JP7480044B2 - State estimation of ultrasonic end effector and its control system - Google Patents

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
This application claims the benefit under 35 U.S.C. §119(e) to U.S. Nonprovisional Patent Application No. 16/115,214, filed Aug. 28, 2018, entitled “ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,” the entire disclosure of which is incorporated herein by reference.

This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/721,995, filed August 23, 2018, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION," the entire disclosure of which is incorporated herein by reference.

This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/721,998, filed August 23, 2018, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS," the entire disclosure of which is incorporated herein by reference.

This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/721,999, filed August 23, 2018, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING," the entire disclosure of which is incorporated herein by reference.

This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/721,994, filed August 23, 2018, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY," the entire disclosure of which is incorporated herein by reference.

This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62/721,996, filed August 23, 2018, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS," the entire disclosure of which is incorporated herein by reference.

This application further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/692,747, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE," filed June 30, 2018, U.S. Provisional Patent Application No. 62/692,748, entitled "SMART ENERGY ARCHITECTURE," filed June 30, 2018, and U.S. Provisional Patent Application No. 62/692,768, entitled "SMART ENERGY DEVICES," filed June 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety.

This application further claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," and U.S. Provisional Patent Application No. 62/640,415, filed March 8, 2018, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR," the disclosures of each of which are incorporated herein by reference in their entirety.

This application is further protected under 35 U.S.C. § 119(e) from U.S. Provisional Patent Application No. 62/650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS," and U.S. Provisional Patent Application No. 62/650,887, filed March 30, 2018, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES," each of which is incorporated herein by reference in its entirety. This application claims the benefit of priority to U.S. Provisional Patent Application No. 62/650,882, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS," and U.S. Provisional Patent Application No. 62/650,877, filed March 30, 2018, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS."

This application further claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, U.S. Provisional Patent Application No. 62/611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," filed December 28, 2017, and U.S. Provisional Patent Application No. 62/611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM," filed December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety.

In surgical environments, smart energy devices within a smart energy architecture environment may be required. Ultrasonic surgical devices, such as ultrasonic scalpels, are finding increasingly widespread use in surgical procedures due to their unique performance characteristics. With certain device configurations and operating parameters, ultrasonic surgical devices can provide homeostasis with substantially simultaneous transection and coagulation of tissue, desirably minimizing patient trauma. Ultrasonic surgical devices may include a handpiece including an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer having a distally attached end effector (e.g., a blade tip) for cutting and sealing tissue. In some cases, the instrument may be permanently attached to the handpiece. In other cases, such as in the case of disposable or replaceable instruments, the instrument may be removable from the handpiece. The end effector transmits ultrasonic energy to tissue in contact with the end effector to achieve the cutting and sealing action. Such ultrasonic surgical devices may be configured for open surgical applications, laparoscopic or endoscopic surgery, including robotic assisted surgery.

Ultrasonic energy cuts and coagulates tissue using lower temperatures than those used in electrosurgical procedures and can be transmitted to the end effector by an ultrasonic generator in communication with the handpiece. The ultrasonic blade vibrates at high frequencies (e.g., 55,500 cycles per second) to denature proteins in the tissue to form a sticky coagulant. Pressure applied by the blade surface against the tissue collapses blood vessels, allowing the coagulant to form a hemostatic seal. The surgeon can control the speed of cutting and coagulation by the force applied to the tissue by the end effector, the time the force is applied, and the performance level of the end effector selected.

An ultrasonic transducer may be modeled as an equivalent circuit including a first branch with a capacitance, a second "operational" branch with a series-connected inductance, resistance, and capacitance that define the electromechanical properties of the resonator. Known ultrasonic generators may include a tuning inductor for tuning out the capacitance at a certain resonant frequency so that substantially all of the generator drive signal current flows in the operational branch. Thus, by using a tuning inductor, the generator drive signal current represents the operational branch current, and thus the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency locking ability of the generator. However, the tuning inductor must be matched to the specific capacitance of the ultrasonic transducer at the operational resonant frequency. In other words, different ultrasonic transducers with different capacitances require different tuning inductors.

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

In addition, electromagnetic interference in noisy environments reduces the generator's ability to maintain the ultrasonic transducer's resonant frequency locked, increasing the likelihood of invalid control algorithm inputs.

Electrosurgical devices for applying electrical energy to tissue to treat and/or destroy the tissue are also finding increasingly widespread use in surgical procedures. The electrosurgical device may include an instrument having a handpiece and a distally attached end effector (e.g., one or more electrodes). The end effector may be positioned relative to the tissue such that electrical current is introduced into the tissue. The electrosurgical device may be configured for bipolar or monopolar operation. During bipolar operation, electrical current is introduced into the tissue by the active electrode of the end effector and returned from the tissue by the return electrode of the end effector, respectively. During monopolar operation, electrical current is introduced into the tissue by the active electrode of the end effector and returned via a return electrode (e.g., a ground pad) separately located on the patient's body. Heat generated by the electrical current flowing through the tissue may form a hemostatic seal within and/or between the tissue and may thus be particularly useful, for example, for sealing blood vessels. The end effector of the electrosurgical device may also include a cutting member that is movable relative to the tissue, and an electrode for transecting the tissue.

The electrical energy applied by the electrosurgical device may be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy may be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that may be in the frequency range of 300 kHz to 1 MHz, as described in EN60601-2-2:2009+A11:2011, Definition 201.3.218-HIGH FREQUENCY. For example, frequencies in monopolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, the frequency may be nearly any value. Frequencies above 200 kHz are typically used in monopolar applications to avoid unnecessary stimulation of nerves and muscles resulting from the use of low frequency currents. Lower frequencies may be used for bipolar techniques if risk analysis indicates that the potential for neuromuscular stimulation has been mitigated to an acceptable level. Frequencies above 5 MHz are not typically used to minimize problems associated with high frequency leakage currents. 10 mA is generally recognized as the lower threshold for thermal effects on tissue.

During its operation, the electrosurgical device can transmit low frequency RF energy through tissue, which causes ionic agitation or friction, i.e. resistive heating, increasing the temperature of the tissue. A sharp boundary can be formed between the tissue being treated and its surrounding tissue, allowing the surgeon to operate with a high level of precision 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, shrinking, or sculpting soft tissue. RF energy can work particularly well on connective tissue, which is primarily composed of collagen and contracts when in contact with heat.

Due to these unique drive signals, sensing and feedback needs, ultrasonic and electrosurgical devices have typically required different generators. In addition, where the instruments are disposable or interchangeable with handpieces, ultrasonic and electrosurgical generators are limited in their ability to recognize the particular instrument configuration being used and therefore optimize the control and diagnostic process. Furthermore, capacitive coupling between the generator's non-isolated circuitry and the patient-isolated circuitry can result in exposing the patient to unacceptable levels of leakage current, especially when higher voltages and frequencies are used.

Furthermore, due to these unique drive signal, sensing and feedback needs, ultrasonic and electrosurgical devices have typically required different user interfaces for the different generators. In such 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. Such user interfaces include hand and/or foot activated user interfaces, such as hand and/or foot activated switches. As various aspects of combined generators for use with both ultrasonic and electrosurgical instruments are contemplated in the subsequent disclosure, additional user interfaces configured to operate with both ultrasonic and/or electrosurgical instrument generators are also contemplated.

Additional user interfaces for providing feedback to either a user or other machines to provide feedback indicative of the operating mode or status of either the ultrasonic and/or electrosurgical instruments are contemplated within the subsequent disclosure. Providing user and/or machine feedback for operating a combination ultrasonic and/or electrosurgical instrument requires providing sensory feedback to the user and providing electrical/mechanical/electromechanical feedback to the machine. Feedback devices incorporating visual feedback devices (e.g., LCD display screens, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators) for use with a combined ultrasonic and/or electrosurgical instrument are contemplated within the subsequent disclosure.

Other electrosurgical instruments include, but are not limited to, irreversible and/or reversible electroporation and/or microwave technology, among others. Thus, the techniques disclosed herein are applicable to ultrasonic, bipolar or monopolar RF (electrosurgical), irreversible and/or reversible electroporation, and/or microwave based surgical instruments, among others.

In one general aspect, a method of inferring a state of an end effector of an ultrasonic device is provided. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade. The method includes measuring, by a control circuit, a complex impedance of the ultrasonic transducer, the complex impedance being determined by:

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。

and
The method includes receiving, by a control circuit, the complex impedance measurement data points; comparing, by the control circuit, the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern; classifying, by the control circuit, the complex impedance measurement data points based on results of the comparative analysis; and assigning, by the control circuit, a state or status of the end effector based on results of the comparative analysis.

In another aspect, a generator is provided for inferring a state of an end effector of an ultrasonic device. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system includes an ultrasonic transducer coupled to an ultrasonic blade, the generator includes a control circuit coupled to a memory, the control circuit measures a complex impedance of the ultrasonic transducer, the complex impedance being determined by:

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。

a complex impedance measurement data point representing a state or status of the end effector based on a result of the comparative analysis; receiving complex impedance measurement data points; comparing the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern; classifying the complex impedance measurement data points based on a result of the comparative analysis; and assigning a state or status of the end effector based on a result of the comparative analysis.

In yet another aspect, an ultrasonic device for inferring a state of an end effector is provided. The ultrasonic device includes an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, and a control circuit coupled to a memory, the control circuit measuring a complex impedance of the ultrasonic transducer, the complex impedance being determined by:

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。

a complex impedance measurement data point representing a state or status of the end effector based on a result of the comparative analysis; receiving complex impedance measurement data points; comparing the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern; classifying the complex impedance measurement data points based on a result of the comparative analysis; and assigning a state or status of the end effector based on a result of the comparative analysis.

In yet another aspect, a method of inferring a state of an end effector of an ultrasonic device is provided, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the method including applying, by a drive circuit, a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency;
sweeping, by a processor or control circuit, the frequency of the drive signal from below resonance to above resonance of the electromagnetic ultrasonic system;
measuring and recording, by a processor or control circuit, the impedance/admittance circle variables R _e , G _e , X _e , B _e ; comparing, by the processor or control circuit, the measured impedance/admittance circle variables R _e , G _e , X _e , B _e with reference impedance/admittance circle variables R _ref , G _ref , X _ref , B _ref ; and determining, by the processor or control circuit, a state or status of the end effector based on results of the comparative analysis.

The features of the various aspects are set forth in detail in the appended claims, however the various aspects, both as to organization and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings in which:
FIG. 1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure. 1 is a surgical system used to perform a surgical procedure in an operating room, according to at least one aspect of the present disclosure. 1 is a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument according to at least one aspect of the present disclosure. FIG. 13 is a partial perspective view of a surgical hub housing and of a combination generator module slidably receivable within a drawer of the surgical hub housing, in accordance with at least one aspect of the present disclosure. FIG. 1 is a perspective view of a combination generator module with bipolar, ultrasonic, and monopolar contacts and smoke evacuation components in accordance with at least one aspect of the present disclosure. 1 illustrates individual power bus attachments for multiple lateral docking ports of a lateral modular housing configured to receive multiple modules, in accordance with at least one aspect of the present disclosure. 1 illustrates a vertical modular housing configured to receive a plurality of modules in accordance with at least one aspect of the present disclosure. FIG. 1 illustrates a surgical data network comprising a modular communications hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room in a medical facility equipped with specialized equipment for surgical procedures, to a cloud, in accordance with at least one aspect of the present disclosure. 1 illustrates a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical hub comprising a plurality of modules coupled to a modular control tower in accordance with at least one aspect of the present disclosure. 1 illustrates one aspect of a Universal Serial Bus (USB) network hub device in accordance with at least one aspect of the present disclosure. 1 illustrates a logic diagram of a control system for a surgical instrument or tool, according to at least one aspect of the present disclosure. 1 illustrates a control circuit configured to control an aspect of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a combinatorial logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure. 1 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions, in accordance with at least one aspect of the present disclosure. FIG. 1 is a circuit diagram of a robotic surgical instrument configured to manipulate a surgical tool described herein, in accordance with at least one aspect of the present disclosure. FIG. 1 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member, in accordance with at least one aspect of the present disclosure. FIG. 1 is a circuit diagram of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure. In accordance with at least one aspect of the present disclosure, a system configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network that includes a modular communications hub. 1 illustrates an embodiment of a generator in accordance with at least one aspect of the present disclosure. In accordance with at least one aspect of the present disclosure, a surgical system includes a generator and various surgical instruments usable with the generator. 1 is an end effector according to at least one aspect of the present disclosure. FIG. 23 is a diagram of the surgical system of FIG. 22 in accordance with at least one aspect of the present disclosure. 1 is a model illustrating motional branch currents in accordance with at least one aspect of the present disclosure. FIG. 2 is a structural diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. FIG. 2 is a functional diagram of a generator architecture in accordance with at least one aspect of the present disclosure. 1 illustrates structural and functional aspects of a generator in accordance with at least one aspect of the present disclosure. 1 illustrates structural and functional aspects of a generator in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of one embodiment of an ultrasonic drive circuit. FIG. 30 is a circuit diagram of a transformer coupled to the ultrasonic drive circuit shown in FIG. 29 in accordance with at least one aspect of the present disclosure. FIG. 31 is a circuit diagram of the transformer shown in FIG. 30 coupled to a test circuit in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of a control circuit in accordance with at least one aspect of the present disclosure. FIG. 13 shows a simplified block circuit diagram illustrating another electrical circuit contained within a modular ultrasonic surgical instrument in accordance with at least one aspect of the present disclosure. 1 illustrates a generator circuit divided into multiple stages in accordance with at least one aspect of the present disclosure. 1 illustrates a generator circuit split into multiple stages, with a first stage circuit in common with a second stage circuit, in accordance with at least one aspect of the present disclosure. FIG. 2 is a circuit diagram of one embodiment of a drive circuit configured to drive radio frequency (RF) current in accordance with at least one embodiment of the present disclosure. FIG. 35 is a circuit diagram of a transformer coupled to the RF drive circuit shown in FIG. 34 in accordance with at least one aspect of the present disclosure. FIG. 2 is a schematic diagram of a circuit with separate power supplies for a high power energy/drive circuit and a low power circuit, according to one aspect of the resent disclosure. A control circuit is shown that enables a dual generator system to switch between RF generator energy modalities and ultrasonic generator energy modalities for a surgical instrument. 1 shows a diagram of one embodiment of a surgical instrument with a feedback system for use with the surgical instrument, according to one embodiment of the recited disclosure. 1 illustrates one aspect of a basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms for an electrical signal waveform for use in a surgical instrument, in accordance with at least one aspect of the present disclosure. 1 illustrates one aspect of a direct digital synthesis (DDS) circuit configured to generate a plurality of waveforms of an electrical signal waveform for use in a surgical instrument in accordance with at least one aspect of the present disclosure. 1 illustrates one cycle of a discrete-time digital electrical signal waveform (shown superimposed on the discrete-time digital electrical signal waveform for comparison purposes) of an analog waveform according to at least one aspect of the present disclosure; FIG. 13 illustrates a control system configured to provide progressive closure of the closure member as it advances distally to close the clamp arms and apply a closure force load at a desired rate, according to one aspect of the present disclosure. 1 illustrates a proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure. FIG. 13 is an elevational exploded view of a modular handheld ultrasonic surgical instrument with the left shell half removed from the handle assembly to expose a device identifier communicatively coupled to the multi-lead handle terminal assembly according to one aspect of the present disclosure. FIG. 47 is a detailed view of a trigger and switch of the ultrasonic surgical instrument shown in FIG. 46 in accordance with at least one aspect of the present disclosure. FIG. 13 is a fragmentary, close-up perspective view of an end effector from a distal end with the jaw members in an open position, in accordance with at least one aspect of the present disclosure. FIG. 1 is a system diagram of a segmented circuit comprising multiple independently operating circuit segments in accordance with at least one aspect of the present disclosure. FIG. 1 is a circuit diagram of various components of a surgical instrument with motor control functionality in accordance with at least one aspect of the present disclosure. 1 illustrates one aspect of an end effector with an RF data sensor located on a jaw member in accordance with at least one aspect of the present disclosure. FIG. 52 illustrates one embodiment of a flexible circuit, as shown in FIG. 51, in which a sensor may be attached to the flexible circuit or may be integrally formed with the flexible circuit, in accordance with at least one embodiment of the present disclosure. 1 is an alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system in accordance with at least one aspect of the present disclosure. 1A-1C are spectra of the same ultrasonic device with various different states and conditions of the end effector, where the phase and magnitude of the impedance of the ultrasonic transducer are plotted as a function of frequency, in accordance with at least one aspect of the present disclosure. FIG. 2 is a graphical illustration of a plot of a set of 3D training data S in which the magnitude and phase of ultrasonic transducer impedance are plotted as a function of frequency, in accordance with at least one aspect of the present disclosure. FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for determining jaw status based on a complex impedance characteristic pattern (fingerprint) in accordance with at least one aspect of the present disclosure. 1 is a circle plot of complex impedance plotted as imaginary component versus real component of a piezoelectric transducer in accordance with at least one aspect of the present disclosure. 1 is a circle plot of complex admittance plotted as imaginary component versus real component of a piezoelectric transducer in accordance with at least one aspect of the present disclosure. 1 is a circle plot of the complex admittance of a 55.5 kHz ultrasonic piezoelectric transducer. FIG. 1 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasonic device with jaws open and no load, with red indicating admittance and blue indicating impedance, in accordance with at least one aspect of the present disclosure. FIG. 1 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasound device with jaws clamped on a dry chamois, with red indicating admittance and blue indicating impedance, in accordance with at least one aspect of the present disclosure. FIG. 1 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasonic device with jaw tips clamped on a wet chamois, with red indicating admittance and blue indicating impedance, in accordance with at least one aspect of the present disclosure. FIG. 13 is a graphical representation of an impedance analyzer showing an impedance/admittance circle plot of an ultrasonic device with the jaws fully clamped on a wet chamois, with red indicating admittance and blue indicating impedance, in accordance with at least one aspect of the present disclosure. FIG. 13 is a graphical representation of an impedance analyzer showing an impedance/admittance plot where the frequency is swept from 48 kHz to 62 kHz to capture multiple resonances of an ultrasonic device with jaws open to aid in seeing the circles with gray overlap, in accordance with at least one aspect of the present disclosure. FIG. 13 is a logic flow diagram of a process illustrating a control program or logic configuration for determining jaw status based on estimation of impedance/admittance circle radius and offset in accordance with at least one aspect of the present disclosure. 1 is a graphical representation of an ultrasonic transducer current hemostasis algorithm;FIG. 2 is a graphical representation of percent of maximum current to the ultrasonic transducer as a function of time; 10A-10C are graphical illustrations of an ultrasonic transducer current hemostasis algorithm, and FIGURE 11A-10D are graphical illustrations of ultrasonic blade temperature as a function of time and tissue type, in accordance with at least one aspect of the present disclosure. FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for controlling the temperature of an ultrasonic blade based on tissue type in accordance with at least one aspect of the present disclosure. FIG. 1 is a logic flow diagram of a process illustrating a control program or logic configuration for monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, according to one aspect of the present disclosure. 1 is a series of graphs of an ultrasonic transducer's initial impedance as a function of time for profiling an ultrasonic blade and delivering power to the ultrasonic blade on the profile, in accordance with one aspect of the present disclosure; 1 is a series of graphical illustrations of monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, and power delivered to the ultrasonic blade as a function of time based on initial impedance, according to one aspect of the present disclosure; 1 is a series of graphs of the new impedance of an ultrasonic transducer as a function of time for profiling an ultrasonic blade and delivering power to the ultrasonic blade on the profile, in accordance with one aspect of the present disclosure; 1 is a series of graphs of monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, and adjusted power delivered to the ultrasonic blade based on the new impedance, according to one aspect of the present disclosure. According to at least one aspect of the present disclosure, a system for adjusting the complex impedance of an ultrasonic transducer to compensate for power losses when an ultrasonic blade is articulated. FIG. 13 is a process logic flow diagram illustrating a control program or logic configuration for compensating output power as a function of joint angle in accordance with at least one aspect of the present disclosure. 1 is a system for measuring complex impedance of an ultrasonic transducer in real time to determine the motion being performed by an ultrasonic blade in accordance with at least one aspect of the present disclosure. FIG. 1 is a logic flow diagram of a process illustrating a control program or logic configuration for determining the action being performed by an ultrasonic blade based on a complex impedance pattern in accordance with at least one aspect of the present disclosure. FIG. 13 is a logic flow diagram of an adaptive process illustrating a control program or logic configuration for identifying a hemostatic vessel in accordance with at least one aspect of the present disclosure. FIG. 1 is a graphical illustration of ultrasound transducer current profiles as a function of time for venous and arterial vessel types in accordance with at least one aspect of the present disclosure. FIG. 13 is a logic flow diagram of an adaptive process illustrating a control program or logic configuration for identifying a hemostatic vessel in accordance with at least one aspect of the present disclosure. FIG. 1 is a graphical illustration of ultrasound transducer frequency profiles as a function of time for venous and arterial blood vessel types, in accordance with at least one aspect of the present disclosure. FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for identifying calcified blood vessels in accordance with at least one aspect of the present disclosure. FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for identifying calcified blood vessels in accordance with at least one aspect of the present disclosure. FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for identifying calcified blood vessels in accordance with at least one aspect of the present disclosure. FIG. 1 is an illustration of a liver resection with blood vessels buried in parenchyma, in accordance with at least one aspect of the present disclosure. FIG. 1 is a diagram of an ultrasonic blade within parenchymal tissue but not in contact with a blood vessel, in accordance with at least one aspect of the present disclosure. 1 is a magnitude/phase plot of ultrasound transducer impedance with parenchymal tissue curve shown in red, in accordance with at least one aspect of the present disclosure. 1 is a magnitude/phase plot of ultrasound transducer impedance with parenchymal tissue curve shown in red, in accordance with at least one aspect of the present disclosure. FIG. 1 is a diagram of an ultrasonic blade in parenchymal tissue and in contact with a large blood vessel. 1 is a magnitude/phase plot of ultrasound transducer impedance with a large vessel curve shown in blue, in accordance with at least one aspect of the present disclosure. 1 is a magnitude/phase plot of ultrasound transducer impedance with a large vessel curve shown in blue, in accordance with at least one aspect of the present disclosure. FIG. 13 is a process logic flow diagram illustrating a control program or logic configuration for treating tissue in parenchyma when a blood vessel is detected, in accordance with at least one aspect of the present disclosure. In accordance with at least one aspect of the present disclosure, an ultrasound device configured to identify an ultrasonic blade status and determine a clocked clamp arm status to determine if a disposable portion of a reusable and disposable ultrasound device is properly installed. 88 is an end effector portion of the ultrasonic device shown in FIG. 87. In accordance with at least one aspect of the present disclosure, an ultrasound device configured to identify the status of an ultrasound blade and determine if a clamp arm is not fully distal to determine if a disposable portion of a reusable and disposable ultrasound device is properly installed. FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration for identifying the status of reusable and disposable device components in accordance with at least one aspect of the present disclosure. FIG. 13 is a three-dimensional graphical illustration of tissue radio frequency (RF) impedance classification, in accordance with at least one aspect of the present disclosure. FIG. 1 is a three-dimensional graphical illustration of tissue radio frequency (RF) impedance analysis, in accordance with at least one aspect of the present disclosure. FIG. 1 is a graphical illustration of carotid technique sensitivity in which the time impedance (Z) derivative is plotted as a function of initial radio frequency (RF) impedance, in accordance with at least one aspect of the present disclosure. FIG. 1 is a graphical illustration of the relationship between initial frequency and the frequency change required to achieve a temperature of about 340° C., in accordance with at least one aspect of the present disclosure. 1 illustrates a feedback control system including an ultrasonic generator that adjusts a current (i) setpoint applied to an ultrasonic transducer of an ultrasonic electromechanical system to prevent the frequency (f) of the ultrasonic transducer from dropping below a predetermined threshold, in accordance with at least one aspect of the present disclosure. FIG. 1 is a process logic flow diagram illustrating a control program or logic configuration of a controlled thermal management process for protecting an end effector pad in accordance with at least one aspect of the present disclosure. FIG. 1 is a graph of temperature versus time comparing the desired temperature of an ultrasonic blade with a smart ultrasonic blade and a conventional ultrasonic blade, in accordance with at least one aspect of the present disclosure. 1 is a timeline illustrating situational awareness of a surgical hub in accordance with at least one aspect of the present disclosure.

The applicant of this application owns the following U.S. patent applications, filed August 28, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
U.S. Patent Application Serial No. END8560USNP2/180106-2, entitled "TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR";
U.S. Patent Application Serial No. END8561USNP1/180144-1, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS";
U.S. Patent Application Serial No. END8563USNP1/180139-1, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";
U.S. Patent Application Serial No. END8563USNP2/180139-2, entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE";
U.S. Patent Application Serial No. END8563USNP3/180139-3, entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM";
U.S. Patent Application Serial No. END8563USNP4/180139-4, entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT";
U.S. Patent Application Serial No. END8563USNP5/180139-5, entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR";
U.S. Patent Application Serial No. END8564USNP1/180140-1, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS";
U.S. Patent Application Serial No. END8564USNP2/180140-2, entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT";
U.S. Patent Application Serial No. END8564USNP3/180140-3, entitled "DETECTION OF END EFFECTOR IMMERSION IN LIQUID";
U.S. Patent Application Serial No. END8565USNP1/180142-1, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING";
U.S. Patent Application Serial No. END8565USNP2/180142-2, entitled "INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP";
- U.S. Patent Application Serial No. END8566USNP1/180143-1 entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY"; and - U.S. Patent Application Serial No. END8573USNP1/180145-1 entitled "ACTIVATION OF ENERGY DEVICES".

The applicant of this application owns the following U.S. patent applications, filed August 23, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
U.S. Provisional Patent Application No. 62/721,995, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION";
- U.S. Provisional Patent Application No. 62/721,998, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS";
- U.S. Provisional Patent Application No. 62/721,999, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIIVE COUPLING";
No. 62/721,994, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY" and U.S. Provisional Patent Application No. 62/721,996, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS".

The applicant of this application owns the following U.S. patent applications, filed June 30, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
- U.S. Provisional Patent Application No. 62/692,747, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE";
- U.S. Provisional Patent Application No. 62/692,748, entitled "SMART ENERGY ARCHITECTURE", and - U.S. Provisional Patent Application No. 62/692,768, entitled "SMART ENERGY DEVICES".

The applicant of this application owns the following U.S. patent applications, filed June 29, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
U.S. Patent Application Serial No. 16/024,090, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";
U.S. Patent Application Serial No. 16/024,057, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
U.S. Patent Application Serial No. 16/024,067, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION";
- U.S. Patent Application Serial No. 16/024,075, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
- U.S. Patent Application Serial No. 16/024,083, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING";
U.S. Patent Application Serial No. 16/024,094, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES";
U.S. Patent Application Serial No. 16/024,138, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE";
- U.S. Patent Application Serial No. 16/024,150, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES";
U.S. Patent Application Serial No. 16/024,160, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY";
- U.S. Patent Application Serial No. 16/024,124, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
- U.S. Patent Application Serial No. 16/024,132, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT";
U.S. Patent Application Serial No. 16/024,141, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY";
U.S. Patent Application Serial No. 16/024,162, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES";
U.S. patent application Ser. No. 16/024,066, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. Patent Application Serial No. 16/024,096, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS";
- U.S. Patent Application Serial No. 16/024,116, entitled "SURGICAL EVACUATION FLOW PATHS";
U.S. Patent Application Serial No. 16/024,149, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL";
U.S. Patent Application Serial No. 16/024,180, entitled "SURGICAL EVACUATION SENSING AND DISPLAY";
U.S. patent application Ser. No. 16/024,245, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";
U.S. patent application Ser. No. 16/024,258, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM";
No. 16/024,265, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOK EVACUATION DEVICE" and U.S. patent application Ser. No. 16/024,273, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS."

The applicant of this application owns the following U.S. provisional patent applications, filed June 28, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
- U.S. Provisional Patent Application No. 62/691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES";
U.S. Provisional Patent Application No. 62/691,227, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS";
- U.S. Provisional Patent Application No. 62/691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE";
U.S. Provisional Patent Application No. 62/691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL";
U.S. Provisional Patent Application No. 62/691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM";
No. 62/691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOK EVACUATION DEVICE" and U.S. Provisional Patent Application No. 62/691,251, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS."

The applicant of this application owns the following U.S. provisional patent applications, filed April 19, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
- U.S. Provisional Patent Application No. 62/659,900, entitled "METHOD OF HUB COMMUNICATION."

The applicant of this application owns the following U.S. provisional patent applications, filed March 30, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
U.S. Provisional Patent Application No. 62/650,898, filed March 30, 2018, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS";
- U.S. Provisional Patent Application No. 62/650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES";
- U.S. Provisional Patent Application No. 62/650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM", and - U.S. Provisional Patent Application No. 62/650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS".

The applicant of this application owns the following U.S. patent applications, filed March 29, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
- U.S. Patent Application Serial No. 15/940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
U.S. Patent Application Serial No. 15/940,648, entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES";
U.S. Patent Application Serial No. 15/940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES";
- U.S. Patent Application Serial No. 15/940,666, entitled "SPECIAL AWARENESS OF SURGICAL HUB IN OPERATING ROOMS";
- U.S. Patent Application Serial No. 15/940,670, entitled "COOPERATORY UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBSM";
- U.S. Patent Application Serial No. 15/940,677, entitled "SURGICAL HUB CONTROL ARRANGEMENTS";
U.S. Patent Application Serial No. 15/940,632, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
U.S. patent application Ser. No. 15/940,640, entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS";
U.S. Patent Application Serial No. 15/940,645, entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT";
U.S. Patent Application Serial No. 15/940,649, entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME";
- U.S. Patent Application Serial No. 15/940,654, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
- U.S. Patent Application Serial No. 15/940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING";
- U.S. Patent Application Serial No. 15/940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA";
- U.S. Patent Application Serial No. 15/940,671, entitled "SURGICAL HUB SPECIAL AWARENESS TO DETERMINATION DEVICES IN OPERATING THEATER";
U.S. Patent Application Serial No. 15/940,686, entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE";
U.S. Patent Application Serial No. 15/940,700, entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS";
- U.S. Patent Application Serial No. 15/940,629, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. Patent Application Serial No. 15/940,704, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINATION PROPERTIES OF BACK SCATTERED LIGHT";
U.S. patent application Ser. No. 15/940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIONITY" and U.S. patent application Ser. No. 15/940,742, entitled "DUAL CMOS ARRAY IMAGING".
- U.S. Patent Application Serial No. 15/940,636, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
- U.S. Patent Application Serial No. 15/940,653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS";
U.S. Patent Application Serial No. 15/940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. Patent Application Serial No. 15/940,679, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGE DATA SET";
U.S. Patent Application Serial No. 15/940,694, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION";
U.S. Patent Application Serial No. 15/940,634, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
U.S. patent application Ser. No. 15/940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK" and U.S. patent application Ser. No. 15/940,675, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES."
U.S. Patent Application Serial No. 15/940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application Serial No. 15/940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application Serial No. 15/940,642, entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application Serial No. 15/940,676, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
U.S. Patent Application Serial No. 15/940,680, entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Patent Application Serial No. 15/940,683, entitled "COOPERATORY SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. patent application Ser. No. 15/940,690, entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; and - U.S. patent application Ser. No. 15/940,711, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".

The applicant of this application owns the following U.S. provisional patent applications, filed March 28, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
- U.S. Provisional Patent Application No. 62/649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES";
- U.S. Provisional Patent Application Publication No. 62/649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD";
- U.S. Provisional Patent Application Publication No. 62/649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS";
- U.S. Provisional Patent Application Publication No. 62/649,309, entitled "SURGICAL HUB SPECIAL AWARENESS TO DETERMINATION DEVICES IN OPERATING THEATER";
- U.S. Provisional Patent Application Publication No. 62/649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS";
U.S. Provisional Patent Application Publication No. 62/649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINATION PROPERTIES OF BACK SCATTERED LIGHT";
- U.S. Provisional Patent Application Publication No. 62/649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES";
- U.S. Provisional Patent Application Publication No. 62/649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER";
U.S. Provisional Patent Application Publication No. 62/649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES";
- U.S. Provisional Patent Application Publication No. 62/649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK";
- U.S. Provisional Patent Application Publication No. 62/649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES";
U.S. Provisional Patent Application Publication No. 62/649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS";
- U.S. Provisional Patent Application Publication No. 62/649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS", and - U.S. Provisional Patent Application Publication No. 62/649,323, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS".

The applicant of this application owns the following U.S. provisional patent applications, filed March 8, 2018, the disclosures of each of which are incorporated by reference in their entirety herein:
- U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR", and - U.S. Provisional Patent Application No. 62/640,415, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR".

The applicant of this application owns the following U.S. provisional patent applications, filed December 28, 2017, the disclosures of each of which are incorporated by reference in their entirety herein:
- U.S. Provisional Patent Application No. U.S. Provisional Patent Application No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM";
- U.S. Provisional Patent Application No. 62/611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," and - U.S. Provisional Patent Application No. 62/611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM."

Before describing the various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The illustrative embodiments may be embodied or incorporated in other aspects, variations, and modifications and may be practiced or carried out in various ways. Moreover, unless otherwise specified, the terms and phrases used herein have been selected for the convenience of the reader and for the purpose of describing the illustrative embodiments and not for the purpose of limiting them. Furthermore, it should be understood that one or more of the aspects, embodiment of the aspects, and/or embodiments described below can be combined with any one or more of the other aspects, embodiment of the aspects, and/or embodiments described below.

Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical devices may be configured, for example, to transect and/or coagulate tissue during a surgical procedure. Aspects of the electrosurgical devices may be configured, for example, to transect, coagulate, scale, weld, and/or desiccate tissue during a surgical procedure.

With reference to FIG. 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104 that may include a remote server 113. In one embodiment, as shown in FIG. 1, the surgical systems 102 include a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112 configured to communicate with each other and/or with the hub 106. In some aspects, the surgical system 102 may include M hubs 106, N visualization systems 108, O robotic systems 110, and P handheld intelligent surgical instruments 112, where M, N, O, and P are integers equal to or greater than 1.

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 a surgical room 116. A robotic system 110 is used as part of the surgical system 102 in the surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. The patient side cart 120 can manipulate at least one detachably coupled surgical tool 117 during minimally invasive incision of the patient's body while the surgeon views the surgical site via the surgeon's console 118. Images of the surgical site can be obtained by a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.

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

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

In various aspects, the imager 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge-coupled device (CCD) sensors and complementary metal-oxide semiconductor (CMOS) sensors.

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

The one or more illumination sources may be configured to emit electromagnetic energy in the visible and invisible spectrum. The visible spectrum, sometimes called the optical spectrum or emission spectrum, is the portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and is sometimes called visible light, or simply light. A typical human eye responds to wavelengths in air between about 380 nm and about 750 nm.

The invisible spectrum (i.e., the non-radiative spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths 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 are invisible infrared (IR), microwave, and wireless electromagnetic radiation. Wavelengths below about 380 nm are shorter than the violet spectrum, which are invisible ultraviolet, 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, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophagogastroduodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes, sigmoidoscopes, thoracoscopes, and ureteroscopes.

In one aspect, the imaging device uses multispectral monitoring to distinguish between topography and underlying structures. Multispectral imaging captures image data within specific wavelength ranges across the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments sensitive to light from specific wavelengths including frequencies beyond the visible light range, e.g., IR and ultraviolet light. Spectral imaging can allow for the extraction of additional information that the human eye cannot capture with its red, green, and blue receptors. The use of multispectral imaging is described in detail in the "Advanced Imaging Acquisition Module" section of U.S. 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. Multispectral monitoring can be a useful tool to reposition the surgical field after a surgical procedure is completed to perform one or more of the above-mentioned tests on the treated tissue.

It is self-evident that any surgical procedure requires rigorous sterilization of the operating room and surgical equipment. The strict sanitary and sterile conditions required in the "surgical theater", i.e., operating room or procedure room, require the utmost sterility of all medical devices and equipment. Part of that sterilization process is the need to sterilize everything that comes into contact with the patient or enters the sterile field, including the imaging device 124 and its accessories and components. It will be understood that the sterile field may be considered a specific area that is deemed free of microorganisms, such as in a tray or on a sterile towel, or the sterile field may be considered the area immediately surrounding the patient who is prepared for the surgical procedure. The sterile field may include cleaned team members in appropriate clothing, as well as all the equipment and fixtures in the area.

In various aspects, the visualization system 108 includes one or more imaging sensors strategically positioned relative to the sterile field, as shown in FIG. 2, one or more image processing units, one or more storage arrays, and one or more displays. In one aspect, the visualization system 108 includes HL7, PACS, and EMR interfaces. The various components of the visualization system 108 are described in the "Advanced Imaging Acquisition Module" section of U.S. Provisional Patent Application Publication No. 62/611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed December 28, 2017, the entire disclosure of which is incorporated herein by reference.

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

In one aspect, the hub 106 is also configured to send diagnostic input or feedback entered by a non-sterile operator located in the sterile field at the visualization tower 111 to the primary display 119 in the sterile field for viewing by a sterile operator located at the operating table. In one example, the input may be in the form of a correction to a snapshot displayed on the non-sterile display 107 or 109 that can be sent by the hub 106 to the primary display 119.

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

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

During a surgical procedure, the application of energy to tissue for sealing and/or cutting is typically accompanied by smoke evacuation, aspiration of excess fluid, and/or irrigation of tissue. Fluid, power, and/or data lines from different sources often become tangled during a surgical procedure. Valuable time may be lost during a surgical procedure addressing this issue. Untangling the lines may require unplugging the lines from their corresponding modules, which may require resetting the modules. The hub's modular housing 136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of such line tangling.

Aspects of the present disclosure present a surgical hub for use in a surgical procedure involving the application of energy to tissue at a surgical site. The surgical hub comprises a hub housing and a combination generator module slidably receivable within a docking station of the hub housing. The docking station includes data and power contacts. The combination generator module comprises two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component housed within a single unit. In one aspect, the combination generator module further comprises a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluid, and/or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluid line extends from a remote surgical site to an aspiration and irrigation module that is slidably received within the hub housing. In one aspect, the hub housing includes a fluid interface.

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

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

In addition to the above, the modular surgical housing further includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data and power contacts, the second energy generator module being slidably movable into electrical engagement with the power and data contacts, and the second energy generator module being slidably movable out of electrical engagement with the second power and data contacts.

Additionally, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

3-7, aspects of the disclosure are presented regarding the hub's modular housing 136 that allows for modular integration of the generator module 140, the smoke evacuation module 126, and the suction/irrigation module 128. The hub's modular housing 136 further facilitates bidirectional communication between the modules 140, 126, 128. As shown in FIG. 5, the generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasonic components supported in a single housing unit 139 that is slidably insertable into the hub's modular housing 136. As shown in FIG. 5, the generator module 140 may be configured to connect to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may comprise a series of monopolar, bipolar, and/or ultrasonic generator modules that interact via the hub's modular housing 136. The hub modular housing 136 may be configured to facilitate insertion of multiple generators and bidirectional communication between the generators docked to the hub modular housing 136 such that the multiple generators function as a single generator.

In one aspect, the hub's modular housing 136 includes a modular power and communications backplane 149 with external and wireless communication headers to enable removable attachment of the modules 140, 126, 128 and bidirectional communication therebetween.

In one aspect, the hub modular housing 136 includes a docking station or drawer 151, also referred to herein as a drawer, configured to slidably receive the modules 140, 126, 128. FIG. 4 shows a partial perspective view of the surgical hub housing 136 and a combination generator module 145 slidably receivable in the docking station 151 of the surgical hub housing 136. A docking port 152 having power and data contacts on the rear side of the combination generator module 145 is configured to engage the corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the hub modular housing 136 when the combination generator module 145 is slid into position within the corresponding docking station 151 of the hub modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasonic, and monopolar modules, as well as a smoke evacuation module integrated with a single housing unit 139, as shown in FIG. 5.

In various aspects, the smoke evacuation module 126 includes fluid lines 154 that transport captured/collected smoke and/or fluid away from the surgical site, for example, to the smoke evacuation module 126. Vacuum suction generated from the smoke evacuation module 126 can draw the smoke into an opening in a utility conduit at the surgical site. The utility conduit coupled to the fluid line may be in the form of a flexible tube that terminates at the smoke evacuation module 126. The utility conduit and fluid line define a fluid path that extends toward the smoke evacuation module 126, which is received within the hub housing 136.

In various aspects, the aspiration/irrigation module 128 is coupled to a surgical tool that includes an aspiration fluid line and a suction fluid line. In one embodiment, the aspiration and aspiration fluid lines are in the form of flexible tubing that extends from the surgical site toward the aspiration/irrigation module 128. One or more drive systems can be configured to cause irrigation and suction of fluids to and from the surgical site.

In one aspect, the surgical tool includes a shaft having an end effector at its distal end, at least one energy treatment portion associated with the end effector, a suction tube, and an irrigation tube. The suction tube can have an inlet port at its distal end, and the suction tube extends through the shaft. Similarly, the irrigation tube can extend through the shaft and have an inlet port proximate to the energy delivery instrument. The energy delivery instrument is configured to deliver ultrasonic and/or RF energy to the surgical site and is initially coupled to the generator module 140 by a cable extending through the shaft.

The irrigation tube can be in fluid communication with a fluid source and the suction tube can be in fluid communication with a vacuum source. The fluid source and/or vacuum source can be housed within the aspiration/irrigation module 128. In one embodiment, the fluid source and/or vacuum source can be housed within the hub housing 136 separate from the aspiration/irrigation module 128. In such an embodiment, the fluid interface can be configured to connect the aspiration/irrigation module 128 to the fluid source and/or vacuum source.

In one aspect, the modules 140, 126, 128 and/or their corresponding docking stations on the hub's modular housing 136 may include alignment features configured to align the docking ports of the modules to engage with their counterparts in the docking stations of the hub's modular housing 136. For example, as shown in FIG. 4, the combination generator module 145 includes a side bracket 155 configured to slidably engage with a corresponding bracket 156 of the corresponding docking station 151 of the hub's modular housing 136. The brackets cooperate to guide the docking port contacts of the combination generator module 145 into electrical engagement with the docking port contacts of the hub's modular housing 136.

In some aspects, the drawers 151 of the hub's modular housing 136 are the same or substantially the same size, and the modules are sized to be received within the drawers 151. For example, the side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are different sizes, each designed to accommodate a particular module.

Furthermore, to prevent inserting a module into a drawer with incompatible contacts, the contacts of a particular module may be keyed to engage with the contacts of a particular drawer.

As shown in FIG. 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate bidirectional communication between modules housed within the hub's modular housing 136. Alternatively or additionally, the docking port 150 of the hub's modular housing 136 may facilitate wireless bidirectional communication between modules housed within the hub's modular housing 136. Any suitable wireless communication may be used, such as, for example, Air Titan-Bluetooth.

FIG. 6 illustrates individual power bus attachments of multiple lateral docking ports of lateral modular housing 160 configured to receive multiple modules of surgical hub 206. Lateral modular housing 160 is configured to laterally receive and interconnect modules 161. Modules 161 are slidably inserted into docking stations 162 of lateral modular housing 160 that include a backplane for interconnecting modules 161. As shown in FIG. 6, modules 161 are arranged laterally within lateral modular housing 160. Alternatively, modules 161 may be arranged vertically within lateral modular housing.

