Using spectroscopy to determine device usage status in combination devices

Abstract

The ultrasonic device may include an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system also including an ultrasonic transducer coupled to an ultrasonic blade. A method of delivering energy to an ultrasonic device may include: measuring the complex impedance of an ultrasonic blade coupled to the ultrasonic transducer; comparing the measured complex impedance with a stored value of a complex impedance pattern associated with an ultrasonic blade function; and applying an algorithm based on the comparison to control the power output to the ultrasonic transducer. The method may also include delivering energy to the ultrasonic device based on a state or condition of an end effector, wherein the state or condition of the end effector corresponds to a state of sealing tissue only or coagulating tissue spots.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. non-provisional patent application serial number 16 / 144,427, filed on September 27, 2018, entitled “USING SPECTROSCOPY TO DETERMINED EVICE USE STATE IN COMBO INSTRUMENT,” the disclosure of which is incorporated herein by reference in its entirety.

[0003] This application also 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 disclosures of each of which are incorporated herein by reference in their entirety. Background Art

[0004] 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 surgical applications due to their unique performance characteristics. Depending on the specific device configuration and operating parameters, the ultrasonic surgical device can generally 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 transmits 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 surgery, including robot-assisted surgery.

[0005] Ultrasonic energy uses temperatures lower than those used in electrosurgery 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 vibration (e.g., 55,500 cycles per second), the ultrasonic knife denatures the protein 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 offset level of the end effector.

[0006] 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 curve of the ultrasonic transducer to improve the frequency locking capability of the generator. 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.

[0007] 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.

[0008] 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.

[0009] 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 may also include a cutting member capable of moving relative to the tissue and an electrode for transecting the tissue.

[0010] The electrical energy applied by the electrosurgical device can be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy can be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that can be in the frequency range of 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 generally limited to less than 5MHz. However, in bipolar RF applications, the frequency can be almost any value. Monopolar applications generally use frequencies above 200kHz in order to avoid unwanted stimulation of nerves and muscles due to the use of low-frequency currents. If a risk analysis shows that the potential for neuromuscular stimulation has been reduced to an acceptable level, lower frequencies can be used in bipolar techniques. 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.

[0011] During its operation, an electrosurgical device transmits low-frequency RF energy through tissue, which causes ionic vibration or friction and actually causes resistive heating, thereby raising the temperature of the tissue. Because a sharp boundary can be formed between the affected tissue and the surrounding tissue, the surgeon can operate with a high level of precision and control without damaging adjacent non-target tissue. The low operating temperature of RF energy can be suitable for removing soft tissue while sealing blood vessels, shrinking soft tissue, or shaping soft tissue. RF energy can be particularly well suited for connective tissue, which is primarily composed of collagen and shrinks when exposed to heat.

[0012] 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.

[0013] 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 be operable with an ultrasonic and / or electrosurgical instrument generator are also contemplated.

[0014] 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.

[0015] 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

[0016] One aspect of an ultrasonic device may include an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system also having an ultrasonic transducer coupled to an ultrasonic blade. One aspect of a method of delivering energy to an ultrasonic device may include measuring, by a processor or control circuit: a complex impedance of an ultrasonic blade coupled to the ultrasonic transducer, comparing, by the processor or control circuit, the measured complex impedance with a stored value of a complex impedance pattern associated with an ultrasonic blade function, and applying, by the processor or control circuit, an algorithm based on the comparison to control the power output to the ultrasonic transducer.

[0017] In one aspect, the method may further include delivering energy to the ultrasonic device based on the state or condition of the end effector by the processor or control circuit, wherein determining the state or condition of the end effector may include measuring, by the processor or control circuit, the complex impedance of the ultrasonic transducer, wherein the complex impedance is defined as The complex impedance measurement data points are received by a processor or control circuit, the complex impedance measurement data points are compared by the processor or control circuit with data points in a reference complex impedance signature pattern, the complex impedance measurement data points are classified by the processor or control circuit based on the results of the comparative analysis, and the state or condition of the end effector is designated by the processor or control circuit based on the results of the comparative analysis.

[0018] In one aspect of the method, designating, by the processor or control circuit, a state or condition of the end effector based on the results of the comparative analysis may include designating, by the processor or control circuit, a state or condition of the end effector corresponding to a state in which only tissue is sealed.

[0019] In one aspect of the method, designating, by the processor or control circuit, a state or condition of the end effector based on the results of the comparative analysis may include designating, by the processor or control circuit, a state or condition of the end effector corresponding to a state of coagulating the tissue spot.

[0020] In one aspect, the method may further include delivering energy to the ultrasonic device based on the state or condition of the end effector by the processor or control circuit, wherein determining the state or condition of the end effector may include: applying a drive signal to the ultrasonic transducer by the drive circuit, wherein the drive signal is a periodic signal defined by an amplitude and a frequency, sweeping the frequency of the drive signal from below resonance to above resonance of the electromechanical ultrasonic system by the processor or control circuit, and measuring and recording impedance / admittance circle variables R by the processor or control circuit. e , G e , X e and B e The processor or control circuit converts the measured impedance / admittance circle variable R e , G e , X e and B e With reference impedance / admittance circle variable R ref , G ref , X ref and B ref A comparison is made, and a determination is made by a processor or control circuit about the state or condition of the end effector based on the results of the comparative analysis.

[0021] In one aspect of the method, designating, by the processor or control circuit, a state or condition of the end effector based on the results of the comparative analysis may include designating, by the processor or control circuit, a state or condition of the end effector corresponding to a state in which only tissue is sealed.

[0022] In one aspect of the method, designating, by the processor or control circuit, a state or condition of the end effector based on the results of the comparative analysis may include designating, by the processor or control circuit, a state or condition of the end effector corresponding to a state of coagulating the tissue spot.

