Adaptive Advanced Tissue Therapy Pad Protection Mode

Abstract

The present invention discloses a method for controlling the temperature of an ultrasonic scalpel between two temperature set points, the method comprising: applying a first power level to an ultrasonic transducer to set the temperature of the ultrasonic scalpel to a first target temperature T1; monitoring a voltage V applied to the transducer; g (t)Signal and current I g (t) a phase angle #imgabs0# between the signals; inferring the temperature of the blade based on the phase angle #imgabs1#; determining that the transection process is complete; and applying a second power level to the transducer to set the blade temperature to a second target temperature T2. The transducer may be coupled to the blade via an ultrasonic guide. The first target temperature may be optimized for vessel sealing, and the second target temperature may be optimized for clamp arm pad life. The control circuit may determine that the transection is complete by determining that the ultrasonic blade contacts the clamp arm pad.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. non-provisional patent application serial number 16 / 144,423, filed on September 27, 2018, entitled “ADAPTIVE ADVANCED TISSUETREATMENT PAD SAVER MODE,” the disclosure of each of which is incorporated herein by reference in its entirety.

[0003] This application claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 640,417, filed on March 8, 2018, entitled “TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,” and U.S. Provisional Patent Application Serial No. 62 / 640,415, filed on March 8, 2018, entitled “ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,” the disclosure of each of which is incorporated herein by reference in its entirety. Technical Field

[0004] The present application relates to the field of surgical technology, and more particularly, to an ultrasonic surgical instrument and a generator for the ultrasonic surgical instrument. Background Art

[0005] In a surgical environment, smart energy devices may be required in a smart energy architecture environment. Ultrasonic surgical devices, such as ultrasonic scalpels, are used in a variety of applications in surgical procedures due to their unique performance characteristics. Depending on the specific device configuration and operating parameters, the ultrasonic surgical device can substantially provide tissue transection and hemostasis by coagulation at the same time, thereby advantageously minimizing patient trauma. The ultrasonic surgical device may include a handpiece including an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer, the ultrasonic transducer having an end effector (e.g., a knife tip) mounted at the distal end to cut and seal tissue. In some cases, the instrument may be permanently attached to the handpiece. In other cases, the instrument may be detachable from the handpiece, such as in the case of a disposable instrument or an interchangeable instrument. The end effector emits ultrasonic energy to the tissue in contact with the end effector to achieve cutting and sealing actions. Ultrasonic surgical devices with this property can be configured for open surgical use, laparoscopic or endoscopic surgical procedures, including robot-assisted procedures.

[0006] Ultrasonic energy uses temperatures lower than those used in electrosurgical procedures to cut and coagulate tissue, and can be transmitted to the end effector by an ultrasonic generator in communication with the handpiece. Under high-frequency vibrations (e.g., 55,500 cycles per second), the ultrasonic knife denatures proteins in the tissue to form a viscous coagulant. The pressure exerted by the surface of the knife on the tissue collapses the blood vessels and forms a hemostatic seal with the coagulant. The surgeon can control the cutting speed and coagulation by the force applied to the tissue by the end effector, the time of applying the force, and the selected deflection level of the end effector.

[0007] The ultrasonic transducer can be modeled as an equivalent circuit including a first branch having a static capacitance and a second "dynamic" branch having an inductance, a resistance and a capacitance connected in series, which define the electromechanical characteristics of the resonator. A known ultrasonic generator may include a tuning inductor for detuning the static capacitance at the resonant frequency so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using the tuning inductor, the generator's drive signal current represents the dynamic branch current, and the generator is thus able to control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance diagram of the ultrasonic transducer to improve the generator's frequency locking capability. However, the tuning inductor must be matched to the specific static capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.

[0008] Additionally, in some ultrasonic generator architectures, the generator's drive signal exhibits asymmetric harmonic distortion, which complicates impedance magnitude and phase measurements. For example, the accuracy of impedance phase measurements can be reduced due to harmonic distortion in current and voltage signals.

[0009] Additionally, electromagnetic interference in noisy environments can degrade the generator's ability to maintain lock to the ultrasonic transducer's resonant frequency, increasing the likelihood of invalid control algorithm inputs.

[0010] Electrosurgical devices for applying electrical energy to tissue to treat and / or destroy tissue are also increasingly used in surgical procedures. Electrosurgical devices include a handpiece and an instrument having a distally mounted end effector (e.g., one or more electrodes). The end effector can be positioned against the tissue so that current is introduced into the tissue. Electrosurgical devices can be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into the tissue and returned from the tissue through the active electrode and return electrode of the end effector, respectively. During monopolar operation, current is introduced into the tissue through the active electrode of the end effector and returned through a return electrode (e.g., a ground pad) positioned separately on the patient's body. The heat generated by the current flowing through the tissue can form a hemostatic seal within the tissue and / or between the tissues, and can therefore be particularly suitable for, for example, sealing blood vessels. The end effector of the electrosurgical device can also include a cutting member that can move relative to the tissue and an electrode for transecting the tissue.

[0011] The electrical energy applied by the electrosurgical device may be transmitted to the instrument by a generator that communicates 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 300kHz to 1MHz, as described in EN60601-2-2:2009+A11:2011, definition 201.3.218-high frequency. For example, the frequency in monopolar RF applications is typically limited to less than 5MHz. However, in bipolar RF applications, the frequency can be almost any value. Monopolar applications typically use frequencies above 200kHz in order to avoid unwanted stimulation of nerves and muscles due to the use of low-frequency currents. Bipolar techniques may use lower frequencies if a risk analysis shows that the potential for neuromuscular stimulation has been mitigated to an acceptable level. Typically, frequencies above 5MHz are not used to minimize problems associated with high-frequency leakage currents. It is generally believed that 10mA is the lower threshold for tissue thermal effects.

[0012] During its operation, an electrosurgical device may transmit low frequency RF energy through tissue, which may cause ion oscillation or friction and actually cause resistive heating, thereby raising the temperature of the tissue. Since a sharp boundary may be formed between the affected tissue and the surrounding tissue, the surgeon is able to operate with a high level of precision and control without damaging adjacent non-target tissue. The low operating temperature of RF energy may be useful for removing, shrinking, or shaping soft tissue while sealing blood vessels. RF energy may be particularly well suited for connective tissue, which is primarily composed of collagen and shrinks when exposed to heat.

[0013] Ultrasonic and electrosurgical devices typically require different generators due to their unique drive signal, sensing, and feedback requirements. In addition, in situations where the instruments are disposable or interchangeable with handpieces, the ability of ultrasonic and electrosurgical generators to identify the specific instrument configuration used and optimize control and diagnostic processes accordingly is limited. Furthermore, capacitive coupling between the non-isolated circuitry of the generator and the patient-isolated circuitry, especially when using higher voltages and frequencies, can result in patient exposure to unacceptable levels of leakage current.

[0014] In addition, due to their unique drive signals, sensing and feedback needs, ultrasonic and electrosurgical devices generally require different user interfaces for different generators. In such conventional ultrasonic and electrosurgical devices, one user interface is 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 a hand activated switch and / or a foot activated switch. As various aspects of a combined generator for use with an ultrasonic surgical instrument and an electrosurgical instrument are contemplated in the subsequent disclosure, additional user interfaces configured to operate with an ultrasonic and / or electrosurgical instrument generator are also contemplated.

[0015] Additional user interfaces for providing feedback to a user or other machine are contemplated in subsequent disclosures to provide feedback indicating the operating mode or state of the ultrasonic and / or electrosurgical instrument. Providing combined user and / or machine feedback for operating an ultrasonic and / or electrosurgical instrument will require providing sensory feedback to the user and electrical / mechanical / electromechanical feedback to the machine. Feedback devices incorporating visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators) for combined ultrasonic and / or electrosurgical instruments are contemplated in subsequent disclosures.

[0016] Other electrosurgical instruments include, but are not limited to, irreversible and / or reversible electroporation, and / or microwave technology, etc. Thus, the technology disclosed herein may be applicable to ultrasonic, bipolar or monopolar RF (electrosurgery), irreversible and / or reversible electroporation, and / or microwave-based surgical instruments, etc. Summary of the invention

[0017] One aspect of a method for controlling the temperature of an ultrasonic blade between two temperature set points may include: applying a first power level to an ultrasonic transducer to set the temperature of the ultrasonic blade to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide; monitoring a voltage V applied to the ultrasonic transducer; g (t)Signal and current I g (t) Phase angle between signals Based on the voltage V applied to the ultrasonic transducer g(t)Signal and current I g (t) Phase angle between signals To infer the temperature of the ultrasonic blade; determine that the transection process is completed; and apply a second power level to the ultrasonic transducer to set the temperature of the ultrasonic blade to a second target temperature T2.

[0018] In one aspect of the method, applying the first power level to the ultrasonic transducer to set the ultrasonic blade temperature to the first target temperature T1 includes applying the first power level to the ultrasonic transducer to set the ultrasonic blade temperature to the first target temperature T1 that is higher than the second target temperature T2.

[0019] In one aspect of the method, applying a first power level to the ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1 includes applying a first power level to the ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature optimized for vessel sealing.

[0020] In one aspect of the method, applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2 includes applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature optimized for clamp arm pad life.

[0021] In one aspect of the method, applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature optimized for clamp arm pad life includes applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to 325°C.

[0022] In one aspect of the method, determining that the transection process is complete includes determining that the ultrasonic blade contacts the clamp arm pad.

[0023] One aspect of an ultrasonic surgical instrument may include: an ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide; a clamp arm pad; and a generator configured to supply power to the ultrasonic transducer. The generator may also include a control circuit configured to: apply a first power level to the ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide; monitor a voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals Based on the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals To infer the temperature of the ultrasonic blade; determine that the transection process is completed; and apply a second power level to the ultrasonic transducer to set the temperature of the ultrasonic blade to a second target temperature T2.

[0024] In one aspect of the ultrasonic surgical instrument, the first target temperature T1 is higher than the second target temperature T2.

[0025] In one aspect of the ultrasonic surgical instrument, the first target temperature T1 is optimized for vessel sealing.

[0026] In one aspect of the ultrasonic surgical instrument, the second target temperature T2 is optimized for clamp arm pad life.

[0027] In one aspect of the ultrasonic surgical instrument, the second target temperature is 325°C.

[0028] In one aspect of the ultrasonic surgical instrument, the control circuitry configured to determine that the transection process is complete includes control circuitry for determining that the ultrasonic blade contacts the clamp arm pad.

[0029] In one aspect, a generator for an ultrasonic surgical instrument may include a control circuit configured to: apply a first power level to an ultrasonic transducer to set an ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide; monitor a voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals Based on the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals To infer the temperature of the ultrasonic blade; determine that the transection process is completed; and apply a second power level to the ultrasonic transducer to set the temperature of the ultrasonic blade to a second target temperature T2.

[0030] In one aspect of the generator, the first target temperature T1 is higher than the second target temperature T2.

[0031] In one aspect of the generator, the first target temperature T1 is optimized for vessel sealing.

[0032] In one aspect of the generator, the second target temperature T2 is optimized for clamp arm pad life.

[0033] In one aspect of the generator, the second target temperature is 325°C.

[0034] In one aspect of the generator, the control circuitry configured to determine that the transection process is complete may include control circuitry for determining that the ultrasonic blade contacts the clamp arm pad.

[0035] One aspect of an ultrasonic surgical system may include a processor and a non-volatile memory. The non-volatile memory may include instructions that, when executed by the processor, cause the processor to: apply a first power level to an ultrasonic transducer to set an ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide; monitor a voltage V applied to the ultrasonic transducer; g (t)Signal and current I g (t) Phase angle between signals Based on the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals To infer the temperature of the ultrasonic blade; determine that the transection process is completed; and apply a second power level to the ultrasonic transducer to set the temperature of the ultrasonic blade to a second target temperature T2. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The features of the various aspects are particularly described in the appended claims. However, the various aspects (relating to surgical organizations and methods) and further objects and advantages thereof may best be understood by reference to the following description taken in conjunction with the following drawings.

[0037] Figure 1 A system is provided according to at least one aspect of the present disclosure and is configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub.

[0038] Figure 2 An example of a generator according to at least one aspect of the present disclosure is shown.

[0039] Figure 3 A surgical system according to at least one aspect of the present disclosure includes a generator and various surgical instruments that can be used therewith.

[0040] Figure 4 An end actuator according to at least one aspect of the present disclosure.

[0041] Figure 5 According to at least one aspect of the present disclosure Figure 3 Illustration of the surgical system.

[0042] Figure 6 A model showing dynamic branch current according to at least one aspect of the present disclosure is provided.

[0043] Figure 7 is a structural diagram of a generator architecture according to at least one aspect of the present disclosure.

[0044] Figures 8A-8C A functional view of a generator architecture according to at least one aspect of the present disclosure.

[0045] Figures 9A-9B Structural and functional aspects of a generator according to at least one aspect of the present disclosure.

[0046] Fig.10 Control circuitry configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure is shown.

[0047] Fig.11 Combinatorial logic circuits configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure are shown.

[0048] Fig.12 A sequential logic circuit configured to control various aspects of a surgical instrument or tool according to at least one aspect of the present disclosure is shown.

[0049] Fig.13 An aspect of a basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms of electrical signal waveforms for use in a surgical instrument in accordance with at least one aspect of the present disclosure is shown.

[0050] Fig.14 An aspect of a direct digital synthesis (DDS) circuit configured to generate a plurality of waveform shapes of an electrical signal waveform for use in a surgical instrument in accordance with at least one aspect of the present disclosure is shown.

[0051] Fig.15 One cycle of a discrete-time digital electrical signal according to at least one aspect of the present disclosure is shown according to an analog waveform (shown superimposed on the discrete-time digital electrical signal waveform for comparison purposes) according to at least one aspect of the present disclosure.

[0052] Fig.16 is a diagram of a control system according to one aspect of the present disclosure.

[0053] Fig.17 A proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure is shown.

[0054] Fig.18 An alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system according to at least one aspect of the present disclosure is provided.

[0055] Figures 19A-19B is a complex impedance spectrum of the same ultrasonic device with cold and hot ultrasonic blades according to at least one aspect of the present disclosure, wherein

[0056] Fig.19Ais a graphical representation of the impedance phase angle as a function of the resonant frequency of the same ultrasonic device with a cold (solid line) and hot (dashed line) ultrasonic blade; and

[0057] Fig.19B Graph representation of impedance magnitude as a function of resonant frequency for the same ultrasonic device with cold (solid line) and hot (dashed line) ultrasonic blades.

[0058] Fig. 20 An illustration of a Kalman filter that improves a temperature estimator and a state-space model based on impedance measured on an ultrasound transducer at multiple frequencies in accordance with at least one aspect of the present disclosure.

[0059] Fig.21 According to at least one aspect of the present disclosure Fig. 20 The Kalman filter state estimator shown in is used to maximize the three probability distributions of the estimate.

[0060] Fig.22A A graphical representation of the temperature versus time of an ultrasonic device reaching a maximum temperature of 490°C without temperature control.

[0061] Fig. 22B is a graphical representation of temperature versus time for an ultrasonic device reaching a maximum temperature of 320° C. with temperature control in accordance with at least one aspect of the present disclosure.

[0062] Fig.23 A graphical representation of the relationship between the initial frequency and the change in frequency required to achieve a temperature of approximately 340° C. in accordance with at least one aspect of the present disclosure.

[0063] Fig.24 A feedback control system according to at least one aspect of the present disclosure is shown, which includes an ultrasonic generator to adjust a current (i) set point applied to an ultrasonic transducer of an ultrasonic electromechanical system to prevent the frequency (f) of the ultrasonic transducer from decreasing below a predetermined threshold.

[0064] Fig.25 To illustrate a logic flow diagram of a process in accordance with at least one aspect of the present disclosure, a control routine or logic configuration is depicted for a controlled thermal management method for protecting an end effector pad.

[0065] Fig.26 is a graphical representation of temperature versus time comparing the expected temperature of an ultrasonic blade with an intelligent ultrasonic blade and a conventional ultrasonic blade according to at least one aspect of the present disclosure.

[0066] Fig. 27 is a graphical representation of ultrasonic blade temperature as a function of time during vessel firing in accordance with at least one aspect of the present disclosure.

[0067] Fig.28 A logic flow diagram depicting a process of a control program or logic configuration for controlling the temperature of an ultrasonic blade between two temperature set points in accordance with at least one aspect of the present disclosure. DETAILED DESCRIPTION

[0068] The applicant of the present patent application also owns the following concurrently filed U.S. patent applications, each of which is incorporated herein by reference in its entirety:

[0069] U.S. Provisional Patent Application entitled “METHODS FOR CONTROLLING TEMPERATURE IN ULTRASONIC DEVICE” and attorney docket number END8560USNP1 / 180106-1M;

[0070] U.S. Provisional Patent Application entitled “ULTRASONIC SEALING ALGORITHM WITH TEMPERATURE CONTROL”, attorney docket number END8560USNP3 / 180106-3;

[0071] U.S. Provisional Patent Application entitled “APPLICATION OF SMART ULTRASONIC BLADE TECHNOLOGY” and attorney docket number END8560USNP4 / 180106-4;

[0072] U.S. Provisional Patent Application entitled “SMART BLADE TECHNOLOGY TO CONTROL BLADE INSTABILITY” and attorney docket number END8560USNP6 / 180106-6; and

[0073] U.S. Provisional Patent Application entitled “START TEMPERATURE OF BLADE” and attorney docket number END8560USNP7 / 180106-7.

[0074] The applicant of the present patent application also owns the following concurrently filed U.S. patent applications, each of which is incorporated herein by reference in its entirety:

[0075] U.S. Provisional Patent Application entitled “METHODS FOR ESTIMATING AND CONTROLLING STATE OF ULTRASONIC END EFFECTOR” and attorney docket number END8536USNP1 / 180107-1M;

[0076] U.S. Provisional Patent Application entitled “IN-THE-JAW CLASSIFIER BASED ON MODEL” and attorney docket number END8536USNP3 / 180107-3;

[0077] U.S. Provisional Patent Application entitled “APPLICATION OF SMART BLADE TECHNOLOGY” and attorney docket number END8536USNP4 / 180107-4;

[0078] U.S. Provisional Patent Application entitled “SMART BLADE AND POWER PULSING” and attorney docket number END8536USNP5 / 180107-5;

[0079] U.S. Provisional Patent Application entitled “ADJUSTMENT OF COMPLEX IMPEDANCE TO COMPENSATE FOR LOST POWER IN AN ARTICULATING ULTRASONIC DEVICE” and attorney docket number END8536USNP6 / 180107-6;

[0080] U.S. Provisional Patent Application entitled “USING SPECTROSCOPY TO DETERMINE DEVICE USE STATE IN COMBOINSTRUMENT” and attorney docket number END8536USNP7 / 180107-7;

[0081] U.S. Provisional Patent Application entitled “VESSEL SENSING FOR ADAPTIVE ADVANCED HEMOSTASIS” and attorney docket number END8536USNP8 / 180107-8;

[0082] U.S. Provisional Patent Application entitled “CALCIFIED VESSEL IDENTIFICATION” and attorney docket number END8536USNP9 / 180107-9;

[0083] U.S. Provisional Patent Application entitled “DETECTION OF LARGE VESSELSDURING PARENCHYMAL DISSECTION USING A SMART BLADE” and attorney docket number END8536USNP10 / 180107-10;

[0084] U.S. Provisional Patent Application entitled “SMART BLADE APPLICATION FOR REUSABLE AND DISPOSABLE DEVICES” and attorney docket number END8536USNP11 / 180107-11;

[0085] U.S. Provisional Patent Application entitled “LIVE TIME TISSUE CLASSIFICATION USING ELECTRICAL PARAMETERS” and attorney docket number END8536USNP12 / 180107-12; and

[0086] U.S. Provisional Patent Application entitled “FINE DISSECTION MODE FOR TISSUE CLASSIFICATION” and attorney docket number END8536USNP13 / 180107-13.