7 illustrates a vertical modular housing 164 configured to receive a plurality of modules 165 of the surgical hub 106. The modules 165 are slidably inserted into a docking station or drawer 167 of the vertical modular housing 164 that includes a backplane for interconnecting the modules 165. Although the drawer 167 of the vertical modular housing 164 is vertically oriented, in certain cases the vertical modular housing 164 may include a horizontally oriented drawer. Additionally, the modules 165 may interact with each other via the docking ports of the vertical modular housing 164. In the embodiment of FIG. 7, a display 177 is provided for displaying data related to the operation of the modules 165. Additionally, the vertical modular housing 164 includes a master module 178 that houses a plurality of sub-modules that are slidably received within the master module 178.

In various aspects, the imaging module 138 includes an integrated video processor and a modular light source and is adapted for use with various imaging devices. In one aspect, the imaging device is configured with a modular housing that can be assembled with a light source module and a camera module. The housing can be a disposable housing. In at least one embodiment, the disposable housing is removably coupled with a reusable controller, a light source module, and a camera module. The light source module and/or the camera module can be selectively selected depending on the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for imaging of the scanned beam. Similarly, the light source module can be configured to deliver white light or a different light depending on the surgical procedure.

During a surgical procedure, it may be inefficient to remove a surgical device from the surgical field and replace it with another surgical device that includes a different camera or a different light source. Temporary loss of view of the surgical field may result in undesirable results. The modular imaging device of the present disclosure is configured to allow replacement of a light source module or a camera module midstream during a surgical procedure without the need to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module that may be configured for snap-fit engagement with the first channel. A second channel is configured to slidably receive a light source module that may be configured for snap-fit engagement with the second channel. In another embodiment, the camera module and/or the light source module may be rotated into a final position within their corresponding channels. A threaded engagement may be employed in place of the snap-fit engagement.

In various embodiments, multiple imaging devices are positioned at various locations within the surgical field to provide multiple fields of view. The imaging module 138 can be configured to switch between the imaging devices to provide an optimal field of view. In various aspects, the imaging module 138 can be configured to integrate images from the different imaging devices.

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

FIG. 8 illustrates a surgical data network 201 comprising a modular communication hub 203 configured to connect modular devices located in one or more operating rooms of a medical facility, or any room in a medical facility with specialized equipment for surgical procedures, to a cloud-based system (e.g., cloud 204, which may include a remote server 213 coupled to storage device 205). In one aspect, the modular communication hub 203 comprises a network hub 207 and/or a network switch 209 in communication with a network router. The modular communication hub 203 can further be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, allowing data to go from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional mechanisms that allow traffic to pass through the monitored surgical data network and configure each port in the network hub 207 or network switch 209. An intelligent surgical data network can be referred to as a manageable hub or switch. A switching hub reads the destination address of each packet and then forwards the packet to the correct port.

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

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

In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch(es), and network router(s) that connect the devices 1a-1n/2a-2m to the cloud. Any one or all of the devices 1a-1n/2a-2m coupled to the network hub or network switch can collect data in real time and transfer the data to a cloud computer for data processing and manipulation. It will be understood that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. Although the term "cloud" may be used as a metaphor for the "internet," the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "a type of internet-based computing," where various services such as servers, storage, and applications are delivered to the modular communications hub 203 and/or computer system 210 located at the surgical site (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communications hub 203 and/or computer system 210 via the internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices 1a-1n/2a-2m located in one or more operating rooms. The cloud computing services may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware allows multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.

By applying cloud computer data processing techniques to data collected by the devices 1a-1n/2a-2m, the surgical data network provides improved surgical outcomes, reduced costs, and improved patient satisfaction. At least some of the devices 1a-1n/2a-2m can be used to observe tissue status and evaluate leakage or perfusion of the sealed tissue after tissue sealing and cutting procedures. At least some of the devices 1a-1n/2a-2m can be used to diagnostically inspect data including images of samples of body tissue to identify pathologies such as disease effects using cloud-based computing. This includes tissue and phenotype localization and margin confirmation. At least some of the devices 1a-1n/2a-2m can be used to identify anatomical structures of the body using techniques such as various sensors integrated with the imaging devices and overlaying images captured by multiple imaging devices. Data collected by the devices 1a-1n/2a-2m, including image data, may be transferred to the cloud 204 or a local computer system 210, or both, for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve the outcome of the surgical procedure by determining whether further treatments can be pursued, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and application of precision robotics to tissue-specific sites and conditions. Such data analysis may further employ prognostic analysis processes, and using a standardized approach can provide useful feedback to either confirm or suggest modifications to surgical treatments and surgeon performance.

In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 via wired or wireless channels depending on the configuration of the devices 1a-1n relative to the network hub. The network hub 207 may be implemented in one aspect as a local network broadcast device that operates on the physical layer of the Open Systems Interconnection (OSI) model. The network hub provides connectivity to the devices 1a-1n located in the same operating room network. The network hub 207 collects data in the form of packets and sends them to the router in half-duplex mode. The network hub 207 does not store any media access control/internet protocol (MAC/IP) for forwarding device data. Only one of the devices 1a-1n can send data at a time through the network hub 207. The network hub 207 does not have a routing table or intelligence on where to send the information and broadcasts all network data across each connection and to the remote server 213 (FIG. 9) on the cloud 204. Although the network hub 207 can detect basic network errors such as collisions, broadcasting all information to multiple ports can pose a security risk and cause bottlenecks.

In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via wired or wireless channels. The network switch 209 functions within the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 transmits data in the form of frames to the network router 211 and functions in full duplex mode. Multiple devices 2a-2m can transmit data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to forward data.

The network hub 207 and/or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 functions within the network layer of the OSI model. The network router 211 creates a path for sending data packets received from the network hub 207 and/or the network switch 211 to cloud-based computer resources for further processing and manipulation of data collected by any one or all of the devices 1a-1n/2a-2m. The network router 211 may be used to connect two or more different networks located in different locations, such as, for example, different networks located in different operating rooms in the same medical facility, or different operating rooms in different medical facilities. The network router 211 transmits data in the form of packets to the cloud 204 and functions in full-duplex mode. Multiple devices can transmit data simultaneously. The network router 211 uses IP addresses to forward data.

In one embodiment, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub may expand a single USB port into several tiers so that more ports are available for connecting devices to the host system computer. The network hub 207 may include wired or wireless capabilities for receiving information over wired or wireless channels. In one aspect, a wireless USB short-range, high-bandwidth wireless communication protocol may be used for communication between devices 1a-1n and 2a-2m located in the operating room.

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

The modular communications hub 203 can act as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handles data types known as frames. Frames carry data generated by the devices 1a-1n/2a-2m. Once the frames are received by the modular communications hub 203, they are amplified and transmitted to the network router 211, which forwards this data to cloud computing resources by using any number of wireless or wired communications standards or protocols described herein.

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 the operating room devices 1a-1n/2a-2m.

9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 that communicates with a cloud 204 that may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. As shown in FIG. 10, the modular control tower 236 includes a modular communication hub 203 coupled to a computer system 210. As illustrated in the embodiment of FIG. 9, the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuator module 226, a suction/irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device/instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via the modular control tower 236. The robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. The devices/instruments 235, visualization system 208, among others, may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols described herein. The modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) for displaying and overlaying images received from the imaging module, device/instrument display, and/or other visualization system 208. The hub display may also display data received from devices connected to the modular control tower along with images and overlay images.

10 illustrates a surgical hub 206 comprising a number of modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communications hub 203, e.g., a network-connected device, and a computer system 210, e.g., for providing local processing, visualization, and imaging. As shown in FIG. 10, the modular communications hub 203 can be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that can be connected to the modular communications hub 203 to transfer data associated with the modules to the computer system 210, cloud computing resources, or both. As shown in FIG. 10, each of the network hubs/switches in the modular communications hub 203 includes three downstream ports and one upstream port. The upstream network hub/switch is connected to a processor to provide a communications connection to the cloud computing resources and a local display 217. Communications to the cloud 204 can be via either wired or wireless communication channels.

The surgical hub 206 uses a non-contact sensor module 242 to measure the dimensions of the operating room and generate a map of the operating site using either an ultrasound or laser-based non-contact measurement device. As described in the section entitled "Surgical Hub Spatial Awareness Within an Operating Room" of U.S. 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, the ultrasound-based non-contact sensor module is configured to scan the operating room by transmitting bursts of ultrasound and receiving echoes as the bursts of ultrasound reflect off the exterior walls of the operating room, where the sensor module determines the size of the operating room and adjusts the distance limit for Bluetooth pairing. The laser-based non-contact sensor module scans the operating room, for example, by transmitting a laser light pulse, receiving the laser light pulse that reflects off the exterior walls of the operating room, and comparing the phase of the transmitted pulse to the received pulse to determine the size of the operating room and adjust the Bluetooth pairing distance limit.

The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled to a communication module 247, a storage 248, a memory 249, a non-volatile memory 250, and an input/output interface 251 via a system bus. The system bus may be any of several types of bus structure(s) including a memory bus or memory controller, a peripheral bus or external bus, and/or a local bus using any of a variety of bus architectures, including, but not limited to, a 9-bit bus, an Industry Standard Architecture (ISA), a MicroChannel Architecture (MSA), an Enhanced ISA (EISA), an Intelligent Drive Electronics (IDE), a VESA Local Bus (VLB), a Peripheral Component Interconnect (PCI), a USB, an Advanced Graphics Port (AGP), a Personal Computer Memory Card International Association bus (PCMCIA), a Small Computer System Interface (SCSI), or any other proprietary bus.

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

In one aspect, the processor 244 may include a safety controller, including two controller families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

System memory includes volatile and nonvolatile memory. The basic input/output system (BIOS), containing the basic routines for transferring information between elements within a computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM), which acts as external cache memory. In addition, RAM is available in many forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), SyncLink DRAM (SLDRAM), and direct RAMbus RAM (DRRAM).

The computer system 210 also includes removable/non-removable, volatile/non-volatile computer storage media, such as disk storage. Disk storage includes, but is not limited to, devices such as magnetic disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage can include storage media either independently or in combination with other storage media, including, but not limited to, optical disk drives, such as compact disk ROM drives (CD-ROM), compact disk recordable drives (CD-R drives), compact disk rewriteable drives (CD-RW drives), or digital versatile disk ROM drives (DVD-ROM). Removable or non-removable interfaces may be used to facilitate connection of disk storage devices to the system bus.

It should be appreciated that computer system 210 includes software that acts as an intermediary between users and basic computer resources as described in the preferred operating environment. Such software includes an operating system. The operating system, which may be stored on disk storage, functions to control and allocate resources of the computer system. System applications leverage resource management by the operating system through program modules and program data stored either in system memory or on disk storage. It should be appreciated that the various components described herein may be implemented with various operating systems or combinations of operating systems.

A user inputs commands or information into the computer system 210 through input device(s) coupled to the I/O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, trackball, stylus, touchpad, keyboard, microphone, joystick, gamepad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, webcam, and the like. These and other input devices connect to the processor through the system bus via interface port(s). Interface port(s) include, for example, serial port, parallel port, game port, and USB. Output device(s) use some of the same types of ports as the input device(s). Thus, for example, a USB port may be used to provide input to the computer system and also to output information from the computer system to an output device. An output adapter is provided to illustrate that there are some output devices such as monitors, displays, speakers, and printers, among other output devices that require special adapters. Output adapters include, by way of example and not limitation, video and sound cards that provide a means of connection between an output device and a system bus. It should be noted that other devices and/or systems of devices, such as a remote computer(s), may provide both input and output capabilities.

The computer system 210 can operate in a networked environment using logical connections to one or more remote computers, such as cloud computer(s), or local computers. The remote cloud computer(s) can be a personal computer, server, router, network PC, workstation, microprocessor-based equipment, peer device, or other general network node, and typically includes many or all of the elements described with respect to the computer system. For simplicity, only memory storage devices are shown with the remote computer(s). The remote computer(s) are logically connected to the computer system through a network interface, which is then physically connected through a communication connection. The network interface encompasses communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit-switched networks such as Integrated Services Digital Networks (ISDN) and variations thereon, packet-switched networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imaging module 238 of FIGS. 9-10, and/or the visualization system 208, and/or the processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) used to process digital images. The image processor may use parallel computing with single instruction multiple data (SIMD) or multiple instruction multiple data (MIMD) technology to increase speed and efficiency. The digital image processing engine may perform a variety of tasks. The image processor may be a system on a chip with a multi-core processor architecture.

The communications connection(s) refers to the hardware/software used to connect the network interface to the bus. Although the communications connections are shown internal to the computer system for clarity of illustration, the communications connections may be external to computer system 210. By way of example only, the hardware/software required to connect to the network interface may include internal and external technologies such as modems, including regular telephone grade modems, cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

11 illustrates a functional block diagram of one embodiment of a USB network hub 300 device in accordance with at least one embodiment of the present disclosure. In the 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 an upstream USB transmit/receive port 302 and up to three downstream USB transmit/receive ports 304, 306, 308 that conform to the USB 2.0 standard. The upstream USB transmit/receive port 302 is a differential rooted data port that includes a differential data minus (DM0) input paired with a differential data plus (DP0) input. The three downstream USB transmit/receive ports 304, 306, 308 are differential data ports, each including a differential data plus (DP1-DP3) output paired with a differential data minus (DM1-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 transceiver is integrated into the circuitry of the upstream USB transmit/receive port 302 and all downstream USB transmit/receive ports 304, 306, 308. The downstream USB transmit/receive ports 304, 306, 308 support both full speed and low speed devices by automatically setting the slew rate depending on the speed of the device attached to the port. The USB network hub 300 device may be configured in either bus-powered or self-powered mode and includes hub power logic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocol described in Chapter 8 of the USB specification. The SIE 310 typically understands signaling down to the transaction level. Functions it handles may include packet recognition, transaction reordering, detection/generation of SOP, EOP, RESET, and RESUME signals, clock/data separation, non-return to zero inverted (NRZI) data encoding/decoding and bit stuffing, CRC generation and checking (token and data), Packet ID (PID) generation and checking/decoding, and/or serial-to-parallel/parallel-to-serial conversion. 310 receives a clock input 314 and is coupled to a suspend/resume logic and frame timer 316 circuit and a hub repeater circuit 318 to control communication between the upstream USB transmit/receive port 302 and the downstream USB transmit/receive ports 304, 306, 308 via port logic circuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326 via interface logic for controlling commands from a serial EEPROM via a serial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect up to 127 functions organized in up to six logical layers to a single computer. Additionally, the USB network hub 300 can connect to all peripherals using a standardized four-wire cable that provides both communication and power distribution. The power configurations are bus-powered and self-powered. The USB network hub 300 may be configured to support four modes of power management: bus-powered hub with either individual or ganged port power management, and self-powered hub with either individual or ganged port power management. In one aspect, using a USB cable, the USB network hub 300, the upstream USB transmit/receive port 302 is plugged into a USB host controller, and the downstream USB transmit/receive ports 304, 306, 308 are exposed for connecting USB compatible devices, and so on.

Surgical Instrument Hardware FIG. 12 shows a logic diagram of a surgical instrument or tool control system 470 according to one or more aspects of the present disclosure. The system 470 comprises a control circuit. The control circuit includes a microcontroller 461 with a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor driver 492 operably couples the longitudinally movable displacement member to drive the clamp arm closure member. A tracking system 480 is configured to determine the position of the longitudinally movable displacement member. The position information is provided to the processor 462, which can be programmed or configured to determine the position of the longitudinally movable drive member and the position of the closure member. Additional motors may be provided in the tool driver interface to control the movement of the closure tube, the rotation of the shaft, the articulation, or the closure of the clamp arm, or a combination of the above. A display 473 displays various operating conditions of the instrument and may include touch screen functionality for data entry. Information displayed on the display 473 can be overlaid with images acquired via the endoscopic imaging module.

In one aspect, the microcontroller 461 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the main microcontroller 461 may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, including on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a pre-fetch buffer to improve performance beyond 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, and/or one or more 12-bit ADCs with 12 analog input channels, details of which are available in the product data sheet.

In one aspect, the microcontroller 461 may include a safety controller, including two controller families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functions such as precise control of the speed and position of the knife, articulation system, clamp arm, or combinations of the above. In one aspect, the microcontroller 461 includes a processor 462 and a memory 468. The electric motor 482 may be a brushed direct current (DC) motor with a gearbox and mechanical linkage to the articulation or knife system. In one aspect, the motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. Other motor drivers may be easily substituted for use with the tracking system 480 with an absolute positioning system. A detailed description of the absolute positioning system is provided in U.S. Patent Application Publication No. 2017/0296213, published October 19, 2017, entitled "SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT," which is incorporated herein by reference in its entirety.

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

In one aspect, the motor 482 may be controlled by a motor driver 492 and may be used by the surgical instrument or tool firing system. In various configurations, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of, for example, about 25,000 RPM. In another 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 field-effect transistors (FETs). The motor 482 may be powered by a power supply assembly releasably attached to the handle assembly or tool housing to provide control power to the surgical instrument or tool. The power supply assembly may include a battery that may include multiple battery cells connected in series that may be used as a power source to power the surgical instrument or tool. Under certain circumstances, the battery cells of the power supply assembly may be replaceable and/or rechargeable battery cells. In at least one example, the battery cells may be lithium ion batteries that may be connectable to and separable from the power supply assembly.

The motor driver 492 may be an A3941 available from Allegro Microsystems, Inc. The A3941 492 is a full-bridge controller for use with external N-channel power metal-oxide-semiconductor field-effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. The driver 492 has an intrinsic charge pump regulator that provides full (>10V) gate drive for battery voltages up to 7V, allowing the A3941 to operate with reduced gate drive down to 5.5V. A bootstrap capacitor may be used to provide the required above battery supply voltage for the N-channel MOSFETs. An internal charge pump for the high-side drive allows DC (100% duty cycle) operation. The full-bridge may be driven in fast or slow decay mode with diode or synchronous rectification. In slow decay mode, current recirculation is possible through either the high-side or low-side FETs. The power FETs are protected from shoot-through by resistor adjustable dead time. Integrated diagnostics indicate undervoltage, overtemperature, and power bridge faults and can be configured to protect the power MOSFETs under most short circuit conditions. Other motor drivers can be easily substituted for use in tracking system 480 with an absolute positioning system.

The tracking system 480 includes a controlled motor drive circuitry including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In another aspect, the displacement member represents a firing member that may be adapted and configured to include a rack of drive teeth. In yet another aspect, the displacement member represents a longitudinally movable member for opening and closing a clamp arm, which may be adapted and configured to include a rack of drive teeth. In another aspect, the displacement member represents a clamp arm closure member configured to open and close a clamp arm of a stapler, ultrasonic, or electrosurgical device, or a combination of the above. Thus, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool, such as a drive member, a clamp arm, or any element that can be displaced. Thus, the absolute positioning system can actually track the displacement of a clamp arm by tracking the linear displacement of a longitudinally movable drive member.

In other aspects, the absolute positioning system may be configured to track the position of the clamp arm in the opening and closing process. In various other aspects, the displacement member may be coupled to any suitable position sensor 472 for measuring linear displacement. Thus, the longitudinally movable drive member, or the clamp arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may include contact or non-contact displacement sensors. The linear displacement sensor may include linear variable differential transformers (LVDTs), differential variable reluctance transducers (DVRTs), slide potentiometers, magnetic sensing systems with movable magnets and Hall effect sensors arranged in a series of lines, magnetic sensing systems with fixed magnets and Hall effect sensors arranged in a series of movable lines, optical detection systems with movable light sources and photodiodes or photodetectors arranged in a series of lines, optical detection systems with fixed light sources and photodiodes or photodetectors arranged in a series of movable lines, or any combination thereof.

The electric motor 482 may include a rotatable shaft that operably interfaces with a gear assembly that is mounted in meshing engagement with a set or rack of drive teeth on the displacement member. The sensor element may be operably coupled to the gear assembly such that one revolution of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The gearing and sensor mechanism may be connected to a linear actuator by a rack and pinion mechanism or to a rotary actuator by a spur gear or other connection. A power source provides power to the absolute positioning system, and an output indicator may display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member with a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of a gear reducer assembly. The displacement member represents a longitudinally movable firing member that opens and closes the clamp arm.

One revolution of the sensor element associated with the position sensor 472 corresponds to a linear longitudinal displacement di of the displacement member, where di is the linear longitudinal distance traveled by the displacement member from point "a" to point "b" after one revolution of the sensor element coupled to the displacement member. The sensor mechanism may be connected via a gear reduction that results in the position sensor 472 completing one or more revolutions for a full stroke of the displacement member. The position sensor 472 may complete multiple revolutions for a full stroke of the displacement member.

A series of switches (where n is an integer greater than 1) may be used alone or in combination with gear reduction to provide a unique position signal for two or more revolutions of the position sensor 472. The states of the switches are fed back to the microcontroller 461 which applies logic to determine a unique position signal corresponding to the longitudinal linear displacement _d1 + _d2 + ... _dn of the displacement member. The output of the position sensor 472 is provided to the microcontroller 461. The sensor mechanism position sensor 472 may comprise a magnetic sensor, an analog rotary sensor such as a potentiometer, or an array of analog Hall effect elements that output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensing elements, such as magnetic sensors classified based on whether they measure the total magnetic field or vector components of a magnetic field. The technologies used to produce both types of magnetic sensors involve many aspects of physics and electronics. Technologies used to sense magnetic fields include search coils, fluxgates, optical pumping, nuclear precession, SQUIDs, Hall effect, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive/piezoelectric composites, magnetodiodes, magnetotransistors, optical fiber, magneto-optical, and microelectromechanical systems based magnetic sensors, among others.

In one aspect, the position sensor 472 of the tracking system 480 with absolute positioning system comprises a magnetic rotation absolute positioning system. The position sensor 472 may be implemented as an AS5055EQFT single chip magnetic rotation position sensor available from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide the absolute positioning system. The position sensor 472 is a low voltage, low power component and includes four Hall effect elements in the area of the position sensor 472 located above the magnet. Additionally, a high resolution ADC and a smart power management controller are provided on the chip. A Coordinate Rotation Digital Computer (CORDIC) processor, also known as the digit-by-digit method and Volder's algorithm, is provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations. The angular position, alarm bits, and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface, such as a Serial Peripheral Interface (SPI) interface. The position sensor 472 provides 12-bit or 14-bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4x4x0.85mm package.

The tracking system 480 with absolute positioning system may include and/or be programmed to implement a feedback controller, such as PID, state feedback, and adaptive controllers. A power supply converts the signal from the feedback controller into a physical input to the system, in this case voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by the position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, the other sensor(s) may include any of the sensors described in U.S. Pat. No. 9,345,481, issued May 24, 2016, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; U.S. Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM," which is incorporated herein by reference in its entirety; and U.S. Patent Application Publication No. 2014/0263552, published September 18, 2014, entitled "TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND Examples of sensor mechanisms include those described in U.S. Patent Application Publication No. 15/628,175, filed June 20, 2017, entitled "A CUTTING INSTRUMENT." In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system has a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using algorithms such as weighted averages and theoretical control loops that drive the calculated response towards the measured response. The calculated response of the physical system takes into account properties such as mass, inertia, viscous friction, and induced resistance in order to predict what the state and output of the physical system will be given knowledge of the input.

The absolute positioning system provides an absolute position of the displacement member upon powering up of the instrument without forcing the displacement member to retract or advance to a reset (zero or home) position, as may be required with conventional rotary encoders that simply count the number of steps taken by the motor 482 forward or backward to estimate the position of the device actuator, drive bar, knife, etc.

The sensor 474, e.g., a strain gauge or microstrain gauge, is configured to measure one or more parameters of the end effector, e.g., the amplitude of strain exerted on the anvil during the clamping operation, which can be indicative of the closure force applied to the anvil. The measured strain is converted to a digital signal and provided to the processor 462. Instead of or in addition to the sensor 474, a sensor 476, e.g., a load sensor, can measure the closure force that the closure drive system applies to the anvil in a stapler or clamp arm in an ultrasonic or electrosurgical instrument. For example, the sensor 476, e.g., a load sensor, can measure the firing force applied to a closure member coupled to a clamp arm of a surgical instrument or tool, or the force applied by the clamp arm to tissue located in the jaws of an ultrasonic or electrosurgical instrument. Alternatively, a current sensor 478 can be used to measure the current draw by the motor 482. The displacement member can also be configured to engage and open and close the clamp arm. The force sensor can be configured to measure the clamp force on the tissue. The force required to advance the displacement member can correspond to the current drawn by the motor 482, for example. The measured force is converted to a digital signal and provided to the processor 462.

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

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

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

13 illustrates 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 various processes described herein. The control circuit 500 can include a microcontroller that includes one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuit 504 stores machine executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement various processes described herein. The processor 502 can be any one of a number of single or multi-core processors known in the art. The memory circuit 504 can include volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present disclosure.

14 illustrates a combinational logic circuit 510 configured to control aspects of a surgical instrument or tool, according to one aspect of the present disclosure. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 can include a finite state machine including combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data through the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool according to one aspect of the disclosure. The sequential logic circuit 520 or combinatorial logic 522 can be configured to implement various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 can store a current state of the finite state machine. In certain examples, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data by the combinatorial logic 522, and provide an output 528. In other aspects, the circuit may include a combination of a processor (e.g., processor 502 of FIG. 13) and a finite state machine that implements various processes herein. In other aspects, the finite state machine may include a combination of combinational logic (e.g., combinational logic 510 of FIG. 14) and sequential logic 520.

16 illustrates a surgical instrument or tool with multiple motors that can be activated to perform various functions. In a particular example, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, a third motor can be activated to perform a third function, a fourth motor can be activated to perform a fourth function, and so on. In a particular example, the multiple motors of the robotic surgical instrument 600 can be individually activated to produce a firing, closing, and/or articulation motion in the end effector. The firing, closing, and/or articulation motion can be transmitted to the end effector via a shaft assembly, for example.

In certain examples, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transfer the firing motion generated by the motor 602 to an end effector, specifically to displace a clamp arm closure member. The closure member may be retracted by reversing the direction of the motor 602, thereby further opening the clamp arm.

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

In certain examples, a surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operatively coupled to corresponding articulation motor drive assemblies 608a, 608b that may be configured to transmit articulation motion generated by the motors 606a, 606b to an end effector. In certain examples, the articulation motion may, for example, cause the end effector to articulate relative to the shaft.

As discussed above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In certain examples, multiple motors of a surgical instrument or tool may be independently or separately activated to perform one or more functions while other motors remain stopped. For example, articulation motors 606a, 606b may be activated to articulate an end effector while firing motor 602 remains stopped. Alternatively, firing motor 602 may be activated to fire multiple staples and/or advance a cutting edge while articulation motor 606 is stopped. Additionally, closure motor 603 may be activated simultaneously with firing motor 602 to distally advance a closure tube or member, as described in more detail herein below.

In certain examples, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In certain examples, the common control module 610 can accommodate one of the multiple motors at a time. For example, the common control module 610 may be capable of individually coupling and decoupling multiple motors of a robotic surgical instrument. In certain examples, multiple motors of a surgical instrument or tool may share one or more common control modules, such as the common control module 610. In certain examples, multiple motors of a surgical instrument or tool can be independently and selectively engaged with the common control module 610. In certain examples, the common control module 610 can be selectively switched from coupling with one of the multiple motors of the surgical instrument or tool to coupling with another of the multiple motors of the surgical instrument or tool.

In at least one example, the common control module 610 can be selectively switched between operative engagement with the articulation motors 606a, 606b and operative engagement with either the firing motor 602 or the closing motor 603. In at least one example, as shown in FIG. 16, the switch 614 can be moved or transitioned between a plurality of positions and/or states. For example, in a first position 616, the switch 614 can electrically couple the common control module 610 to the firing motor 602, in a second position 617, the switch 614 can electrically couple the common control module 610 to the closing motor 603, in a third position 618a, the switch 614 can electrically couple the common control module 610 to the first articulation motor 606a, and in a fourth position 618b, the switch 614 can electrically couple the common control module 610 to the second articulation motor 606b. In certain examples, a separate common control module 610 may be electrically coupled to the firing motor 602, the closing motor 603, and the articulation motors 606a, 606b at the same time. In certain examples, the switch 614 may be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switching mechanism.

Each of the motors 602, 603, 606a, 606b may be equipped with a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor outside the jaws or by a torque sensor on the motor that actuates the jaws.

16, the common control module 610 may include a motor driver 626, which may include one or more H-bridge FETs. The motor driver 626 may modulate the power transferred from a power source 628 to a motor coupled to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In certain examples, the microcontroller 620 may be used to determine, for example, the current drawn by a motor while the motor is coupled to the common control module 610, as described above.

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

In certain examples, the power source 628 may be used to, for example, power the microcontroller 620. In certain examples, the power source 628 may include a battery (or "battery pack" or "power pack"), such as, for example, a lithium ion battery. In certain examples, the battery pack may be configured to be releasably attached to the handle to power the surgical instrument 600. Multiple battery cells connected in series may be used as the power source 628. In certain examples, the power source 628 may be, for example, replaceable and/or rechargeable.

In various examples, the processor 622 can control the motor driver 626 to control the position, direction, and/or speed of the motors coupled to the common control module 610. In certain examples, the processor 622 can signal the motor driver 626 to stop and/or disable the motors coupled to the common control module 610. The term "processor" as used herein should be understood to include any suitable microprocessor, microcontroller, or other basic computing device that integrates the functionality of a computer's central processing unit (CPU) on one integrated circuit or up to a few integrated circuits. The processor 622 is a general-purpose programmable device that accepts digital data as input, processes the data according to instructions stored in memory, and provides the results as output. It is an example of sequential digital logic because it has internal memory. The processor operates on numbers and symbols represented in the binary system.

In one example, the processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In a particular example, the microcontroller 620 may be, for example, an LM 4F230H5QR available from Texas Instruments. In at least one embodiment, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes, among other characteristics readily available in the product data sheet, on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a pre-fetch buffer to improve performance beyond 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels. Other microcontrollers may be readily substituted for use with module 4410. Thus, the present disclosure should not be limited in this context.

In certain examples, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that may be coupled to a common control module 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606a, 606b. Such program instructions may cause the processor 622 to control the firing, closing, and articulation functions according to inputs from an algorithm or control program of the surgical instrument or tool.

In certain examples, one or more mechanisms and/or sensors, such as, for example, sensor 630, can be used to alert processor 622 to program instructions to be used in a particular setting. For example, sensor 630 can alert processor 622 to use program instructions associated with firing, closing, and articulation of the end effector. In certain examples, sensor 630 can include a position sensor that can be used to sense the position of switch 614, for example. Thus, processor 622 can use program instructions associated with firing a closure member coupled to a clamp arm of the end effector when it detects, for example, via sensor 630, that switch 614 is in the first position 616; processor 622 can use program instructions associated with closing anvil when it detects, for example, via sensor 630, that switch 614 is in the second position 617; processor 622 can use program instructions associated with articulation of the end effector when it detects, for example, via sensor 630, that switch 614 is in the third position 618a or the fourth position 618b.

17 is a circuit diagram of a robotic surgical instrument 700 configured to operate a surgical tool described herein, according to one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of the displacement member, distal/proximal displacement of the closure tube, shaft rotation, and articulation, using either single or multiple articulation drive couplings. In one aspect, the surgical instrument 700 may be programmed or configured to individually control the firing member, the closure member, the shaft member, or one or more articulation members, or a combination thereof. The surgical instrument 700 includes a control circuit 710 configured to control a motorized firing member, a closure member, a shaft member, or one or more articulation members, or a combination thereof.

In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the clamp arm 716 and closure member 714 portions of the end effector 702, the ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721, the shaft 740, and one or more articulating members 742a, 742b via a number of motors 704a-704e. The position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. Another sensor 738 may be configured to provide feedback to the control circuit 710. The timer/counter 731 provides timing and counting information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e may be individually operated by the control circuit 710 in open-loop or closed-loop feedback control.

In one aspect, the control circuitry 710 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the processor or processors to perform one or more tasks. In one aspect, the timer/counter 731 provides an output signal, such as an elapsed time or digital count, to the control circuitry 710 to correlate the position of the closure member 714 determined by the position sensor 734 with the output of the timer/counter 731, such that the control circuitry 710 can determine the position of the closure member 714 at a particular time (t) relative to a starting position or time (t) when the closure member 714 is in a particular position relative to the starting position. The timer/counter 731 may be configured to measure elapsed time, count an external event, or measure the time of an external event.

In one aspect, the control circuitry 710 may be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuitry 710 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuitry 710 may be programmed to select a firing control program or a closing control program based on the tissue condition. The firing control program may describe the distal motion of the displacement member. Different firing control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuitry 710 may be programmed to translate the displacement member at a slower speed and/or with less power. When thinner tissue is present, the control circuitry 710 may be programmed to translate the displacement member at a higher speed and/or with more power. The closing control program may control the closing force applied to the tissue by the clamp arm 716. Other control programs control the rotation of the shaft 740 and the articulating members 742a, 742b.

In one aspect, the control circuitry 710 can generate motor set point signals. The motor set point signals can be provided to various motor controllers 708a-708e. The motor controllers 708a-708e can include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e as described herein. In some embodiments, the motors 704a-704e can be brushed DC electric motors. For example, the speed of the motors 704a-704e can be proportional to the respective motor drive signals. In some embodiments, the motors 704a-704e can be brushless DC electric motors, and the respective motor drive signals can include PWM signals provided to one or more stator windings of the motors 704a-704e. Also, in some embodiments, the motor controllers 708a-708e can be omitted, and the control circuitry 710 can generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the stroke of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program for a closed-loop configuration. The instrument response may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, the sum of the pulse widths of the motor drive signals, etc. After the open-loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity.

In one aspect, the motors 704a-704e can receive power from an energy source 712. The energy source 712 may be a DC power source driven by a mains AC power source, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to respective moveable mechanical elements, such as the closure member 714, the clamp arm 716, the shaft 740, the joint 742a, and the joint 742b, via respective transmissions 706a-706e. The transmissions 706a-706e may include one or more gears or other coupling components for coupling the motors 704a-704e to the moveable mechanical elements. The position sensor 734 may sense the position of the closure member 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuitry 710 as the closure member 714 translates distally and proximally. The control circuitry 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some embodiments, the position sensor 734 may be omitted. If any of the motors 704a-704e are step motors, the control circuitry 710 may track the position of the closure member 714 by summing up the number and direction of steps the motor 704 is commanded to perform. The position sensor 734 may be located in the end effector 702 or in any other part of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firing member, such as the closure member 714 portion of the end effector 702. The control circuit 710 provides motor settings to the motor control 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a, which is coupled to the closure member 714. The transmission 706a includes a movable mechanical element, such as a rotating element and a firing member, for controlling the movement of the closure member 714 in the distal and proximal directions along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly including a knife gear reduction set including a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal is indicative of the force required to fire or displace the closure member 714. The position sensor 734 may be configured to provide the position of the closure member 714 or the firing member along the firing stroke as a feedback signal to the control circuit 710. The end effector 702 may include additional sensors 738 configured to provide feedback signals to the control circuit 710. When ready for use, the control circuit 710 may provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a may drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal start-of-stroke position to an end-of-stroke position distal to the start-of-stroke position. As the closure member 714 translates distally, the clamp arm 716 closes against the ultrasonic blade 718.

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

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

In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to a motor controller 708d, which provides a drive signal to the motor 704d. The output shaft of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d, which is coupled to the articulation member 742a. The transmission 706d includes a movable mechanical element, such as an articulation element, for controlling the ±65° articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut, which is rotatably journaled on a proximal end portion of the distal spine portion and rotatably driven by an articulation gear assembly on the proximal end portion of the distal spine portion. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal is indicative of the articulation force applied to the end effector 702. A sensor 738, such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members, or linkages 742a, 742b. These articulation members 742a, 742b are driven by separate disks on a robot interface (rack) driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the articulation linkages 742a, 742b may be driven antagonistically relative to the other linkage to provide resistive holding motion and loading to the head when the head is not moving, and to provide articulation motion when the head is articulating. The articulation members 742a, 742b are attached to the head at a fixed radius as the head rotates. Thus, as the head rotates, the mechanical efficiency of the push-pull linkage changes. This change in mechanical efficiency may be more pronounced with other articulation linkage drive systems.

In one aspect, one or more of the motors 704a-704e may comprise brushed DC motors with gearboxes and mechanical connections to the firing members, closure members, or articulation members. Another example includes electric motors 704a-704e operating moving mechanical elements such as displacement members, articulation connections, closure tubes, and shafts. External influences are the unmeasured and unpredictable influences of things such as tissue, surroundings, and friction on a physical system. Such external influences may be referred to as drags that act against one of the electric motors 704a-704e. External influences such as drags may cause the operation of a physical system to deviate from the desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may comprise a magnetic rotary absolute positioning system implemented as an AS5055EQFT single chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 734 may interface with the control circuit 710 to provide an absolute positioning system. The position may include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit and Boulder algorithms, which are provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.

In one aspect, the control circuitry 710 may be in communication with one or more sensors 738. The sensor 738 may be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensor 738 may comprise a magnetic sensor, a magnetic field sensor, a strain gauge, a load cell, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and/or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 may include one or more sensors. The sensor 738 may be positioned on the clamp arm 716 to determine the position of the tissue using a split electrode. The torque sensors 744a-744e may be configured to sense forces, such as firing force, closure force, and/or articulation force, among others. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member in the rack and its position, (3) which portion of the ultrasonic blade 718 has tissue thereon, and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the clamp arm 716 during the clamped state. The strain gauge provides an electrical signal that varies in amplitude with the magnitude of strain. The sensor 738 may comprise a pressure sensor configured to detect pressure 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 indicative of the thickness and/or fullness of the tissue located therebetween.

In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, among others. In other implementations, the sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 738 may include a non-conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.

In one aspect, the sensor 738 may be configured to measure the force applied to the clamp arm 716 by the closure drive system. For example, one or more sensors 738 may be located at an interaction point between the closure tube and the clamp arm 716 to detect the closure force applied to the clamp arm 716 by the closure tube. The force applied to the clamp arm 716 may be representative of tissue compression experienced by a tissue slice captured between the clamp arm 716 and the ultrasonic blade 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closure force applied to the clamp arm 716 by the closure drive system. The one or more sensors 738 may be sampled in real time during the clamping operation by a processor of the control circuitry 710. The control circuitry 710 receives the real time sample measurements to provide and analyze time-based information to evaluate the closure force applied to the clamp arm 716 in real time.

In one aspect, a current sensor 736 can be used to measure the current drawn by each of the motors 704a-704e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current drawn by one of the motors 704a-704e. The force is converted to a digital signal and provided to the control circuit 710. The control circuit 710 can be configured to simulate the response of the actual system of the instrument in the controller software. The displacement member can be actuated to move the closure member 714 in the end effector 702 at or near a target velocity. The robotic surgical instrument 700 can include a feedback controller, which can be any one of any feedback controllers, including, but not limited to, a PID, a state feedback, a linear quadratic (LQR), and/or an adaptive controller. The robotic surgical instrument 700 can include a power source to convert the signal from the feedback controller into a physical input, such as, for example, a case voltage, a PWM voltage, a frequency modulated voltage, a current, a torque, and/or a force. Further details are disclosed in U.S. 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.

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 a displacement member, such as a closure member 764. The surgical instrument 750 includes an end effector 752 that may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.

The position, movement, displacement, and/or translation of a linear displacement member, such as the closure member 764, can be measured by an absolute positioning system, a sensor mechanism, and a position sensor 784. Because the closure member 764 is coupled to a longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the closure member 764 can be achieved by the position sensor 784 described herein. The control circuitry 760 may be programmed to control the translation of a displacement member, such as the closure member 764. In some embodiments, the control circuitry 760 may comprise one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause a processor or processors to control a displacement member, such as the closure member 764, in the manner described. In one aspect, the timer/counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the closure member 764 determined by the position sensor 784 with the output of the timer/counter 781 so that the control circuit 760 can determine the position of the closure member 764 at a particular time (t) relative to a starting position. The timer/counter 781 may be configured to measure elapsed time, count an external event, or measure the time of an external event.

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

The motor 754 may receive power from an energy source 762. The energy source 762 may be or may include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closure member 764 via a transmission 756. The transmission 756 may include one or more gears or other coupling components for coupling the motor 754 to the closure member 764. The position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or may include any type of sensor capable of generating position data indicative of the position of the closure member 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuitry 760 as the closure member 764 translates in the distal and proximal directions. The control circuitry 760 may track the pulses to determine the position of the closure member 764. Other suitable position sensors may be used, including, for example, a proximity sensor. Other types of position sensors may provide other signals indicative of the movement of the closure member 764. Also, in some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuitry 760 can track the position of the closure member 764 by summing the number and direction of steps the motor 754 is commanded to take. The position sensor 784 can be located in the end effector 752 or in any other portion of the instrument.

The control circuitry 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 can include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensors 788 can include one or more sensors.

The one or more sensors 788 may comprise a strain gauge, such as a micro strain gauge, configured to measure the magnitude of strain in the clamp arm 766 during the clamped state. The strain gauge provides an electrical signal that varies in amplitude with the magnitude of strain. The sensor 788 may comprise a pressure sensor configured to detect pressure 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 indicative of the thickness and/or fullness of the tissue located therebetween.

The sensor 788 may be configured to measure the force exerted by the closure drive system on the clamp arm 766. For example, one or more sensors 788 may be located at an interaction point between the closure tube and the clamp arm 766 to detect the closure force applied by the closure tube to the clamp arm 766. The force exerted on the clamp arm 766 may be representative of tissue compression experienced by a tissue slice captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied by the closure drive system to the clamp arm 766. The one or more sensors 788 may be sampled in real time during the clamping operation by a processor of the control circuitry 760. The control circuitry 760 receives the real time sample measurements to provide and analyze time-based information to evaluate the closure 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 closure member 764 corresponds to the current drawn by the motor 754. The force is converted to a digital signal and provided to the control circuit 760.

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

The actual drive system of the surgical instrument 750 is configured to drive the displacement, cutting or closure member 764 by a brushed DC motor with a gearbox and mechanical linkage to the articulation and/or knife system. Another example is an electric motor 754 that operates, for example, the displacement member and the articulation driver of an interchangeable shaft assembly. External influences are the unmeasured and unpredictable influences of things like tissue, surroundings and friction on the physical system. Such external influences may be referred to as impediments that act against the electric motor 754. External influences such as impediments may cause the operation of the physical system to deviate from the desired operation of the physical system.

Various exemplary aspects relate to a surgical instrument 750 that includes an end effector 752 having a motor-driven surgical sealing and cutting instrument. For example, a motor 754 may drive a displacement member in a distal and proximal direction along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766 and, when configured for use, an ultrasonic blade 768 positioned opposite the clamp arm 766. A clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768 as described herein. When the instrument 750 is ready to be used, the clinician may provide a firing signal, for example, by pressing a trigger of the instrument 750. In response to the firing signal, the motor 754 may drive the displacement member in a distal direction along the longitudinal axis of the end effector 752 from a proximal stroke start position to an end stroke position distal to the stroke start position. As the displacement member translates distally, the closure member 764, which includes a cutting element positioned at its distal end, can cut tissue between the ultrasonic blade 768 and the clamp arm 766.

In various embodiments, the surgical instrument 750 may include a control circuit 760 programmed to control the distal translation of a displacement member, such as the closure member 764, based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, either directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on the tissue condition. The control program may describe the distal movement of the displacement member. Different control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a slower speed and/or with less power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and/or with more power.

