to the voltage controlled oscillator 132016 (VCO). VCO132016 applies the output frequency _{f o} the modeled ultrasonic transducer portion of the ultrasound-electromechanical systems 132,002 depicted herein as equivalent electric circuit. The voltage and current signals applied to the ultrasonic transducer are monitored by the voltage sensor 132018 and the current sensor 132020.

The outputs of the voltage sensor 132018 and the current sensor 13020 are applied to another phase / frequency detector 132022 to determine the phase angle between the voltage and current measured by the voltage sensor 132018 and the current sensor 13020. The output of the phase / frequency detector 132022 is applied to one channel of the high speed analog-to-digital converter 132024 (ADC) and is provided to the processor 132004 via it. Optionally, to determine the phase angle between the voltage and current signals applied to the ultrasonic electromechanical system 132002, the outputs of the voltage sensor 132018 and the current sensor 132020 are applied to each channel of the two-channel ADC 132020. And may be provided to processor 132004 for zero crossover, FFT, or other algorithms described herein.

Optionally, the adjustment voltage _{V t} which is proportional to the output frequency _{f o} may be fed back to the processor 132,004 through ADC132024. This feedback signal proportional to the output frequency f _o is provided to the processor 132 004, it is possible to adjust and control the output frequency f _o using this feedback.

Guessing the condition of the jaws (pad burnthrough, staples, broken blades, bones in the jaws, tissue in the jaws)
A challenge with ultrasonic energy delivery is that ultrasonic acoustics applied to the wrong material or wrong tissue can result in equipment failure, such as burning the clamp arm pad or damaging the ultrasonic blade. Is. It is also desirable to detect what is located within the jaws of the end effector of the ultrasonic device and detect the state of the jaws without adding additional sensors within the jaws. Positioning the sensor within the jaws of an ultrasonic end effector poses reliability, cost, and complexity issues.

The ultrasonic spectroscopic smart blade algorithm technique is the impedance of an ultrasonic transducer configured to drive an ultrasonic transducer blade in accordance with at least one aspect of the present disclosure.

に基づいて、ジョーの状態（クランプアームパッドのバーンスルー、ステープル、破断したブレード、ジョー内の骨、ジョー内の組織、ジョーを閉鎖した状態での後方切断など）を推測するために使用されてもよい。インピーダンスＺ_ｇ（ｔ）、大きさ｜Ｚ｜、及び位相φは、周波数ｆの関数としてプロットされる。

Used to infer the condition of the jaws (clamp arm pad burnthrough, staples, broken blades, bone in the jaws, tissue in the jaws, posterior cutting with the jaws closed, etc.) May be good. Impedance Z _g (t), magnitude | Z |, and phase φ are plotted as a function of frequency f.

Dynamic mechanical analysis (DMA), also known as dynamic mechanical spectroscopy or simply mechanical spectroscopy, is a technique used to study and characterize materials. A sinusoidal stress is applied to the material and the strain in the material is measured, allowing the determination of the complex modulus of the material. The spectroscopy applied to the ultrasonic device is to excite the tip of the ultrasonic blade by frequency sweep (composite signal or conventional frequency sweep), to measure the obtained complex impedance at each frequency, and to measure the obtained complex impedance at each frequency. including. Complex impedance measurements of ultrasonic transducers over a frequency range are used in classifiers or models for inferring the characteristics of ultrasonic end effectors. In one aspect, the present disclosure is an adaptive technique for determining the state of an ultrasonic end effector (clamp arm, jaw) to drive automation in an ultrasonic device (disabling the power protecting the device). Provides algorithms (running algorithms, retrieving information, identifying organizations, etc.).

_{FIG. 54 has various different states and situations of end effectors in which impedance Z g} (t), magnitude | Z |, and phase φ are plotted as a function of frequency f according to at least one aspect of the present disclosure. , The spectrum of the ultrasonic device is 132030. The spectrum 132030 is plotted in three-dimensional space, the frequency (Hz) is plotted along the x-axis, the phase (radians) is plotted along the y-axis, and the magnitude (ohm) is along the z-axis. Is plotted.

Spectral analysis of different jaw occlusions and device states produces different complex impedance characteristic patterns (fingerprints) over a frequency range for different situations and states. Each state or situation has a different characteristic pattern in 3D space when plotted. These characteristic patterns can be used to infer the status and condition of the end effector. FIG. 54 shows spectra of air 132032, clamp arm pads 132304, chamois 132036, staples 132038, and broken blades 132040. Chamois 132036 may be used to characterize different types of tissue.

The spectrum 132030 can be evaluated by applying a low power electrical signal across the ultrasonic transducer to generate a non-therapeutic excitation of the ultrasonic blade. Low power electrical signals impedance across ultrasonic transducers using FFT in series (sweep) or parallel (composite signal) frequency range

を測定するために、掃引又は複合フーリエ級数の形態で印加することができる。

Can be applied in the form of a sweep or compound Fourier series to measure.

New data classification method For each characteristic pattern, parametric lines can be applied to the data used for training using polynomials, Fourier series, or any other form of parameter equations, as can be conveniently determined. it can. New data points are then received and classified by using the Euclidean vertical distance from the new data points to the trajectory adapted to the characteristic pattern training data. The vertical distance to each of the trajectories of the new data points (each trajectory representing a different state or situation) is used to assign the points to the state or situation.

The probability distribution of the distance from each point in the training data to the fitted curve can be used to infer the probability of a new accurately classified data point. This essentially builds a two-dimensional probability distribution in a plane perpendicular to the fitted locus at each new data point of the fitted locus. New data points were then included in the training set based on the probability of correct classification to easily detect high frequency changes in state, but occurred in system performance such as dirty equipment or worn pads. An adaptive learning classifier that fits to delay the deviation can be made.

_{FIG. 55 is a 3D training data set (S) in which the ultrasonic transducer impedance Z g} (t), magnitude | Z |, and phase φ are plotted as a function of frequency f according to at least one aspect of the present disclosure. It is a graph of the plot 1302042 of the set of. In the 3D training dataset (S) plot 1302042, the phase (Rad) is plotted along the x-axis, the frequency (Hz) is plotted along the y-axis, and the magnitude (ohm) is plotted along the z-axis. , Parametric Fourier series are shown graphically in three-dimensional space fitted to the 3D training dataset (S). The method for classifying the data is based on a 3D training dataset (S0 is used to generate plot 1302042).

The parametric Fourier series applied to the 3D training dataset (S) is defined by the following equation:

New point

について、

about,

までの垂直距離は、次式によって求められる：

The vertical distance to is calculated by the following equation:

式中、

During the ceremony

であるときに、
Ｄ＝Ｄ_⊥である。

When
D = D _⊥ .

Data points belonging to group S using the probability distribution of D

の確率を推測することができる。

The probability of

Controls Various automated tasks and safety measures can be implemented based on the classification of data measured before, during, or after activation of the ultrasonic transducer / ultrasonic blade. Similarly, the condition of the tissue located in the end effector and the temperature of the ultrasonic blade are estimated to some extent and can be used to better inform the user of the condition of the ultrasonic device or to protect important structures etc. it can. Temperature control of ultrasonic blades is described in US Provisional Patent Application No. 62 / 640,417 co-owned on March 8, 2018, entitled "TEMPERATURE CONTOROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR". The whole is incorporated herein by reference.

Similarly, if the ultrasonic blade is likely to contact the clamp arm pad (eg, there is no tissue in between), or the ultrasonic blade is broken, or the ultrasonic blade is in contact with metal (eg, staples). Power delivery can be reduced if there is a certainty. In addition, if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad, the posterior cut can be released.

Integration of other data to improve classification This system uses probability functions and Kalman filters to combine data from this process with the data described above, depending on sensors, users, patient metrics, environmental factors, etc. Can be used with other information provided. The Kalman filter considers various uncertain measurements of reliability to determine the maximum likelihood of a condition or situation occurring. Since this method allows the assignment of probabilities to newly classified data points, the information in this algorithm can be implemented using other measurements or estimates within the Kalman filter.

FIG. 56 is a logical flow of a process showing a control program or logical configuration for determining a jaw situation based on a complex impedance characteristic pattern (fingerprint) according to at least one aspect of the present disclosure. Before determining the jaw condition based on the complex impedance characteristic pattern (fingerprint), the database includes air 132032, clamp arm pad 132034, chamois 132036, staple 132038, broken blade 132040 as shown in FIG. 82. Various Joe situations are added, as well as reference complex impedance characteristic patterns or training datasets (S) that characterize various tissue types and situations. Dry or wet chamois, complete bite or tip may be used to characterize different types of tissue. The data points used to generate the reference composite impedance characteristic pattern or training dataset are obtained by applying a drive signal below the therapeutic level to the ultrasonic transducer. The drive frequency is swept over a predetermined frequency range from below resonance to above resonance, the complex impedance at each frequency is measured, and data points are recorded. Data points are then fitted to the curve using various numerical methods, including polynomial curve fitting, Fourier series, and / or parameter equations. It is described herein to apply a parametric Fourier series to a reference complex impedance characteristic pattern or training data set (S).

When the reference complex impedance characteristic pattern or training data set (S) is generated, the ultrasonic instrument measures new data points, classifies the new points, and sets the new data points as the reference complex impedance characteristic pattern or training data set ( It is determined whether or not it should be added to S).

Here, referring to the logic flow diagram of FIG. 56, in one aspect, the control circuit measures the complex impedance of the ultrasonic transducer (132046), where the complex impedance is:

として定義される。制御回路は、複素インピーダンス測定データ点を受信し（１３２０４８）、かつ複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較する（１３２０５０）。制御回路は、比較解析の結果に基づいて、複素インピーダンス測定データ点を分類し（１３２０５２）、かつ比較解析の結果に基づいて、エンドエフェクタの状態又は状況を割り当てる（１３２０５４）。

Is defined as. The control circuit receives the complex impedance measurement data points (132048) and compares the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern (132050). The control circuit classifies the complex impedance measurement data points based on the results of the comparative analysis (132052) and assigns the end effector state or status based on the results of the comparative analysis (132054).

In one aspect, the control circuit receives a reference complex impedance characteristic pattern from a database or memory attached to the processor. In one aspect, the control circuit generates a reference complex impedance characteristic pattern as follows. The drive circuit connected to the control circuit starts at the initial frequency, ends at the final frequency, and applies non-therapeutic drive signals at multiple frequencies in between to the ultrasonic transducer. The control circuit measures the impedance of the ultrasonic transducer at each frequency and stores the data points corresponding to each impedance measurement. The control circuit fits the curves to multiple data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, where magnitude | Z | and phase φ are plotted as a function of frequency f. .. Curve fitting includes polynomial curve fitting, Fourier series, and / or parameter equations.

In one aspect, the control circuit receives a new impedance measurement data point and uses the Euclidean vertical distance from the new impedance measurement data point to the trajectory fitted to the reference complex impedance characteristic pattern to make the new impedance measurement. Classify data points. The control circuit estimates the probability that the new impedance measurement data points will be correctly classified. The control circuit adds the new impedance measurement data points to the reference complex impedance characteristic pattern based on the estimated correct classification probability of the new impedance measurement data points. In one aspect, the control circuit classifies the data based on the training data set (S), where the training data set (S) contains multiple complex impedance measurement data and is trained using a parametric Fourier series. A curve is fitted to the dataset (S), where S is defined herein and the probability distribution is used to infer the probability of new impedance measurement data points belonging to group S.

Model-based jaw classifier status There is existing interest in classifying substances located within the jaws of ultrasonic devices, including tissue types and conditions. In various aspects, it can be shown that this classification is possible using high data sampling and advanced pattern recognition. This approach is based on impedance as a function of frequency, where magnitude, phase, and frequency are plotted in 3D and as shown in the logical flow diagrams of FIGS. 54 and 55, and 56. , The pattern looks like a ribbon. The present disclosure provides an alternative smart blade algorithm approach based on a well-established model of piezoelectric transducers.

As an example, an equivalent electrical centralized parameter model is known to be an accurate model of a physical piezoelectric transducer. This is based on the Mittag-Leffler expansion of the tangent near mechanical resonance. When complex impedance or complex admittance is plotted as an imaginary component with respect to a real component, a circle is formed. FIG. 57 is a circle plot of complex impedance 132056 plotted as an imaginary component with respect to the real component of the piezoelectric oscillator according to at least one aspect of the present disclosure. FIG. 58 is a circle plot of complex admittance 132058 plotted as an imaginary component with respect to the real component of the piezoelectric oscillator according to at least one aspect of the present disclosure. The circles depicted in FIGS. 57 and 58 are taken from the IEEE 177 standard, which is incorporated herein by reference in its entirety. Tables 1 to 4 are taken from the IEEE 177 standard and are disclosed herein for completeness.

This circle is created when the frequency is swept from below resonance to above resonance. Instead of drawing the circle in 3D, identify the circle and infer the radius (r) and offset (a, b) of the circle. These values are then compared to the values established for a given situation. These situations may be 1) the jaws are not open at all, 2) tip occlusion, 3) full jaw occlusion and staple fastening. When sweeping produces multiple resonances, there are circles with different characteristics for each resonance. Each circle is drawn before the next circle if the resonances are separated. Instead of fitting a 3D curve with a series approximation, fit a circle to the data. The radii (r) and offsets (a, b) can be calculated using a processor programmed to perform various mathematical or numerical techniques described below. These values may be inferred by capturing an image of the circle and using image processing techniques, inferring the radii (r) and offsets (a, b) that define the circle.

FIG. 59 is a complex admittance circle plot 132060 of a 55.5 kHz ultrasonic piezoelectric transducer for centralized parameter inputs and outputs specified below. Complex admittance was generated using the values of the centralized parameter model. A medium load was applied to the model. The acquired admittance circle generated by MathCad is shown in FIG. The circular plot 132060 is formed when the frequency is swept at 54-58 kHz.

The centralized parameter input values are:
Co = 3.0nF
Cs = 8.22pF
Ls = 1.0H
Rs = 450Ω

The output of the model based on the inputs is:

The output values are used to plot the circle plot 132060 shown in FIG. 59. The circle plot 132060 has a radius (r) and the center 132062 is an offset (a, b) from the origin 1302064 as follows.
r = 1.012 * 10 ³
a = 1.013 * 10 ³
b = -954.585

The sums A to E specified below are required to infer the circle plot 132060 plot of the example given in FIG. 59 according to at least one aspect of the present disclosure. There are several algorithms for calculating the fit to the circle. A circle is defined by its radius (r) and its center offset from its origin (a, b):
r ² = (x−a) ² + (y−b) ²

The modified least squares method (Umbach and Jones) is convenient in that there are simple approximate solutions for a, b, and R.

The caret symbol above the variable "a" indicates the estimated value of the true value. A, B, C, D, and E are sums of various products calculated from the data. These are included herein for completeness such as:

Ｚ１、ｉは、コンダクタンスと呼ばれる実数成分の第１のベクトルであり、
Ｚ２、ｉは、サセプタンスと呼ばれる虚数成分の第２のベクトルであり、
Ｚ３、ｉは、アドミッタンスが計算される周波数を表す第３のベクトルである。

Z1 and i are first vectors of real number components called conductance.
Z2 and i are the second vectors of the imaginary component called susceptance.
Z3 and i are third vectors representing the frequencies for which admittance is calculated.

The present disclosure works for ultrasonic systems and can be applied to electrosurgical systems even when the electrosurgical system is resonance independent.

60-64 show images taken from an impedance analyzer showing impedance / admittance circle plots of ultrasonic devices in various open or closed configurations and with load-bearing end effector jaws. According to at least one aspect of the present disclosure, a solid circle plot indicates impedance and a dashed circle plot indicates admittance. As an example, an impedance / admittance circle plot is generated by connecting an ultrasonic device to an impedance analyzer. The impedance analyzer display is set to complex impedance and complex admittance, which may be selectable from the impedance analyzer front panel. The initial display can be obtained, for example, using the jaws of the ultrasonic end effector in the open position and the ultrasonic device in the no-load state, as described below in connection with FIG. 60. The autoscale display feature of the impedance analyzer can be used to generate both complex impedance and admittance circle plots. The same display is used in subsequent runs of ultrasonic devices with different load conditions, as shown in subsequent FIGS. 60-64. You can upload data files using the LabVIEW application. In another technique, the displayed image may be captured by a camera such as a smartphone camera such as iPhone or Android. Therefore, the displayed image may include some keystone effects and generally does not have to appear parallel to the screen. Using this technique, the circular plot lines on the display will appear distorted in the captured image. This approach can be used to classify materials located within the jaws of ultrasonic end effectors.

Complex impedance and complex admittance are reciprocals of each other. No new information should be added by looking at both. Another consideration involves determining how sensitive the estimates are to noise when using complex impedance or complex admittance.

In the embodiments shown in FIGS. 60-64, the impedance analyzer is set in a range that simply captures the main resonance. By scanning over a wider range of frequencies, more resonances may be encountered and multiple circular plots may be formed. The equivalent circuit of the ultrasonic transducer has a first "working" branch with continuously connected inductance Ls, resistors Rs, capacitance Cs, and capacitance C0, which define the electrosurgical properties of the resonator. It can be modeled by a second capacitive branch with. In the impedance / admittance plots shown in FIGS. 60-64 below, the values of the components of the equivalent circuit are:
Ls = L1 = 1.1068H
Rs = R1 = 311.352Ω
Cs = C1 = 7.43265pF
C0 = C0 = 3.64026nF

The oscillator voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept at 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div. Measurements of values that can characterize the impedance (Z) and admittance (Y) circle plots may be obtained at positions on the circle plot as indicated by the impedance and admittance cursors.