[0087] The applicant of the present application owns the following U.S. patent applications filed on September 10, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0088] U.S. Provisional Patent Application Serial No. 62 / 729,177, entitled “AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFIINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION”;

[0089] U.S. Provisional Patent Application Serial No. 62 / 729,182, entitled “SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO-POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO THE HUB”;

[0090] U.S. Provisional Patent Application Serial No. 62 / 729,184, entitled “POWERED SURGICAL TOOL WITH A PREDEFINED ADJUSTABLE CONTROL ALGORITHM FOR CONTROLLING AT LEAST ONE END-EFFECTOR PARAMETER AND A MEANS FOR LIMITING THE ADJUSTMENT”;

[0091] U.S. Provisional Patent Application Serial No. 62 / 729,183, entitled “SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION”;

[0092] U.S. Provisional Patent Application Serial No. 62 / 729,191, entitled “A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR USAGE”;

[0093] U.S. Provisional Patent Application Serial No. 62 / 729,176, entitled “INDIRECT COMMAND AND CONTROL OF A FIRST OPERATING ROOM SYSTEM THROUGH THE USE OF A SECOND OPERATING ROOM SYSTEM WITHIN A STERILEFIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY AND SECONDARY OPERATING MODES”;

[0094] U.S. Provisional Patent Application Serial No. 62 / 729,186, entitled “WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICEWITHIN A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS OF DEVICES”; and

[0095] U.S. Provisional Patent Application Serial No. 62 / 729,185, entitled “POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER OF THE DEVICE BASED ON SENSED PARAMETER OF FIRING OR CLAMPING”

[0096] The applicant of the present application owns the following U.S. patent applications filed on August 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0097] U.S. Patent Application Serial No. 16 / 115,214, entitled “ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR”;

[0098] U.S. Patent Application Serial No. 16 / 115,205, entitled “TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR”;

[0099] U.S. Patent Application Serial No. 16 / 115,233, entitled “RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINEDELECTRICAL SIGNALS”;

[0100] U.S. Patent Application Serial No. 16 / 115,208, entitled “CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TOTISSUE LOCATION”;

[0101] U.S. Patent Application Serial No. 16 / 115,220, entitled “CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE”;

[0102] U.S. Patent Application Serial No. 16 / 115,232, entitled “DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM”;

[0103] U.S. Patent Application Serial No. 16 / 115,239, entitled “DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT”;

[0104] U.S. Patent Application Serial No. 16 / 115,247, entitled “DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR”;

[0105] U.S. Patent Application Serial No. 16 / 115,211, entitled “SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS”;

[0106] U.S. Patent Application Serial No. 16 / 115,226, entitled “MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT”;

[0107] U.S. Patent Application Serial No. 16 / 115,240, entitled “DETECTION OF END EFFECTOR EMERSION IN LIQUID”;

[0108] U.S. Patent Application Serial No. 16 / 115,249, entitled “INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING”;

[0109] · Titled “INCREASING RADIO FREQUENCY TO CREATE PAD-

[0110] LESS MONOPOLAR LOOP”;

[0111] U.S. Patent Application Serial No. 16 / 115,223, entitled “BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTSPRESSURE BASED ON ENERGY MODALITY”; and

[0112] • U.S. Patent Application Serial No. 16 / 115,238, entitled “ACTIVATION OF ENERGY DEVICES.”

[0113] The applicant of the present application owns the following U.S. patent applications filed on August 23, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0114] U.S. Provisional Patent Application No. 62 / 721,995, entitled “CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TOTISSUE LOCATION”;

[0115] U.S. Provisional Patent Application No. 62 / 721,998, entitled “SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS”;

[0116] U.S. Provisional Patent Application No. 62 / 721,999, entitled “INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING”;

[0117] U.S. Provisional Patent Application No. 62 / 721,994, entitled “BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTSPRESSURE BASED ON ENERGY MODALITY”; and

[0118] U.S. Provisional Patent Application No. 62 / 721,996, entitled “RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINEDELECTRICAL SIGNALS”

[0119] The applicant of the present application owns the following U.S. patent applications filed on June 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0120] U.S. Provisional Patent Application 62 / 692,747, entitled “SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE”;

[0121] U.S. Provisional Patent Application No. 62 / 692,748, entitled “SMART ENERGY ARCHITECTURE”; and

[0122] • U.S. Provisional Patent Application 62 / 692,768, entitled “SMART ENERGY DEVICES.”

[0123] The applicant of the present application owns the following U.S. patent applications filed on June 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0124] U.S. Patent Application Serial No. 16 / 024,090, entitled “CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAYELEMENTS”;

[0125] U.S. Patent Application Serial No. 16 / 024,057, entitled “CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS”;

[0126] U.S. Patent Application Serial No. 16 / 024,067, entitled “SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION”;

[0127] U.S. Patent Application Serial No. 16 / 024,075, entitled “SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING”;

[0128] U.S. Patent Application Serial No. 16 / 024,083, entitled “SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING”;

[0129] U.S. Patent Application Serial No. 16 / 024,094, entitled “SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUEDISTRIBUTION IRREGULARITIES”;

[0130] U.S. Patent Application Serial No. 16 / 024,138, entitled “SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TOCANCEROUS TISSUE”;

[0131] U.S. Patent Application Serial No. 16 / 024,150, entitled “SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES”;

[0132] U.S. Patent Application Serial No. 16 / 024,160, entitled “VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY”;

[0133] U.S. Patent Application Serial No. 16 / 024,124, entitled “SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE”;

[0134] U.S. Patent Application Serial No. 16 / 024,132, entitled “SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT”;

[0135] U.S. Patent Application Serial No. 16 / 024,141, entitled “SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY”;

[0136] U.S. Patent Application Serial No. 16 / 024,162, entitled “SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES”;

[0137] U.S. Patent Application Serial No. 16 / 024,066, entitled “SURGICAL EVACUATION SENSING AND MOTOR CONTROL”;

[0138] U.S. Patent Application Serial No. 16 / 024,096, entitled “SURGICAL EVACUATION SENSOR ARRANGEMENTS”;

[0139] U.S. Patent Application Serial No. 16 / 024,116, entitled “SURGICAL EVACUATION FLOW PATHS”;

[0140] U.S. Patent Application Serial No. 16 / 024,149, entitled “SURGICAL EVACUATION SENSING AND GENERATOR CONTROL”;

[0141] U.S. Patent Application Serial No. 16 / 024,180, entitled “SURGICAL EVACUATION SENSING AND DISPLAY”;

[0142] U.S. Patent Application Serial No. 16 / 024,245, entitled “COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUBOR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”;

[0143] U.S. Patent Application Serial No. 16 / 024,258, entitled “SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROLCIRCUIT FOR INTERACTIVE SURGICAL PLATFORM”;

[0144] U.S. Patent Application Serial No. 16 / 024,265, entitled “SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE”; and

[0145] • U.S. Patent Application Serial No. 16 / 024,273, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS."

[0146] The applicant of the present application owns the following U.S. provisional patent applications filed on June 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0147] U.S. Provisional Patent Application Serial No. 62 / 691,228, entitled “A Method of using reinforced flex circuits with multiple sensors with electrosurgical devices”;

[0148] U.S. Provisional Patent Application Serial No. 62 / 691,227, entitled “controlling a surgical instrument according to sensed closure parameters”;

[0149] U.S. Provisional Patent Application Serial No. 62 / 691,230, entitled “SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE”;

[0150] U.S. Provisional Patent Application Serial No. 62 / 691,219, entitled “SURGICAL EVACUATION SENSING AND MOTOR CONTROL”;

[0151] U.S. Provisional Patent Application Serial No. 62 / 691,257, entitled “COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUBOR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”;

[0152] U.S. Provisional Patent Application Serial No. 62 / 691,262, entitled “SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE”; and

[0153] • U.S. Provisional Patent Application Serial No. 62 / 691,251, entitled “DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.”

[0154] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on April 19, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0155] • U.S. Provisional Patent Application Serial No. 62 / 659,900, entitled “METHOD OF HUB COMMUNICATION.”

[0156] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on March 30, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0157] U.S. Provisional Patent Application No. 62 / 650,898, filed on March 30, 2018, entitled “CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS”;

[0158] U.S. Provisional Patent Application Serial No. 62 / 650,887, entitled “SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES”;

[0159] U.S. Provisional Patent Application Serial No. 62 / 650,882, entitled “SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”; and

[0160] US Patent Application Serial No. 62 / 650,877, entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS."

[0161] The applicant of the present application owns the following U.S. patent applications filed on March 29, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0162] U.S. Patent Application Serial No. 15 / 940,641, entitled “INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES”;

[0163] U.S. Patent Application Serial No. 15 / 940,648, entitled “INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES”;

[0164] U.S. Patent Application Serial No. 15 / 940,656, entitled “SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES”;

[0165] U.S. Patent Application Serial No. 15 / 940,666, entitled “SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS”;

[0166] U.S. Patent Application Serial No. 15 / 940,670, entitled “COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS”;

[0167] U.S. Patent Application Serial No. 15 / 940,677, entitled “SURGICAL HUB CONTROL ARRANGEMENTS”;

[0168] U.S. Patent Application Serial No. 15 / 940,632, entitled “DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”;

[0169] U.S. Patent Application Serial 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”;

[0170] 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”;

[0171] U.S. Patent Application Serial No. 15 / 940,654, entitled “SURGICAL HUB SITUATIONAL AWARENESS”;

[0172] U.S. Patent Application Serial No. 15 / 940,663, entitled “SURGICAL SYSTEM DISTRIBUTED PROCESSING”;

[0173] U.S. Patent Application Serial No. 15 / 940,668, entitled “AGGREGATION AND REPORTING OF SURGICAL HUB DATA”;

[0174] U.S. Patent Application Serial No. 15 / 940,671, entitled “SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”;

[0175] 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”;

[0176] U.S. Patent Application Serial No. 15 / 940,629, entitled “COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”;

[0177] U.S. Patent Application Serial No. 15 / 940,704, entitled “USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”;

[0178] U.S. Patent Application Serial No. 15 / 940,722, entitled “CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY”; and

[0179] • U.S. Patent Application Serial No. 15 / 940,742, entitled “DUAL CMOS ARRAY IMAGING”.

[0180] U.S. Patent Application Serial No. 15 / 940,636, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”;

[0181] U.S. Patent Application Serial No. 15 / 940,653, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS”;

[0182] U.S. Patent Application Serial No. 15 / 940,660, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”;

[0183] U.S. Patent Application Serial No. 15 / 940,679, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGETRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET”;

[0184] U.S. Patent Application Serial No. 15 / 940,694, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION”;

[0185] U.S. Patent Application Serial No. 15 / 940,634, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”;

[0186] U.S. Patent Application Serial No. 15 / 940,706, entitled “DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK”; and

[0187] • U.S. Patent Application Serial No. 15 / 940,675, entitled “CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES.”

[0188] U.S. Patent Application Serial No. 15 / 940,627, entitled “DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”;

[0189] · Titled “COMMUNICATION ARRANGEMENTS FOR ROBOT-

[0190] ASSISTED SURGICAL PLATFORMS”;

[0191] U.S. Patent Application Serial No. 15 / 940,642, entitled “CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”;

[0192] · Titled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-

[0193] ASSISTED SURGICAL PLATFORMS”;

[0194] U.S. Patent Application Serial No. 15 / 940,680, entitled “CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”;

[0195] · Titled “COOPERATIVE SURGICAL ACTIONS FOR ROBOT-

[0196] ASSISTED SURGICAL PLATFORMS”;

[0197] U.S. Patent Application Serial No. 15 / 940,690, entitled “DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”; and

[0198] • U.S. Patent Application Serial No. 15 / 940,711, entitled “SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.”

[0199] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on March 28, 2018, the disclosures of each of which are incorporated herein by reference in their entirety:

[0200] U.S. Provisional Patent Application Serial No. 62 / 649,302, entitled “INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES”;

[0201] U.S. Provisional Patent Application Serial No. 62 / 649,294, entitled “DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”;

[0202] U.S. Provisional Patent Application Serial No. 62 / 649,300, entitled “SURGICAL HUB SITUATIONAL AWARENESS”;

[0203] U.S. Provisional Patent Application Serial No. 62 / 649,309, entitled “SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”;

[0204] U.S. Provisional Patent Application Serial No. 62 / 649,310, entitled “COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”;

[0205] U.S. Provisional Patent Application Serial No. 62 / 649,291, entitled “USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”;

[0206] U.S. Provisional Patent Application Serial No. 62 / 649,296, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”;

[0207] U.S. Provisional Patent Application Serial No. 62 / 649,333, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”;

[0208] U.S. Provisional Patent Application Serial No. 62 / 649,327, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”;

[0209] U.S. Provisional Patent Application Serial No. 62 / 649,315, entitled “DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK”; U.S. Provisional Patent Application Serial No. 62 / 649,313, entitled “CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”;

[0210] U.S. Provisional Patent Application Serial No. 62 / 649,320, entitled “DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”; U.S. Provisional Patent Application Serial No. 62 / 649,320, entitled “AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-

[0211] U.S. Provisional Patent Application Serial No. 62 / 649,307 for "ASSISTED SURGICAL PLATFORMS"; and

[0212] • U.S. Provisional Patent Application Serial No. 62 / 649,323, entitled “SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.”

[0213] The applicant of the present application owns the following U.S. Provisional Patent Applications filed on December 28, 2017, the disclosures of each of which are incorporated herein by reference in their entirety:

[0214] U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM”;

[0215] U.S. Provisional Patent Application Serial No. 62 / 611,340, entitled “CLOUD-BASED MEDICAL ANALYTICS”; and

[0216] • U.S. Provisional Patent Application Serial No. 62 / 611,339, entitled “ROBOT ASSISTED SURGICAL PLATFORM.”

[0217] Before describing in detail various aspects of the surgical device and generator, it should be noted that the application or use of the illustrative examples is not limited to the details of the construction and arrangement of the components shown in the drawings and detailed description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications, and may be practiced or performed in a variety of ways. In addition, unless otherwise indicated, the terms and expressions used herein are selected for the convenience of the reader to describe the exemplary embodiments and are not for limiting purposes. Moreover, it should be understood that one or more of the aspects, expressions of aspects and / or examples described below may be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.

[0218] Various aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Various aspects of ultrasonic surgical devices can be configured for, for example, transecting and / or coagulating tissue during a surgical procedure. Various aspects of electrosurgical devices can be configured for, for example, transecting, coagulating, targeting, welding, and / or desiccating tissue during a surgical procedure.

[0219] Adaptive ultrasonic knife control algorithm

[0220] In various aspects, the intelligent ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic scalpel. In one aspect, the ultrasonic scalpel adaptive control algorithm is configured to identify tissue types and adjust device parameters. In one aspect, the ultrasonic scalpel control algorithm is configured to parameterize tissue types. The following section of the present disclosure describes an algorithm for detecting the collagen / elasticity ratio of tissue to tune the amplitude of the distal tip of the ultrasonic scalpel. This article is combined with, for example, Figure 1-2 Therefore, the following description of the adaptive ultrasonic knife control algorithm should be combined with Figure 1-2 and the description associated with it.

[0221] In certain surgical procedures, it is desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm can be used to adjust the parameters of an ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device can be adjusted based on the position of the tissue in the jaws of the ultrasonic end effector (e.g., the position of the tissue between the clamping arm and the ultrasonic blade). The impedance of the ultrasonic transducer can be used to distinguish the percentage of tissue in the distal end or proximal end of the end effector. The response of the ultrasonic device can be based on the type of tissue or the compressibility of the tissue. On the other hand, the parameters of the ultrasonic device can be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade can be tuned based on the ratio of collagen to elastin tissue detected during the tissue identification process. The ratio of collagen to elastin tissue can be detected using a variety of techniques, including infrared (IR) surface reflectivity and specific emissivity. The force applied to the tissue by the clamping arm and / or the stroke of the clamping arm to produce gaps and compression. The electrical continuity across the jaws equipped with electrodes can be used to determine the percentage of the jaws covered by tissue.

[0222] Figure 1 The system 800 is configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to execute an adaptive ultrasonic blade control algorithm 802 as described herein. In another aspect, the device / instrument 235 is configured to execute an adaptive ultrasonic blade control algorithm 802 as described herein. Figure 25-28The adaptive ultrasonic blade control algorithm 804 described herein. In another aspect, both the device / instrument 235 and the device / instrument 235 are configured to perform as described herein with reference to Figure 13-18 The adaptive ultrasonic knife control algorithms 802 and 804.

[0223] The generator module 240 may include a patient isolation stage that communicates with a non-isolated stage via a power transformer. The secondary winding of the power transformer is contained in the isolation stage and may include a tap configuration (e.g., a center tap or a non-center tap configuration) to define a drive signal output that is used to deliver the drive signal to different surgical instruments, such as ultrasonic surgical instruments, RF electrosurgical instruments, and multi-function surgical instruments that include ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. Specifically, the drive signal output may output an ultrasonic drive signal (e.g., a 420V root mean square (RMS) drive signal) to an ultrasonic surgical instrument 241, and the drive signal output may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument 241. Reference is made herein to Figure 7-12 Various aspects of the generator module 240 are described.

[0224] The generator module 240 or the device / instrument 235 or both are coupled to a modular control tower 236 that is connected to a plurality of operating room devices, such as intelligent surgical instruments, robots, and other computerized devices located in the operating room. In some aspects, the surgical data network may include a modular communication hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room in a medical facility specifically equipped for surgical procedures, to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device).

[0225] Modular devices located in an operating room may be coupled to a modular communication hub. A network hub and / or a network switch may be coupled to a network router to connect the device to the cloud 204 or a local computer system. Data associated with the device may be transmitted to a cloud-based computer via a router for remote data processing and manipulation. Data associated with the device may also be transmitted to a local computer system for local data processing and manipulation. Modular devices located in the same operating room may also be coupled to a network switch. A network switch may be coupled to a network hub and / or a network router to connect the device to the cloud 204. Data associated with the device may be transmitted to the cloud 204 via a network router for data processing and manipulation. Data associated with the device may also be transmitted to a local computer system for local data processing and manipulation.

[0226] It should be understood that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" can be used as a metaphor for the "Internet", although the term is not limited to this. Therefore, the term "cloud computing" can be used herein to refer to a "type of Internet-based computing", in which different services (such as servers, storage devices, and applications) are delivered to a modular communication hub and / or computer system located in a surgical room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and a device connected to the modular communication hub and / or computer system via the Internet. The cloud infrastructure can be maintained by a cloud service provider. In this case, a cloud service provider can be an entity that coordinates the use and control of devices located in one or more operating rooms. Cloud computing services can perform a large number of calculations based on data collected by intelligent surgical instruments, robots, and other computerized devices located in an operating room. The hub hardware enables multiple devices or connections to be connected to a computer that communicates with cloud computing resources and memory.

[0227] Figure 1 Also shown are some aspects of a computer-implemented interactive surgical system including a modular communication hub, which may include a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network. The surgical system may include at least one surgical hub in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system includes a modular control tower 236 that is connected to a plurality of operating room devices, such as smart surgical instruments, robots, and other computerized devices located in the operating room. The modular control tower 236 may include a modular communication hub connected to a computer system. In some aspects, the modular control tower 236 is connected to: an imaging module connected to an endoscope, a generator module 240 connected to an energy device 241, and a smart device / instrument 235 optionally connected to a display 237. The operating room devices are connected 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. Devices / instruments 235, visualization systems 208, etc. may be coupled to a modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 may be coupled to a hub display 215 (e.g., monitor, screen) to display and overlay images received from imaging modules, device / instrument displays, and / or other visualization systems 208. The hub display 215 may also display data received from devices connected to the modular control tower in conjunction with images and overlay images.

[0228] Generator Hardware

[0229] Figure 2An example of a generator 900 is shown, which is a form of a generator configured to be coupled to an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, such as Figure 1 As shown in . Generator 900 is configured to deliver multiple energy modes to surgical instruments. Generator 900 provides RF signals and ultrasonic signals for independently or simultaneously delivering energy to surgical instruments. RF signals and ultrasonic signals can be provided separately or in combination, and can be provided simultaneously. As described above, at least one generator output can deliver multiple energy modes (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation and / or microwave energy, etc.) through a single port, and these signals can be delivered to the end effector separately or simultaneously to treat tissue. Generator 900 includes a processor 902 connected to a waveform generator 904. Processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory connected to processor 902, and the memory is not shown for clarity of this disclosure. Digital information associated with the waveform is provided to waveform generator 904, which includes one or more DAC circuits to convert digital input into analog output. The analog output is fed to amplifier 906 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to a power transformer 908. The signal is coupled to a secondary side in the patient isolation side through power transformer 908. A first signal in a first energy mode is provided to a surgical instrument between terminals labeled "Energy 1" and "Return." A second signal in a second energy mode is coupled across capacitor 910 and provided to a surgical instrument between terminals labeled "Energy 2" and "Return." It should be understood that more than two energy modes may be output, and thus the subscript "n" may be used to specify that up to n "energy modes" may be provided. n " terminal, where n is a positive integer greater than 1. It should also be understood that up to n return paths "return" may be provided without departing from the scope of the present disclosure. n ”.