In some embodiments, the control circuit 760 may initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the stroke of the displacement member. Based on the response of the instrument 750 during the open-loop portion of the stroke, the control circuit 760 may select a firing control program. The response of the instrument may include the translation distance of the displacement member during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to the motor 754 during the open-loop portion, the total pulse width of the motor drive signal, etc. After the open-loop portion, the control circuit 760 may implement the selected firing control program for a second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 760 may modulate the motor 754 in a closed-loop manner based on translation data describing the position of the displacement member to translate the displacement member at a constant velocity. Further details are disclosed in U.S. Patent Application Publication No. 15/720,852, entitled "SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT," filed September 29, 2017, which is incorporated herein by reference in its entirety.

19 is a schematic diagram of a surgical instrument 790 configured to control various functions, according to one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of a displacement member, such as a closure member 764. The surgical instrument 790 includes an end effector 792 that may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 that may be replaced by or work in conjunction with one or more RF electrodes 796 (shown in dashed lines). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 that is driven by an ultrasonic generator 771.

In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid-state switch, a Hall effect device, an MR device, a GMR device, a magnetometer, among others. In other implementations, the sensor 638 may be a solid-state switch that operates under the influence of light, such as a light sensor, an IR sensor, an ultraviolet sensor, among others. Additionally, the switch may be a solid-state device such as a transistor (e.g., FET, junction FET, MOSFET, bipolar, etc.). In other implementations, the sensor 788 may include a non-conductor-containing switch, an ultrasonic switch, an accelerometer, and an inertial sensor, among others.

In one aspect, the position sensor 784 may be implemented as an absolute positioning system with a magnetic rotary absolute positioning system implemented as an AS5055EQFT single chip magnetic rotary position sensor available from Austria Microsystems, AG. The position sensor 784 may interface with the control circuit 760 to provide an absolute positioning system. The position may include multiple Hall effect elements located above a magnet and coupled to a CORDIC processor, also known as the digit-by-digit and Boulder algorithms, which are provided to implement simple and efficient algorithms for calculating hyperbolic and trigonometric functions, requiring only addition, subtraction, bit shifting, and table lookup operations.

In some embodiments, the position sensor 784 may be omitted. If the motor 754 is a stepper motor, the control circuitry 760 can track the position of the closure member 764 by summing the number and direction of steps the motor is commanded to perform. The position sensor 784 can be located in the end effector 792 or in any other portion of the instrument.

The control circuitry 760 can be in communication with one or more sensors 788. The sensors 788 can be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 788 can include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors for measuring one or more parameters of the end effector 792. The sensors 788 can include one or more sensors.

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

Further details are disclosed in U.S. Patent Application Publication No. 15/636,096, entitled "SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME," filed June 28, 2017, which is incorporated herein by reference in its entirety.

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 the tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize the tissue type. An algorithm for detecting the collagen/elasticity ratio of tissue to adjust the amplitude of the distal tip of the ultrasonic blade is described in the following sections of this disclosure. Various aspects of the smart ultrasonic energy device are described herein, for example, in connection with FIGS. 1-94. Thus, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with FIGS. 1-94 and their associated description.

Identifying Tissue Type and Adjusting Device Parameters In certain surgical procedures, it may be desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust 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 location of the tissue within the jaws of the ultrasonic end effector, for example, the location of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasonic transducer may be used to identify which percentage of the tissue is located at the distal or proximal end of the end effector. The response of the ultrasonic device may be based on the tissue type or tissue compressibility. In another aspect, the parameters of the ultrasonic device may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be adjusted based on the ration of collagen to elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue may be detected using various techniques, including infrared (IR) surface reflectance and emissivity. The force applied to the tissue by the clamp arm and/or the stroke of the clamp arm to create gap and compression. Electrical continuity across the jaw with the electrodes can be used to determine what percentage of the jaw is covered with tissue.

20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network with a modular communications 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/instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 described herein with reference to FIGS. 53-105. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 described herein with reference to FIGS. 53-105.

The generator module 240 may include a patient-isolated stage that communicates with the non-isolated stage via a power transformer. A secondary winding of the power transformer is housed within the isolated stage and may include a tap configuration (e.g., center-tapped or non-center-tapped configuration) to define a drive signal output for delivering drive signals to various surgical instruments, such as ultrasonic surgical instruments, RF electrosurgical instruments, and multifunction surgical instruments including ultrasonic and RF energy modes that can be delivered alone or simultaneously. Specifically, the drive signal output can output an ultrasonic drive signal (e.g., a 420V root-mean-square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output can output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to FIGS. 21-28B.

The generator module 240, or the device/instrument 235, or both, are coupled to a modular control tower 236, which is connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room, as described, for example, with reference to Figures 8-11.

FIG. 21 shows an example of a generator 900, a form of generator configured to interface with an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communication hub as shown in FIG. 20. The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, for delivering energy to the surgical instrument. The RF and ultrasonic signals may be provided alone or in combination, and may be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, among others) through a single port, which signals can be delivered individually or simultaneously to an end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory (not shown for clarity of disclosure) coupled to the processor 902. Digital information related to the waveforms is provided to the waveform generator 904, which includes one or more DAC circuits to convert the digital input to an analog output. The analog output is provided to an amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled across the power transformer 908 to a secondary side on the patient isolated side. A first signal of a first energy modality is provided between the terminals labeled ENERGY ₁ and RETURN of the surgical instrument. A second signal of a second energy modality is coupled across a capacitor 910 and provided between the terminals labeled ENERGY ₂ and RETURN of the surgical instrument. It will be understood that more than two energy modalities may be output, and thus the subscript "n" may be used to indicate that up to n ENERGY _n terminals may be provided, where n is a positive integer greater than 1. It will also be understood that up to "n" return paths (RETURN _n ) may be provided without departing from the scope of this disclosure.

A first voltage sense circuit 912 is coupled across the terminals labeled ENERGY ₁ and RETURN paths and measures the output voltage therebetween. A second voltage sense circuit 924 is coupled across the terminals labeled ENERGY ₂ and RETURN paths and measures the output voltage therebetween. A current sense circuit 914 is disposed in series with the RETURN section of the secondary side of the illustrated power transformer 908 to measure the output current of either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit must be provided in each return section. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to corresponding isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side (non-patient isolated side) of the power transformer 908 are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculations. Output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and to calculate output impedance, among other parameters. Input/output communication between the processor 902 and the patient isolation circuitry is provided through an interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 by dividing the output of either the first voltage sense circuit 912 coupled across the terminals labeled ENERGY ₁ /RETURN or the second voltage sense circuit 924 coupled across the terminals labeled ENERGY ₂ /RETURN by the output of a current sense circuit 914 placed in series with the RETURN section on the secondary side of the power transformer 908. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 916. Digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 to calculate the impedance. As an example, the first energy modality ENERGY ₁ may be ultrasound energy and the second energy modality ENERGY ₂ may be RF energy. Yet, in addition to ultrasound energy modalities and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and/or reversible electroporation and/or microwave energy, among others. Also, while the example illustrated in FIG. 21 shows that a single return path (RETURN) may be provided to two or more energy modalities, in other aspects, multiple return paths RETURN _n may be provided to each energy modality ENERGY _n . Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sense circuit 912 by the current sense circuit 914, and the impedance of the tissue may be measured by dividing the output of the second voltage sense circuit 924 by the current sense circuit 914.

As shown in FIG. 21 , a generator 900 including at least one output port can include a power transformer 908 with a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities, such as, for example, ultrasonic, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, among others, depending on the type of tissue treatment being performed. For example, the generator 900 can deliver energy with either monopolar or bipolar RF electrosurgical electrodes, at high voltage and low current to drive an ultrasonic transducer, at low voltage and high current to drive an RF electrode for tissue sealing, or in a coagulation waveform for spot coagulation. The output waveform from the generator 900 can be directed, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the generator 900 output would preferably be located between the output labeled ENERGY ₁ and RETURN as shown in FIG. 21 . In one embodiment, the RF bipolar electrode connection to the generator 900 output would preferably be located between the output labeled ENERGY ₂ and RETURN. In the case of a monopolar output, the preferred connection would be an active electrode (e.g., a pencil or other probe) to a suitable return pad connected to the ENERGY ₂ and RETURN outputs.

Further details are disclosed in U.S. Patent Application Publication No. 2017/0086914, published March 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety.

As used throughout this description, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that may communicate data through the use of modulated electromagnetic radiation over a non-solid medium. This term does not imply that the associated devices do not include any wires, although in some aspects they may not be present. The communication modules may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and beyond. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.

As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, usually a memory or some other data stream. The term is used herein to refer to a system that combines many dedicated "processors" or the central processor (central processing unit) in a computer system, especially a system-on-chip (SoC).

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

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

As used herein, the term controller or microcontroller may be a standalone IC or chip device that interfaces with a peripheral device. It may also be the link between two parts of a computer or controller on an external device that manages the operation of (and connections to) that device.

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

In one aspect, the processor may include a safety controller, including two controller families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be specifically configured for IEC 61508 and ISO 26262 safety limit applications, among others, to provide advanced integrated safety mechanisms while offering scalable performance, connectivity, and memory options.

Modular devices include modules that can be received in a surgical hub (e.g., as described in connection with FIGS. 3 and 9 ) and surgical devices or instruments that can be connected to various modules to connect or pair with corresponding surgical hubs. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction/irrigation devices, smoke evacuators, energy generators, ventilators, aspirators, and displays. The modular devices described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on the surgical hub to which a particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data can relate to the patient during surgery (e.g., tissue characteristics or injection pressure) or the modular device itself (e.g., advancing knife speed, motor current, or energy level). For example, a control algorithm for a surgical stapling and severing instrument can control the speed at which the instrument's motor drives the knife through tissue based on the resistance the knife encounters as it advances.

FIG. 22 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multi-function surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument. The generator 1100 is configurable for use with various surgical instruments. According to various forms, the generator 1100 may be configurable for use with various types of various surgical devices including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. In the embodiment of FIG. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, however, in one embodiment, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on a front panel of the console of the generator 1100. The input device 1110 may include any suitable device for generating signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.

The generator 1100 is configured to drive a number of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104, which includes a hand piece 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 hand piece 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, 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 and includes a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamp arms 1142a, 1142b and back through the conductor portion of the shaft 1127. The electrodes are coupled to and energized by a bipolar energy source in the generator 1100.

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

The generator 1100 is also configured to drive a multi-function surgical instrument 1108. The multi-function surgical instrument 1108 includes a hand piece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to an ultrasonic transducer 1120. The hand piece 1109 includes a trigger 1147 for actuating the clamp arm 1146, and a combination of toggle buttons 1137a, 1137b, 1137c for energizing and driving the ultrasonic blade 1149 or other functions. The toggle buttons 1137a, 1137b, 1137c can be configured to energize the ultrasonic transducer 1120 using the generator 1100, and to energize the ultrasonic blade 1149 using a bipolar energy source also housed within the generator 1100.

The generator 1100 is configurable for use with a variety of surgical instruments. According to various configurations, the generator 1100 may be configurable for use with a variety of different surgical devices, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. In the configuration of FIG. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, but in another configuration, the generator 1100 may be integrally formed with any one of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on a front panel of the console of the generator 1100. The input device 1110 may include any suitable device that generates a signal suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Further aspects of the generator for digitally generating electrical signal waveforms and surgical instruments are described in U.S. Patent Application Publication No. 2017-0086914-A1, the entirety of which is incorporated herein by reference.

23 is an end effector 1122 of an example ultrasonic device 1104 according to at least one aspect of the present disclosure. The end effector 1122 can include a blade 1128 that can be coupled to an ultrasonic transducer 1120 via a waveguide. When driven by the ultrasonic transducer 1120, the blade 1128 can vibrate and, upon contact with tissue, can cut and/or coagulate the tissue, as described herein. According to various aspects and as illustrated in FIG. 23, the end effector 1122 can further include a clamp arm 1140 that can be configured to cooperate with the blade 1128 of the end effector 1122. Along with the blade 1128, the clamp arm 1140 can include a series of jaws. The clamp arm 1140 can be pivotally connected to a distal end of the shaft 1126 of the instrument portion 1104. The clamp arm 1140 may include a clamp arm tissue pad 1163, which may be formed from TEFLON® or other suitable low friction material. The pad 1163 may be mounted to cooperate with the blade 1128 such that pivotal movement of the clamp arm 1140 may position the clamp pad 1163 in a substantially parallel relationship with and in contact with the blade 1128. With this configuration, a piece of tissue to be clamped may be grasped between the tissue pad 1163 and the blade 1128. The tissue pad 1163 may include a sawtooth-like configuration including a plurality of axially spaced apart and proximally extending grasping teeth 1161 to cooperate with the blade 1128 to improve the gripping of the tissue. The clamp arm 1140 may transition from an open position, shown in FIG. 23, to a closed position (where the clamp arm 1140 is in contact with or in close proximity to the blade 1128) in any suitable manner. For example, the hand piece 1105 may include a jaw closure trigger. When actuated by the clinician, the jaw closure trigger may pivot the clamp arm 1140 in any suitable manner.

The generator 1100 may be activated to provide a drive signal to the ultrasonic transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 (FIG. 24) coupled to the generator 1100 via a foot switch cable 1432. The clinician may activate the ultrasonic transducer 1120, and thereby the ultrasonic transducer 1120 and the blade 1128, by depressing the foot switch 1430. In addition to or instead of the foot switch 1430, some aspects of the device 1104 may employ one or more switches positioned on the handpiece 1105 that, when activated, can cause the generator 1100 to operate the ultrasonic transducer 1120. In one aspect, for example, the one or more switches may include a pair of toggle buttons 1134a, 1134b, 1134c (FIG. 22), for example, to determine the operating mode of the device 1104. For example, when the toggle button 1134a is depressed, 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 to indicate the position of a jaw closing trigger, for example, to manipulate the jaws via the clamp arm 1140 of the end effector 1122. Also, in some aspects, the ultrasonic generator 1100 can be activated based on the position of the jaw closing trigger (e.g., ultrasonic energy can be applied when the clinician depresses the jaw closing trigger to close the jaws via the clamp arm 1140).

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

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

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

In some aspects, the RF electrosurgical end effector 1124, 1125 (FIG. 22) may also include a pair of electrodes. The electrodes may be in communication with the generator 1100, for example, via a cable. The electrodes may be used to measure the impedance of a piece of tissue that exists, for example, between the clamp arm 1142a, 1146 and the blade 1142b, 1149. The generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. The impedance of the piece of tissue may be found, for example, by monitoring the current, voltage, etc. of the signal.

In various aspects, the generator 1100 may comprise several separate functional elements, such as modules and/or blocks shown in FIG. 24, which is a schematic of the surgical system 1000 of FIG. 22. The various functional elements or modules may be configured to drive various types of surgical devices 1104, 1106, 1108. For example, the ultrasonic generator module may drive an ultrasonic device, such as the ultrasonic device 1104. The electrosurgical/RF generator module may drive the electrosurgical device 1106. The modules may generate corresponding drive signals to drive the surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and/or the electrosurgical/RF generator module may each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (The modules are shown in phantom to illustrate this option.) Also, in some aspects, the electrosurgical/RF generator module may be integrally formed with the ultrasonic generator module, or vice versa.

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

According to the described aspects, the electrosurgical/RF generator module may use radio frequency (RF) energy to generate a drive signal or multiple drive signals at an output power sufficient to perform a bipolar electrosurgical procedure. In a bipolar electrosurgical application, for example, the drive signal may be provided to, for example, electrodes of the electrosurgical device 1106, as described above. Thus, the generator 1100 may be configured for therapeutic purposes by applying electrical energy to tissue sufficient to treat the tissue (e.g., coagulation, cauterization, tissue welding, etc.).

The generator 1100 can include an input device 2150 (FIG. 27B) located, for example, on a front panel of the console of the generator 1100. The input device 2150 can include any suitable device that generates signals suitable for programming the operation of the generator 1100. During operation, a user can use the input device 2150 to program or otherwise control the operation of the generator 1100. The input device 2150 can include any suitable device that generates signals that can be used by the generator (e.g., by one or more processors housed within the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasonic generator module and/or the electrosurgical/RF generator module). In various aspects, the input device 2150 includes one or more of a button, a switch, a thumb wheel, a keyboard, a keypad, a touch screen monitor, a pointing device, and a remote connection to a general-purpose or dedicated computer. In other aspects, the input device 2150 may include a suitable user interface, such as, for example, one or more user interface screens displayed on a touch screen monitor. Thus, the input device 2150 allows a user to set or program various operating parameters of the generator, such as, for example, the current (I), voltage (V), frequency (f), and/or duration (T) of the drive signal or signals generated by the ultrasonic generator module and/or the electrosurgical/RF generator module.

The generator 1100 may also include an output device 2140 (FIG. 27B), located, for example, on a 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, visual feedback devices (e.g., LCD display screen, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., haptic actuators).

Although certain modules and/or blocks of the generator 1100 may be described as examples, it will be understood that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the aspects. Furthermore, while various aspects may be described in terms of modules and/or blocks for ease of explanation, such modules and/or blocks may be implemented by one or more hardware components, e.g., processors, digital signal processors (DSPs), programmable logic devices (PLDs), application specific integrated circuits (ASICs), circuits, registers, and/or software components, e.g., programs, subroutines, logic, and/or combinations of hardware and software components.

In one aspect, the ultrasonic generator drive module and the electrosurgical/RF drive module 1110 (FIG. 22) may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and the like. The firmware may be stored in a non-volatile memory (NVM) such as a bit-masked read-only memory (ROM) or a flash memory. In various implementations, storing the firmware in a ROM may preserve flash memory. The NVM may include other types of memory, including, for example, a programmable ROM (PROM), an erasable programmable ROM (EPROM), an electrically erasable programmable ROM (EEPROM), or a battery-backed random access memory (RAM) such as a dynamic RAM (DRAM), a double data rate DRAM (DDRAM), and/or a synchronous DRAM (SDRAM).

In one aspect, the module includes hardware components implemented as a processor to execute program instructions for monitoring various measurable characteristics of the devices 1104, 1106, 1108 and generate a corresponding output drive signal or signals for operating the devices 1104, 1106, 1108. In an aspect where the generator 1100 is used with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in a cutting and/or coagulation mode of operation. The electrical characteristics of the device 1104 and/or tissue may be measured and used to control aspects of the operation of the generator 1100 and/or provided as feedback to the user. In an aspect where the generator 1100 is used with the device 1106, the drive signal may provide electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation and/or desiccation mode. The electrical characteristics of the device 1106 and/or tissue may be measured and used to control aspects of the operation of the generator 1100 and/or provided as feedback to the user. In various aspects, the hardware components may be implemented as DSPs, PLDs, ASICs, circuits, and/or registers, as described above. In one aspect, the processor may be configured to store and execute computer software program instructions to generate step function output signals for driving various components of the devices 1104, 1106, 1108, such as the ultrasonic transducer 1120 and the end effectors 1122, 1124, 1125.

The electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic blade. The electromechanical ultrasonic system has an initial resonant frequency defined by the physical properties of the ultrasonic transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is excited by an alternating voltage _Vg (t) and current _lg (t) signal that is equal to the resonant frequency of the electromechanical ultrasonic system. When the electromechanical ultrasonic system resonates, the phase difference between the voltage _Vg (t) and current _lg (t) signals is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. When the ultrasonic blade heats up, the compliance of the ultrasonic blade (modeled as an equivalent capacitance) changes the resonant frequency of the electromechanical ultrasonic system. Thus, the inductive impedance is no longer equal to the capacitive impedance, which causes a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasonic system. The system now operates "off-resonance". The mismatch between the drive frequency and the resonant frequency appears as a phase difference between the voltage _Vg (t) and current _lg (t) signals applied to the ultrasonic transducer. The generator electronics can easily monitor the phase difference between the voltage _Vg (t) and current _lg (t) signals and continuously adjust the drive frequency until the phase difference is again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. The change in phase and/or frequency can be used as an indirect measure of the ultrasonic blade temperature.

As shown in FIG. 25, the electromechanical properties of an ultrasonic transducer may be modeled as an equivalent circuit including a first branch with a capacitance and a second "operational" branch with a series-connected inductance, resistance, and capacitance that define the electromechanical properties of the resonator. Known ultrasonic generators may include a tuning inductor to tune out the capacitance at a certain resonant frequency so that substantially all of the generator drive signal current flows in the operational branch. Thus, by using a tuning inductor, the generator drive signal current represents the operational branch current, and thus the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency locking ability of the generator. However, the tuning inductor must be matched to the specific capacitance of the ultrasonic transducer at the operational resonant frequency. In other words, different ultrasonic transducers with different capacitances require different tuning inductors.

25 illustrates an equivalent circuit 1500 of an ultrasonic transducer, such as ultrasonic transducer 1120, according to one embodiment. Circuit 1500 includes a first "motional" branch having series-connected inductance _Ls , resistance _Rs , and capacitance _Cs that define the electromechanical properties of the resonator, and a second capacitive branch having capacitance _C0 . A drive current _Ig (t) may be received at a drive voltage _Vg (t) from a generator, with a motional current _Im (t) flowing through the first branch and currents _Ig (t) to _Im (t) flowing through the capacitive branch. Control of the electromechanical properties of the ultrasonic transducer may be achieved by suitably controlling _Ig (t) and _Vg (t). As mentioned above, known generator architectures can include a tuning inductor Lt (shown in phantom in FIG. 25) for tuning out the capacitance _C0 in a parallel resonant circuit at a resonant frequency so that substantially all of the generator's current output _Ig ( _t ) flows through the motional branch. In this way, control of the motional branch current _Im (t) is achieved by controlling the generator's current output _Ig (t). The tuning inductor _Lt is specific to the capacitance _C0 of the ultrasonic transducer, but different ultrasonic transducers with different static capacitances require different tuning inductors _Lt. Also, because the tuning inductor _Lt matches the nominal value of the capacitance _C0 at a single resonant frequency, precise control of the motional branch current _Im (t) is guaranteed only at that frequency. If the frequency decreases due to the temperature of the transducer, precise control of the motional branch current is compromised.

Various aspects of the generator 1100 can monitor the motional branch current I _m (t) without relying on the tuning inductor L _t . Rather, the generator 1100 can use measurements of the capacitance C ₀ during application of power for a particular ultrasonic surgical device 1104 (along with drive signal voltage and current feedback data) to determine the value of the motional branch current I m (t) on a dynamic and ongoing basis (e.g., in real time). Thus, these aspects of the generator 1100 can provide virtual tuning to simulate a system that is tuned or resonates with any value of capacitance C ₀ at any frequency, rather than only at a single resonant frequency determined by a nominal value of capacitance C ₀ .

FIG. 26 is a simplified block diagram of one embodiment of a generator 1100 for providing the inductorless regulation described above, among other advantages. FIGS. 27A-27C show the architecture of the generator 1100 of FIG. 26 according to one embodiment. Referring to FIG. 26, the generator 1100 may include a patient-isolated stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is included in the isolated stage 1520 and may include a tap configuration (e.g., center tap or non-center tap configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to various surgical devices, such as the ultrasonic surgical device 1104 and the electrosurgical device 1106. In particular, drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to the ultrasonic surgical device 1104, and drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to the electrosurgical device 1106, where output 1600b corresponds to a center tap of the power transformer 1560. The non-isolated stage 1540 may include a power amplifier 1620 having an output connected to the primary winding 1640 of the power transformer 1560. In certain aspects, the power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may further include a programmable logic 1660 for providing a digital output to a digital-to-analog converter (DAC) 1680, which then provides a corresponding analog signal to the input of the power amplifier 1620. In certain aspects, the programmable logic 1660 may include, for example, a field programmable gate array (FPGA). The programmable logic 1660 may control the input of the power amplifier 1620 via the DAC 1680, thereby controlling any of a number of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal appearing at the drive signal outputs 1600a, 1600b, 1600c. In certain aspects, and as described below, the programmable logic 1660, in conjunction with a processor (e.g., processor 1740, described below), can execute a number of digital signal processing (DSP)-based and/or other control algorithms to control parameters of the drive signal output by the generator 1100.

Power can be provided to the bus of the power amplifier 1620 by a switch mode regulator 1700. In certain aspects, the switch mode regulator 1700 can include, for example, an adjustable buck regulator. As mentioned above, the non-isolated stage 1540 can further include a processor 1740, which in one aspect can include, for example, a DSP processor, such as an ADSP-21469 SHARC DSP available from Analog Devices, Norwood, Mass. In certain aspects, the processor 1740 can 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. For example, in one aspect, the processor 1740 can receive as an input via the ADC 1760 the waveform envelope of a signal (e.g., an RF signal) to be amplified by the power amplifier 1620. The processor 1740 can then control the switch mode regulator 1700 (e.g., via a pulse width modulated (PWM) output) so that the rail voltages supplied to the power amplifier 1620 track the waveform envelope of the amplified signal. By dynamically modulating the rail voltages of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved compared to a fixed rail voltage amplifier scheme. The processor 1740 may be configured for wired or wireless communication.

In certain aspects, and as described in further detail in connection with FIGS. 28A-28B, the programmable logic 1660, in conjunction with the processor 1740, may execute a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency, and/or amplitude of the drive signal output by the generator 1100. In one aspect, for example, the programmable logic 1660 may execute a DDS control algorithm 2680 (FIG. 28A) by recalling waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT, which may be embedded in an FPGA. This control algorithm is particularly useful in ultrasonic applications where an ultrasonic transducer, such as the ultrasonic transducer 1120, may be driven by a well-defined sinusoidal current at its resonant frequency. Minimizing or reducing the total distortion of the operating branch current may correspondingly minimize or reduce undesirable resonant effects, since other frequencies may excite parasitic resonances. Because the waveform shape of the drive signal output by the generator 1100 may be affected by various distortion sources present in the output drive circuit (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal may be input to an algorithm, such as an error control algorithm executed by the processor 1740, which compensates for the distortion by suitably pre-distorting or modifying the waveform samples stored in the LUT on a dynamic, ongoing basis (e.g., in real time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated motional branch current and the desired current waveform shape, the error being determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuit, may result in a motional branch drive signal having a desired waveform shape (e.g., sinusoidal) to optimally drive the ultrasonic transducer. Thus, in such an aspect, the LUT waveform samples represent not the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately generate the motional branch drive signal of the desired waveform when considering distortion effects.

The non-isolated stage 1540 may further include ADC 1780 and ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 to sample the voltage and current, respectively, of the drive signal output by the generator 1100. In certain aspects, the ADCs 1780, 1800 may be configured to sample at a high speed (e.g., 80 Msps) to allow oversampling of the drive signal. In one aspect, for example, the sampling rate of the ADCs 1780, 1800 may allow oversampling of the drive signal by approximately 200 times (depending on the drive frequency). In certain aspects, the sampling operation of the ADCs 1780, 1800 may be performed by a single ADC that receives the input voltage and current signals via a bidirectional multiplexer. The use of high speed sampling in embodiments of the generator 1100 can enable, among other things, the calculation of complex currents flowing through the motional branches (which may be used in certain embodiments to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and highly accurate calculation of actual power consumption. The voltage and current feedback data output by the ADCs 1780, 1800 may be received by the programmable logic 1660 and processed (e.g., FIFO buffering, multiplexing) and stored in a data memory, for subsequent retrieval, e.g., by the processor 1740. As noted above, the voltage and current feedback data may be used as input to an algorithm to pre-distort or modify the LUT waveform samples on a dynamic and ongoing basis. In certain embodiments, this may require that each stored voltage and current feedback data pair be indexed or otherwise associated with the corresponding LUT sample output by the programmable logic 1660 as the voltage and current feedback data pair is acquired. Synchronizing the LUT samples with the voltage and current feedback data in this manner contributes to precise timing and stability of the predistortion algorithm.

In certain aspects, the voltage and current feedback data can be used to control the frequency and/or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, the voltage and current feedback data can be used to determine the impedance phase, e.g., the phase difference between the voltage drive signal and the current drive signal. The frequency of the drive signal can then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the measurement accuracy of the impedance phase. The determination of the phase impedance and frequency control signal can be performed, for example, by the processor 1740, with the frequency control signal being provided as an input to a DDS control algorithm executed by the programmable logic 1660.

The impedance phase may be determined by Fourier analysis. In one aspect, the phase difference between the generator voltage _Vg (t) and current _Ig (t) drive signals may be determined using a Fast Fourier Transform (FFT) or Discrete Fourier Transform (DFT) as follows:

Evaluating the Fourier transform at the frequency of the sine wave gives:

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

where 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 the voltage _Vg (t) and current _Ig (t) signals is the zero-crossing method, which produces highly accurate results. For voltage _Vg (t) and current _Ig (t) signals with the same frequency, each negative-to-positive zero crossing of the voltage signal _Vg (t) triggers the start of a pulse, while each negative-to-positive zero crossing of the current signal _Ig (t) triggers the end of a pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train can be passed through an averaging filter to obtain a measurement of the phase difference. Additionally, positive-to-negative zero crossings can also be used in a similar manner, and any effects of DC and harmonic content can be reduced when the results are averaged. In one implementation, the analog voltage _Vg (t) and current _Ig (t) signals are converted to digital signals that are high when the analog signal is positive and low when the analog signal is negative. High accuracy phase estimation requires a sharp transition between high and low. In one aspect, a Schmitt trigger can be used in conjunction with an RC stabilization network to convert the analog signal to a digital signal. In another aspect, an edge-triggered RS flip-flop and supporting circuitry may be used. In yet another aspect, the zero-crossing technique may use an eXclusive OR (XOR) gate.

Other techniques for determining the phase difference between the voltage and current signals include monitoring Lissajous figures and images, methods such as the three-voltmeter method, the cross-coil method, the vector voltmeter method, and the vector impedance method, as well as using phase standard instruments, phase-locked loops, and other techniques described in Phase Measurement, Peter O'Shea, 2000 CRC Press LLC, <http://www.engnetbase.com>, which 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 a current amplitude setpoint. The current amplitude setpoint can be directly specified or indirectly determined based on specified voltage amplitude and power setpoints. In certain aspects, control of the current amplitude can be performed by a control algorithm, such as, for example, a proportional-integral-derivative (PID) control algorithm in the processor 1740. Variables controlled by the control algorithm to suitably control the current amplitude of the drive signal can include, for example, the scaling of the LUT waveform samples stored in the programmable logic 1660 and/or the full-scale output voltage of the DAC 1680 (which provides an input to the power amplifier 1620) via the DAC 1860.

The non-isolated stage 1540 may further include a processor 1900 to provide, among other things, user interface (UI) functions. In one aspect, the processor 1900 may include, for example, an Atmel AT91 SAM9263 processor with an ARM926EJ-S core available from Atmel Corporation, San Jose, Calif. Examples of UI functions supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with a foot switch 1430, communication with an input device 2150 (e.g., a touch screen display), and communication with an output device 2140 (e.g., a speaker). The processor 1900 may communicate with the processor 1740 and the programmable logic (e.g., via a serial peripheral interface (SPI) bus). The processor 1900 may primarily support UI functions, but may also cooperate with the processor 1740 in certain aspects to provide hazard mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user input and/or other input (e.g., touch screen input 2150, foot switch 1430 input, temperature sensor input 2160) and may disable the drive output of the generator 1100 if an erroneous condition is detected.

In certain aspects, both processor 1740 (FIGS. 26, 27A) and processor 1900 (FIGS. 26, 27B) can determine and monitor the operating state of generator 1100. In the case of processor 1740, the operating state of generator 1100 can determine, for example, which control and/or diagnostic processes are executed by processor 1740. In the case of processor 1900, the operating state of generator 1100 can determine, for example, which elements of the user interface (e.g., display screen, sound) are provided to the user. Processors 1740, 1900 separately maintain the current operating state of generator 1100 and recognize and evaluate possible transitions from the current operating state. Processor 1740 acts as a master in this relationship and can 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 verify that the requested transition is valid. If the transition between states requested by processor 1900 is determined to be invalid, processor 1900 can place generator 1100 in a failure mode.

The non-isolated stage 1540 may further include a controller 1960 (FIGS. 26, 27B) for monitoring the input device 2150 (e.g., a capacitive touch sensor, a capacitive touch screen used to turn the generator 1100 on and off). In certain aspects, the controller 1960 may comprise at least one processor and/or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 may comprise a processor (e.g., a Mega168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 may comprise a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) for controlling and managing the acquisition of touch data from the capacitive touch screen.

In certain aspects, when the generator 1100 is in the "power off" state, the controller 1960 can continue to receive operating power (e.g., via a line from a power source of the generator 1100, such as the power source 2110 (FIG. 26) described below). In this manner, the controller 1960 can continue to monitor an input device 2150 (e.g., a capacitive touch sensor located on the front panel of the generator 1100) for turning the generator 1100 on and off. When the generator 1100 is in the "power off" state, the controller 1960 can activate the power source (e.g., enable operation of one or more DC/DC voltage converters 2130 (FIG. 26) of the power source 2110) upon detection of activation of the "on/off" input device 2150 by a user. As a result, the controller 1960 can initiate a sequence to transition the generator 1100 to the "power on" state. Conversely, when activation of the "on/off" input device 2150 is detected while the generator 1100 is in the "power on" state, the controller 1960 can initiate a sequence to transition the generator 1100 to the "power off" state. In certain aspects, for example, the controller 1960 can report activation of the "on/off" input device 2150 to the processor 1900, which then executes the processing sequence necessary to transition the generator 1100 to the "power off" state. In such aspects, the controller 1960 may not have the independent ability to cause the removal of power from the generator 1100 after its "power on" state has been established.

In certain aspects, the controller 1960 may cause the generator 1100 to provide auditory or other sensory feedback to alert the user that a "power on" or "power off" sequence has begun. Such an alert may be provided at the start of the "power on" or "power off" sequence and prior to the start of other processes associated with the sequence.

In certain aspects, the isolated stage 1520 may include an instrument interface circuit 1980 to provide a communication interface between, for example, the surgical device's control circuitry (e.g., control circuitry including the handpiece switch) and the components of the non-isolated stage 1540 (e.g., programmable logic 1660, processor 1740, and/or processor 1900, etc.). The instrument interface circuit 1980 may exchange information with the components of the non-isolated stage 1540 via a communication link that maintains a suitable degree of electrical isolation between the stages 1520, 1540, such as, for example, an infrared (IR) based communication link. For example, the instrument interface circuit 1980 may be powered using a low dropout voltage regulator powered by an isolation transformer driven from the non-isolated stage 1540.

In one aspect, the instrument interface circuit 1980 can include a programmable logic 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (FIGS. 26 and 27C). The signal conditioning circuit 2020 can be configured to receive a periodic signal (e.g., a 2 kHz square wave) from the programmable logic 2000 and generate a bipolar interrogation signal having the same frequency. The interrogation signal can be generated, for example, using a bipolar current source fed by a differential amplifier. The interrogation signal can be communicated to a surgical device control circuit (e.g., by using a conductive pair in a cable connecting the generator 1100 to the surgical device) and monitored to determine the state or configuration of the control circuit. For example, the control circuit can include a number of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that the state or configuration of the control circuit is individually identifiable based on the one or more characteristics. For example, in one aspect, the signal conditioning circuitry 2020 may include an ADC to generate samples of a voltage signal appearing across an input of the control circuitry caused by the interrogation signal passing through it. The programmable logic 2000 (or a component of the non-isolated stage 1540) may then determine a state or configuration of the control circuitry based on the ADC samples.

In one aspect, the instrument interface circuit 1980 can include a first data circuit interface 2040 that allows for the exchange of information between the programmable logic 2000 (or other elements of the instrument interface circuit 1980) and a first data circuit disposed within or otherwise associated with the surgical device. In certain aspects, for example, the first data circuit 2060 can be disposed in a cable integrally attached to a handpiece of the surgical device, or in an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit can include a non-volatile storage device, such as an electrically erasable programmable read only memory (EEPROM) device. In certain aspects, and referring again to FIG. 26, the first data circuit interface 2040 can be implemented separately from the programmable logic 2000 and can include suitable circuitry (e.g., separate logic, processor) that allows for communication between the programmable logic 2000 and the first data circuit. In other embodiments, the first data circuit interface 2040 may be integral with the programmable logic device 2000.

In certain aspects, the first data circuit 2060 can store information regarding the particular surgical device with which the first data circuit 2060 is associated. Such information can include, for example, a model number, a serial number, a number of operations the surgical device has been used in, and/or other types of information. This information can be read by the instrument interface circuit 1980 (e.g., by the programmable logic 2000) and forwarded to components of the non-isolated stage 1540 (e.g., the programmable logic 1660, the processor 1740, and/or the processor 1900) for presentation to a user via the output device 2140 and/or for controlling the functions or operations of the generator 1100. Additionally, any type of information can be communicated to the first data circuit 2060 via the first data circuit interface 2040 (e.g., using the programmable logic 2000) for storage within the first data circuit 2060. Such information can include, for example, the most recent number of operations the surgical device has been used in, and/or the date and/or time of its use.

As noted above, the surgical instruments may be removable from the handpiece (e.g., instrument 1106 may be removable from handpiece 1107) to facilitate interchangeability and/or disposability of the instruments. In such cases, known generators may be limited in their ability to recognize the particular instrument configuration being used and correspondingly optimize their control and diagnostic processes. However, adding readable data circuitry to the surgical device instrument to address this issue is problematic from a compatibility standpoint. For example, designing a surgical device to be backward compatible with generators that lack the necessary data read capabilities may not be practical due to, for example, different signaling schemes, design complexity, and expense. Other aspects of the instrument address these concerns by economically using data circuitry that may be implemented in existing surgical instruments and minimizing design changes to maintain compatibility of the surgical device with modern generator platforms.

Additionally, aspects of the generator 1100 may enable communication with an instrument-based data circuit. For example, the generator 1100 may be configured to communicate with a second data circuit (e.g., a data circuit) housed within an instrument (e.g., instrument 1104, 1106, or 1108) of a surgical device. The instrument interface circuit 1980 may include a second data circuit interface 2100 that enables this communication. In one aspect, the second data circuit interface 2100 may include a tri-state digital interface, although other interfaces may be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and/or receiving data. In one aspect, for example, the second data circuit may store information regarding the particular surgical instrument with which it is associated. Such information may include, for example, a model number, a serial number, a number of operations the surgical instrument has been used in, and/or any other type of information. Additionally or alternatively, any type of information can be communicated to the second data circuit via the second data circuit interface 2100 (e.g., using the programmable logic 2000) for storage in the second data circuit. Such information may include, for example, the most recent number of operations the instrument was used for, and/or the date and/or time of its use. In certain aspects, the second data circuit can transmit data acquired by one or more sensors (e.g., instrument-based temperature sensors). In certain aspects, the second data circuit can receive data from the generator 1100 and provide an indication (e.g., an LED indication or other visual indication) to the user based on the received data.

In certain aspects, the second data circuit and the second data circuit interface 2100 can be configured to allow communication between the programmable logic 2000 and the second data circuit to be achieved without the need to provide additional conductors for this purpose (e.g., dedicated conductors in the cable connecting the handpiece to the generator 1100). In one aspect, a one-wire bus communication scheme implemented on existing cable wiring can be used to communicate information to and from the second data circuit, for example, with one of the conductors used transmitting an interrogation signal from the signal conditioning circuit 2020 to the control circuit in the handpiece. In this way, design changes or modifications to the surgical device that may otherwise be required are minimized or reduced. Furthermore, because various types of communication can be implemented over a common physical channel (either with or without frequency band separation), the presence of the second data circuit is "invisible" to generators that do not have the necessary data reading capabilities, thus allowing for backward compatibility of surgical device instruments.

In certain aspects, the isolation stage 1520 can include at least one blocking capacitor 2960-1 (FIG. 27C) connected to the drive signal output 1600b to prevent DC current from passing through the patient. A single blocking capacitor may be required, for example, to comply with medical regulations or standards. Although failure in a single capacitor design is relatively rare, such failure may still have negative consequences. In one aspect, a second blocking capacitor 2960-2 can be provided in series with the blocking capacitor 2960-1 to monitor current leakage from a point between the blocking capacitors 2960-1, 2960-2, for example, by an ADC 2980 for sampling a voltage induced by the leakage current. The samples can be received, for example, by the programmable logic 2000. Based on the change in leakage current (shown by a voltage sample in the aspect of FIG. 26), the generator 1100 can determine when at least one of the blocking capacitors 2960-1, 2960-2 has failed. Thus, the embodiment of FIG. 26 can provide benefits over a single capacitor design with a single point of failure.

In certain aspects, the non-isolated stage 1540 may include a power supply 2110 for outputting DC power at a suitable voltage and current. The power supply may include, for example, a 400 W power supply for outputting a 48 VDC system voltage. As described above, the power supply 2110 may further include one or more DC/DC voltage converters 2130 for receiving the output of the power supply and generating a DC output at the voltage and current required by the various components of the generator 1100. As described above in connection with the controller 1960, one or more of the DC/DC voltage converters 2130 may receive input from the controller 1960 when activation of an "on/off" input device 2150 by a user is detected by the controller 1960, allowing operation or activation of the DC/DC voltage converters 2130.

28A-28B show certain functional and structural aspects of one embodiment of the generator 1100. Feedback indicative of the current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by the ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 may be implemented as two-channel ADCs and may sample the feedback signal at a high speed (e.g., 80 Msps) to allow for oversampling of the drive signal (e.g., approximately 200 times oversampling). The current and voltage feedback signals may be suitably conditioned (e.g., amplified, filtered) in the analog domain prior to processing by the ADCs 1780, 1800. The current and voltage feedback samples from the ADCs 1780, 1800 may be individually buffered and then multiplexed or interleaved into a single data stream in block 2120 of the programmable logic 1660. In the embodiment of Figures 28A-28B, the programmable logic 1660 comprises an FPGA.

The multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented in block 2144 of processor 1740. The PDAP may include a packing unit for implementing any of a number of methods for correlating the multiplexed feedback samples with memory addresses. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by programmable logic 1660 may be stored at one or more memory addresses that are associated with or indexed to the LUT address of the LUT sample. In another aspect, feedback samples corresponding to a particular LUT sample output by programmable logic 1660 may be stored in a common memory location along with the LUT address of the LUT sample. In any case, the feedback samples may be stored such that the address of the LUT sample from which a particular set of feedback samples originates may subsequently be ascertained. As noted above, the synchronization of the LUT sample addresses and feedback samples thus contributes to the precise timing and stability of the predistortion algorithm. A direct memory access (DMA) controller implemented in block 2166 of the processor 1740 can store the feedback samples (and any LUT sample address data, if applicable) in a specified memory location 2180 (e.g., internal RAM) of the processor 1740.

Block 2200 of processor 1740 can implement a pre-distortion algorithm to pre-distort or modify the LUT samples stored in programmable logic device 1660 on a dynamic, ongoing basis. As described above, pre-distortion of the LUT samples can compensate for various sources of distortion present in the output drive circuitry of generator 1100. The pre-distorted LUT samples thus, when processed by the drive circuitry, produce a drive signal having a desired waveform shape (e.g., a sine wave) to optimally drive an ultrasonic transducer.

In block 2220 of the pre-distortion algorithm, the current through the motional branch of the ultrasonic transducer is determined. The motional branch current may be determined using Kirchhoff's current law, for example, based on the current and voltage feedback samples stored in memory location 2180 (which, when appropriately scaled, may represent _Ig and _Vg of the model of FIG. 25 above), the value of the ultrasonic transducer capacitance _C0 (measured or known a priori), and the known value of the drive frequency. For each set of stored current and voltage feedback samples associated with a LUT sample, the motional branch current sample may be determined.