Jaw State: Open with no load FIG. 60 shows the complex impedance (Z) / admittance (Z) / admittance of an ultrasonic device with a jaw open and no load according to at least one aspect of the present disclosure. Y) It is a graph display 132066 of the impedance analyzer showing the circle plots 132068 and 132070, the solid circle plot 132068 shows the complex impedance, and the broken circle plot 132070 shows the complex admittance. The oscillator voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept at 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div. Measurements of values that can characterize the complex impedance (Z) and admittance (Y) circle plots 132068, 132070 are obtained at positions on the circle plots 132068, 132070 as indicated by the impedance cursors 132072 and the admittance cursor 132704. May be good. Thus, the impedance cursor 132072 is located on a portion of the impedance circle plot 132068 equal to about 55.55 kHz and the admittance cursor 132074 is located on a portion of the admittance circle plot 132070 equal to about 55.29 kHz. As shown in FIG. 60, the position of the impedance cursor 132072 corresponds to the following values.
R = 1.66026Ω
X = -697.309Ω

In the formula, R is a resistance (real value) and X is a reactance (imaginary value). Similarly, the position of the admittance cursor 132704 corresponds to the following values:
G = 64.0322 μS
B = 1.63007mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Jaw State: Clamped on Dry Chamois Figure 61 shows the complex impedance (Z) / admittance of an end effector ultrasound device in which the tip of a jaw is clamped on the dry chamois according to at least one aspect of the present disclosure. Y) The graph display 132076 of the impedance analyzer showing the circle plots 132078 and 132080, the impedance circle plot 132078 is shown by a solid line, and the admittance circle plot 132080 is shown by a broken line. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept at 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div.

Measurements of values that can characterize the complex impedance (Z) and admittance (Y) circle plots 132078, 132080 are obtained at positions on the circle plots 132078, 132080 as indicated by the impedance cursors 132082 and admittance cursors 132804. May be good. Thus, the impedance cursor 132082 is located on a portion of the impedance circle plot 132078 equal to about 55.68 kHz and the admittance cursor 132084 is located on a portion of the admittance circle plot 132080 equal to about 55.29 kHz. As shown in FIG. 61, the position of the impedance cursor 132082 corresponds to the following values.
R = 434.577Ω
X = -758.772Ω
In the formula, R is a resistance (real value) and X is a reactance (imaginary value).

Similarly, the position of the admittance cursor 132804 corresponds to the following values:
G = 85.1712 μS
B = 1.49569mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Jaw State: Clamped on Wet Chamois Figure 62 shows the complex impedance (Z) / admittance (Y) of an ultrasonic device in which the tip of a jaw is clamped on a wet chamois according to at least one aspect of the present disclosure. ) It is a graph display 132586 of the impedance analyzer showing the circle plots 132098 and 132090, the impedance circle plot 132808 is shown by a solid line, and the admittance circle plot 132090 is shown by a broken line. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept at 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div.

Measurements of values that can characterize the complex impedance (Z) and complex admittance (Y) circle plots 132808, 132090 are obtained at positions on the circle plots 132808, 132090 as indicated by the impedance cursors 1322092 and the admittance cursor 132094. You may. Thus, the impedance cursor 132092 is located on a portion of the impedance circle plot 132088 equal to about 55.68 kHz and the admittance cursor 132094 is located on a portion of the admittance circle plot 132090 equal to about 55.29 kHz. As shown in FIG. 63, the impedance cursor 132092 corresponds to the following values.
R = 445.259Ω
X = -750.082Ω

In the formula, R is a resistance (real value) and X is a reactance (imaginary value). Similarly, the admittance cursor 132094 corresponds to the following values:
G = 96.2179 μS
B = 1.50236mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Joe's State: Fully Clamped on Wet Chamois Figure 63 shows the complex impedance (Z) / admittance of an ultrasonic device in which Joe's is fully clamped on a wet chamois according to at least one aspect of the present disclosure. (Y) It is a graph display 132096 of the impedance analyzer showing the circle plots 132098 and 132100, the impedance circle plot 132098 is shown by a solid line, and the admittance circle plot 132100 is shown by a broken line. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept at 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div.

Measurements of values that can characterize the impedance and admittance circle plots 132098, 132100 may be obtained at positions on the circle plots 132098, 1332100 as indicated by the impedance cursor 13212 and the admittance cursor 132104. Thus, the impedance cursor 132102 is located on a portion of the impedance circle plot 132098 equal to about 55.63 kHz and the admittance cursor 132104 is located on a portion of the admittance circle plot 132100 equal to about 55.29 kHz. As shown in FIG. 63, the impedance cursor 132102 corresponds to a value of R, a resistance (a real value, not shown), and an X, a reactance (an imaginary value, also not shown).

Similarly, the admittance cursor 132104 corresponds to the following values.
G = 137.272 μS
B = 1.48481mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Jaw State: Open with no load FIG. 64 is a graph display 132106 of an impedance analyzer showing an impedance (Z) / admittance (Y) circle plot according to at least one aspect of the present disclosure, with jaws. The region specified by the quadrature 132108, with frequencies swept from 48 kHz to 62 kHz to capture multiple resonances of the admittance, open and unloaded, is shown by the solid line. It is intended to help you see the impedance circle plots 132110a, 132110b, 132110c, and the admittance circle plots 132112a, 132112b, 132112c. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 48 kHz to 62 kHz. The impedance (Z) scale is 500 Ω / div and the admittance (Y) scale is 500 μS / div.

Measurements of values that can characterize the impedance and admittance circle plots 132110a-c, 132112a-c are obtained at the positions of the impedance and admittance circle plots 132110a-c, 132112a-c indicated by the impedance cursor 132114 and the admittance cursor 132116. be able to. Thus, the impedance cursor 132114 is located in part of the impedance circle plots 132110a-c equal to about 55.52 kHz, and the admittance cursor 132116 is located in part of the admittance circle plot 132112a-c equal to about 59.55 kHz. As shown in FIG. 64, the impedance cursor 132114 corresponds to the following values.
R = 1.86163kΩ
X = -536.229Ω

In the formula, R is a resistance (real value) and X is a reactance (imaginary value). Similarly, the admittance cursor 132116 corresponds to the following values:
G = 649.956 μS
B = 2.51975mS
In the formula, G is conductance (real value) and B is susceptance (imaginary value).

Since there are only 400 samples over the sweep range of the impedance analyzer, there are only a few points around the resonance. For this reason, the circle on the right side has a bad shape. However, this is only due to the impedance analyzer and the settings used to cover multiple resonances.

If there are multiple resonances, there is more information to improve the classifier. The fit of the circle plots 132110a-c, 132112a-c can be calculated for each encountered to maintain fast execution of the algorithm. Therefore, the presence of complex admittance intersections, which means circles, allows the fit to be calculated during the sweep.

Advantages include a jaw classification unit based on well-known models for data and ultrasound systems. Circle counting and characterization are well known in visual systems. Therefore, data processing is easily available. For example, there are closed forms of solution for calculating the radius and axis offset of a circle. This technique can be relatively fast.

Table 2 is a list of symbols used in the centralized parameter model of piezoelectric transducers (from the IEEE 177 standard).

Table 3 is a list of symbols for the transmission network (from the IEEE 177 standard).

^＊実根を指す。無視される複素根。

^* Refers to the real root. Ignored complex roots.

Table 4 is a list of solutions for various characteristic frequencies (from the IEEE 177 standard).

^＊実根を指す。無視される複素根

^* Refers to the real root. Ignored complex roots

Table 5 lists the losses of the three categories of piezoelectric materials.

圧電振動子の様々な種類について予想される比Ｑ^ｒ／ｒの最小値

^{Minimum expected ratio Qr} / r for various types of piezoelectric oscillators

Table 6 estimates the circle based on real-time measurements of the jaw situation, the complex impedance / admitance of the circle represented by the inferred parameters Re, Ge, Xe, Be, the radius (re), and the offset (ae and be). Real-time parameters, as shown in FIGS. 60-64, the complex impedance / admittance, radius (rr), and offset (ar, br) of the reference circle represented by the reference variables Rref, Gref, Xref, Blef. The parameters of the reference circle plot based on the measured values are shown. These values are then compared to the values established for a given situation. These situations may be 1) open with nothing on the jaws, 2) tip occlusion, 3) complete occlusion and staple fastening of the jaws. The equivalent circuit of the ultrasonic transducer was modeled as follows and the frequency was swept from 55 kHz to 56 kHz.
Ls = L1 = 1.1068H
Rs = R1 = 311.352Ω
Cs = C1 = 7.43265pF and C0 = C0 = 3.64026nF

During use, the ultrasonic generator sweeps the frequency, records the measured variables and determines the estimated values Re, Ge, Xe, Be. Then, these estimated values are compared with the reference variables Rref, Gref, Xref, and Blef stored in the memory (for example, stored in the lookup table) to determine the jaw status. The reference jaw situations shown in Table 6 are merely examples. Additional or less reference jaw status may be classified and stored in memory. These variables can be used to infer the radius and offset of the impedance / admittance circle.

FIG. 65 shows a control program or logical configuration for determining the jaw situation based on the estimation of the radius (r) and offset (a, b) of the impedance / admittance circle according to at least one aspect of the present disclosure. FIG. 132120 is a logical flow diagram. First, a reference value is added to the database or look-up table based on the reference jaw situation, as described in connection with FIGS. 60-64 and 6. Set the reference jaw condition and sweep the frequency from below resonance to above resonance. The reference values Rref, Gref, Xref, Blef that define the corresponding impedance / admittance circle plot are stored in the database or lookup table. During use, under the control of a control program or logical configuration, the control circuit of the generator or instrument sweeps the frequency from below-resonant to above-resonant (132122). The control circuit measures and records (eg, stores in memory) the variables Re, Ge, Xe, Be that define the corresponding impedance / admittance circle plot (eg, stored in memory) (132124) and is a reference value stored in a database or lookup table. Compare with Rref, Gref, Xref, Blef (132126). The control circuit determines, eg, guesses, the end effector jaw status based on the results of the comparison (132128).

Application of "Smart Blade Technology" Current ultrasound and / or ultrasound / RF tissue treatment status combinations use advanced tissue treatment algorithms with a given current level for each step of the algorithm. Instead of using an advanced hemostatic tissue treatment algorithm with a predetermined current level for each step of the algorithm, the proposed advanced tissue treatment technique uses a frequency temperature control system to heat the ultrasonic blade to a constant temperature. Adjust the current delivered to the ultrasonic transducer to drive the.

66A-66B are graphs of an advanced ultrasonic transducer current controlled hemostasis algorithm. For example, the tissue treatment process may be initiated by driving an ultrasonic transducer current to generate a high constant temperature during the first predetermined period T1. At the end of the first predetermined period T1, the process drives the ultrasonic transducer current to generate a lower constant temperature of the ultrasonic blade during the second predetermined period T2. The lower temperature of the ultrasonic blade may be suitable for achieving tissue encapsulation, but may not be suitable for achieving tissue incision. Finally, the process drives the ultrasonic transducer current to raise (increase) the temperature of the ultrasonic blade to a higher constant temperature during a third predetermined period T3. Higher temperatures are high enough to complete the transverse incision, but below the melting point of the clamp arm pad. For example, the higher ultrasonic blade temperature during the third predetermined period T3 may be selected, for example, to be lower than the melting point of Teflon, a material commonly used for clamp arm pads.

FIG. 66A is a graph 132130 of the percentage of maximum current delivered to an ultrasonic transducer as a function of time, according to at least one aspect of the present disclosure. The vertical axis represents the percentage (%) of the maximum current delivered to the ultrasonic transducer, and the horizontal axis represents the time (seconds). The ratio of the transducer current is set to the first ratio of the maximum current X1% in order to raise the temperature of the ultrasonic blade during the first period T1. The ratio of the transducer current is then reduced to a second ratio of maximum current x 2% over the second period T2, and the blade temperature is suitable for sealing the tissue but for traversing the tissue. Reduce to unsuitable values. The ratio of the transducer current is then increased to a third ratio of maximum current x 3% during the third period T3 to raise the blade temperature to a clamp arm pad (eg, suitable for cross-incision of tissue). , Teflon) is raised to a value lower than the melting point. According to the process graphically shown in FIG. 66A, the same proportion of ultrasonic transducer current profiles can be used for all tissue types, load conditions and the like.

FIG. 66B is a graph 132140 of ultrasonic blade temperature as a function of time and tissue type according to at least one aspect of the present disclosure. The vertical axis represents the temperature (° F) of the ultrasonic blade, and the horizontal axis represents the time (seconds). This technique may be combined with impedance spectroscopy to detect tissues of varying thickness. For example, thick tissue vs. thin tissue located within the jaws of an ultrasonic end effector. Once tissue thickness is detected, the ultrasonic blade temperature is controlled to accommodate different levels of energy delivery, adjusting for advanced hemostatic algorithms in real time, as may be required across a range of tissue types. can do. When the tissue type is detected or determined, the ultrasonic blade temperature is set to the _{nominal temperature Temp 1 by controlling the drive current to the ultrasonic transducer.} The temperature of the ultrasonic blade may _{be set to the first temperature Temp 1} and increased (+) or decreased (−) based on the type of tissue over the first period T1. _{The ultrasonic blade temperature is then lowered to a second} temperature, Temp 2, over a second period of T2, to a value suitable for sealing the tissue but not suitable for transverse incision of the tissue. .. The second temperature Temp ₂ may be increased (+) or decreased (−) based on the type of tissue detected. The ultrasonic blade temperature is then raised to a value below _{the melting point temperature TMP} of the clamp jawpad material, which is suitable for cross-cutting the tissue _{over a third period T3 up to a third temperature Temp3.} .. According to the process shown in FIG. 66B, the temperature of the ultrasonic blade can be changed based on the type of tissue, the load condition, and the like. In addition, the ultrasonic blade temperature vs. time profile can be varied by varying the periods T1 to T3. Finally, the ultrasonic blade temperature vs. time profile can be changed by varying both the ultrasonic blade temperature and periods T1 to T3.

In one embodiment, for audible surgeon feedback, the tone can be tied to achieving a particular temperature threshold. This improves consistency in high hemostasis transverse incision time and hemostasis across a range of tissue types.

FIG. 67 is a logical flow diagram 132150 of a process showing a control program or logical configuration for controlling the temperature of an ultrasonic blade based on tissue type according to at least one aspect of the present disclosure. Tissue types are shown in FIGS. 54-56 under the heading "Guessing jaw condition (pad burnthrough, staples, broken blades, bones in jaws, tissue in jaws)" and / or "based on the model". The technique for estimating the temperature of the ultrasonic blade, which can be determined using the techniques described in FIGS. 57-65 (132152) under the heading "State of jaw classification", is generally referenced. It is described in connection with US patent provisional application No. 62 / 640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al., Which is incorporated herein by. According to this process, the control circuit in the generator or instrument determines the tissue type by controlling the drive current into the ultrasonic transducer and sets the initial temperature of the ultrasonic blade to the nominal temperature. The control circuit raises (+) or lowers (-) the temperature of the ultrasonic blade based on the type of tissue over the first period T1. The control circuit then lowers the temperature of the ultrasonic blade to a second temperature over a second period T2, a value that is suitable for sealing the tissue but not suitable for transverse incision of the tissue. Let me. The control circuit raises (+) or lowers (-) the second temperature based on the detected tissue type. The control circuit is suitable for raising the temperature of the ultrasonic blade to a third temperature and making a transverse incision of the tissue over the third period T3, but below the melting point of the clamp jaw pad material (eg, Teflon). Raise to value.

During surgery using smart blades and power pulse ultrasonic shearing devices, the power delivered to the tissue is set to a predetermined level. This predetermined level is used to make a transverse incision in the tissue through a transverse incision procedure. Certain tissues can be better sealed or better / faster cut if the delivered power varies throughout the transverse incision procedure. A solution is needed to change the power delivered to the tissue through the blades during the transverse incision process. In various aspects, the tissue type and changes to tissue during the transverse incision process are headed "guess of jaw condition (pad burnthrough, staples, broken blades, bone in jaw, tissue in jaw)". 54-56 and / or the technique described in FIGS. 57-65 under the heading "State of jaw classification based on model" and / or of the ultrasonic blade. Techniques for estimating temperature relate to US Patent Application No. 62 / 640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al., Which is incorporated herein by reference in its entirety. It is described as.

One solution that provides better ultrasonic transverse incisions is to use the impedance feedback of the ultrasonic blades. As mentioned above, the impedance of the ultrasonic blade is related to the impedance of the electromechanical ultrasonic system, and as described herein, with the voltage and current signals applied to the ultrasonic transducer. It can be determined by measuring the phase angle between. This technique may be used to measure the magnitude and phase of the impedance of an ultrasonic transducer. The impedance of the ultrasonic transducer may be used to profile factors that may affect the ultrasonic blade during use (eg, force, temperature, vibration, force over time, etc.). This information may be used to influence the power delivered to the ultrasonic blades during the transverse incision process.

FIG. 68 shows a control program or logical configuration for monitoring the impedance of an ultrasonic transducer in order to profile the ultrasonic blade and deliver power to the ultrasonic blade on the profile, according to one aspect of the present disclosure. FIG. 132170. According to the process, the control circuit determines (eg, measures) the impedance (Z) of the ultrasonic transducer during the tissue transverse incision process (132172). The control circuit analyzes and profiles the ultrasonic blade 132174 immediately after the tissue is completely clamped to the jaws of the end effector of the ultrasonic device based on the determined (132172) impedance (Z). The control circuit adjusts the power output level based on the profile of the ultrasonic blades (eg, high power in high density tissue, low power in thin tissue) (132176). The control circuit controls the generator to momentarily drive the ultrasonic transducer and ultrasonic blade, and then stops. The control circuit again determines the impedance (Z) of the ultrasonic blade (132172) and profiles the ultrasonic blade based on the determined (132172) impedance (Z) (132174). The control circuit controls the generator to adjust or keep the output power level based on the profile of the ultrasonic blade. The control circuit again controls the generator to momentarily drive the ultrasonic transducer and ultrasonic blade, and then stops. The process is repeated, determining the impedance (Z) (132172), determining the profile of the ultrasonic blade (132174), adjusting the power level until the detected impedance profile is that of the clamp arm pad (132176). The power is then adjusted to prevent the clamp arm pad from melting.

The process described in connection with FIG. 68 allows the power level of the ultrasonic transducer to be adjusted on the fly as the tissue changes from being heated and cut. Therefore, if the tissue is initially hard and then weakened, or if different layers of tissue are encountered during the transverse incision process, the power level can be optimally adjusted to match the profile of the ultrasonic blade. This method eliminates the need for the user to set the power level. The ultrasonic device is selected by adapting the appropriate power level based on the current tissue condition and the transverse incision process.