[0230] The first voltage sensing circuit 912 is connected to the two ends of the terminals marked as "energy 1" and "return" paths to measure the output voltage therebetween. The second voltage sensing circuit 924 is connected to the two ends of the terminals marked as "energy 2" and "return" paths to measure the output voltage therebetween. As shown, the current sensing circuit 914 is arranged in series with the "return" branch on the secondary side of the power transformer 908 to measure the output current of any energy mode. If a different return path is provided for each energy mode, a separate current sensing circuit should be provided in each return branch. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to the corresponding isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (non-patient isolation side) are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculation. The output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and calculate parameters such as output impedance. Input / output communication between the processor 902 and the patient isolation circuit is provided through the interface circuit 920. The sensor can also be in electrical communication with the processor 902 through the interface 920.

[0231] In one aspect, the impedance may be determined by the processor 902 by dividing the output of a first voltage sensing circuit 912 coupled across terminals labeled “Energy 1” / “Return” or a second voltage sensing circuit 924 coupled across terminals labeled “Energy 2” / “Return” by the output of a current sensing circuit 914 arranged in series with the “return” branch of the secondary side of the power transformer 908. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for use in calculating the impedance. For example, the first energy modality “Energy 1” may be ultrasonic energy, and the second energy modality “Energy 2” may be RF energy. However, in addition to ultrasonic and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. Moreover, although Figure 2 The example shown in FIG. 1 shows that a single return path “return” may be provided for two or more energy modes, but in other aspects, a single return path “return” may be provided for each energy mode. n "Provide multiple return paths" return n”. Thus, as described herein, the ultrasonic transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914, and the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.

[0232] like Figure 2 As shown in , a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities (such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy with a higher voltage and lower current to drive an ultrasonic transducer, deliver energy with a lower voltage and higher current to drive an RF electrode for sealing tissue, or deliver energy with a coagulation waveform for spot coagulation using a monopolar or bipolar RF electrosurgical electrode. The output waveform from the generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 900 will preferably be located between the outputs labeled "Energy 1" and "Return", as shown in FIG. Figure 2 In one example, the connection of the RF bipolar electrodes to the generator 900 output will preferably be between the outputs labeled "Energy 2" and "Return". In the case of a monopolar output, the preferred connection would be the active electrode (e.g., pencil or other probe) to the "Energy 2" output and to a suitable return pad connected to the "Return" output.

[0233] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published on March 30, 2017, entitled “TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS,” which is incorporated herein by reference in its entirety.

[0234] As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that can transmit data through a non-solid medium using modulated electromagnetic radiation. The term does not mean that the associated organization does not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, and its Ethernet derivatives, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.

[0235] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually a memory or some other data stream). The term is used herein to refer to a central processing unit (Central Processing Unit) in one or more systems (especially System on Chip (SoC)) that combine multiple specialized "processors".

[0236] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It can contain digital, analog, mixed signal, and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), a Wi-Fi module, or a coprocessor. A SoC may or may not include built-in memory.

[0237] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for a microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; an SoC may include a microcontroller as one of its components. A microcontroller may include one or more core processing units (CPUs) as well as memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory, or OTP ROM, as well as a small amount of RAM, is also often included on the chip. Compared to microprocessors used in personal computers or other general-purpose applications consisting of various discrete chips, microcontrollers can be used for embedded applications.

[0238] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between the two components of a computer or a controller on an external device that manages the operation of the device (and the connection to the device).

[0239] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be, for example, the LM4F230H5QR ARMCortex-M4F processor core available from Texas Instruments, which includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improving performance beyond 40 MHz, 32KB of single-cycle serial random access memory (SRAM), a 32-bit MCU loaded with 128-bit MCUs, and a 32-bit MCU. Internal read-only memory (ROM) for software, 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features that are readily available.

[0240] In one aspect, the processor may include a safety controller including two families based on controllers such as the TMS570 and RM4x also offered by Texas Instruments under the trade name Hercules ARMCortex R4. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.

[0241] The modular device includes a module that can be received in a surgical hub (such as a combination of Figure 3The invention relates to a surgical device or instrument that can be connected to various modules so as to be connected or paired with a corresponding surgical hub. The modular device includes, for example, an intelligent surgical instrument, a medical imaging device, a suction / irrigation device, a smoke evacuator, an energy generator, a ventilator, an insufflator, and a display. The modular device described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on a surgical hub paired with a specific modular device, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). The data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which the knife is advanced, the motor current, or the energy level). For example, the control algorithm of a surgical suturing and cutting instrument can control the rate at which the motor of the instrument drives its knife through the tissue according to the resistance encountered by the knife as it advances.

[0242] Figure 3 One form of a surgical system 1000 is shown that includes a generator 1100 and various surgical instruments 1104, 1106, 1108 that can be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination ultrasonic / RF electrosurgical instrument. The generator 1100 may be configured for use with a variety of surgical instruments. According to various forms, the generator 1100 may be configurable for use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates simultaneous delivery of RF energy and ultrasonic energy from the generator 1100. Although in Figure 3 In one form, the generator 1100 is shown as being separate from the surgical instruments 1104, 1106, 1108, however in one form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on a front panel of the console of the generator 1100. The input device 1110 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.

[0243] The generator 1100 is configured to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 acoustically coupled to the ultrasonic transducer 1120. The handpiece 1105 includes a trigger 1143 for operating the clamp arm 1140 and a combination of switch buttons 1134a, 1134b, 1134c for energizing the ultrasonic blade 1128 and driving the ultrasonic blade 1128 or other functions. The switch buttons 1134a, 1134b, 1134c can be configured to energize the ultrasonic transducer 1120 with the generator 1100.

[0244] 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 hand piece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamping arms 1142a, 1142b and returns through the electrical conductor portion of the shaft 1127. These electrodes are coupled to and powered by a bipolar energy source within the generator 1100. The hand piece 1107 includes a trigger 1145 for operating the clamping arms 1142a, 1142b and an energy button 1135 for actuating an energy switch to power the electrodes in the end effector 1124.

[0245] The generator 1100 is also configured to drive the multifunctional surgical instrument 1108. The multifunctional surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 for operating the clamp arm 1146 and a combination of switch buttons 1137a, 1137b, 1137c for energizing the ultrasonic blade 1149 and driving the ultrasonic blade 1149 or other functions. The switch buttons 1137a, 1137b, 1137c can be configured to energize the ultrasonic transducer 1120 with the generator 1100, and to energize the ultrasonic blade 1149 with a bipolar energy source also included in the generator 1100.

[0246] The generator 1100 may be configured for use with a variety of surgical instruments. According to various forms, the generator 1100 may be configurable for use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument 1108 that integrates simultaneous delivery of RF energy and ultrasonic energy from the generator 1100. Figure 3In one form, the generator 1100 is shown as being separate from the surgical instruments 1104, 1106, 1108, however in another form, the generator 1100 may be integrally formed with any 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 the front panel of the generator 1100 console. 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. Additional aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in U.S. Patent Publication US-2017-0086914-A1, which is incorporated herein by reference in its entirety.

[0247] Figure 4 1 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 may include a blade 1128 that may be coupled to an ultrasonic transducer 1120 via a waveguide. When driven by the ultrasonic transducer 1120, the blade 1128 may vibrate and, when in contact with tissue, may cut and / or coagulate tissue as described herein. According to various aspects, and as Figure 4 As shown in FIG. 1 , the end effector 1122 may also include a clamp arm 1140 that may be configured to cooperate with the blade 1128 of the end effector 1122. With the blade 1128, the clamp arm 1140 may include a set of jaws. The clamp arm 1140 may be pivotally connected at the distal end of the shaft 1126 of the instrument portion 1104. The clamp arm 1140 may include a clamp arm tissue pad 1163 that may be provided by or other suitable low friction material. Pad 1163 may be mounted for cooperation with knife 1128, wherein pivoting movement of clamp arm 1140 positions clamp pad 1163 substantially parallel to and in contact with knife 1128. With this configuration, tissue to be clamped may be gripped between tissue pad 1163 and knife 1128. Tissue pad 1163 may have a serrated configuration including a plurality of axially spaced proximally extending gripping teeth 1161 to enhance gripping of tissue in cooperation with knife 1128. Clamp arm 1140 may be adapted to move from Figure 4 1128 to a closed position (wherein the clamp arm 1140 is in contact with or proximate to the knife 1128) in any suitable manner. For example, the handpiece 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.

[0248] 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 ( Figure 5 ), the foot switch 1430 is coupled to the generator 1100 via a foot switch cable 1432. The clinician can activate the ultrasonic transducer 1120 by depressing the foot switch 1430, and thereby activate the ultrasonic transducer 1120 and the blade 1128. In addition, or as an alternative to the foot switch 1430, some aspects of the device 1104 can utilize one or more switches located on the handpiece 1105, which, when activated, can cause the generator 1100 to activate the ultrasonic transducer 1120. In one aspect, for example, the one or more switches can include a pair of toggle buttons 1134, 1134a, 1134b ( Figure 3 ) For example, to determine the operating mode of the device 1104. When the toggle button 1134a is pressed, for example, the ultrasonic generator 1100 may provide a maximum drive signal to the ultrasonic transducer 1120, thereby causing it to produce a maximum ultrasonic energy output. Pressing the toggle button 1134b may cause the ultrasonic generator 1100 to provide a user-selectable drive signal to the ultrasonic transducer 1120, thereby causing it to produce an ultrasonic energy output less than the maximum value. Additionally or alternatively, the device 1104 may include a second switch to, for example, indicate the position of a jaw closure trigger for operating the jaws via the clamping arm 1140 of the end effector 1122. In addition, in some aspects, the ultrasonic generator 1100 may be activated based on the position of the jaw closure trigger (e.g., when the clinician presses the jaw closure trigger to close the jaws via the clamping arm 1140, ultrasonic energy may be applied).

[0249] Additionally or alternatively, the one or more switches may include a toggle button 1134 that, when depressed, causes the generator 1100 to provide a pulsed output ( Figure 3 ). The pulses may be provided, for example, at any suitable frequency and grouping. In some aspects, for example, the power level of the pulses may be the power level (maximum, less than maximum) associated with the toggle buttons 1134a, 1134b.

[0250] It should be understood that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134 ( Figure 3). For example, the device 1104 can be configured to have only two toggle buttons: a toggle button 1134a for generating maximum ultrasonic energy output and a toggle button 1134 for generating pulsed output at or below the maximum power level. In this way, the drive signal output configuration of the generator 1100 can be five continuous signals, or any discrete number of single pulse signals (1, 2, 3, 4, or 5). In certain aspects, a specific drive signal configuration can be controlled based on, for example, an EEPROM setting in the generator 1100 and / or a user power level selection.

[0251] In some aspects, a two-position switch may be provided to replace the toggle button 1134 ( Figure 3 ). For example, the device 1104 may include a toggle button 1134a for producing a continuous output at a maximum power level and a two-position toggle button 1134b. In a first detent position, the toggle button 1134b may produce a continuous output at a power level less than the maximum power level, and in a second detent position, the toggle button 1134b may produce a pulsed output (e.g., at a maximum power level or less than the maximum power level, depending on the EEPROM setting).

[0252] In some aspects, the RF electrosurgical end effectors 1124, 1125 ( Figure 3 ) may also include a pair of electrodes. The electrodes may communicate with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of tissue engagement between the clamp arms 1142a, 1146 and the blades 1142b, 1149. The generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. For example, the impedance of tissue engagement may be found by monitoring the current, voltage, etc. of the signal.

[0253] In various aspects, the generator 1100 may include a number of independent functional elements, such as modules and / or blocks, such as Figure 5 , Figure 3 100. Different functional elements or modules can be configured to drive different kinds of surgical devices 1104, 1106, 1108. For example, an ultrasonic generator module can drive an ultrasonic device, such as ultrasonic surgical device 1104. An electrosurgery / RF generator module can drive an electrosurgery device 1106. For example, the module can generate a corresponding drive signal for driving surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and / or the electrosurgery / RF generator module can each be integrally formed with the generator 1100. Alternatively, one or more of the modules can be configured as a separate circuit module electrically coupled to the generator 1100. (The modules are shown in dashed lines to illustrate the portion.) In addition, in some aspects, the electrosurgery / RF generator module can be integrally formed with the ultrasonic generator module, or vice versa.

[0254] According to the described aspects, the ultrasonic generator module can generate one or more drive signals of a specific voltage, current, and frequency (e.g., 55,500 cycles per second or Hz). The one or more drive signals can be provided to the ultrasonic device 1104, in particular the transducer 1120, which can be operated, for example, as described above. In one aspect, the generator 1100 can be configured to generate a drive signal of a specific voltage, current, and / or frequency output signal that can be modified in terms of high resolution, accuracy, and reproducibility.

[0255] According to the described aspects, the electrosurgery / RF generator module can generate one or more drive signals having an output power sufficient to perform bipolar electrosurgery using radio frequency (RF) energy. In bipolar electrosurgery applications, the drive signals can be provided to, for example, electrodes of an electrosurgical device 1106, as described above. Thus, the generator 1100 can be configured to achieve a therapeutic purpose by applying electrical energy to tissue sufficient to treat the tissue (e.g., coagulation, cauterization, tissue welding, etc.).

[0256] The generator 1100 may include an input device 2150 ( Figure 8B ). The input device 2150 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. In operation, a user may use the input device 2150 to program or otherwise control the operation of the generator 1100. The input device 2150 may include any suitable device that generates signals that can be used by the generator (e.g., by one or more processors contained in the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasonic generator module and / or the electrosurgery / RF generator module). In various aspects, the input device 2150 includes one or more of the following: a button, a switch, a thumbwheel, a keyboard, a keypad, a touch screen monitor, a pointing device, a remote connection to a general purpose or special purpose computer. In other aspects, the input device 2150 may, for example, include a suitable user interface, such as one or more user interface screens displayed on a touch screen monitor, for example. Thus, through the input device 2150, the user can set or program various operating parameters of the generator, such as the current (I), voltage (V), frequency (f) and / or period (T) of one or more drive signals generated by the ultrasonic generator module and / or the electrosurgery / RF generator module.

[0257] The generator 1100 may also include an input device 2140 ( Figure 8B). 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, LED indicator), audio feedback devices (e.g., speaker, buzzer) or tactile feedback devices (e.g., tactile actuator).

[0258] Although certain modules and / or blocks of the generator 1100 may be described by way of example, it is understood that a greater or lesser number of modules and / or blocks may be used and still fall within the scope of the aspects. In addition, although various aspects may be described in terms of modules and / or blocks for ease of description, 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 a combination of hardware components and software components.

[0259] In one aspect, the ultrasonic generator drive module and the electrosurgery / RF drive module 1110 ( Figure 3 ) may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. Modules may include various executable modules, such as software, programs, data, drivers, application programming interfaces (APIs), etc. The firmware may be stored in a non-volatile memory (NVM) such as a bit-masked read-only memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may protect the 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)).

[0260] In one aspect, the module includes a hardware component implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1104, 1106, 1108 and generating corresponding output drive signals for operating the devices 1104, 1106, 1108. In aspects where the generator 1100 is used in conjunction with the device 1104, the drive signal can drive the ultrasonic transducer 1120 in a cutting and / or coagulation mode of operation. Electrical characteristics of the device 1104 and / or tissue can be measured and used to control operational aspects of the generator 1100 and / or can be provided as feedback to a user. In aspects where the generator 1100 is used in conjunction with the device 1106, the drive signal can supply electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation, and / or desiccation mode. Electrical characteristics of the device 1106 and / or tissue can be measured and used to control operational aspects of the generator 1100 and / or can be provided as feedback to a user. In various aspects, as previously described, the hardware components can be implemented as DSPs, PLDs, ASICs, circuits, and / or registers. In one aspect, the processor can be configured to store and execute computer software program instructions to generate step function output signals for driving various components of the apparatus 1104, 1106, 1108 (e.g., the ultrasonic transducer 1120 and the end effectors 1122, 1124, 1125).

[0261] The electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide and an ultrasonic scalpel. The electromechanical ultrasonic system has an initial resonant frequency defined by the physical properties of the ultrasonic transducer, the waveguide and the ultrasonic scalpel. The ultrasonic transducer is excited by an alternating voltage V g (t)Signal and current I g (t) The resonant frequency of the signal is equal to the electromechanical ultrasonic system. When the ultrasonic electromechanical system is in resonance, the voltage V g (t)Signal and current I g (t) The phase difference between the signals is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. When the ultrasonic blade is heated, the compliance of the ultrasonic blade (modeled as an equivalent capacitor) causes the resonant frequency of the electromechanical ultrasonic system to shift. Therefore, the inductive impedance is no longer equal to the capacitive impedance, resulting in 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 is manifested as a voltage V applied to the ultrasonic transducer. g (t)Signal and current I g (t) The phase difference between the signals. The generator electronics can easily monitor the voltage V g (t)Signal and current I gThe phase difference between the (t) signals and the drive frequency can be continuously adjusted until the phase difference is zero again. 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 measurement of the temperature of the ultrasonic knife.

[0262] like Figure 6 As shown in , the electromechanical characteristics of an ultrasonic transducer can be modeled as an equivalent circuit including a first branch having a static capacitance and a second "dynamic" branch having a series connection of an inductance, a resistance and a capacitance that define the electromechanical characteristics of the resonator. A known ultrasonic generator may include a tuning inductor for detuning the static capacitance at the resonant frequency so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using the tuning inductor, the generator's drive signal current represents the dynamic branch current, and the generator is thus able to control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance diagram of the ultrasonic transducer to improve the generator's frequency locking capability. However, the tuning inductor must be matched to the specific static capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.

[0263] Figure 6 An equivalent circuit 1500 of an ultrasonic transducer such as ultrasonic transducer 1120 according to one aspect is shown. Circuit 1500 includes a series-connected inductor L having electromechanical properties defining a resonator. s , resistor R s and capacitor C s The first "dynamic" branch and the second capacitive branch C0 with static capacitance can be driven at a voltage V g (t) receives the driving current I from the generator g (t), where the dynamic current I m (t) flows through the first branch and the current I g (t)-I m (t) flows through the capacitor branch. This can be achieved by properly controlling I g (t) and V g (t) to achieve control of the electromechanical characteristics of the ultrasonic transducer. As described above, a known generator architecture may include a tuned inductor L in a parallel resonant circuit. t (exist Figure 6 The tuning inductor is used to tune the static capacitance C0 to the resonant frequency so that the current output I of the generator is substantially g All of (t) flows through the dynamic branch. In this way, by controlling the generator current output I g (t) to realize the dynamic branch current I m (t) is controlled. However, the tuning inductor Lt The static capacitance C0 is specific to the ultrasonic transducer, and different ultrasonic transducers with different static capacitances require different tuning inductors L t In addition, because the tuning inductor L t The nominal value of the static capacitance C0 at a single resonant frequency is matched, so the dynamic branch current I is only guaranteed at this frequency. m As the frequency shifts downward with the temperature of the transducer, precise control of the motional branch current is compromised.

[0264] Various aspects of the generator 1100 may not rely on the tuning inductor L t To monitor the dynamic branch current I m (t). Instead, the generator 1100 may use measurements of the static capacitance C0 between the power applied for a particular ultrasonic surgical device 1104 (along with the drive signal voltage and current feedback data) to determine the motional branch current I on a dynamic, ongoing basis (e.g., in real time). m Thus, such aspects of the generator 1100 can provide virtual tuning to simulate a system being tuned or resonating with any value of static capacitance C0 at any frequency, rather than just resonating at a single resonant frequency dictated by the nominal value of static capacitance C0.

[0265] Figure 7 1100 is a simplified block diagram of one aspect of a generator 1100 that provides inductorless tuning as described above, among other benefits. Figures 8A-8C According to one aspect Figure 7 The architecture of the generator 1100. Figure 7, the generator 1100 may include a patient isolation stage 1520 that communicates with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is included in the isolation stage 1520 and may include a tapping configuration (e.g., a center tap or a non-center tap configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to different surgical devices (e.g., an ultrasonic surgical device 1104 and an electrosurgical device 1106). Specifically, the 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 the drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to the electrosurgical device 1106, wherein the output 1060b corresponds to the center tap of the power transformer 1560. The non-isolated stage 1540 may include a power amplifier 1620 having an output connected to a primary winding 1640 of a power transformer 1560. In some aspects, the power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may also include a programmable logic device 1660 for supplying a digital output to a digital-to-analog converter (DAC) 1680, which in turn supplies a corresponding analog signal to an input of the power amplifier 1620. In some aspects, the programmable logic device 1660 may include, for example, a field programmable gate array (FPGA). Since the input of the power amplifier 1620 is controlled via the DAC 1680, the programmable logic device 1660 may thus control any of a plurality 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 device 1660 in conjunction with a processor (e.g., the processor 1740 described below) may implement a plurality of digital signal processing (DSP) based algorithms and / or other control algorithms to control parameters of the drive signal output by the generator 1100.