In block 2240 of the predistortion algorithm, each motion branch current sample determined in block 2220 is compared to a sample of the desired current waveform shape to determine the difference or sample amplitude error between the compared samples. For this determination, the current waveform shape sample may be provided from a waveform shape LUT 2260, for example, which includes amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 used for the comparison may be determined by the LUT sample address associated with the motion branch current sample used for the comparison. Thus, the input of the motion branch current to block 2240 may be synchronized with the input of its associated LUT sample address to block 2240. Thus, the LUT samples stored in programmable logic 1660 and the LUT samples stored in waveform shape LUT 2260 may be numerically equivalent. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT 2260 may be a fundamental sine wave. Other waveform shapes may be desirable. For example, it is contemplated that a fundamental sine wave may be used to drive the primary longitudinal motion of an ultrasonic transducer overlapped with one or more other drive signals at other wavelengths, such as the third harmonic, to drive at least two mechanical resonances for beneficial vibration in the lateral or other modes.

Each value of sample amplitude error determined in block 2240 can be communicated to the LUT of programmable logic 1660 (shown in block 2280 of FIG. 28A) along with an index of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and, optionally, a previously received value of sample amplitude error for the same LUT address), LUT 2280 (or other control block of programmable logic 1660) can pre-distort or modify the value of the LUT sample stored at the LUT address, thereby reducing or minimizing the sample amplitude error. It will be appreciated that such pre-distortion or modification of each LUT sample in an iterative manner across the entire range of LUT addresses causes the waveform shape of the generator output current to match or conform to the desired current waveform shape represented by the samples of waveform shape LUT 2260.

Current and voltage amplitude measurements, power measurements, and impedance measurements may be determined in block 2300 of processor 1740 based on the current and voltage feedback samples stored in memory location 2180. Prior to the determination of these values, the feedback samples may be suitably scaled and, in certain aspects, processed through a suitable filter 2320 to remove, for example, noise and induced harmonic components caused by the data acquisition process. The filtered voltage and current samples may thus substantially represent the fundamental frequency of the generator's drive output signal. In certain aspects, filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such aspects may use a fast Fourier transform (FFT) of the output drive signal current and voltage signals. In certain aspects, the resulting frequency spectrum may be used to provide additional generator functions. In one aspect, for example, the ratio of second and/or third harmonic components to the fundamental frequency component may be used as a diagnostic indicator.

At block 2340 (FIG. 28B), a root-mean-square (RMS) calculation may be applied to a sample size of current feedback samples representing an integer number of cycles of the drive signal to generate a measurement I _rms representative of the drive signal output current. At block 2360, a root-mean-square (RMS) calculation may be applied to a sample size of voltage feedback samples representing an integer number of cycles of the drive signal to determine a measurement V _rms representative of the drive signal output voltage.

In block 2380, the current and voltage feedback samples may be multiplied point by point and an averaging calculation applied to the samples representing an integer number of cycles of the drive signal to determine a measure of the actual output power of the generator, P _r .

In block 2400, a measurement of the generator's apparent output power P _a may be determined as the product V _{rms ·} I _rms .

At block 2420, a measure of the load impedance magnitude _Zm may be determined as the quotient _Vrms / _Irms .

In certain aspects, the values _Irms , _Vrms , _Pr , _Pa , and _Zm determined in blocks 2340, 2360, 2380, 2400, and 2420 may be used by the generator 1100 to implement any of a number of control and/or diagnostic processes. In certain aspects, any of these values may be communicated to a user through a suitable communications interface (e.g., a USB interface), for example, via an output device 2140 integral with the generator 1100 or connected to the generator 1100. The various diagnostic processes may include, for example, but are not limited to, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, overvoltage condition, overcurrent condition, overpower condition, voltage sense failure, current sense failure, audible indicator failure, visual indicator failure, short circuit condition, power supply failure, or blocking capacitor failure.

Block 2440 of processor 1740 may implement a phase control algorithm to determine and control the impedance phase of an electrical load (e.g., an ultrasonic transducer) driven by generator 1100. As described above, the frequency of the drive signal may be controlled to minimize or reduce the difference between the determined impedance phase and an impedance phase setpoint (e.g., 0°) to minimize or reduce the effects of harmonic distortion and improve the accuracy of the phase measurement.

The phase control algorithm receives as input the current and voltage feedback samples stored in memory location 2180. Before using them in the phase control algorithm, the feedback samples may be suitably scaled and, in certain aspects, processed through a suitable filter 2460 (which may be the same as filter 2320) to remove noise arising from, for example, the data acquisition process and induced harmonic content. The filtered voltage and current samples may thus substantially represent the fundamental frequency of the generator drive output signal.

At block 2480 of the phase control algorithm, the current through the motional branch of the ultrasonic transducer is determined. This determination may be the same as that described above in connection with block 2220 of the predistortion algorithm. Thus, the output of block 2480 may be a motional branch current sample for each set of stored current and voltage feedback samples associated with a LUT sample.

In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized input of the motional branch current samples and corresponding voltage feedback samples determined in block 2480. In 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 to a phase set point 2540 to determine the difference or phase error between the compared values.

In phase control algorithm block 2560 (FIG. 28A), a frequency output is determined to control the frequency of the drive signal based on the value of the phase error determined in block 2520 and the magnitude of the impedance determined in block 2420. The frequency output value may be continuously adjusted by block 2560 and forwarded to DDS control block 2680 (described below) to maintain the impedance phase determined in block 2500 at the phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0° phase set point. In this way, any amount of harmonic distortion is centered around the top of the voltage waveform, improving the accuracy of the phase impedance determination.

Block 2580 of processor 1740 can implement algorithms for modulating the current amplitude of the drive signal to control the drive signal current, voltage, and power according to a set point specified by a user or according to requirements specified by other processes or algorithms implemented by generator 1100. Control of these values can be achieved, for example, by scaling the LUT samples in LUT 2280 and/or by adjusting the full-scale output voltage of DAC 1680 (which provides an input to power amplifier 1620) via DAC 1860. Block 2600 (which in certain aspects may be implemented as a PID controller) can receive as input a current feedback sample (which may be suitably scaled and filtered) from memory location 2180. The current feedback sample can be compared to a "current demand" _Id value determined by the controlled variable (e.g., current, voltage, or power) to determine if the drive signal is providing the required current. In aspects where the drive signal current is the controlled variable, the current demand _Id can be specified directly by the current set point 2620A ( _Isp ). For example, the RMS value of the current feedback data (determined in block 2340) may be compared to a user-specified RMS current set point _Isp to determine the appropriate controller action. For example, if the current feedback data indicates an RMS value lower than the current set point _Isp , then the LUT scaling and/or the full-scale output voltage of DAC 1680 may be adjusted by block 2600 such that the drive signal current is increased. Conversely, if the current feedback data indicates an RMS value higher than the current set point _Isp , then block 2600 may adjust the LUT scaling and/or the full-scale output voltage of DAC 1680 such that the drive signal current is decreased.

In aspects where drive signal voltage is the controlled variable, the current demand _Id may be indirectly specified based on the current required to maintain the desired voltage set point 2620B ( _Vsp ) given the magnitude of the load impedance _Zm measured in block 2420 (e.g., _Id = _Vsp / Zm). Similarly, in aspects where drive signal power is the controlled variable, the current demand _Id may be indirectly specified based on the current required to maintain the desired power set point 2620C ( _Psp ) given the voltage _Vrms measured in block 2360 (e.g., _Id = _Psp / _Vrms ).

Block 2680 (FIG. 28A) can implement a DDS control algorithm to control the drive signal by recalling the LUT samples stored in LUT 2280. In a particular aspect, the DDS control algorithm can be a numerically controlled oscillator (NCO) algorithm for generating waveform samples at a fixed clock rate using a point (memory location) skip technique. The NCO algorithm can implement a phase accumulator, or a frequency/phase converter, that acts as an address pointer to recall the LUT samples from LUT 2280. In one aspect, the phase accumulator can be a D step size, modulo N phase accumulator, where D is a positive integer representing a frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D=1 can cause the phase accumulator to sequentially address all of LUT 2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. If D>1, the phase accumulator can skip addresses in the LUT 2280, resulting in a waveform output having a higher frequency. This allows the frequency of the waveform generated by the DDS control algorithm to be controlled accordingly by suitably varying the frequency control value. In certain aspects, 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 provide an input to the DAC 1680, which in turn provides a corresponding analog signal to the input of the power amplifier 1620.

Block 2700 of processor 1740 may implement a switch mode converter control algorithm to dynamically modulate the rail voltage of power amplifier 1620 based on the waveform envelope of the signal being amplified, thereby improving the efficiency of power amplifier 1620. In certain aspects, the characteristics of the waveform envelope may be determined by monitoring one or more signals included in power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope may be determined by monitoring a minimum value of a drain voltage (e.g., a MOSFET drain voltage) that is modulated according to the envelope of the amplified signal. The minimum voltage signal may be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal may be sampled by ADC 1760, and the output minimum voltage sample may be received at block 2720 of the switch mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 may control the PWM signal output by PWM generator 2760, which in turn controls the rail voltage supplied to power amplifier 1620 by switch mode regulator 1700. In certain aspects, the rail voltage may be modulated according to the waveform envelope characterized by the minimum voltage sample as long as the value of the minimum voltage sample is less than the minimum target 2780 input to block 2720. For example, a low rail voltage may be provided by block 2740 to the power amplifier 1620 when the minimum voltage sample indicates a low envelope power level, and full rail voltage may be provided only when the minimum voltage sample indicates a maximum envelope power level. When the minimum voltage sample is below the minimum target 2780, the rail voltage may be maintained by block 2740 at a minimum value suitable to ensure suitable operation of the power amplifier 1620.

29 is a circuit diagram of one embodiment of an electrical circuit 2900 suitable for driving an ultrasonic transducer, such as ultrasonic transducer 1120, according to at least one embodiment of the present disclosure. The electrical circuit 2900 includes an analog multiplexer 2980. The analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A, such as ultrasonic, battery, and power control circuitry. A current sensor 2982 is coupled in series with the return or ground section of the power supply circuit and measures the current provided by the power supply. A field effect transistor (FET) temperature sensor 2984 provides the ambient temperature. A pulse width modulation (PWM) watchdog timer 2988 automatically causes a system reset if the main program neglects to provide a periodic system reset. This is provided to automatically reset the electrical circuit 2900 if it hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 2900 may be configured as an RF driver circuit for driving an ultrasonic transducer or for driving an RF electrode, such as the electrical circuit 3600 shown in FIG. 36. Thus, referring back now to FIG. 29, the electrical circuit 2900 may be used to alternately drive both an ultrasonic transducer and an RF electrode. If driven simultaneously, a filter circuit may be provided within the corresponding first stage circuit 3404 (FIG. 34) to select either the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned U.S. Patent Application Publication No. 2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR," which is incorporated herein by reference in its entirety.

The drive circuit 2986 provides left and right ultrasonic energy outputs. Digital signals representing signal waveforms are provided to the SCL-A, SDA-A inputs of the analog multiplexer 2980 from a control circuit such as the control circuit 3200 (FIG. 32). A digital-to-analog converter 2990 (DAC) converts the digital input to an analog output to drive a PWM circuit 2992 coupled to an oscillator 2994. The PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to a first transistor output stage 2998a to drive a first ultrasonic (left) energy output. The PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to a second transistor output stage 2998b to drive a second ultrasonic (right) energy output. A voltage sensor 2999 is coupled between the ultrasonic left/right output terminals to measure the output voltage. The driver circuit 2986, the first and second driver circuits 2996a and 2996b, and the first and second transistor output stages 2998a and 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 (FIG. 32) generates a digital waveform 4300 (FIG. 43) using a circuit such as a direct digital synthesis (DDS) circuit 4100, 4200 (FIGS. 41 and 42). The DAC 2990 receives the digital waveform 4300 and converts it to an analog waveform, which is received and amplified by the first stage amplifier circuit.

30 is a circuit diagram of a transformer 3000 coupled to the electrical circuit 2900 shown in FIG. 29 in accordance with at least one aspect of the present disclosure. The ultrasonic left/right input terminals (primary winding) of the transformer 3000 are electrically coupled to the ultrasonic left/right output terminals of the electrical circuit 2900. The secondary winding of the transformer 3000 is coupled to the positive electrode 3074a and the negative electrode 3074b. The positive and negative electrodes 3074a, 3074b of the transformer 3000 are coupled to the positive terminal (stack 1) and the negative terminal (stack 2) of the ultrasonic transducer. In one aspect, the transformer 3000 has a turns ratio of _n1 : _n2 of 1:50.

31 is a circuit diagram of the transformer 3000 shown in FIG. 30 coupled to a test circuit 3165 in accordance with at least one aspect of the present disclosure. The test circuit 3165 is coupled to the positive and negative electrodes 3074a, 3074b. A switch 3167 is placed in series with an inductor/capacitor/resistor (LCR) load device that simulates an ultrasonic transducer load.

32 is a circuit diagram of a control circuit 3200, such as control circuit 3212, in accordance with at least one aspect of the present disclosure. The control circuit 3200 is located within a housing of a battery assembly. The battery assembly is the energy source for various local power sources 3215. The control circuit comprises a main processor 3214 coupled to various downstream circuits via an interface master 3218, for example, by outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. In one aspect, the interface master 3218 is a general purpose serial interface, such as an 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 (e.g., and LCD display), and various indicators 3228 via GPIO 3222. A watchdog processor 3216 is provided to control the main processor 3214. A switch 3230 is provided in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.

In one aspect, the main processor 3214 is coupled to the electrical circuit 2900 (FIG. 29) by output terminals SCL-A, SDA-A. The main processor 3214 includes a memory for storing, for example, a table of digitized drive signals or waveforms that are transmitted to the electrical circuit 2900 to drive the ultrasonic transducer 1120. In other aspects, the main processor 3214 may generate and transmit digital waveforms to the electrical circuit 2900 or store digital waveforms for later transmission to the electrical circuit 2900. The main processor 3214 may also provide RF drive by output terminals SCL-B, SDA-B and various sensors (e.g., Hall effect sensors, magnetorheological fluid (MRF) sensors, etc.) by output terminals SCL-C, SDA-C. In one aspect, the main processor 3214 is configured to sense the presence of the ultrasonic drive circuit and/or the RF drive circuit to enable appropriate software and user interface functions.

In one aspect, the main processor 3214 may be, for example, an LM 4F230H5QR available from Texas Instruments. In at least one example, the LM4F230H5QR from Texas Instruments is an ARM Cortex-M4F processor core that includes, among other features readily available from the product data sheet, on-chip memory of 256 KB of single-cycle flash memory or other non-volatile memory up to 40 MHz, a pre-fetch buffer to improve performance beyond 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QED) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels. Other processors may be readily substituted, and thus the disclosure should not be limited in this context.

33 shows a simplified block diagram illustrating another electrical circuit 3300 housed within a modular ultrasonic surgical instrument 3334 according to at least one aspect of the present disclosure. The electrical circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power source 3304 (e.g., a battery), a switch 3306, such as a metal oxide semiconductor field effect transistor (MOSFET) power switch, a drive circuit 3308 (PLL), a transformer 3310, a signal smoothing circuit 3312 (also referred to as a matching circuit, which may be, for example, a tank circuit), a sensing circuit 3314, a transducer 1120, and a shaft assembly (e.g., shaft assembly 1126, 1129) with an ultrasonic transmission waveguide that terminates in an ultrasonic blade (e.g., ultrasonic blade 1128, 1149), which may also be referred to simply as a waveguide herein.

One feature of the present disclosure that breaks the dependency on high voltage (120 VAC) input power (characteristic of typical ultrasonic cutting devices) is the use of low voltage switching throughout the wave formation process and amplification of the drive signal only just prior to the transformer stage. For this reason, in one aspect of the present disclosure, power is derived solely from a battery or battery group that is small enough to fit either within the handle assembly. State-of-the-art battery technology provides powerful batteries that are a few centimeters in height and width, and a few millimeters in depth. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasonic device, reduced manufacturing costs can be achieved.

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

The output of the power supply 3304 is also directed to a switch 3306, which has a duty cycle controlled by the processor 3302. By controlling the on-time of the switch 3306, the processor 3302 can determine the total amount of power that is ultimately delivered to the transducer 1120. In one aspect, the switch 3306 is a MOSFET, but other switch and switching configurations are equally applicable. The output of the switch 3306 is provided to a drive circuit 3308, which may include, for example, a phase detector phase-locked loop (PLL) and/or a low pass filter and/or a voltage controlled oscillator. The output of the switch 3306 is sampled by the processor 3302 to determine the voltage and current of the output signal (V _IN and I _IN , respectively). These values are used in a feedback architecture to adjust the pulse width modulation of the switch 3306. For example, the duty cycle of the switch 3306 may vary from about 20% to about 80%, depending on the actual output desired from the switch 3306.

Drive circuit 3308, which receives the signal from switch 3306, includes an oscillator circuit that converts the output of switch 3306 into an electrical signal at an ultrasonic frequency, e.g., 55 kHz (VCO). As described above, a smoothed version of this ultrasonic waveform is ultimately fed to ultrasonic transducer 1120 to generate a resonant sine wave along the ultrasonic transmission waveguide.

At the output of the drive circuit 3308 is a transformer 3310 that can step up the low voltage signal(s) to a higher voltage. Note that upstream switching is performed at a low (e.g., battery-powered) voltage before the transformer 3310, something that has not been possible in ultrasonic cutting and cauterization devices to date. This is at least partially due to the fact that the device advantageously uses low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they produce lower switching losses and less heat than conventional MOSFET devices and can pass higher currents. Thus, the switching stage (pre-transformer) can be characterized as low voltage/high current. To ensure a lower on-resistance of the amplifier MOSFET(s), the MOSFET(s) are run at, for example, 10V. In such a case, a separate 10V DC power supply can be used to supply the MOSFET gates, ensuring that the MOSFETs are fully on and a reasonably low on-resistance is achieved. In one aspect of the present disclosure, the transformer 3310 steps up the battery voltage to 120V root mean square (RMS). Transformers are known in the art and therefore will not be described in detail here.

In the described circuit configuration, degradation of the circuit components can negatively affect the circuit performance of the circuit. One factor that directly affects the performance of the components is heat. Known circuits typically monitor switching temperatures (e.g., MOSFET temperature). However, with technological advances in MOSFET design and corresponding size reductions, MOSFET temperature is no longer an effective indicator of circuit load and heat. Thus, 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 is operated at or near its maximum temperature during use of the device. Additional temperature can break down the core material, e.g., ferrite, and permanent damage can occur. The present disclosure can respond to the maximum temperature of the transformer 3310, for example, by reducing the driving power in the transformer 3310, signaling the user, turning off the power, pulsing the power, or other suitable response.

In one aspect of the disclosure, the processor 3302 is communicatively coupled to an end effector (e.g., 1122, 1125), which is used to place a material into physical contact with an ultrasonic blade (e.g., 1128, 1149). A sensor is provided in the end effector to measure a clamping force value (which is within a known range), and based on the received clamping force value, the processor 3302 varies the operating voltage V _M. Because high force values combined with a set operating speed may result in high blade temperatures, a temperature sensor 3332 may be communicatively coupled to the processor 3302, where the processor 3302 is operable to receive and interpret a signal indicative of the current temperature of the blade from the temperature sensor 3336, and determine a target frequency of blade movement based on the received temperature. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to a trigger (e.g., 1143, 1147) to measure the force applied to the trigger by a user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch button such that the displacement magnitude corresponds to the force applied to the switch button by the user.

According to at least one aspect of the present disclosure, a PLL portion of the drive circuit 3308 coupled to the processor 3302 can determine the frequency of the waveguide motion and communicate that frequency to the processor 3302. The processor 3302 stores this frequency value in memory 3326 when the device is turned off. By reading the clock 3330, the processor 3302 can determine the elapsed time since the device was shut off and, if the elapsed time is less than a predetermined value, can read the last frequency of the waveguide motion. The device can then start at the last frequency, which is presumably the optimal frequency for the current load.

Modular battery powered handheld surgical instrument with a multi-stage generator circuit In another aspect, the present disclosure provides a modular battery powered handheld surgical instrument with a multi-stage generator circuit. A surgical instrument is disclosed that includes a battery assembly, a handle assembly, and a shaft assembly, the battery assembly and the shaft assembly configured to be in mechanical and electrical communication with the handle assembly. The battery assembly includes a control circuit configured to generate a digital waveform. The handle assembly includes a first stage circuit configured to receive the digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform. The shaft assembly includes a second stage circuit coupled to the first stage circuit for receiving, amplifying, and applying the analog waveform to a load device.

In one aspect, the present disclosure provides a surgical instrument comprising: a battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, the processor configured to generate a digital waveform; a handle assembly including a first stage circuit coupled to the processor, the first stage circuit including a digital-to-analog (DAC) converter and a first stage amplifier circuit, the DAC configured to receive the digital waveform and convert the digital waveform to an analog waveform, and the first stage amplifier circuit configured to receive and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the first stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load device, the battery assembly and the shaft assembly being configured to be in mechanical and electrical communication with the handle assembly.

The load device may include any one of an ultrasonic transducer, an electrode, or a sensor, or any combination thereof. The first stage circuit may include a first stage ultrasonic drive circuit and a first stage high frequency current drive circuit. The control circuit may be configured to drive the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit individually or simultaneously. The first stage ultrasonic drive circuit may be configured to couple to a second stage ultrasonic drive circuit. The second stage ultrasonic drive circuit may be configured to couple to an ultrasonic transducer. The first stage high frequency current drive circuit may be configured to couple to a second stage high frequency drive circuit. The second stage high frequency drive circuit may be configured to couple to an electrode.

The first stage circuitry may include a first stage sensor drive circuit. The first stage sensor drive circuit may be configured with a second stage sensor drive circuit. The second stage sensor drive circuit may be configured to couple to the sensor.

In another aspect, the present disclosure provides a surgical instrument comprising: a battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, the processor configured to generate a digital waveform; a handle assembly including a common first stage circuit coupled to the processor, the common first stage circuit including a digital-to-analog (DAC) converter and a common first stage amplifier circuit, the DAC configured to receive the digital waveform and convert the digital waveform to an analog waveform, and the common first stage amplifier circuit configured to receive and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the common first stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load device, the battery assembly and the shaft assembly being configured to be in mechanical and electrical communication with the handle assembly.

The load device may include any one of an ultrasonic transducer, an electrode, or a sensor, or any combination thereof. The common first stage circuit may be configured to drive an ultrasonic, a high frequency current, or a sensor circuit. The common first stage drive circuit may be configured to couple with a second stage ultrasonic drive circuit, a second stage high frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to couple with an ultrasonic transducer, the second stage high frequency drive circuit configured to couple with an electrode, and the second stage sensor drive circuit configured to couple with a sensor.

In another aspect, the present disclosure provides a surgical instrument comprising: a control circuit including a memory coupled to a processor, the processor configured to generate a digital waveform; a handle assembly including a common first stage circuit coupled to the processor, the common first stage circuit configured to receive the digital waveform, convert the digital waveform to an analog waveform, and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the common first stage circuit to receive and amplify the analog waveform, the shaft assembly configured to be in mechanical and electrical communication with the handle assembly.

The common first stage circuit may be configured to drive an ultrasonic, high frequency current, or sensor circuit. The common first stage drive circuit may be configured to couple with a second stage ultrasonic drive circuit, a second stage high frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to couple with an ultrasonic transducer, the second stage high frequency drive circuit configured to couple with an electrode, and the second stage sensor drive circuit configured to couple with a sensor.

34 illustrates a generator circuit 3400 split 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 instruments of the surgical system 1000 described herein may include a generator circuit 3400 split into multiple stages. For example, the surgical instruments of the surgical system 1000 may include a generator circuit 3400 split into at least two circuits, a first stage circuit 3404 and a second stage circuit 3406 of amplification that allow operation of only RF energy, only ultrasonic energy, and/or a combination of RF and ultrasonic energy. The combination modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located in the handle assembly 3412 and a modular second stage circuit 3406 integral 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 mechanically and electrically connect with the handle assembly 3412. The end effector assembly is configured to mechanically and electrically connect with the shaft assembly 3414.

34, the generator circuit 3400 is divided into multiple stages located in multiple modular assemblies of a surgical instrument, such as the surgical instrument of the surgical system 1000 described herein. In one aspect, the control stage circuit 3402 may be located in the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is the control circuit 3200 described in connection with FIG. 32. The control circuit 3200 comprises a processor 3214 including internal memory 3217 (FIG. 34) (e.g., volatile and non-volatile memory) and is in electrical communication with a battery 3211. The battery 3211 provides power to the first stage circuit 3404, the second stage circuit 3406, and the third stage circuit 3408, respectively. As described above, the control circuit 3200 generates the digital waveform 4300 (FIG. 43) using the circuits and techniques described in connection with FIGS. 41 and 42. Referring again to FIG. 34, the digital waveform 4300 may be configured to drive an ultrasound transducer, a radio frequency (e.g., RF) electrode, or a combination thereof, either individually or simultaneously. If driven simultaneously, a filter circuit may be provided within the corresponding first stage circuit 3404 to select either the ultrasound waveform or the RF waveform. Such filtering techniques are described in commonly owned U.S. Patent Application Publication No. 2017-0086910-A1, entitled "TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR," which is incorporated herein by reference in its entirety.

The first stage circuitry 3404 (e.g., first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, and first stage sensor drive circuit 3424) are located within the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic drive signal to the first stage ultrasonic drive circuit 3420 via outputs SCL-A, SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 is described in detail in connection with FIG. 29. The control circuit 3200 provides an RF drive signal to the first stage RF drive circuit 3422 via outputs SCL-B, SDA-B of the control circuit 3200. The first stage RF drive circuit 3422 is described in detail in connection with FIG. 36. The control circuit 3200 provides a sensor drive signal to the first stage sensor drive circuit 3424 via outputs SCL-C, SDA-C of the control circuit 3200. Generally, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section to drive 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 is configured to detect whether the first stage ultrasonic drive circuit 3420, the first stage RF drive circuit 3422, or the first stage sensor drive circuit 3424 located in the handle assembly 3412 are connected to the battery assembly 3410. Similarly, each of the first stage circuits 3404 can detect which second stage circuit 3406 is connected to it, and that information is returned to the control circuit 3200 to determine the type of signal waveform to generate. Similarly, each of the second stage circuits 3406 can detect which third stage circuit 3408 or component is connected to it, and that information is returned to the control circuit 3200 to determine the type of signal waveform to generate.

In one aspect, the second stage circuit 3406 (e.g., ultrasonic drive second stage circuit 3430, RF drive second stage circuit 3432, and sensor drive second stage circuit 3434) is located in the shaft assembly 3414 of the surgical instrument. The first stage ultrasonic drive circuit 3420 provides signals to the second stage ultrasonic drive circuit 3430 via outputs US Left/US Right. The second stage ultrasonic drive circuit 3430 is described in detail in connection with FIGS. 30 and 31. In addition to the transformer (FIGS. 30 and 31), the second stage ultrasonic drive circuit 3430 may further include filters, amplifiers, and signal conditioning circuits. The first stage radio frequency (RF) current drive circuit 3422 provides signals to the second stage RF drive circuit 3432 via outputs RF Left/RF Right. In addition to the transformer and blocking capacitors, the second stage RF drive circuit 3432 may further include filters, amplifiers, and signal conditioning circuits. The first stage sensor driver circuit 3424 provides a signal via the output sensor 1/sensor 2 to the second stage sensor driver circuit 3434. The second stage sensor driver circuit 3434 may include filters, amplifiers, and signal conditioning circuitry depending on the type of sensor. The output of the second stage circuit 3406 is provided to the input of the third stage circuit 3408.

In one aspect, the third stage circuit 3408 (e.g., ultrasonic transducer 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 aspects, 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 a drive signal to the RF electrodes 3074a, 3074b, which are generally located within the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides a drive signal to various sensors 3440 located throughout the surgical instrument.

35 illustrates a generator circuit 3500 split into multiple stages, with a first stage circuit 3504 in common with a second stage circuit 3506, according to at least one aspect of the present disclosure. In one aspect, the surgical instruments of the surgical system 1000 described herein may include a generator circuit 3500 split into multiple stages. For example, the surgical instruments of the surgical system 1000 may include a generator circuit 3500 split into at least two circuits, a first stage circuit 3504 and a second stage circuit 3506 of amplification that allow operation of only radio frequency (RF) energy, only ultrasonic energy, and/or a combination of RF and ultrasonic energy. The combination modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located in the handle assembly 3512 and a modular second stage circuit 3506 integral with the modular shaft assembly 3514. As described 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 mechanically and electrically connect with the handle assembly 3512. The end effector assembly is configured to mechanically and electrically connect with the shaft assembly 3514.

As shown in the embodiment of FIG. 35, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502 that includes the control circuit 3200 described above. The handle assembly 3512 that connects to the battery assembly 3510 includes a common first stage drive circuit 3420. As described above, the first stage drive circuit 3420 is configured to drive ultrasonic, radio frequency (RF) current, and sensor loads. The output of the common first stage drive circuit 3420 can drive any one of the second stage circuits 3506, such as the second stage ultrasonic drive circuit 3430, the second stage radio frequency (RF) current drive circuit 3432, and/or the second stage sensor drive circuit 3434. The common first stage drive circuit 3420 detects which second stage circuit 3506 is located within the shaft assembly 3514 when the shaft assembly 3514 is connected to the handle assembly 3512. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 determines which one of the second stage circuits 3506 (e.g., the second stage ultrasonic drive circuit 3430, the second stage RF drive circuit 3432, and/or the second stage sensor drive circuit 3434) is located in the shaft assembly 3514. This information is provided to the control circuit 3200 located in the handle assembly 3512 to provide a suitable digital waveform 4300 (FIG. 43) to the second stage circuit 3506 to drive the appropriate load (e.g., ultrasonic, RF, or sensor). It will be appreciated that identification circuits may be included in the various assemblies 3516 in the third stage circuit 3508, such as the ultrasonic transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. Thus, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.

36 is a circuit diagram of one embodiment of an electrical circuit 3600 configured to drive a radio frequency current (RF) according to at least one embodiment of the present disclosure. The electrical circuit 3600 includes an analog multiplexer 3680. The analog multiplexer 3680 multiplexes various signals from upstream channels SCL-A, SDA-A, such as RF, battery, and power control circuitry. A current sensor 3682 is coupled in series with the return or ground section of the power supply circuit and measures the current provided by the power supply. A field effect transistor (FET) temperature sensor 3684 provides the ambient temperature. A pulse width modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program neglects to provide a periodic system reset. This is provided to automatically reset the electrical circuit 3600 if it hangs or freezes due to a software or hardware failure. It will be appreciated that the electrical circuit 3600 may be configured to drive RF electrodes or to drive the ultrasonic transducer 1120, for example, as described with respect to FIG. 29. Thus, referring back now to FIG. 36, the electrical circuit 3600 may be used to alternately drive both ultrasonic and RF electrodes.

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

37 is a schematic diagram 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 coupled to the RF+/RF output terminal of the electrical circuit 3600. One side of the secondary winding is coupled in series with a first blocking capacitor 3706 and a second blocking capacitor 3708. The second blocking capacitor is coupled to a positive terminal of a second stage RF drive circuit 3774a. The other side of the secondary winding is coupled to a negative terminal of a second stage RF drive circuit 3774b. The positive output of the second stage RF drive circuit 3774a is coupled to the ultrasonic blade and the negative ground terminal of the second stage RF drive circuit 3774b is coupled to the outer tube. In one aspect, the transformer has a turns ratio of _n1 : _n2 of 1:50.

38 is a circuit diagram of a circuit 3800 with separate power sources for the high power energy/drive circuitry and the low power circuitry, according to at least one aspect of the present disclosure. The power supply 3812 includes a primary battery pack including a first primary battery 3815 and a second primary battery 3817 (e.g., Li-ion batteries) that are connected to the circuit 3800 by a switch 3818 when the power supply 3812 is inserted into the battery assembly, and a secondary battery pack including a secondary battery 3820 that is connected to the circuit by a switch 3823. The secondary battery 3820 is a sag-proof battery with components that are resistant to gamma or other radiation sterilization. For example, a switch mode power supply 3827 and optional charging circuitry in the battery assembly can be incorporated to enable the secondary battery 3820 to reduce voltage sags of the primary batteries 3815, 3817. This ensures fully charged cells at the start of surgery for easy introduction into the sterile field. The primary batteries 3815, 3817 can be used to directly power the motor control circuitry 3826 and the energy circuitry 3832. The motor control circuit 3826 is configured to control a motor, such as the motor 3829. The power supply/battery pack 3812 may include a dual type battery assembly including a primary Li-ion battery 3815, 3817 with a dedicated energy cell 3820 for controlling the handle electronics circuit 3830 from a dedicated energy cell 3815, 3817 for running the motor control circuit 3826 and the energy circuit 3832. In this case, if the primary battery 3815, 3817 involved in driving the energy circuit 3832 and/or the motor control circuit 3826 drops low, the circuit 3810 draws from the secondary battery 3820 involved in driving the handle electronics circuit 3830. In various aspects, the circuit 3810 may include a one-way diode that does not allow current to flow in the opposite direction (e.g., from the battery involved in driving the energy and/or motor control circuit to the battery involved in driving the electronics circuit).

Furthermore, a gamma-friendly charging circuit can be provided that includes a switch mode power supply 3827 that uses diode and vacuum tube components to minimize voltage sag at a predetermined level. By including a minimum sag voltage that is a division of the NiMH voltage (three NiMH cells), the switch mode power supply 3827 can be eliminated. Furthermore, a modular system can be provided in which radiation hardened components are located in modules, making the modules sterilizable by radiation sterilization. Other non-radiation hardened components can be included in other modular components and connections made between the modular components, so that the components operate together as if they were located together on the same circuit board. If only two NiMH cells are desired, the diode and vacuum tube based switch mode power supply 3827 allows for sterilizable electronics in a disposable primary battery pack.

39, there is shown a control circuit 3900 for operating an RF generator circuit 3902 powered by a battery 3901 for use with a surgical instrument, according to at least one aspect of the present disclosure. The surgical instrument is configured to perform a surgical coagulation/cutting procedure on living tissue using both ultrasonic vibrations and radio frequency current, and to perform a surgical coagulation procedure on living tissue using radio frequency current.

39 shows a control circuit 3900 that allows the dual generator system to switch between the energy modalities of the RF generator circuit 3902 and the ultrasonic generator circuit 3920 for the surgical instrument of the surgical system 1000. In one aspect, a current threshold in the RF signal is detected. When tissue impedance is low, the high frequency current through the tissue is high when RF energy is used as a source of tissue treatment. According to one aspect, a visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 may be configured to be in an ON state during this high current period. When the current falls below the threshold, the visual indicator 3912 is in an OFF state. Thus, the phototransistor 3914 can be configured to detect the transition from an ON state to an OFF state and release the RF energy, as shown in the control circuit 3900 shown in FIG. 39. Thus, 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 held in an OFF state.

39, in one aspect, a method is provided for managing the RF generator circuit 3902 and the ultrasonic generator circuit 3920. The RF generator circuit 3902 and/or the ultrasonic generator circuit 3920 may be located, for example, in the handle assembly 1109, the ultrasonic transducer/RF generator assembly 1120, the battery assembly, the shaft assembly 1129 and/or the nozzle of the multifunction electrosurgical instrument 1108. The control circuit 3900 is held in a reset state when the energy switch 3926 is off (e.g., open). Thus, when the energy switch 3926 is open, 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 (e.g., closed), RF energy is delivered to the tissue and the visual indicator 3912 operated by the current sensing step-up transformer 3904 is illuminated while the tissue impedance is low. The light from the visual indicator 3912 provides a logic signal to maintain the ultrasonic generator circuit 3920 in an off state. Once the tissue impedance increases above a threshold and the radio frequency current through the tissue decreases below the threshold, the visual indicator 3912 turns off and the light transitions to an off state. This transition generates a logic signal that turns off the relay 3908, which turns off the RF generator circuit 3902 and turns on the ultrasonic generator circuit 3920 to complete the coagulation and cutting cycle.

39, in one aspect, the dual generator circuit configuration uses an on-board RF generator circuit 3902 for one modality that is powered by a battery 3901 and a second on-board ultrasonic generator circuit 3920 that may be on-board, for example, in the handle assembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or ultrasonic transducer/RF generator assembly 1120 of the multifunction electrosurgical instrument 1108. The ultrasonic generator circuit 3920 is also powered by the 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 the dual RF/ultrasonic generator circuits 3902, 3920 as part of the handle assembly 1109 may 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 a cordless generator system.

Either type of system can have separate controls for the modalities that do not communicate with each other. The surgeon activates RF and ultrasound separately and at will. Another approach is to provide a fully integrated communication scheme that shares buttons, tissue status, instrument actuation parameters (e.g. jaw closure, force, etc.) and algorithms for managing 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, with the 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 (i.e., active electrode 3906a and return electrode 3906b), and is configured to drive the electrodes 3906a, 3906b with RF energy (e.g., radio frequency current). A first winding 3910a of a 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 pole 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 a switch contact 3909 of a relay 3908, or to any suitable electromagnetic switching device including an armature moved by an electromagnet 3936 to operate the switch contact 3909. When the electromagnet 3936 is energized, the switch contact 3909 is closed, and when the electromagnet 3936 is de-energized, the switch contact 3909 is open. When the switch contact is closed, RF current flows through conductive tissue (not shown) located between the electrodes 3906a and 3906b. It will be appreciated that in one aspect, the active electrode 3906a is connected to the positive pole of the bipolar RF generator circuit 3902.

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

In operation, when the switch contact 3909 of the relay 3908 is open, the active electrode 3906a is isolated from the positive pole of the bipolar RF generator circuit 3902, and no current flows through the tissue, the return electrode 3906b, and the first winding 3910a of the step-up transformer 3904. As a result, 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 pole of the bipolar RF generator circuit 3902, and current flows through the tissue, the return electrode 3906b, and the first winding 3910a of the step-up transformer 3904 to operate on the tissue, e.g., to cut and cauterize the tissue.

A 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, providing a first voltage across the first winding 3910a of the step-up transformer 3904. A boosted second voltage is induced across the second winding 3910b of the step-up transformer 3904. A secondary voltage appears across resistor R2, energizing the visual indicator 3912 to illuminate the neon bulb when the current through the tissue is greater than a predetermined threshold. It will be understood that the circuit and component values are exemplary and not limiting. When the switch contact 3909 of the relay 3908 closes, current flows through the tissue and the visual indicator 3912 is turned on.

Now referring to the energy switch 3926 portion of the control circuit 3900, when the energy switch 3926 is in the open position, a logic high is applied to the input of the first inverter 3928 and a logic low is applied to one of the two inputs of the AND gate 3932. Thus, the output of the AND gate 3932 is low and the transistor 3934 is off, preventing current from flowing through the winding of the electromagnet 3936. With the electromagnet 3936 in a de-energized state, the switch contact 3909 of the relay 3908 remains open, preventing current from flowing through the electrodes 3906a, 3906b. The logic low output of the first inverter 3928 is also applied to the second inverter 3930, causing the output to go high and resetting the flip-flop 3918 (e.g., a D-type flip-flop). At this time, the Q output goes low, turning off the ultrasonic generator circuit 3920 circuit 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 goes high and is applied to the other input of AND gate 3932 .

When a 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 low to the input of the first inverter 3928, which applies a logic high to the other input of the AND gate 3932, causing the output of the AND gate 3932 to be high, turning on the transistor 3934. In the on state, the transistor 3934 conducts and sinks current through the winding of the electromagnet 3936 to energize the electromagnet 3936 and closes the switch contact 3909 of the relay 3908. As described above, when the switch contact 3909 is closed, current can flow through the electrodes 3906a, 3906b and the first winding 3910a of the step-up transformer 3904 when tissue is located between the electrodes 3906a and 3906b.

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

出力に影響を与えず、Ｑ出力は低いままであり、

The output is not affected and 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 power 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 multifunction electrosurgical instrument are not activated.

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

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

A logic high at the Q output turns on the ultrasonic generator circuit 3920, activating the ultrasonic transducer 3922 and ultrasonic blade 3924 to begin cutting the tissue located between the electrodes 3906a and 3906b. At or about the same time that the ultrasonic generator circuit 3920 turns 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 goes low, causing the output of AND gate 3932 to go low, turning off transistor 3934, thereby de-energizing electromagnet 3936 and opening switch contacts 3909 of relay 3908, interrupting the flow of current through electrodes 3906a, 3906b.

While the switch contacts 3909 of the relay 3908 are 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 developed across the second winding 3910b and no current flows through the visual indicator 3912.

The user holds the energy switch 3926 on the instrument handle and holds the energy switch 3926 closed while the Q and Q of the flip-flop 3918 are

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. Thus, while no current is flowing from the bipolar RF generator circuit 3902 through the electrodes 3906a, 3906b, the ultrasonic blade 3924 remains activated and continues to cut tissue between the jaws of the end effector. When the user releases the energy switch 3926 in the instrument handle, the energy switch 3926 opens, causing the output of the first inverter 3928 to go low and the output of the second inverter 3930 to go high resetting the flip-flop 3918 and driving the Q output low to 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 goes high and the circuit is now in the off state and the user is ready to actuate the energy switch 3926 on the instrument handle, closing the energy switch 3926 and applying current to the tissue located between the electrodes 3906a, 3906b, and repeating the cycle of applying RF energy to the tissue and applying ultrasonic energy to the tissue as described above.

FIG. 40 is a diagram of a surgical system 4000 representing one aspect of the 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. The surgical system 4000 may include a generator 4002 coupled to a surgical instrument including an end effector 4006 that may be activated when a clinician manipulates a trigger 4010. In various aspects, the end effector 4006 may include an ultrasonic blade for delivering ultrasonic vibrations to perform a surgical coagulation/cutting procedure on living tissue. In other aspects, the end effector 4006 may include a conductive element coupled to a source of electrosurgical high frequency current energy to perform a surgical coagulation or cauterization procedure on living tissue, and either a mechanical knife or an ultrasonic blade with a sharp cutting edge to perform a cutting procedure on living tissue. When the trigger 4010 is actuated, the force sensor 4012 may generate a signal indicative of the amount of force being applied to the trigger 4010. In addition to or instead of the force sensor 4012, the surgical instrument can include a position sensor 4013 that can generate a signal indicative of the position of the trigger 4010 (e.g., how deeply the trigger is depressed or otherwise actuated). In one aspect, the position sensor 4013 can 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 can 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 for proximity switching, positioning, speed detection and current sensing applications. In one aspect, the Hall effect sensor operates as an analog transducer and returns a voltage directly. With a known magnetic field, the distance from the Hall plate can be determined.

The control circuit 4008 can receive signals from the sensors 4012 and/or 4013. The control circuit 4008 can include any suitable analog or digital circuit components. The control circuit 4008 can further communicate with the generator 4002 and/or the transducer 4004 to modulate the power delivered to the end effector 4006 and/or the generator level or ultrasonic blade amplitude of the end effector 4006 based on the force applied to the trigger 4010 and/or the position of the trigger 4010 and/or the position of the outer tubular sheath relative to a reciprocating tubular actuating member located within the outer tubular sheath (e.g., as measured by a combination of a Hall effect sensor and a magnet). For example, the more force applied to the trigger 4010, the more power and/or the higher ultrasonic blade amplitude can be delivered to the end effector 4006. According to various aspects, the force sensor 4012 can be replaced by a multi-position switch.