[0023] One aspect of an ultrasonic surgical instrument may include an ultrasonic electromechanical system having an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide and a generator configured to supply power to the ultrasonic transducer. One aspect of the generator may include a control circuit configured to measure the complex impedance of the ultrasonic blade coupled to the ultrasonic transducer, compare the measured complex impedance with a value of a complex impedance pattern associated with a stored ultrasonic blade function, and apply an algorithm based on the comparison to control the power output to the ultrasonic transducer.

[0024] In one aspect of the ultrasonic surgical instrument, the generator may include a control circuit that is further configured to deliver energy to the ultrasonic device based on a state or condition of the end effector when the control circuit is further configured to measure a complex impedance of the ultrasonic transducer, wherein the complex impedance is defined as A complex impedance measurement data point is received, the complex impedance measurement data point is compared with data points in a reference complex impedance signature pattern, the complex impedance measurement data point is classified based on the results of the comparative analysis, and a state or condition of the end effector is assigned based on the results of the comparative analysis.

[0025] In one aspect of the ultrasonic surgical instrument, the state or condition of the end effector corresponds to a state in which only tissue is sealed.

[0026] In one aspect of the ultrasonic surgical instrument, the state or condition of the end effector corresponds to a state in which the tissue spot is coagulated.

[0027] In one aspect of the ultrasonic surgical instrument, the generator may include a control circuit that is further configured to deliver energy to the ultrasonic device based on a state or condition of the end effector when the control circuit is further configured to cause the drive circuit to apply a drive signal to the ultrasonic transducer, wherein the drive signal is a periodic signal defined by an amplitude and a frequency, sweeping the frequency of the drive signal from below resonance to above resonance of the electromechanical ultrasonic system, measuring and recording an impedance / admittance circle variable R e , G e , X e and B e , the measured impedance / admittance circle variable Re , G e , X e and B e With reference impedance / admittance circle variable R ref , G ref , X ref and B ref A comparison is performed, and a state or condition of the end effector is determined based on the results of the comparative analysis.

[0028] In one aspect of the ultrasonic surgical instrument, the state or condition of the end effector corresponds to the state of only the tissue.

[0029] In one aspect of the ultrasonic surgical instrument, the state or condition of the end effector corresponds to a state in which the tissue spot is coagulated.

[0030] One aspect of a generator for an ultrasonic surgical instrument may include a control circuit configured to measure a complex impedance of an ultrasonic blade coupled to an ultrasonic transducer, compare the measured complex impedance to a value of a stored complex impedance pattern associated with an ultrasonic blade function, and apply an algorithm based on the comparison to control power output to the ultrasonic transducer.

[0031] In one aspect of the generator, the control circuit is further configured to deliver energy to the ultrasonic surgical instrument based on a state or condition of the end effector when the control circuit is further configured to measure a complex impedance of the ultrasonic transducer, wherein the complex impedance is defined as A complex impedance measurement data point is received, the complex impedance measurement data point is compared with data points in a reference complex impedance signature pattern, the complex impedance measurement data point is classified based on the results of the comparative analysis, and a state or condition of the end effector is assigned based on the results of the comparative analysis.

[0032] In one aspect of the generator, the state or condition of the end effector corresponds to a state in which only tissue is sealed.

[0033] In one aspect of the generator, the state or condition of the end effector corresponds to a state that causes coagulation of the tissue spot.

[0034] In one aspect of the generator, the control circuit is further configured to enable the drive circuit to apply a drive signal to the ultrasonic transducer based on the state or condition of the end effector to deliver energy to the ultrasonic surgical instrument, wherein the drive signal is a periodic signal defined by amplitude and frequency, sweep the frequency of the drive signal from below resonance to above resonance of the electromechanical ultrasonic system, measure and record the impedance / admittance circle variable R e , G e , X e and B e , the measured impedance / admittance circle variable Re , G e , X e and B e With reference impedance / admittance circle variable R ref , G ref , X ref and B ref A comparison is performed, and a state or condition of the end effector is determined based on the results of the comparative analysis.

[0035] In one aspect of the generator, the state or condition of the end effector corresponds to a state in which only tissue is sealed.

[0036] In one aspect of the generator, the state or condition of the end effector corresponds to a state that causes coagulation of the tissue spot. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] 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.

[0038] Figure 1 A system according to at least one aspect of the present disclosure is configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub.

[0039] Figure 2 An example of a generator according to at least one aspect of the present disclosure is shown.

[0040] 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.

[0041] Figure 4 An end actuator according to at least one aspect of the present disclosure.

[0042] Figure 5 According to at least one aspect of the present disclosure Figure 3 Illustration of the surgical system.

[0043] Figure 6 A model showing dynamic branch current according to at least one aspect of the present disclosure is provided.

[0044] Figure 7 is a structural diagram of a generator architecture according to at least one aspect of the present disclosure.

[0045] FIG. 8A to FIG. 8C A functional view of a generator architecture according to at least one aspect of the present disclosure.

[0046] FIG. 9A to FIG. 9B Structural and functional aspects of a generator according to at least one aspect of the present disclosure.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] Fig.14 An aspect of a direct digital synthesis (DDS) circuit configured to generate multiple waveform shapes of electrical signal waveforms for use in a surgical instrument in accordance with at least one aspect of the present disclosure is shown.

[0052] 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 a discrete-time digital electrical signal waveform for comparison purposes) according to at least one aspect of the present disclosure.

[0053] Fig.16 is a diagram of a control system according to one aspect of the present disclosure.

[0054] Fig.17 A proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure is shown.

[0055] 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.

[0056] Fig.19 Spectral graphs of the same ultrasonic device under various states and conditions of the end effector according to at least one aspect of the present disclosure, wherein the phase and amplitude of the impedance of the ultrasonic transducer are plotted as a function of frequency.

[0057] Fig. 20is a graphical representation of a graph of a set of 3D training data S in which ultrasound transducer impedance magnitude and phase are plotted as a function of frequency according to at least one aspect of the present disclosure.