[0266] Power may be supplied to the power rail of the power amplifier 1620 by the switch-mode regulator 1700. In certain aspects, the switch-mode regulator 1700 may include, for example, an adjustable buck regulator. As described above, the non-isolated stage 1540 may also include a processor 1740, which in one aspect may include a DSP processor such as an ADSP-21469 SHARC DSP, which may be obtained, for example, from Analog Devices, Norwood, Mass. In certain aspects, the processor 1740 may control the operation of the switch-mode power converter 1700 in response to voltage feedback data received by the processor 1740 from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. In one aspect, for example, the processor 1740 may receive as input via the ADC 1760 a waveform envelope of a signal (e.g., an RF signal) being amplified by the power amplifier 1620. The processor 1740 can then control the switch mode regulator 1700 (e.g., via a pulse width modulation (PWM) output) so that the rail voltage supplied to the power amplifier 1620 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved relative to a fixed rail voltage amplifier solution. The processor 1740 can be configured for wired or wireless communication.

[0267] In some respects and as combined Figures 9A-9B As discussed in more detail, the programmable logic device 1660 in conjunction with the processor 1740 may implement a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency, and / or amplitude of the drive signal output by the generator 1100. In one aspect, for example, the programmable logic device 1660 may implement the DDS control algorithm 2680 by recalling waveform samples stored in a dynamically updated lookup table (LUT), such as a RAM LUT that may be embedded in an FPGA. Fig.9A). The control algorithm is particularly useful for ultrasonic applications in which an ultrasonic transducer, such as ultrasonic transducer 1120, may be driven by a pure sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the overall distortion of the motional branch current may correspondingly minimize or reduce adverse resonant effects. Because the waveform shape of the drive signal output by the generator 1100 is affected by various sources of distortion 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 into an algorithm (such as an error control algorithm implemented by processor 1740) that compensates for distortion by appropriately pre-distorting or modifying waveform samples stored in the LUT on a dynamically ongoing basis (e.g., in real time). In one form, 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, where the error may be determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuit, can cause the motional branch drive signal to have a desired waveform shape (e.g., a sinusoidal shape) to optimally drive the ultrasonic transducer. Thus, in such aspects, when the distortion effects are taken into account, the LUT waveform samples will therefore not represent the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately produce the desired waveform shape of the motional branch drive signal.

[0268] The non-isolated stage 1540 may also include an ADC 1780 and an ADC 1800, which are coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840, for respectively sampling the voltage and current 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., 80Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling speed of the ADCs 1780, 1800 may enable oversampling of the drive signal by approximately 200X (depending on the frequency). In certain aspects, the sampling operation of the ADCs 1780, 1800 may be performed by a single ADC that receives the input voltage signal and the current signal via a two-way multiplexer. By using high speed sampling in aspects of the generator 1100, among other things, calculations of complex currents flowing through the motional branches (which in some aspects can be used to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and calculation of true power consumption with high accuracy can be achieved. The voltage and current feedback data output by the ADCs 1780, 1800 can be received and processed (e.g., FIFO buffering, multiplexing) by the programmable logic device 1660 and stored in a data memory for subsequent retrieval by, for example, the DSP processor 1740. As described above, the voltage and current feedback data can be used as input to an algorithm for pre-distorting or modifying LUT waveform samples in a dynamic and ongoing manner. In some aspects, when voltage and current feedback data pairs are acquired, this may require indexing each stored voltage and current feedback data pair based on or otherwise associated with a corresponding LUT sample output by the programmable logic device 1660. Synchronizing the LUT samples and the voltage and current feedback data in this manner facilitates accurate timing and stability of the pre-distortion algorithm.

[0269] In certain aspects, the voltage and current feedback data may be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, the voltage and current feedback data may be used to determine the impedance phase, such as the phase difference between the voltage and current drive signals. Subsequently, the frequency of the drive signal may be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the impedance phase measurement accuracy. The determination of the phase impedance and frequency control signal may be implemented in the processor 1740, for example, where the frequency control signal is supplied as an input to a DDS control algorithm implemented by the programmable logic device 1660.

[0270] The impedance phase can be determined by Fourier analysis. In one aspect, the generator voltage V can be determined using a Fast Fourier Transform (FFT) or a Discrete Fourier Transform (DFT) as follows g (t) Drive signal and generator current I g (t) Phase difference between driving signals:

[0271]

[0272] Evaluating the Fourier transform at sinusoidal frequencies yields:

[0273]

[0274] Other methods include weighted least squares estimation, Kalman filtering, and space vector based techniques. For example, almost all of the processing in the FFT or DFT techniques can be performed in the digital domain with the assistance of, for example, a 2-channel high speed ADC 1780, 1800. In one technique, digital signal samples of the voltage signal and the current signal are Fourier transformed using an FFT or DFT. The phase angle at any point in time can be calculated by the following formula

[0275]

[0276] in is the phase angle, f is the frequency, t is the time, and is the phase at t=0.

[0277] To determine the voltage V g (t)Signal and current I g Another technique for measuring the phase difference between the (t) signals is the zero crossing method and produces very accurate results. For voltages V with the same frequency g (t)Signal and current I g (t) signal, voltage signal V g (t) each negative to positive zero crossing triggers the water boiling pulse, and the current signal I g Each negative to positive zero crossing of (t) triggers the end of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage signal and the current signal. In one aspect, the pulse train can be passed through an averaging filter to obtain a measurement of the phase difference. In addition, if positive to negative zero crossings are also used in a similar manner and the results are averaged, any effects of DC and harmonic components can be reduced. In one specific implementation, the analog voltage V g (t)Signal and current I gThe (t) signal is converted to a digital signal that is high when the analog signal is positive and low when the analog signal is negative. High-precision phase estimation requires sharp transitions between high and low values. In one aspect, a Schmitt trigger and an RC stabilization network can be used to convert the analog signal to a digital signal. In other aspects, an edge-triggered RS flip-flop and auxiliary circuits can be used. In yet another aspect, the zero-crossing technique can use an exclusive-OR (XOR) gate.

[0278] Other techniques for determining the phase difference between the voltage and current signals include Lissajous plots and monitoring of images; methods such as the trivoltmeter method, the cross-coil method, the vector voltmeter, and the vector impedance method; and the use of phase standard devices, phase-locked loops, and methods such as Peter O'Shea, 2000 CRC Publishing Co., Ltd.<http: / / www.engnetbase.com> "Phase Measurement" (Peter O'Shea, 2000CRC Press LLC,<http: / / www.engnetbase.com> ), which is incorporated herein by reference.

[0279] In another aspect, for example, current feedback data may be monitored to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point may be specified directly or determined indirectly based on a particular voltage amplitude and power set point. In certain aspects, control of the current amplitude may be achieved by a control algorithm in the processor 1740, such as a proportional integral derivative (PID) control algorithm. The variables controlled by the control algorithm to properly control the current amplitude of the drive signal may include, for example, scaling of LUT waveform samples stored in the programmable logic device 1660 and / or a full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via the DAC 1860.

[0280] The non-isolated stage 1540 may also include a processor 1900 for providing, among other things, a user interface (UI) function. In one aspect, the processor 1900 may include, for example, an Atmel AT91 SAM9263 processor with an ARM 926EJ-S core purchased 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 a programmable logic device (e.g., via a serial peripheral interface (SPI) bus). Although the processor 1900 may primarily support UI functions, in some aspects, it may also cooperate with the processor 1740 to achieve risk mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user input and / or other inputs (e.g., touch screen input 2150, foot switch 1430 input, temperature sensor input 2160) and disable the drive output of the generator 1100 when an error condition is detected.

[0281] In some aspects, the processor 1740 ( Figure 7 , Fig. 8A ) and processor 1900( Figure 7 , Figure 8B ) can determine and monitor the operating state of the generator 1100. For the processor 1740, the operating state of the generator 1100 can indicate, for example, which control and / or diagnostic processes are implemented by the processor 1740. For the processor 1900, the operating state of the generator 1100 can indicate, for example, which elements of the user interface (e.g., display screen, sound) are presented to the user. The processors 1740, 1900 can independently maintain the current operating state of the generator 1100 and identify and evaluate possible transitions of the current operating state. The processor 1740 can act as the subject in this relationship and determine when a transition between operating states will occur. The processor 1900 can note valid transitions between operating states and can verify whether a particular transition is appropriate. For example, when the processor 1740 commands the processor 1900 to transition to a particular state, the processor 1900 can verify that the requested transition is valid. In the event that the processor 1900 determines that the requested transition between states is invalid, the processor 1900 can cause the generator 1100 to enter a fault mode.

[0282] The non-isolated stage 1540 may also include a controller 1960 ( Figure 7 , Figure 8B) for monitoring input devices 2150 (e.g., capacitive touch sensors, capacitive touch screens for turning generator 1100 on and off). In certain aspects, controller 1960 can include at least one processor and / or other controller devices in communication with processor 1900. In one aspect, for example, controller 1960 can include 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, controller 1960 can include a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) to control and manage the collection of touch data from a capacitive touch screen.

[0283] In certain aspects, when the generator 1100 is in the “power off” state, the controller 1960 may continue to receive operating power (e.g., via a power source from the generator 1100 (such as the power source 2110 discussed below). Figure 7 )) pipeline). In this way, the controller 1960 can continue to monitor the 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, if the user's activation of the "on / off" input device 2150 is detected, the controller 1960 can wake up the power source (e.g., enable one or more DC / DC voltage converters 2130 ( Figure 7 ) operation). The controller 1960 may thus initiate a sequence to transition the generator 1100 to the "power on" state. Conversely, when the generator 1100 is in the "power on" state, if activation of the "on / off" input device 2150 is detected, the controller 1960 may initiate a sequence to transition the generator 1100 to the "power off" state. In certain aspects, for example, the controller 1960 may report the activation of the "on / off" input device 2150 to the processor 1900, which in turn implements the required sequence of processes to transition the generator 1100 to the "power off" state. In such aspects, the controller 1960 may not have an independent ability to remove power from the generator 1100 after the "power off" state has been established.

[0284] In certain aspects, the controller 1960 can cause the generator 1100 to provide audible or other sensory feedback to alert the user that a "power on" or "power off" sequence has begun. This alert can be provided when a "power on" or "power off" sequence begins and before other processes associated with the sequence begin.

[0285] In certain aspects, the isolation stage 1520 may include an instrument interface circuit 1980 to provide, for example, a communication interface between control circuitry of a surgical device (e.g., control circuitry including a handpiece switch) and components of the non-isolated stage 1540 (e.g., programmable logic device 1660, processor 1740, and / or processor 1900). The instrument interface circuit 1980 may exchange information with components of the non-isolated stage 1540 via a communication link (e.g., an infrared (IR)-based communication link) that maintains a suitable degree of electrical isolation between the stages 1520, 1540. For example, the instrument interface circuit 1980 may be powered using a low dropout voltage regulator powered by an isolation transformer that is driven from the non-isolated stage 1540.

[0286] In one aspect, the instrument interface circuit 1980 may include a signal conditioning circuit 2020 ( Figure 7 and Figure 8C ) is communicated with a programmable logic device 2000 (e.g., an FPGA). The signal conditioning circuit 2020 can be configured to receive a periodic signal (e.g., a 2kHz square wave) from the programmable logic circuit 2000 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal can be generated using a bipolar current source fed by a differential amplifier. The interrogation signal can be sent to the 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 may include a plurality of switches, resistors, and / or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal so that the state or configuration of the control circuit can be uniquely identified based on the one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating samples of a voltage signal that appears at the input of the control circuit due to the interrogation signal passing through the control circuit. The programmable logic device 2000 (or a component of the non-isolated stage 1540) can then determine the state or configuration of the control circuit based on the ADC samples.

[0287] In one aspect, the instrument interface circuit 1980 may include a first data circuit interface 2040 to enable information exchange between the programmable logic device 2000 (or other elements of the instrument interface circuit 1980) and a first data circuit disposed in or otherwise associated with the surgical device. In certain aspects, for example, the first data circuit 2060 may be disposed in a cable integrally attached to a surgical device handpiece, or in an adapter used to interface a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit may include a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device. In certain aspects and again referring to Figure 7, the first data circuit interface 2040 can be implemented separately from the programmable logic device 2000 and include suitable circuit systems (e.g., discrete logic devices, processors) to implement communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 can be integrated with the logic device 2000.

[0288] In certain aspects, the first data circuit 2060 may store information related to the associated particular surgical device. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical device has been used, and / or any other type of information. This information may be read by the instrument interface circuit 1980 (e.g., via the programmable logic device 2000), transmitted to a component of the non-isolated stage 1540 (e.g., to the programmable logic device 1660, the processor 1740, and / or the processor 1900) for presentation to a user via the output device 2140 and / or to control the function or operation of the generator 1100. In addition, any type of information may be sent to the first data circuit 2060 via the first data circuit interface 2040 (e.g., using the programmable logic device 2000) for storage therein. Such information may include, for example, an updated number of operations in which the surgical device has been used and / or the date and / or time of its use.

[0289] As previously discussed, surgical instruments may be detachable from handpieces (e.g., instrument 1106 may be detachable from handpiece 1107) to facilitate instrument interchangeability and / or disposability. In such cases, it is known that the ability of a generator to identify the particular instrument configuration being used and to optimize control and diagnostic processes accordingly may be limited. However, addressing this issue by adding readable data circuits to surgical device instruments is problematic from a compatibility perspective. For example, designing a surgical device to maintain backward compatibility with a generator that lacks the requisite data reading functionality may be impractical due to, for example, different signal schemes, design complexity, and cost. Other aspects of the instrument address these issues by using data circuits that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical device with current generator platforms.

[0290] In addition, aspects of the generator 1100 can enable communication with instrument-based data circuits. For example, the generator 1100 can be configured to communicate with a second data circuit included in 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 for implementing the communication. In one aspect, the second data circuit interface 2100 may include a tri-state digital interface, however other interfaces may also be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and / or receiving data. In one aspect, the second data circuit may store information related to an associated specific surgical instrument. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and / or any other type of information. Additionally or alternatively, any type of information may be sent to the second data circuit via the second data circuit interface 2100 (e.g., using the programmable logic device 2000) for storage therein. Such information may, for example, include an updated number of operations in which the surgical instrument is used 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., an instrument-based temperature sensor). In certain aspects, the second data circuit can receive data from the generator 1100 and provide an indication to the user (e.g., an LED indication or other visual indication) based on the received data.

[0291] In certain aspects, the second data circuit and the second data circuit interface 2100 may be configured such that communication between the programmable logic device 2000 and the second data circuit may be achieved without providing additional conductors for this purpose (e.g., dedicated conductors of a cable connecting the hand piece to the generator 1100). In one aspect, for example, information may be sent to and from the second data circuit using a single bus communication scheme implemented on an existing cable (such as one of the conductors used to transmit an interrogation signal from the signal conditioning circuit 2020 to the control circuit in the hand piece). In this way, design changes or modifications to the surgical device that may otherwise be necessary may be minimized or reduced. In addition, because different types of communications may be achieved on a common physical channel (with or without frequency band separation), the presence of the second data circuit may be "invisible" to a generator that does not have the requisite data reading functionality, thereby enabling backward compatibility of surgical device instruments.

[0292] In some aspects, the isolation stage 1520 may include at least one blocking capacitor 2960-1 ( Figure 8C), the at least one blocking capacitor is connected to the drive signal output terminal 1600b to prevent DC current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. Although failures are relatively rare in single capacitor designs, such failures may have adverse consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1, wherein current leakage from a point between the blocking capacitors 2960-1 and 2960-2 is detected by, for example, an ADC 2980 to sample a voltage induced by the leakage current. The sample may be received, for example, by the programmable logic device 2000. Based on changes in the leakage current (such as Figure 7 ), the generator 1100 can determine when at least one of the blocking capacitors 2960-1, 2960-2 fails. Figure 7 The aspect of this has benefits over a single capacitor design with a single point of failure.

[0293] In certain aspects, the non-isolated stage 1540 may include a power source 2110 for outputting DC power at an appropriate voltage and current. The power source may include, for example, a 400W power source for outputting a system voltage of 48VDC. As described above, the power source 2110 may also include one or more DC / DC voltage converters 2130 for receiving the output of the power source to generate a DC output at the voltage and current required by the various components of the generator 1100. As described above in conjunction with the controller 1960, when the controller 1960 detects that the user activates the "on / off" input device 2150 to enable operation of the DC / DC voltage converter 2130 or wake up the DC / DC voltage converter 2130, one or more of the DC / DC voltage converters 2130 may receive input from the controller 1960.

[0294] Figures 9A-9B Certain functional and structural aspects of one aspect of the generator 1100 are shown. Feedback indicative of the current and voltage outputs from the secondary winding 1580 of the power transformer 1560 is received by ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 may be implemented as 2-channel ADCs and may sample the feedback signals at a high speed (e.g., 80Msps) to allow the drive signals to be oversampled (e.g., approximately 200x oversampling). Prior to being processed by the ADCs 1780, 1800, the current feedback signal and the voltage feedback signal may be appropriately conditioned (e.g., amplified, filtered) in the analog domain. The current and voltage feedback samples from the ADCs 1780, 1800 may be buffered separately and subsequently multiplexed or interleaved into a single data stream within block 2120 of the programmable logic device 1660. In Figures 9A-9BIn some aspects, programmable logic device 1660 includes an FPGA.

[0295] The multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented within block 2144 of the processor 1740. The PDAP may include a packaging unit for implementing any of a variety of methods for associating multiplexed feedback samples with memory addresses. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored at one or more memory addresses associated with or indexed to the LUT address of the LUT sample. On the other hand, feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored at a common memory location together with the LUT address of the LUT sample. In any case, the feedback samples may be stored so that the address of the LUT sample of a particular set of feedback samples derived therefrom can be subsequently determined. As described above, synchronizing the LUT sample addresses and feedback samples in this manner facilitates the correct timing and stability of the pre-distortion algorithm. A direct memory access (DMA) controller implemented at block 2166 of the processor 1740 may store the feedback samples (and any LUT sample address data, if applicable) at a designated memory location 2180 (eg, internal RAM) of the processor 1740 .

[0296] Block 2200 of the processor 1740 may implement a predistortion algorithm for predistorting or modifying the LUT samples stored in the programmable logic device 1660 on a dynamic, ongoing basis. As described above, predistortion of the LUT samples may compensate for various sources of distortion present in the output drive circuit of the generator 1100. The predistorted LUT samples, when processed by the drive circuit, will thus cause the drive signal to have a desired waveform shape (e.g., a sinusoidal shape) to optimally drive the ultrasonic transducer.

[0297] At block 2220 of the predistortion algorithm, the current through the motional branch of the ultrasonic transducer is determined. This may be based on, for example, current and voltage feedback samples stored at memory location 2180 (which, when properly scaled, may represent the above-discussed Figure 6 I in the model g and V g ), the value of the ultrasonic transducer static capacitance C0, and the known value of the drive frequency, Kirchhoff's current law is used to determine the motional branch current. A motional branch current sample can be determined for each set of stored current and voltage feedback samples associated with the LUT sample.

[0298] At block 2240 of the predistortion algorithm, each motional branch current sample determined at block 2220 is compared with a sample of the desired current waveform shape to determine the difference or sample amplitude error between the compared samples. For this determination, a sample of the desired current waveform shape may be supplied, for example, from a waveform shape LUT 2260, which contains amplitude samples of one cycle of the desired current waveform shape. The specific sample of the desired current waveform shape from LUT 2260 for comparison may be determined by the LUT sample address associated with the motional branch current sample for comparison. Therefore, the input of the motional branch current to block 2240 may be synchronized to the input of the LUT sample address associated with it to block 2240. Therefore, the number of LUT samples stored in the programmable logic device 1660 and the number of LUT samples stored in the waveform shape LUT 2260 may be equal. In some aspects, the desired current waveform shape represented by the LUT samples stored in the waveform shape LUT 2260 may be a basic sine wave. Other waveform shapes may be desired. For example, it is contemplated that a fundamental sine wave for driving the primary longitudinal motion of the ultrasonic transducer may be used superimposed with one or more other drive signals at other frequencies, such as a third harmonic for driving at least two mechanical resonances for beneficial vibration in transverse or other modes.