This technique provides intelligent control for power level setting based on organizational feedback. This technique can eliminate the need for power setting on the generator and can result in faster transverse incision times. In one aspect, in an ultrasonic transverse incision medical device comprising a jaw with an ultrasonic blade, the impedance of the ultrasonically driven blade is to profile the characteristics of the ultrasonic blade (force, heat, vibration, etc.). Used, the profile is used to influence the power output of the transducer during the incision process. Tissue changes can be read for feedback between pulses and the power can be pulsed on and off so that the power can be adjusted during the transverse incision process.

FIGS. 69A-69D are a series of graphs of the impedance of an ultrasonic transducer for profiling an ultrasonic blade and delivering power to the ultrasonic blade based on the profile, according to at least one aspect of the present disclosure. FIG. 69A is a graph 132180 of impedance vs. time of the ultrasonic transducer. The generator control circuit reads the initial impedance Z1 based on the contents of the jaws and applies the pulse power P1 to the ultrasonic transducer as shown in FIG. 69B, which is a graph representation of pulse power vs. time 132182. FIG. 69C is a new impedance Z2 vs. time graph 132184. The generator control circuit reads the new impedance Z2 and pulsed the pulse power to the ultrasonic transducer to adapt to the new tissue conditions, as plotted in FIG. 69D, which is a graph of pulse power P2 vs. time 132186. Apply P2.

Adjustment of Complex Impedance to Compensate for Power Loss of Joint Motion Ultrasound Device FIG. 70 is for compensating for power lost when the ultrasonic blade 132194 is in joint motion according to at least one aspect of the present disclosure. In addition, it is a system 132190 for adjusting the complex impedance of the ultrasonic transducer 132192. The performance of the joint-movable ultrasonic blade 132194 is inconsistent across the complete joint angles θ of A-B. For example, when the ultrasonic blade 132194 moves jointly, power is lost. Knowing the joint angle θ in which the ultrasonic blade 132194 is present, the generator 132196 or the surgical instrument 132199 adjusts the complex impedance (Z) to compensate for the power lost when the ultrasonic blade 132194 joints. be able to. Also, by analyzing the performance of the ultrasonic blade 132194 through its perfect joint angle θ, the generator 132196 can execute an algorithm for adjusting the complex impedance (Z) to compensate for power loss. ..

Ultrasonic blade 132194 is headed "guessing jaw condition (pad burn-through, staples, broken blades, bones in jaws, tissue in jaws)" in FIGS. 54-56 and / or in the model. Adjusting the complex impedance of ultrasonic transducer 132192 to compensate for the lost power and / or ultrasound when the techniques described in FIGS. 57-65 are available under the heading "State of Joe Classification Based on". A technique for estimating the temperature of a blade is described in US Patent Application No. 62 / 640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al., Which is incorporated herein by reference in its entirety. It is described in relation.

Using these techniques, the joint angle θ of the ultrasonic blade 132194 can be determined by sweeping the joint angle θ in the range A to B in a predetermined angle increment. At each angle increment, the sonic transducer 132192 is activated at a therapeutic or non-therapeutic energy level, the complex impedance (Z) of the sonic transducer 132192 is measured, and a set of complex impedance (Z) measurements is recorded. Generate a reference complex impedance characteristic pattern or training data set S as a function of joint angle θ and store the reference complex impedance characteristic pattern or training data set S in a memory or database accessible by the ultrasonic instrument 132199 during the surgical procedure. .. During the surgical procedure, the ultrasonic instrument 132199 can determine the joint angle θ by comparing the real-time complex impedance (Z) measurements of the ultrasonic transducer 132192 with the reference complex impedance characteristic pattern or training dataset S. ..

Articulated ultrasonic waveguides 132198 are described in US Pat. No. 9,095,367, entitled "Flexible Harmonic Waveguides / Blades For Surgical Instruments," which is incorporated herein by reference. See FIGS. 47-66B and related description. Measurements of joint angle are described in US Pat. No. 9,808,244, entitled "Sensor Arrangements For Absolute Positioning System For Surgical Instruments," which is incorporated herein by reference. See FIGS. 193 to 196 and related description.

FIG. 71 is a logical flow diagram 132200 of a process showing a control program or logical configuration for compensating for output power as a function of joint angle according to at least one aspect of the present disclosure. Therefore, together with FIG. 70 in use, the generator 132196 or the instrument control circuit determines the joint angle θ of the ultrasonic blade 132194 (132202). The control circuit adjusts the complex impedance (Z) to compensate for the power loss as a function of the joint angle θ (132204). The control circuit applies the output power of the generator 132196 applied to the ultrasonic transducer 132192 based on the joint angle θ of the ultrasonic blade 132194 (132206).

Use of Spectroscopy to Determine Device Usage in Combination Instruments FIG. 72 shows the complex impedance of ultrasonic transducer 132212 to determine the operation performed by the ultrasonic blade 132214 according to at least one aspect of the present disclosure. 132210 for measuring in real time. Current surgical instruments include three functions (sealing + cutting, sealing only, and spot coagulation). These functions can be performed by activating two buttons. It would be useful if the surgeon could receive either the encapsulation alone or the spot coagulation algorithm based on the desired action performed with the push of a single button. The complex impedance (Z) of the ultrasonic blade 132214 can be measured in real time using ultrasonic spectroscopy. Real-time measurements can be compared to default data to determine which action is being performed. The different complex impedance (Z) patterns between spot solidification and sealing only allow the generator 132216 to determine which operation is being performed and to execute the appropriate algorithm.

To determine the operation performed by the ultrasonic blade 132214, measuring the complex impedance (Z) of the ultrasonic transducer 132212 in real time is "guessing the state of the jaws (pad burnthrough, staple, breakage). Using the techniques described in FIGS. 54-56 under the heading "Blade, bone in jaw, tissue in jaw" and / or in FIGS. 57-65 under the heading "State of jaw classification based on model". A technique for estimating the temperature of an ultrasonic blade that can and / or is incorporated herein by reference in its entirety, a US patent entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al. It is described in connection with provisional application Nos. 62 / 640,417.

Table 7 is a chart of ultrasonic blade operation and corresponding complex impedance. This information is stored in a memory lookup table or database.

FIG. 73 is a logical flow diagram of a process showing a control program or logical configuration for determining the operation performed by the ultrasonic blade 132214 (FIG. 72) based on a complex impedance pattern according to at least one aspect of the present disclosure. 132220. Prior to implementing the process described in FIG. 73, and in conjunction with FIG. 72, data on the operation of ultrasonic blade 132214 was added to the database or memory lookup table and associated with the operation of ultrasonic blade 132214. Complex impedance (Z) is observed. The database or look-up table can be accessed by the ultrasonic instrument 132218 or the generator 132216 while performing the operation of the ultrasonic blade 132214. Therefore, during the hemostatic procedure, the control circuit of the generator 132216 or instrument 13218 determines the complex impedance (Z) of the ultrasonic blade 132214 (132222). The control circuit compares the measured complex impedance (Z) with the stored value of the complex impedance pattern associated with the ultrasonic blade 132214 function (132224). The control circuit controls the generator 132216 to apply the output power algorithm to the ultrasonic transducer 132212 (132226) based on the comparison.

Vascular Sensing for Adaptive Advanced Hemostasis In various aspects, the present disclosure provides an adaptive vascular encapsulation mode. In one aspect, the ultrasonic instrument can deliver ultrasonic energy uniquely to the veins, as opposed to the arteries.

In another aspect, the present disclosure provides a technique for identifying the jaw contents of an ultrasonic device. Using this approach, vessels clamped within the jaws are identified as either veins or arteries that can be characterized as vessel walls and pressure differences. Knowing that a blood vessel is a vein or an artery can initiate an advanced hemostatic cycle unique to each type. Advanced hemostatic cycles include lower currents and longer times at the vascular sealing portion of the cycle, as veins require more time and lower temperature due to the thinner vessel wall.

FIG. 74 is a logical flow of an adaptive process showing a control program or logical configuration for identifying hemostatic vessels according to at least one aspect of the present disclosure. According to the process, the control circuit of the generator or equipment is shown in FIGS. 54-56 under the heading "guessing the condition of the jaws (pad burnthrough, staples, broken blades, bones in the jaws, tissue in the jaws)". , And / or any of the smart blade algorithm techniques for inferring or classifying the jaw states of ultrasonic devices described in connection with FIGS. 57-65 under the heading "Model-based jaw classification states". Techniques for using to sense blood vessels located within the jaws of an ultrasonic device (132232) and / or estimating the temperature of an ultrasonic blade are incorporated herein by reference in their entirety, by Nott et al. It is described in connection with US Patent Provisional Application No. 62 / 640,417 entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROLL SYSTEM THEREFOR". When a vein is sensed (132234) or an artery is sensed (132236), the control circuit receives a command to seal either the vein or the artery and is based on the type of blood vessel sensed. Invokes an advanced hemostatic algorithm (132238). In one aspect, the command may be issued by the user from a button located on the device to invoke a suitable advanced hemostatic algorithm. In other embodiments, the command may be issued automatically based on a tissue characterization algorithm.

When the vein is sensed (132234), the control circuit executes a first algorithm that can be sealed later at lower power levels and lower ultrasonic blade temperatures (132240). Therefore, to treat the veins, the control circuit controls the generator to output the lower power P1 and activates the generator for a longer time T1.

When an artery is sensed (132236), the control circuit executes a second algorithm that can seal faster at higher power levels and higher ultrasonic blade temperatures (132242). Therefore, to treat the artery, the control circuit controls the generator to output a higher power P2 and activates the generator for a shorter period of time T2.

FIG. 75 is a graph 132250 of an ultrasonic transducer current profile as a function of time for venous and arterial vessel types according to at least one aspect of the present disclosure. The vertical axis is the generator output current (I) delivered to the ultrasonic transducer, and the horizontal axis is the time (seconds). Also referring to FIG. 74, the first curve 132252 represents a vein and is treated with a lower power (I1 at P1) and a longer period (T1), the second curve 132254 represents an artery and the first curve. It is treated with higher power (P2 at I2) applied during a shorter period (T2) relative to 132252.

In another aspect, the present disclosure provides a technique for delivering an ultrasonic transducer current (I) within a feedback control loop in order to achieve the target frequency associated with the desired ultrasonic blade temperature. When sealing a vein, for example, a feedback control loop drives to a higher target frequency that corresponds to a cooler ultrasonic blade temperature suitable (and potentially ideal) for sealing the vein. .. The arteries are driven to a slightly lower frequency target associated with the hotter ultrasonic blade temperature.

FIG. 76 is a logical flow of an adaptive process showing a control program or logical configuration for identifying hemostatic vessels according to at least one aspect of the present disclosure. According to the process, the control circuit of the generator or equipment is shown in FIGS. 54-56 under the heading "guessing the condition of the jaws (pad burnthrough, staples, broken blades, bones in the jaws, tissue in the jaws)". , And / or any of the smart blade algorithmic techniques for inferring or classifying the jaw states of ultrasonic devices described in connection with FIGS. 57-65 under the heading "Model-based jaw classification states". Techniques for sensing blood vessels in jaws (132262) and / or estimating the temperature of ultrasonic blades in use are incorporated herein by reference in their entirety, "TEMPERATURE CONTROL IN ULTRASONIC" by Nott et al. It is described in connection with US Patent Provisional Application No. 62 / 640,417 entitled "DEVICE AND CONTROL SYSTEM THE REFOR".

When the vein is sensed (132264), the control circuit executes a first algorithm for supplying current to the ultrasonic transducer (132268) to achieve the target sealing temperature of the vein. The feedback control loop estimates the temperature of the ultrasonic blade and adjusts the current delivered to the ultrasonic transducer to control the temperature of the ultrasonic blade. When the artery is sensed (132266), the control circuit executes a second algorithm for supplying current to the ultrasonic transducer (132269) to achieve the target sealing temperature of the artery. The feedback control loop estimates the temperature of the ultrasonic blade and adjusts the current delivered to the ultrasonic transducer to control the temperature of the ultrasonic blade.

FIG. 77 is a graph of an ultrasonic transducer frequency profile as a function of time for venous and arterial vessel types according to at least one aspect of the present disclosure. The vertical axis represents the frequency (kHz) of the signal applied to the ultrasonic transducer, and the horizontal axis represents the time (seconds). The first curve 132272 represents a vein. Veins require a cooler ultrasonic blade temperature to provide a seal. The first algorithm controls the temperature of the ultrasonic blade by setting the frequency applied to the ultrasonic transducer to a higher frequency, and the current delivered to the ultrasonic transducer to maintain the set frequency. Control. The second curve 132274 represents an artery. The arteries require a higher ultrasonic blade temperature to provide a seal. The second algorithm controls the temperature of the ultrasonic blade by setting the frequency applied to the ultrasonic transducer to a lower frequency, and the current delivered to the ultrasonic transducer to maintain the set frequency. Control.

Identification of Calcified Blood Vessels In various aspects, the present disclosure provides various techniques for improving hemostasis when sealing calcified blood vessels, and challenges the sealing of calcified blood vessels. deal with. In one aspect, the ultrasound device is configured to intelligently manage the sealing of calcified blood vessels. In one aspect, the jaw contents are in FIGS. 54-56 under the heading "guessing the condition of the jaws (pad burnthrough, staples, broken blades, bones in the jaws, tissue in the jaws)" and /. Alternatively, an identified identifier using smart blade algorithmic techniques for inferring or classifying the jaw states of the ultrasonic device described in connection with FIGS. 57-65 under the heading "Model-based jaw classification states". The technique for estimating the temperature of an ultrasonic blade, which may be and / or is incorporated herein by reference in its entirety, is the United States entitled "TEMPERATURE CONTORL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al. It is described in connection with Patent Provisional Application Nos. 62 / 640,417. Therefore, these techniques can be used to identify calcified blood vessels when clamped within the jaws of an ultrasonic instrument.

Three possible scenarios are disclosed. In one aspect, the user warns from the generator that Joe is clamped in a calcified blood vessel and the device will not fire. In another aspect, the instrument prompts the user that Joe is clamping a calcified blood vessel, allowing the instrument to fire until the minimum amount of compression time (eg, 10-15 seconds) has elapsed. do not do. This additional time allows the calcification / plaque to move away from the transverse incision side and improve the hemostasis of the seal. In a third aspect, when the calcified vessel is grasped and the activation button is pressed, the instrument uses an internal motor to displace the spring stack by an additional amount, resulting in a slightly higher clamping force on the calcified vessel. And deliver better compression.

FIG. 78 is a logical flow of a process showing a control program or logical configuration for identifying calcified blood vessels according to at least one aspect of the present disclosure. According to the process, the generator or instrument control circuit identifies the vessel located within the jaw of the ultrasonic device when the jaw clamps over the vessel (1322282). When the control circuit identifies a calcified blood vessel (132284), the control circuit sends a warning message that can be perceived by the user (132286). The message contains information to notify the user that a calcified blood vessel has been detected. The control circuit then prompts the maintenance of compression on the calcified vessel for a predetermined waiting period T1 (eg, x seconds) (132288). This allows the calcification to move away from the jaws. At the end of the compression standby period T1, the control circuit allows the ultrasonic generator to be activated (132290). When the control circuit "identifies a normal (eg, non-calcified) blood vessel (132292), the control circuit allows the ultrasonic device to be activated normally (132294). Therefore, the ultrasonic device , One or more hemostatic algorithms as described herein can be performed.

FIG. 79 is a logical flow diagram 132300 of a process showing a control program or logical configuration for identifying calcified blood vessels according to at least one aspect of the present disclosure. According to the process, the generator or instrument control circuit identifies the vessel located within the jaw of the ultrasonic device when the jaw clamp 132302 is clamped onto the vessel (1322282). When the control circuit identifies a calcified blood vessel (132304), the control circuit sends a warning message that the detection of the calcified vessel can be perceived by the user (132306). The control circuit either disables the ultrasonic device (132308) or does not allow its activation. When the control circuit identifies a "normal" blood vessel (eg, not calcified) (132310), the control circuit allows for normal activation of the ultrasonic device (132312). Thus, the ultrasonic device can perform one or more hemostatic algorithms as described herein.

FIG. 80 is a logical flow diagram 132320 of a process showing a control program or logical configuration for identifying calcified blood vessels according to at least one aspect of the present disclosure. According to the process, the generator or instrument control circuit identifies the vessel located within the jaw of the ultrasonic device when the jaw is clamped onto the vessel (1322282). When the control circuit identifies a calcified blood vessel (132324), the control circuit sends a warning message that the detection of the calcified vessel can be perceived by the user (132326). The control circuit uses a motor to increase the jaw clamping force to achieve better compression of the calcified blood vessels (132328). The control circuit then allows the activation of ultrasonic energy after adjusting the clamping force (132330). When the control circuit identifies a "normal" blood vessel (eg, not calcified) (132332), the control circuit allows the ultrasonic device to be activated normally (132334). Thus, the ultrasonic device can perform one or more hemostatic algorithms as described herein.

Detection of Large Blood Vessels During Parenchymal Tissue Incision Using Smart Blade During a liver resection procedure, the surgeon will not be able to see the large blood vessels because the large blood vessels are buried inside the incised parenchymal tissue. There is a risk of disconnection. FIGS. 81-86 of the present disclosure can detect differences between parenchymal tissue and large blood vessels within parenchymal tissue by using the magnitude and phase of impedance measurements over the swept frequency range. It outlines applications that can be "smart blades" (eg, ultrasonic blades with feedback to provide jaw content identification). During the parenchymal tissue incision procedure, the blood vessels are shown in FIGS. 54-56 under the heading "guess of jaw condition (pad burnthrough, staples, broken blades, bone in jaw, tissue in jaw)" and / Alternatively, the detection using the smart blade algorithm technique for estimating or classifying the jaw state of the ultrasonic device described in connection with FIGS. 57-65 under the heading "Model-based jaw classification state". A US patent provisional application entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al. It is described in connection with Nos. 62 / 640,417.