[0058] Fig.21 A logic flow diagram depicting a control procedure or logic configuration for determining jaw condition based on a complex impedance signature pattern (fingerprint) in accordance with at least one aspect of the present disclosure.

[0059] Fig. 22 is a circular graph of complex impedance plotted as a relationship between an imaginary component and a real component of a piezoelectric vibrator according to at least one aspect of the present disclosure.

[0060] Fig.23 is a circular graph of a complex admittance plotted as a relationship between an imaginary component and a real component of a piezoelectric vibrator according to at least one aspect of the present disclosure.

[0061] Fig.24 Circular diagram of the complex admittance of a 55.5kHz ultrasonic piezoelectric transducer.

[0062] Fig.25 1 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure, showing an impedance / admittance graph of an ultrasonic device with jaws open and no load, wherein the complex admittance is depicted as a dashed line and the complex impedance is depicted as a solid line.

[0063] Fig.26 A graphical representation of an impedance analyzer according to at least one aspect of the present disclosure shows an impedance / admittance graph of an ultrasonic device with jaws clamped on dry chamois, with complex admittance depicted as a dashed line and complex impedance depicted as a solid line.

[0064] Fig. 27 A graphical representation of an impedance analyzer according to at least one aspect of the present disclosure shows an impedance / admittance graph of an ultrasonic device with jaw tips clamped on wet chamois leather, wherein the complex admittance is depicted as a dashed line and the complex impedance is depicted as a solid line.

[0065] Fig.28 A graphical representation of an impedance analyzer according to at least one aspect of the present disclosure shows an impedance / admittance graph of an ultrasonic device with jaws fully clamped on wet chamois leather, wherein the complex admittance is depicted as a dashed line and the complex impedance is depicted as a solid line.

[0066] Fig.29 A graphical display of an impedance analyzer according to at least one aspect of the present disclosure showing an impedance / admittance plot of multiple resonances of an ultrasonic device where the frequency is swept from 48 kHz to 62 kHz to capture jaw opening, wherein the rectangular stackup shown in dashed lines helps to see the circle.

[0067] Fig.30 A logic flow diagram depicting a process for a control program or logic configuration to determine a jaw condition based on an estimate of the radius and offset of an impedance / admittance circle in accordance with at least one aspect of the present disclosure.

[0068] Fig.31 The system is a system according to at least one aspect of the present disclosure, and is used to measure the complex impedance of an ultrasonic transducer in real time to determine the action being performed by an ultrasonic knife.

[0069] Fig.32 1 is a logic flow diagram of a process according to at least one aspect of the present disclosure that depicts a control program or logic configuration for determining an action being performed by an ultrasonic blade based on a complex impedance pattern.

[0070] manual

[0071] 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:

[0072] U.S. Provisional Patent Application entitled “METHODS FOR CONTROLLING TEMPERATURE INULTRASONIC DEVICE” and attorney docket number END8560USNP1 / 180106-1M;

[0073] U.S. Provisional Patent Application entitled “ULTRASONIC SEALING ALGORITHM WITH TEMPERATURE CONTROL”, attorney docket number END8560USNP3 / 180106-3;

[0074] U.S. Provisional Patent Application entitled “APPLICATION OF SMART ULTRASONIC BLADE TECHNOLOGY” and attorney docket number END8560USNP4 / 180106-4;

[0075] U.S. Provisional Patent Application entitled “ADAPTIVE ADVANCED TISSUE TREATMENT PADSAVER MODE” and attorney docket number END8560USNP5 / 180106-5;

[0076] U.S. Provisional Patent Application entitled “SMART BLADE TECHNOLOGY TO CONTROL BLADE INSTABILITY” and attorney docket number END8560USNP6 / 180106-6; and

[0077] U.S. Provisional Patent Application entitled “START TEMPERATURE OF BLADE” and attorney docket number END8560USNP7 / 180106-7.

[0078] 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:

[0079] U.S. Provisional Patent Application entitled “METHODS FOR ESTIMATING AND CONTROLLING STATE OF ULTRASONIC END EFFECTOR” and attorney docket number END8536USNP1 / 180107-1M;

[0080] U.S. Provisional Patent Application entitled “IN-THE-JAW CLASSIFIER BASED ON MODEL” and attorney docket number END8536USNP3 / 180107-3;

[0081] · Title: "APPLICATION OF SMART BLADE TECHNOLOGY",

[0082] U.S. Provisional Patent Application with attorney docket number END8536USNP4 / 180107-4;

[0083] U.S. Provisional Patent Application entitled “SMART BLADE AND POWER PULSING” and attorney docket number END8536USNP5 / 180107-5;

[0084] 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;

[0085] U.S. Provisional Patent Application entitled “VESSEL SENSING FOR ADAPTIVE ADVANCED HEMOSTASIS” and attorney docket number END8536USNP8 / 180107-8;

[0086] U.S. Provisional Patent Application entitled “CALCIFIED VESSEL IDENTIFICATION” and attorney docket number END8536USNP9 / 180107-9;

[0087] U.S. Provisional Patent Application entitled “DETECTION OF LARGE VESSELSDURING PARENCHYMAL DISSECTION USING A SMART BLADE” and attorney docket number END8536USNP10 / 180107-10;

[0088] U.S. Provisional Patent Application entitled “SMART BLADE APPLICATION FOR REUSABLE AND DISPOSABLE DEVICES” and attorney docket number END8536USNP11 / 180107-11;

[0089] U.S. Provisional Patent Application entitled “LIVE TIME TISSUE CLASSIFICATION USING ELECTRICAL PARAMETERS” and attorney docket number END8536USNP12 / 180107-12; and

[0090] U.S. Provisional Patent Application entitled “FINE DISSECTION MODE FOR TISSUE CLASSIFICATION” and attorney docket number END8536USNP13 / 180107-13.