[0299] Each value of the sample amplitude error determined at block 2240 is transmitted to the LUT of the programmable logic device 1660 (at Fig.9A 2280 in FIG. 10 ). Based on the value of the sample amplitude error and its associated address (and optionally, the value of the sample amplitude error of the same LUT address previously received), the LUT 2280 (or other control block of the programmable logic device 1660) may pre-distort or modify the value of the LUT sample stored at the LUT address so that the sample amplitude error is reduced or minimized. It should be understood that performing such pre-distortion or modification on each LUT sample in an iterative manner over the entire LUT address range will result in the waveform shape of the output current of the generator matching or conforming to the desired current waveform shape represented by the samples of the waveform shape LUT 2260.

[0300] Current and voltage amplitude measurements, power measurements, and impedance measurements may be determined at block 2300 of the processor 1740 based on current and voltage feedback samples stored at memory location 2180. Prior to determining these quantities, the feedback samples may be appropriately scaled and, in certain aspects, processed through a suitable filter 2320 to remove noise generated by, for example, the data acquisition process and induced harmonic components. Thus, the filtered voltage and current samples may generally represent the fundamental frequency of the drive output signal of the generator. In certain aspects, the filter 2320 may be a finite impulse response (FIR) filter applied to 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 spectrum may be used to provide additional generator functionality. In one aspect, for example, the ratio of the second order harmonic component and / or the third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.

[0301] In block 2340 ( Fig. 9B ), 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 value I representing the output current of the drive signal rms .

[0302] At block 2360, a root mean square (RMS) calculation may be applied to a sample size of the voltage feedback samples representing an integer number of cycles of the drive signal to determine a measured value V representing the output voltage of the drive signal. rms .

[0303] At block 2380, the current and voltage feedback samples may be multiplied point by point, and the samples representing an integer number of cycles of the drive signal may be averaged to determine a measure of the true output power of the generator, P r .

[0304] At block 2400, a measurement of the apparent output power of the generator, P a can be determined as the product V rms I rms .

[0305] At block 2420, the measured value Z of the load resistance magnitude is m can be determined as the quotient V rms / I rms .

[0306] In some aspects, the amount I determined at blocks 2340, 2360, 2380, 2400, and 2420 rms 、V rms , P r , P a and Z mmay be used by the generator 1100 to implement any of a number of control and / or diagnostic processes. In certain aspects, any of these quantities may be communicated to a user via, for example, an output device 2140 integral to the generator 1100 or connected to the generator 1100 via a suitable communication interface (e.g., a USB interface). For example, various diagnostic processes may include, but are not limited to, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock fault, overvoltage condition, overcurrent condition, overpower condition, voltage sensing fault, current sensing fault, audio indication fault, visual indication fault, short circuit condition, power delivery fault, or blocking capacitor fault.

[0307] Block 2440 of the processor 1740 may implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (e.g., an ultrasonic transducer) driven by the generator 1100. As described above, by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and an impedance phase set point (e.g., 0°), the effects of harmonic distortion may be minimized or reduced, and the accuracy of the phase measurement increased.

[0308] The phase control algorithm receives as input the current and voltage feedback samples stored in memory location 2180. Before being used in the phase control algorithm, the feedback samples may be appropriately scaled and processed in some aspects by a suitable filter 2460 (which may be identical to filter 2320) to remove noise generated by, for example, the data acquisition process and induced harmonic components. Thus, the filtered voltage and current samples may generally represent the fundamental frequency of the drive output signal of the generator.

[0309] 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, for each set of stored current and voltage feedback samples associated with the LUT samples, the output of block 2480 may be a motional branch current sample.

[0310] At block 2500 of the phase control algorithm, an impedance phase is determined based on the synchronized input of the motional branch current samples and the corresponding voltage feedback samples determined at block 2480. In certain aspects, the impedance phase is determined as an average of an impedance phase measured at a rising edge of the waveform and an impedance phase measured at a falling edge of the waveform.

[0311] At block 2520 of the phase control algorithm, the impedance phase value determined at block 2520 is compared to a phase set point 2540 to determine the difference or phase error between the compared values.

[0312] In block 2560 of the phase control algorithm ( Fig.9A ), based on the value of the phase error determined at block 2520 and the impedance magnitude determined at block 2420, a frequency output for controlling the frequency of the drive signal is determined. The value of the frequency output may be continuously adjusted by block 2560 and transmitted to a DDS control block 2680 (discussed below) to maintain the impedance phase determined at block 2500 at a phase set point (e.g., zero phase error). In some aspects, the impedance phase may be adjusted to a 0° phase set point. In this way, any harmonic distortion will be centered around the peaks of the voltage waveform, thereby improving the accuracy of the phase impedance determination.

[0313] Block 2580 of processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal so as to control the drive signal current, voltage, and power according to a user specified set point or according to requirements specified by other processes or algorithms implemented by generator 1100. Control of these quantities may be achieved, for example, by scaling LUT samples in LUT 2280 and / or by adjusting the full-scale output voltage of DAC 1680 (which supplies input to power amplifier 1620) via DAC 1860. Block 2600 (which may be implemented as a PID controller in some aspects) may receive as input current feedback samples (which may be appropriately scaled and filtered) from memory location 2180. The current feedback samples may be compared to a “current demand” I specified by a controlled variable (e.g., current, voltage, or power). d The current requirement I is compared with the drive signal current to determine whether the drive signal supplies the necessary current. d The current setting point 2620A (I sp ) is directly specified. For example, the RMS value of the current feedback data (as determined in block 2340) can be compared with the user-specified RMS current set point I sp A comparison is made to determine the appropriate controller action. For example, if the current feedback data indicates that the RMS value is less than the current set point I sp , then the LUT calibration and / or full-scale output voltage of DAC 1680 can be adjusted by block 2600 so that the drive signal current increases. Conversely, when the current feedback data indicates that the RMS value is greater than the current set point I sp When , block 2600 may adjust the LUT scaling and / or full-scale output voltage of DAC 1680 to reduce the drive signal current.

[0314] In terms of the driving signal voltage as the controlled variable, the current demand I d The load impedance magnitude Z measured at block 2420 may be maintained, for example, based on m Given the desired voltage set point 2620B (V sp ) The required current is specified indirectly (for example, I d =Vsp / Z m ). Similarly, in terms of the driving signal power being the controlled variable, the current demand I d The voltage V measured at block 2360 may be, for example, based on rms Given the desired set point 2620C (P sp ) The required current is specified indirectly (for example, I d =P sp / V rms ).

[0315] Block 2680( Fig.9A ) may implement a DDS control algorithm for controlling a drive signal by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a digitally controlled oscillator (NCO) algorithm for generating samples of a waveform at a fixed clock rate using a point (memory location)-skipping technique. The NCO algorithm may implement a phase accumulator or a frequency-to-phase converter that serves as an address pointer for retrieving LUT samples from LUT 2280. In one aspect, the phase accumulator may be a phase accumulator of D steps and modulus N, 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 may cause the phase accumulator to sequentially point to each address of LUT 2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. When D>1, the phase accumulator may skip addresses in LUT 2280, thereby producing a waveform output with a higher frequency. Thus, the frequency of the waveform generated by the DDS control algorithm can be controlled by appropriately changing the frequency control value. In some aspects, the frequency control value can be determined based on the output of the phase control algorithm implemented at block 2440. The output of block 2680 can supply the input of DAC 1680, which in turn supplies the corresponding analog signal to the input of power amplifier 1620.

[0316] Block 2700 of processor 1740 may implement a switch-mode converter control algorithm for dynamically modulating the rail voltage of power amplifier 1620 based on the waveform envelope of the amplified signal, thereby improving the efficiency of power amplifier 1620. In some 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 the minimum value of the drain voltage (e.g., MOSFET drain voltage) modulated according to the envelope of the amplified signal. A 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, where the output minimum voltage sample is received at block 2720 of the switch-mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 may control a 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 mains 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 into block 2720. For example, when the minimum voltage sample indicates a low envelope power level, block 2740 may cause a low mains voltage to be supplied to the power amplifier 1620, wherein the full mains voltage is supplied only when the minimum voltage sample indicates a maximum envelope power level. When the minimum voltage sample falls below the minimum target 2780, block 2740 may cause the mains voltage to be maintained at a minimum value suitable for ensuring proper operation of the power amplifier 1620.

[0317] Fig.10 A control circuit 500 configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure is shown. The control circuit 500 may be configured to implement the various processes described herein. The circuit 500 may include a microcontroller including one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuit 504 stores machine executable instructions that cause the processor 502 to execute machine instructions to implement the various processes described herein when executed by the processor 502. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. The memory circuit 504 may include a volatile storage medium and a non-volatile storage medium. The processor 502 may include an instruction processing unit 506 and an operation unit 508. The instruction processing unit may be configured to receive instructions from the memory circuit 504 of the present disclosure.

[0318] Fig.11A combinatorial logic circuit 510 configured to control various aspects of a surgical instrument or tool is shown in accordance with one aspect of the present disclosure. The combinatorial logic circuit 510 may be configured to implement various processes described herein. The combinatorial logic circuit 510 may include a finite state machine including combinatorial logic 512 configured to receive data associated with a surgical instrument or tool at an input 514, process the data through the combinatorial logic 512, and provide an output 516.

[0319] Fig.12 A sequential logic circuit 520 configured to control various aspects of a surgical instrument or tool is shown according to one aspect of the present disclosure. The sequential logic circuit 520 or the combinatorial logic 522 may be configured to implement the various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, the combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with a surgical instrument or tool from an input 526, process the data through the combinatorial logic 522, and provide an output 528. In other aspects, the circuit may include a processor (e.g., the processor 502, Fig.13 ) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may include a combinational logic circuit (e.g., combinational logic circuit 510, Fig.14 ) and a sequential logic circuit 520.

[0320] In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 can be configured to digitally generate an electrical signal waveform such that it is desirable to digitize the waveform using a predetermined number of phase points stored in a lookup table. The phase points can be stored in a table defined in a memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. Fig.13 One aspect of the basic architecture of a digital synthesis circuit such as a direct digital synthesis (DDS) circuit 4100 is shown, which is configured to generate multiple wave shapes of electrical signal waveforms. The generator software and digital control can command the FPGA to scan the address in the lookup table 4104, which in turn provides a varying digital input value to the DAC circuit 4108 that feeds the power amplifier. The address can be scanned according to the frequency of interest. Using this lookup table 4104, various types of waveforms can be generated, which can be fed to tissue or transducers, RF electrodes, multiple transducers, multiple RF electrodes, or a combination of RF instruments and ultrasonic instruments at the same time. In addition, multiple lookup tables 4104 representing multiple wave shapes can be created, stored, and applied to tissue from the generator.

[0321] 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 an RF electrode or multiples thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). In addition, in the case where the surgical instrument includes an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Therefore, the generator may be configured to provide a waveform signal to at least one surgical instrument, wherein the waveform signal corresponds to at least one of the plurality of waveform shapes in the table. In addition, the waveform signal provided to the two surgical instruments may include two or more waveform shapes. The table may include information associated with a plurality of waveform shapes, and the table may be stored in the generator. In one aspect or example, the table may be a direct digital synthesis table that may be stored in an FPGA of the generator. The table may be addressed in any manner that facilitates the classification of the waveform shapes. According to one aspect, the table (which may be a direct digital synthesis table) is addressed according to the frequency of the waveform signal. In addition, the information associated with the plurality of waveform shapes may be stored in the table as digital information.

[0322] 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 multiples thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). In addition, in the case where the surgical instrument includes an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Therefore, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, wherein the analog electrical signal waveform corresponds to at least one of the multiple waveform shapes stored in the lookup table 4104. In addition, the analog electrical signal waveform provided to the two surgical instruments may include two or more waveform shapes. The lookup table 4104 may include information associated with multiple waveform shapes, and the lookup table 4104 may be stored in the generator circuit or the surgical instrument. In one aspect or example, the lookup table 4104 may be a direct digital synthesis table that may be stored in an FPGA of the generator circuit or the surgical instrument. The lookup table 4104 may be addressed by any means that conveniently classifies the waveform shapes. 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. In addition, information associated with the plurality of waveform shapes may be stored in the lookup table 4104 as digital information.

[0323] With the widespread use of digital technology in instruments and communication systems, digitally controlled methods for generating multiple frequencies from a reference frequency source have evolved and are known as direct digital synthesis. The basic architecture is shown in Fig.13In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic device of the generator circuit and to a memory circuit located in the generator circuit of the surgical system 1000. The DDS circuit 4100 includes an address counter 4102, a lookup table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. The stable clock f c The DAC circuit 4108 is connected to the analog output signal 4110. The spectral purity of the analog output signal 4110 is mainly determined by the DAC circuit 4108. The phase noise is basically the reference clock f. c The first analog output signal 4110 output from the DAC circuit 4108 is filtered by the filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has a frequency f 输出 .

[0324] Because DDS circuit 4100 is a sampled data system, issues involved in sampling must be considered: quantization noise, aliasing, filtering, etc. For example, higher-order harmonics of the DAC circuit 4108 output frequency fold back into the Nyquist bandwidth, making them unfilterable, while higher-order harmonics of the output of a phase-locked loop (PLL)-based synthesizer can be filtered. Lookup table 4104 contains signal data for an integer number of cycles. The reference clock frequency f can be changed by changing the reference clock frequency f c Or by reprogramming the PROM to change the final output frequency f 输出 .

[0325] The DDS circuit 4100 may include a plurality of lookup tables 4104, wherein the lookup tables 4104 store waveforms represented by a predetermined number of samples, wherein the samples define a predetermined shape of the waveform. Thus, a plurality of waveforms having unique shapes may be stored in the plurality of lookup tables 4104 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4100 may create a plurality of waveform shape lookup tables 4104 and switch between different waveform shapes stored in separate lookup tables 4104 during a tissue treatment process (e.g., "on-the-fly" or virtual real-time based on user or sensor input) based on desired tissue effects and / or tissue feedback. Thus, switching between waveform shapes may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4104 may store electrical signal waveforms that are shaped to maximize the power delivered to the tissue per cycle (i.e., a trapezoidal or square wave). In other aspects, the lookup table 4104 may store waveforms synchronized in such a manner that the multifunctional surgical instrument of the surgical system 1000 maximizes power delivery when delivering RF drive signals and ultrasonic drive signals. In other aspects, the lookup table 4104 may store electrical signal waveforms to simultaneously drive ultrasonic energy and RF treatment energy, and / or sub-treatment energy, while maintaining ultrasonic frequency lock. Customized wave shapes specific to different instruments and their tissue effects may be stored in the non-volatile memory of the generator circuit or in the non-volatile memory of the surgical system 1000 (e.g., EEPROM) and retrieved when the multifunctional surgical instrument is connected to the generator circuit. An example of an exponentially decaying sinusoidal curve such as used in many high crest factor "coagulation" waveforms is shown in FIG. Fig.15 Shown in.

[0326] A more flexible and efficient implementation of DDS circuit 4100 employs a digital circuit known as a numerically controlled oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit such as DDS circuit 4200 is provided in Fig.14 4206. In this simplified block diagram, the DDS circuit 4200 is coupled to a processor, controller, or logic device of the generator and is connected to a memory circuit located in the generator or in any of the surgical instruments of the surgical system 1000. The DDS circuit 4200 includes a load register 4202, a parallel incremental phase register 4204, an adder circuit 4216, a phase register 4208, a lookup table 4210 (phase to amplitude converter), a DAC circuit 4212, and a filter 4214. The adder circuit 4216 and the phase register 4208 form part of the phase accumulator 4206. The clock frequency f cis applied to the phase register 4208 and the DAC circuit 4212. The load register 4202 receives the reference clock frequency signal f that specifies the output frequency as c The output of the load register 4202 is provided to the parallel incremental phase register 4204 as the tuning word M.

[0327] The DDS circuit 4200 includes a clock frequency f c The sampling clock of the phase accumulator 4206 and the lookup table 4210 (eg, phase to amplitude converter) are provided. Each clock cycle f c The contents of phase accumulator 4206 are updated once. When the time for updating phase accumulator 4206 is reached, the number M stored in parallel incremental phase register 4204 is added to the number in phase register 4208 by adder circuit 4216. Assume that the number in parallel incremental phase register 4204 is 00...01 and the initial contents of phase accumulator 4206 are 00...00. Phase accumulator 4206 is updated 00...01 every clock cycle. If phase accumulator 4206 is 232 bits wide, 232 clock cycles (over 4 billion) are required before phase accumulator 4206 returns to 00...00, and the cycle is repeated.

[0328] The truncated output 4218 of the phase accumulator 4206 is provided to a phase to amplitude converter lookup table 4210, and the output of the lookup table 4210 is coupled to a DAC circuit 4212. The truncated output 4218 of the phase accumulator 4206 serves as an address for a sine (or cosine) lookup table. The addresses in the lookup table correspond to phase points on a sine wave from 0° to 360°. The lookup table 4210 contains the corresponding digital amplitude information for one complete cycle of the sine wave. Thus, the lookup 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 and is filtered by a filter 4214. The output of the filter 4214 is a second analog signal 4222, which is provided to a power amplifier coupled to the output of the generator circuit.

[0329] In one aspect, the electrical signal waveform may be digitized into 1024 (210) phase points, but the waveform may be digitized into any suitable number of 2n phase points in the range of 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 at point n is n The phase angle θ at the phase point at point n is called nThe number of discrete phase points n determines the DDS circuit 4200 (and Fig.13 The tuning resolution of the DDS circuit 4100) shown in FIG.

[0330] Table 1 specifies the waveform of an electrical signal digitized into a plurality of phase points.

[0331] N <![CDATA[Stage Points 2 n > 8 256 10 1,024 12 4,096 14 16,384 16 65,536 18 262,144 20 1,048,576 22 4,194,304 24 16,777,216 26 67,108,864 28 268,435,456 ... ... 32 4,294,967,296 ... ... 48 281,474,976,710,656 ... ...

[0332] Table 1

[0333] The generator circuit algorithm and digital control circuit scan the address in the lookup table 4210, which in turn provides a varying digital input value to the DAC circuit 4212 that feeds the filter 4214 and the power amplifier. The address can be scanned according to the frequency of interest. Using the lookup table, various types of shapes can be generated, which can be converted into analog output signals by the DAC circuit 4212, filtered by the filter 4214, amplified by the power amplifier connected to the output of the generator circuit, or fed to the tissue in the form of RF energy, or fed to the tissue in the form of ultrasonic vibrations, which deliver energy to the tissue in the form of heat. The output of the amplifier can be applied to an RF electrode, to multiple RF electrodes simultaneously, to an ultrasonic transducer, to multiple ultrasonic transducers simultaneously, or to a combination of RF and ultrasonic transducers. In addition, multiple waveform tables can be created, stored and applied to the tissue from the generator circuit.

[0334] Re-reference Fig.13 , for n=32 and M=1, the phase accumulator 4206 steps through 232 possible outputs before it overflows and restarts. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M=2, the phase register 1708 "rolls over" twice as fast, and the output frequency is doubled. This can be summarized as follows.

[0335] For a phase accumulator 4206 configured to accumulate n bits (n is typically in the range of 24 to 32 in most DDS systems, but as previously described n can be selected from a wide range of options), there are 2 n possible phase points. The digital word M in the incremental phase register represents the amount by which the phase accumulator increments per clock cycle. If f c is the clock frequency, then the frequency of the output sine wave is equal to:

[0336]

[0337] The above equation is called the DDS “tuning equation.” Note that the frequency resolution of the system is equal to For n=32, the resolution is greater than one part in four billion. In one aspect of the DDS circuit 4200, instead of all bits from the phase accumulator 4206 being passed to the lookup table 4210, they are truncated, leaving only, for example, the first 13 to 15 most significant bits (MSBs). This reduces the size of the lookup table 4210 and does not affect the frequency resolution. The phase truncation only adds a small but acceptable amount of phase noise to the final output.