During liver resection and incision procedures for other vascular parenchymal tissue, the surgeon cannot see the vessels that are substantially buried in the parenchymal tissue along the incision surface. This can cause the surgeon to cut large blood vessels without sealing, resulting in bleeding in the patient and excessive bleeding that stresses the surgeon. FIGS. 81-86 illustrate solutions that provide a method of detecting large blood vessels buried in parenchymal tissue without the need to visualize large blood vessels using the application of smart ultrasonic blades.

The ultrasound apparatus described herein may be used to achieve the next vessel detection before initiating the liver resection and incision procedure. The control circuit of the generator or ultrasonic device initiates frequency sweep from less than resonance to above resonance of the electromechanical ultrasonic system to allow measurement of impedance magnitude and phase. The results are plotted on a 3D curve as described in relation to FIGS. 54-56. The resulting 3D curve will have a particular morphology when the ultrasonic blade is in contact with the parenchymal tissue and will be described later when the ultrasonic blade is in contact with a tissue other than the parenchymal tissue. Will have the form of.

When the ultrasonic blade is in contact with a large blood vessel, a different 3D curve is generated by frequency sweep. When the ultrasonic blade contacts a blood vessel, the control circuit compares the test frequency sweep of the new (vascular) curve with the frequency sweep of the old (parenchymal tissue) curve and the new (vascular) curve the old (substantial) curve. Tissue) Identify as different from the curve. Based on the comparison results, the control circuit is the action taken by the ultrasonic device to prevent cutting into large blood vessels, and the large blood vessels are located on or in contact with the ultrasonic blade. Allows the surgeon to be notified that he / she is present.

The various actions that can be taken by the ultrasound device are to change the procedural output of the device to prevent amputation of the blood vessel, or tones from the generator to notify the surgeon that a blood vessel has been detected. Or a combination thereof, but is not limited to these.

Alternatively, various aspects of this technique may be applied to detect blood when a vessel is cut, allowing the surgeon to quickly seal the vessel without looking at the cut vessel. ..

FIG. 81 is FIG. 132340 of a liver resection section 132350 having a blood vessel 132354 (FIG. 82) buried in parenchymal tissue, according to at least one aspect of the present disclosure. An ultrasonic instrument 132342, including an ultrasonic blade 132344 and a clamp arm 132346, is shown cut into the liver 132348 to form a resection 132350. The ultrasonic instrument 132342 is connected to a generator 132352 that controls the delivery of energy to the ultrasonic instrument 132342. Either or both of the generator 132252 and the ultrasonic instrument 132342 include control circuits configured to perform the advanced smart blade algorithms described herein.

FIG. 82 is FIG. 132356 of the ultrasonic blade 132344 in the process of cutting through parenchymal tissue without contact with blood vessels 132354 buried within the liver 132348, according to at least one aspect of the present disclosure. During the excision process, the control circuit monitors the impedance, magnitude, and phase of the signal driving the ultrasonic transducer, as shown in FIGS. 83A and 83B, to determine the condition of the jaws, eg, the condition of the ultrasonic blade 132344. evaluate. Thus, when the ultrasonic blade 132344 excises the liver 132348, the ultrasonic transducer produces a first response, and when the ultrasonic blade 132344 comes into contact with the buried vessel 132354, the ultrasonic transducer is shown in FIGS. 54-. As described herein in connection with FIG. 81, it produces a second response associated with the type of buried vessel 132354.

83A and 83B are graphs of magnitude / phase of ultrasonic transducer impedance with the parenchymal structure curve 132362 shown by thick line according to at least one aspect of the present disclosure. FIG. 83A is a three-dimensional plot and FIG. 83B is a two-dimensional plot. These curves occur according to FIGS. 54-56 and are related to the heading, for example, guessing the condition of the jaws (pad burnthrough, staples, broken blades, bone in the jaws, tissue in the jaws). Is. Alternatively, techniques for estimating or classifying the jaw states of the ultrasonic device described in connection with FIGS. 57 and 56 under the heading "Model-based jaw classification states" and / or the temperature of the ultrasonic blade. Techniques for inferring the temperature may be described and used in connection with US Patent Provisional Application No. 62 / 640,417 entitled "TEMPERATURE CONTOROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR".

FIG. 84 is FIG. 132364 of the ultrasonic blade 132344 in the process of cutting through the parenchymal tissue into the blood vessel 132354 buried in the liver 132348 and contacting the blood vessel 132354 according to at least one aspect of the present disclosure. When the ultrasonic blade 132344 makes a transverse incision in the parenchymal tissue of the liver 132348, the ultrasonic blade 132344 contacts the blood vessel 132354 at position 132366 and thus shifts the resonant frequency of the ultrasonic transducer as shown in FIGS. 85A and 85B. Let me. The control circuit monitors the impedance, magnitude, and phase of the signal driving the ultrasonic transducer, as shown in FIGS. 85A and 85B, and superimposes while in contact with the state of the jaw, eg, vessel 132354. The condition of the ultrasonic blade 132344 is evaluated.

85A and 85B are graphs of magnitude / phase of ultrasonic transducer impedance with curve 132372 of large blood vessels shown by thick lines, according to at least one aspect of the present disclosure. FIG. 85A is a three-dimensional plot and FIG. 85B is a two-dimensional plot. These curves occur in connection with FIGS. 54-56 and are related to the heading "Guessing the state of the jaws (pad burnthrough, staples, broken blades, bone in the jaws, tissue in the jaws)". It is a description. Alternatively, a technique for estimating or classifying the jaw states of the ultrasonic apparatus described in connection with FIGS. 57-65, entitled "Model-Based Joe Classification States", and / or ultrasonic blades. Techniques for estimating temperature are described and may be used in connection with US Patent Provisional Application No. 62 / 640,417 entitled "TEMPERATURE CONTROLL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR".

FIG. 86 is a logic of a process showing a control program or logical configuration for treating tissue in parenchymal tissue when blood vessels are detected, as shown in FIGS. 84-85B, according to at least one aspect of the present disclosure. It is a flow figure 132380. According to the process, under the heading "Guessing the condition of the jaws (pad burnthrough, staples, broken blades, bones in the jaws, tissue in the jaws)", and / or "model-based jaws". Using techniques for estimating or classifying the jaw states of ultrasonic devices described in connection with FIGS. 57-65 under the heading "Classification State" and / or estimating the temperature of the ultrasonic blade. Techniques for this have been described in connection with US Patent Application No. 62 / 640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al., Which is incorporated herein by reference in its entirety. The control circuit determines whether the blood vessel 132354 is located in contact with the ultrasonic device 132344. If the control circuit detects blood vessel 132382, the control circuit stops the cutting energy (132384), switches to a lower power level (132386), and sends a warning message or warning to the user (132388). For example, the control circuit reduces the excitation voltage / current signal power to a level lower than the level required to cut the blood vessel. The warning message or alarm may include emitting a light, making a sound, activating a buzzer, and the like. If no blood vessel 132354 is detected, the excision process follows 132390.

Uses of Smart Ultrasonic Blades for Reusable and Disposable Devices The smart blade algorithm uses spectroscopy to identify the status of ultrasonic blades. This feature can be applied to reusable and disposable devices with removable clamp arms to identify if the disposable part of the device is installed correctly. The status of the ultrasonic blades is in FIGS. 54-56 under the heading "Guessing Joe's Condition (Pad Burnthrough, Staples, Broken Blades, Bone in Joes, Tissue in Joes)" and / or " The state of jaw classification based on the model can be determined using the smart blade algorithm technique for estimating or classifying the jaw state of the ultrasonic device described in connection with FIGS. 57-65. And / or a technique for estimating the temperature of an ultrasonic blade is incorporated herein by reference in its entirety, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THE REFOR" by Nott et al. It is described in relation to / 640,417.

The smart blade algorithmic techniques described herein can be used to identify the state of reusable and disposable device components. In one aspect, the status of the ultrasonic blade can be determined to distinguish whether the disposable portion of the reusable and disposable device is properly installed.

87 and 88 identify the status of the ultrasonic blade 132402 to determine if a portion of the reusable and disposable ultrasonic device 132400 is properly installed according to at least one aspect of the present disclosure. , A reusable and disposable ultrasonic device 132400 configured to determine the clocked status of the clamp arm 132404. FIG. 88 is the end effector 132406 portion of the reusable and disposable ultrasonic device 132400 shown in FIG. 87. Similarities and differences between spectroscopic signatures can be used to determine if the reusable and disposable components of the reusable and disposable ultrasound device 132400 are installed correctly.

The reusable and disposable ultrasonic device 132400 shown in FIGS. 87 and 88 includes a reusable handle 132408 and a disposable ultrasonic waveguide / blade 132402. Prior to use, the proximal end 132410 of the disposable ultrasonic waveguide / blade 132402 was inserted into the distal opening 132412 of the reusable handle 132408 (132414) and as shown in FIG. 87, the disposable ultra. Twist or rotate the ultrasonic waveguide / blade 132402 clockwise to lock it into the handle 132408 (132416). If the disposable ultrasound waveguide / blade 132402 is not fully inserted (132414) and / or not fully rotated clockwise (132416), the reusable and disposable ultrasound device 132400 is suitable. Do not work. For example, improper insertion and rotation 132416 of disposable ultrasonic waveguide / blade 132402 results in poor mechanical connection of disposable ultrasonic waveguide / blade 132402, producing different spectral signatures. Therefore, the smart blade algorithm technique described herein is to determine if the disposable portion of the reusable and disposable ultrasound device 132400 has been inserted into (132414) and fully rotated (132416). Can be used for.

In another misaligned configuration, if the clamp arm 132404 shown in FIG. 88 is clocked (rotated) with respect to the ultrasonic blade 132402, the orientation of the ultrasonic blade 132402 with respect to the clamp arm 132404 will be misaligned. Become. This also results in the generation of different spectroscopic signatures when the reusable and disposable ultrasound device 132400 is activated and / or clamped. Therefore, the smart blade algorithm technique described herein is used to determine if the disposable portion of the reusable and disposable ultrasound device 132400 is properly clocked (rotated) with respect to the clamp arm 132404. can do.

In another aspect, the disposable portion of the reusable and disposable ultrasonic device 132400 is pushed into or inserted into the reusable portion 132408 using the smart blade algorithm technique described herein. It can be determined whether or not it has been (132414). This is because, for example, a reusable portion such as the handle 132408 was inserted into a disposable portion such as the ultrasonic blade 132402 (132414) prior to operation, for example, the reusable and disposable ultrasonic device 132400 in FIG. 89 below. It may be applicable to.

FIG. 89 identifies and clamps the status of the ultrasonic blade 132422 to determine if the disposable portion 132426 of the reusable and disposable ultrasonic device 132420 according to at least one aspect of the present disclosure is properly installed. A reusable and disposable ultrasound device 132420 configured to determine if the arm 132424 is not completely distal. If the clamp arm is not installed completely distally, a different spectroscopic signature will be present when the device is clamped. In another aspect, if the disposable portion 132426 is not installed completely distally on the reusable component 132428, the spectral signature of the ultrasonic blade 132422 will be different when clamped in place. .. Therefore, the smart blade algorithm technique described herein is used to determine if the disposable portion 132426 of the reusable and disposable ultrasonic device 132420 is fully and properly coupled to the reusable portion 132428. can do.

FIG. 90 is a logical flow of a process showing a control program or logical configuration for identifying the status of a reusable and disposable ultrasonic device configuration according to at least one aspect of the present disclosure. Logic Flow According to the process shown by FIG. 132430, the generator or instrument control circuit performs smart blade algorithm technology and is assembled reusable and disposable ultrasound device 132400 including reusable and disposable components. , 132420 (FIGS. 88 and 89) to determine the spectroscopic signature 132432. The control circuit compares the measured spectroscopic signature with the reference spectroscopic signature (132434), and the reference spectroscopic signature is associated with properly assembled reusable and disposable ultrasound devices 132400, 132420, of the generator or instrument. Stored in database or memory. When the control circuit determines that the measured spectroscopic signature differs from the reference spectroscopic signature (132436), the control circuit disables the operation of the reusable and disposable ultrasound devices 132400, 132420 (132438) and is perceived by the user. Raise a possible warning (132440). The tapering may include activating a light source or vibration source. If the measured spectroscopic signature is the same as or substantially similar to the reference spectroscopic signature, the control circuit allows normal operation of the reusable and disposable ultrasound devices 132400, 132420 (132442).

Live Time Tissue Classification Using Electrical Parameters Sealing Without Cutting, RF / Ultrasound Combination Techniques, Arranged Algorithms In one aspect, the present disclosure provides algorithms for grouping tissues. The ability to classify organizations by live time allows the algorithm to be tuned for specific tissue groups. The tuned algorithm can adjust the sealing time and hemostasis across all tissue types. In one aspect, the present disclosure provides a hemostasis required for large blood vessels and provides a sealing algorithm for rapidly sealing smaller structures that do not require extended energy activation. The ability to classify these distinct tissue types allows for an optimized algorithm for each group during live time.

In this embodiment, during the first 0.75 seconds of activation, the three RF electrical parameters are used in the plot to classify the tissues into separate groups. These electrical parameters are the initial RF impedance (taken in 0.15 seconds), the minimum RF impedance in the first 0.75 seconds, and the amount of time the RF impedance gradient is about 0 in milliseconds. It is possible to implement multiple other times when these data points are taken. All of this data is collected in a set amount of time and then the organization is categorized into separate groups at live time using a Support Vector Machine (SVM) or another classification algorithm. be able to. Each organization group has an algorithm specific to the algorithm that will be implemented for the rest of the launch. Types of SVMs include linear functions, polynomial functions, and radial basis functions (RBFs).

FIG. 91 is a three-dimensional graph of epidermal growth factor (EGF) radio frequency (RF) tissue impedance classification according to at least one aspect of the present disclosure. The X-axis represents the minimum RF impedance (Zmin) of the tissue, the y-axis represents the initial RF impedance (Zinit) of the tissue, and the z-axis is the time when the derivative of the RF impedance (Z) of the tissue is about 0. Represents the amount of. FIG. 91 shows the initial RF impedance, the minimum RF impedance, and the amount of time the derivative (gradient) of the RF impedance is about 0 within the first 0.75 seconds of activation, using three RF parameters. It shows the grouping of large blood vessels 132452, such as carotid-thick tissue, and small blood vessels 132454, such as thymus-thin tissue. A feature of this classification method is that tissue types can be classified within a set amount of time. The advantage of this method is that special tissue healing procedures can be initiated before exiting the RF bath, as tissue-specific algorithms can be selected towards the initiation of activation. In the context of tissue impedance under the influence of RF energy, it will be appreciated that the bath region is a curve in which the tissue impedance decreases after the initial application of RF energy and stabilizes until the tissue begins to dry. After that, the tissue impedance increases. Therefore, the impedance vs. time curve resembles the shape of a "bathtub".

Using this data, support vector machines were trained and tested to group thick and thin tissues, and 94% of the time was accurately classified.

In one aspect, the present disclosure provides a device that includes one combined RF / ultrasound algorithm used for all tissue types, where thin tissue encapsulation rates are longer than necessary, but larger vessels and thicker. The structure has been identified as being able to benefit from extended launch. This classification scheme allows the combined RF / ultrasound device to seal small structures at optimal speed and burst pressure, as well as large structures to achieve maximum hemostasis.

FIG. 92 is a three-dimensional graph of epidermal growth factor (EGF) radio frequency (RF) tissue impedance analysis according to at least one aspect of the present disclosure. The X = axis represents the minimum RF impedance (Zmin) of the tissue, the y-axis represents the initial RF impedance (Zinit) of the tissue, and the z-axis represents the derivative of the RF impedance (Z) of the tissue being about 0. Represents the amount of time. To determine if this classification model of thin tissue 132464 vs. thick tissue 132462 is robust against different tissue types, we add data for different benchtop tissue types and group the tissues into two separate groups. It became. It is possible to separate this data into multiple groups if it is deemed useful or necessary. Types of tissue 132462 of different thickness include, for example, carotid artery, jejunum, mesentery, cervical canal, and liver tissue. Types of different thin tissues 132464 include, for example, the thyroid gland and the middle thyroid vein.

Microincision Modes for Tissue Classification Tissue Classification Allows Multiple Modes for Consideration of Different Surgical Procedures In one aspect, the present disclosure classifies tissues into groups and groups specific tissue classes in live time. Provides an algorithm that adjusts the algorithm for. The present disclosure, under the heading "Live Time Tissue Classification Using Electrical Parameters", builds on the basis and details of another potential benefit to tissue classification, as described herein. doing.

FIG. 93 is a graph of carotid technique sensitivity, FIG. 132470, in which the time at which the RF impedance (Z) derivative is about 0 is plotted as a function of the initial RF impedance, according to at least one aspect of the present disclosure. It is known that different surgical techniques exist in different parts of the world and change significantly from surgeon to surgeon. For this reason, a technical mode is set up on the generator to allow more efficient energy delivery based on the user's specific surgical technique, for example, tip occlusion of tissue vs. complete occlusion of tissue. May be provided to. Tip occlusion refers to the end effector of a surgical device that grips tissue with only the tip. Complete occlusion refers to the end effector of a surgical device that grips tissue within the entire end effector. The generator may be configured to detect whether the user is consistently operating with a tip occlusion of tissue or a complete occlusion of tissue. As shown in FIG. 93, initial RF impedance data was measured and plotted as group 1 132472 for tip occlusion and as group 2 132474 for complete occlusion. As shown, tissue group 1 132472 tip occlusion _{registers an initial RF impedance Z Init} of less than 250 ohms, and tissue group 2 132474 complete occlusion has an initial impedance Z _Init of 250 ohms to 500 ohms, maximum. Register the RF tissue impedance Z _Max. Upon detecting whether the user is grasping the tip occlusion of the tissue or the complete occlusion of the tissue, the algorithm can suggest a predetermined incision mode. For example, in the case of tissue tip occlusion, the algorithm may suggest a fine incision mode to the user, or this option may be selected prior to treatment. For example, in the case of complete occlusion of tissue, the algorithm may suggest a course incision mode to the user, or this option may be selected prior to treatment. In microincision mode, the algorithm can be tuned to optimize the energy delivery of this surgical technique by reducing ultrasonic displacement and protecting the clamp arm pad from burnthrough. It is also known that tip occlusion has a larger amount of RF noise, causing longer sealing times and greater variations in sealing performance. The fine occlusal cold incision mode has an algorithm tuned to have a lower RF termination impedance and / or a different filtering signal to improve the accuracy of energy delivery.