[0091] 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:

[0092] U.S. Provisional Patent Application Serial No. 62 / 729,177, entitled “AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINIED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION”;

[0093] U.S. Provisional Patent Application Serial No. 62 / 729,182, entitled “SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONOPOLAR RETURN PAD ELECTRODE TO PROVIDESITUATIONAL AWARENESS TO THE HUB”;

[0094] 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”;

[0095] U.S. Provisional Patent Application Serial No. 62 / 729,183, entitled “SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINSTABASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION”;

[0096] 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 BASEDONA SENSED SITUATION OR USAGE”;

[0097] 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 SECONDOPERATING ROOM SYSTEM WITHIN A STERILE FIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY AND SECONDARY OPERATING MODES”;

[0098] U.S. Provisional Patent Application Serial No. 62 / 729,186, entitled “WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITH IN A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS OF DEVICES”; and

[0099] U.S. Provisional Patent Application Serial No. 62 / 729,185, entitled “POWEREDSTAPLING DEVICETHAT IS CAPABLE OF ADJUSTING FORCE, ADVANCEMENT SPEED, AND OVERALL STROKEOFCUTTING MEMBER OF THE DEVICE BASED ON SENSED PARAMETER OF FIRING OR CLAMPING”.

[0100] 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:

[0101] U.S. Patent Application Serial No. 16 / 115,214, entitled “ESTIMATINGSTATE OF ULTRASONICEND EFFECTOR AND CONTROLSYSTEM THEREFOR”;

[0102] U.S. Patent Application Serial No. 16 / 115,205, entitled “TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR”;

[0103] U.S. Patent Application Serial No. 16 / 115,233, entitled “RADIOFREQUENCY ENERGY DEVICE FOR DELIVERING COMBINEDELECTRICAL SIGNALS”;

[0104] U.S. Patent Application Serial No. 16 / 115,208, entitled “CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TOTISSUE LOCATION”;

[0105] U.S. Patent Application Serial No. 16 / 115,220, entitled “CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE”;

[0106] U.S. Patent Application Serial No. 16 / 115,232, entitled “DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM”;

[0107] U.S. Patent Application Serial No. 16 / 115,239, entitled “DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT”;

[0108] U.S. Patent Application Serial No. 16 / 115,247, entitled “DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR”;

[0109] U.S. Patent Application Serial No. 16 / 115,211, entitled “SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS”;

[0110] U.S. Patent Application Serial No. 16 / 115,226, entitled “MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT”;

[0111] U.S. Patent Application Serial No. 16 / 115,240, entitled “DETECTION OF END EFFECTOREMERSION IN LIQUID”;

[0112] U.S. Patent Application Serial No. 16 / 115,249, entitled “INTERRUPTION OF ENERGY DUE TO A DYNAMIC CAPACITIVE COUPLING”; U.S. Patent Application Serial No. 16 / 115,256, entitled “INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP”;

[0113] U.S. Patent Application Serial No. 16 / 115,223, entitled “BIPOLAR COMBINATION DEVICETHAT AUTOMATICALLY ADJUSTSPRESSURE BASED ON ENERGY MODALITY”; and

[0114] • U.S. Patent Application Serial No. 16 / 115,238, entitled “ACTIVATION OF ENERGY DEVICES.”

[0115] 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:

[0116] U.S. Provisional Patent Application No. 62 / 721,995, entitled “CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TOTISSUE LOCATION”;

[0117] U.S. Provisional Patent Application No. 62 / 721,998, entitled “SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS”;

[0118] U.S. Provisional Patent Application No. 62 / 721,999, entitled “INTERRUPTION OF ENERGY DUE TO TOUCHING VERTENT CAPACITIVE COUPLING”;

[0119] U.S. Provisional Patent Application 62 / 721,994, entitled “BIPOLAR COMBINATION DEVICE THATAUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY”; and

[0120] • U.S. Provisional Patent Application 62 / 721,996, entitled “RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS.”

[0121] 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:

[0122] U.S. Provisional Patent Application 62 / 692,747, entitled “SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE”;

[0123] U.S. Provisional Patent Application 62 / 692,748, entitled “SMART ENERGY ARCHITECTURE”; and

[0124] • U.S. Provisional Patent Application 62 / 692,768, entitled “SMART ENERGY DEVICES.”

[0125] 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:

[0126] U.S. Patent Application Serial No. 16 / 024,090, entitled “CAPACITIVE COUPLED RETURN PATHPAD WITH SEPARABLE ARRAYELEMENTS”;

[0127] U.S. Patent Application Serial No. 16 / 024,057, entitled “CONTROLLING ASURGICALINSTRUMENT ACCORDING TO SENSED CLOSUREPARAMETERS”;

[0128] U.S. Patent Application Serial No. 16 / 024,067, entitled “SYSTEMS FOR ADJUSTING ENDEFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION”;

[0129] U.S. Patent Application Serial No. 16 / 024,075, entitled “SAFETY SYSTEMSFOR SMARTPOWERED SURGICAL STAPLING”;

[0130] U.S. Patent Application Serial No. 16 / 024,083, entitled “SAFETY SYSTEMSFOR SMARTPOWERED SURGICAL STAPLING”;

[0131] U.S. Patent Application Serial No. 16 / 024,094, entitled “SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUEDISTRIBUTION IRREGULARITIES”;

[0132] U.S. Patent Application Serial No. 16 / 024,138, entitled “SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TOCANCEROUS TISSUE”;

[0133] U.S. Patent Application Serial No. 16 / 024,150, entitled “SURGICALINSTRUMENT CARTRIDGESENSOR ASSEMBLIES”;

[0134] U.S. Patent Application Serial No. 16 / 024,160, entitled “VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY”;

[0135] U.S. Patent Application Serial No. 16 / 024,124, entitled “SURGICALINSTRUMENT HAVING AFLEXIBLE ELECTRODE”;