[0338] The electrical signal waveform may be characterized by a current, voltage, or power at a predetermined frequency. In addition, where any of the surgical instruments of the surgical system 1000 includes an ultrasonic component, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasonic transducer of at least one surgical instrument. Thus, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, wherein the electrical signal waveform is generated by storing in the lookup table 4210 (or Fig.13 The waveform of the electrical signal may be characterized by a predetermined waveform shape in a lookup table 4104 of the generator circuit. In addition, the electrical signal waveform may be a combination of two or more waveform shapes. Lookup table 4210 may include information associated with multiple waveform shapes. In one aspect or example, lookup table 4210 may be generated by DDS circuit 4200 and may be referred to as a direct digital synthesis table. DDS works by first storing a large number of repetitive waveforms in an onboard memory. The cycle of a waveform (sine, triangle, square, arbitrary) may be represented by a predetermined number of phase points as shown in Table 1 and stored in the memory. Once the waveform is stored in the memory, it can 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 may be implemented by an FPGA circuit in the available generator circuit. Lookup table 4210 may be addressed by any suitable technique that facilitates the classification of the waveform shape. According to one aspect, lookup table 4210 is addressed according to the frequency of the electrical signal waveform. In addition, the information associated with the multiple waveform shapes may be stored in the memory as digital information or as part of lookup table 4210.

[0339] In one aspect, the generator circuit can be configured to provide an electrical signal waveform to at least two surgical instruments simultaneously. The generator circuit can also be configured to provide an electrical signal waveform to two surgical instruments simultaneously via an output channel of the generator circuit, and the electrical signal waveform can be characterized by two or more waveforms. For example, in one aspect, the electrical signal waveform includes a first electrical signal (e.g., an ultrasonic drive signal) for driving an ultrasonic transducer, a second RF drive signal, and / or a combination thereof. In addition, the electrical signal waveform may include multiple ultrasonic drive signals, multiple RF drive signals, and / or a combination of multiple ultrasonic drive signals and RF drive signals.

[0340] In addition, 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, wherein generating the electrical signal waveform includes receiving information associated with the electrical signal waveform from a memory. The generated electrical signal waveform includes at least one waveform shape. In addition, providing the generated electrical signal waveform to at least one surgical instrument includes providing the electrical signal waveform to at least two surgical instruments simultaneously.

[0341] The generator circuit as described herein may allow for the generation of various types of direct digital synthesis tables. Examples of waveform shapes of RF / electrosurgical signals suitable for treating a variety of tissues generated by the generator circuit include RF signals with high crest factors (which may be used for surface coagulation in RF mode), low crest factor RF signals (which may be used for deeper tissue penetration), and waveforms that promote effective touch coagulation. The generator circuit may also employ a direct digital synthesis lookup table 4210 to generate multiple waveform shapes, and may quickly switch between specific waveform shapes based on the desired tissue effect. The switching may be based on tissue impedance and / or other factors.

[0342] In addition to traditional sine / cosine wave shapes, the generator circuit can also be configured to generate a wave shape (i.e., a trapezoidal or square wave) that maximizes the power entering the tissue in each cycle. The generator circuit can provide a wave shape that is synchronized to maximize the power delivered to the load and maintain ultrasonic lock when driving the RF signal and the ultrasonic signal simultaneously, provided that the generator circuit includes a circuit topology capable of driving the RF signal and the ultrasonic signal simultaneously. In addition, a customized wave shape specific to the instrument and its tissue effect can be stored in a non-volatile memory (NVM) or instrument EEPROM and can be retrieved when any of the surgical instruments of the surgical system 1000 is connected to the generator circuit.

[0343] The DDS circuit 4200 may include a plurality of lookup tables 4104, wherein the lookup table 4210 stores waveforms represented by a predetermined number of phase points (also referred to as samples), wherein the phase points define a predetermined shape of the waveform. Thus, a plurality of waveforms having unique shapes may be stored in the plurality of lookup tables 4210 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4200 may create a plurality of waveform shape lookup tables 4210 and switch between different waveform shapes stored in different lookup tables 4210 during a tissue treatment process (e.g., "on-the-fly" or virtual real-time based on user or sensor input) based on desired tissue effects and / or tissue feedback. Thus, switching between waveform shapes may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4210 may store electrical signal waveforms that are shaped to maximize the power delivered to the tissue per cycle (i.e., a trapezoidal or square wave). In other aspects, the lookup table 4210 may store wave shapes that are synchronized in such a way that when the RF signal and the ultrasonic drive signal are delivered, they maximize power delivery through any of the surgical instruments of the surgical system 1000. In other aspects, the lookup table 4210 may store electrical signal waveforms to simultaneously drive ultrasonic energy and RF treatment energy, and / or sub-treatment energy, while maintaining ultrasonic lock. Generally speaking, the output wave shape may be in the form of a sine wave, a cosine wave, a pulse wave, a square wave, etc. However, more complex and customized waveforms specific to different instruments and their tissue effects may be stored in the non-volatile memory of the generator circuit or the non-volatile memory of the surgical instrument (e.g., an EEPROM) and retrieved when the surgical instrument is connected to the generator circuit. An example of a customized wave shape is an exponentially decaying sine curve used in many high crest factor "coagulation" waveforms, such as Fig.15 as shown in .

[0344] Fig.15 One cycle of a discrete-time digital electrical signal waveform 4300 in accordance with at least one aspect of the present disclosure is shown for an analog waveform 4304 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison). 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 the desired analog waveform 4304. The digital electrical signal waveform 4300 is generated by storing amplitude phase points 4302 that represent one cycle or period T. o Each clock cycle T clk The digital electrical signal waveform 4300 is processed by any suitable digital processing circuit in a period To The amplitude phase points are digital words stored in the memory circuit. Fig.13 , Fig.14 In the example shown in , the digital word is a six-bit word capable of storing amplitude phase points at a resolution of 26 or 64 bits. It should be understood that Fig.13 , Fig.14 The examples shown in are for illustrative purposes, and in actual implementations, the resolution may be higher. o The digital amplitude phase points 4302 on the 4304 are stored in the memory as a string of words in the lookup table 4104, 4210, such as in combination with e.g. Fig.13 , Fig.14 To generate an analog version of analog waveform 4304, the memory is clocked in cycles T clk From 0 to T o The amplitude phase point 4302 is read in sequence and converted by the DAC circuits 4108 and 4212, and also combined with Fig.13 , Fig.14 The amplitude phase point 4302 of the digital electrical signal waveform 4300 can be changed from 0 to T o Additional cycles are generated by repeatedly reading as many cycles or periods as possible. Fig.13 and 14 ) Filter the outputs of DAC circuits 4108, 4212 to achieve a smooth analog version of analog waveform 4304. The filtered analog output signals 4114, 4222 ( Fig.13 and 14 ) is applied to the input of the power amplifier.

[0345] Fig.16 1 is a diagram of a control system 12950 that can be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) that is used to continuously calculate the difference between a desired set point and a measured process variable as an error value and apply corrections based on proportional, integral, and derivative terms (sometimes represented as 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 can be as shown in FIG. Fig.17 PID controller 12972 shown in , and secondary controller 12955 can also be as shown Fig.1712952. The primary controller 12952 controls the primary process 12958, and the secondary controller 12955 controls the secondary process 12960. The output 12966 of the primary process 12958 is the first summer 12962 subtracted from the primary set point SP1. The first summer 12962 produces a single sum output signal 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 the second summer 12964 subtracted from the secondary set point SP2.

[0346] Fig.17 A PID feedback control system 12970 is shown according to one aspect of the present 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 the desired set point r(t) (e.g., the closing force threshold) and the measured process variable y(t) (e.g., the speed and direction of the closing tube), and applies corrections based on 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 variable μ(t) (e.g., the speed and direction of the closing tube).

[0347] According to the PID algorithm, the "P" element 12974 calculates the current value of the error. For example, if the error is large and positive, then the control output will also be large and positive. According to the present disclosure, the error term e(t) is the difference between the desired closing force of the closing tube and the measured closing force. The "I" element 12976 calculates the past value of the error. For example, if the current output is not strong enough, then the integral of the error will accumulate over time, and the controller will respond by applying a stronger action. The "D" element 12978 calculates the possible future trend of the error based on its current rate of change. For example, continuing with the above P example, when a large positive control output successfully brings the error closer to zero, it also puts the process on the path of a large negative error in the near future. In this case, the derivative becomes negative, and the D module reduces the intensity of the action to prevent the overshoot.

[0348] It should be understood that other variables and set points may be monitored and controlled according to 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: firing member stroke position, firing member load, displacement of the cutting element, velocity of the cutting element, closure tube stroke position, closure tube load, and the like.

[0349] Fig.18 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 is provided. The system 132000 may be incorporated into a generator. A processor 132004 coupled to a memory 132026 programs a programmable counter 132006 to tune to the output frequency f of the ultrasonic electromechanical system 132002. o The input frequency is generated by a crystal oscillator 132008 and is input to a fixed counter 132010 to scale the frequency to an appropriate value. The outputs of the fixed counter 132010 and the programmable counter 132006 are 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 tuning voltage V which is applied to a voltage controlled oscillator 13206 (VCO). t The VCO 132016 will output a frequency f o The ultrasonic transducer portion of the ultrasonic electromechanical system 132002 is modeled as an equivalent circuit as shown in this article. The voltage signal and current signal applied to the ultrasonic transducer are monitored by a voltage sensor 132018 and a current sensor 132020.

[0350] The outputs of the voltage sensor 132018 and the current sensor 132020 are applied to another phase / frequency detector 132022 to determine the phase angle between the voltage and current as measured by the voltage sensor 132018 and the current sensor 132020. 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 dual channel ADC 132024 and provided to the processor 132004 for zero crossing, FFT, or other algorithms described herein for determining the phase angle between the voltage signal and the current signal applied to the ultrasonic electromechanical system 132002.

[0351] Optionally tune the voltage V t (This voltage and output frequency f o The output frequency f is proportional to the output frequency f. o proportional feedback signal and can use this feedback to regulate and control the output frequency f o .

[0352] Temperature inference

[0353] Figures 19A-19B 133000, 133010 are graphical representations of complex impedance spectra of the same ultrasonic device with a cold (room temperature) ultrasonic blade and a hot ultrasonic blade according to at least one aspect of the present disclosure. As used herein, a cold ultrasonic blade refers to an ultrasonic blade at room temperature, while a hot ultrasonic blade refers to an ultrasonic blade after friction heating during use. Fig.19A is the resonant frequency f of the same ultrasonic device with cold ultrasonic blade and hot ultrasonic blade o The impedance phase angle as a function of A graphical representation of 133000, and Fig.19B is the resonant frequency f of the same ultrasonic device with cold ultrasonic blade and hot ultrasonic blade o Graphical representation of the impedance magnitude |Z| as a function of 133010. Impedance Phase Angle and the impedance magnitude |Z| at the resonant frequency f o At minimum value.

[0354] Ultrasonic transducer impedance Z g (t) can be measured as the driving signal generator voltage V g (t) Driving signal and current I g (t) Ratio of driving signal:

[0355]

[0356] like Fig.19A As shown in FIG, when the ultrasonic blade is cold (e.g., at room temperature) and not frictionally heated, the electromechanical resonant frequency f of the ultrasonic device is o is about 55,500 Hz, and the excitation frequency of the ultrasonic transducer is set to 55,500 Hz. o When the ultrasonic knife is cold, the phase angle is at a minimum or approximately 0 Rad, as indicated by the cold knife curve graph 133002. Fig.19B As shown in FIG, when the ultrasonic knife is cold and the ultrasonic transducer is at the electromechanical resonant frequency f o When excited under the condition of |Z|, the impedance value |Z| is 800Ω, for example, the impedance value |Z| is at the minimum impedance, and the driving signal amplitude is at the maximum value due to the series resonance equivalent circuit of the ultrasonic electromechanical system, such as Figure 6 Depicted.

[0357] Now re-reference Fig.19A and Fig.19B , when the ultrasonic transducer is at the electromechanical resonant frequency f of 55,500 Hz o The generator voltage V g (t)Signal and generator current I g (t) When the signal is driven, the generator voltage V g (t)Signal and generator current I g (t) Phase angle between signals is zero, the impedance magnitude |Z| is at the minimum impedance (e.g., 800Ω), and the signal amplitude is at a peak or maximum value due to the series resonant equivalent circuit of the ultrasonic electromechanical system. When the temperature of the ultrasonic blade increases, the electromechanical resonant frequency f of the ultrasonic device increases due to the friction heat generated during use. o ' is reduced. Because the ultrasonic transducer drive generator voltage is still 55,500Hz of the previous (cold knife) electromechanical resonant frequency f o The generator voltage V g (t)Signal and generator current I g (t) signal drive, so the ultrasonic device is non-resonant f o ' operation, resulting in the generator voltage V g (t)Signal and generator current I g (t) Phase angle between signals There is also an increase in the impedance magnitude |Z| and a decrease in the peak magnitude of the drive signal relative to the previous (cold knife) electromechanical resonant frequency of 55,500 Hz. oThe generator voltage V changes due to the temperature change of the ultrasonic knife. g (t)Signal and generator current I g (t) Phase angle between signals To infer the temperature of the ultrasonic knife.

[0358] As mentioned above, the electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic knife. The ultrasonic transducer can be modeled as an equivalent series resonant circuit (see Figure 6 ), the equivalent series resonant circuit includes a first branch with static capacitance and a second "dynamic" branch with a series connection of inductance, resistance and capacitance that defines the electromechanical characteristics of the resonator. The electromechanical ultrasonic system has an initial electromechanical resonant frequency defined by the physical characteristics of the ultrasonic transducer, waveguide and ultrasonic blade. The ultrasonic transducer is supplied with an AC voltage V at a frequency equal to the electromechanical resonant frequency (e.g., the resonant frequency of the electromechanical ultrasonic system). g (t)Signal and current I g (t) Signal excitation. When the electromechanical ultrasonic system is excited at the resonant frequency, the voltage V g (t)Signal and current I g (t) Phase angle between signals is zero.

[0359] In other words, at resonance, the simulated inductive impedance of the electromechanical ultrasonic system is equal to the simulated capacitive impedance of the electromechanical ultrasonic system. When the ultrasonic blade is heated, for example due to frictional engagement with tissue, the compliance of the ultrasonic blade (modeled as a simulated capacitor) causes the resonant frequency of the electromechanical ultrasonic system to shift. In this example, when the temperature of the ultrasonic blade increases, the resonant frequency of the electromechanical ultrasonic system decreases. Therefore, the simulated inductive impedance of the electromechanical ultrasonic system is no longer equal to the simulated capacitive impedance of the electromechanical ultrasonic system, resulting in a mismatch between the drive frequency and the new resonant frequency of the electromechanical ultrasonic system. Therefore, using a thermal ultrasonic blade, the electromechanical ultrasonic system operates "non-resonantly". The mismatch between the drive frequency and the resonant frequency is manifested as a voltage V applied to the ultrasonic transducer. g (t)Signal and current I g (t) Phase angle between signals

[0360] As discussed previously, the generator electronics can easily monitor the voltage V applied to the ultrasonic transducer. g (t)Signal and current I g (t) Phase angle between signals Phase Angle It can be determined by Fourier analysis, weighted least squares estimation, Kalman filtering, space vector based techniques, zero crossing method, Lissajous plot, three voltmeter method, cross coil method, vector voltmeter and vector impedance method, phase standard instrument, phase locked loop, etc. The generator can continuously monitor the phase angle And adjust the drive frequency until the phase angle becomes zero. At this point, the new driving frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. Phase angle And / or changes in the generator drive frequency can be used as an indirect or inferred measurement of the temperature of the ultrasonic blade.

[0361] A variety of techniques can be used to estimate temperature from data in these spectra. Most notably, a set of time-varying nonlinear state-space equations can be used to model the dynamic relationship between the temperature of the ultrasonic blade and the measured impedance.

[0362]

[0363] Within a range of generator drive frequencies, where the range of generator drive frequencies is specific to the device model.

[0364] Temperature estimation method

[0365] One aspect of estimating or inferring the temperature of an ultrasonic scalpel may include three steps. First, a state-space model of temperature and frequency that depends on time and energy is defined. In order to model temperature as a function of frequency content, a set of nonlinear state-space formulas are used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic scalpel. Secondly, a Kalman filter is applied to improve the accuracy of the temperature estimator and the state-space model over time. Thirdly, a state estimator is provided in the feedback loop of the Kalman filter to control the power applied to the ultrasonic transducer and therefore the ultrasonic scalpel, thereby adjusting the temperature of the ultrasonic scalpel. These three steps are described below.

[0366] Step 1

[0367] The first step is to define a state-space model of temperature and frequency that depends on time and energy. In order to model temperature as a function of frequency content, a set of nonlinear state-space formulas are used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic blade. In one aspect, the state-space model is defined by:

[0368]

[0369] The state-space model represents the relative frequency F n(t) , temperature T(t), energy E(t) and time t of the electromechanical ultrasonic system The rate of change and the temperature of the ultrasonic knife The rate of change. represents a measurable and observable variable such as the natural frequency F of an electromechanical ultrasonic system n(t) , the temperature T(t) of the ultrasonic blade, the energy E(t) applied to the ultrasonic blade, and the observability of time t. The temperature T(t) of the ultrasonic blade can be observed as an estimate.

[0370] Step 2

[0371] The second step is to apply a Kalman filter to improve the temperature estimator and the state-space model. Fig. 20 133020 is a diagram of a Kalman filter 133020 that improves the temperature estimator and state-space model based on impedance according to the following formula:

[0372]

[0373] It represents the impedance across the ultrasound transducer measured at various frequencies according to at least one aspect of the present disclosure.

[0374] Kalman filter 133020 can be used to improve the performance of temperature estimation and allow the addition of external sensors, models or previous information to improve temperature prediction in noisy data. Kalman filter 133020 includes regulator 133022 and plant 133024. In control theory, plant 133024 is a combination of process and actuator. Plant 133024 is referred to as having a transfer function that indicates the relationship between the input signal and the output signal of the system. Regulator 133022 includes state estimator 133026 and controller K 133028. State regulator 133026 includes feedback loop 133030. State regulator 133026 receives y, the output of plant 133024 as input and feedback variable u. State estimator 133026 is an internal feedback system that converges with the true value of the system state. The output of state estimator 133026 is a full feedback control variable Including electromechanical ultrasonic system F n(t) , estimation of the temperature T(t) of the ultrasonic scalpel, the energy E(t) applied to the ultrasonic scalpel, the phase angle

[0375] and time t. The input to the controller K 133028 is And the output u of controller K 133028 is fed back to the state estimator 133026 and t of device 133024.

[0376] Kalman filtering (also known as linear quadratic estimation (LQE)) is an algorithm that uses a series of measurements observed over time (containing statistical noise and other inaccuracies) and generates estimates of unknown variables by estimating the joint probability distribution of the variables for each time frame and thus calculating the maximum likelihood estimate of the actual measurement. The algorithm works in a two-step process. In the prediction step, the Kalman filter 133020 generates estimates of the current state variables and their uncertainties. Once the results of the next measurement are observed (necessarily corrupted by a certain amount of error (including random noise)), these estimates are updated using a weighted average, and the higher the weight given, the higher the certainty of the estimate. The algorithm is recursive and can be run in real time, using only the current input measurement and the previously calculated state and its uncertainty matrix; no additional past information is required.

[0377] The Kalman filter 133020 uses a dynamic model of the electromechanical ultrasonic system, known control inputs to the system, and multiple time-series measurements (observations) of the natural frequency and phase angle of the signal applied to the ultrasonic transducer (e.g., the magnitude and phase of the electrical impedance of the ultrasonic transducer) to form an estimate of the changing quantity of the electromechanical ultrasonic system (its state) to predict the temperature of the ultrasonic blade portion of the electromechanical ultrasonic system better than the estimate obtained using only one single measurement. Therefore, the Kalman filter 133020 is an algorithm that includes sensors and data fusion to provide a maximum likelihood estimate of the temperature of the ultrasonic blade.

[0378] The Kalman filter 133020 effectively handles the uncertainty caused by the noisy measurement of the signal applied to the ultrasonic transducer to measure the natural frequency and phase shift data, and also effectively handles the uncertainty caused by random external factors. The Kalman filter 133020 generates an estimate of the state of the electromechanical ultrasonic system with the average of the predicted state of the system and the new measurement using the weighted average. The weighted value provides a better (i.e., smaller) estimated uncertainty and is more "trustworthy" than the unweighted value. The weights can be calculated by the covariance, a measure of the estimated uncertainty of the system state prediction. The result of the weighted average is a new state estimate that is between the predicted state and the measured state, and has a better estimated uncertainty than a single one. This process is repeated at each step, where the new estimate and its covariance inform the prediction used in the following iteration. This recursive nature of the Kalman filter 133020 only requires the last "best guess" of the state of the electromechanical ultrasonic system instead of the entire history to calculate the new state.