According to various aspects, the end effector 4006 may include a clamp or clamping mechanism. When the trigger 4010 is first actuated, the clamping mechanism may close to clamp tissue between the clamp arm and the end effector 4006. As the force applied to the trigger increases (e.g., as sensed by the force sensor 4012), the control circuit 4008 may increase the power delivered by the transducer 4004 to the end effector 4006 and/or the generator level or ultrasonic blade amplitude brought about the end effector 4006. 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 (e.g., with a Hall Effect sensor) may be used by the control circuit 4008 to set the power and/or amplitude of the end effector 4006. For example, as the trigger is moved further toward the fully actuated position or the clamp or clamp arm is moved further toward the ultrasonic blade (or end effector 4006), the power and/or amplitude of the end effector 4006 may be increased.

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 indicative of the power of the end effector. According to various aspects, the speaker 4014 can emit a series of pulsed tones, the frequency of which indicates the power. In addition to or instead of the speaker 4014, the surgical instrument can include a visual display 4016. The visual display 4016 can indicate the power of the end effector according to any suitable manner. For example, the visual display 4016 can include a series of LEDs, where the power of the end effector is indicated by the number of LEDs illuminated. The speaker 4014 and/or the visual display 4016 can be driven by the control circuitry 4008. According to various aspects, the surgical instrument can include a ratchet device connected to the trigger 4010. As more force is applied to the trigger 4010, the ratchet device can generate an audible sound to provide an indirect indication of the end effector power. The surgical instrument can include other features that can enhance safety. For example, the control circuit 4008 can be configured to prevent power from being delivered to the end effector 4006 above a predetermined threshold. The control circuit 4008 can also provide a delay between the time a change in end effector power is indicated (e.g., by the speaker 4014 or visual display 4016) and the time the change in end effector power is delivered. In this way, the clinician can be given ample warning that the level of ultrasonic power delivered to the end effector 4006 is about to change.

In one aspect, the ultrasonic or radio frequency current generator of the surgical system 1000 may be configured to digitally generate the electrical signal waveform, desirably using a predetermined number of phase points stored in a lookup table to digitize the waveform. The phase points may be stored in a table defined in a memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 41 shows one aspect of a basic architecture for a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 4100, configured to generate multiple waveforms for the electrical signal waveform. The generator software and digital control may instruct the FPGA to scan addresses in the lookup table 4104, which in turn provides various digital input values to the DAC circuit 4108 that feeds the power amplifier. The addresses may be scanned according to the frequency of interest. Using such a lookup table 4104 allows for the generation of various types of waveforms that can be delivered into tissue, or into a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasonic instruments. Additionally, multiple lookup tables 4104 representing multiple waveforms can be created, stored, and applied to tissue from the generator.

The waveform signal may be configured to control at least one of the output current, output voltage, or output power of an ultrasonic transducer and/or RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and/or two or more RF electrodes). Furthermore, if the surgical instrument includes an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Thus, the generator may be configured to provide a waveform signal to at least one surgical instrument, the waveform signal being responsive to at least one waveform of the plurality of waveforms in the table. It should be noted that the waveform signals provided to the two surgical instruments may include two or more waveforms. The table may include information related to the plurality of waveforms, and the table may be stored in the generator. In one aspect or embodiment, the table may be a direct digital synthesis table and may be stored in the FPGA of the generator. The table may be addressed by any method that is convenient for categorizing the waveforms. According to one aspect, the table, which may be a direct digital synthesis table, is addressed according to the frequency of the waveform signal. Additionally, information related to multiple waveforms may be stored as digital information in a table.

The analog electrical signal waveform may be configured to control at least one of the output current, output voltage, or output power of an ultrasonic transducer and/or an RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and/or two or more RF electrodes). Furthermore, if the surgical instrument includes an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Thus, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, where the analog electrical signal waveform corresponds to at least one waveform of the plurality of waveforms stored in the lookup table 4104. It should be noted that the analog electrical signal waveform provided to the two surgical instruments may include two or more waveforms. The lookup table 4104 may include information related to the plurality of waveforms, and the lookup table 4104 may be stored in either the generator circuit or the surgical instrument. In one aspect or embodiment, the lookup table 4104 may be a direct digital synthesis table, which may be stored in the generator circuitry or the FPGA of the surgical instrument. The lookup 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 synthesis table, is addressed according to the frequency of the desired analog electrical signal waveform. Additionally, information related to multiple waveforms may be stored in the lookup table 4104 as digital information.

With the widespread use of digital technology in instrumentation and communication systems, a digitally controlled method of generating multiple frequencies from a reference frequency has been developed and is called direct digital synthesis. The basic architecture is shown in Figure 41. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic of the generator circuit and a memory circuit located in the generator circuit of the surgical system 1000. The DDS circuit 4100 comprises an address counter 4102, a look-up table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. A stable clock f _c is received by the address counter 4102, and the register 4106 drives a programmable read only memory (PROM) that stores one or more integer numbers of cycles of a sine wave (or any other waveform) in the look-up table 4104. As the address counter 4102 steps through the memory locations, the values stored in the lookup table 4104 are written to a register 4106 coupled to a DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location of the lookup table 4104 drives the DAC circuit 4108 which then generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is determined primarily by the DAC circuit 4108. The phase noise is essentially that of the reference clock f _c . The first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112 and a second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has a frequency f _out .

Because the DDS circuit 4100 is a sampled data system, it must consider problems associated with sampling, such as quantization noise, aliasing, filtering, etc. For example, while higher harmonics of the output of a phase-locked loop (PLL)-based synthesizer can be filtered, higher harmonics of the DAC circuit 4108 output frequency fold back into the Nyquist bandwidth, making them unfilterable. The look-up table 4104 contains signal data for an integer number of cycles. The final output frequency f _out can be changed by changing the reference clock frequency f _c or by reprogramming the PROM.

The DDS circuit 4100 may include multiple lookup tables 4104 that store waveforms represented by a predetermined number of samples, the samples defining a predetermined waveform shape. Thus, multiple waveforms having unique shapes can be stored in the multiple lookup tables 4104 to provide various tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuit 4100 can create multiple waveform lookup tables 4104 and can switch between various waveforms stored in the individual lookup tables 4104 during a tissue treatment procedure (e.g., "on the fly" or in real time based on user or sensor input) based on the desired tissue effect and/or tissue feedback.

Thus, switching between waveforms can be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4104 can store electrical signal waveforms (i.e., trapezoidal or square waves) that are configured to maximize the power delivered into the tissue per cycle. In other aspects, the lookup table 4104 can store synchronized waveforms that maximize power delivery by the multifunction surgical instrument of the surgical system 1000 while delivering RF and ultrasonic drive signals. In yet other aspects, the lookup table 4104 can store electrical signal waveforms that simultaneously drive ultrasonic and RF therapeutic and/or sub-therapeutic energy while maintaining ultrasonic frequency lock. Custom waveforms specific to various instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (e.g., EEPROM) of the surgical system 1000 and fetched upon connecting the multifunction surgical instrument to the generator circuit. An example of an exponentially decaying sine curve used in many high crest factor "coagulation" waveforms is shown in Figure 43.

A more flexible and efficient implementation of the DDS circuit 4100 uses a digital circuit called a Numerically Controlled Oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as DDS circuit 4200, is shown in FIG. 42. In this simplified block diagram, the DDS circuit 4200 is coupled to a processor, controller, or logic of the generator and to a memory circuit located either in the generator or in the surgical instrument of the surgical system 1000. The DDS circuit 4200 comprises a load register 4202, a parallel delta phase register 4204, a summer circuit 4216, a phase register 4208, a look-up table 4210 (phase to amplitude converter), a DAC circuit 4212, and a filter 4214. The summer circuit 4216 and the phase register 4208 form part of a phase accumulator 4206. A clock frequency f _c is applied to the phase register 4208 and the DAC circuit 4212. The load register 4202 receives an adjustment word that specifies an output frequency as a fraction of the reference clock frequency signal f _c The output of the load register 4202, along with the adjustment word M, is provided to a parallel delta phase register 4204.

DDS circuit 4200 includes a sample clock generating a clock frequency f _c , a phase accumulator 4206, and a look-up table 4210 (e.g., a phase-to-amplitude converter). The contents of phase accumulator 4206 are updated once every clock cycle f _c . When phase accumulator 4206 is updated, the digital number M stored in parallel delta phase register 4204 is added to the number in phase register 4208 by adder circuit 4216. Assume the number in parallel delta phase register 4204 is 00...01 and the initial contents of phase accumulator 4206 are 00...00. Phase accumulator 4206 is updated with 00...01 every clock cycle. If phase accumulator 4206 is 32-bit wide, then when phase accumulator 4206 is 00...00, the digital number M is added to the number in phase register 4208 by adder circuit 4216. It takes 232 clock cycles (over 4 billion) to wrap around to 00 and then the cycle repeats.

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

In one aspect, the electrical signal waveform may be digitized into 1024 (210) phase points, although the waveform that may be digitized may be any suitable number of 2n phase points ranging from 256 (28) to 281,474,976,710,656 (248), where n is a positive integer as shown in Table 1. The electrical signal waveform may be represented as A _n (θ _n ), where the normalized amplitude A _n at point n is represented by the phase angle θ _n and is referred to as the phase point at point n. The number of distinct phase points n determines the adjustment resolution of DDS circuit 4200 (and DDS circuit 4100 shown in FIG. 41).

Table 1 specifies the electrical signal waveform digitized into multiple phase points.

The generator circuit algorithm and digital control circuit scans the addresses in the lookup table 4210, which then provides various digital input values to the filter 4214 and the DAC circuit 4212 that feeds the power amplifier. The addresses may be scanned according to the desired frequency. Using the lookup table, it is possible to generate various types of shapes that can be converted to an analog output signal by the DAC circuit 4212, filtered by the filter 4214, amplified by a power amplifier coupled to the output of the generator circuit, and applied to the tissue in the form of RF energy or to an ultrasonic transducer and in the form of ultrasonic vibrations that deliver energy to the tissue in the form of heat. The output of the amplifier can be applied to, for example, a single RF electrode, multiple RF electrodes simultaneously, a single ultrasonic transducer, multiple ultrasonic transducers simultaneously, or a combination of RF and ultrasonic transducers. Additionally, multiple waveform tables can be created, stored, and applied to the 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. For M=2, the phase register 1708 "rolls over" twice as fast and the output frequency doubles. This can be generalized as follows:

With the phase accumulator 4206 configured to accumulate n-bits (where n typically ranges from 24 to 32 in most DDS systems, but as noted 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 the phase accumulator increments every clock cycle. If f _c is the clock frequency, then the frequency of the output sine wave is equal to:

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

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 for n=32, the resolution is greater than one in four hundred million. In one aspect of the DDS circuit 4200, not all bits outside the phase accumulator 4206 are passed to the lookup table 4210, but are truncated, leaving, for example, only the first 13-15 most significant bits (MSBs). This reduces the size of the lookup table 4210 and does not affect the frequency resolution. The phase truncation adds only a small but acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by a current, voltage, or power at a predetermined frequency. Furthermore, if the surgical instruments of the surgical system 1000 include an ultrasonic component, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of the at least one surgical instrument. Thus, the generator circuit may be configured to provide an electrical signal waveform to the at least one surgical instrument, the electrical signal waveform being characterized by a predetermined waveform stored in the lookup table 4210 (or the lookup table 4104 of FIG. 41). It should be noted that the electrical signal waveform may be a combination of two or more waveforms. The lookup table 4210 may include information related to multiple waveforms. In one aspect or embodiment, the lookup table 4210 may be generated by the DDS circuit 4200 and may be referred to as a direct digital synthesis table. The DDS operates by first storing a large repeating waveform in an on-board memory. A cycle of a waveform (sine, triangle, square, any) may be represented by a predetermined number of phase points and stored in memory, as shown in Table 1. Once the waveform is stored in memory, the waveform may be generated at a very precise frequency. The direct digital synthesis table may be stored in a non-volatile memory of the generator circuit and/or implemented with an FPGA circuit in the generator circuit. The lookup table 4210 may be addressed by any suitable technique that is convenient for categorizing the waveform. According to one aspect, the lookup table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, information related to multiple waveforms may be stored as digital information in memory or as part of the lookup table 4210.

In one aspect, the generator circuit may be configured to provide electrical signal waveforms to at least two surgical instruments simultaneously. The generator circuit may also be configured to provide electrical signal waveforms (which may be characterized by two or more waveforms) simultaneously to two surgical instruments via a single output channel of the generator circuit. For example, in one aspect, the electrical signal waveform includes a first electrical signal (e.g., an ultrasonic drive signal), a second RF drive signal, and/or combinations thereof that drive an ultrasonic transducer. Additionally, the electrical signal waveform may include multiple ultrasonic drive signals, multiple RF drive signals, and/or combinations of multiple ultrasonic and RF drive signals.

Further, a method of operating a 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, where generating the electrical signal waveform includes 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 the at least one surgical instrument includes providing the electrical signal waveform to at least two surgical instruments simultaneously.

The generator circuit described herein may enable the generation of various types of direct digital synthesis tables. Examples of waveforms of RF/electrosurgical signals generated by the generator circuit suitable for treating various tissues include RF signals with high crest factors (which may be used for superficial coagulation in RF mode), RF signals with low crest factors (which may be used for deeper tissue penetration), and waveforms that promote efficient modified coagulation. The generator circuit may also generate multiple waveforms using the direct digital synthesis lookup table 4210 and may switch between specific waveforms based on the desired tissue effect on the fly. The switching may be based on tissue impedance and/or other factors.

In addition to traditional sine/cosine waveforms, the generator circuit may be configured to generate a waveform(s) (i.e., trapezoidal or square wave) that maximizes the power to the tissue per cycle. If the generator circuit includes a circuit topology that allows for simultaneous driving of RF and ultrasonic signals, the generator circuit can provide a waveform(s) that is synchronized to maximize the power delivered to the load and maintain ultrasonic frequency lock when driving RF and ultrasonic signals simultaneously. Additionally, custom waveforms specific to the instrument and its tissue effect can be stored in a non-volatile memory (NVM) or in the instrument's EEPROM and fetched upon connecting any one of the surgical instruments of the surgical system 1000 to the generator circuit.

The DDS circuit 4200 may include multiple lookup tables 4104, where the lookup table 4210 stores waveforms represented by a predetermined number of phase points (sometimes called samples), which define the shape of the predetermined waveform. Thus, multiple waveforms having unique shapes can be stored in the multiple lookup tables 4210 to provide different tissue treatments based on the instrument settings or tissue feedback. Examples of waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuit 4200 may create multiple waveform lookup tables 4210 and may switch between different waveforms stored in the different lookup tables 4210 during a tissue treatment procedure (e.g., "on the fly" or in real time based on user or sensor input) based on the desired tissue effect and/or tissue feedback.

Thus, switching between waveforms can be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4210 can store electrical signal waveforms (i.e., trapezoidal or square waves) that are shaped to maximize the power delivered into the tissue per cycle. In other aspects, the lookup table 4210 can store synchronized waveforms that maximize power delivery by any one of the surgical instruments of the surgical system 1000 when delivering RF and ultrasonic drive signals. In yet other aspects, the lookup table 4210 can store electrical signal waveforms that simultaneously drive ultrasonic and RF therapeutic and/or sub-therapeutic energy while maintaining ultrasonic frequency lock. In general, the output waveforms may be in the form of sine waves, cosine waves, pulse waves, square waves, etc. 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 (e.g., EEPROM) of the surgical instrument and can be fetched upon connecting the surgical instrument to the generator circuit. An example of a custom waveform is an exponentially decaying sine waveform used in many high crest factor "coagulation" waveforms, as shown in FIG. 43.

FIG. 43 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 according to at least one aspect of the present disclosure of an analog waveform 4304 (shown superimposed on a 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 electrical signal waveform 4300 is, for example, a digital discrete-time version of a desired analog waveform 4304. The digital electrical signal waveform 4300 is generated by storing amplitude phase points 4302, which represent the amplitude per clock cycle T _L over one cycle or period T _o . The digital electrical signal waveform 4300 is generated over one period T _o by any suitable digital processing circuit. The amplitude phase points are digital words stored in a memory circuit. In the examples shown in FIGS. 41 and 42, the digital words are 6-bit words capable of storing amplitude phase points, with 26 or 64 bits of resolution. It will be understood that the examples shown in Figures 41 and 42 are for illustrative purposes and that in an actual implementation the resolution may be much higher. The digital amplitude phase points 4302 over one _cycle To are stored in memory as a string of string words in a look-up table 4104, 4210, for example, as described with respect to Figures 41 and 42. The amplitude phase points 4302 are read from memory in sequence from 0 to To every clock cycle _Tclk and converted by a DAC circuit 4108 _, 4212 to generate an analog version of the analog waveform 4304, also as described with respect to Figures 41 and 42. Additional cycles can be generated by repeatedly reading the amplitude phase points 4302 of the digital electrical signal waveform 4300 from 0 to _To over as many cycles or periods as may be desired. A smoothed analog version of the analog waveform 4304 is achieved by filtering the output of the DAC circuit 4108, 4212 by a filter 4112, 4214 (Figures 41 and 42). The filtered analog output signals 4114, 4222 (FIGS. 41 and 42) are applied to the inputs of the power amplifiers.

44 is a diagram of a control system 12950 configured to provide progressive closure of a closure member (e.g., closure tube) to reduce the closure force load on the closure member at a desired rate and reduce the firing force load on the firing member when a displacement member advances distally and couples with a clamp arm (e.g., anvil) according to one aspect of the present disclosure. In one aspect, the control system 12950 may be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) for continuously calculating an error value as the difference between a desired set point and a measured process variable, and applies corrections based on proportional, integral, and derivative terms (which may be denoted P, I, and D, respectively). 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 12956. The primary controller 12952 may be a PID controller 12972 as shown in FIG. 45, and the secondary controller 12955 may also be a PID controller 12972 as shown in FIG. 45. The primary controller 12952 controls a primary process 12958, and the secondary controller 12955 controls a secondary process 12960. The output 12966 of the primary process 12958 is subtracted from the primary set point SPi by a first adder 12962. The first adder 12962 generates a single sum output signal that is applied to the primary controller 12952. The output of the primary controller 12952 is the secondary set point _SP2 . The output 12968 of the secondary process 12960 is subtracted from the secondary set point _SP2 by a second adder 12964.

In the context of controlling the displacement of the closure tube, the control system 12950 may be configured such that the primary setpoint SPi is the desired closing force value and the primary controller 12952 is configured to receive the closing force from a torque sensor coupled to the output of the closure motor to determine the motor speed of the closing motor setpoint _SP2 . In other aspects, the closing force may be measured with a strain gauge, load cell, or other suitable force sensor. The closing motor speed setpoint _SP2 is compared to the actual speed of the closure tube as determined by the secondary controller 12955. The actual speed of the closure tube may be measured by comparing a measurement of the closure tube displacement using a position sensor and a measurement of the elapsed time using a timer/counter. Other techniques such as a linear or rotary encoder may be used to measure the displacement of the closure tube. The output 12968 of the secondary process 12960 is the actual speed of the closure tube. This closure tube speed output 12968 is provided to a primary process 12958 which determines the force acting on the closure tube and is fed back to a summer 12962 which subtracts the measured closure force from a primary set point _SP1 , which may be _an upper or lower threshold. Based on the output of the summer 12962, the primary controller 12952 controls the speed and direction of the closure motor. The secondary controller 12955 controls the speed of the closure motor based on the actual speed of the closure tube as measured by the secondary process 12960 and a secondary set point _SP2 which is based on a comparison of the actual firing force with the upper and lower firing force thresholds.

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

According to the PID algorithm, the "P" element 12974 accounts for the current value of the error. For example, if the error is large and positive, the control output will also be large and positive. According to the present disclosure, the error term eft is the difference between the desired and measured closing force of the closing tube. The "I" element 12976 accounts for the past value of the error. For example, if the current output is not strong enough, the integral of the error will accumulate over time and the controller will respond by applying stronger action. The "D" element 12978 accounts for the possible future trend of the error based on its current rate of change. For example, going back to the P example above, if a large positive control output succeeds in bringing the error closer to zero, it also puts the process on a path that will lead to a large negative error in the near future. In this case, the derivative will become negative and the D module will reduce the strength of the action to prevent this overshoot.

It will be appreciated that other variables and set points may be monitored and controlled in accordance with the feedback control systems 12950, 12970. For example, the adaptive closure member velocity control algorithm described herein may measure at least two of the following parameters, among others: firing member stroke position, firing member load, cutting element displacement, cutting element velocity, closure tube stroke position, and closure tube load.

Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical devices may be configured, for example, to transect and/or coagulate tissue during a surgical procedure. Aspects of the electrosurgical devices may be configured, for example, to transect, coagulate, scale, weld, and/or desiccate tissue during a surgical procedure.

Aspects of the generator use high speed analog-to-digital sampling (e.g., about 200x oversampling by frequency) of the generator drive signal current and voltage along with digital signal processing, providing many advantages and benefits over known generator structures. In one aspect, for example, based on current and voltage feedback data, ultrasonic transducer capacitance values, and drive signal frequency values, the generator may determine the motional branch current of the ultrasonic transducer. This provides the benefit of a substantially tuned system, simulating the existence of a system that is tuned or resonant with any value of capacitance (e.g., CO in FIG. 4) at any frequency. Thus, control of the motional branch current may be achieved by tuning out the effect of capacitance without the need for a tuning inductor. Additionally, elimination of the tuning inductor may not degrade the frequency locking capability of the generator, since frequency locking may be achieved by suitably processing the current and voltage feedback data.

High speed analog-to-digital sampling of the generator drive signal current and voltage, along with digital signal processing, may also allow accurate digital filtering of the samples. For example, embodiments of the generator may use a low pass digital filter (e.g., a finite impulse response (FIR) filter) that rolls off between the fundamental drive signal frequency and the second harmonic to reduce asymmetric harmonic distortion and EMI induced noise in the current and voltage feedback samples. The filtered current and voltage feedback samples substantially represent the fundamental drive signal frequency, thus allowing more accurate impedance phase measurements with respect to the fundamental drive signal frequency, and improved ability of the generator to maintain resonant frequency lock. The accuracy of the impedance phase measurement may 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 may 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 may enable the generator to implement many useful algorithms, such as, for example, controlling the amount of power delivered to the tissue as the tissue impedance changes, and controlling the power delivery to maintain a constant rate of tissue impedance increase. Some of these algorithms are used to determine the phase difference between the generator drive signal current and voltage signals. 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 signal and the voltage signal is zero. The phase information may also be used to estimate the condition of the ultrasonic blade. In particular, as described in more detail below, the phase changes as a function of the temperature of the ultrasonic blade. Thus, the phase information may be used to control the temperature of the ultrasonic blade. This may be done, for example, by reducing the power delivered to the ultrasonic blade when it is operating too hot and by increasing the power delivered to the ultrasonic blade when it is operating too cold.

Various aspects of the generator may have a wide frequency range and increased output power necessary to drive both ultrasonic and electrosurgical devices. The lower voltage, higher current demands of the electrosurgical device may be met by a dedicated tap on a wideband power transformer, thus eliminating the need for a separate power amplifier and output converter. Additionally, the generator's sensing and feedback circuitry may support a large dynamic range to meet the needs of both ultrasonic and electrosurgical applications with minimal distortion.

Various aspects may provide a simple and economical means for the generator to read from, and optionally write to, data circuitry (e.g., single-wire bus devices, such as 1-wire protocol EEPROMs known under the trade name "1-Wire") located within the instrument attached to the handpiece using an existing multi-conductor generator/handpiece cable. In this manner, the generator can read and process instrument-specific data from the instrument attached to the handpiece. This may allow the generator to provide better control and improved diagnostics and error detection. In addition, the ability of the generator to write data to the instrument creates possible new functionality, for example, in terms of tracking instrument usage and capturing operational data. In addition, the use of frequency bands allows for backward compatibility of instruments that include existing generator bus devices.

The disclosed aspects of the generator provide active elimination of leakage current caused by unintentional capacitive coupling between the generator's non-isolated circuitry and the patient-isolated circuitry. In addition to reducing patient risk, reducing leakage current may also reduce electromagnetic emissions. These and other benefits of the disclosed aspects will become apparent from the description that follows.

It will be understood that the terms "proximal" and "distal" are used herein with reference to a clinician gripping the handpiece. Thus, the end effector is distal to the more proximal handpiece. It will also be understood that for convenience and clarity, spatial terms such as "upper" and "lower" may also be used herein with reference to the clinician gripping the handpiece. However, surgical devices are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

46 is an elevational exploded view of a modular handheld ultrasonic surgical instrument 6480 with the left shell half removed from the handle assembly 6482 to expose a device identifier communicatively coupled to the multi-lead handle terminal assembly according to one aspect of the present disclosure. In an additional aspect of the present disclosure, an intelligent or smart battery is used to power the modular handheld ultrasonic surgical instrument 6480. However, smart batteries are not limited to the modular handheld ultrasonic surgical instrument 6480 and can be used in a variety of devices that may or may not have different power requirements (e.g., current and voltage) as described below. The smart battery assembly 6486 according to one aspect of the present disclosure can advantageously identify the particular device to which it is electrically coupled. It does so by encrypted or non-encrypted identification methods. For example, the smart battery assembly 6486 can have a connection portion, such as a connection portion 6488. The handle assembly 6482 can also be provided with a device identifier communicatively coupled to the multi-lead handle terminal assembly 6491 and operable to communicate at least one piece of information regarding the handle assembly 6482. This information may relate to the number of times the handle assembly 6482 has been used, the number of times the ultrasonic transducer/generator assembly 6484 (now disconnected from the handle assembly 6482) has been used, the number of times the waveguide shaft assembly 6490 (now connected to the handle assembly 6482) has been used, the type of waveguide shaft assembly 6490 currently connected to the handle assembly 6482, the type or identity of the ultrasonic transducer/generator assembly 6484 currently connected to the handle assembly 6482, and/or many other characteristics. When the smart battery assembly 6486 is inserted into the handle assembly 6482, a connection portion 6488 in the smart battery assembly 6486 is in communicative contact 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-activation or in response to a request from the smart battery assembly 6486). This communicated identifier is received by the connection portion 6488 of the smart battery assembly 6486. In one aspect, once the smart battery assembly 6486 receives the information, the communication portion is operable to control the output of the smart battery assembly 6486 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 may be separate or a single component. The processor 6493, in combination with the memory, may provide intelligent power management for the modular handheld ultrasonic surgical instrument 6480. This aspect is particularly advantageous because an ultrasonic device such as the modular handheld ultrasonic surgical instrument 6480 has power requirements (frequency, current and voltage) that may be unique to the modular handheld ultrasonic surgical instrument 6480. Indeed, the modular handheld ultrasonic surgical instrument 6480 may have specific power requirements or limitations for one size or type of outer tube 6494, and a second, different power requirement for a second type of waveguide having a different size, shape and/or configuration.

Thus, 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. Because 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 do not need to be concerned as to which power source they are attempting to install within the electronics device being used. This is particularly advantageous in operating environments where the battery assembly needs to be replaced or swapped for 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 the memory 6497 each time a particular device is used. This record can be useful to assess the end of the device's useful or acceptable life. For example, if a device is used 20 times, the device is defined as a "no longer reliable" surgical instrument, and such batteries in the smart battery assembly 6486 connected to the device will refuse to power the device. Reliability is determined based on 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, parts of the device may wear out and exceed the tolerance between the parts. For example, the smart battery assembly 6486 can sense the number of button presses received by the handle assembly 6482 and can 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 becomes contaminated with, for example, salt water.

This wear can lead to unacceptable failures during procedures. In some aspects, the smart battery assembly 6486 can recognize which parts are combined together in the device, and even how many uses the parts have experienced. For example, if the smart battery assembly 6486 is a smart battery according to the present disclosure, it can identify the handle assembly 6482, the waveguide shaft assembly 6490, and the ultrasonic transducer/generator assembly 6484 well before the user attempts to use the combined device. A memory 6497 in the smart battery assembly 6486 can record, for example, the time that the ultrasonic transducer/generator assembly 6484 has been operating, as well as how, when, and for how long. If the ultrasonic transducer/generator assembly 6484 has an individual identifier, the smart battery assembly 6486 can track the usage of the ultrasonic transducer/generator assembly 6484 and deny power to the ultrasonic transducer/generator assembly 6484 once the handle assembly 6482 or ultrasonic transducer/generator assembly 6484 exceeds its maximum number of uses. The ultrasonic transducer/generator assembly 6484, handle assembly 6482, waveguide shaft assembly 6490, or other components can include a memory chip that records this information as well. In this manner, any number of smart batteries in the smart battery assembly 6486 can be used with any number of ultrasonic transducer/generator assemblies 6484, staplers, vessel sealers, etc. and still be able to determine the total number of uses, or total hours of use (through the use of a clock), or total number of operations, etc., or charge or discharge cycles of the ultrasonic transducer/generator assembly 6484, stapler, vessel sealer, etc. The smart functionality may be external to 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 terminating the life of the ultrasonic transducer/generator assembly 6484, the surgical instrument accurately distinguishes between the completion of an actual use of the ultrasonic transducer/generator assembly 6484 in a surgical procedure and a momentary loss of operation of the ultrasonic transducer/generator assembly 6484 due to, for example, a battery change or a momentary delay in the surgical procedure. Therefore, as an alternative to simply counting the number of activations of the ultrasonic transducer/generator assembly 6484, a real-time clock (RTC) circuit can be implemented to track the amount of time the ultrasonic transducer/generator assembly 6484 has actually been shut down. From the measured length of time, it can be determined by appropriate logic whether the shutdown was significant enough to be considered the end of an actual use or whether the shutdown was too short to be considered the end of a use. Thus, in some applications, this method may more accurately determine the useful life of the ultrasonic transducer/generator assembly 6484 than a simple "activation-based" algorithm, where, for example, if 10 "activations" occur during a surgical procedure, the 10 activations should indicate that a counter should be incremented by one. In general, this internal clocking type and system prevents misuse of the device designed to circumvent simple "activation-based" algorithms, and also prevents erroneous logging of completed use when there has only been a simple disconnection of the ultrasonic transducer/generator assembly 6484 or smart battery assembly 6486 that is legitimately required.

The ultrasonic transducer/generator assembly 6484 of the surgical instrument 6480 is reusable, but in one aspect may have a finite number of uses due to the harsh conditions the surgical instrument 6480 is exposed to during cleaning and sterilization. More specifically, the battery pack is configured to be sterilized. Regardless of the material used for the exterior surface, there is a limited expected lifespan for the actual material used. This lifespan is determined by various characteristics, which may include, for example, the amount of time the pack has actually been sterilized, the time since the pack was manufactured, and the number of times the pack has been refilled, to name just a few. The battery cells themselves also have a finite lifespan. The software of the present disclosure incorporates an algorithm of the present invention that verifies 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. An analysis of the battery pack exterior in each of the possible sterilization methods can be performed. Based on the most severe sterilization procedure, a 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 expected to be used after it is charged, the charge count can be defined as equal to the number of sterilizations a particular pack will encounter.

In one aspect, hardware within the battery pack can be disabled to minimize or eliminate safety concerns due to continuous drain from the battery cells after the pack has been disabled by software. There may be situations where the battery's internal hardware is unable to disable the battery under certain low voltage conditions. In such situations, in one aspect, the charger can be used to "shut down" the battery. Due to the fact that the battery microcontroller is off while the battery is in its charger, a non-volatile system management bus (SMB) based electrically erasable programmable read only memory (EEPROM) can be used to exchange information between the battery microcontroller and the charger. Thus, a series of EEPROMs can be used to store information that can be written and read even when the battery microcontroller is off, which is very beneficial when trying to exchange information with a charger or other peripheral device. The EEPROM of this example may be configured to include sufficient memory registers to store at least (a) a usage count limit (battery usage count) at which the battery should be disabled, (b) the number of procedures the battery has undergone (battery usage count), and/or (c) the number of charges the battery has undergone (charge count), just to name a few. Some of the information stored in the EEPROM, such as the usage count register and the charge count register, are stored in a write-protected portion of the EEPROM to prevent users from modifying the information. In one aspect, the usage and counters are stored with corresponding bit-reversed small registers to detect data corruption.

Any residual voltage on the SMBus lines can damage the microcontroller and corrupt the SMBus signal. Therefore, relays are provided between the external SMBus lines and the battery microcontroller board to ensure that the battery controller's SMBus lines do 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, an "end of charge" state of the battery in the smart battery assembly 6486 is determined when the current flow into the battery tapers off below a given threshold. To accurately detect this "end of charge" state, the battery microcontroller and back board are powered down and turned off during charging of the battery to reduce any current drain that may be caused by the board and that may interfere with taper current detection. Additionally, the microcontroller and back board are powered down during charging to prevent any resulting corruption of the SMBus signals.

With regard 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, the exterior of the smart battery assembly 6486 is provided with a mechanism for holding the charger. A cup for securely holding the smart battery assembly 6486 in the charger is configured with a tapered shape that matches the contour to prevent the smart battery assembly 6486 from being mistakenly inserted in any way other than the correct (intended) way. It is further anticipated 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 transmissions from the battery protection circuit as well as resistors located in the protection board. In such a case, the charger may be able to control the voltage exposed at the charger pins until the smart battery assembly 6486 is properly seated or placed in a predetermined position in the charger. This is because the exposed voltage at the charger pins represents a danger and risk that an electrical short will occur across the pins and the charger will start charging unintentionally.

In some aspects, the smart battery assembly 6486 can communicate to the user through audio and/or visual feedback. For example, the smart battery assembly 6486 can cause an LED to light up in a pre-defined manner. In such a case, even though a microcontroller in the ultrasonic transducer/generator assembly 6484 controls the LED, the microcontroller receives instructions to be executed directly 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 a 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, greatly reducing the current drain. The processor continues to ping and waits to sense 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 can be built into the ultrasonic transducer/generator assembly 6484 and connected to a communication line, so that the LEDs can be independently controlled by the processor 6493 while the microcontroller of the ultrasonic transducer/generator assembly 6484 is in "off" or "sleep mode". This is a power saving mechanism that eliminates the need to wake up the microcontroller in the ultrasonic transducer/generator assembly 6484. Power is conserved by turning off the generator while still allowing active control of the user interface indicators.

Another aspect is to slow down one or more of the microcontrollers to conserve power when not in use. For example, the clock frequency of both microcontrollers can be reduced to save power. To maintain synchronous operation, the microcontrollers coordinate both the approximately simultaneous changes in their respective clock frequencies and the reduction when full speed operation is required, followed by a subsequent increase in frequency. For example, upon entering idle mode, the clock frequency is reduced, and upon exiting idle mode, the frequency is increased.

In an additional aspect, the smart battery assembly 6486 can determine the amount of available power remaining in its cells and is programmed to operate the attached surgical instrument only if it determines that there is sufficient battery power remaining to operate the instrument as expected throughout the entire anticipated procedure. For example, the smart battery assembly 6486 can remain in a non-operating state if there is not enough power in the cells 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 cells at the end of its most recent preceding function, e.g., a surgical cut. In this aspect, the smart battery assembly 6486 thus does not allow subsequent functions to be performed if it determines that the cells are low on power during the procedure, for example. Alternatively, if the smart battery assembly 6486 determines during the procedure that there is sufficient power for the subsequent procedure and falls below that threshold, it allows the ongoing procedure to be completed without interruption and prevents additional procedures from occurring thereafter.

The following describes the advantages of maximizing the use of devices with the smart battery assembly 6486 of the present disclosure. In this example, a set of different devices has different ultrasonic transmission waveguides. By definition, the waveguides may have their own maximum allowable power limit, and exceeding that power limit will overstress the waveguide and eventually cause it to break. One waveguide from a set of waveguides will inherently have the smallest maximum power allowable range. Because prior art batteries lack intelligent battery power management, the output of a prior art battery must be limited by the minimum of the maximum allowable power input for the smallest/thinnest/most fragile waveguide of the set that is intended to be used with the device/battery. This is true even though a larger, thicker waveguide may later be attached to its handle, allowing, by definition, a larger force to be applied. This limit is also true for the maximum battery power. For example, if a battery is designed to be used with multiple devices, its maximum output power is limited to the lowest maximum power rating of any of the devices with which it is used. Such a configuration may prevent one or more devices or device configurations from maximizing battery usage because the battery is unaware of the specific limitations of a particular device.

In one aspect, the smart battery assembly 6486 can be used to intelligently circumvent the limitations of the ultrasound devices discussed above. The smart battery assembly 6486 can generate one output for one device or a particular device configuration, and the same smart battery assembly 6486 can later generate a different output for a second device or device configuration. This universal smart battery surgical system is suited for modern operating rooms where space and time are at a premium. By powering many different devices with a smart battery pack, 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 and efficiency of use and reducing the cost of operating room charging equipment.

In addition, other surgical instruments, such as electric staplers, may have different power requirements than the modular handheld ultrasonic surgical instrument 6480. According to various aspects of the present disclosure, the smart battery assembly 6486 may be used with any one of a series of surgical instruments and may be manufactured to tailor its power output to the particular device in which it is installed. In one aspect, this power conditioning is accomplished by controlling the duty cycle of a switch mode power supply, such as a buck, buck-boost, boost, or other configuration, that is integral with or otherwise coupled to the smart battery assembly 6486 and controlled by the smart battery assembly 6486. In other aspects, the smart battery assembly 6486 may dynamically change its power output during device operation. For example, in vessel sealing devices, power management provides improved tissue sealing. In these devices, a large constant current value is required. As the tissue is sealed, its impedance changes, and therefore 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 (or device) to application (or device) based on the requirements of the application or device.

47 is a detailed view of the trigger 6483 portion and switch of the ultrasonic surgical instrument 6480 shown in FIG. 46, in accordance with at least one aspect of the present disclosure. The trigger 6483 is operably coupled to a jaw member 6495 of an end effector 6492. The ultrasonic blade 6496 is energized by the ultrasonic transducer/generator assembly 6484 upon actuation of an activation switch 6485. With continued reference to FIG. 46 and also with reference to FIG. 47, the trigger 6483 and activation switch 6485 are shown as components of the handle assembly 6482. The trigger 6483 activates the end effector 6492 in a cooperative relationship with the ultrasonic blade 6496 of the waveguide shaft assembly 6490 to allow various contacts of the end effector jaw member 6495 and ultrasonic blade 6496 with tissue and/or other material. The jaw member 6495 of the end effector 6492 is typically a pivoting jaw that acts to grasp or clamp tissue disposed between the jaw and the ultrasonic blade 6496. In one aspect, audible feedback is provided in the trigger that clicks when the trigger is fully depressed. The noise can be generated by a thin metal part that snaps as the trigger closes. This feature adds an audible component to the user feedback that notifies the user that the jaws are fully compressed against the waveguide and that sufficient clamping pressure has been applied to achieve a vessel seal. 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, can be coupled to the switch 6485 button such that the displacement magnitude corresponds to the force applied to the switch 6485 button by the user.

When depressed, the activation switch 6485 places the modular handheld ultrasonic surgical instrument 6480 in an ultrasonic operating mode to produce ultrasonic motion in the waveguide shaft assembly 6490. In one aspect, depression of the activation switch 6485 closes electrical contacts in the switch, thereby completing a circuit between the smart battery assembly 6486 and the ultrasonic transducer/generator assembly 6484, and applying power to the ultrasonic transducer as described above. In another aspect, depression of the activation switch 6485 closes electrical contacts to the smart battery assembly 6486. It should be understood that the description of closing electrical contacts in a circuit herein is merely an exemplary general description of switch operation. There are many alternative aspects that can include open contacts or processor-controlled power delivery that receives information from the switch and directs a corresponding circuit response based on that information.

FIG. 48 is a fragmentary, close-up perspective view of an end effector 6492 from a distal end with a jaw member 6495 in an open position, according to at least one aspect of the present disclosure. Referring to FIG. 48, a perspective partial view of a distal end 6498 of a waveguide shaft assembly 6490 is shown. The waveguide shaft assembly 6490 includes an outer tube 6494 that surrounds a portion of the waveguide. An ultrasonic blade 6496 portion of the waveguide 6499 protrudes from the distal end 6498 of the outer tube 6494. It is the ultrasonic blade 6496 portion that contacts and transfers ultrasonic energy to tissue during a medical procedure. The waveguide shaft assembly 6490 also includes a jaw member 6495 coupled to the outer tube 6494 and an inner tube (not visible in this view). The jaw member 6495, together with the inner and outer tubes and the ultrasonic blade 6496 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 one another. Relative movement between the outer tube 6494 and the inner tube (not shown) causes the jaw members 6495 to pivot on a pivot point, thereby opening and closing the jaw members 6495. When closed, the jaw members 6495 exert a clamping force on tissue located between the jaw members 6495 and the ultrasonic blade 6496, ensuring positive and efficient blade-to-tissue contact.

49 is a system diagram 7400 of a segmented circuit 7401 comprising multiple circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 operating independently, according to at least one aspect of the present disclosure. The circuit segments of the multiple circuit segments of the segmented circuit 7401 include one or more circuits and one or more sets of machine-executable instructions stored in one or more memory devices. The one or more circuits of the circuit segments are coupled for electrical communication through one or more wired or wireless connection media. The multiple circuit segments are configured to transition between three modes, including a sleep mode, a standby mode, and an operating mode.

In one embodiment shown, the circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 start in a standby mode first, transition to a sleep mode second, and transition to an operational mode third. However, in other embodiments, the circuit segments can transition from any one of the three modes to any other one of the three modes. For example, the circuit segments can transition directly from the standby mode to the operational mode. Individual circuit segments can be placed in specific states by the voltage control circuitry 7408 based on the processor's execution of machine-executable instructions. These states include an unpowered state, a low energy state, and a powered state. The unpowered state corresponds to a sleep mode, the low energy state corresponds to a standby mode, and the powered state corresponds to an operational mode. The transition to the low energy state can be achieved, for example, by the use of a potentiometer.

In one aspect, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 can transition from a sleep mode or standby mode to an operational mode according to a power-on sequence. The plurality of circuit segments can also transition from an operational mode to a standby mode or sleep mode according to a de-energization sequence. The power-on sequence and the de-energization sequence may be different. In some aspects, the power-on sequence includes energizing only a subset of the circuit segments of the plurality of circuit segments. In some aspects, the de-energization sequence includes de-energizing only a subset of the circuit segments of the plurality of circuit segments.

Referring again to the system diagram 7400 of FIG. 49, the segmented circuit 7401 comprises a plurality of circuit segments including 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, an energy treatment circuit segment 7434, and a shaft circuit segment 7440. The transition circuit segment comprises a wake-up circuit 7404, a boost current circuit 7406, a voltage control circuit 7408, a safety controller 7410, and a POST controller 7412. The transition circuit segment 7402 is configured to implement de-energization and energization sequences, safety detection protocols, and POST.

In some aspects, the wake-up circuit 7404 includes an accelerometer button sensor 7405. In an aspect, the transition circuit segment 7402 is configured to be in an energized state, while other circuit segments of the multiple circuit segments of the segmented circuit 7401 are configured to be in a low energy state, a non-energized state, or an energized state. The accelerometer button sensor 7405 may monitor movement or acceleration of the surgical instrument 6480 described herein. For example, the movement may be a change in orientation or a rotation of the surgical instrument. The surgical instrument may be moved in any direction relative to the three-dimensional Euclidean space, for example, by a user of the surgical instrument. When the accelerometer button sensor 7405 senses the movement or acceleration, the accelerometer button sensor 7405 sends a signal to the voltage control circuit 7408, causing the voltage control circuit 7408 to apply a voltage to the processor circuit segment 7414, transitioning the processor and volatile memory to an energized state. In an aspect, the processor and volatile memory are in an energized state before the voltage control circuit 7409 applies a voltage to the processor and volatile memory. In the operational mode, the processor can initiate a power-on sequence or a power-off sequence. In various aspects, the accelerometer button sensor 7405 can also send a signal to the processor to cause the processor to initiate a power-on sequence or a power-off sequence. In some aspects, the processor initiates a power-on sequence when a majority of the individual circuit segments are in a low energy or power-off state. In other aspects, the processor initiates a power-off sequence when a majority of the individual circuit segments are in a power-on state.