[0136] U.S. Patent Application Serial No. 16 / 024,132, entitled “SURGICALINSTRUMENT HAVING AFLEXIBLE CIRCUIT”;

[0137] U.S. Patent Application Serial No. 16 / 024,141, entitled “SURGICALINSTRUMENT WITH ATISSUE MARKING ASSEMBLY”;

[0138] U.S. Patent Application Serial No. 16 / 024,162, entitled “SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES”;

[0139] U.S. Patent Application Serial No. 16 / 024,066, entitled “SURGICALEVACUATION SENSING AND MOTOR CONTROL”;

[0140] U.S. Patent Application Serial No. 16 / 024,096, entitled “SURGICALEVACUATION SENSORARRANGEMENTS”;

[0141] U.S. Patent Application Serial No. 16 / 024,116, entitled “SURGICALEVACUATION FLOWPATHS”;

[0142] U.S. Patent Application Serial No. 16 / 024,149, entitled “SURGICALEVACUATION SENSING AND GENERATOR CONTROL”;

[0143] U.S. Patent Application Serial No. 16 / 024,180, entitled “SURGICALEVACUATION SENSING AND DISPLAY”;

[0144] U.S. Patent Application Serial No. 16 / 024,245, entitled “COMMUNICATION OF SMOKE VACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE VACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM”;

[0145] U.S. Patent Application Serial No. 16 / 024,258, entitled “SMOKEEVACUATION SYSTEM INCLUDING A SEGMENTED CONTROLCIRCUIT FOR INTERACTIVE SURGICAL PLATFORM”;

[0146] U.S. Patent Application Serial No. 16 / 024,265, entitled "SURGICALEVACUATION SYSTEMWITH A COMMUNICATION CIRCUITFOR COMMUNICATION BETWEEN A FILTER AND ASMOKEEVACUATION DEVICE"; and

[0147] • U.S. Patent Application Serial No. 16 / 024,273, entitled "DUAL IN-SERIES LARGE AND SMALLDROPLET FILTERS."

[0148] 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:

[0149] U.S. Provisional Patent Application Serial No. 62 / 691,228, entitled “A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES”;

[0150] U.S. Provisional Patent Application Serial No. 62 / 691,227, entitled “Controlling asurgical instrument according to sensed closure parameters”;

[0151] U.S. Provisional Patent Application Serial No. 62 / 691,230, entitled “SURGICALINSTRUMENT HAVINGA FLEXIBLE ELECTRODE”;

[0152] U.S. Provisional Patent Application Serial No. 62 / 691,219, entitled “SURGICALEVACUATION SENSING AND MOTOR CONTROL”;

[0153] U.S. Provisional Patent Application Serial No. 62 / 691,257, entitled

[0154] "COMMUNICATION OF SMOKE EVACUATION SYSTEMPARAMETERS TO HUB OR CLOUDIN SMOKE EVACUATIONMODULE FOR INTERACTIVE SURGICAL PLATFORM";

[0155] U.S. Provisional Patent Application Serial No. 62 / 691,262, entitled “SURGICALEVACUATION SYSTEMWITH A COMMUNICATION CIRCUITFOR COMMUNICATION BETWEEN A FILTER AND ASMOKEEVACUATION DEVICE”; and

[0156] U.S. Provisional Patent Application Serial No. 62 / 691,251, entitled “DUAL IN-

[0157] SERIES LARGE AND SMALL DROPLET FILTERS”.

[0158] 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:

[0159] U.S. Provisional Patent Application Serial No. 62 / 659,900, entitled “METHOD OF HUB COMMUNICATION”;

[0160] 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:

[0161] U.S. Provisional Patent Application No. 62 / 650,898, filed on March 30, 2018, entitled

[0162] "CAPACITIVE COUPLED RETURN PATH PAD WITHSEPARABLE ARRAY ELEMENTS";

[0163] U.S. Provisional Patent Application Serial No. 62 / 650,887, entitled “SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES”;

[0164] U.S. Patent Application Serial No. 62 / 650,882, entitled "SMOKEEVACUATION MODULE FOR INTERACTIVE SURGICALPLATFORM"; and

[0165] U.S. Patent Application Serial No. 62 / 650,877, entitled “SURGICAL SMOKEEVACUATION SENSING AND CONTROLS”

[0166] The applicant of the present patent application owns the following U.S. patent applications filed on March 29, 2018, the disclosures of each of these provisional patent applications are incorporated herein by reference in their entirety:

[0167] U.S. Patent Application Serial No. 15 / 940,641, entitled “INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES”;

[0168] U.S. Patent Application Serial No. 15 / 940,648, entitled “INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES”;

[0169] U.S. Patent Application Serial No. 15 / 940,656, entitled “SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES”;

[0170] U.S. Patent Application Serial No. 15 / 940,666, entitled “SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS”;

[0171] U.S. Patent Application Serial No. 15 / 940,670, entitled “COOPERATIVEUTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS”;

[0172] U.S. Patent Application Serial No. 15 / 940,677, entitled “SURGICAL HUBCONTROLARRANGEMENTS”;

[0173] U.S. Patent Application Serial No. 15 / 940,632, entitled “DATA STRIPPINGMETHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”;

[0174] 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”;

[0175] U.S. Patent Application Serial No. 15 / 940,645, entitled “SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT”;

[0176] U.S. Patent Application Serial No. 15 / 940,649, entitled “DATA PAIRING TO INTERCONNECT ADEVICE MEASURED PARAMETER WITH AN OUTCOME”;

[0177] U.S. Patent Application Serial No. 15 / 940,654, entitled “SURGICAL HUBSITUATIONAL AWARENESS”;

[0178] U.S. Patent Application Serial No. 15 / 940,663, entitled “SURGICAL SYSTEM DISTRIBUTED PROCESSING”;