[0379] The relative certainty of the measurements and current state estimates are important considerations, and it is common to discuss the response of the filter in terms of the gain K of the Kalman filter 133020. The Kalman gain K is the relative weight given to the measurements and the current state estimate, and can be "tuned" to achieve specific performance. With a high gain K, the Kalman filter 133020 places more weight on recent measurements and therefore follows them more responsively. With a low gain K, the Kalman filter 133020 follows the model predictions more closely. In extreme cases, a high gain close to one will cause the estimated trajectory to be more jumpy, while a low gain close to zero will smooth out the noise but reduce responsiveness.

[0380] When performing the actual calculations of the Kalman filter 133020 (described below), the state estimates and covariances are encoded as matrices to handle the multiple dimensions involved in a single set of calculations. This allows the linear relationship between different state variables (such as position, velocity, and acceleration) to be represented in either the transition model or the covariance. Using the Kalman filter 133020 does not assume that the errors are Gaussian. However, in the special case where all errors are Gaussian distributed, the Kalman filter 133020 produces accurate conditional probability estimates.

[0381] Step 3

[0382] The third step uses the state estimator 133026 in the feedback loop 133032 of the Kalman filter 133020 to control the power applied to the ultrasonic transducer and therefore to the ultrasonic blade to adjust the temperature of the ultrasonic blade.

[0383] Fig.21 According to at least one aspect of the present disclosure Fig. 20 133040 is a graphical representation of three probability distributions used by the state estimator 133026 of the Kalman filter 133020 shown in FIG. 133040 to maximize the estimated value. The probability distributions include a previous probability distribution 133042, a predicted (state) probability distribution 133044, and an observed probability distribution 133046. According to at least one aspect of the present disclosure, the three probability distributions 133042, 133044, 1330467 are used for feedback control of the power applied to the ultrasonic transducer to adjust the temperature based on the impedance across the ultrasonic transducer measured at multiple frequencies. The estimator used in the feedback control of the power applied to the ultrasonic transducer for adjusting the temperature based on the impedance is defined by the following expression:

[0384]

[0385] It is the impedance across the ultrasound transducer measured at multiple frequencies according to at least one aspect of the present disclosure.

[0386] The previous probability distribution 133042 includes a state variance defined by the following expression:

[0387]

[0388] State variance It is used to predict the next state of the system, which is represented by the predicted (state) probability distribution 133044. The observed probability distribution 133046 is the observed variance σ m The probability distribution of actual observations of the state of the system for a defined gain is defined by the following expression:

[0389]

[0390] Feedback Control

[0391] The power input is reduced to ensure that the temperature (as estimated by the state estimator and Kalman filter) is controlled.

[0392] In one aspect, the initial proof of concept assumes that there is a static linear relationship between the natural frequency of the electromechanical ultrasonic system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasonic system (i.e., adjusting the temperature with feedback control), the temperature of the ultrasonic blade tip can be directly controlled. In this example, the temperature of the distal tip of the ultrasonic blade can be controlled to not exceed the melting point of the Teflon pad.

[0393] Fig.22A 133050 is a graphical representation of the temperature versus time relationship of an ultrasonic device without temperature feedback control. The temperature (°C) of the ultrasonic blade is shown along the vertical axis, and time (seconds) is shown along the horizontal axis. The test was conducted with a chamois skin located in the jaws of the ultrasonic device. One jaw is an ultrasonic blade, and the other jaw is a clamping arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the chamois skin clamped between the ultrasonic blade and the clamping arm. Over time, the temperature (°C) of the ultrasonic blade increases due to the frictional engagement with the chamois skin. Over time, the temperature distribution 133052 of the ultrasonic blade increases until the chamois skin sample is cut after about 19.5 seconds at a temperature of 220°C, as indicated at point 133054. Without temperature feedback control, after cutting the chamois skin sample, the temperature of the ultrasonic blade increases to a temperature of ~380°C to ~490°C, which is much higher than the melting point of TEFLON. At point 133056, the temperature of the ultrasonic knife reaches a maximum temperature of 490°C until the TEFLON pad is completely melted. After the pad is completely gone, the temperature of the ultrasonic knife drops slightly from the peak temperature at point 133056.

[0394] Fig. 22B133064 。 The temperature of the ultrasonic blade (°C) is shown along the vertical axis, and the time (seconds) is shown along the horizontal axis. The test was conducted with a chamois leather sample located in the jaws of the ultrasonic device. One jaw is an ultrasonic blade, and the other jaw is a clamping arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the chamois leather clamped between the ultrasonic blade and the clamping arm pad. Over time, the temperature profile 133062 of the ultrasonic blade increases until the chamois leather sample is cut after about 23 seconds at a temperature of 220°C, as indicated at point 133064. In the case of temperature feedback control, as indicated at point 133066, the temperature of the ultrasonic blade rises to a maximum temperature of about 380°C, just below the melting point of TEFLON, and then decreases to an average value of about 330°C as generally indicated at area 133068, thereby preventing the TEFLON pad from melting.

[0395] Controlled Thermal Management (CTM) for Pad Protection

[0396] In one aspect, the present disclosure provides a controlled thermal management (CTM) algorithm to adjust temperature using feedback control. The output of the feedback control can be used to prevent burn-through of the ultrasonic end effector clamp arm pad, which is not a desired effect for ultrasonic surgical instruments. As previously mentioned, generally speaking, pad burn-through is caused by the continued application of ultrasonic energy to the ultrasonic blade in contact with the pad after the tissue grasped in the end effector has been transected.

[0397] The CTM algorithm exploits the fact that the resonant frequency of an ultrasonic blade, which is typically made of titanium, varies 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 when the distal end of the ultrasonic blade is hot but the waveguide is cold, the frequency difference (δ) to achieve a predetermined temperature is different than when both the distal end of the ultrasonic blade and the waveguide are hot.

[0398] In one aspect, the CTM algorithm calculates the frequency change of the ultrasonic transducer drive signal that is required to reach a certain predetermined temperature as a function of the resonant frequency of the ultrasonic electromechanical system at the beginning of activation (at lock-in). The ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade by an ultrasonic waveguide has a predefined resonant frequency that changes with temperature. The resonant frequency of the ultrasonic electromechanical system at lock-in can be used to estimate the change in the ultrasonic transducer drive frequency that is required to achieve a temperature endpoint to account for the initial thermal state of the ultrasonic blade. The resonant frequency of the ultrasonic electromechanical system may change as a function of the temperature of the ultrasonic transducer or the ultrasonic waveguide or the ultrasonic blade or a combination of these components.

[0399] Fig.23133300 is a graphical representation of the relationship between an initial resonant frequency (locking frequency) and a change in frequency (delta frequency) required to achieve a temperature of approximately 340° C. according to 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 measured data points 133302, shown as a scatter plot, there is a linear relationship 133304 between the change in frequency required to reach an ultrasonic blade temperature of approximately 340° C. and the resonant frequency at lock.

[0400] When the resonant frequency is locked, the CTM algorithm uses a linear relationship 133304 between the locked frequency and the delta frequency required to reach a temperature just below the melting point of the TEFLON pad (approximately 340° C.). According to at least one aspect of the present disclosure, once the frequency is within a certain buffer distance from the lower frequency limit, such as Fig.24 As shown in , a feedback control system 133310 including an ultrasonic generator 133312 adjusts a current (i) set point applied to an ultrasonic transducer of an ultrasonic electromechanical system 133314 to prevent the frequency (f) of the ultrasonic transducer from decreasing below a predetermined threshold. Lowering the current set point can reduce 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 the current applied to the ultrasonic transducer to be changed to adjust the natural frequency of the ultrasonic blade and indirectly control the temperature of the ultrasonic blade or the ultrasonic electromechanical system 133314. In one aspect, the generator 133312 can be implemented as a reference Figure 2 , Figure 7 , Figures 8A-8C and Figures 9A-9B The feedback control system 133310 can be implemented as a reference Figure 16-17 The PID controller, for example.

[0401] Fig.25 133320 is a flowchart of a method or logic configuration for 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 method or logic configuration illustrated by flowchart 133320 may be performed by an ultrasonic generator 133312 as described herein or a control circuit located in an ultrasonic instrument, or a combination thereof. As previously described, the generator 133312 may be implemented as a reference Figure 2 , Figure 7 , Figures 8A-8C and Figures 9A-9B The generator.

[0402] In one aspect, the control circuit in the generator 133312 initially activates the ultrasonic instrument by applying current to the ultrasonic transducer. The resonant frequency of the ultrasonic electromechanical system is initially locked under the initial condition that the temperature of the ultrasonic blade is cold or close to room temperature. When the temperature of the ultrasonic blade increases due to frictional contact with the tissue, for example, the control circuit monitors the change or δ of the resonant frequency of the ultrasonic electromechanical system, and determines 133324 whether the δ frequency threshold of the predetermined blade temperature has been reached. If the δ frequency is below the threshold, the method continues along the "no" branch, and the control circuit continues to find 133324 a new resonant frequency and monitor the δ frequency. When the δ frequency meets or exceeds the δ frequency threshold, the method continues along the "yes" branch, and calculates 133326 a new lower frequency limit (threshold) that corresponds to the melting point of the clamp arm pad. In a non-limiting example, the clamp arm pad is made of TEFLON and has a melting point of approximately 340°C.

[0403] Once the new lower frequency limit 133326 is calculated, the control circuit determines 133328 whether the resonant frequency is close to the newly calculated lower frequency limit. For example, in the case of the TEFLON clamp arm pad, the control circuit determines 133328 whether the ultrasonic knife temperature is close to 350°C, for example, based on the current resonant frequency. If the current resonant frequency is higher than the lower frequency limit, the method continues along the "no" branch and a normal level of current is applied 133330 to the ultrasonic transducer suitable for tissue transection. Alternatively, if the current resonant frequency is at or below the lower frequency limit, the method continues along the "yes" branch and the resonant frequency is adjusted 133332 by modifying the current applied to the ultrasonic transducer. For example, in one aspect, the control circuit adopts a method as described in reference. Figure 16-17 The control circuit adjusts the frequency in the loop 133332 to determine when the frequency approaches the lower limit 133328 until the "seal and cut" surgical procedure is terminated and the ultrasonic transducer is deactivated. Since the CTM algorithm shown in the logic flow diagram 133320 is only effective at or near the melting point of the clamp arm pad, the CTM algorithm is activated after transecting the tissue.

[0404] Burst pressure testing performed on samples showed that when the CTM method or logic configuration depicted in logic flow diagram 133320 is used to seal and cut blood vessels or other tissues, there is no effect on the rupture pressure of the seal. In addition, based on the test samples, the number of transections is affected. In addition, temperature measurements confirmed that the ultrasonic blade temperature is limited by the CTM algorithm, and the device that performs 10 firings at maximum power (resting for 5 seconds between firings) shows significantly reduced pad wear compared to the device without CTM algorithm feedback control, while the device without CTM algorithm feedback control did not last more than 2 firings in this abuse test.

[0405] Fig.26133340 is a temperature versus time graph comparing the desired temperature of an ultrasonic scalpel with an intelligent ultrasonic scalpel and a conventional ultrasonic scalpel according to at least one aspect of the present disclosure. Temperature (degrees Celsius) is shown along the vertical axis, and time (seconds) is shown along the horizontal axis. In the graph, the dotted line is a temperature threshold 133342 representing the desired temperature of the ultrasonic scalpel. The solid line is the reference Fig.24 and Fig.25 The temperature versus time curve 133344 of the intelligent ultrasonic scalpel under the control of the CTM algorithm. The dotted line is the temperature versus time curve 133346 of the conventional ultrasonic scalpel, which is not in the reference Fig.24 and Fig.25 As shown in the figure, once the temperature of the intelligent ultrasonic scalpel under the control of the CTM algorithm exceeds the desired temperature threshold (~340°C), the CTM algorithm controls and adjusts the temperature of the intelligent ultrasonic scalpel to match the threshold as closely as possible until the transection procedure is completed and the power of the ultrasonic transducer is deactivated or cut off.

[0406] On the other hand, the present disclosure provides a CTM algorithm for a "seal only" tissue effect of an ultrasonic device (such as ultrasonic scissors). Generally speaking, ultrasonic surgical instruments usually seal and cut tissue at the same time. Since it is uncertain when the seal will be completed before the cutting begins, it is not difficult to manufacture an ultrasonic device configured to only seal without cutting using only ultrasonic technology. In one aspect, the CTM algorithm can be configured to protect the end effector clamp arm pad by allowing the temperature of the ultrasonic knife to exceed the temperature required to cut (transect) the tissue, but not exceed the melting point of the clamp arm pad. On the other hand, the CTM sealing algorithm can be tuned to exceed the sealing temperature of the tissue (approximately 115°C to approximately 180°C based on experiments), but not exceed the cutting (transecting) temperature of the tissue (approximately 180°C to approximately 350°C). In the latter configuration, the CTM sealing algorithm provides a "seal only" tissue effect that has been successfully demonstrated. For example, in calculating a linear fit of the frequency change relative to the initial locking frequency, such as Fig.25 As shown in , changing 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 tissue sealing but no cutting. In one aspect, increasing the clamping force can improve the sealing method without affecting the clamp arm pad burn-through because the temperature of the blade is controlled by the CTM sealing algorithm only. As previously described, for example, the CTM sealing algorithm only can be controlled by reference Figure 2 , Figure 7 , Figures 8A-8C , Figures 9A-9B , Fig.16 and Fig.17 The generator and PID controller are implemented as described above. Therefore, it is possible to modify Fig.25, causes the control circuit to calculate 133326 a new lower frequency limit (threshold t corresponds to a “seal only” temperature, such as approximately 180° C., determine 133328 when the frequency approaches the lower limit, and adjust 133332 the temperature until the “seal only” surgical procedure is terminated and the ultrasonic transducer is deactivated.

[0407] In another aspect, the present invention provides a cooling thermal monitoring (CTMo) algorithm configured to detect when atraumatic grasping is feasible. Acoustic ultrasonic energy causes the ultrasonic blade temperature to be about 230°C to about 300°C to achieve the desired effect of cutting or transecting tissue. Because heat remains in the metal body of the ultrasonic blade for a period of time after the ultrasonic transducer is deactivated, if the ultrasonic end effector is used to grasp tissue before the ultrasonic blade has a chance to cool, the residual heat stored in the ultrasonic blade can cause tissue damage.

[0408] In one aspect, the CTMo algorithm calculates the change in the natural frequency of the ultrasonic electromechanical system from the natural frequency in the hot state to the natural frequency at a temperature at which the tissue grasped by the end effector is grasped without damage. In a direct or predetermined period of time after activating the ultrasonic transducer, a non-therapeutic signal (approximately 5 mA) is applied to the ultrasonic transducer, the non-therapeutic signal containing, for example, a frequency bandwidth of approximately 48,000 Hz to 52,000 Hz, under which the natural frequency is expected to be found. An FFT algorithm of the ultrasonic transducer impedance measured during stimulation of the ultrasonic transducer with the non-therapeutic signal or other mathematically valid algorithms for detecting the natural frequency of the ultrasonic electromechanical system will indicate that the natural frequency of the ultrasonic blade is the frequency at which the impedance magnitude is the smallest. Continuously stimulating 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 algorithms for estimating or measuring the natural frequency. When a change in the natural frequency corresponding to a temperature feasible for non-invasive grasping is detected, a tone, or an LED, or a screen display or other form of notification, or a combination thereof, is provided to indicate that the device is capable of non-invasive grasping.

[0409] In another aspect, the present disclosure provides a CTM algorithm configured to tone for sealing and end of cutting or transecting. Providing "tissue sealing" and "end of cutting" notifications is a challenge for conventional ultrasonic devices because temperature measurements cannot be easily mounted directly to the ultrasonic blade and the blade uses sensors that are not explicitly detected by the clamp arm pad. The CTM algorithm can indicate the temperature state of the ultrasonic blade and can be used to indicate "end of cutting" or "tissue sealing", or both, because these are temperature-based events.

[0410] In one aspect, the CTM algorithm according to the present disclosure detects an "end of cutting" state and activates a notification. Tissue is usually cut at about 210°C to about 320°C with a high probability. The CTM algorithm can activate a tone at 320°C (or a similar temperature) to indicate that further activation on the tissue is invalid because the tissue may be cut, and the ultrasonic blade is now traveling against the clamp arm pad, which is acceptable when the CTM algorithm is activated because it controls the temperature of the ultrasonic blade. In one aspect, the CTM algorithm is programmed to control or adjust the power of the ultrasonic transducer when the temperature of the ultrasonic blade is estimated to have reached 320°C to maintain the temperature of the ultrasonic blade at about 320°C. At this time, the tone starts to provide an indication that the tissue has been cut. The CTM algorithm is based on the change of frequency with temperature. After determining the initial state temperature (based on the initial frequency), the CTM algorithm can calculate the frequency change corresponding to the temperature indicating when the tissue is cut. For example, if the starting frequency is 51,000Hz, the CTM algorithm will calculate the frequency change required to achieve 320°C, which may be -112Hz. It will then start controlling to maintain that frequency set point (e.g., 50,888 Hz), thereby adjusting the temperature of the ultrasonic blade. Similarly, the frequency change can be calculated based on the initial frequency indicating when the ultrasonic blade is at a temperature indicating that the tissue may be cut. At this point, the CTM algorithm does not have to control the power, but simply starts a tone to indicate the state of the tissue, or the CTM algorithm can control the frequency at this time to maintain the temperature (if necessary). Either way, it indicates "end of cutting."

[0411] In one aspect, a CTM algorithm according to the present disclosure detects a "tissue seal" state and activates a notification. Similar to end-of-cut detection, tissue is sealed between approximately 105°C and approximately 200°C. The frequency change from the initial frequency required to indicate that the temperature of the ultrasonic blade has reached 200°C (which indicates a seal-only state) can be calculated when the ultrasonic transducer begins to activate. The CTM algorithm can activate the tone at this point, and if the surgeon wishes to obtain a seal-only state, the surgeon can stop activating or obtain a seal-only state. The surgeon can stop activating the ultrasonic transducer and automatically start a specific seal-only algorithm from this point on, or the surgeon can continue to activate the ultrasonic transducer to obtain a tissue cutting state.

[0412] Adaptive Advanced Tissue Therapy Pad Protection Mode

[0413] Fig. 27A graphical representation 133110 of ultrasonic blade temperature as a function of time during vessel firing according to at least one aspect of the present disclosure. A graph 133112 of ultrasonic blade temperature is plotted along the vertical axis as a function of time along the horizontal axis. The frequency temperature feedback control algorithm combines the temperature of the ultrasonic blade feedback control with the jaw sensing capability. The frequency temperature feedback control algorithm provides optimal hemostasis balanced with device durability and is able to intelligently deliver energy for optimal sealing while protecting the clamp arm pads.

[0414] like Fig. 27 As shown in FIG. 1 , the optimal temperature 133114 for vessel sealing is labeled as the first target temperature T1, and the optimal temperature 133116 for "infinite" clamp arm pad life is labeled as the second target temperature T2. The frequency temperature feedback control algorithm infers the temperature of the ultrasonic blade and maintains the temperature of the ultrasonic blade between the first target temperature threshold T1 and the second target temperature threshold T2. Therefore, the generator power output is driven to achieve the optimal ultrasonic blade temperature for sealing the vessel and extending the life of the clamp arm pad.

[0415] Initially, the temperature of the ultrasonic blade increases as the blade heats and eventually exceeds the first target temperature threshold T1. The frequency-temperature feedback control algorithm takes over to control the temperature of the blade to T1 until 133118 vessel transection is completed at t0 and the ultrasonic blade temperature drops below the second target temperature threshold T2. The processor or control circuit of the generator or instrument or both detects when the ultrasonic blade contacts the clamp arm pad, which can be an indication that the vessel transection is complete. Once the vessel transection is completed and detected at t0, the frequency-temperature feedback control algorithm switches to controlling the temperature of the ultrasonic blade to the second target threshold T2 to extend the life of the clamp arm pad. The optimal clamp arm pad life temperature of the TEFLON clamp arm pad is approximately 325°C. In one aspect, the advanced tissue treatment can be notified to the user with a second activation tone.