Technical sensitivity analysis was performed as part of the classification development work. The test was performed by transversely incising a 3-7 mm vessel in a benchtop setting using different surgical techniques such as complete occlusal transverse incision with or without tension and tip occlusal incision with or without tension. It was implemented. The initial RF impedance and the time RF impedance of the gradient = 0 were all examined as significant factors in grouping the tissues.

It has been determined that surgical techniques can be grouped into three separate groups based on the _{initial RF impedance Z Init.} An initial RF impedance Z _{Init in} the range 0-100 ohms indicates that it is generally operating in the bloodstream field. An initial RF impedance Z _{Init in} the range of 100-300 ohms generally indicates operation under normal conditions, and an initial RF impedance Z _Init above 300 ohms indicates usage, especially in the presence of tension. ing.

Controlled thermal management (CTM) for pad protection
In one aspect, the present disclosure provides a controlled thermal management (CTM) algorithm for controlling temperature using feedback control. The output of the feedback control can be used to prevent the clamp arm pad of the ultrasonic end effector from melting, which is not a desirable effect for ultrasonic surgical instruments. As mentioned above, pad meltdown is generally caused by the continuous application of ultrasonic energy to the ultrasonic blades in contact with the pad after a transverse incision has been made in the tissue gripped within the end effector. ..

The CTM algorithm takes advantage of the fact that the resonant frequency of ultrasonic blades, typically made of titanium, changes in proportion to temperature. As the temperature rises, the elastic modulus of the ultrasonic blade decreases, and the natural frequency of the ultrasonic blade also decreases. Factors to consider are that the distal end of the ultrasonic blade is hot, but the waveguide is cold, which is different from the case where both the distal end of the ultrasonic blade and the waveguide are hot. There is a frequency difference (delta) to achieve the temperature of.

In one aspect, the CTM algorithm changes the frequency of the ultrasonic transducer drive signal required to reach a certain predetermined temperature as a function of the resonant frequency of the ultrasonic electromechanical system at the start of activation (when locked). calculate. An ultrasonic electromechanical system with an ultrasonic transducer connected to an ultrasonic blade by an ultrasonic waveguide has a predetermined resonance frequency that changes with temperature. Using the resonant frequency of the ultrasonic electromechanical system at lock, infer the change in ultrasonic transducer drive frequency required to achieve the cause and temperature endpoint, taking into account the initial thermal state of the ultrasonic blade. Can be done. The resonant frequency of an ultrasonic electromechanical system can vary as a function of the temperature of an ultrasonic transducer, or ultrasonic waveguide, or ultrasonic blade, or a combination of these components.

FIG. 94 is a graph of the relationship between the initial resonant frequency (locking frequency) and the change in frequency (delta frequency) required to achieve a temperature of about 340 ° C. according to at least one aspect of the present disclosure. FIG. 133300. The frequency change required to reach the ultrasonic blade temperature of about 340 ° C. is shown along the vertical axis, and the resonant frequency of the electromechanical ultrasonic system when locked is shown along the horizontal axis. Based on the measurement data points 133302 shown as a scatter plot, there is a linear relationship 133304 between the frequency change required to reach the ultrasonic blade temperature of about 340 ° C. and the resonant frequency at the lock. ..

When the resonant frequency is locked, the CTM algorithm uses a linear relationship 133304 between the locking frequency and the delta frequency required to achieve a temperature just below the melting point of the TEFLON pad (about 340 ° C.). As shown in FIG. 95, when the frequency is within a certain buffer distance from the lower limit of the frequency, the feedback control system 133310 including the ultrasonic generator 133310 follows at least one aspect of the present disclosure, the frequency of the ultrasonic transducer In order to prevent (f) from falling below a predetermined threshold, the current (i) set value applied to the ultrasonic transducer of the ultrasonic electromechanical system 133314 is adjusted. By lowering the set value of the current, the displacement of the ultrasonic blade is reduced, subsequently the temperature of the ultrasonic blade is lowered, and the natural frequency of the ultrasonic blade is raised. This relationship allows changes in the current applied to the ultrasonic transducer to adjust the intrinsic frequency of the ultrasonic blade and indirectly control the temperature of the ultrasonic blade or ultrasonic electromechanical system 133314. In one aspect, the generator 133312 may be implemented, for example, as an ultrasonic generator as described with reference to FIGS. 21, 26, 27A-27C, and 28A-28B. The feedback control system 133310 may be implemented, for example, as a PID controller described with reference to FIGS. 44-45.

FIG. 96 is a process or logical configuration flow of a controlled thermal management (CTM) algorithm for protecting a clamp arm pad in an ultrasonic end effector according to at least one aspect of the present disclosure. Flow The process or logical configuration exemplified by FIG. 133320 may be performed by the ultrasonic generator 133312 described herein, or by a control circuit located within the ultrasonic instrument or a combination thereof. As described above, the generator 133312 may be implemented as a generator as described, for example, with reference to FIGS. 21, 26, 27A-27C, and 28A-28B.

In one aspect, the control circuit in the generator 133312 first activates the ultrasonic instrument by applying an electric current to the ultrasonic transducer. The resonant frequency of the ultrasonic electromechanical system is initially locked in the initial state where the ultrasonic blade temperature is low or close to room temperature. For example, when the temperature of the ultrasonic blade rises due to frictional contact with the tissue, the control circuit monitors the change or delta in the resonance frequency of the ultrasonic electromechanical system to see if the delta frequency threshold for a given blade temperature has been reached. (133324). If the delta frequency is below the threshold, the process proceeds along the "no" branch and the control circuit continues to search for a new resonant frequency (133325) and monitor the delta frequency. When the delta frequency meets or exceeds the delta frequency threshold, the process proceeds along the "yes" branch and calculates a new low frequency limit (threshold) corresponding to the melting point of the clamp arm pad (133326). In one non-limiting example, the clamp arm pad is made of TEFLON and has a melting point of about 340 ° C.

When the new lower frequency limit is calculated (133326), the control circuit determines if the resonant frequency is close to the newly calculated lower frequency limit (133328). For example, in the case of a TEFLON clamp arm pad, the control circuit determines, for example, whether the ultrasonic blade temperature is approaching 350 ° C. based on the current resonant frequency (133328). If the resonant frequency of the current exceeds the low frequency limit, the process proceeds along the "no" branch and applies normal levels of current to the ultrasonic transducer suitable for cross-tissue incision (133330). Alternatively, if the resonant frequency of the current is below the low frequency limit, the process proceeds along the "yes" branch and adjusts the resonant frequency by modifying the current applied to the ultrasonic transducer (133332). In one aspect, the control circuit employs, for example, a PID controller as described with reference to FIGS. 44-45. The control circuit adjusts the frequency in the loop (133332) to determine when the frequency is approaching the lower limit until the "sealing and cutting" surgical procedure is completed and the ultrasonic transducer is deactivated (). 133328). Logic Flow Since the CTM algorithm shown by FIG. 133320 has an effect only at or near the melting point of the clamp arm pad, the CTM algorithm is invoked after the tissue has been traversed.

The burst pressure test performed on the sample shows the effect of the sealing on the burst pressure when the CTM process or logic configuration shown in Logic Flow Figure 133320 is used to seal and cleave blood vessels or other tissues. Indicates that does not exist. In addition, the transverse incision time was affected, based on the test sample. In addition, temperature measurements show that the ultrasonic blade temperature is bounded by the CTM algorithm compared to a device without CTM feedback algorithm control, with a 5 second rest between launches, maximum within 10 seconds with respect to the pad. A device that has experienced 10 firings at power has significantly reduced pad wear, and a device without CTM algorithm feedback control confirms that it did not withstand more than 3 times in this abuse test.

FIG. 97 is a temperature vs. time graph of 133340 comparing a desired temperature of an ultrasonic blade with a smart ultrasonic blade and a conventional ultrasonic blade according to at least one aspect of the present disclosure. Temperature (° C) is shown along the vertical axis and time (seconds) is shown along the horizontal axis. In the plot, the dashed line is the temperature threshold 133342, which represents the desired temperature of the ultrasonic blade. The solid line is the temperature vs. time curve 133344 of the smart ultrasonic blade under the control of the CTM algorithm described with reference to FIGS. 95 and 96. The dotted line is the temperature vs. time curve 133346 of a standard ultrasonic blade that is not under the control of the CTM algorithm described with reference to FIGS. 95 and 96. As shown. When the temperature of the smart ultrasonic blade under the control of the CTM algorithm exceeds the desired temperature threshold (about 340 ° C.), the CTM algorithm gains control and the transverse incision procedure is completed to power the ultrasonic transducer. Controls the temperature of the smart ultrasonic blade to match the threshold as closely as possible until it is stopped or shut off.

In another aspect, the present disclosure provides a CTM algorithm for "sealing only" tissue effects by ultrasonic devices, such as ultrasonic shearing. Generally speaking, ultrasonic surgical instruments typically seal and cut tissue simultaneously. Making an ultrasonic device configured to only seal without cutting requires only ultrasonic techniques because it is uncertain when the sealing will be completed before starting cutting. It was not difficult to achieve using. In one aspect, the CTM algorithm allows the temperature of the ultrasonic blade to exceed the temperature required to cut (transversely incis) the tissue, but by ensuring that it does not exceed the melting point of the clamp arm pad, the end effector. It may be configured to protect the clamp arm pad of the. In another aspect, the CTM sealing only algorithm exceeds the tissue sealing temperature (experimentally about 115 ° C. to about 180 ° C.), but the tissue cutting (transverse incision) temperature (about 180 ° C. to about 350 ° C.). It may be adjusted so as not to exceed ° C.). In the latter configuration, the CTM encapsulation-only algorithm provides a successfully proven "encapsulation-only" texture effect. For example, in a linear fit that calculates the change in frequency with respect to the initial lock frequency shown in FIG. 94, changing the intercept section adjusts the final steady-state temperature of the ultrasonic blade. By adjusting the section parameters, the ultrasonic blade can be set to never exceed about 180 ° C., resulting in tissue encapsulation but not cutting. In one aspect, increasing the clamping force can improve the sealing process without affecting the melt-off of the clamp arm pad, since the blade temperature is controlled only by the CTM sealing algorithm. As described above, the CTM encapsulation-only algorithm includes, for example, the generator and PID controller described with reference to FIGS. 21, 26, 27A-27C, 28A-28B, and 44-45. May be implemented by. Therefore, in the flow diagram 133320 shown in FIG. 96, the control circuit calculates a new low frequency limit (133326) (threshold t corresponds to a "sealing only" temperature, eg, about 180 ° C.) and the frequency is It may be modified to determine when the lower limit is approaching (133328) and adjust the temperature until the "sealing only" surgical procedure is complete and the ultrasonic transducer is stopped (133332).

In another aspect, the present disclosure provides a Cold Thermal Monitoring (CTMo) algorithm configured to detect when a non-traumatic grip is feasible. Acoustic ultrasonic energy results in an ultrasonic blade temperature of about 230 ° C to about 300 ° C to achieve the desired effect of cutting or transversely incising the tissue. Since heat is retained in the metal body of the ultrasonic blade for a period of time after the ultrasonic transducer is stopped, the residual heat stored in the ultrasonic blade is ultrasonic before the ultrasonic blade has a chance to cool. When an end effector is used to grip tissue, it can cause tissue damage.

In one aspect, the CTMo algorithm is at the intrinsic frequency of the ultrasonic electromechanical system from the intrinsic frequency at high temperatures to the intrinsic frequency at a temperature at which non-traumatic gripping is feasible without damaging the tissue gripped by the end effector. Calculate the change. Non-therapeutic signals (about) containing bandwidths of frequencies of, for example, about 48,000 Hz to 52,000 Hz, where natural frequencies are expected to be found, either directly or for a period of time after invoking the ultrasonic transducer. 5mA) is applied to the ultrasonic transducer. The FFT algorithm, or a mathematically valid algorithm for detecting the intrinsic frequency of other ultrasonic electromechanical systems of ultrasonic transducer impedance measured while stimulating the ultrasonic transducer with a non-therapeutic signal, has a large impedance. The intrinsic frequency of the ultrasonic blade is shown as the frequency at which is the minimum. By continuously stimulating the ultrasonic transducer in this way, it provides continuous feedback of the intrinsic frequency of the ultrasonic blade within the frequency resolution of the FFT or other algorithms for estimating or measuring the intrinsic frequency. When a change in the intrinsic frequency corresponding to the temperature at which a non-traumatic grip is feasible is detected, the device indicates that a non-traumatic grip is possible with a tone, or LED, or screen display, or other. A form of notification, or a combination thereof, is provided.

In another aspect, the present disclosure provides a CTM algorithm configured to tune for the termination of sealing and cutting or transverse incision. Providing "tissue sealing" and "end of cutting" notifications does not allow temperature measurements to be easily mounted directly on the ultrasonic blade, and the clamp arm pad is clearly detected by the blade using a sensor. This is a difficult task for conventional ultrasonic devices. The CTM algorithm can indicate the temperature state of the ultrasonic blade, and since the "end of cutting" and / or "tissue sealing" states are temperature-based events, they are used to indicate these. obtain.

In one aspect, the CTM algorithm according to the present disclosure detects a "end of disconnect" state and triggers a notification. Tissue is typically cleaved at about 210 ° C to about 320 ° C with a high probability. The CTM algorithm activates the tone at 320 ° C. (or similar), the tissue is probably cut, and the ultrasonic blade is now operating against the clamp arm pad, so further activation on the tissue. Can be shown to be unproductive, which is acceptable while the CTM algorithm is in operation because the CTM algorithm controls the temperature of the ultrasonic blades. In one aspect, the CTM algorithm controls or adjusts the power to the ultrasonic transducer to maintain the ultrasonic blade temperature at about 320 ° C. once the ultrasonic blade temperature is estimated to reach 320 ° C. Programmed in. Initiating the tone at this point provides an indicator that the tissue has been severed. The CTM algorithm is based on frequency fluctuations with temperature. After determining the initial state temperature (based on the initial frequency), the CTM algorithm can calculate the frequency change corresponding to the temperature indicating when the tissue was cut. For example, if the starting frequency is 51,000 Hz, the CTM algorithm calculates the frequency change required to reach 320 ° C., which can be −112 Hz. The CTM algorithm then initiates control and maintains its frequency set (eg 50,888 Hz), thereby adjusting the temperature of the ultrasonic blade. Similarly, the frequency change can be calculated based on the initial frequency, which indicates when the ultrasonic blade is at a temperature that indicates that the tissue has probably been cut. At this point, the CTM algorithm does not need to control the power, it can simply start a tone to indicate the state of the tissue, or if desired, the CTM algorithm controls its frequency at this point. The temperature can be maintained. Either way, "end of disconnection" is indicated.

In one aspect, the CTM algorithm according to the present disclosure detects a "tissue sealing" condition and triggers a notification. Tissues are sealed at about 105 ° C to about 200 ° C, similar to detecting the end of cutting. The frequency change from the initial frequency required to indicate that the temperature of the ultrasonic blade has reached 200 ° C., which indicates the state of sealing only, can be calculated at the start of activation of the ultrasonic transducer. The CTM algorithm can activate the tone at this point, and if the surgeon wishes to obtain a sealing-only condition, the surgeon may stop activation or achieve a sealing-only condition. If desired, the surgeon may stop activating the ultrasound transducer and automatically start the algorithm for a particular seal only from this point, or the surgeon may ultrasonically to achieve a tissue cutting condition. The transducer may continue to activate.

Situational Awareness With reference to FIG. 98, a timeline 5200 indicating situational awareness of a hub, such as a surgical hub 106 or 206, is shown. Time line 5200 is exemplary surgical procedure and contextual information that surgical hubs 106, 206 can derive from data received from a data source at each step of the surgical procedure. Timeline 5200 is taken by nurses, surgeons, and other healthcare professionals in the process of lung segment resection surgery, which begins with the establishment of an operating room and ends with the transfer of the patient to the postoperative recovery room. Here is a typical process that would be.

Situation Aware Surgical Hubs 106, 206 are data sources that include data generated each time a healthcare professional uses a modular device paired with Surgical Hubs 106, 206 throughout the surgical procedure. Receive from. Surgical hubs 106, 206 receive this data from paired modular devices and other data sources to provide new data such as which step of the procedure is being performed at any given time. When received, estimates (ie, contextual information) about ongoing actions can be continuously derived. Situational awareness systems at surgical hubs 106, 206 may be associated with, for example, recording procedure data to generate reports, verifying steps taken by healthcare professionals, and specific procedure steps. Providing data or prompts (eg, via a display screen), adjusting modular devices based on context (eg, activating a monitor, adjusting the visibility (FOV) of a medical imaging device, or super It is possible to perform (such as changing the energy level of an ultrasonic or RF electrosurgical instrument) and any of the other such actions described above.

As a first step 5202 in this exemplary procedure, the hospital staff reads the patient's EMR from the hospital's EMR database. Based on selected patient data in the EMR, surgical hubs 106, 206 determine that the procedure performed is a thoracic procedure.

In the second step 5204, the staff scans incoming medical supplies for treatment. Surgical hubs 106, 206 cross-reference the scanned supplies with a list of supplies used in various types of procedures to ensure that the mix of supplies corresponds to the thoracic procedure. In addition, the surgical hubs 106, 206 can also determine that the procedure is not a wedge-shaped procedure (the incoming supplies do not contain the specific supplies required for the thoracic wedge-shaped procedure, or otherwise the thoracic Either because it does not support wedge-shaped treatment).

In step 5206, the healthcare professional scans the patient's band via a scanner communicatively connected to the surgical hubs 106, 206. Surgical hubs 106, 206 can then confirm patient identification information based on the scanned data.