Additionally or alternatively, the accelerometer button sensor 7405 can sense an external movement within a predetermined vicinity of the surgical instrument. For example, the accelerometer button sensor 7405 can sense a user of the surgical instrument 6480 described herein moving the user's hand within a predetermined vicinity. 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 send a signal to the processor, as described above. After receiving the sent signal, the processor can initiate a power-on sequence or a power-off sequence to transition one or more circuit segments between the three modes. In an aspect, the signal sent to the voltage control circuit 7408 is sent to verify that the processor is in an operational mode. In some aspects, the accelerometer button sensor 7405 can sense when the surgical instrument is dropped and send a signal to the processor based on the detected drop. For example, the signal can indicate an error in the operation of an individual circuit segment. The one or more sensors can sense damage or malfunction of the affected individual circuit segments. Based on the sensed damage or malfunction, the POST controller 7412 can perform a POST of the corresponding individual circuit segments.

The energizing or de-energizing sequence may be defined based on the accelerometer button sensor 7405. For example, the accelerometer button sensor 7405 may sense a particular motion or sequence of motions indicative of a selection of a particular circuit segment of the plurality of circuit segments. Based on the sensed motion or sequence of sensed motions, the accelerometer button sensor 7405 may transmit a signal to the processor including an indication of one or more circuit segments of the plurality of circuit segments when the processor is in an energized state. Based on the signal, the processor determines an energizing sequence including the selected one or more circuit segments. Additionally or alternatively, a user of the surgical instrument 6480 described herein may select the number and order of the circuit segments to define an energizing or de-energizing sequence based on interaction with a graphical user interface (GUI) of the surgical instrument.

In various aspects, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and send a signal to the processor only when the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein or external movement within a predetermined vicinity that exceeds a predetermined threshold. For example, a signal can be sent only if movement is sensed for more than 5 seconds or if the surgical instrument is moved more than 5 inches. In other aspects, the accelerometer button sensor 7405 can signal the voltage control circuit 7408 and send a signal to the processor only when the accelerometer button sensor 7405 detects vibration movement of the surgical instrument. The predetermined threshold reduces inadvertent transitions of the circuit segments of the surgical instrument. As previously mentioned, the transitions can include transitions to an operating mode following a power-on sequence, transitions to a low energy mode following a power-off sequence, or transitions to a sleep mode following a power-off sequence. In some aspects, the surgical instrument includes an actuator that can be actuated by a user of the surgical instrument. This actuation is sensed by the accelerometer button sensor 7405. The actuator may be a slider, a toggle switch, or a momentary contact switch. Based on the sensed actuation, the accelerometer button sensor 7405 can send a signal to the voltage control circuitry 7408 and to the processor.

The boost current circuit 7406 is coupled to the battery. The boost current circuit 7406 is a current amplifier, such as a relay or transistor, configured to amplify the magnitude of the current of the individual circuit segments. The initial magnitude of the current corresponds to the power 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 the individual circuit segments or circuits that require more current draw during operation of the surgical instrument 6480 described herein. For example, an increase in current 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 the individual circuit segment can cause a corresponding decrease in current in another circuit segment or multiple circuit segments. Additionally or alternatively, the increase in current can correspond to a voltage provided by an additional voltage source operating in conjunction with the battery.

The voltage control circuit 7408 is coupled to the battery. The voltage control circuit 7408 is configured to provide or remove a voltage to the multiple circuit segments. The voltage control circuit 7408 is also configured to increase or decrease the voltage provided to the multiple circuit segments of the segmented circuit 7401. In various aspects, the voltage control circuit 7408 comprises a combinational logic circuit, such as a multiplexer (MUX) that selects an input, a plurality of electronic switches, and a plurality of voltage converters. The electronic switches of the plurality of electronic switches may be configured to switch between an open configuration and a closed configuration to disconnect or connect the respective circuit segments from the battery. The plurality of electronic switches may be solid-state devices, such as transistors, or other types of switches, such as wireless switches, ultrasonic switches, accelerometers, inertial sensors, among others. The combinational logic circuit is configured to select the individual electronic switches to switch to an open configuration to allow application of a voltage to the corresponding circuit segment. The combinational logic circuit is also configured to select the individual electronic switches to switch to a closed configuration to allow removal of a voltage from the corresponding circuit segment. By selecting the individual electronic switches, the combinational logic circuit can implement a de-energized or energized sequence. The voltage converters can provide step-up or step-down voltages to the circuit segments. The voltage control circuit 7408 may also include a microprocessor and a memory device.

The safety controller 7410 is configured to perform safety checks on the circuit segments. In some aspects, the safety controller 7410 performs safety checks when one or more individual circuit segments are in an operational mode. The safety checks may be performed to determine whether there are any errors or defects in the function or operation of the circuit segments. The safety controller 7410 may monitor one or more parameters of the multiple circuit segments. The safety controller 7410 may verify the identity and operation of the multiple circuit segments by comparing one or more parameters to predefined parameters. For example, when an RF energy modality is selected, the safety controller 7410 may verify that the shaft articulation parameters match predefined articulation parameters to verify the operation of the RF energy modality of the surgical instrument 6480 described herein. In some aspects, the safety controller 7410 may monitor, via a sensor, a predefined relationship between one or more characteristics of the surgical instrument to detect a fault. A fault may occur when one or more characteristics do not match the predefined relationship. When the safety controller 7410 determines that a fault exists, an error exists, or the operation of a portion of the multiple circuit segments has not been verified, the safety controller 7410 prevents or disables operation of the particular circuit segment in which the fault, error, or verification failure occurred.

The POST controller 7412 performs a POST to verify the proper operation of the plurality of circuit segments. In some aspects, the POST is performed on each of the plurality of circuit segments before the voltage control circuit 7408 applies voltage to the individual circuit segments to transition the individual circuit segments from a standby mode or a sleep mode to an operational mode. If the individual circuit segments do not pass the POST, the particular circuit segment does not transition from a standby mode or a sleep mode to an operational mode. The POST of the handle circuit segment 7416 may include, for example, testing whether the handle control sensor 7418 senses actuation of a handle control of the surgical instrument 6480 described herein. In some aspects, the POST controller 7412 may send a signal to the accelerometer button sensor 7405 to verify the operation of the individual circuit segments as part of the POST. For example, after receiving a signal, the accelerometer button sensor 7405 may prompt the user of the surgical instrument to move the surgical instrument to a plurality of different positions to verify the operation of the surgical instrument. The accelerometer button sensor 7405 may also monitor the output of a circuit segment or the circuitry of a circuit segment as part of the POST. For example, the accelerometer button sensor 7405 may sense incremental motor pulses generated by the motor 7432 to verify operation. A motor controller in the motor control circuitry 7430 may 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 may cause the POST controller 7412 to send a signal requesting matching encryption parameters from multiple circuit segments. Failure to receive matching encryption parameters from an individual circuit segment indicates to the POST controller 7412 that the corresponding circuit segment is damaged or malfunctioning. In some aspects, if the POST controller 7412 determines that a processor is damaged or malfunctioning based on the POST, the POST controller 7412 may send a signal to one or more secondary processors to cause the one or more secondary processors to perform a limiting function that the processor cannot perform. In some aspects, if the POST controller 7412 determines that one or more circuit segments are not operating properly based on POST, the POST controller 7412 can initiate a reduced performance mode for properly operating circuit segments while locking out circuit segments that have failed POST or are not operating properly. The locked-out circuit segments can function similarly to circuit segments in a standby or sleep mode.

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

The handle circuit segment 7416 includes a handle control sensor 7418. The handle control sensor 7418 may sense actuation of one or more handle controls of the surgical instrument 6480 described herein. In various aspects, the one or more handle controls include a clamp control, a release button, an articulation switch, an energy activation button, and/or any other suitable handle control. A user may activate the energy activation button to select an RF energy mode, an ultrasonic energy mode, or a combination of an RF energy mode and an ultrasonic energy mode. The handle control sensor 7418 may also facilitate attachment of the modular handle to the surgical instrument. For example, the handle control sensor 7418 may sense proper attachment of the modular handle to the surgical instrument and indicate the sensed attachment to a user of the surgical instrument. The LCD display 7426 may provide a graphical representation of the sensed attachment. In some aspects, the handle control sensor 7418 senses actuation of one or more handle controls. Based on the sensed actuation, the processor may initiate either an energizing sequence or a de-energizing sequence.

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

The display circuit segment 7424 includes an LCD display 7426. The LCD display 7426 can include a liquid crystal display screen, an LED indicator, or the like. In some aspects, the LCD display 7426 is an organic light emitting diode (OLED) screen. The display may be located on, embedded in, or remotely located in the surgical instrument 6480 described herein. For example, the display may be located on the handle of the 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 aspects, the surgical instrument can also comprise an audible feedback device, such as a speaker or buzzer, and a tactile feedback device, such as a haptic actuator.

The motor control circuit segment 7428 includes a motor control circuit 7430 coupled to a motor 7432. The motor 7432 is coupled to the processor by a driver and a transistor, such as a FET. In various aspects, the motor control circuit 7430 includes a motor current sensor in signal communication with the processor and provides a signal to the processor indicative of a measurement of the motor's current draw. The processor transmits the signal to a display. The display receives the signal and displays the measurement of the motor's current draw. The processor can use the signal to, for example, monitor that the motor's current draw is within an acceptable range, compare the current draw to one or more parameters of the multiple circuit segments, and determine one or more parameters of the patient treatment site. In various aspects, the motor control circuit 7430 includes a motor controller that controls the operation of the motor. For example, the motor control circuit 7430 controls various motor parameters, such as by adjusting the speed, torque, and acceleration of the motor 7432. The adjustments are made based on the current through the motor 7432 measured by the motor current sensor.

In various aspects, the motor control circuitry 7430 includes a force sensor that measures the force and torque generated by the motor 7432. The motor 7432 is configured to actuate the mechanism of the surgical instrument 6480 described herein. For example, the motor 7432 is configured to control the actuation of the shaft of the surgical instrument to achieve clamping, rotating, and articulation functions. For example, the motor 7432 can actuate the shaft to achieve clamping 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 can also determine the extent to which the jaws clamp the material. For example, the motor controller can determine the degree of opening and closing of the jaws based on the derivative of the sensed motor current or motor voltage. In some aspects, the motor 7432 is configured to actuate the transducer to cause the transducer to apply a torque to the handle or control the articulation 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 predefined threshold limit, the motor controller initiates a corresponding change in motor control behavior. For example, exceeding the motor current limit causes the motor controller to reduce the motor's current draw.

The energy treatment circuit segment 7434 includes an RF amplifier and safety circuit 7436 and an ultrasonic signal generator circuit 7438 to implement the energy module functions of the surgical instrument 6480 described herein. In various aspects, the RF amplifier and safety circuit 7436 is 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 and the ultrasonic signal generator circuit 7438 can jointly operate to control a combined RF and ultrasonic energy modality.

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

50 is a schematic diagram of various components of a surgical instrument with motor control functionality circuit 7925 according to at least one aspect of the present disclosure. In various aspects, the surgical instrument 6480 described herein may include a drive mechanism 7930 configured to drive shafts and/or gear components to perform various operations associated with the surgical instrument 6480. In one aspect, the drive mechanism 7930 includes a rotational drive train 7932 configured to rotate, for example, the end effector about a longitudinal axis relative to the handle housing. The drive mechanism 7930 further includes a closure drive train 7934 configured to close the jaw members to grasp tissue with the end effector. Additionally, the drive mechanism 7930 includes a firing drive train 7936 configured to open and close a clamp arm portion of the end effector to grasp tissue with the end effector.

The drive mechanism 7930 includes a selector gearbox assembly 7938 that can be located in a handle assembly of the surgical instrument. Proximal to the selector gearbox assembly 7938 is a function selection module including a first motor 7942 that functions to selectively move gear elements within the selector gearbox assembly 7938 to selectively position one of the drive trains 7932, 7934, 7936 to engage the input drive components of an optional second motor 7944 and motor drive circuit 7946 (shown in dashed lines to indicate that the second motor 7944 and motor drive circuit 7946 are optional components).

Continuing to refer to FIG. 50, the motors 7942, 7944 are coupled to motor control circuits 7946, 7948, respectively, which are configured to control the operation of the motors 7942, 7944, including the flow of electrical energy from a power source 7950 to the motors 7942, 7944. The power source 7950 may be a DC battery (e.g., a rechargeable lead-based, nickel-based, lithium-ion-based battery, etc.) or any other power source suitable for providing electrical energy to a surgical instrument.

The surgical instrument further includes 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 7956 ("memory"). In certain examples, the memory 7956 can store various program instructions that, when executed, can cause the processor 7954 to perform a number of functions and/or calculations described herein. The power source 7950 can be configured to provide power to the controller 7952, for example.

The processor 7954 may be in communication with the motor control circuit 7946. Additionally, the memory 7956 may store program instructions that, when executed by the processor 7954 in response to the user input 7958 or the feedback element 7960, may cause the motor control circuit 7946 to stimulate the motor 7942 to generate at least one rotational motion and selectively move the gear elements in the selector gearbox assembly 7938 to selectively position one of the drive trains 7932, 7934, 7936 to engage the input drive component of the second motor 7944. Additionally, the processor 7954 may be in communication with the motor control circuit 7948. The memory 7956 may also store program instructions that, when executed by the processor 7954 in response to the user input 7958, may cause the motor control circuit 7948 to stimulate the motor 7944 to generate at least one rotational motion, for example, to drive a drive train engaged with the input drive component of the second motor 7948.

The controller 7952 and/or other controllers of the present disclosure may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor elements, chips, microchips, chipsets, microcontrollers, systems on chips (SoCs), and/or single in-line packages (SIPs). Examples of discrete hardware elements 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 a hybrid circuit comprising discrete and integrated circuit elements or components, for example, on one or more substrates.

In a particular example, the controller 7952 and/or other controllers of the present disclosure may be, for example, an LM 4F230H5QR available from Texas Instruments. In a particular example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core including up to 40 MHz, 256 KB of on-chip memory of single-cycle flash memory or other non-volatile memory, a pre-fetch buffer to improve performance above 40 MHz, 32 KB of single-cycle SRAM, internal ROM loaded with StellarisWare® software, 2 KB of EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels, among other readily available characteristics. Other microcontrollers may be readily substituted for use with the present disclosure. Therefore, the present disclosure should not be limited in this context.

In various examples, one or more of the various steps described herein may be implemented by a finite state machine including either a combinational logic circuit or a sequential logic circuit, where either the combinational logic circuit or the sequential logic circuit is coupled to at least one memory circuit. The at least one memory circuit stores the current state of the finite state machine. The combinational or sequential logic circuit is configured to subject the finite state machine to these steps. The sequential logic circuit may be synchronous or asynchronous. In other cases, one or more of the various steps described herein may be implemented by a circuit including, for example, a combination of a processor 7958 and a finite state machine.

In various examples, it may be advantageous to be able to assess the state of function of a surgical instrument to ensure proper function. For example, a drive mechanism configured to include various motor, drive train and/or gear components to perform various operations of a surgical instrument, as described above, may wear down over time. While this may occur through normal use, in some examples, the drive mechanism may wear out more quickly due to abuse conditions. In certain examples, the surgical instrument may be configured to perform a self-assessment to determine the state, e.g., health, of the drive mechanism and its various components.

For example, self-diagnosis can be used to determine if the surgical instrument is capable of performing its function before resterilization or if some of the components should be replaced and/or repaired. Evaluation of the drive mechanism and its components, including but not limited to the rotation drive train 7932, the closure drive train 7934, and/or the firing drive train 7936, can be accomplished in a variety of ways. The magnitude of deviation from predicted performance can be used to determine the likelihood of a sensed failure and the severity of such failure. Several metrics can be used, including periodic analysis of repeatably predictable events, peaks or drops above expected thresholds, and width of failure.

In various examples, the characteristic waveform of one or more of a properly functioning drive mechanism or its components can be used to assess the condition of the drive mechanism or one or more of its components. One or more vibration sensors can be positioned relative to the properly functioning drive mechanism or one or more of its components to record various vibrations that occur during operation of the properly functioning drive mechanism or one or more of its components. The recorded vibrations can be used to generate a characteristic waveform. Future waveforms can be compared to the characteristic waveform to assess the condition of the drive mechanism and its components.

Continuing to refer to FIG. 50, the surgical instrument 7930 includes a drivetrain fault detection module 7962 configured to record and analyze one or more audible outputs of one or more of the drivetrains 7932, 7934, 7936. The processor 7954 may be in communication with or otherwise control the module 7962. As described in more detail below, the module 7962 may be embodied as a variety of means, such as a circuit, hardware, a computer program product comprising a computer-readable medium (e.g., memory 7956) that stores computer-readable program instructions executable by a processing unit (e.g., processor 7954), or some combination thereof. In some aspects, the processor 36 may include or otherwise control the module 7962.

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 clamping tissue 8410 located between the jaw member 8402 and the ultrasonic blade 8404. The first sensor 8406 is located in a central portion of the jaw member 8402. The second sensor 8408a and the third sensor 8408b are located on an 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 a surgical instrument. The sensors 8406, 8408a, 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 signals generated by the sensors 8406, 8408a, 8408b are provided to analog and/or digital processing circuitry of the control circuit.

In one aspect, the first sensor 8406 is a force sensor for measuring a normal force F3 applied by the jaw member 8402 to the tissue 8410. The second sensor 8408a and the third sensor 8408b apply RF energy to the tissue 8410 and include one or more elements for measuring tissue impedance, downward force F1, lateral force F2, and temperature, among other parameters. The electrodes 8409a, 8409b are electrically coupled to an energy source and 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 measurements of the downward force F1, lateral force F2, and normal force F3 can be readily converted to pressure by determining the surface area over which the force sensors 8406, 8408a, 8408b act. Additionally, as described in more detail herein, the flexible circuit 8412 may include a temperature sensor embedded within one or more layers of the flexible circuit 8412. The one or more temperature sensors may be symmetrically or asymmetrically positioned and may provide tissue 8410 temperature feedback to the control circuitry of the ultrasonic drive circuit and the RF drive circuit.

FIG. 52 illustrates one embodiment of the flexible circuit 8412 shown in FIG. 51, where the sensors 8406, 8408a, 8408b may be attached to or integrally formed 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, asymmetric temperature sensors 8414a, 8414b are attached to the flexible circuit 8412, allowing for the temperature of tissue 8410 (FIG. 51) to be measured.

53 is an alternative system 132000 for controlling the frequency of an ultrasonic electromechanical system 132002 and detecting its impedance, according to at least one aspect of the present disclosure. The system 132000 may be incorporated into a generator. A processor 132004 coupled to a memory 132026 programs a programmable counter 132006 to tune the output frequency f _o of the ultrasonic electromechanical system 132002. The input frequency is generated by a crystal oscillator 132008 and input to a fixed counter 132010 to scale the frequency to a suitable value. The output of the fixed counter 132010 and the programmable counter 132006 is applied to a phase/frequency detector 132012. The output of the phase/frequency detector 132012 is applied to an amplifier/active filter circuit 132014 to generate a tuned voltage V _t that is applied to a voltage controlled oscillator 132016 (VCO). The VCO 132016 applies an output frequency f _o to the ultrasonic transducer portion of the ultrasonic electromechanical system 132002, which is shown modeled herein as an equivalent electrical circuit. The voltage and current signals applied to the ultrasonic transducer are monitored by a voltage sensor 132018 and a 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 a high-speed analog-to-digital converter 132024 (ADC) and provided therethrough to the processor 132004. Optionally, the outputs of the voltage sensor 132018 and the current sensor 132020 may be applied to respective channels of a two-channel ADC 132024 and provided to the processor 132004 for zero crossing, FFT, or other algorithms described herein to determine the phase angle between the voltage and current signals applied to the ultrasonic electromechanical system 132002.

Optionally, the regulated voltage _Vt proportional to the output frequency f _o may be fed back to the processor 132004 via the ADC 132024. This provides the processor 132004 with a feedback signal proportional to the output frequency f _o , which can be used to regulate and control the output frequency f _o .

Jaw condition estimation (burn-through pads, staples, broken blades, bone in jaw, tissue in jaw)
A challenge with ultrasonic energy delivery is that ultrasonic sounds applied to the wrong material or the wrong tissue can result in device failure, e.g., the clamp arm pads burning or the ultrasonic blade breaking. It is also desirable to detect what is located in the jaws of an ultrasonic device's end effector and detect the condition of the jaws without adding additional sensors in the jaws. Locating sensors in the jaws of an ultrasonic end effector poses reliability, cost, and complexity challenges.

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

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。

may be used to infer the state of the jaws (burn-through of clamp arm pads, staples, broken blade, bone in jaws, tissue in jaws, back cut with jaws closed, etc.) based on the impedance _Zg (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. Spectroscopy applied to ultrasonic devices involves exciting the tip of an ultrasonic blade with a sweep of frequencies (composite signal or conventional frequency sweep) and measuring the resulting complex impedance at each frequency. The complex impedance measurements of the ultrasonic transducer over a range of frequencies are used in a classifier or model to infer the properties of the ultrasonic end effector. In one aspect, the present disclosure provides a technique for determining the state of the ultrasonic end effector (clamp arm, jaws) to drive automation in the ultrasonic device (disable power to protect the device, run adaptive algorithms, extract information, identify tissue, etc.).

54 is a spectrum 132030 of an ultrasonic device having a variety of different states and conditions of the end effector where impedance _Zg (t), magnitude |Z|, and phase φ are plotted as a function of frequency f in accordance with at least one aspect of the present disclosure. The spectrum 132030 is plotted in three dimensional space where frequency (Hz) is plotted along the x-axis, phase (radians) is plotted along the y-axis, and magnitude (ohms) is plotted along the z-axis.

Spectral analysis of different jaw occlusion and instrument conditions produces different complex impedance signature patterns (fingerprints) across a range of frequencies for different situations and conditions. Each condition or state has a different signature pattern in 3D space when plotted. These signature patterns can be used to infer the situation and state of the end effector. FIG. 54 shows the spectra of air 132032, clamp arm pad 132034, chamfer 132036, staple 132038, and broken blade 132040. Chamfer 132036 may be used to characterize different types of tissue.

Spectra 132030 can be evaluated by applying a low power electrical signal across the ultrasound transducer to generate a non-therapeutic excitation of the ultrasound blade. The low power electrical signal is impedance measured across the ultrasound transducer using FFTs over a range of frequencies in series (swept) or parallel (composite signal).

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。

It can be applied in the form of a sweep or complex Fourier series to measure

How to Classify New Data For each characteristic pattern, a parametric line can be fitted to the data used for training using a polynomial, a Fourier series, or any other form of parametric equation, as may be conveniently determined. New data points are then received and classified by using the Euclidean perpendicular distance from the new data point to the trajectories that were fitted to the characteristic pattern training data. The perpendicular distance of the new data point to each of the trajectories (each trajectory representing a different state or condition) is used to assign the point to a state or condition.

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 data point being correctly classified. This essentially builds a two-dimensional probability distribution in the plane perpendicular to the fitted trajectory at each new data point in the fitted trajectory. New data points can then be included in the training set based on their probability of correct classification to create an adaptive learning classifier that easily detects high frequency changes in conditions but adapts to slow emerging deviations in system performance, such as dirty equipment or worn pads.

55 is a graphical illustration of a plot 132042 of a set of 3D training data sets (S) in which ultrasonic transducer impedance _Zg (t), magnitude |Z|, and phase φ are plotted as a function of frequency f, in accordance with at least one aspect of the present disclosure. The 3D training data sets (S) plot 132042 is graphically shown in three-dimensional space with phase (Rad) plotted along the x-axis, frequency (Hz) plotted along the y-axis, magnitude (Ohms) plotted along the z-axis, and a parametric Fourier series is fitted to the 3D training data sets (S). A method for classifying the data is based on the 3D training data sets (S0 is used to generate the plot 132042).

The parametric Fourier series that is fitted to the 3D training data set (S) is defined by the following equation:

New points

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 formula:

式中、

In the formula,

であるときに、
Ｄ＝Ｄ_⊥である。

When
D= _D⊥ .

Using the probability distribution of D, data points that belong to group S

の確率を推測することができる。

The probability of can be estimated.

Controls Various automated tasks and safety measures can be implemented based on classification of data measured before, during, or after activation of the ultrasonic transducer/blade. Similarly, the condition of the tissue located in the end effector and the temperature of the ultrasonic blade can also be inferred to some extent and used to better inform the user of the condition of the ultrasonic device or to protect critical structures, etc. Ultrasonic blade temperature control is described in commonly owned U.S. Provisional Patent Application No. 62/640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," which is incorporated herein by reference in its entirety.

Similarly, power delivery can be reduced if there is a high probability that the ultrasonic blade will contact the clamp arm pad (e.g., no tissue in between), or if there is a probability that the ultrasonic blade has broken or is in contact with metal (e.g., a staple). Additionally, the rear cut can be released if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad.

Integrating other data to improve classification The system can be used with other information provided by sensors, user and patient metrics, environmental factors, etc., by combining data from this process with the aforementioned data using probability functions and a Kalman filter. The Kalman filter determines the maximum likelihood of a state or situation occurring given uncertain measurements of various reliability. The information in this algorithm can be implemented using other measurements or estimates in the Kalman filter, as this method allows for the assignment of probabilities to newly classified data points.

56 is a process logic flow diagram 132044 illustrating a control program or logic configuration for determining jaw conditions based on a complex impedance characteristic pattern (fingerprint) according to at least one aspect of the present disclosure. Prior to determining jaw conditions based on a complex impedance characteristic pattern (fingerprint), a database is populated with reference complex impedance characteristic patterns or training data sets (S) that characterize various jaw conditions, including but not limited to air 132032, clamp arm pads 132034, chamfer 132036, staple 132038, broken blade 132040 as shown in FIG. 82, as well as various tissue types and conditions. Dry or wet chamfer, full bite or tip may be used to characterize different types of tissue. The data points used to generate the reference complex impedance characteristic pattern or training data set are obtained by applying a subtherapeutic drive signal to the ultrasound transducer. The drive frequency is swept over a predetermined frequency range from below resonance to above resonance, measuring the complex impedance at each frequency, and recording the data points. The data points are then fitted to a curve using various numerical methods including polynomial curve fitting, Fourier series, and/or parametric equations. Fitting a parametric Fourier series to the reference complex impedance characteristic pattern or training data set (S) is described herein.

Once a reference complex impedance characteristic pattern or training data set (S) is generated, the ultrasound instrument measures new data points, classifies the new points, and determines whether the new data points should be added to the reference complex impedance characteristic pattern or training data set (S).

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

The control circuit receives 132048 the complex impedance measurement data points and compares 132050 the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern. The control circuit classifies 132052 the complex impedance measurement data points based on the results of the comparative analysis, and assigns 132054 a state or status of the end effector based on the results of the comparative analysis.

In one aspect, the control circuit receives a reference complex impedance characteristic pattern from a database or memory coupled to the processor. In one aspect, the control circuit generates the reference complex impedance characteristic pattern as follows: A drive circuit coupled to the control circuit applies a non-therapeutic drive signal to the ultrasound transducer starting at an initial frequency, ending at a final frequency, and at multiple frequencies therebetween. The control circuit measures the impedance of the ultrasound transducer at each frequency and stores a data point corresponding to each impedance measurement. The control circuit fits a curve to the 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. The curve fitting includes polynomial curve fitting, Fourier series, and/or parametric equations.

In one aspect, the control circuit receives a new impedance measurement data point and classifies the new impedance measurement data point using a Euclidean perpendicular distance from the new impedance measurement data point to a locus fitted to the reference complex impedance characteristic pattern. The control circuit estimates a probability that the new impedance measurement data point will be correctly classified. The control circuit adds the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point. In one aspect, the control circuit classifies the data based on a training data set (S), where the training data set (S) includes a plurality of complex impedance measurement data, and fits a curve to the training data set (S) using a parametric Fourier series, where S is defined herein, and a probability distribution is used to estimate the probability of the new impedance measurement data point belonging to group S.

Model-Based Jaw Classifier Status There is an existing interest in classifying material located within the jaws of an ultrasound device, including tissue type and condition. In various aspects, using high data sampling and advanced pattern recognition, this classification can be shown to be possible. This approach is based on impedance as a function of frequency, where magnitude, phase, and frequency are plotted in 3D and the pattern appears as a ribbon, as shown in Figures 54 and 55, as well as the logic flow diagram in Figure 56. The present disclosure provides an alternative smart blade algorithm approach based on a well-established model of the piezoelectric transducer.

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

The circle is created as the frequency is swept from below resonance to above resonance. Rather than drawing the circle in 3D, the circle is identified and the radius (r) and offsets (a, b) of the circle are inferred. These values are then compared to values established for the given situation. These situations may be 1) jaws not open at all, 2) tips interlocking, 3) jaws fully interlocking and stapled. If the sweep generates multiple resonances, there will be a circle of different characteristics for each resonance. Each circle is drawn before the next if the resonance is isolated. Rather than fitting a 3D curve in a serial approximation, a circle is fitted to the data. The radius (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 to infer the radius (r) and offsets (a, b) that define the circle.

Figure 59 is a circle plot 132060 of the complex admittance of a 55.5 kHz ultrasonic piezoelectric transducer for lumped parameter inputs and outputs specified below. The complex admittance was generated using values from the lumped parameter model. A moderate load was applied to the model. The resulting admittance circle generated in MathCad is shown in Figure 59. The circle plot 132060 is formed as the frequency is swept from 54 to 58 kHz.

The lumped parameter input values are as follows:
Co=3.0 nF
Cs=8.22 pF
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 Figure 59. The circle plot 132060 has a radius (r) and a center 132062 that is offset (a, b) from the origin 132064 as follows:
r = 1.012 * ¹⁰³
a = 1.013 * ¹⁰³
b = -954.585

The sums A-E specified below are necessary to deduce the example circle plot 132060 plot given in FIG. 59, in accordance with at least one aspect of the present disclosure. There are several algorithms to calculate the circle fit. A circle is defined by its radius (r) and the offset of its center from the origin (a, b):
^r2 = (x-a) ² + (y-b) ²

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

The caret symbol above the variable "a" indicates a guess at the true value. A, B, C, D, and E are sums of various products calculated from the data. They are included here for completeness as follows:

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,i is the first vector of real components called conductances,
Z2,i is a second vector of imaginary components called susceptances,
Z3,i is a third vector representing the frequencies at which the admittance is calculated.

The present disclosure works for ultrasonic systems and may be applied to electrosurgical systems, even if the electrosurgical system does not rely on resonance.

60-64 show images taken from an impedance analyzer showing impedance/admittance circle plots of an ultrasonic device with the end effector jaws in various open or closed configurations and with a load. In accordance with at least one aspect of the present disclosure, the solid circle plots show impedance and the dashed circle plots show admittance. By way of example, the impedance/admittance circle plots are generated by connecting an ultrasonic device to the impedance analyzer. The impedance analyzer display is set to complex impedance and complex admittance, which may be selectable from the impedance analyzer front panel. An initial display may be obtained, for example, with the ultrasonic end effector jaws in the open position and the ultrasonic device in an unloaded state, as described below in connection with FIG. 60. The impedance analyzer's autoscale display feature may be used to generate both the complex impedance and admittance circle plots. The same display is used for subsequent runs of the ultrasonic device with different load conditions, as shown in subsequent FIGS. 60-64. A LabVIEW application may be used to upload data files. In another technique, the display image may be captured with a camera, such as a smartphone camera, such as an iPhone or Android. The display image may therefore contain some keystone effects and may not generally appear parallel to the screen. Using this technique, a circular plot line on the display will appear distorted in the captured image. This approach can be used to classify materials located within the jaws of an ultrasonic end effector.

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 estimate is to noise when using complex impedance or admittance.

In the example shown in Figures 60-64, the impedance analyzer is set at a range that simply captures the dominant resonance. By scanning over a wider range of frequencies, more resonances may be encountered and multiple circle plots may be formed. The equivalent circuit of the ultrasonic transducer may be modeled by a first "operational" branch with serially connected inductance Ls, resistance Rs, capacitance Cs, and a second capacitive branch with capacitance C0 that define the electrosurgical characteristics of the resonator. In the impedance/admittance plots shown in Figures 60-64 below, the component values of the equivalent circuit are as follows:
Ls = L1 = 1.1068H
Rs = R1 = 311.352 Ω
Cs = C1 = 7.43265 pF
C0 = C0 = 3.64026 nF

The oscillator voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 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) circular plots may be taken at locations on the circular plots as indicated by the impedance and admittance cursors.

Jaw State: Open with No Load FIG. 60 is a graphical representation 132066 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circle plots 132068, 132070 of an ultrasound device with jaws open and no load, in accordance with at least one aspect of the present disclosure, where the solid circle plot 132068 shows the complex impedance and the dashed circle plot 132070 shows the complex admittance. The oscillator voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 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 may be taken at locations on the circle plots 132068, 132070 as indicated by the impedance cursor 132072 and the admittance cursor 132074. Thus, the impedance cursor 132072 is located on a portion of the impedance circle plot 132068 equal to approximately 55.55 kHz, and the admittance cursor 132074 is located on a portion of the admittance circle plot 132070 equal to approximately 55.29 kHz. As shown in FIG. 60, the positions of the impedance cursor 132072 correspond to the following values:
R = 1.66026 Ω
X = -697.309 Ω

where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of the admittance cursor 132074 corresponds to the following values:
G = 64.0322 μS
B = 1.63007 mS
where G is the conductance (real value) and B is the susceptance (imaginary value).

61 is a graphical representation 132076 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circle plots 132078, 132080 of an ultrasonic device with the jaw tips clamped on dry chamois end effector, in accordance with at least one aspect of the present disclosure, where the impedance circle plot 132078 is shown in solid line and the admittance circle plot 132080 is shown in dashed line. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 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 may be taken at locations on the circle plots 132078, 132080 as indicated by the impedance cursor 132082 and the admittance cursor 132084. Thus, the impedance cursor 132082 is located on a portion of the impedance circle plot 132078 equal to approximately 55.68 kHz, and the admittance cursor 132084 is located on a portion of the admittance circle plot 132080 equal to approximately 55.29 kHz. As shown in FIG. 61, the positions of the impedance cursor 132082 correspond to the following values:
R = 434.577 Ω
X = -758.772 Ω
where R is the resistance (real value) and X is the reactance (imaginary value).

Similarly, the position of the admittance cursor 132084 corresponds to the following values:
G = 85.1712 μS
B = 1.49569 mS
where G is the conductance (real value) and B is the susceptance (imaginary value).

62 is a graphical representation 132086 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circle plots 132098, 132090 of an ultrasonic device with the jaw tips clamped on a wet chamois, in accordance with at least one aspect of the present disclosure, where the impedance circle plot 132088 is shown in solid line and the admittance circle plot 132090 is shown in dashed line. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 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 132088, 132090 may be taken at locations on the circle plots 132088, 132090 as indicated by the impedance cursor 132092 and the admittance cursor 132094. Thus, the impedance cursor 132092 is located on a portion of the impedance circle plot 132088 equal to approximately 55.68 kHz, and the admittance cursor 132094 is located on a portion of the admittance circle plot 132090 equal to approximately 55.29 kHz. As shown in FIG. 63, the impedance cursor 132092 corresponds to the following values:
R = 445.259 Ω
X = -750.082 Ω

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

63 is a graphical representation 132096 of an impedance analyzer showing complex impedance (Z)/admittance (Y) circle plots 132098, 132100 of an ultrasound device with the jaws fully clamped on a wet chamois, in accordance with at least one aspect of the present disclosure, where the impedance circle plot 132098 is shown in solid line and the admittance circle plot 132100 is shown in dashed line. The voltage applied to the ultrasound transducer is 500 mV and the frequency is swept from 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 taken at locations 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 approximately 55.63 kHz, and the admittance cursor 132104 is located on a portion of the admittance circle plot 132100 equal to approximately 55.29 kHz. As shown in FIG. 63, the impedance cursor 132102 corresponds to values of R, resistance (which is a real value, not shown), and X, reactance (which is an imaginary value, also not shown).

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

Jaw State: Open with No Load Fig. 64 is a graphical representation 132106 of an impedance analyzer showing impedance (Z)/admittance (Y) circle plots in accordance with at least one aspect of the present disclosure, where the frequency is swept from 48 kHz to 62 kHz to capture multiple resonances of an ultrasonic device with jaws open and no load, and the area designated by the rectangle 132108 shown in dashed lines is to aid in viewing the impedance circle plots 132110a, 132110b, 132110c and admittance circle plots 132112a, 132112b, 132112c shown in solid lines. 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 can be taken at locations on the impedance and admittance circle plots 132110a-c, 132112a-c indicated by the impedance cursor 132114 and the admittance cursor 132116. Thus, the impedance cursor 132114 is located on a portion of the impedance circle plots 132110a-c equal to approximately 55.52 kHz, and the admittance cursor 132116 is located on a portion of the admittance circle plots 132112a-c equal to approximately 59.55 kHz. As shown in FIG. 64, the impedance cursor 132114 corresponds to the following values:
R = 1.86163 kΩ
X = -536.229 Ω

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

There are only 400 samples across the sweep range of the impedance analyzer, so there are only a few points around the resonance. This makes the circle on the right look misshapen. However, this is simply due to the impedance analyzer and the settings used to cover multiple resonances.

When multiple resonances are present, there is more information to improve the classifier. A fit of the circle plots 132110a-c, 132112a-c can be calculated for each one encountered to keep the algorithm running fast. So when there is a crossing of the complex admittances that means the circle, the fit can be calculated during the sweep.

Advantages include a jaw classification unit based on data and well-known models for ultrasound systems. Circle counting and characterization is well-known in vision systems, so data processing is readily available. For example, closed-form solutions exist for calculating circle radii and axis offsets. This technique can be relatively fast.

Table 2 lists the symbols used in the lumped parameter model of piezoelectric transducers (from the IEEE 177 standard).

Table 3 lists symbols for transmission networks (from the IEEE 177 standard).

^＊実根を指す。無視される複素根。

^* Real roots. Complex roots are ignored.

Table 4 lists solutions for various characteristic frequencies (from the IEEE 177 standard).

^＊実根を指す。無視される複素根

^* Real roots. Complex roots are ignored.

Table 5 lists the losses for 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

The minimum expected ratio ^Qr /r for various types of piezoelectric transducers

Table 6 shows the jaw situation, the estimated parameters of the circle based on real-time measurements of the complex impedance/admittance, radius (re), offset (ae and be) of the circle represented by the estimated variables Re, Ge, Xe, Be, and the parameters of the reference circle plot based on real-time measurements of the complex impedance/admittance, radius (rr), and offset (ar, br) of the reference circle represented by the reference variables Rref, Gref, Xref, Bref as described in Figures 60-64. These values are then compared to the established values for the given situations. These situations may be: 1) open with no jaws, 2) tip occlusion, 3) jaws fully occluded and stapled. 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 = 311.352 Ω
Cs = C1 = 7.43265 pF and C0 = C0 = 3.64026 nF

In use, the ultrasonic generator sweeps the frequency, records the measured variables, and determines the estimated values Re, Ge, Xe, Be. These estimates are then compared to reference variables Rref, Gref, Xref, Bref stored in memory (e.g., stored in a lookup table) to determine the jaw condition. The reference jaw conditions shown in Table 6 are merely examples. Additional or fewer reference jaw conditions may be classified and stored in memory. These variables can be used to estimate the radius and offset of the impedance/admittance circle.

65 is a logic flow diagram 132120 of a process illustrating a control program or logic configuration for determining jaw status based on an estimate of the radius (r) and offset (a, b) of the impedance/admittance circle according to at least one aspect of the present disclosure. Initially, a database or lookup table is populated with reference values based on the reference jaw status as described in connection with FIGS. 60-64 and Table 6. The reference jaw status is set and the frequency is swept from below resonance to above resonance. The reference values Rref, Gref, Xref, Bref that define the corresponding impedance/admittance circle plot are stored in the database or lookup table. In use, under the control of the control program or logic configuration, the generator or instrument control circuitry causes the frequency to be swept from below resonance to above resonance (132122). The control circuit measures and records (e.g., stores in memory) the variables Re, Ge, Xe, and Be that define the corresponding impedance/admittance circle plot (132124) and compares them to reference values Rref, Gref, Xref, and Bref stored in a database or lookup table (132126). The control circuit determines, e.g., infers, the end effector jaw status based on the results of the comparison (132128).

Application of "Smart Blade Technology" Current ultrasonic and/or combined ultrasonic/RF tissue treatment situations use advanced tissue treatment algorithms with predefined current levels for each step of the algorithm. Instead of using advanced hemostatic tissue treatment algorithms with predefined current levels for each step of the algorithm, the proposed advanced tissue treatment technology uses a frequency temperature control system to adjust the current delivered to the ultrasonic transducer to drive the ultrasonic blade to a constant temperature.

66A-66B are graphs of an advanced ultrasonic transducer current controlled hemostasis algorithm. For example, a tissue treatment process may be initiated by driving the ultrasonic transducer current to generate a high constant temperature for a 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 for a second predetermined period T2. The lower temperature of the ultrasonic blade may be suitable for achieving a tissue seal but may not be suitable for achieving a tissue incision. Finally, the process drives the ultrasonic transducer current to increase the temperature of the ultrasonic blade to a higher constant temperature for a third predetermined period T3. The higher temperature is high enough to complete the transection 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 to be lower than the melting point of Teflon, a material commonly used for clamp arm pads.

FIG. 66A is a graphical illustration 132130 of the percentage of maximum current delivered to the ultrasonic transducer as a function of time, according to at least one aspect of the present disclosure. The vertical axis represents the percentage of maximum current delivered to the ultrasonic transducer, and the horizontal axis represents time (seconds). The transducer current percentage is set to a first percentage of maximum current X1% to raise the temperature of the ultrasonic blade during a first period T1. The transducer current percentage is then reduced to a second percentage of maximum current X2% for a second period T2 to lower the blade temperature to a value suitable for sealing tissue but not suitable for transecting tissue. The transducer current percentage is then increased to a third percentage of maximum current X3% for a third period T3 to raise the blade temperature to a value suitable for transecting tissue but below the melting point of the clamp arm pad (e.g., Teflon). The process graphically illustrated in FIG. 66A allows the same percentage ultrasound transducer current profile to be used for all tissue types, loading conditions, etc.