[0416] Fig.28 To describe the temperature of the ultrasonic knife according to at least one aspect of the present disclosure, Fig. 27 133120 is a logic flow diagram of a process for controlling a program or logic configuration between two temperature set points depicted in FIG. 133120. According to the process, the generator performs one aspect of a frequency-temperature feedback control algorithm to control the temperature of the ultrasonic transducer by, for example, adjusting the voltage V applied to the ultrasonic transducer. g (t) Signal and / or current I g (t) signal to apply 133122 a first power level to the ultrasonic transducer, thereby setting the ultrasonic blade temperature to a first target T1 optimized for vessel sealing. As previously described, the generator monitors 133124 the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals And based on this phase angle The generator uses this article combined Figure 19A-21 The described technology infers 133126 the temperature of the ultrasonic blade. According to the frequency temperature feedback control algorithm, the processor or control circuit of the generator or the instrument or both maintains the temperature of the ultrasonic blade at the first target temperature T1 until the transection is completed. The frequency temperature feedback control algorithm can be used to detect the completion of the vessel transection process. The processor or control circuit of the generator or the instrument or both determines 133128 when the vessel transection is completed. When the vessel transection is not completed, the method continues along the NO branch, and when the vessel transection is completed, it continues along the YES branch.

[0417] When vessel transection is not complete, the processor or control circuitry of the generator or instrument or both determines 133130 whether the temperature of the ultrasonic blade is set to a temperature T1 optimized for vessel sealing and transection. If the temperature of the ultrasonic blade is set to T1, the process continues along the "yes" branch, and the processor or control circuitry of the generator or instrument or both continues to monitor 133124 the voltage V applied to the ultrasonic transducer. g (t)Signal and current I g (t) Phase angle between signals Based on this phase angle If the temperature of the ultrasonic blade is not set to T1, the process continues along the "NO" branch and the processor or control circuit of the generator or the instrument or both continues to apply 133122 the first power level to the ultrasonic transducer.

[0418] When the vessel transection is complete, the processor or control circuit of the generator or the instrument or both applies 133132 a second power level to the ultrasonic transducer to set the ultrasonic blade to a second target temperature T2 optimized for maintaining or extending the life of the clamp arm pad. In some aspects, the processor or control circuit of the generator or the instrument or both detects when the ultrasonic blade contacts the clamp arm pad as an indication that the vessel transection is complete. The processor or control circuit of the generator or the instrument or both determines 133134 whether the temperature of the ultrasonic blade is at the set temperature T2. If the temperature of the ultrasonic blade is not set to T2, the processor or control circuit of the generator or the instrument or both continues to monitor 133124 the voltage V applied to the ultrasonic transducer. g (t)Signal and current I g (t) Phase angle between signals Since the vessel transection is completed, for example, the processor or control circuit of the generator or the instrument or both detects that the ultrasonic blade contacts the clamp arm pad, the processor or control circuit of the generator or the instrument or both applies 133132 a second power level to the ultrasonic transducer to set the ultrasonic blade to a second target temperature T2. If the temperature of the ultrasonic blade is set to T2, the process completes 133136 the vessel transection procedure.

[0419] Although multiple forms have been illustrated and described, it is not the intention of the applicant to restrict or limit the scope of the appended claims to such details. Without departing from the scope of the present disclosure, many modifications, changes, alterations, substitutions, combinations and equivalents to these forms can be realized, and those skilled in the art will think of many modifications, changes, alterations, substitutions, combinations and equivalents to these forms. In addition, alternatively, the structure of each element associated with the described form can be described as a device for providing the function performed by the element. In addition, in the case of disclosing materials for certain parts, other materials can also be used. Therefore, it should be understood that the above-mentioned specific embodiments and the appended claims are intended to cover all such modifications, combinations and variants within the scope of the forms disclosed by the present invention. The appended claims are intended to cover all such modifications, changes, alterations, substitutions, modifications and equivalents.

[0420] The above specific embodiments have been described in various forms of devices and / or methods by using block diagrams, flow charts and / or examples. As long as such block diagrams, flow charts and / or examples contain one or more functions and / or operations, those skilled in the art will understand that each function and / or operation in such block diagrams, flow charts and / or examples can be implemented individually and / or collectively by a variety of hardware, software, firmware or any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein can be implemented equivalently in integrated circuits 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 as any combination thereof in whole or in part, and according to the present invention, designing electronic circuits and / or writing software and / or firmware codes will be within the technical scope of those skilled in the art. In addition, those skilled in the art will recognize that the mechanisms of the subject matter described herein can be distributed as one or more program products in various forms, and that the exemplary forms of the subject matter described herein are applicable regardless of the specific type of signal-bearing medium used to actually carry out the distribution.

[0421] Instructions for programming logic to perform various disclosed aspects may be stored in a memory within the system, such as a dynamic random access memory (DRAM), a cache, a flash memory, or other memory. In addition, the instructions may be distributed via a network or through other computer-readable media. Therefore, a machine-readable medium may include a mechanism for storing or transmitting information in a machine (e.g., computer) readable form, but is not limited to a floppy disk, an optical disk, an optical disk, a read-only memory (CD-ROM), a magneto-optical disk, a read-only memory (ROM), a random access memory (RAM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic card or an optical card, a flash memory, or a tangible, machine-readable storage device used when transmitting information on the Internet via an electrical signal, an optical signal, an acoustic signal, or other form of propagation signal (e.g., a carrier wave, an infrared signal, a digital signal, etc.). Therefore, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a machine (e.g., computer) readable form.

[0422] As used in any aspect of this document, the term "control circuitry" may refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more separate instruction processing cores, a processing unit, a processor, a microcontroller, a microcontroller unit, a controller, a digital signal processor (DSP), a programmable logic device (PLD), a programmable logic array (PLA), a field programmable gate array (FPGA)), a state machine circuitry, firmware that stores instructions executed by the programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry that forms part of a larger system, such as 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 smart phone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program to at least partially implement the methods and / or apparatus described herein, or a microprocessor configured by a computer program to at least partially implement the methods and / or apparatus described herein), electronic circuitry forming a storage device (e.g., in the form of random access memory), and / or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). 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.

[0423] As used in any aspect of this document, the term "logic" may refer to an application, software, firmware, and / or circuitry configured to perform any of the foregoing operations. 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, instruction sets, and / or data hard-coded (e.g., non-volatile) in a storage device.

[0424] As used in any aspect of this document, the terms "component," "system," "module" and the like may refer to a computer-related entity, hardware, a combination of hardware and software, software, or software in execution.

[0425] As used in any aspect herein, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result, wherein the "steps" refer to manipulations of physical quantities and / or logical states which may, but need not, take the form of electrical or magnetic signals capable of being stored, converted, combined, compared, and otherwise manipulated. References to such signals are often made to bits, values, elements, symbols, characters, terms, numbers, and the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to such quantities and / or states.

[0426] The network may include a packet switching network. The communication devices may be able to communicate with each other using the selected packet switching network communication protocol. An exemplary communication protocol may include an Ethernet communication protocol that allows communication using a transmission control protocol / Internet protocol (TCP / IP). The Ethernet protocol may comply with or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" issued by the Institute of Electrical and Electronics Engineers (IEEE) in December 2008 and / or a higher version of this standard. Alternatively or additionally, the communication devices may be able to communicate with each other using an X.25 communication protocol. The X.25 communication protocol may comply with or comply with the standards promulgated by the International Telecommunication Union Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may be able to communicate with each other using a frame relay communication protocol. The frame relay communication protocol may comply with or comply with the standards issued by the International Telephone and Telephone Consultation Committee (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be able to communicate with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard entitled "ATM-MPLS Network Interworking 2.0" released by the ATM Forum in August 2001 and / or a later version of the standard. Of course, different and / or later developed connection-oriented network communication protocols are also contemplated herein.

[0427] Unless otherwise expressly indicated in the above disclosure, it is understood that discussions using terms such as "processing," "computing," "calculating," "determining," and "displaying" in the above disclosure refer to the actions and processes of a computer system or similar electronic computing device that manipulates data represented as physical (electronic) quantities within the computer system's registers and memories and transforms it into other data similarly represented as physical quantities within the computer system's memories or registers or other such information storage, transmission, or display devices.

[0428] One or more components may be referred to herein as being "configured to", "configurable to", "operable / operably", "suitable / adaptable to", "capable of", "conformable / conformable to", etc. Those skilled in the art will recognize that, unless the context indicates otherwise, "configured to" may generally encompass components in an active state and / or components in an inactive state and / or components in a standby state.

[0429] The terms "proximal" and "distal" are used herein relative to a clinician manipulating the 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 positioned away from the clinician. It should also be understood that for brevity and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein in conjunction with the accompanying drawings. However, surgical instruments are used in many orientations and positions, and these terms are not restrictive and / or absolute.

[0430] Those skilled in the art will recognize that, in general, the terms used herein, and in particular in the appended claims (e.g., the body of the appended claims), are generally intended to be "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 "comprising" should be interpreted as "including but not limited to", etc.). Those skilled in the art will also understand that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such a recitation, no such intent is present. For example, to aid understanding, the following appended claims may contain use of the introductory phrases "at least one" and "one or more" to introduce claims. However, the use of such phrases should not be construed as implying that the introduction of a claim recitation by the indefinite article "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and an indefinite article such as "a" or "an" (e.g., "a" and / or "an" should generally be interpreted as meaning "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations.

[0431] In addition, even if a specific number of claim recitations is explicitly recited, those skilled in the art will recognize that such recitation should generally be interpreted to mean at least the recited number (e.g., a bare recitation of "two recitations" without other modifiers generally means at least two recitations, or two or more recitations). In addition, in those cases where a convention similar to "at least one of A, B, and C, etc." is used, generally, such construction is intended to have the meaning that those skilled in the art will understand the convention (e.g., "a system having at least one of A, B, and C" will include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). In those cases where a convention similar to "at least one of A, B, or C, etc." is used, generally, such construction is intended to have the meaning that those skilled in the art will understand the convention (e.g., "a system having at least one of A, B, or C" will include, but is not limited to, systems having only A, only B, only C, A and B together, A and C together, B and C together, and / or A, B, and C together, etc.). Those skilled in the art will also understand that, generally, unless the context indicates otherwise, transitional words and / or phrases presenting two or more alternative terms in the detailed description, claims, or drawings should be understood to include the possibility of including one of the terms, any one of the terms, or both of the terms. For example, the phrase "A or B" will generally be understood to include the possibility of "A" or "B" or "A and B".

[0432] For the attached claims, it will be understood by those skilled in the art that the operations described therein can generally be performed in any order. In addition, although multiple operation flow charts are listed in sequence, it should be understood that the multiple operations can be performed in other orders different from the order shown, or the multiple operations can be performed simultaneously. Unless the context otherwise provides, examples of such alternative ordering may include overlapping, interlaced, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, reverse, or other changed ordering. In addition, unless the context otherwise provides, terms such as "responsive to", "related to" or other past tense adjectives are generally not intended to exclude such variants.

[0433] It is worth mentioning that any reference to "one aspect", "an aspect", "an example", or "an example" means that the specific features, structures, or characteristics described in conjunction with the aspect are included in at least one aspect. Therefore, the phrases "in one aspect", "in an aspect", "in an example", or "in an example" appearing in different places throughout the specification do not necessarily refer to the same aspect. In addition, the specific features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

[0434] Any patent application, patent, non-patent publication or other public material referred to in this specification and / or listed in any application data sheet is incorporated herein by reference to the extent that the incorporated material is inconsistent herewith. Therefore, and to the extent necessary, the disclosure explicitly listed herein supersedes any conflicting material incorporated herein by reference. Any material or portion thereof that is allegedly incorporated herein by reference but conflicts with existing definitions, statements or other public material listed herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public material.

[0435] In summary, many of the benefits resulting from the adoption of the concepts described herein have been described. For purposes of illustration and description, one or more of the above specific embodiments have been provided. These specific embodiments are not intended to be exhaustive or limited to the precise forms disclosed by the invention. The invention may be modified or varied in accordance with the above teachings. The one or more forms selected and described are intended to illustrate the principles and practical applications so that one of ordinary skill in the art can utilize the multiple forms and various modifications suitable for the intended specific use. The claims filed herewith are intended to define the full scope.

[0436] Various aspects of the subject matter described herein are set forth in the following numbered examples:

[0437] Embodiment 1: A method for controlling the temperature of an ultrasonic knife between two temperature set points, the method comprising:

[0438] applying a first power level to an ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide;

[0439] Monitor the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals

[0440] Based on the voltage V applied to the ultrasonic transducer g (t) signal and the current I g (t) The phase angle between the signals To infer the temperature of the ultrasonic knife;

[0441] Determine that the cross-cutting process is complete; and

[0442] A second power level is applied to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2.

[0443] Embodiment 2: A method according to Embodiment 1, wherein applying a first power level to the ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1 includes applying a first power level to the ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1 higher than the second target temperature T2.

[0444] Embodiment 3: A method according to any one or more of Embodiments 1 to 2, wherein applying a first power level to the ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1 includes applying a first power level to the ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature optimized for blood vessel sealing.

[0445] Embodiment 4: A method according to any one or more of Embodiments 1 to 3, wherein applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2 includes applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature optimized for the life of the clamping arm pad.

[0446] Embodiment 5: A method according to Embodiment 4, wherein applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature optimized for the clamp arm pad life includes applying a second power level to the ultrasonic transducer to set the ultrasonic blade temperature to 325°C.

[0447] Embodiment 6: The method according to any one or more of embodiments 1 to 5, wherein determining that the transection process is complete includes determining that the ultrasonic blade contacts the clamp arm pad.

[0448] Embodiment 7: An ultrasonic surgical instrument, comprising:

[0449] The ultrasonic electromechanical system comprises an ultrasonic electromechanical system coupled to an ultrasonic

[0450] The ultrasonic transducer of the knife;

[0451] clamp arm pads; and

[0452] a generator configured to supply power to the ultrasonic transducer, wherein

[0453] The generator comprises a control circuit configured to:

[0454] applying a first power level to an ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide;

[0455] Monitor the voltage V applied to the ultrasonic transducer g (t)Signal and current I g(t) Phase angle between signals

[0456] Based on the voltage V applied to the ultrasonic transducer g (t) signal and the current I g (t) The phase angle between the signals To infer the temperature of the ultrasonic knife;

[0457] Determine that the cross-cutting process is complete; and

[0458] A second power level is applied to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2.

[0459] Embodiment 8: The ultrasonic surgical instrument according to Embodiment 7, wherein the first target temperature T1 is higher than the second target temperature T2.

[0460] Embodiment 9: The ultrasonic surgical instrument according to any one or more of Embodiments 7 to 8, wherein the first target temperature T1 is optimized for blood vessel sealing.

[0461] Embodiment 10: The ultrasonic surgical instrument according to any one or more of Embodiments 7 to 9, wherein the second target temperature T2 is optimized for clamp arm pad life.

[0462] Embodiment 11: An ultrasonic surgical instrument according to Embodiment 10, wherein the second target temperature is 325°C.

[0463] Embodiment 12: An ultrasonic surgical instrument according to any one or more of Embodiments 7 to 11, wherein the control circuit configured to determine that the transection process is complete includes a control circuit for determining that the ultrasonic blade contacts the clamp arm pad.

[0464] Embodiment 13: A generator for an ultrasonic surgical instrument, the generator comprising:

[0465] A control circuit, the control circuit being configured to:

[0466] applying a first power level to an ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide;

[0467] Monitor the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals

[0468] Based on the voltage V applied to the ultrasonic transducer g(t) signal and the current I g (t) The phase angle between the signals To infer the temperature of the ultrasonic knife;

[0469] Determine that the cross-cutting process is complete; and

[0470] A second power level is applied to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2.

[0471] Embodiment 14: The generator according to Embodiment 13, wherein the first target temperature T1 is higher than the second target temperature T2.

[0472] Embodiment 15: The generator according to any one or more of embodiments 13 to 14, wherein the first target temperature T1 is optimized for blood vessel sealing.

[0473] Embodiment 16: The generator according to any one or more of embodiments 13 to 15, wherein the second target temperature T2 is optimized for clamp arm pad life.

[0474] Embodiment 17: The generator of embodiment 16, wherein the second target temperature is 325°C.

[0475] Embodiment 18: The generator of any one or more of Embodiments 13 to 17, wherein the control circuit configured to determine that the transection process is complete includes a control circuit for determining that the ultrasonic blade contacts the clamp arm pad.

[0476] Embodiment 19: An ultrasonic surgical system, comprising:

[0477] a processor and a non-volatile memory, wherein the non-volatile memory contains instructions, the

[0478] The instructions, when executed by the processor, cause the processor to:

[0479] applying a first power level to an ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide;

[0480] Monitor the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals

[0481] Based on the voltage V applied to the ultrasonic transducer g (t) signal and the current I g (t) The phase angle between the signals To infer the temperature of the ultrasonic knife;

[0482] Determine that the cross-cutting process is complete; and

[0483] A second power level is applied to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2.

Claims

1. An ultrasonic surgical instrument, comprising: an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide; Clamping arm pad; as well as a generator configured to supply power to the ultrasonic transducer, wherein the generator comprises a control circuit configured to: applying a first power level to an ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide; Monitor the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle φ between the signals; Based on a state-space model of temperature and frequency depending on time and energy, the voltage V applied to the ultrasonic transducer g (t) signal and the current I g (t) and (t) the phase angle φ between the signals to infer the temperature of the ultrasonic scalpel, wherein inferring the temperature of the ultrasonic scalpel comprises: Using a set of nonlinear state-space formulas to model the relationship between frequency and temperature of the ultrasonic blade; applying a Kalman filter to improve the accuracy of the temperature estimator and the state-space model over time; and providing a state estimator in a feedback loop of the Kalman filter to adjust the temperature of the ultrasonic blade, Determine that the cross-cutting process is complete; and A second power level is applied to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2.

2. The ultrasonic surgical instrument according to claim 1, wherein: The first target temperature T1 is higher than the second target temperature T2.

3. The ultrasonic surgical instrument according to claim 1, wherein: The first target temperature T1 is optimized for blood vessel sealing.

4. The ultrasonic surgical instrument according to claim 1, wherein: The second target temperature T2 is optimized for clamp arm pad life.

5. The ultrasonic surgical instrument according to claim 4, wherein: The second target temperature is 325°C.

6. The ultrasonic surgical instrument according to claim 1, wherein: The control circuitry configured to determine that a transection process is complete includes control circuitry for determining that the ultrasonic blade contacts the clamp arm pad.

7. A generator for an ultrasonic surgical instrument, the generator comprising: A control circuit, the control circuit being configured to: applying a first power level to an ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide; Monitor the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle φ between the signals; Based on a state-space model of temperature and frequency depending on time and energy, the voltage V applied to the ultrasonic transducer g (t) signal and the current I g (t) and (t) the phase angle φ between the signals to infer the temperature of the ultrasonic scalpel, wherein inferring the temperature of the ultrasonic scalpel comprises: Using a set of nonlinear state-space formulas to model the relationship between frequency and temperature of the ultrasonic blade; applying a Kalman filter to improve the accuracy of the temperature estimator and the state-space model over time; and providing a state estimator in a feedback loop of the Kalman filter to adjust the temperature of the ultrasonic blade, Determine that the cross-cutting process is complete; and A second power level is applied to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2.

8. The generator according to claim 7, wherein The first target temperature T1 is higher than the second target temperature T2.

9. The generator according to claim 7, wherein The first target temperature T1 is optimized for blood vessel sealing.

10. The generator according to claim 7, wherein The second target temperature T2 is optimized for the life of the clamp arm pad of the ultrasonic surgical instrument.

11. The generator according to claim 10, wherein The second target temperature is 325°C.

12. The generator according to claim 7, wherein: The control circuitry configured to determine that a transection process is complete includes control circuitry for determining that the ultrasonic blade contacts a clamp arm pad of the ultrasonic surgical instrument.

13. An ultrasonic surgical system, comprising: a processor and a non-transitory memory, wherein the non-transitory memory includes instructions that, when executed by the processor, cause the processor to: applying a first power level to an ultrasonic transducer to set the ultrasonic blade temperature to a first target temperature T1, wherein the ultrasonic transducer is coupled to the ultrasonic blade via an ultrasonic waveguide; Monitor the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle φ between the signals; Based on a state-space model of temperature and frequency depending on time and energy, the voltage V applied to the ultrasonic transducer g (t) signal and the current I g (t) and (t) the phase angle φ between the signals to infer the temperature of the ultrasonic scalpel, wherein inferring the temperature of the ultrasonic scalpel comprises: Using a set of nonlinear state-space formulas to model the relationship between frequency and temperature of the ultrasonic blade; applying a Kalman filter to improve the accuracy of the temperature estimator and the state-space model over time; and providing a state estimator in a feedback loop of the Kalman filter to adjust the temperature of the ultrasonic blade, Determine that the cross-cutting process is complete; and A second power level is applied to the ultrasonic transducer to set the ultrasonic blade temperature to a second target temperature T2.

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