In step 4 5208, the medical staff turns on the assistive device. Auxiliary devices utilized may vary depending on the type of surgical procedure and the technique used by the surgeon, but in this exemplary case, these include smoke evacuators, inhalers, and medical imaging devices. Upon activation, the modular device, the auxiliary device, can be automatically paired with surgical hubs 106, 206 located within a particular neighborhood of the modular device as part of its initialization process. .. Surgical hubs 106, 206 can then derive contextual information about the surgical procedure by detecting the type of modular device paired with it preoperatively or during this initialization phase. In this particular embodiment, surgical hubs 106, 206 determine that the surgical procedure is VATS surgery based on this particular combination of paired modular devices. Based on the combination of data from the patient's EMR, the list of medical supplies used in the surgery, and the type of modular device connected to the hub, the surgical hubs 106, 206 generally describe the specific procedure performed by the surgical team. Can be estimated. Once the surgical hubs 106, 206 know what specific procedure is being performed, the surgical hubs 106, 206 are then read from memory or from the cloud the process of that procedure and then connected. Data subsequently received from other data sources (eg, modular and patient monitoring devices) can be cross-referenced to estimate which step of the surgical procedure is being performed by the surgical team.

In the fifth step 5210, the staff attaches the EKG electrode and other patient monitoring device to the patient. EKG electrodes and other patient monitoring devices can be paired with surgical hubs 106, 206. When the surgical hubs 106, 206 start receiving data from the patient monitoring device, the surgical hubs 106, 206 confirm that the patient is in the operating room.

In step 5212, the healthcare professional induces anesthesia in the patient. Surgical hubs 106, 206 indicate that the patient is under anesthesia, based on data from modular and / or patient monitoring devices, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Can be estimated. When the sixth step 5212 is completed, the preoperative part of the lung segment resection surgery is completed and the surgical part is started.

In step 5214, the operated patient's lungs are collapsed (while ventilation is switched to the contralateral lungs). Surgical hubs 106, 206 can, for example, estimate from ventilator data that the patient's lungs have collapsed. Surgical hubs 106, 206 can compare the detection of collapse of the patient's lungs with the expected steps of the procedure (which can be pre-accessed or read) so that the surgical part of the procedure It can be presumed that it has begun, thereby collapsing the lungs, which can be determined to be the first surgical step in this particular procedure.

In the eighth step 5216, a medical imaging device (eg, a scope) is inserted and a video image from the medical imaging device is started. Surgical hubs 106, 206 receive medical imaging device data (ie, video or image data) through a connection to a medical imaging device. Upon receiving the medical imaging device data, the surgical hubs 106, 206 can determine that the laparoscopic portion of the surgical procedure has begun. In addition, surgical hubs 106, 206 can determine that the particular procedure being performed is a segmental resection as opposed to a lobectomy (in the data received in the second step 5204 of the procedure). Note that the wedge procedure has already been discounted by the surgical hubs 106, 206). The data from the medical imaging device 124 (FIG. 2) has been used (ie, activated) by determining the angle of the medical imaging device that is oriented with respect to the visualization of the patient's anatomical structure. Among many different methods, including by monitoring the number or medical imaging device (paired with surgical hubs 106, 206) and by monitoring the type of visualization device used. Can be used to determine contextual information about the type of treatment being performed from. For example, one technique for performing a VATS lobectomy is to place the camera above the diaphragm in the anterior inferior corner of the patient's thoracic cavity, while one technique for performing a VATS segmental resection is a camera. Is placed at the anterior intercostal position with respect to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situation recognition system can be trained to recognize the location of a medical imaging device based on a visualization of the patient's anatomical structure. As another example, one technique for performing VATS lobectomy utilizes a single medical imaging device, while another technique for performing VATS segmental resection utilizes multiple cameras. As yet another example, one technique for performing VATS segmental resection uses an infrared light source (which can be communicatively linked to a surgical hub as part of a visualization system) to visualize segmental fissures. , This is not used in VATS lobectomy. By tracking any or all of this data from a medical imaging device, surgical hubs 106, 206 are used for a particular type of surgical procedure in progress and / or a particular type of surgical procedure. You can determine which technology you have.

In step 5218, the surgical team initiates the procedure incision step. The surgical hubs 106, 206 are presumed to be in the process of the surgeon incising and separating the patient's lungs to receive data from the RF or ultrasound generator indicating that the energy device is being fired. Can be done. Surgical hubs 106, 206 cross-reference the received data with the read process of the surgical procedure and the energy fired at this point in the process (ie, after the procedure of the procedure described above is complete). It can be determined that the instrument is compatible with the incision process. In certain examples, the energy instrument can be an energy tool attached to the robot arm of a robotic surgical system.

In step 10 5220, the surgical team proceeds to the procedure ligation step. Since the surgical hubs 106, 206 receive data from surgical staples and cutting instruments indicating that the instrument is being fired, it can be presumed that the surgeon is ligating the arteries and veins. Similar to the previous step, surgical hubs 106, 206 can derive this estimate by cross-referencing the reception of data from surgical staples and cutting instruments with the steps in the read process. .. In certain examples, the surgical instrument can be a surgical tool attached to the robot arm of a robotic surgical system.

In step 5222, a segmental excision portion of the procedure is performed. Surgical hubs 106, 206 can be presumed that the surgeon is making a transverse incision in parenchymal tissue based on data from surgical staples and cutting instruments, including data from the cartridge. The data in the cartridge can correspond, for example, to the size or type of staple fired by the instrument. Since different types of staples are utilized for different types of tissue, the cartridge data can indicate the type of tissue that has been stapled and / or traversed. In this case, the type of staple fired is used for parenchymal tissue (or other similar tissue type), thereby presuming that surgical hubs 106, 206 are performing a segmental resection of the procedure. Can be done.

Then, in the twelfth step 5224, a nodule incision step is performed. Surgical hubs 106, 206 are presumed to have a surgical team incising a nodule and performing a leak test based on data received from a generator indicating that an RF or ultrasonic instrument is being fired. Can be done. For this particular procedure, the RF or ultrasound instrument used after the parenchymal tissue has been transversely incised corresponds to a nodular incision step, which allows surgical hubs 106, 206 to make this estimate. It will be possible. Surgeons regularly staple / cut instruments and surgical energy (ie, RF or ultrasound), depending on the particular step during the procedure, because different instruments better fit to a particular task. Note that it alternates between the instrument and the device. Thus, the particular sequence in which stapled / cutting instruments and surgical energy instruments are used can indicate which step of the procedure the surgeon is performing. In addition, in certain cases, robotic tools can be used for one or more steps during a surgical procedure and / or handheld surgical instruments for one or more steps during a surgical procedure. Can be used. The surgeon (s) can, for example, alternate between the robot tool and the handheld surgical instrument in sequence and / or, for example, the device can be used simultaneously. Upon completion of the twelfth step 5224, the incision is closed and the postoperative portion of the procedure begins.

In step 5226, the patient's anesthesia is reversed. Surgical hubs 106, 206 can be estimated, for example, based on ventilator data (ie, the patient's respiratory rate begins to increase) that the patient is awakening from anesthesia.

Finally, the fourteenth step 5228 is for the healthcare professional to remove various patient monitoring devices from the patient. Therefore, surgical hubs 106, 206 can presume that the patient is being transferred to the recovery room when the hub loses other data from the EKG, BP, and patient monitoring device. As can be seen from the description of this exemplary procedure, the surgical hubs 106, 206 are given a given surgical procedure, based on data received from various data sources communicatively linked to the surgical hubs 106, 206. It is possible to determine or estimate when each step of is occurring.

Situational awareness is further described in US Provisional Patent Application No. 62 / 611,341, filed December 28, 2017, entitled "INTERACTIVE SURGICAL PLATFORM," which is incorporated herein by reference in its entirety. In certain examples, the behavior of a robotic surgical system, including, for example, the various robotic surgical systems disclosed herein, is based on its situational awareness and / or feedback from its components, and / or from the cloud 102. Can be controlled by hubs 106, 206 based on the information in.

Although several forms have been exemplified and described, it is not the applicant's intent to limit or limit the accompanying "claims" to such details. A number of modifications, modifications, changes, substitutions, combinations and equivalents of these forms can be implemented and will be conceived by those skilled in the art without departing from the scope of the present disclosure. Further, the structure of each element associated with the form described can be described alternative as a means for providing the functionality performed by that element. Also, although the material is disclosed for a particular component, other materials may be used. Therefore, the above description and the appended claims are intended to cover all such modifications, combinations, and modifications as included within the scope of the disclosed form. I want you to understand. The appended claims are intended to cover all such modifications, modifications, changes, substitutions, modifications, and equivalents.

The above detailed description has described various forms of equipment and / or processes using block diagrams, flowcharts, and / or examples. As long as such block diagrams, flowcharts, and / or embodiments include one or more functions and / or operations, it is appreciated by those skilled in the art that such block diagrams, flowcharts, and / or Each function and / or operation included in the embodiments can be implemented individually and / or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. To those skilled in the art, all or part of some of the embodiments disclosed herein may be as one or more computer programs running on one or more computers (eg, 1). As one or more programs running on one or more computer systems (as one or more programs running on one or more computer systems) (eg, as one or more programs running on one or more processors) Can be equivalently implemented on an integrated circuit as one or more programs running on a microprocessor, as firmware, or as virtually any combination thereof, and designing the circuit. And / or writing code for software and / or firmware will be understood to be within the skill of those skilled in the art in light of the present disclosure. Further, as will be appreciated by those skilled in the art, the mechanisms of subject matter described herein can be distributed in a variety of forms as one or more program products, which are described herein. The specific forms of the described subject matter are used regardless of the particular type of signal carrier used in the actual distribution.

Instructions used to program logic to perform various disclosed aspects can be stored in in-system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage. In addition, instructions can be distributed over the network or by other computer-readable media. Therefore, the machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (for example, a computer), such as a floppy diskette, an optical disk, a compact disk, or a read-only memory (CD). -ROM), as well as magnetic optical disks, read-only memory (ROM), random access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, Tangible machine readable used to transmit information over the Internet via flash memory or electrical, optical, acoustic, or other forms of propagating signals (eg, carriers, infrared signals, digital signals, etc.) Not limited to storage. Thus, non-transitory computer-readable media include any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).

As used in any aspect of the specification, the term "control circuit" refers, for example, to a hard-wired circuit, a programmable circuit (eg, a computer processor containing one or more individual instruction processing cores, a processing unit). By a processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic mechanism (PLD), programmable logic array (PLA), or field programmable gate array (FPGA)), state mechanical circuit, programmable circuit. It can refer to a firmware that stores the instructions to be executed, and any combination thereof. Control circuits can be collectively or individually, for example, integrated circuits (ICs), application-specific integrated circuits (ASICs), system-on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. , Can be embodied as a circuit that forms part of a larger system. Therefore, as used herein, the "control circuit" is an electric circuit having at least one individual electric circuit, an electric circuit having at least one integrated circuit, and an electric circuit having at least one integrated circuit for a specific application. A circuit, a general-purpose computing device composed of a computer program (for example, a general-purpose computer composed of a computer program that executes at least a part of the process and / or the device described in the present specification, or a process described in the present specification. And / or electrical circuits that form a computer program that at least partially executes the device, electrical circuits that form a memory device (eg, in the form of a random access memory), and / or a communication device (eg, a communication device). Examples include, but are not limited to, electrical circuits that form modems, communication switches, or optical-electrical equipment. Those skilled in the art will recognize that the subjects described herein may be realized in analog or digital forms or some combination thereof.

As used in any aspect of the specification, the term "logic" may refer to an application, software, firmware, and / or circuit configured to perform any of the aforementioned operations. The software may be embodied as software packages, codes, instructions, instruction sets, and / or data recorded on non-temporary computer-readable storage media. The firmware may be embodied as code, instructions, or instruction sets in a memory device, and / or as hard-coded (eg, non-volatile) data.

As used in any aspect of the specification, the terms "component", "system", "module", etc. are either hardware, a combination of hardware and software, software, or running software. Can point to a computer-related entity.

As used in any aspect of the specification, an "algorithm" refers to a self-consistent sequence of steps that leads to a desired result, and a "step" is, but is not necessarily necessary, a memory, transfer, combination, Refers to the manipulation of physical quantities and / or logical states that can be in the form of electrical or magnetic signals that can be compared and manipulated differently. It is common practice to refer to these signals as bits, values, elements, symbols, letters, terms, numbers, and so on. These and similar terms may be associated with appropriate physical quantities and are simply convenient labels that apply to these quantities and / or conditions.

The network may include a packet switching network. Communication devices can communicate with each other using selected packet-switched network communication protocols. One exemplary communication protocol includes an Ethernet communication protocol that can enable communication using a transmission control protocol / Internet Protocol (TCP / IP). The Ethernet protocol conforms to or is compatible with the December 2008 title "IEEE 802.3 Standard" published by the Institute of Electrical and Electronics Engineers (IEEE) and / or later versions of the Ethernet standard. There can be. Alternatively or additionally, the communication device is X.I. Twenty-five communication protocols can be used to communicate with each other. X. The 25 communication protocols may conform to or be compatible with the standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices can communicate with each other using the Frame Relay communication protocol. The Frame Relay communication protocol conforms to or is compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transmitters and receivers may be able to communicate with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published in August 2001 under the title "ATM-MPLS Network Interworking 2.0" by the ATM Forum and / or later versions of this standard. .. Not surprisingly, connection-oriented network communication protocols developed differently and / or later are equally contemplated herein.

Unless otherwise stated, as is clear from the above disclosure, throughout the above disclosure, "process," "calculate," "calculate," "determine," "display," etc. Discussions that use the term refer to data expressed as a physical (electronic) quantity in a computer system's memory or memory as a physical quantity in the computer's memory or register or such information storage, transmission, or display. It will be appreciated that it refers to the operation and processing of a computer system or similar electronic computing device that manipulates and transforms into other similarly represented data.

One or more components are "configured to", "configurable to", and "operable / as" herein. "Operaable / operative to", "adapted / adaptive", "able to", "conformable / conformable" to) ”and so on. Those skilled in the art will generally appreciate that "configured as" is an active component and / or an inactive component and / or a standby component, unless the context should be interpreted in other ways. You will understand that it can contain elements.

The terms "proximal" and "distal" are used herein with reference to the clinician operating the handle portion of the surgical instrument. The term "proximal" refers to the part closest to the clinician, and the term "distal" refers to the part located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical", "horizontal", "top", and "bottom" may be used for drawings herein. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limited and / or absolute.

Those skilled in the art generally intend that the terms used herein, and in particular in the appended claims (eg, the text of the appended claims), are generally "open" terms. The term "including" should be interpreted as "including but not limited to" and the term "having". Should be interpreted as "having at least" and the term "includes" should be interpreted as "includes but is not limited to" You will understand that it should be done, etc.). In addition, if a particular number is intended in the introduced claim recitation, such intent is clearly stated in the claim, and in the absence of such intent, such intent does not exist. However, those skilled in the art will understand. For example, as an aid to understanding, the following claims introduce the introductory phrases "at least one" and "one or more" and the claims. May be included to do. However, the use of such a phrase is an introductory phrase such as "one or more" or "at least one" in the same claim, even if the claim description is introduced by the indefinite definite article "a" or "an". And any particular claim, including such an introduced claim statement, is limited to a claim that includes only one such claim, even if it contains the indefinite definite "a" or "an". Should not be construed as suggesting (eg, "a" and / or "an" should usually be construed as meaning "at least one" or "one or more". ). The same is true when introducing claims using definite articles.

Moreover, even if a particular number is specified in the introduced claims, such statement should typically be construed to mean at least the number stated. , Will be recognized by those skilled in the art (eg, if there is a mere "two entries" with no other modifiers, then generally at least two entries, or two or more statements. Means matter). Further, when a notation similar to "at least one of A, B, C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art will understand the notation (eg, for example. , "A system having at least one of A, B, and C", but is not limited to, A only, B only, C only, both A and B, both A and C, B and Includes systems with both C and / or all of A, B and C, etc.). When a notation similar to "at least one of A, B, C, etc." is used, such syntax is generally intended to mean that one of ordinary skill in the art will understand the notation (eg, "" A system having at least one of A, B, or C "is, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C. Includes systems with both and / or all of A, B and C, etc.). Moreover, typically any selective word and / or phrase representing two or more selective terms is used in the specification unless the context requires other meanings. It is understood that it is intended to include one of those terms, any of those terms, or both, whether in the claims, in the claims, or in the drawings. Those skilled in the art will understand that it should be. For example, the phrase "A or B" will typically be understood to include the possibility of "A" or "B" or "A and B".

With respect to the appended claims, one of ordinary skill in the art will appreciate that the actions cited herein can generally be performed in any order. In addition, although the flow charts of various operations are shown in a sequence (s), it is understood that the various operations may be performed in an order other than those illustrated, or may be performed at the same time. It should be. Examples of such alternative ordering are duplicates, alternations, interrupts, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different ordering, unless the context requires other meanings. May include. In addition, terms such as "responding to", "related to", or other past tense adjectives may generally exclude such variants unless they should be interpreted in other ways in the context. Not intended.

Any reference to "one aspect", "aspect", "exemplification", "one example", etc. includes a particular mechanism, structure, or property described in connection with that aspect in at least one aspect. It is worth noting that it means. Therefore, the terms "in one aspect", "in an embodiment", "in an example", and "in an example" found in various places throughout the specification do not necessarily all refer to the same aspect. Moreover, certain features, structures, or properties can be combined in any suitable manner in one or more embodiments.

Any patent application, patent, non-patent publication, or other disclosed material referenced herein and / or listed in any application datasheet is to the extent that the material incorporated is consistent with this specification. , Incorporated herein by reference. As such, and to the extent necessary, the disclosures expressly stated herein shall supersede any contradictory statements incorporated herein by reference. Any content that conflicts with current definitions, views, or other disclosures described herein, or parts thereof, shall be incorporated herein by reference, but with reference and current disclosure. It shall be referred to only to the extent that there is no contradiction with.