[0179] U.S. Patent Application Serial No. 15 / 940,668, entitled “AGGREGATION AND REPORTING OF SURGICAL HUB DATA”;

[0180] U.S. Patent Application Serial No. 15 / 940,671, entitled “SURGICAL HUBSPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”;

[0181] U.S. Patent Application Serial No. 15 / 940,686, entitled “DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE”;

[0182] U.S. Patent Application Serial No. 15 / 940,700, entitled “STERILE FIELD INTERACTIVE CONTROL DISPLAYS”;

[0183] U.S. Patent Application Serial No. 15 / 940,629, entitled “COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”;

[0184] U.S. Patent Application Serial No. 15 / 940,704, entitled “USE OF LASERLIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”;

[0185] U.S. Patent Application Serial No. 15 / 940,722, entitled

[0186] "CHARACTERIZATION OF TISSUE IRREGULARITIESTHROUGH THE USE OF MONO-CHROMATIC LIGHTREFRACTIVITY"; and

[0187] U.S. Patent Application Serial No. 15 / 940,742, entitled “DUAL CMOSARRAY IMAGING”;

[0188] U.S. Patent Application Serial No. 15 / 940,636, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”; U.S. Patent Application Serial No. 15 / 940,653, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS”;

[0189] U.S. Patent Application Serial No. 15 / 940,660, entitled “CLOUD-BASED EDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”;

[0190] U.S. Patent Application Serial No. 15 / 940,679, entitled “CLOUD-BASED EDICAL ANALYTICS FOR LINKING OF LOCAL USA GETRENDS WITH THE RESOURCE ACQUISITION BEHAVIORSOFLARGER DATA SET”;

[0191] U.S. Patent Application Serial No. 15 / 940,694, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION”;

[0192] U.S. Patent Application Serial No. 15 / 940,634, entitled “CLOUD-BASED EDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”;

[0193] U.S. Patent Application Serial No. 15 / 940,706, entitled “DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK”; and

[0194] U.S. Patent Application Serial No. 15 / 940,675, entitled “CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”;

[0195] U.S. Patent Application Serial No. 15 / 940,627, entitled “DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”;

[0196] U.S. Patent Application Serial No. 15 / 940,637, entitled “COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”;

[0197] U.S. Patent Application Serial No. 15 / 940,642, entitled “CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”;

[0198] U.S. Patent Application Serial No. 15 / 940,676, entitled “AUTOMATIC TOOLAD JUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”;

[0199] U.S. Patent Application Serial No. 15 / 940,680, entitled “CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS”;

[0200] U.S. Patent Application Serial No. 15 / 940,683, entitled “COOPERATIVE SURGICAL ACTIONSFOR ROBOT-ASSISTED SURGICALPLATFORMS”;

[0201] U.S. Patent Application Serial No. 15 / 940,690, entitled “DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”; and

[0202] • U.S. Patent Application Serial No. 15 / 940,711, entitled “SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS.”

[0203] 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:

[0204] U.S. Provisional Patent Application Serial No. 62 / 649,302, entitled “INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES”;

[0205] U.S. Provisional Patent Application Serial No. 62 / 649,294, entitled “DATASTRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD”;

[0206] U.S. Provisional Patent Application Serial No. 62 / 649,300, entitled “SURGICALHUB SITUATIONAL AWARENESS”;

[0207] U.S. Provisional Patent Application Serial No. 62 / 649,309, entitled “SURGICALHUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER”;

[0208] U.S. Provisional Patent Application Serial No. 62 / 649,310, entitled “COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS”;

[0209] U.S. Provisional Patent Application Serial No. 62 / 649,291, entitled “USE OF LASERLIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT”;

[0210] U.S. Provisional Patent Application Serial No. 62 / 649,296, entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES”;

[0211] U.S. Provisional Patent Application Serial No. 62 / 649,333, entitled “CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER”;

[0212] U.S. Provisional Patent Application Serial No. 62 / 649,327, entitled “CLOUD-BASEDMEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES”;

[0213] U.S. Provisional Patent Application Serial No. 62 / 649,315, entitled “DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK”;

[0214] U.S. Provisional Patent Application Serial No. 62 / 649,313, entitled “CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES”;

[0215] U.S. Provisional Patent Application Serial No. 62 / 649,320, entitled “DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”;

[0216] U.S. Provisional Patent Application Serial No. 62 / 649,307, entitled “AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS”; and

[0217] • U.S. Provisional Patent Application Serial No. 62 / 649,323, entitled “SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICALPLATFORMS.”

[0218] 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:

[0219] U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM”;

[0220] U.S. Provisional Patent Application Serial No. 62 / 611,340, entitled “CLOUD-BASED MEDICAL ANALYTICS”; and

[0221] U.S. Provisional Patent Application Serial No. 62 / 611,339, entitled “ROBOTASSISTED SURGICALPLATFORM”;

[0222] 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 construction and arrangement of 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 various ways. In addition, unless otherwise indicated, the terms and expressions used herein are selected for the convenience of the reader to describe the illustrative 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.

[0223] 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.

[0224] Adaptive ultrasonic knife control algorithm

[0225] 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 be able to identify tissue types and adjust device parameters. In one aspect, the ultrasonic scalpel control algorithm is configured to be able 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 end of the ultrasonic scalpel. This article is combined with, for example, Figure 1 to Figure 2 Therefore, the following description of the adaptive ultrasonic knife control algorithm should be combined with Figure 1 to Figure 2 and the description associated with it.

[0226] 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 an ultrasonic device can be adjusted based on the position of the tissue in the jaws of an ultrasonic end effector (e.g., the position of the tissue between the clamping arm and the ultrasonic blade). The impedance of an 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 end 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.