FIG. 66B is a graphical illustration 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 ultrasonic blade temperature (°F) and the horizontal axis represents time (seconds). This technique may be combined with impedance spectroscopy to detect tissues of various thicknesses, such as thick versus thin tissue located within the jaws of an ultrasonic end effector. Once the tissue thickness is detected, the temperature of the ultrasonic blade may be controlled to accommodate different levels of energy delivery as may be required across a range of tissue types, adjusting advanced hemostasis algorithms in real time. Once the tissue type is detected or determined, the ultrasonic blade temperature is set to a nominal temperature Temp ₁ by controlling the drive current to the ultrasonic transducer. The temperature of the ultrasonic blade may be set to a first temperature Temp ₁ and increased (+) or decreased (-) based on the tissue type over a first time period T1. The ultrasonic blade temperature is then decreased to a second temperature Temp ₂ for a second period T2, a value suitable for sealing tissue but not suitable for transecting tissue. The second temperature Temp ₂ may be increased (+) or decreased (-) based on the type of tissue detected. The ultrasonic blade temperature is then increased to a third temperature Temp ₃ for a third period T3, a value suitable for transecting tissue but below the melting point temperature _TMP of the clamp jaw pad material. According to the process shown in FIG. 66B, the temperature of the ultrasonic blade can be varied based on the type of tissue, loading conditions, etc. Additionally, the ultrasonic blade temperature versus time profile can be varied by varying the periods T1-T3. Finally, the ultrasonic blade temperature versus time profile can be varied by varying both the temperature of the ultrasonic blade and the periods T1-T3.

In one embodiment, a tone can be tied to the achievement of a specific temperature threshold for audible surgeon feedback. This improves consistency in advanced hemostatic transection times and hemostasis across a range of tissue types.

67 is a process logic flow diagram 132150 illustrating a control program or logic configuration for controlling ultrasonic blade temperature based on tissue type, according to at least one aspect of the present disclosure. Tissue type can be determined (132152) using techniques described in FIGS. 54-56 under the heading "Jaw Condition Prediction (Pad Burn-Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or in FIGS. 57-65 under the heading "Model-Based Jaw Classification Condition" and/or techniques for predicting ultrasonic blade temperature described in connection with U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," by Nott et al., which is incorporated herein by reference in its entirety. According to this process, a 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 a nominal temperature. The control circuit increases (+) or decreases (-) the temperature of the ultrasonic blade based on the tissue type over a first period T1. The control circuit then decreases the temperature of the ultrasonic blade to a second temperature over a second period T2, suitable for sealing tissue but not suitable for transecting tissue. The control circuit increases (+) or decreases (-) the second temperature based on the detected tissue type. The control circuit increases the temperature of the ultrasonic blade to a third temperature over a third period T3, suitable for transecting tissue but below the melting point of the clamp jaw pad material (e.g., Teflon).

Smart Blades and Power Pulses During surgery using an ultrasonic shearing device, the power delivered to the tissue is set at a predetermined level. This predetermined level is used to transect the tissue throughout the transection procedure. Certain tissues may seal better or cut better/quicker if the power delivered is varied throughout the transection procedure. A solution is needed to vary the power delivered to the tissue through the blade during the transection process. In various aspects, the tissue type and changes to the tissue during the transection process can be determined using the techniques described in FIGS. 54-56 under the heading "Jaw State Prediction (Pad Burn Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or in FIGS. 57-65 under the heading "Model Based Jaw Classification State" and/or techniques for predicting the temperature of the ultrasonic blade are described in connection with U.S. Provisional Patent Application No. 62/640,417 to Nott et al., entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," which is incorporated herein by reference in its entirety.

One solution to better provide ultrasonic transection is to use ultrasonic blade impedance feedback. As previously described, the impedance of the ultrasonic blade is related to the impedance of the electromechanical ultrasonic system and may be determined by measuring the phase angle between the voltage and current signals applied to the ultrasonic transducer as described herein. This technique may be used to measure the magnitude and phase of the impedance of the ultrasonic transducer. The impedance of the ultrasonic transducer may be used to profile factors that may affect the ultrasonic blade during use (e.g., force, temperature, vibration, force over time, etc.). This information may be used to affect the power delivered to the ultrasonic blade during the transection process.

FIG. 68 is a logic flow diagram 132170 of a process illustrating a control program or logic configuration for monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, according to one aspect of the disclosure. According to the process, the control circuit determines (e.g., measures) 132172 the impedance (Z) of the ultrasonic transducer during the tissue transection process. Based on the determined (132172) impedance (Z), the control circuit analyzes and profiles the ultrasonic blade 132174 immediately after the tissue is fully clamped in the jaws of the end effector of the ultrasonic device. The control circuit adjusts 132176 the power output level based on the profile of the ultrasonic blade (e.g., high power for dense tissue, low power for thin tissue). The control circuit controls the generator to momentarily drive the ultrasonic transducer and ultrasonic blade and then shut it off. The control circuit again determines (132172) the impedance (Z) of the ultrasonic blade and profiles (132174) the ultrasonic blade based on the determined (132172) impedance (Z). The control circuit controls the generator to adjust or keep the same output power level based on the ultrasonic blade profile. The control circuit again controls the generator to momentarily drive the ultrasonic transducer and ultrasonic blade and then stop. The process repeats, determining (132172) the impedance (Z), determining (132174) the profile of the ultrasonic blade, adjusting (132176) the power level until the detected impedance profile is that of the clamp arm pad, and then adjusting the power 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. Thus, if the tissue is initially hard and then becomes weak, or if different layers of tissue are encountered during the transection process, the power level can be optimally adjusted to match the profile of the ultrasonic blade. This method can eliminate the need for the user to set the power level. The ultrasonic device adaptively selects the appropriate power level based on the current tissue conditions and the transection process.

This technique provides intelligent control for power level setting based on tissue feedback. This technique can eliminate the need for power setting on the generator, resulting in faster transection times. In one aspect, in an ultrasonic transection medical device that includes a jaw with an ultrasonic blade, the impedance of the ultrasonically driven blade is used to profile the properties of the ultrasonic blade (force, heat, vibration, etc.), which is used to affect the power output of the transducer during the transection process. The power can be pulsed on and off so that changes in the tissue can be read for feedback between pulses, and the power can be adjusted during the transection process.

69A-69D are a series of graphical illustrations of ultrasonic transducer impedance 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 graphical illustration 132180 of ultrasonic transducer impedance versus time. The generator control circuit reads the initial impedance Z1 based on the jaw contents and applies pulsed power P1 to the ultrasonic transducer as shown in FIG. 69B, which is a graphical illustration 132182 of pulsed power versus time. FIG. 69C is a graphical illustration 132184 of new impedance Z2 versus time. The generator control circuit reads the new impedance Z2 and applies pulsed power P2 to the ultrasonic transducer to match the new tissue conditions as plotted in FIG. 69D, which is a graphical illustration 132186 of pulsed power P2 versus time.

Adjusting Complex Impedance to Compensate for Lost Power of an Articulating Ultrasonic Device FIG. 70 is a system 132190 for adjusting the complex impedance of an ultrasonic transducer 132192 to compensate for power lost when the ultrasonic blade 132194 is articulating, in accordance with at least one aspect of the present disclosure. The performance of an articulatable ultrasonic blade 132194 is not consistent across a full articulation angle θ from A to B. For example, as the ultrasonic blade 132194 articulates, power is lost. Knowing the articulation angle θ at which the ultrasonic blade 132194 is at, the generator 132196 or surgical instrument 132199 can adjust the complex impedance (Z) to compensate for the power lost as the ultrasonic blade 132194 articulates. Also, by analyzing the performance of the ultrasonic blade 132194 through its full articulation angle θ, the generator 132196 can execute an algorithm to adjust the complex impedance (Z) to compensate for the power loss.

Techniques for adjusting the complex impedance of the ultrasonic transducer 132192 to compensate for lost power and/or for estimating the temperature of the ultrasonic blade when the ultrasonic blade 132194 can use the techniques described in Figures 54-56 under the heading "Jaw Condition Estimation (Pad Burn-Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or in Figures 57-65 under the heading "Model-Based Jaw Classification Condition" are described in connection with U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," by Nott et al., which is incorporated herein by reference in its entirety.

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 at predetermined angle increments. At each angle increment, activate the ultrasonic transducer 132192 at a therapeutic or non-therapeutic energy level, measure the complex impedance (Z) of the ultrasonic transducer 132192, record a set of complex impedance (Z) measurements, generate a reference complex impedance characteristic pattern or training data set S as a function of the 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 to the reference complex impedance characteristic pattern or training data set S.

The articulatable ultrasonic waveguide 132198 is described in U.S. Patent No. 9,095,367, entitled "Flexible Harmonic Waveguides/Blades For Surgical Instruments," which is incorporated herein by reference. See Figures 47-66B and related discussion. Measurement of articulation angles is described in U.S. Patent No. 9,808,244, entitled "Sensor Arrangements For Absolute Positioning System For Surgical Instruments," which is incorporated herein by reference. See Figures 193-196 and related discussion.

FIG. 71 is a logic flow diagram 132200 of a process illustrating a control program or logic configuration for compensating output power as a function of joint angle according to at least one aspect of the present disclosure. Thus, in conjunction with FIG. 70 in use, the generator 132196 or control circuitry of the instrument determines the joint angle θ of the ultrasonic blade 132194 (132202). The control circuit adjusts the complex impedance (Z) to compensate for the lost power 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).

72 is a system 132210 for measuring the complex impedance of an ultrasonic transducer 132212 in real time to determine the operation being performed by an ultrasonic blade 132214, according to at least one aspect of the present disclosure. Current surgical instruments include three functions (seal + cut, seal only, and spot coagulation). These functions can be performed by activating two buttons. It would be useful if the surgeon could simply press one button to receive either a seal only or spot coagulation algorithm based on the desired operation to be performed. Using ultrasonic spectroscopy, the complex impedance (Z) of the ultrasonic blade 132214 can be measured in real time. The real time measurements can be compared to predefined data to determine which operation is being performed. The different complex impedance (Z) patterns between spot coagulation and seal only allow the generator 132216 to determine which operation is being performed and execute the appropriate algorithm.

Measuring the complex impedance (Z) of the ultrasonic transducer 132212 in real time to determine the operation being performed by the ultrasonic blade 132214 can use the techniques described in Figures 54-56 under the heading "Jaw Condition Estimation (Pad Burn-Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or in Figures 57-65 under the heading "Model-Based Jaw Classification Condition" and/or the techniques for estimating the temperature of the ultrasonic blade are described in connection with U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," by Nott et al., which is incorporated herein by reference in its entirety.

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

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

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

In another aspect, the present disclosure provides a technique for identifying the jaw contents of an ultrasound device. Using this approach, a vessel clamped within the jaws is identified as either a vein or an artery, which can be characterized as a vessel wall and pressure difference. Knowing that the vessel is a vein or an artery, a unique advanced hemostatic cycle for each type can be initiated. Veins require more time and lower temperatures due to thinner vessel walls, so the advanced hemostatic cycle involves lower current and longer time in the vessel sealing portion of the cycle.

Figure 74 is a logical flow diagram 132230 of an adaptive process showing a control program or logical configuration for identifying a hemostatic vessel according to at least one aspect of the present disclosure. According to the process, the generator or instrument control circuitry senses blood vessels located within the jaws of the ultrasonic device (132232) using any of the smart blade algorithm techniques for inferring or classifying the state of the jaws of an ultrasonic device described in connection with FIGS. 54-56 under the heading "Jaw State Inference (Pad Burn Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or FIGS. 57-65 under the heading "Model Based Jaw Classification State", and/or techniques for inferring the temperature of the ultrasonic blade are described in connection with U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR", by Nott et al., which is incorporated herein by reference in its entirety. Once a vein is sensed (132234) or an artery is sensed (132236), the control circuit receives a command to seal either the vein or artery and initiates an advanced hemostasis algorithm based on the type of vessel sensed (132238). In one aspect, the command may be issued by a user from a button located on the instrument to initiate the appropriate advanced hemostasis algorithm. In other aspects, the command may be issued automatically based on the tissue characterization algorithm.

When a vein is sensed (132234), the control circuit executes a first algorithm that allows for slower sealing with lower power levels and lower ultrasonic blade temperatures (132240). Thus, to treat the vein, the control circuit controls the generator to output a 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 (132242) that allows for faster sealing with a higher power level and higher ultrasonic blade temperature. Thus, to treat the artery, the control circuit controls the generator to output a higher power P2 and activates the generator for a shorter time T2.

75 is a graphical illustration 132250 of ultrasound transducer current profiles 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 ultrasound transducer, and the horizontal axis is time (seconds). Referring also to FIG. 74, the first curve 132252 represents a vein, treated with lower power (I1 at P1) and a longer period (T1), and the second curve 132254 represents an artery, treated with higher power (P2 at I2) applied for a shorter period (T2) relative to the first curve 132252.

In another aspect, the present disclosure provides techniques for delivering ultrasonic transducer current (I) in a feedback control loop to achieve a target frequency associated with a desired ultrasonic blade temperature. When sealing a vein, for example, the feedback control loop drives a higher target frequency, corresponding to a cooler ultrasonic blade temperature suitable (and may be ideal) for sealing a vein. An artery is driven to a slightly lower frequency target, associated with a hotter ultrasonic blade temperature.

Figure 76 is a logical flow diagram 132260 of an adaptive process showing a control program or logical configuration for identifying a hemostatic vessel according to at least one aspect of the present disclosure. According to the process, the generator or device control circuitry uses any of the smart blade algorithm techniques for predicting or classifying the state of the jaws of an ultrasonic device described in connection with FIGS. 54-56 under the heading "Jaw State Prediction (Pad Burn-Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or in connection with FIGS. 57-65 under the heading "Model-Based Jaw Classification State" to sense blood vessels in the jaws (132262) and/or to predict the temperature of the ultrasonic blade, as described in connection with U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," by Nott et al., which is incorporated herein by reference in its entirety.

When a vein is sensed (132264), the control circuit executes a first algorithm for providing current to the ultrasonic transducer (132268) to achieve a target sealing temperature of the vein. A 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 an artery is sensed (132266), the control circuit executes a second algorithm for providing current to the ultrasonic transducer (132269) to achieve a target sealing temperature of the artery. A 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.

77 is a graphical illustration 132270 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 time (seconds). The first curve 132272 represents a vein. The vein requires a lower ultrasonic blade temperature to create 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 controls the current delivered to the ultrasonic transducer to maintain the set frequency. The second curve 132274 represents an artery. The artery requires a higher ultrasonic blade temperature to create 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 controls the current delivered to the ultrasonic transducer to maintain the set frequency.

Identifying Calcified Vessels In various aspects, the present disclosure provides various techniques for improving hemostasis in sealing calcified vessels and addresses the challenges in sealing calcified vessels. In one aspect, an ultrasonic instrument is configured to intelligently manage the sealing of calcified vessels. In one aspect, the jaw contents may be identified using the smart blade algorithm techniques for inferring or classifying the condition of the jaws of an ultrasonic device described in connection with Figures 54-56 under the heading "Jaw Condition Prediction (Burn Through Pad, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or Figures 57-65 under the heading "Model Based Jaw Classification Condition" and/or techniques for inferring the temperature of an ultrasonic blade described in connection with U.S. Provisional Patent Application No. 62/640,417 to Nott et al., entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," which is incorporated herein by reference in its entirety. Thus, these techniques may 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 is prompted by a warning from the generator that the jaws are clamped on a calcified vessel and the instrument does not fire. In another aspect, the instrument prompts the user that the jaws are clamping on a calcified vessel and does not allow the instrument to fire until a minimum amount of compression time has elapsed (e.g., 10-15 seconds). This additional time allows the calcification/plaque to migrate away from the transection side and improves hemostasis of the seal. In a third aspect, upon grasping a calcified vessel and pressing the activation button, the instrument uses an internal motor to displace the spring stack an additional amount to deliver a slightly higher clamping force and better compression of the calcified vessel.

FIG. 78 is a logic flow diagram 132280 of a process illustrating a control program or logic configuration for identifying a calcified blood vessel, according to at least one aspect of the present disclosure. According to the process, the generator or instrument control circuitry identifies a blood vessel located within the jaws of the ultrasound device when the jaws clamp on the blood vessel (132282). When the control circuitry identifies a calcified blood vessel (132284), the control circuitry transmits an alert message that can be perceived by a user (132286). The message includes information to inform the user that a calcified blood vessel has been detected. The control circuitry then prompts to maintain compression on the calcified blood vessel for a predetermined waiting period T1 (e.g., x seconds) (132288). This allows the calcification to move away from the jaws. When the compression waiting period T1 expires, the control circuitry enables activation of the ultrasound generator (132290). When the control circuit identifies a "normal (e.g., non-calcified) blood vessel (132292), the control circuit enables normal activation of the ultrasound device (132294). Thus, the ultrasound device can execute one or more hemostasis algorithms as described herein.

FIG. 79 is a logic flow diagram 132300 of a process illustrating a control program or logical configuration for identifying a calcified vessel, according to at least one aspect of the present disclosure. According to the process, the generator or instrument control circuitry identifies a vessel located within the jaws of the ultrasound device when the jaw clamp 132302 clamps on the vessel (132282). When the control circuitry identifies a calcified vessel (132304), the control circuitry transmits a warning message that can be perceived by a user that a calcified vessel has been detected (132306). The control circuitry disables (132308) or does not allow activation of the ultrasound device. When the control circuitry identifies (132310) a "normal" vessel (e.g., not calcified), the control circuitry allows (132312) normal activation of the ultrasound device. Thus, the ultrasound device can execute one or more hemostasis algorithms as described herein.

FIG. 80 is a logic flow diagram 132320 of a process illustrating a control program or logical configuration for identifying a calcified vessel according to at least one aspect of the present disclosure. According to the process, the generator or instrument control circuitry identifies a vessel located within the jaws of the ultrasound device when the jaws clamp on the vessel (132282). When the control circuitry identifies a calcified vessel (132324), the control circuitry sends a warning message that can be perceived by a user that a calcified vessel has been detected (132326). The control circuitry increases the jaw clamping force using a motor to achieve better compression of the calcified vessel (132328). The control circuitry then allows activation of ultrasonic energy after clamping force adjustment (132330). When the control circuitry identifies a "normal" vessel (e.g., not calcified) (132332), the control circuitry allows normal activation of the ultrasound device (132334). Thus, the ultrasound device can execute one or more hemostasis algorithms as described herein.

Detecting Large Vessels During Parenchymal Dissection Using a Smart Blade During liver resection procedures, surgeons risk cutting large vessels because they are buried inside the parenchyma being dissected and therefore cannot be seen. Figures 81-86 of the present disclosure outline an application for a "smart blade" (e.g., an ultrasonic blade with feedback to provide jaw content discrimination) that can detect the difference between the parenchyma and large vessels within the parenchyma by using the magnitude and phase of impedance measurements over a swept frequency range. During a parenchymal tissue dissection procedure, blood vessels can be detected using the smart blade algorithm techniques for inferring or classifying the state of the jaws of an ultrasonic device described in connection with FIGS. 54-56 under the heading "Jaw State Prediction (Burn Through Pad, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or in connection with FIGS. 57-65 under the heading "Model Based Jaw Classification State" and/or techniques for inferring the temperature of an ultrasonic blade described in connection with U.S. Provisional Patent Application No. 62/640,417 by Nott et al., entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," which is incorporated herein by reference in its entirety.

During liver resection and dissection procedures of otherwise vascular parenchymal tissue, the surgeon is unable to see the blood vessels that are substantially buried in the parenchymal tissue along the dissection plane. This can cause the surgeon to cut large vessels without sealing them, resulting in excessive bleeding that causes bleeding to the patient and stress to the surgeon. Figures 81-86 describe a solution that provides a way to detect large vessels buried in the parenchymal tissue without the need to visualize the large vessels using the application of a smart ultrasonic blade.

The ultrasound device described herein may be used to achieve subsequent vascular detection prior to initiating a liver resection and dissection procedure. The generator or ultrasound device control circuitry initiates a frequency sweep from below to above resonance of the electromechanical ultrasound system to allow for impedance magnitude and phase measurements. The results are plotted on a 3D curve as described in connection with Figures 54-56. The resulting 3D curve will have a particular form when the ultrasonic blade is in contact with parenchymal tissue and another form as described below when the ultrasonic blade is in contact with tissue other than parenchymal tissue.

When the ultrasonic blade contacts a large blood vessel, a different 3D curve is generated by the frequency sweep. When the ultrasonic blade contacts a blood vessel, the control circuit compares the test frequency sweep of the new (vessel) curve with the frequency sweep of the old (parenchymal) curve and identifies the new (vessel) curve as different from the old (parenchymal) curve. Based on the comparison, the control circuit enables actions to be taken by the ultrasonic device to prevent cutting into the large blood vessel and to notify the surgeon that a large blood vessel is located on or in contact with the ultrasonic blade.

Various actions that can be taken by the ultrasound device include, but are not limited to, changing the therapeutic output of the device to prevent severing the blood vessel, or changing the tone from the generator to notify the surgeon that a blood vessel has been detected, or a combination of these.

Alternatively, various aspects of this technology may be applied to detect blood if a blood vessel is severed, allowing the surgeon to quickly seal the vessel without seeing the severed vessel.

81 is a diagram 132340 of a liver resection 132350 having a blood vessel 132354 (FIG. 82) embedded 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 cutting into the liver 132348 to form the resection 132350. The ultrasonic instrument 132342 is coupled to a generator 132352 that controls the delivery of energy to the ultrasonic instrument 132342. Either the generator 132252 or the ultrasonic instrument 132342, or both, include control circuitry configured to execute the advanced smart blade algorithms described herein.

82 is a diagram 132356 of an ultrasonic blade 132344 in the process of cutting through parenchymal tissue without contacting a blood vessel 132354 buried within the liver 132348, according to at least one aspect of the present disclosure. During the ablation process, the control circuitry monitors the impedance, magnitude, and phase of the signal driving the ultrasonic transducer to assess the state of the jaws, e.g., the state of the ultrasonic blade 132344, as shown in FIGS. 83A and 83B. Thus, when the ultrasonic blade 132344 ablates the liver 132348, the ultrasonic transducer generates a first response, and when the ultrasonic blade 132344 contacts the buried blood vessel 132354, the ultrasonic transducer generates a second response associated with the type of buried blood vessel 132354, as described herein in connection with FIGS. 54-81.

83A and 83B are graphs 132360 of ultrasound transducer impedance magnitude/phase with parenchymal tissue curve 132362 shown in bold, in accordance with 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 are generated in accordance with FIGS. 54-56, for example, and associated descriptions under the heading "Jaw Condition Prediction (Pad Burn-Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)." Alternatively, the techniques for inferring or classifying the state of the jaws of an ultrasonic device described in connection with FIGS. 57 and 56 under the heading "Model-Based Jaw Classification State" and/or the techniques for inferring the temperature of an ultrasonic blade may be used as described in connection with U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR."

84 is a diagram 132364 of an ultrasonic blade 132344 in the process of cutting through parenchyma to a blood vessel 132354 embedded in a liver 132348 and contacting the blood vessel 132354, according to at least one aspect of the present disclosure. As the ultrasonic blade 132344 transects the parenchyma of the liver 132348, the ultrasonic blade 132344 contacts the blood vessel 132354 at location 132366, thus shifting the resonant frequency of the ultrasonic transducer, as shown in FIGS. 85A and 85B. The control circuitry monitors the impedance, magnitude, and phase of the signal driving the ultrasonic transducer to assess the state of the jaws, e.g., the state of the ultrasonic blade 132344 while contacting the blood vessel 132354, as shown in FIGS. 85A and 85B.

85A and 85B are graphs 132370 of ultrasound transducer impedance magnitude/phase with a large vessel curve 132372 shown in bold, in accordance with 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 are generated in conjunction with FIGS. 54-56 and the associated description under the heading "Inferring Jaw Condition (Pad Burn-Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)." Alternatively, the techniques for inferring or classifying the state of the jaws of an ultrasonic device and/or the techniques for inferring the temperature of an ultrasonic blade described in connection with Figures 57-65, entitled "Model-Based Jaw Classification State", may be used as described in connection with U.S. Provisional Patent Application No. 62/640,417, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR".

Figure 86 is a logic flow diagram 132380 of a process showing a control program or logic configuration for treating tissue in parenchyma when a blood vessel is detected as shown in Figures 84-85B according to at least one aspect of the present disclosure. According to the process, using the techniques for inferring or classifying the state of the jaws of an ultrasonic device described in connection with FIGS. 54-56 under the heading "Jaw State Inference (Burn Through Pad, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or in connection with FIGS. 57-65 under the heading "Model Based Jaw Classification State", and/or for inferring the temperature of an ultrasonic blade, the control circuit determines whether a blood vessel 132354 is located in contact with the ultrasonic device 132344. If the control circuit detects a blood vessel 132382, the control circuit stops the cutting energy (132384), switches to a lower power level (132386), and sends a warning message or alert to the user (132388). For example, the control circuit reduces the excitation voltage/current signal power to a level lower than that required to cut the blood vessel. The warning message or alert may include emitting a light, emitting a sound, activating a buzzer, etc. If a blood vessel 132354 is not detected, the ablation process continues at 132390.

Smart Ultrasonic Blade Applications for Reusable and Disposable Devices The smart blade algorithm uses spectroscopy to identify the status of the ultrasonic blade. This feature can be applied to reusable and disposable devices with a removable clamp arm to identify if the disposable portion of the device is installed correctly. The status of the ultrasonic blade can be determined using the smart blade algorithm techniques for inferring or classifying the state of the jaws of an ultrasonic device described in connection with Figures 54-56 under the heading "Jaw State Inference (Pad Burn Through, Staples, Broken Blade, Bone in Jaw, Tissue in Jaw)" and/or Figures 57-65 under the heading "Model Based Jaw Classification State" and/or techniques for inferring the temperature of the ultrasonic blade are described in connection with U.S. Provisional Patent Application No. 62/640,417 by Nott et al., entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," which is incorporated herein by reference in its entirety.

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

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

The reusable and disposable ultrasonic device 132400 shown in FIG. 87 and FIG. 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 is inserted (132414) into the distal opening 132412 of the reusable handle 132408 and twisted or rotated (132416) clockwise to lock the disposable ultrasonic waveguide/blade 132402 into the handle 132408, as shown in FIG. 87. If the disposable ultrasonic waveguide/blade 132402 is not fully inserted (132414) and/or fully rotated clockwise (132416), the reusable and disposable ultrasonic device 132400 will not operate properly. For example, improper insertion 132414 and rotation 132416 of the disposable ultrasonic waveguide/blade 132402 will result in a mechanical misalignment of the disposable ultrasonic waveguide/blade 132402, producing a different spectroscopic signature. Thus, the smart blade algorithm techniques described herein can be used to determine whether the disposable portion of the reusable and disposable ultrasonic device 132400 has been inserted (132414) and fully rotated (132416).

In another misaligned configuration, when the clamp arm 132404 shown in FIG. 88 is clocked relative to the ultrasonic blade 132402, the orientation of the ultrasonic blade 132402 relative to the clamp arm 132404 will be misaligned. This will also result in different spectroscopic signatures being produced when the reusable and disposable ultrasonic device 132400 is activated and/or clamped. Thus, the smart blade algorithm techniques described herein can be used to determine whether the disposable portion of the reusable and disposable ultrasonic device 132400 is properly clocked relative to the clamp arm 132404.

In another aspect, the smart blade algorithm techniques described herein can be used to determine if the disposable portion of the reusable and disposable ultrasonic device 132400 has been pushed or fully inserted (132414) into the reusable portion 132408. This may be applicable, for example, to the reusable and disposable ultrasonic device 132400 of FIG. 89 below, where the reusable portion, such as the handle 132408, has been inserted (132414) into the disposable portion, such as the ultrasonic blade 132402, prior to operation.

89 is a reusable and disposable ultrasonic device 132420 configured to identify the status of the ultrasonic blade 132422 and determine if the clamp arm 132424 is not fully distal to determine if the disposable portion 132426 of the reusable and disposable ultrasonic device 132420 is properly installed, according to at least one aspect of the present disclosure. If the clamp arm is not fully distally installed, there will be a different spectroscopic signature when the device is clamped. In another aspect, if the disposable portion 132426 is not fully distally installed on the reusable component 132428, the spectroscopic signature of the ultrasonic blade 132422 will be different when clamped in place. Thus, the smart blade algorithm techniques described herein can be 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.

90 is a process logic flow diagram 132430 illustrating a control program or logic configuration for identifying the status of a configuration of reusable and disposable ultrasound devices according to at least one aspect of the present disclosure. According to the process illustrated by the logic flow diagram 132430, the generator or instrument control circuitry executes the Smart Blade algorithm technique to determine a spectroscopic signature 132432 of an assembled reusable and disposable ultrasound device 132400, 132420 (FIGS. 88 and 89) including reusable and disposable components. The control circuitry compares (132434) the measured spectroscopic signature to a reference spectroscopic signature, which is associated with a properly assembled reusable and disposable ultrasound device 132400, 132420 and stored in a database or memory of the generator or instrument. If the control circuitry determines that the measured spectroscopic signature differs from the reference spectroscopic signature (132436), the control circuitry disables operation of the reusable and disposable ultrasound devices 132400, 132420 (132438) and generates an alert that may be perceived by a user (132440). The tapering may include activating a source sound or vibration source. If the measured spectroscopic signature is the same or substantially similar to the reference spectroscopic signature, the control circuitry enables normal operation of the reusable and disposable ultrasound devices 132400, 132420 (132442).

Live-time tissue classification using electrical parameters, sealing without cutting, combined RF/ultrasound techniques, tailored algorithms In one aspect, the present disclosure provides algorithms for classifying tissues into groups. The ability to classify tissues in live-time allows the algorithm to be tailored for specific tissue groups. The tailored algorithm can adjust sealing time and hemostasis across all tissue types. In one aspect, the present disclosure provides sealing algorithms to provide the hemostasis required for large vessels and quickly seal smaller structures that do not require extended energy activation. The ability to classify these distinct tissue types allows for optimized algorithms for each group in live-time.

In this aspect, during the first 0.75 seconds of the run, three RF electrical parameters are used in the plot to classify the tissues into distinct groups. These electrical parameters are the initial RF impedance (taken at 0.15 seconds), the minimum RF impedance in the first 0.75 seconds, and the amount of time in milliseconds that the RF impedance slope is approximately 0. Other times at which these data points are taken can be implemented. All of this data is collected for a set amount of time, and then a Support Vector Machine (SVM) or another classification algorithm can be used to classify the tissues into distinct groups by live time. Each tissue group has an algorithm specific to the algorithm that will be implemented for the remainder of the run. Types of SVM include linear, polynomial, and radial basis functions (RBF).

FIG. 91 is a three-dimensional graphical representation 132450 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 represents the amount of time that the derivative of the tissue's RF impedance (Z) is about zero. FIG. 91 illustrates the grouping of large vessels 132452, e.g., carotid artery - thick tissue, and small vessels 132454, e.g., thymus - thin tissue, using three RF parameters: initial RF impedance, minimum RF impedance, and the amount of time that the derivative (slope) of the RF impedance is about zero within the first 0.75 seconds of activation. A feature of this classification method is that tissue types can be classified within a set amount of time. An advantage of this method is that tissue-specific algorithms can be selected toward the beginning of activation so that specialized tissue treatments can be initiated before exiting the RF bath. In the context of tissue impedance under the influence of RF energy, the bathtub region will be understood to be the curve where tissue impedance drops after the initial application of RF energy and stabilizes until the tissue begins to dry. Thereafter, tissue impedance increases. Thus, the impedance versus time curve resembles the shape of a "bathtub."

Using this data, we trained and tested a support vector machine to group thick and thin tissues, correctly classifying them 94% of the time.

In one aspect, the present disclosure provides a device that includes one combined RF/ultrasound algorithm that is used for all tissue types, identifying that sealing speeds for thin tissues are longer than necessary, while larger vessels and thicker structures can benefit from extended actuation. This classification scheme allows the combined RF/ultrasound device to seal small structures with optimal speed and burst pressure, and to seal larger structures to achieve maximum hemostasis.

92 is a three-dimensional graphical representation 132460 of an 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 amount of time the derivative of the tissue's RF impedance (Z) is approximately zero. To determine whether this classification model of thin tissue 132464 vs. thick tissue 132462 is robust to different tissue types, data was added for various benchtop tissue types and the tissues were grouped into two separate groups. It is possible to separate this data into multiple groups if deemed beneficial or necessary. Different thickness tissue 132462 types include, for example, carotid, jejunal, mesenteric, cervical, and liver tissue. Different thin tissue 132464 types include, for example, thyroid and thyroid vein.

Micro-Dissection Modes for Tissue Classification Tissue Classification Allows for Multiple Modes for Considerations of Different Surgical Procedures In one aspect, the present disclosure provides algorithms for classifying tissue into groups and tailoring algorithms for live-time classification of specific tissue classes. The present disclosure builds upon the foundations and details of another potential advantage to classifying tissue as previously described herein under the heading "Live-time Tissue Classification Using Electrical Parameters."

FIG. 93 is a graphical illustration 132470 of carotid technique sensitivity where the time at which the RF impedance (Z) derivative is approximately zero is plotted as a function of initial RF impedance, according to at least one aspect of the present disclosure. Different surgical techniques exist in different parts of the world and are known to vary greatly from surgeon to surgeon. For this reason, technique modes may be provided on the generator to allow for more efficient energy delivery based on the user's particular surgical technique, such as, for example, tip bite of tissue versus full bite of tissue. Tip bite refers to the end effector of the surgical device grasping tissue only at the tip. Full bite refers to the end effector of the surgical device grasping tissue within the entire end effector. The generator may be configured to detect whether the user is consistently operating at tip bite of tissue or full bite of tissue. As shown in FIG. 93, initial RF impedance data was measured and plotted for tip bite as group 1 132472 and full bite as group 2 132474. As shown, the apical bite of tissue group 1 132472 registers an initial RF impedance Z _Init of less than 250 ohms, and the full bite of tissue group 2 132474 registers an initial impedance Z _Init between 250 ohms and 500 ohms, maximum RF tissue impedance Z _Max . Upon detecting whether the user is gripping the apical bite of tissue or the full bite of tissue, the algorithm can suggest a predefined dissection mode. For example, in the case of apical bite of tissue, the algorithm may suggest a fine dissection mode to the user, or this option may be selected prior to the procedure. For example, in the case of full bite of tissue, the algorithm may suggest a course dissection mode to the user, or this option may be selected prior to the procedure. In the fine dissection mode, the algorithm may be tuned to optimize the energy delivery of this surgical technique by lowering the ultrasonic displacement to protect the clamp arm pads from burn-through. It is also known that apical bite has a greater amount of RF noise, causing longer seal times and greater variation in seal performance. The tip bite cold fine incision mode has a tuned algorithm to have a lower RF termination impedance and/or a different filtered signal to increase the accuracy of energy delivery.

A technique sensitivity analysis was performed as part of the classification development work. Testing was performed by transecting 3-7 mm vessels in a bench-top setting using different surgical techniques such as full occlusal lateral incision with or without tension, and apical occlusal incision with or without tension. Initial RF impedance, and time RF impedance of gradient = 0 were all examined as significant factors in classifying tissues into groups.

It has been determined that surgical techniques can be grouped into three distinct groups based on the initial RF impedance Z _Init : an initial RF impedance Z _Init in the range of 0-100 ohms generally indicates operation in a blood flow 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 use situations specifically where tension is present.

Controlled Thermal Management (CTM) for pad protection
In one aspect, the present disclosure provides a controlled thermal management (CTM) algorithm for regulating temperature using feedback control. The output of the feedback control can be used to prevent burn-through of the clamp arm pads of an ultrasonic end effector, which is not a desired effect for ultrasonic surgical instruments. As discussed above, pad burn-through is generally caused by the continued application of ultrasonic energy to an ultrasonic blade in contact with the pad after tissue grasped within the end effector has been transected.

The CTM algorithm takes advantage of the fact that the resonant frequency of an ultrasonic blade, typically made from titanium, changes proportionally with temperature. As temperature increases, the elastic modulus of the ultrasonic blade decreases, and the natural frequency of the ultrasonic blade also decreases. A factor to consider is that if the distal end of the ultrasonic blade is hot, but the waveguide is cold, there will be a different frequency difference (delta) to achieve a given temperature than if both the distal end of the ultrasonic blade and the waveguide are hot.

In one aspect, the CTM algorithm calculates the change in frequency of the ultrasonic transducer drive signal required to reach a particular predetermined temperature as a function of the resonant frequency of the ultrasonic electromechanical system at the beginning of startup (at lock). The ultrasonic electromechanical system, which comprises an ultrasonic transducer coupled to an ultrasonic blade by an ultrasonic waveguide, has a predetermined resonant frequency that varies with temperature. The resonant frequency of the ultrasonic electromechanical system at lock can be used to infer the change in ultrasonic transducer drive frequency required to achieve the cause and temperature endpoint given the initial thermal state of the ultrasonic blade. The resonant frequency of the ultrasonic electromechanical system can vary as a function of the temperature of the ultrasonic transducer, or ultrasonic waveguide, or ultrasonic blade, or a combination of these components.

94 is a graphical representation 133300 of the relationship between the initial resonant frequency (frequency at lock) and the change in frequency (delta frequency) required to achieve a temperature of approximately 340° C., in accordance with at least one aspect of the present disclosure. The change in frequency required to reach an ultrasonic blade temperature of approximately 340° C. is shown along the vertical axis, and the resonant frequency of the electromechanical ultrasonic system at lock is shown along the horizontal axis. Based on the measured data points 133302 shown as a scatter plot, a linear relationship 133304 exists between the change in frequency required to reach an ultrasonic blade temperature of approximately 340° C. and the resonant frequency at lock.

At resonant frequency lock, the CTM algorithm uses a linear relationship 133304 between the lock frequency and the delta frequency required to achieve a temperature just below the melting point of the TEFLON pad (approximately 340° C.). As shown in FIG. 95, once the frequency is within a certain buffer distance from the lower frequency limit, the feedback control system 133310 comprising the ultrasonic generator 133312 adjusts the current (i) setpoint applied to the ultrasonic transducer of the ultrasonic electromechanical system 133314 to prevent the frequency (f) of the ultrasonic transducer from dropping below a predetermined threshold, in accordance with at least one aspect of the present disclosure. Reducing the current setpoint reduces the displacement of the ultrasonic blade, which in turn reduces the temperature of the ultrasonic blade and increases the natural frequency of the ultrasonic blade. This relationship allows changes in the current applied to the ultrasonic transducer to adjust the natural 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 as an ultrasonic generator, for example, as described with reference to Figures 21, 26, 27A-27C, and 28A-28B. The feedback control system 133310 may be implemented as a PID controller, for example, as described with reference to Figures 44-45.

96 is a flow diagram 133320 of a process or logical configuration 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. The process or logical configuration illustrated by the flow diagram 133320 may be performed by an ultrasonic generator 133312 described herein, or by a control circuit located in the ultrasonic instrument, or a combination thereof. As described above, the generator 133312 may be implemented as a generator described with reference to, for example, FIGS. 21, 26, 27A-C, and 28A-B.

In one aspect, the control circuitry in the generator 133312 first activates the ultrasonic instrument by applying a current to the ultrasonic transducer. The resonant frequency of the ultrasonic electromechanical system is initially locked at an initial state where the ultrasonic blade temperature is low or close to room temperature. As the temperature of the ultrasonic blade increases, for example due to frictional contact with tissue, the control circuitry monitors the change or delta in the resonant frequency of the ultrasonic electromechanical system and determines whether a delta frequency threshold for a given blade temperature has been reached (133324). If the delta frequency falls below the threshold, the process proceeds along the "no" branch and the control circuitry continues to search for a new resonant frequency (133325) and monitor the delta frequency. If 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 pads (133326). In one non-limiting example, the clamp arm pads are made of TEFLON, which has a melting point of approximately 340°C.

Once the new lower frequency limit is calculated (133326), the control circuit determines whether 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 is above the low frequency limit, the process proceeds along the “No” branch and applies a normal level of current to the ultrasonic transducer suitable for tissue transection (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 a PID controller, for example as described with reference to FIGS. 44-45. The control circuit adjusts the frequency in a loop (133332) to determine when the frequency is approaching a lower limit until the "seal and cut" surgical procedure is terminated and the ultrasonic transducer is deactivated (133328). Because the CTM algorithm illustrated by logic flow diagram 133320 only has an effect at or near the melting point of the clamp arm pads, the CTM algorithm is activated after the tissue is transected.

Burst pressure testing performed on samples indicates that when the CTM process or logic configuration illustrated by logic flow diagram 133320 is used to seal and cut blood vessels or other tissue, there is no effect on the burst pressure of the seal. Additionally, based on the test samples, transection time was affected. Additionally, temperature measurements confirm that the ultrasonic blade temperature was bounded by the CTM algorithm compared to a device without CTM feedback algorithm control, a device experiencing 10 shots at full power in 10 seconds against the pad with 5 seconds of rest between shots experienced significantly reduced pad wear, and a device without CTM algorithm feedback control did not survive more than 3 shots in this abuse test.

97 is a graph 133340 of temperature versus time comparing the desired temperature of an ultrasonic blade with a smart ultrasonic blade and a conventional ultrasonic blade, in accordance with 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 a temperature threshold 133342 representing the desired temperature of the ultrasonic blade. The solid line is a temperature versus 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 a temperature versus time curve 133346 of a standard ultrasonic blade not under the control of the CTM algorithm described with reference to Figs. 95 and 96. As shown. Once the temperature of the smart ultrasonic blade under the control of the CTM algorithm exceeds the desired temperature threshold (approximately 340°C), the CTM algorithm takes control and controls the temperature of the smart ultrasonic blade to match the threshold as closely as possible until the transection procedure is completed and power to the ultrasonic transducer is stopped or shut off.

In another aspect, the present disclosure provides a CTM algorithm for a "seal only" tissue effect with an ultrasonic device, such as an ultrasonic shear. Generally speaking, ultrasonic surgical instruments typically seal and cut tissue simultaneously. Creating an ultrasonic device configured to only seal without cutting has not been difficult to accomplish using ultrasonic technology alone, due to the uncertainty of knowing when sealing will be completed before cutting begins. In one aspect, the CTM algorithm may be configured to protect the clamp arm pads of the end effector by allowing the temperature of the ultrasonic blade to exceed the temperature required to cut (transect) the tissue, but not exceed the melting point of the clamp arm pads. In another aspect, the seal only algorithm of the CTM may be adjusted to exceed the sealing temperature of the tissue (about 115°C to about 180°C based on experiments), but not exceed the cutting (transecting) temperature of the tissue (about 180°C to about 350°C). In the latter configuration, the seal only algorithm of the CTM provides a successfully demonstrated "seal only" tissue effect. For example, in the linear fit calculating the change in frequency relative to the initial lock frequency shown in FIG. 94, varying the intercept of the fit adjusts the final steady state temperature of the ultrasonic blade. By adjusting the intercept parameter, the ultrasonic blade can be set to never exceed about 180° C., resulting in a tissue seal but not cutting. In one aspect, since the temperature of the blade is controlled by the CTM's Seal Only algorithm, increasing the clamp force can improve the sealing process without affecting the burn-through of the clamp arm pad. As mentioned above, the CTM's Seal Only algorithm may be implemented by the generator and PID controller described with reference to, for example, FIGS. 21, 26, 27A-C, 28A-B, and 44-45. Thus, the flow diagram 133320 shown in FIG. 96 may be modified so that the control circuit calculates a new low frequency limit (133326) (where threshold t corresponds to a "seal only" temperature, e.g., about 180° C.), determines when the frequency is approaching the lower limit (133328), and adjusts the temperature (133332) until the "seal only" surgical procedure is completed and the ultrasonic transducer is turned off.

In another aspect, the present disclosure provides a cryo-thermal monitoring (CTMo) algorithm configured to detect when atraumatic grasping 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 transecting tissue. Because heat is retained within the metal body of the ultrasonic blade for a period of time after the ultrasonic transducer is turned off, residual heat stored in the ultrasonic blade can cause tissue damage if the ultrasonic end effector is used to grasp tissue before the ultrasonic blade has a chance to cool.