In summary, many benefits have been described as a result of using the concepts described herein. The above description in one or more forms is presented for purposes of illustration and description. It is not intended to be inclusive or limited to the exact form disclosed. In view of the above teachings, modifications or modifications are possible. One or more forms exemplify the principles and practical applications, thereby making various forms available to those skilled in the art as suitable for the particular application conceived, along with various modifications. Therefore, it has been selected and described. The claims presented with this specification are intended to define the overall scope.

Various aspects of the subject matter described herein are described in the numbered examples below.

Example 1. A method for estimating the state of an end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system is an ultrasonic system. Including an ultrasonic transducer connected to a blade, the method is to measure the complex impedance of the ultrasonic transducer by a control circuit.

として定義される、測定することと、制御回路によって、複素インピーダンス測定データ点を受信することと、制御回路によって、複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、制御回路によって、比較解析の結果に基づいて、複素インピーダンス測定データ点を分類することと、制御回路によって、比較解析の結果に基づいて、エンドエフェクタの状態又は状況を割り当てることと、制御回路によって、超音波装置のエンドエフェクタの状態を推測することと、制御周回によって、推測された状態に基づいて、超音波装置のエンドエフェクタの状態を制御することと、を含む。

The measurement is defined as, the control circuit receives the complex impedance measurement data points, and the control circuit compares the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern. By the control circuit, the complex impedance measurement data points are classified based on the result of the comparative analysis, and by the control circuit, the state or status of the end effector is assigned based on the result of the comparative analysis, and by the control circuit. , The state of the end effector of the ultrasonic device is estimated, and the state of the end effector of the ultrasonic device is controlled based on the estimated state by the control circuit.

Example 2. The control circuit receives the reference complex impedance characteristic pattern from the database or memory connected to the control circuit, and the control circuit generates the reference complex impedance characteristic pattern, which is connected to the control circuit below. By applying a non-therapeutic drive signal to the ultrasonic transducer, which starts at the initial frequency and ends at the final frequency by the drive circuit, and at multiple frequencies between them, and by the control circuit, the ultrasonic transducer In order to measure the impedance of the impedance at each frequency, to store the data points corresponding to each impedance measurement value by the control circuit, and to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the control circuit Fitting a curve to multiple data points, including fitting the curve and causing it to occur, where magnitude | Z | and phase φ are plotted as a function of frequency f. The method according to Example 1.

Example 3. The method of Example 2, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation.

Example 4. The control circuit receives a new impedance measurement data point, and the control circuit uses the Euclidean vertical distance from the new impedance measurement data point to the trajectory applied to the reference complex impedance characteristic pattern to create the new impedance. The method according to any one of Examples 1 to 3, comprising classifying measurement data points.

Example 5. The method of Example 4, wherein the control circuit estimates the probability that the new impedance measurement data points will be correctly classified.

Example 6. The method of Example 5, which comprises adding the new impedance measurement data points to the reference complex impedance characteristic pattern by a control circuit based on the estimated correct classification probability of the new impedance measurement data points. ..

Example 7. The control circuit classifies the data based on the training data set S, the training data set S contains multiple complex impedance measurement data, and the control circuit uses the parametric Fourier series. , Including fitting a curve to the training dataset S, where S is defined by the following equation:

式中、新たなインピーダンス測定データ点

New impedance measurement data points in the equation

について、

about,

までの垂直距離が、次式によって求められ：

The vertical distance to is calculated by the following equation:

であるときに、
Ｄ＝Ｄ_⊥であり、
Ｄの確率分布が、前記グループＳに属する新たなインピーダンス測定データ点

When
D = D _⊥ ,
The probability distribution of D is a new impedance measurement data point belonging to the group S.

の確率を推測するために使用される、実施例４に記載の方法。

The method according to Example 4, which is used to estimate the probability of.

Example 8. The method of Example 1, wherein the control circuit is located on a surgical hub that communicates with an ultrasonic electromechanical system.

Example 9. A generator for estimating the state of the end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system is an ultrasonic system. The generator includes a control circuit connected to a memory, the control circuit is to measure the complex impedance of the ultrasonic transducer, and the complex impedance includes an ultrasonic transducer connected to a sound blade.

として定義される、測定することと、複素インピーダンス測定データ点を受信することと、複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、比較解析の結果に基づいて、複素インピーダンス測定データ点を分類することと、比較解析の結果に基づいて、エンドエフェクタの状態又は状況を割り当てることと、超音波装置のエンドエフェクタの状態を推測し、推測された状態に基づいて超音波装置のエンドエフェクタの状態を制御することと、を行うように構成されている、発生器。

Based on the results of the measurement, receiving the complex impedance measurement data points, comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern, and the results of the comparative analysis. , Classify complex impedance measurement data points, assign end effector states or situations based on the results of comparative analysis, estimate the end effector state of the ultrasonic device, and based on the inferred state A generator that is configured to control the state of the end effector of an ultrasonic device and to do so.

Example 10. Further comprising a drive circuit connected to a control circuit, the drive circuit applies a non-therapeutic drive signal to the ultrasonic transducer, starting at the initial frequency, ending at the final frequency, and at multiple frequencies in between. The control circuit is further configured to generate the reference complex impedance characteristic pattern.
Receiving the reference complex impedance characteristic pattern from the database or memory connected to the control circuit, measuring the impedance of the ultrasonic transducer at each frequency, and data points corresponding to each impedance measurement value. It is to store in memory and to apply a curve to a plurality of data points in order to generate a three-dimensional curve representing a reference complex impedance characteristic pattern, in which magnitude | Z | and phase φ are functions of frequency f. The generator according to Example 9, which is configured to fit a curve and to perform, plotted as.

Example 11. The generator according to any one of Example 10, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation.

Example 12. The control circuit receives a new impedance measurement data point and uses the Euclidean vertical distance from the new impedance measurement data point to the trajectory applied to the reference complex impedance characteristic pattern to create a new impedance measurement data point. The generator according to any one of Examples 9 to 11, further configured to classify and perform.

Example 13. The generator according to Example 11, wherein the control circuit is further configured to estimate the probability that the new impedance measurement data points will be correctly classified.

Example 14. 13. Example 13 wherein the control circuit is further configured to add new impedance measurement data points to the reference complex impedance characteristic pattern based on the estimated correct classification probability of the new impedance measurement data points. Generator.

Example 15. The control circuit is to classify the data based on the training data set S, wherein the training data set S contains a plurality of complex impedance measurement data, and the training data is classified using a parametric Fourier series. It is further configured to fit a curve into the set S, and S is defined by the following equation:

式中、新たなインピーダンス測定データ点

New impedance measurement data points in the equation

について、

about,

までの垂直距離が、次式によって求められ：

The vertical distance to is calculated by the following equation:

であるときに、
Ｄ＝Ｄ_⊥であり、
Ｄの確率分布が、前記グループＳに属する新たなインピーダンス測定データ点

When
D = D _⊥ ,
The probability distribution of D is a new impedance measurement data point belonging to the group S.

の確率を推測するために使用される、実施例１３に記載の発生器。

The generator according to Example 13, which is used to estimate the probability of.

Example 16. The generator according to Example 9, wherein the control circuit and memory are located in a surgical hub that communicates with an ultrasonic electromechanical system.

Example 17. An ultrasonic device for estimating the state of its end effector, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonance frequency, and an electromechanical ultrasonic system. The control circuit includes an ultrasonic transducer connected to an ultrasonic blade and a control circuit connected to a memory, and the control circuit measures the complex impedance of the ultrasonic transducer.

として定義される、測定することと、複素インピーダンス測定データ点を受信することと、複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、比較解析の結果に基づいて、複素インピーダンス測定データ点を分類することと、比較解析の結果に基づいて、エンドエフェクタの状態又は状況を割り当てることと、超音波装置のエンドエフェクタの状態を推測することと、推測された状態に基づいて超音波装置のエンドエフェクタの状態を制御することと、を行うように構成されている、超音波装置。

Based on the measurement, receiving the complex impedance measurement data points, comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern, and the results of the comparative analysis. , Classify complex impedance measurement data points, assign end effector states or situations based on the results of comparative analysis, estimate the end effector state of the ultrasonic device, and make the estimated state An ultrasonic device that is configured to control and perform the state of the end effector of the ultrasonic device based on.

Example 18. Further comprising a drive circuit connected to a control circuit, the drive circuit applies a non-therapeutic drive signal to the ultrasonic transducer, starting at the initial frequency, ending at the final frequency, and at multiple frequencies in between. The control circuit is further configured to generate a reference complex impedance characteristic pattern.
Receive the reference complex impedance characteristic pattern from the database or memory connected to the control circuit, measure the impedance of the ultrasonic transducer at each frequency, and store the data points corresponding to each impedance measurement value in the memory. And to fit the curves to multiple data points in order to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, where magnitude | Z | and phase φ are plotted as a function of frequency f. The ultrasonic apparatus according to Example 17, which is configured to fit a curve and to perform.

Example 19. The ultrasonic apparatus according to Example 18, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation.

Example 20. The control circuit receives a new impedance measurement data point and uses the Euclidean vertical distance from the new impedance measurement data point to the trajectory applied to the reference complex impedance characteristic pattern to create a new impedance measurement data point. The ultrasonic apparatus according to any one of Examples 17 to 19, further configured to classify and perform.

Example 21. The ultrasonic device according to Example 20, wherein the control circuit is further configured to estimate the probability that the new impedance measurement data points will be correctly classified.

Example 22. 23. The control circuit is further configured to add a new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated correct classification probability of the new impedance measurement data point. Ultrasonic device.

Example 23. The control circuit is to classify the data based on the training data set S, wherein the training data set S contains a plurality of complex impedance measurement data, and the training data is classified using a parametric Fourier series. It is further configured to fit a curve into the set S, and S is defined by the following equation:

式中、新たなインピーダンス測定データ点

New impedance measurement data points in the equation

について、

about,

までの垂直距離が、次式によって求められ：

The vertical distance to is calculated by the following equation:

であるときに、
Ｄ＝Ｄ_⊥であり、
Ｄの確率分布が、グループＳに属する新たなインピーダンス測定データ点

When
D = D _⊥ ,
New impedance measurement data points whose probability distribution of D belongs to group S

の確率を推測するために使用される、実施例２１に記載の発生器。

21. The generator according to Example 21, which is used to estimate the probability of.

Example 24. The ultrasonic device according to any one of Examples 17 to 23, wherein the control circuit and memory are located in a surgical hub that communicates with an ultrasonic electromechanical system.

Example 25. A method for estimating the state of an end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and an electromechanical ultrasonic system is an ultrasonic blade. The method is to apply a drive signal to the ultrasonic transducer by a drive circuit, the drive signal being a periodic signal defined by magnitude and frequency. by a processor or control circuit, to above the resonance from below the resonance of the electromagnetic ultrasound system, the method comprising sweeping the frequency of the drive signal, by a processor or control circuit, the impedance / admittance circle variables R _e, G _e, X _e, and that the _{B e} measuring and recording, by a processor or controller, the measured impedance / admittance circle variables _{R e,} G _e, X e, _{B e} and the reference impedance / admittance circle variables _{R ref, G ref} , X _ref , B _ref , and the processor or control circuit to determine the state or status of the end effector based on the results of the comparative analysis.

として定義される、測定することと、
前記制御回路によって、複素インピーダンス測定データ点を受信することと、
前記制御回路によって、前記複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、
前記制御回路によって、前記比較解析の結果に基づいて、前記複素インピーダンス測定データ点を分類することと、
前記制御回路によって、前記比較解析の結果に基づいて、前記エンドエフェクタの状態又は状況を割り当てることと、を含む、方法。
（２） 前記制御回路によって、前記制御回路に連結されたデータベース又はメモリから前記基準複素インピーダンス特性パターンを受信することと、
前記制御回路によって、前記基準複素インピーダンス特性パターンを発生させることであって、以下の
前記制御回路に連結された駆動回路によって、初期周波数において開始し、最終周波数において終了し、かつそれらの間の複数の周波数にある非治療的駆動信号を前記超音波トランスデューサに印加することと、
前記制御回路によって、前記超音波トランスデューサの前記インピーダンスを各周波数において測定することと、
前記制御回路によって、各インピーダンス測定値に対応するデータ点を記憶することと、
前記基準複素インピーダンス特性パターンを表す３次元曲線を発生させるために、前記制御回路によって、複数のデータ点に曲線を当てはめることであって、前記大きさ│Ｚ│及び位相φが、周波数ｆの関数としてプロットされる、曲線を当てはめることと、を行うように、発生させることと、を含む、実施態様１に記載の方法。
（３） 前記曲線の当てはめが、多項式曲線当てはめ、フーリエ級数、及び／又はパラメータ方程式を含む、実施態様２に記載の方法。
（４） 前記制御回路によって、新たなインピーダンス測定データ点を受信することと、
前記制御回路によって、前記新たなインピーダンス測定データ点から前記基準複素インピーダンス特性パターンに当てはめられた軌跡までのユークリッド垂直距離を使用して、前記新たなインピーダンス測定データ点を分類することと、を含む、実施態様１に記載の方法。
（５） 前記制御回路によって、前記新たなインピーダンス測定データ点が正しく分類される確率を推測することを含む、実施態様４に記載の方法。 [Implementation mode]
(1) A method of estimating the state of an end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system includes the electromechanical ultrasonic system. The method comprises an ultrasonic transducer coupled to an ultrasonic blade.
It is to measure the complex impedance of the ultrasonic transducer by the control circuit, and the complex impedance is

Defined as, measuring and
By receiving the complex impedance measurement data point by the control circuit,
Comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern by the control circuit, and
The control circuit classifies the complex impedance measurement data points based on the results of the comparative analysis.
A method comprising assigning a state or status of the end effector by the control circuit based on the result of the comparative analysis.
(2) Receiving the reference complex impedance characteristic pattern from the database or memory connected to the control circuit by the control circuit, and
The control circuit is to generate the reference complex impedance characteristic pattern, which is started at the initial frequency, ended at the final frequency, and is plurality of between them by the following drive circuit connected to the control circuit. Applying a non-therapeutic drive signal at the frequency of
By measuring the impedance of the ultrasonic transducer at each frequency by the control circuit,
The control circuit stores data points corresponding to each impedance measurement value, and
In order to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, a curve is applied to a plurality of data points by the control circuit, and the size │Z│ and the phase φ are functions of the frequency f. The method of embodiment 1, comprising fitting a curve and generating it to do so, plotted as.
(3) The method according to embodiment 2, wherein the curve fit includes a polynomial curve fit, a Fourier series, and / or a parameter equation.
(4) Receiving a new impedance measurement data point by the control circuit and
The control circuit includes classifying the new impedance measurement data points using the Euclidean vertical distance from the new impedance measurement data points to the locus applied to the reference complex impedance characteristic pattern. The method according to the first embodiment.
(5) The method according to embodiment 4, wherein the control circuit estimates the probability that the new impedance measurement data points will be correctly classified.

式中、新たなインピーダンス測定データ点

について、

までの垂直距離が、次式によって求められ：

であるときに、
Ｄ＝Ｄ_⊥であり、
Ｄの確率分布が、前記グループＳに属する前記新たなインピーダンス測定データ点

の前記確率を推測するために使用される、実施態様４に記載の方法。
（８） 前記制御回路が、前記超音波電気機械的システムと通信する外科用ハブに位置する、実施態様１に記載の方法。
（９） 超音波装置のエンドエフェクタの状態を推測するための発生器であって、前記超音波装置が、所定の共振周波数によって定義される電気機械的超音波システムを含み、前記電気機械的超音波システムが、超音波ブレードに連結された超音波トランスデューサを含み、前記発生器が、
メモリに連結された制御回路を含み、前記制御回路が、
超音波トランスデューサの複素インピーダンスを測定することであって、前記複素インピーダンスが、

として定義される、測定することと、
複素インピーダンス測定データ点を受信することと、
前記複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、
前記比較解析の結果に基づいて、前記複素インピーダンス測定データ点を分類することと、
前記比較解析の結果に基づいて、前記エンドエフェクタの状態又は状況を割り当てることと、を行うように構成されている、発生器。
（１０） 前記制御回路に連結された駆動回路を更に備え、前記駆動回路が、初期周波数において開始し、最終周波数において終了し、かつそれらの間の複数の周波数にある非治療的駆動信号を前記超音波トランスデューサに印加するように構成されており、
前記制御回路が、前記基準複素インピーダンス特性パターンを発生させるように更に構成されており、
前記制御回路が、
前記制御回路に連結されたデータベース又は前記メモリから前記基準複素インピーダンス特性パターンを受信することと、
各周波数における前記超音波トランスデューサの前記インピーダンスを測定することと、
各インピーダンス測定値に対応するデータ点を前記メモリに記憶することと、
前記基準複素インピーダンス特性パターンを表す３次元曲線を発生させるために、複数のデータ点に曲線を当てはめることであって、前記大きさ│Ｚ│及び位相φが、周波数ｆの関数としてプロットされる、曲線を当てはめることと、を行うように構成されている、実施態様９に記載の発生器。 (6) The control circuit adds the new impedance measurement data point to the reference complex impedance characteristic pattern based on the probability of the estimated correct classification of the new impedance measurement data point. The method according to embodiment 5.
(7) The control circuit classifies the data based on the training data set S, wherein the training data set S includes a plurality of complex impedance measurement data.
The control circuit includes fitting a curve to the training data set S using a parametric Fourier series.
S is defined by the following equation:

New impedance measurement data points in the equation

about,

The vertical distance to is calculated by the following equation:

When
D = D _⊥ ,
The probability distribution of D is the new impedance measurement data point belonging to the group S.