[0227] Figure 1 The system 800 is configured to be capable of executing 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 be capable of executing an adaptive ultrasonic blade control algorithm 802 as described herein. In another aspect, the device / instrument 235 is configured to be capable of executing an adaptive ultrasonic blade control algorithm 802 as described herein. Figures 19 to 32The adaptive ultrasonic blade control algorithm 804 described herein. In another aspect, both the device / instrument 235 and the device / instrument 235 are configured to be able to perform as described herein with reference to Figures 19 to 32 The adaptive ultrasonic knife control algorithms 802 and 804.

[0228] 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, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multifunctional 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 herein Figures 7 to 12 Aspects of the generator module 240 are described.

[0229] 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, for example, 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 enable connecting 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).

[0230] 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.

[0231] 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 "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, 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, the 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 the operating room. The hub hardware enables multiple devices or connections to be connected to a computer that communicates with cloud computing resources and storage.

[0232] Figure 1 Some aspects of a computer-implemented interactive surgical system including a modular communication hub are further shown, which may include a system 800 configured to be able to execute an adaptive ultrasonic blade control algorithm in a surgical data network. The surgical system may include at least one surgical hub that communicates with a cloud 204 that 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, for example, 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, a generator module 240, a smart device / instrument 235, the imaging module is connected to an endoscope, the generator module is connected to an energy device 241, and the smart device / instrument is 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.

[0233] Generator Hardware

[0234] Figure 2 An example of a generator 900 is shown, which is a form of a generator that is configured to be coupled to an ultrasonic instrument and is also 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 be able 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 be able to generate multiple 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. The first signal of the first energy modality is provided to a signal labeled ENERGY 1 A second signal of the second energy mode is coupled across capacitor 910 and provided to a terminal labeled ENERGY 2 and RETURN terminals of the surgical instrument. 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 terminals, 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 .

[0235] The first voltage sensing circuit 912 is coupled to a voltage labeled ENERGY 1 and RETURN paths to measure the output voltage therebetween. The second voltage sensing circuit 924 is coupled to the terminals labeled ENERGY 2and the two ends of the terminals of the RETURN path to measure the output voltage therebetween. As shown, the current sensing circuit 914 is arranged in series with the RETURN branch of 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. The input / output communication between the processor 902 and the patient isolation circuit is provided by the interface circuit 920. The sensors may also be in electrical communication with the processor 902 via the interface circuit 920 .

[0236] In one aspect, the impedance can be determined by processor 902 by connecting the 1 A first voltage sensing circuit 912 across the / RETURN terminal or connected to the terminal labeled ENERGY 2 The output of the second voltage sensing circuit 924 across the terminals of / RETURN is determined by dividing the output of the current sensing circuit 914 arranged in series with the RETURN branch on 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 calculating the impedance. For example, the first energy mode ENERGY 1 It can be ultrasonic energy, and the second energy mode ENERGY 2 It may be RF energy. However, in addition to ultrasound and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, etc. In addition, 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 ENERGY n Provide multiple return paths RETURN nThus, as described herein, ultrasound 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 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 .

[0237] 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 at the position marked as ENERGY 1 and RETURN output terminals, such as Figure 2 In one example, the connection of the RF bipolar electrodes to the output of the generator 900 will preferably be located at the position marked ENERGY 2 In the case of a unipolar output, the preferred connection would be from the active electrode (e.g., pencil or other probe) to the ENERGY 2 output and connect to a suitable return pad at the RETURN output.

[0238] 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.

[0239] 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 device 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.

[0240] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually memory or some other data stream). The term is used herein to refer to a central processing unit (central processing unit) in one or more systems (especially system-on-chip (SoC)) that combine multiple specialized "processors".

[0241] 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 may include 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.

[0242] 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.

[0243] 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).

[0244] 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 ARM Cortex-M4F processor core available from Texas Instruments, which includes: 256KB of single-cycle flash or other non-volatile memory (up to 40MHz) on-chip memory, a pre-fetch buffer for improving performance above 40MHz, 32KB of single-cycle serial random access memory (SRAM), a 32KB MCU loaded with 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.

[0245] In one example, 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 ARM Cortex 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.

[0246] The modular device includes a module that can be received in the surgical hub (e.g., 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, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. 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.

[0247] 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 configurable for use with a variety of surgical devices. 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, but 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.

[0248] The generator 1100 is configured to be able 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 and driving the ultrasonic blade 1128 or other functions of the ultrasonic blade 1128. The switch buttons 1134a, 1134b, 1134c can be configured to be able to energize the ultrasonic transducer 1120 with the generator 1100.

[0249] The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the 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 handpiece 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.

[0250] The generator 1100 is also configured to be able to drive a multifunctional surgical instrument 1108. The multifunctional surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 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 be able 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.

[0251] The generator 1100 may be configurable for use with a variety of surgical devices. 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 independent of the surgical instruments 1104, 1106, 1108, but 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.

[0252] Figure 4 1 is an end effector 1122 of an exemplary ultrasonic device 1104 according to at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128 that may be coupled to the ultrasonic transducer 1120 via a waveguide. 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 knife 1128 of the end effector 1122. With the knife 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, which 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 grasped between tissue pad 1163 and knife 1128. Tissue pad 1163 may have a serrated configuration including a plurality of axially spaced proximally extending grasping teeth 1161 to enhance grasping of tissue in cooperation with knife 1128. Clamp arm 1140 may be adapted to move from Figure 4 The open position shown in the figure is converted to a closed position (wherein the clamp arm 1140 is in contact with or close 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 can pivot the clamp arm 1140 in any suitable manner.

[0253] 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 ), which 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).

[0254] 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.

[0255] 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 one or more user power level selections.

[0256] 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).

[0257] 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.

[0258] In various aspects, the generator 1100 may include a number of independent functional elements, such as modules and / or blocks, such as Figure 5 middle, Figure 3 As shown in the illustration of the surgical system 1000 of FIG. 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 separate circuit modules 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.

[0259] 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.

[0260] 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.).

[0261] 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, a user can set or program various operating parameters of the generator, such as, for example, 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.