In one aspect, the CTMo algorithm calculates the change in the natural frequency of the ultrasonic electromechanical system from the natural frequency at a high temperature state to the natural frequency at a temperature where atraumatic grasping is feasible without damaging the tissue grasped by the end effector. A non-therapeutic signal (about 5 mA) is applied to the ultrasonic transducer, either directly or for a predetermined period of time after activating the ultrasonic transducer, including a bandwidth of frequencies where the natural frequency is expected to be found, for example, about 48,000 Hz to 52,000 Hz. An FFT algorithm, or other mathematically valid algorithm for detecting the natural frequency of the ultrasonic electromechanical system, of the impedance of the ultrasonic transducer measured while stimulating the ultrasonic transducer with the non-therapeutic signal, indicates the natural frequency of the ultrasonic blade as the frequency at which the magnitude of the impedance is minimum. Continuous stimulation of the ultrasonic transducer in this manner provides continuous feedback of the natural frequency of the ultrasonic blade within the frequency resolution of the FFT or other algorithm for inferring or measuring the natural frequency. When a change in the natural frequency corresponding to the temperature at which an atraumatic grasp is achievable is detected, the device provides a tone, or LED, or screen display, or other form of notification, or a combination thereof, to indicate that an atraumatic grasp is possible.

In another aspect, the present disclosure provides a CTM algorithm configured to adjust for sealing and end of cut or transection. Providing notification of "tissue seal" and "end of cut" is a challenge for conventional ultrasonic devices because temperature measurements cannot be easily attached directly to the ultrasonic blade and the clamp arm pads are not clearly detected by the blade using sensors. The CTM algorithm can indicate the temperature state of the ultrasonic blade and can be used to indicate "end of cut" or "tissue seal" or both conditions since these are temperature based events.

In one aspect, a CTM algorithm according to the present disclosure detects an "end of cut" condition and initiates a notification. Tissue typically cuts at about 210°C to about 320°C with a high probability. The CTM algorithm can initiate a tone at 320°C (or the like) to indicate that the tissue has likely been cut and that further activations on the tissue would not be productive since the ultrasonic blade is now running against the clamp arm pad, which is acceptable while the CTM algorithm is operating since the CTM algorithm is controlling the temperature of the ultrasonic blade. In one aspect, once the CTM algorithm estimates that the temperature of the ultrasonic blade has reached 320°C, it is programmed to control or adjust the power to the ultrasonic transducer to maintain the temperature of the ultrasonic blade at about 320°C. Initiating the tone at this point provides an indication that the tissue has been cut. The CTM algorithm is based on the variation of frequency with temperature. After determining the initial state temperature (based on the initial frequency), the CTM algorithm can calculate a frequency change corresponding to a temperature that indicates when the tissue has been cut. For example, if the starting frequency is 51,000 Hz, the CTM algorithm calculates the change in frequency needed to reach 320°C, which may be -112 Hz. The CTM algorithm then initiates control to maintain that frequency set point (e.g., 50,888 Hz), thereby regulating the temperature of the ultrasonic blade. Similarly, a frequency change can be calculated based on the initial frequency to indicate when the ultrasonic blade is at a temperature that indicates the tissue has likely been cut. At this point, the CTM algorithm does not need to control the power, but can simply initiate a tone to indicate the state of the tissue, or, if desired, the CTM algorithm can control the frequency at this point to maintain that temperature. Either way, the "end of cut" is indicated.

In one aspect, the CTM algorithm according to the present disclosure detects a "tissue seal" condition and initiates a notification. Similar to detecting the end of cutting, tissue seals at about 105°C to about 200°C. The frequency change from the initial frequency required to indicate that the ultrasonic blade temperature has reached 200°C, indicating a seal-only condition, can be calculated at the beginning of ultrasonic transducer activation. The CTM algorithm can initiate a tone at this point, and if the surgeon wishes to obtain a seal-only condition, the surgeon may stop activation, or if the surgeon wishes to achieve a seal-only condition, the surgeon may stop ultrasonic transducer activation and automatically initiate a particular seal-only algorithm from this point, or the surgeon may continue ultrasonic transducer activation to achieve a tissue cut condition.

98, there is shown a timeline 5200 illustrating the situational awareness of a hub, such as, for example, the surgical hub 106 or 206. The timeline 5200 illustrates an exemplary surgical procedure and the contextual information that the surgical hub 106, 206 can derive from data received from data sources at each step of the surgical procedure. The timeline 5200 illustrates typical steps that may be taken by nurses, surgeons, and other medical personnel during the course of a lung segmentectomy surgery, beginning with setting up the operating room and ending with transporting the patient to a post-operative recovery room.

The situation-aware surgical hub 106, 206 receives data from data sources throughout the course of a surgical procedure, including data generated each time medical personnel use a modular device paired with the surgical hub 106, 206. The surgical hub 106, 206 receives this data from the paired modular devices and other data sources to continually derive inferences (i.e., context information) regarding the ongoing procedure as new data is received, such as which steps of the procedure are being performed at any given time. The situation-aware system of the surgical hub 106, 206 can, for example, record data regarding the procedure to generate a report, verify steps being taken by medical personnel, provide data or prompts (e.g., via a display screen) that may be relevant to a particular procedure step, adjust the modular device based on the context (e.g., activate a monitor, adjust the field of view (FOV) of a medical imaging device, or change the energy level of an ultrasonic surgical instrument or an RF electrosurgical instrument), and any other such actions described above.

As a first step 5202 in this exemplary procedure, hospital personnel retrieve the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a thoracic procedure.

In a second step 5204, the personnel scans the incoming medical supplies for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with a list of supplies utilized in various types of procedures to verify that the mix of supplies is compatible with the thoracic procedure. Additionally, the surgical hub 106, 206 may also determine that the procedure is not a wedge procedure (either because the incoming supplies do not include certain supplies required for a thoracic wedge procedure or are not otherwise compatible with a thoracic wedge procedure).

In a third step 5206, medical personnel scan the patient's band via a scanner communicatively connected to the surgical hub 106, 206. The surgical hub 106, 206 can then verify the patient's identity based on the scanned data.

In a fourth step 5208, the medical personnel turns on the auxiliary devices. The auxiliary devices utilized may vary according to the type of surgical procedure and the technology used by the surgeon, but in this exemplary case, they include smoke evacuators, aspirators, and medical imaging devices. Once activated, the auxiliary device, which is a modular device, may automatically pair with the surgical hub 106, 206 located within a particular proximity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive contextual information regarding the surgical procedure by detecting the type of modular device that is paired with it during this pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on a combination of data from the patient's EMR, a list of medical supplies used in the procedure, and the type of modular devices that connect to the hub, the surgical hub 106, 206 may roughly estimate the particular procedure that the surgical team will be performing. Once the surgical hub 106, 206 knows what particular procedure is being performed, it can then retrieve the steps of that procedure from memory or from the cloud and then cross-reference data subsequently received from connected data sources (e.g., modular devices and patient monitors) to extrapolate which steps of the surgical procedure the surgical team is performing.

In a fifth step 5210, personnel attach EKG electrodes and other patient monitoring devices to the patient. The EKG electrodes and other patient monitoring devices may be paired with the surgical hub 106, 206. Once the surgical hub 106, 206 begins receiving data from the patient monitoring devices, the surgical hub 106, 206 confirms that the patient is in the operating room.

In a sixth step 5212, medical personnel induce anesthesia in the patient. The surgical hub 106, 206 can estimate that the patient is under anesthesia based on data from the modular devices and/or patient monitoring devices, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Once the sixth step 5212 is completed, the pre-operative portion of the lung segmentectomy surgery is complete and the operative portion begins.

In a seventh step 5214, the patient's lung being operated on is collapsed (while ventilation is switched to the contralateral lung). The surgical hub 106, 206 can, for example, infer from ventilator data that the patient's lung has been collapsed. Because the surgical hub 106, 206 can compare the detection of the patient's lung being collapsed to the expected steps of the procedure (which may be accessed or read in advance), it can infer that the surgical portion of the procedure has begun, thereby determining that collapsing the lung is the first surgical step in this particular procedure.

In an eighth step 5216, a medical imaging device (e.g., a scope) is inserted and video feed from the medical imaging device is initiated. The surgical hub 106, 206 receives the medical imaging device data (i.e., video or image data) through a connection to the medical imaging device. Upon receiving the medical imaging device data, the surgical hub 106, 206 may determine that the laparoscopic portion of the surgical procedure has begun. Additionally, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmentectomy as opposed to a lobectomy (note that the wedge procedure has already been discounted by the surgical hub 106, 206 based on the data received in the second step 5204 of the procedure). Data from the medical imaging device 124 (FIG. 2) may be used to determine contextual information regarding the type of procedure being performed among many different methods, including by determining the angle at which the medical imaging device is oriented with respect to visualization of the patient's anatomy, by monitoring the number or medical imaging devices being used (i.e., activated and paired with the surgical hub 106, 206), and by monitoring the type of visualization device being used. For example, one technique for performing a VATS lobectomy places the camera above the diaphragm in the anterior inferior corner of the patient's thoracic cavity, while one technique for performing a VATS segmentectomy places the camera in an anterior intercostal position relative to the segmental fissure. For example, using pattern recognition or machine learning techniques, a situational awareness system may be trained to recognize the location of the medical imaging device based on visualization of the patient's anatomy. As another example, one technique for performing a VATS lobectomy utilizes a single medical imaging device, while another technique for performing a VATS segmentectomy utilizes multiple cameras. As yet another example, one technique for performing a VATS segmentectomy uses an infrared light source (which may be communicatively coupled to the surgical hub as part of a visualization system) to visualize the segmental fissure, which is not used in a VATS lobectomy. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can determine the particular type of surgical procedure being performed and/or the technique being used for the particular type of surgical procedure.

At a ninth step 5218, the surgical team begins the dissection step of the procedure. Because the surgical hub 106, 206 receives data from the RF or ultrasonic generator indicating that an energy instrument is being fired, it can infer that the surgeon is in the process of dissecting and separating the patient's lungs. The surgical hub 106, 206 can cross-reference the received data with the retrieved steps of the surgical procedure to determine that the energy instrument being fired at this point in the process (i.e., after the steps of the procedure described above have been completed) corresponds to the dissection step. In a particular example, the energy instrument can be an energy tool attached to a robotic arm of a robotic surgical system.

At a tenth step 5220, the surgical team proceeds to the ligation step of the procedure. Because the surgical hub 106, 206 receives data from the surgical stapling and severing instrument indicating that the instrument is being fired, the surgical hub 106, 206 can infer that the surgeon is ligating the artery and vein. As with the previous step, the surgical hub 106, 206 can derive this inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the steps in the retrieved process. In a particular example, the surgical instrument may be a surgical tool attached to a robotic arm of a robotic surgical system.

In an eleventh step 5222, the segmental resection portion of the procedure is performed. The surgical hub 106, 206 can infer that the surgeon is transecting parenchymal tissue based on data from the surgical stapling and cutting instrument, including data from its cartridge. The cartridge data can correspond to, for example, the size or type of staples fired by the instrument. Because different types of staples are utilized on different types of tissue, the cartridge data can indicate the type of tissue being stapled and/or transected. In this case, the type of staples fired is utilized on parenchymal tissue (or other similar tissue type), which allows the surgical hub 106, 206 to infer that the segmental resection portion of the procedure is being performed.

Then, in a twelfth step 5224, a node dissection step is performed. The surgical hub 106, 206 may infer that the surgical team is dissecting the node and performing a leak test based on data received from the generator indicating that an RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasonic instrument used after the parenchymal tissue is transected corresponds to the node dissection step, which allows the surgical hub 106, 206 to make this inference. It should be noted that the surgeon will periodically alternate between the surgical stapling/cutting instrument and the surgical energy (i.e., RF or ultrasonic) instrument depending on the particular step during the procedure, as different instruments are better suited for certain tasks. Thus, the particular sequence in which the stapling/cutting instrument and the surgical energy instrument are used may indicate which step of the procedure the surgeon is performing. Additionally, in certain instances, a robotic tool may be used for one or more steps during the surgical procedure, and/or a handheld surgical instrument may be used for one or more steps during the surgical procedure. The surgeon(s) can, for example, alternate between the robotic tool and the handheld surgical instrument and/or can, for example, use the devices simultaneously. Once the twelfth step 5224 is completed, the incision is closed and the post-operative portion of the procedure begins.

In a thirteenth step 5226, the patient's anesthesia is reversed. The surgical hub 106, 206 can estimate that the patient is emerging from anesthesia, for example, based on ventilator data (i.e., the patient's breathing rate begins to increase).

Finally, the fourteenth step 5228 is for the medical personnel to remove the various patient monitoring devices from the patient. Thus, the surgical hub 106, 206 can presume that the patient is being transferred to a recovery room when the hub loses EKG, BP, and other data from the patient monitoring devices. As can be seen from this exemplary procedure description, based on data received from various data sources communicatively coupled to the surgical hub 106, 206, the surgical hub 106, 206 can determine or presume when each step of a given surgical procedure is occurring.

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

While several embodiments have been illustrated and described, it is not the applicant's intention to restrict or limit the appended "claims" to such details. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these embodiments can be implemented and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described embodiments can alternatively be described as a means for providing the function performed by that element. Also, although materials are disclosed with respect to specific components, other materials may be used. It is therefore to be understood that the above description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

The above detailed description has described various forms of apparatus and/or processes using block diagrams, flow charts, and/or examples. To the extent that such block diagrams, flow charts, and/or examples include one or more functions and/or operations, it will be understood by those skilled in the art that each function and/or operation included in such block diagrams, flow charts, and/or examples can be implemented individually and/or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will understand that all or a portion of some aspects of the embodiments disclosed herein can be equivalently implemented on an integrated circuit as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or virtually any combination thereof, and that designing circuits and/or writing software and/or firmware code is within the skill of those skilled in the art in view of the present disclosure. Moreover, those skilled in the art will appreciate that the subject matter described herein may be distributed as one or more program products in a variety of formats, and that the specific form of the subject matter described herein may be used regardless of the particular type of signal-bearing medium used to actually effect the distribution.

The instructions used to program the logic to perform the various disclosed aspects may be stored in a system memory such as dynamic random access memory (DRAM), cache, flash memory, or other storage. Additionally, the instructions may be distributed over a network or by other computer-readable media. Thus, a machine-readable medium may include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to floppy diskettes, optical disks, compact disks, read-only memories (CD-ROMs), as well as magneto-optical disks, read-only memories (ROMs), random access memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memories, or tangible machine-readable storage used to transmit information over the Internet via electrical, optical, acoustic, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, non-transitory computer-readable media includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

As used in any aspect of this specification, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor, processing unit, processor, microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (FPGA) including one or more individual instruction processing cores), state machine circuitry, firmware that stores instructions executed by the programmable circuitry, and any combination thereof. The control circuitry may be embodied, collectively or individually, as circuits that form part of a larger system, such as, for example, an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, a "control circuit" includes, but is not limited to, an electrical circuit having at least one discrete electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application specific integrated circuit, an electrical circuit forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially executes the processes and/or devices described herein, or a microprocessor configured by a computer program that at least partially executes the processes and/or devices described herein), an electrical circuit forming a memory device (e.g., a form of random access memory), and/or an electrical circuit forming a communication device (e.g., a modem, a communication switch, or an optical-electrical facility). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.

As used in any aspect of this specification, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions, or instruction sets, and/or hard-coded (e.g., non-volatile) data in a memory device.

When used in any aspect of this specification, the terms "component," "system," "module," etc. may refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.

As used in any aspect of this specification, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result, and the "steps" refer to the manipulation of physical quantities and/or logical states, which may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities or are merely convenient labels applied to these quantities and/or states.

The network may include a packet-switched network. The communication devices may communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include an Ethernet communication protocol that may enable communication using Transmission Control Protocol/Internet Protocol (TCP/IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" issued in December 2008 by the Institute of Electrical and Electronics Engineers (IEEE), and/or later versions of this standard. Alternatively or additionally, the communication devices may communicate with each other using the X.25 communication protocol. The T.25 communication protocol may conform to or be compatible with standards promulgated by the International Telecommunications Union-Telecommunications Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may communicate with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published by the ATM Forum in August 2001, entitled "ATM-MPLS Network Interworking 2.0," and/or any later version of this standard. Of course, different and/or later developed connection-oriented network communication protocols are equally contemplated herein.

Unless expressly specified otherwise, as will be apparent from the foregoing disclosure, discussions throughout the foregoing disclosure using terms such as "processing," "calculating," "computing," "determining," and "displaying" will be understood to refer to the operations and processing of a computer system or similar electronic computing device that manipulates and converts data represented as physical (electronic) quantities in the registers and memory of the computer system into other data similarly represented as physical quantities in the memory or registers of the computer system or such information storage, transmission, or display devices.

One or more components may be referred to herein as being "configured to," "configurable to," "operable/operative to," "adapted/adaptable," "able to," "conformable/conformed to," and the like. Those skilled in the art will understand that "configured to" may generally encompass active and/or inactive and/or standby components, unless the context requires otherwise.

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

Those skilled in the art will understand that the terms used herein generally, and in the appended claims in particular (e.g., the body of the appended claims), are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). Furthermore, those skilled in the art will understand that where a specific number is intended in an introduced claim recitation, such intent is clearly set forth in the claim, and in the absence of such a recitation, no such intent exists. For example, as an aid to understanding, the appended claims may include the introductory phrases "at least one" and "one or more" to introduce the claim recitation. However, the use of such phrases should not be construed as implying that when a claim recitation is introduced by the indefinite article "a" or "an," any particular claim containing such an introduced claim recitation is limited to claims containing only one such recitation, even if the same claim contains an introductory phrase such as "one or more" or "at least one" and the indefinite article "a" or "an" (e.g., "a" and/or "an" should generally be construed to mean "at least one" or "one or more"). The same applies when a definite article is used to introduce a claim recitation.

Furthermore, even when a specific number is specified in an introduced claim description, those skilled in the art will recognize that such a description should typically be interpreted to mean at least the number recited (e.g., a description of "two items" without other qualifiers generally means at least two items, or more than two items). Furthermore, when a notation similar to "at least one of A, B, and C, etc." is used, such syntax is generally intended in the sense that a person skilled in the art would understand the notation (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and/or all of A, B, and C, etc.). When a notation similar to "at least one of A, B, or C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art would understand the notation (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and/or all of A, B, and C, etc.). Furthermore, one of ordinary skill in the art will understand that any disjunctive word and/or phrase that typically expresses two or more alternative terms should be understood to contemplate the possibility of including one of those terms, either of those terms, or both of those terms, unless the context requires otherwise, whether in the specification, claims, or drawings. 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 recited operations herein may generally be performed in any order. Also, while flow diagrams of various operations are shown in sequence(s), it should be understood that the various operations may be performed in orders other than those illustrated, or may be performed simultaneously. Examples of such alternative orderings may include overlapping, interleaving, interrupting, reordering, incremental, preliminary, additional, simultaneous, reverse, or other different orderings, unless the context requires otherwise. Moreover, terms such as "responsive to," "related to," or other past tense adjectives are generally not intended to exclude such variations, unless the context requires otherwise.

It is worth noting that any reference to "one embodiment," "an embodiment," "an example," "an example," or the like means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment," "in an embodiment," "in an example," and "in one example" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

Any patent application, patent, non-patent publication, or other disclosure material referenced herein and/or listed in any Application Data Sheet is incorporated herein by reference to the extent that the incorporated material is not inconsistent with this specification. As such, and to the extent necessary, the disclosure material expressly set forth herein shall prevail over any conflicting statements incorporated herein by reference. Any content, or portions thereof, that conflicts with current definitions, opinions, or other disclosure material set forth herein shall be incorporated herein by reference, but only to the extent that no conflict arises between the reference material and the current disclosure material.

In summary, many benefits have been described that result from using the concepts described herein. The foregoing description of one or more embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or to be limited to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments have been selected and described in order to illustrate the principles and practical applications, thereby enabling those skilled in the art to utilize various embodiments, with various modifications, as suitable for the particular use contemplated. It is intended that the claims presented herewith define the overall scope.

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

Example 1. A method for inferring a state of an end effector of an ultrasonic device, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the method including measuring, by a control circuit, a complex impedance of the ultrasonic transducer, the complex impedance being:

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。

receiving, by the control circuitry, the complex impedance measurement data points; comparing, by the control circuitry, the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern; classifying, by the control circuitry, the complex impedance measurement data points based on results of the comparative analysis; assigning, by the control circuitry, a state or status of the end effector based on results of the comparative analysis; inferring, by the control circuitry, a state of the end effector of the ultrasonic device; and controlling, by a control circuitry, the state of the end effector of the ultrasonic device based on the inferred state.

Example 2. The method of Example 1, comprising: receiving, by the control circuit, a reference complex impedance characteristic pattern from a database or memory coupled to the control circuit; generating, by the control circuit, a reference complex impedance characteristic pattern, comprising: applying, by a drive circuit coupled to the control circuit, a non-therapeutic drive signal to the ultrasound transducer beginning at an initial frequency and ending at a final frequency, and at a plurality of frequencies therebetween; measuring, by the control circuit, the impedance of the ultrasound transducer at each frequency; storing, by the control circuit, data points corresponding to each impedance measurement; and fitting, by the control circuit, a curve to the plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the curve fitting being plotted as a function of frequency f.

Example 3. The method of example 2, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations.

Example 4. The method of any one of Examples 1 to 3, including receiving, by the control circuit, a new impedance measurement data point; and classifying, by the control circuit, the new impedance measurement data point using a Euclidean perpendicular distance from the new impedance measurement data point to a locus fitted to a reference complex impedance characteristic pattern.

Example 5. The method of example 4, including estimating, by the control circuit, the probability that a new impedance measurement data point will be correctly classified.

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

Example 7. Classifying data based on a training data set S by a control circuit, the training data set S including a plurality of complex impedance measurement data, and fitting a curve to the training data set S by the control circuit using a parametric Fourier series, 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

where the new impedance measurement data point

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 formula:

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 determined based on the new impedance measurement data points 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 of Example 4 is used to estimate the probability of

Example 8. The method of example 1, wherein the control circuitry is located in a surgical hub that communicates with the ultrasonic electromechanical system.

Example 9. A generator for estimating the state of an end effector of an ultrasonic device, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the generator including a control circuit coupled to a memory, the control circuit measuring a complex impedance of the sonic transducer, the complex impedance being:

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。

receiving complex impedance measurement data points; comparing the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern; classifying the complex impedance measurement data points based on results of the comparative analysis; assigning a state or status of the end effector based on results of the comparative analysis; inferring a state of the end effector of the ultrasonic device; and controlling the state of the end effector of the ultrasonic device based on the inferred state.

Example 10. A method for treating a vascular endodontic condition comprising: a drive circuit coupled to a control circuit, the drive circuit configured to apply a non-therapeutic drive signal to an ultrasound transducer beginning at an initial frequency and ending at a final frequency, and at a plurality of frequencies therebetween; the control circuit further configured to generate the reference complex impedance characteristic pattern; the control circuit further configured to:
10. The generator of claim 9, configured to receive the reference complex impedance characteristic pattern from a database or the memory coupled to the control circuit, measure the impedance of the ultrasonic transducer at each frequency, store data points corresponding to each impedance measurement in memory, and fit a curve to the plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, wherein magnitude |Z| and phase φ are plotted as functions of frequency f.

Example 11. The generator of any one of Examples 10, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations.

Example 12. The generator of any one of Examples 9 to 11, wherein the control circuit is further configured to receive new impedance measurement data points and classify the new impedance measurement data points using a Euclidean perpendicular distance from the new impedance measurement data points to a locus fitted to the reference complex impedance characteristic pattern.

Example 13. The generator of example 11, wherein the control circuitry is further configured to estimate the probability that a new impedance measurement data point will be correctly classified.

Example 14. The generator of 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 probability of correct classification of the new impedance measurement data points.

Example 15. The control circuit is further configured to classify data based on a training data set S, the training data set S including a plurality of complex impedance measurement data, and to fit a curve to the training data set S using a parametric Fourier series, 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

where the new impedance measurement data point

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 formula:

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 determined based on the new impedance measurement data points 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。

14. The generator of claim 13, used to estimate the probability of

Example 16. The generator of example 9, wherein the control circuitry and memory are located in a surgical hub that communicates with the ultrasonic electromechanical system.

Example 17. An ultrasonic device for inferring a state of its end effector, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade and a control circuit coupled to a memory, the control circuit measuring a complex impedance of the ultrasonic transducer, the complex impedance being

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。

4. An ultrasonic device configured to: measure a complex impedance characteristic pattern defined as a complex impedance characteristic pattern based on a state or status of an end effector of the ultrasonic device; receive complex impedance measurement data points; compare the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern; classify the complex impedance measurement data points based on results of the comparative analysis; assign a state or status of an end effector based on results of the comparative analysis; infer a state of an end effector of the ultrasonic device; and control a state of the end effector of the ultrasonic device based on the inferred state.

Example 18. A method for treating a vascular endodontic disorder further comprising: a drive circuit coupled to the control circuit, the drive circuit configured to apply a non-therapeutic drive signal to the ultrasound transducer beginning at an initial frequency and ending at a final frequency, and at a plurality of frequencies therebetween; the control circuit further configured to generate a reference complex impedance characteristic pattern; the control circuit further configured to:
The ultrasound device of Example 17 is configured to receive a reference complex impedance characteristic pattern from a database or memory coupled to a control circuit, measure the impedance of the ultrasound transducer at each frequency, store data points corresponding to each impedance measurement in memory, and fit a curve to the multiple data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, wherein magnitude |Z| and phase φ are plotted as functions of frequency f.

Example 19. The ultrasound device of Example 18, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations.

Example 20. The ultrasound device of any one of Examples 17 to 19, wherein the control circuit is further configured to receive new impedance measurement data points and classify the new impedance measurement data points using a Euclidean perpendicular distance from the new impedance measurement data points to a locus fitted to the reference complex impedance characteristic pattern.

Example 21. The ultrasound device of Example 20, wherein the control circuitry is further configured to estimate the probability that a new impedance measurement data point will be correctly classified.

Example 22. The ultrasound device of Example 21, wherein the control circuitry is further configured to add new impedance measurement data points to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data points.

Example 23. The control circuit is further configured to classify data based on a training data set S, the training data set S including a plurality of complex impedance measurement data, and to fit a curve to the training data set S using a parametric Fourier series, 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

where the new impedance measurement data point

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 formula:

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 _⊥ ,
The probability distribution of D is the probability distribution of new impedance measurement data points belonging 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。

22. The generator of claim 21, used to estimate the probability of

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

Example 25. A method for inferring a state of an end effector of an ultrasonic device, the ultrasonic device comprising an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system comprising an ultrasonic transducer coupled to an ultrasonic blade, the method comprising: applying, by a drive circuit, a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency; sweeping, by a processor or control circuit, a frequency of the drive signal from below to above the resonance of the electromagnetic ultrasonic system; measuring and recording, by the processor or control circuit, impedance/admittance circle variables R _e , G _e , X _e , B _e ; comparing, by the processor or control circuit, the measured impedance/admittance circle variables R _e , G _e , X _e , B _e with reference impedance/admittance circle variables R _ref , G _ref , X _ref , B _ref ; and determining, by the processor or control circuit, a state or status of the end effector based on a result 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。 [Embodiment]
(1) A method of inferring a state of an end effector of an ultrasonic device, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the method comprising:
measuring a complex impedance of an ultrasonic transducer by a control circuit, the complex impedance being:

and measuring, which is defined as
receiving, by the control circuitry, complex impedance measurement data points;
comparing, by the control circuitry, the complex impedance measurement data points with data points in a reference complex impedance characteristic pattern;
categorizing, by the control circuitry, the complex impedance measurement data points based on results of the comparative analysis; and
and assigning, by the control circuitry, a state or status of the end effector based on results of the comparative analysis.
(2) receiving, by the control circuitry, the reference complex impedance characteristic pattern from a database or memory coupled to the control circuitry;
generating, by said control circuitry, said reference complex impedance characteristic pattern, comprising: applying, by a drive circuit coupled to said control circuitry, a non-therapeutic drive signal to said ultrasound transducer beginning at an initial frequency and ending at a final frequency, and at a number of frequencies therebetween;
measuring the impedance of the ultrasonic transducer at each frequency with the control circuit;
storing, by the control circuitry, a data point corresponding to each impedance measurement;
and generating, by the control circuitry, a curve fitting to a plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the curve fitting being such that the magnitude |Z| and phase φ are plotted as a function of frequency f.
3. The method of claim 2, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations.
(4) receiving, by the control circuitry, a new impedance measurement data point; and
classifying, by the control circuit, the new impedance measurement data point using a Euclidean perpendicular distance from the new impedance measurement data point to a locus fitted to the reference complex impedance characteristic pattern.
5. The method of claim 4, further comprising estimating, by the control circuitry, a probability that the new impedance measurement data point 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 method of claim 5, further comprising adding, by the control circuitry, the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point.
(7) classifying, by the control circuitry, data based on a training data set S, the training data set S including a plurality of complex impedance measurement data; and
and fitting, by said control circuitry, a curve to said training data set S using a parametric Fourier series;
S is defined by the formula:

where the new impedance measurement data point

about,

The vertical distance to is calculated by the formula:

When
D = D _⊥ ,
The probability distribution of D is

5. The method of claim 4, wherein the probability of
8. The method of claim 1, wherein the control circuitry is located in a surgical hub in communication with the ultrasonic electromechanical system.
(9) A generator for inferring a state of an end effector of an ultrasonic device, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the generator comprising:
A control circuit coupled to the memory, the control circuit comprising:
Measuring a complex impedance of an ultrasonic transducer, the complex impedance being:

and measuring, which is defined as
Receiving complex impedance measurement data points;
comparing the complex impedance measurement data points with data points in a reference complex impedance characteristic pattern;
categorizing the complex impedance measurement data points based on results of the comparative analysis; and
and assigning a state or status of the end effector based on results of the comparative analysis.
(10) A drive circuit coupled to the control circuit, the drive circuit configured to apply a non-therapeutic drive signal to the ultrasound transducer starting at an initial frequency, ending at a final frequency, and at a plurality of frequencies therebetween;
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 a database or the memory coupled to the control circuit;
Measuring the impedance of the ultrasonic transducer at each frequency;
storing a data point corresponding to each impedance measurement in said memory;
10. The generator of claim 9, configured to: curve fit a plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, wherein the magnitude |Z| and phase φ are plotted as a function of frequency f.

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 of claim 10, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations.
(12) The control circuit
receiving a new impedance measurement data point;
10. The generator of claim 9, further configured to: classify the new impedance measurement data points using a Euclidean perpendicular distance from the new impedance measurement data points to a locus fitted to the reference complex impedance characteristic pattern.
13. The generator of claim 12, wherein the control circuitry is further configured to estimate a probability that the new impedance measurement data point will be correctly classified.
14. The generator of claim 13, wherein the control circuitry is further configured to add the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point.
(15) The control circuit
classifying data based on a training data set S, the training data set S including a plurality of complex impedance measurement data;
and further configured to fit a curve to the training data set S using a parametric Fourier series;
S is defined by the formula:

where the new impedance measurement data point

about,

The vertical distance to is calculated by the formula:

When
D = D _⊥ ,
The probability distribution of D is

14. The generator of claim 13, which is used to estimate the probability of

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 of claim 9, wherein the control circuitry and the memory are located in a surgical hub in communication with the ultrasonic electromechanical system.
(17) An ultrasonic device for estimating a state of an end effector thereof, the ultrasonic device comprising:
an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade;
A control circuit coupled to the memory, the control circuit comprising:
Measuring a complex impedance of the ultrasonic transducer, the complex impedance being:

and measuring, which is defined as
Receiving complex impedance measurement data points;
comparing the complex impedance measurement data points with data points in a reference complex impedance characteristic pattern;
categorizing the complex impedance measurement data points based on results of the comparative analysis; and
and assigning a state or status of the end effector based on results of the comparative analysis.
(18) The method further comprises a drive circuit coupled to the control circuit, the drive circuit configured to apply a non-therapeutic drive signal to the ultrasound transducer starting at an initial frequency, ending at a final frequency, and at a plurality of frequencies therebetween;
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 a database or the memory coupled to the control circuit;
Measuring the impedance of the ultrasonic transducer at each frequency;
storing a data point corresponding to each impedance measurement in said memory;
18. The ultrasound device of claim 17, configured to perform curve fitting to a plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, wherein the magnitude |Z| and phase φ are plotted as a function of frequency f.
19. The ultrasound device of claim 18, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations.
(20) The control circuit
receiving a new impedance measurement data point;
18. The ultrasound device of claim 17, further configured to: classify the new impedance measurement data points using a Euclidean perpendicular distance from the new impedance measurement data points to a locus fitted to the reference complex impedance characteristic pattern.

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 ultrasound device of claim 20, wherein the control circuitry is further configured to estimate a probability that the new impedance measurement data point will be correctly classified.
22. The ultrasound device of claim 21, wherein the control circuitry is further configured to add the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point.
(23) The control circuit
classifying data based on a training data set S, the training data set S including a plurality of complex impedance measurement data;
and further configured to fit a curve to the training data set S using a parametric Fourier series;
S is defined by the formula:

where the new impedance measurement data point

about,

The vertical distance to is calculated by the formula:

When
D = D _⊥ ,
The probability distribution of D is

22. The ultrasound device of claim 21, wherein the ultrasound device is used to estimate the probability of
24. The ultrasonic device of claim 17, wherein the control circuitry and the memory are located in a surgical hub in communication with the ultrasonic electromechanical system.
25. A method of inferring a state of an end effector of an ultrasonic device, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the method comprising:
applying, by a drive circuit, a drive signal to an ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency;
sweeping, by a processor or control circuit, a frequency of the drive signal from below resonance to above resonance of the electromagnetic ultrasonic system;
measuring and recording impedance/admittance circle variables R _e , G _e , X _e , and B _e by said processor or control circuitry;
comparing, by said processor or control circuitry, the measured impedance/admittance circle parameters R _e , G _e , X _e , B _e with reference impedance/admittance circle parameters R _ref , G _ref , X _ref , B _ref ;
determining, by the processor or control circuitry, a state or status of the end effector based on results of the comparative analysis.

Claims (21)

1. A method of operating an electromechanical ultrasonic system for inferring a state of an end effector of an ultrasonic device, the ultrasonic device comprising: the electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the electromechanical ultrasonic system including control circuitry and driver circuitry, the method comprising:
The control circuit measures a complex impedance of the ultrasonic transducer, the complex impedance being:

and
the control circuit receiving complex impedance measurement data points;
the control circuit comparing the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern;
the control circuit classifying the complex impedance measurement data points based on an analysis of the comparison; and
and the control circuitry assigns a state or status of the end effector based on an analysis of the comparison;
the control circuit receiving the reference complex impedance characteristic pattern from a database or memory coupled to the control circuit;
The control circuit generates the reference complex impedance characteristic pattern, the drive circuit coupled to the control circuit applying a non-therapeutic drive signal to the ultrasound transducer starting at an initial frequency and ending at a final frequency, and at a number of frequencies therebetween;
The control circuit measures the complex impedance of the ultrasonic transducer at each frequency;
the control circuit storing a data point corresponding to each impedance measurement;
and causing the control circuit to fit a curve to a plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the curve fitting including the magnitude |Z| and phase φ being plotted as a function of frequency f;
The method of operating an electromechanical ultrasonic system, wherein the end effector condition is at least one of : burn-through of a clamp arm pad, contact between the ultrasonic blade and a staple, a broken blade, bone grasped by the jaws, and tissue grasped by the jaws. The method of operating an electromechanical ultrasonic system of claim 1, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations. 1. A method of operating an electromechanical ultrasonic system for inferring a state of an end effector of an ultrasonic device, the ultrasonic device comprising: the electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the electromechanical ultrasonic system including control circuitry and driver circuitry, the method comprising:
The control circuit measures a complex impedance of the ultrasonic transducer, the complex impedance being:

and measuring, which is defined as
the control circuit receiving complex impedance measurement data points;
the control circuit comparing the complex impedance measurement data points to data points in a reference complex impedance characteristic pattern;
the control circuit classifying the complex impedance measurement data points based on an analysis of the comparison; and
and the control circuitry assigns a state or status of the end effector based on an analysis of the comparison;
the control circuit receiving a new impedance measurement data point;
the control circuit classifying the new impedance measurement data points using a Euclidean perpendicular distance from the new impedance measurement data points to a locus fitted to the reference complex impedance characteristic pattern;
The method of operating an electromechanical ultrasonic system, wherein the end effector condition is at least one of : burn-through of a clamp arm pad, contact between the ultrasonic blade and a staple, a broken blade, bone grasped by the jaws, and tissue grasped by the jaws. The method of operating an electromechanical ultrasonic system of claim 3, further comprising: the control circuit estimating a probability that the new impedance measurement data point will be correctly classified. The method of operating an electromechanical ultrasonic system of claim 4, further comprising adding, by the control circuitry, the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point. the control circuit classifying data based on a training data set S, the training data set S including a plurality of complex impedance measurement data;
the control circuitry fitting a curve to the training data set S using a parametric Fourier series;
S is defined by the formula:

where the new impedance measurement data point

about,

The vertical distance to is calculated by the formula:

When
D = D _⊥ ,
The probability distribution of D is determined based on the new impedance measurement data points belonging to the training data set S.

The method of claim 3 , wherein the method is used to estimate the probability of The method of claim 1 , wherein the control circuitry is located in a surgical hub in communication with the electromechanical ultrasonic system. 1. A generator for inferring a state of an end effector of an ultrasonic device, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the generator comprising:
A control circuit coupled to the memory, the control circuit comprising:
Measuring a complex impedance of the ultrasonic transducer, the complex impedance being:

and measuring, which is defined as
Receiving complex impedance measurement data points;
comparing the complex impedance measurement data points with data points in a reference complex impedance characteristic pattern;
categorizing the complex impedance measurement data points based on an analysis of the comparison; and
and assigning a state or status of the end effector based on an analysis of the comparison;
a drive circuit coupled to the control circuit, the drive circuit configured to apply a non-therapeutic drive signal to the ultrasound transducer beginning at an initial frequency and ending at a final frequency and at a number of frequencies therebetween;
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 a database or the memory coupled to the control circuit;
Measuring the complex impedance of the ultrasonic transducer at each frequency;
storing a data point corresponding to each impedance measurement in said memory;
curve fitting to a plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the magnitude |Z| and phase φ being plotted as a function of frequency f;
The end effector condition is at least one of : burn-through of a clamp arm pad, contact between the ultrasonic blade and a staple, a broken blade, bone grasped by the jaws, and tissue grasped by the jaws. The generator of claim 8, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations. 1. A generator for inferring a state of an end effector of an ultrasonic device, the ultrasonic device including an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the generator comprising:
A control circuit coupled to the memory, the control circuit comprising:
Measuring a complex impedance of the ultrasonic transducer, the complex impedance being:

and measuring, which is defined as
Receiving complex impedance measurement data points;
comparing the complex impedance measurement data points with data points in a reference complex impedance characteristic pattern;
categorizing the complex impedance measurement data points based on a result of the comparison; and
and assigning a state or status of the end effector based on a result of the comparison;
The control circuit,
receiving a new impedance measurement data point;
classifying the new impedance measurement data points using a Euclidean perpendicular distance from the new impedance measurement data points to a locus fitted to the reference complex impedance characteristic pattern;
the end effector condition is at least one of : burn-through of a clamp arm pad, contact between the ultrasonic blade and a staple, a broken blade, bone grasped by the jaws, and tissue grasped by the jaws;
Generator. The generator of claim 10, wherein the control circuitry is further configured to estimate a probability that the new impedance measurement data point will be correctly classified. The generator of claim 11, wherein the control circuitry is further configured to add the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point. The control circuit,
classifying data based on a training data set S, the training data set S including a plurality of complex impedance measurement data;
and further configured to fit a curve to the training data set S using a parametric Fourier series;
S is defined by the formula:

where the new impedance measurement data point

about,

The vertical distance to is calculated by the formula:

When
D = D _⊥ ,
The probability distribution of D is determined based on the new impedance measurement data points belonging to the training data set S.

12. The generator of claim 11, wherein the generator is used to estimate the probability of The generator of claim 8 , wherein the control circuitry and the memory are located in a surgical hub in communication with the electromechanical ultrasonic system. 1. An ultrasonic device for inferring a state of an end effector thereof, the ultrasonic device comprising:
an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade;
A control circuit coupled to the memory, the control circuit comprising:
Measuring a complex impedance of the ultrasonic transducer, the complex impedance being:

and measuring, which is defined as
Receiving complex impedance measurement data points;
comparing the complex impedance measurement data points with data points in a reference complex impedance characteristic pattern;
categorizing the complex impedance measurement data points based on an analysis of the comparison; and
and assigning a state or status of the end effector based on an analysis of the comparison.
a drive circuit coupled to the control circuit, the drive circuit configured to apply a non-therapeutic drive signal to the ultrasound transducer beginning at an initial frequency and ending at a final frequency and at a number of frequencies therebetween;
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 a database or the memory coupled to the control circuit;
Measuring the complex impedance of the ultrasonic transducer at each frequency;
storing a data point corresponding to each impedance measurement in said memory;
curve fitting to a plurality of data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, the magnitude |Z| and phase φ being plotted as a function of frequency f;
an ultrasonic device, the end effector condition being at least one of : burn-through of a clamp arm pad, contact between the ultrasonic blade and a staple, a broken blade, bone grasped by the jaws, and tissue grasped by the jaws. The ultrasound device of claim 15, wherein the curve fitting comprises polynomial curve fitting, Fourier series, and/or parametric equations. 1. An ultrasonic device for inferring a state of an end effector thereof, the ultrasonic device comprising:
an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade;
A control circuit coupled to the memory, the control circuit comprising:
Measuring a complex impedance of the ultrasonic transducer, the complex impedance being:

and measuring, which is defined as
Receiving complex impedance measurement data points;
comparing the complex impedance measurement data points with data points in a reference complex impedance characteristic pattern;
categorizing the complex impedance measurement data points based on an analysis of the comparison; and
and assigning a state or status of the end effector based on an analysis of the comparison.
The control circuit,
receiving a new impedance measurement data point;
classifying the new impedance measurement data points using a Euclidean perpendicular distance from the new impedance measurement data points to a locus fitted to the reference complex impedance characteristic pattern;
an ultrasonic device, the end effector condition being at least one of : burn-through of a clamp arm pad, contact between the ultrasonic blade and a staple, a broken blade, bone grasped by the jaws, and tissue grasped by the jaws. The ultrasound device of claim 17, wherein the control circuitry is further configured to estimate a probability that the new impedance measurement data point will be correctly classified. The ultrasound device of claim 18, wherein the control circuitry is further configured to add the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point. The control circuit,
classifying data based on a training data set S, the training data set S including a plurality of complex impedance measurement data;
and further configured to fit a curve to the training data set S using a parametric Fourier series;
S is defined by the formula:

where the new impedance measurement data point

about,

The vertical distance to is calculated by the formula:

When
D = D _⊥ ,
The probability distribution of D is determined based on the new impedance measurement data points belonging to the training data set S.

20. The ultrasound device of claim 18, wherein the ultrasound device is used to estimate the probability of 16. The ultrasound device of claim 15, wherein the control circuitry and the memory are located in a surgical hub in communication with the electromechanical ultrasound system.

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