The method according to embodiment 4, which is used to estimate the probability of the above.
(8) The method of embodiment 1, wherein the control circuit is located in a surgical hub that communicates with the ultrasonic electromechanical system.
(9) A generator for estimating the state of an end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical super. The ultrasonic system comprises an ultrasonic transducer connected to an ultrasonic blade, said generator.
The control circuit includes a control circuit connected to a memory.
It is to measure the complex impedance of the ultrasonic transducer, and the complex impedance is

Defined as, measuring and
Receiving complex impedance measurement data points and
Comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern,
By classifying the complex impedance measurement data points based on the result of the comparative analysis,
A generator configured to assign and perform the state or status of the end effector based on the results of the comparative analysis.
(10) Further comprising a drive circuit connected to the control circuit, the drive circuit starts at an initial frequency, ends at a final frequency, and provides a non-therapeutic drive signal at a plurality of frequencies in between. It is configured to be applied to an ultrasonic transducer and
The control circuit is further configured to generate the reference complex impedance characteristic pattern.
The control circuit
Receiving the reference complex impedance characteristic pattern from the database or the memory connected to the control circuit, and
Measuring the impedance of the ultrasonic transducer at each frequency and
The data points corresponding to each impedance measurement value are stored in the memory, and
In order to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the curve is applied to a plurality of data points, and the magnitude │Z│ and the phase φ are plotted as a function of the frequency f. The generator according to embodiment 9, which is configured to fit a curve and to perform.

式中、新たなインピーダンス測定データ点

について、

までの垂直距離が、次式によって求められ：

であるときに、
Ｄ＝Ｄ_⊥であり、
Ｄの確率分布が、前記グループＳに属する前記新たなインピーダンス測定データ点

の前記確率を推測するために使用される、実施態様１３に記載の発生器。 (11) The generator according to embodiment 10, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation.
(12) The control circuit
Receiving new impedance measurement data points and
It is further configured to classify the new impedance measurement data points using the Euclidean vertical distance from the new impedance measurement data points to the locus applied to the reference complex impedance characteristic pattern. The generator according to embodiment 9.
(13) The generator according to embodiment 12, wherein the control circuit is further configured to estimate the probability that the new impedance measurement data points will be correctly classified.
(14) The control circuit is further configured to add the new impedance measurement data points to the reference complex impedance characteristic pattern based on the probability of the estimated correct classification of the new impedance measurement data points. The generator according to the thirteenth embodiment.
(15) The control circuit
To classify data based on the training data set S, wherein the training data set S includes a plurality of complex impedance measurement data.
It is further configured to fit a curve into the training dataset S using a parametric Fourier series.
S is defined by the following equation:

New impedance measurement data points in the equation

about,

The vertical distance to is calculated by the following equation:

When
D = D _⊥ ,
The probability distribution of D is the new impedance measurement data point belonging to the group S.

13. The generator according to embodiment 13, which is used to estimate the probability of the above.

として定義される、測定することと、
複素インピーダンス測定データ点を受信することと、
前記複素インピーダンス測定データ点と基準複素インピーダンス特性パターン内のデータ点とを比較することと、
前記比較解析の結果に基づいて、前記複素インピーダンス測定データ点を分類することと、
前記比較解析の結果に基づいて、前記エンドエフェクタの状態又は状況を割り当てることと、を行うように構成されている、制御回路と、を備える超音波装置。
（１８） 前記制御回路に連結された駆動回路を更に備え、前記駆動回路が、初期周波数において開始し、最終周波数において終了し、かつそれらの間の複数の周波数にある非治療的駆動信号を前記超音波トランスデューサに印加するように構成されており、
前記制御回路が、前記基準複素インピーダンス特性パターンを発生させるように更に構成されており、
前記制御回路が、
前記制御回路に連結されたデータベース又は前記メモリから前記基準複素インピーダンス特性パターンを受信することと、
各周波数における前記超音波トランスデューサの前記インピーダンスを測定することと、
各インピーダンス測定値に対応するデータ点を前記メモリに記憶することと、
前記基準複素インピーダンス特性パターンを表す３次元曲線を発生させるために、複数のデータ点に曲線を当てはめることであって、前記大きさ│Ｚ│及び位相φが、周波数ｆの関数としてプロットされる、曲線を当てはめること、を行うように構成されている、実施態様１７に記載の超音波装置。
（１９） 前記曲線の当てはめが、多項式曲線当てはめ、フーリエ級数、及び／又はパラメータ方程式を含む、実施態様１８に記載の超音波装置。
（２０） 前記制御回路が、
新たなインピーダンス測定データ点を受信することと、
前記新たなインピーダンス測定データ点から前記基準複素インピーダンス特性パターンに当てはめられた軌跡までのユークリッド垂直距離を使用して、前記新たなインピーダンス測定データ点を分類することと、を行うように更に構成されている、実施態様１７に記載の超音波装置。 (16) The generator according to embodiment 9, wherein the control circuit and the memory are located in a surgical hub that communicates with the ultrasonic electromechanical system.
(17) An ultrasonic device for estimating the state of its end effector, and the ultrasonic device is
An electromechanical ultrasonic system defined by a predetermined resonance frequency, which includes an ultrasonic transducer connected to an ultrasonic blade, and an electromechanical ultrasonic system.
A control circuit connected to a memory, wherein the control circuit
By measuring the complex impedance of the ultrasonic transducer, the complex impedance is

Defined as, measuring and
Receiving complex impedance measurement data points and
Comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern,
By classifying the complex impedance measurement data points based on the result of the comparative analysis,
An ultrasonic device comprising a control circuit configured to assign a state or status of the end effector based on the result of the comparative analysis.
(18) Further comprising a drive circuit coupled to the control circuit, the drive circuit starts at an initial frequency, ends at a final frequency, and provides non-therapeutic drive signals at multiple frequencies in between. It is configured to be applied to an ultrasonic transducer and
The control circuit is further configured to generate the reference complex impedance characteristic pattern.
The control circuit
Receiving the reference complex impedance characteristic pattern from the database or the memory connected to the control circuit, and
Measuring the impedance of the ultrasonic transducer at each frequency and
The data points corresponding to each impedance measurement value are stored in the memory, and
In order to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the curve is applied to a plurality of data points, and the magnitude │Z│ and the phase φ are plotted as a function of the frequency f. The ultrasonic device according to embodiment 17, which is configured to fit a curve.
(19) The ultrasonic apparatus according to embodiment 18, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation.
(20) The control circuit
Receiving new impedance measurement data points and
It is further configured to classify the new impedance measurement data points using the Euclidean vertical distance from the new impedance measurement data points to the locus applied to the reference complex impedance characteristic pattern. The ultrasonic device according to embodiment 17.

式中、新たなインピーダンス測定データ点

について、

までの垂直距離が、次式によって求められ：

であるときに、
Ｄ＝Ｄ_⊥であり、
Ｄの確率分布が、前記グループＳに属する前記新たなインピーダンス測定データ点

の前記確率を推測するために使用される、実施態様２１に記載の超音波装置。
（２４） 前記制御回路及び前記メモリが、前記超音波電気機械的システムと通信する外科用ハブに位置する、実施態様１７に記載の超音波装置。
（２５） 超音波装置のエンドエフェクタの状態を推測する方法であって、前記超音波装置が、所定の共振周波数によって定義される電気機械的超音波システムを含み、前記電気機械的超音波システムが、超音波ブレードに連結された超音波トランスデューサを含み、前記方法が、
駆動回路によって、駆動信号を超音波トランスデューサに印加することであって、前記駆動信号が、大きさ及び周波数によって定義される周期信号である、印加することと、
プロセッサ又は制御回路によって、前記電磁超音波システムの共振未満から共振を上回るまで、前記駆動信号の周波数を掃引することと、
前記プロセッサ又は制御回路によって、インピーダンス／アドミッタンス円変数（impedance/admittance circle variables）Ｒ_ｅ、Ｇ_ｅ、Ｘ_ｅ、Ｂ_ｅを測定及び記録することと、
前記プロセッサ又は制御回路によって、測定されたインピーダンス／アドミッタンス円変数Ｒ_ｅ、Ｇ_ｅ、Ｘ_ｅ、Ｂ_ｅと基準インピーダンス／アドミッタンス円変数Ｒ_ｒｅｆ、Ｇ_ｒｅｆ、Ｘ_ｒｅｆ、Ｂ_ｒｅｆとを比較することと、
前記プロセッサ又は制御回路によって、前記比較解析の結果に基づいて、前記エンドエフェクタの状態又は状況を判定することと、を含む、方法。 (21) The ultrasonic device according to embodiment 20, wherein the control circuit is further configured to estimate the probability that the new impedance measurement data points will be correctly classified.
(22) The control circuit is further configured to add the new impedance measurement data points to the reference complex impedance characteristic pattern based on the probability of the estimated correct classification of the new impedance measurement data points. 21. The ultrasonic device according to embodiment 21.
(23) The control circuit
To classify data based on the training data set S, wherein the training data set S includes a plurality of complex impedance measurement data.
It is further configured to fit a curve into the training dataset S using a parametric Fourier series.
S is defined by the following equation:

New impedance measurement data points in the equation

about,

The vertical distance to is calculated by the following equation:

When
D = D _⊥ ,
The probability distribution of D is the new impedance measurement data point belonging to the group S.

21. The ultrasonic device according to embodiment 21, which is used to estimate the probability of the above.
(24) The ultrasonic device according to embodiment 17, wherein the control circuit and the memory are located in a surgical hub that communicates with the ultrasonic electromechanical system.
(25) A method of estimating the state of an end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system includes the electromechanical ultrasonic system. The method comprises an ultrasonic transducer coupled to an ultrasonic blade.
Applying a drive signal to an ultrasonic transducer by a drive circuit, wherein the drive signal is a periodic signal defined by magnitude and frequency.
Sweeping the frequency of the drive signal from less than the resonance to above the resonance of the electromagnetic ultrasonic system by a processor or control circuit.
And that said by a processor or control circuit, the impedance / admittance circle variables _{(impedance / admittance circle variables) R} e, G e, X e, measure and record the _{B e,}
By the processor or control circuit, the measured impedance / admittance circle variables _{R e, G e, X e} , B e and the reference impedance / admittance circle variables _{R ref,} and comparing G _ref, X _ref, and _{B ref} ,
A method comprising determining the state or status of the end effector by the processor or control circuit based on the results of the comparative analysis.

Claims (25)

A method of estimating the state of an end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system is an ultrasonic wave. The method comprises an ultrasonic transducer coupled to a blade.
It is to measure the complex impedance of the ultrasonic transducer by the control circuit, and the complex impedance is

Defined as, measuring and
By receiving the complex impedance measurement data point by the control circuit,
Comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern by the control circuit, and
The control circuit classifies the complex impedance measurement data points based on the results of the comparative analysis.
A method comprising assigning a state or status of the end effector by the control circuit based on the result of the comparative analysis. Receiving the reference complex impedance characteristic pattern from a database or memory connected to the control circuit by the control circuit.
The control circuit is to generate the reference complex impedance characteristic pattern, which is started at the initial frequency, ended at the final frequency, and is plurality of between them by the following drive circuit connected to the control circuit. Applying a non-therapeutic drive signal at the frequency of
By measuring the impedance of the ultrasonic transducer at each frequency by the control circuit,
The control circuit stores data points corresponding to each impedance measurement value, and
In order to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, a curve is applied to a plurality of data points by the control circuit, and the size │Z│ and the phase φ are functions of the frequency f. The method of claim 1, comprising fitting a curve and causing it to occur, plotted as. The method of claim 2, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation. By receiving a new impedance measurement data point by the control circuit,
The control circuit includes classifying the new impedance measurement data points using the Euclidean vertical distance from the new impedance measurement data points to the locus applied to the reference complex impedance characteristic pattern. The method according to claim 1. The method of claim 4, wherein the control circuit estimates the probability that the new impedance measurement data points will be correctly classified. 5. A claim comprising adding the new impedance measurement data point to the reference complex impedance characteristic pattern by the control circuit based on the probability of the estimated correct classification of the new impedance measurement data point. The method described in. By the control circuit, the data based on the training data set S is classified, and the training data set S includes a plurality of complex impedance measurement data.
The control circuit includes fitting a curve to the training data set S using a parametric Fourier series.
S is defined by the following equation:

New impedance measurement data points in the equation

about,

The vertical distance to is calculated by the following equation:

When
D = D _⊥ ,
The probability distribution of D is the new impedance measurement data point belonging to the group S.

The method according to claim 4, which is used to estimate the probability of the above. The method of claim 1, wherein the control circuit is located in a surgical hub that communicates with the ultrasonic electromechanical system. A generator for estimating the state of the end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system includes the electromechanical ultrasonic system. The generator includes an ultrasonic transducer connected to an ultrasonic blade.
The control circuit includes a control circuit connected to a memory.
It is to measure the complex impedance of the ultrasonic transducer, and the complex impedance is

Defined as, measuring and
Receiving complex impedance measurement data points and
Comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern,
By classifying the complex impedance measurement data points based on the result of the comparative analysis,
A generator configured to assign and perform the state or status of the end effector based on the results of the comparative analysis. The ultrasonic transducer further comprises a drive circuit coupled to the control circuit, the drive circuit starting at an initial frequency, ending at the final frequency, and delivering non-therapeutic drive signals at multiple frequencies between them. Is configured to apply to
The control circuit is further configured to generate the reference complex impedance characteristic pattern.
The control circuit
Receiving the reference complex impedance characteristic pattern from the database or the memory connected to the control circuit, and
Measuring the impedance of the ultrasonic transducer at each frequency and
The data points corresponding to each impedance measurement value are stored in the memory, and
In order to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the curve is applied to a plurality of data points, and the magnitude │Z│ and the phase φ are plotted as a function of the frequency f. The generator according to claim 9, which is configured to fit and perform curves. The generator of claim 10, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation. The control circuit
Receiving new impedance measurement data points and
It is further configured to classify the new impedance measurement data points using the Euclidean vertical distance from the new impedance measurement data points to the locus applied to the reference complex impedance characteristic pattern. The generator according to claim 9. The generator according to claim 12, wherein the control circuit is further configured to estimate the probability that the new impedance measurement data points will be correctly classified. The control circuit is further configured to add the new impedance measurement data points to the reference complex impedance characteristic pattern based on the probability of the estimated correct classification of the new impedance measurement data points. , The generator according to claim 13. The control circuit
To classify data based on the training data set S, wherein the training data set S includes a plurality of complex impedance measurement data.
It is further configured to fit a curve into the training dataset S using a parametric Fourier series.
S is defined by the following equation:

New impedance measurement data points in the equation

about,

The vertical distance to is calculated by the following equation:

When
D = D _⊥ ,
The probability distribution of D is the new impedance measurement data point belonging to the group S.

13. The generator according to claim 13, which is used to estimate the probability of the above. The generator according to claim 9, wherein the control circuit and the memory are located in a surgical hub that communicates with the ultrasonic electromechanical system. It is an ultrasonic device for estimating the state of its end effector, and the ultrasonic device is
An electromechanical ultrasonic system defined by a predetermined resonance frequency, which includes an ultrasonic transducer connected to an ultrasonic blade, and an electromechanical ultrasonic system.
A control circuit connected to a memory, wherein the control circuit
By measuring the complex impedance of the ultrasonic transducer, the complex impedance is

Defined as, measuring and
Receiving complex impedance measurement data points and
Comparing the complex impedance measurement data points with the data points in the reference complex impedance characteristic pattern,
By classifying the complex impedance measurement data points based on the result of the comparative analysis,
An ultrasonic device comprising a control circuit configured to assign a state or status of the end effector based on the result of the comparative analysis. The ultrasonic transducer further comprises a drive circuit coupled to the control circuit, the drive circuit starting at an initial frequency, ending at the final frequency, and delivering non-therapeutic drive signals at multiple frequencies between them. Is configured to apply to
The control circuit is further configured to generate the reference complex impedance characteristic pattern.
The control circuit
Receiving the reference complex impedance characteristic pattern from the database or the memory connected to the control circuit, and
Measuring the impedance of the ultrasonic transducer at each frequency and
The data points corresponding to each impedance measurement value are stored in the memory, and
In order to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the curve is applied to a plurality of data points, and the magnitude │Z│ and the phase φ are plotted as a function of the frequency f. The ultrasonic device according to claim 17, wherein the curve fitting is performed. The ultrasonic device according to claim 18, wherein the curve fit comprises a polynomial curve fit, a Fourier series, and / or a parameter equation. The control circuit
Receiving new impedance measurement data points and
It is further configured to classify the new impedance measurement data points using the Euclidean vertical distance from the new impedance measurement data points to the locus applied to the reference complex impedance characteristic pattern. The ultrasonic device according to claim 17. The ultrasonic device according to claim 20, wherein the control circuit is further configured to estimate the probability that the new impedance measurement data points will be correctly classified. The control circuit is further configured to add the new impedance measurement data points to the reference complex impedance characteristic pattern based on the probability of the estimated correct classification of the new impedance measurement data points. The ultrasonic device according to claim 21. The control circuit
To classify data based on the training data set S, wherein the training data set S includes a plurality of complex impedance measurement data.
It is further configured to fit a curve into the training dataset S using a parametric Fourier series.
S is defined by the following equation:

New impedance measurement data points in the equation

about,

The vertical distance to is calculated by the following equation:

When
D = D _⊥ ,
The probability distribution of D is the new impedance measurement data point belonging to the group S.

21. The ultrasonic device according to claim 21, which is used to estimate the probability of the above. The ultrasonic device according to claim 17, wherein the control circuit and the memory are located in a surgical hub that communicates with the ultrasonic electromechanical system. A method of estimating the state of an end effector of an ultrasonic device, wherein the ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonance frequency, and the electromechanical ultrasonic system is an ultrasonic wave. The method comprises an ultrasonic transducer coupled to a blade.
Applying a drive signal to an ultrasonic transducer by a drive circuit, wherein the drive signal is a periodic signal defined by magnitude and frequency.
Sweeping the frequency of the drive signal from less than the resonance to above the resonance of the electromagnetic ultrasonic system by a processor or control circuit.
And that said by a processor or control circuit, the impedance / admittance circle variables _{R e, G e, X e} , measure and record the _{B e,}
By the processor or control circuit, the measured impedance / admittance circle variables _{R e, G e, X e} , B e and the reference impedance / admittance circle variables _{R ref,} and comparing G _ref, X _ref, and _{B ref} ,
A method comprising determining the state or status of the end effector by the processor or control circuit based on the results of the comparative analysis.

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