[0262] The generator 1100 may also include an output device 2140 (eg, located on a front panel of the generator 1100 console). 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).

[0263] 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.

[0264] 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)).

[0265] 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).

[0266] 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 electromechanical ultrasonic 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) and current I g(t) The phase difference between the 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.

[0267] 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 curve of the ultrasonic transducer to improve the frequency locking capability of the generator. 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.

[0268] 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 with static capacitance C 0 . The driving 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 adjust the static capacitance C 0 is tuned to the resonant frequency so that the current output 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 Im (t) is controlled. However, the tuning inductor L t The static capacitance C of the ultrasonic transducer 0 is specific, and different ultrasonic transducers with different static capacitances require different tuning inductors L t In addition, because the tuning inductor L t At a single resonant frequency with the static capacitance C 0 The nominal value of the dynamic branch current I is matched, so only at this frequency is the dynamic branch current I m As the frequency shifts downward with the temperature of the transducer, precise control of the motional branch current is compromised.

[0269] 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 a static capacitance C between the power applied for a particular ultrasonic surgical device 1104 0 The measured values ​​of (together with the drive signal voltage and current feedback data) are used to determine the dynamic branch current I on a dynamic ongoing basis (e.g., in real time) m (t). Thus, such aspects of the generator 1100 are able to provide virtual tuning to simulate a tuned system or with a static capacitance C at any frequency. 0 resonance at any value, not just at the static capacitance C 0 The nominal value resonates at a single resonant frequency as indicated.

[0270] 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. FIG. 8A to FIG. 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 (such as, for example, 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 1600b 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.

[0271] 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 is available from, for example, 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.

[0272] In some respects and as combined FIG. 9A to FIG. 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 represent the waveform shape that is desired to ultimately produce the desired waveform shape of the motional branch drive signal.

[0273] 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 be capable of sampling 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, calculation 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 actual power consumption with high accuracy can be enabled. 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 can 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.

[0274] 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. The frequency of the drive signal may then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the 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.

[0275] 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:

[0276]

[0277] Evaluating the Fourier transform at sinusoidal frequencies yields:

[0278]

[0279] 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 equation

[0280]

[0281] in is the phase angle, f is the frequency, t is the time, and is the phase at t=0.

[0282] 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 Each negative to positive zero crossing of (t) triggers the start of the 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.

[0283] 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.

[0284] 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, for example, 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 a DAC 1680 (which supplies an input to the power amplifier 1620) via a DAC 1860.

[0285] The non-isolated stage 1540 may also include a processor 1900 for providing, among other things, user interface (UI) functions. In one aspect, the processor 1900 may include, for example, an Atmel AT91SAM9263 processor with an ARM926EJ-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.

[0286] 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, for example, indicate which control and / or diagnostic processes are implemented by the processor 1740. For the processor 1900, the operating state of the generator 1100 can, for example, indicate 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 instructs 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 failure mode.

[0287] 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 Atemel) 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 Atemel) to control and manage the collection of touch data from a capacitive touch screen.

[0288] 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). Thus, the controller 1960 may 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.

[0289] 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.

[0290] 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 (such as, for example, the programmable logic device 1660, the processor 1740, and / or the processor 1900). The instrument interface circuit 1980 may exchange information with components of the non-isolated stage 1540 via a communication link (such as, for example, 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.

[0291] 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 device 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 a sample of a voltage signal in the input of the control circuit resulting from 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 sample.

[0292] 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 independently of the programmable logic device 2000 and include suitable circuits (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 programmable logic device 2000.

[0293] In certain aspects, the first data circuit 2060 may store information associated with an 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.

[0294] 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 a data circuit that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical device with current generator platforms.

[0295] 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 enabling such 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 associated with 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.

[0296] 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 transmitted 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.

[0297] 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 negative consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1, wherein current leakage occurring from a point between the blocking capacitors 2960-1, 2960-2 is detected by, for example, an ADC 2980 to sample a voltage induced by the leakage current. The sample may be received by, for example, 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 compared to a single capacitor design with a single failure point.

[0298] 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.

[0299] FIG. 9A to FIG. 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 enable oversampling of the drive signals (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 FIG. 9A to FIG. 9BIn some aspects, programmable logic device 1660 includes an FPGA.

[0300] 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 .

[0301] 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.

[0302] 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 ), ultrasonic transducer static capacitance C 0 The motional branch current is determined using Kirchhoff's current law using the value of and the known value of the drive frequency. A motional branch current sample may be determined for each set of stored current and voltage feedback samples associated with a LUT sample.

[0303] 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.

[0304] Each value of the sample amplitude error determined at block 2240 may be transmitted to a LUT of programmable logic device 1660 (at Fig.9A 2280 in the example embodiment of the present invention). Based on the value of the sample amplitude error and its associated address (and optionally, the value of the sample amplitude error previously received for the same LUT address), 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 such 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 sample of the waveform shape LUT 2260.

[0305] 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 resulting from, 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.

[0306] 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 .

[0307] 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 .

[0308] 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 .

[0309] 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 .

[0310] At block 2420, the load impedance magnitude measurement Z m can be determined as the quotient V rms / I rms .

[0311] 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 procedures. 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 procedures may include, but are not limited to, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, overcurrent condition, overpower condition, voltage sense failure, current sense failure, audio indication failure, visual indication failure, short circuit condition, power delivery failure, or blocking capacitor failure.

[0312] 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.

[0313] 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 resulting from, 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.

[0314] 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.

[0315] 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.

[0316] 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.

[0317] 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 enhancing the accuracy of the phase impedance determination.

[0318] Block 2580 of the 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 the generator 1100. Control of these quantities may be achieved, for example, by scaling LUT samples in the LUT 2280 and / or by adjusting the full-scale output voltage of the DAC 1680 (which supplies input to the power amplifier 1620) via the 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 scaling and / or full-scale output voltage of DAC 1680 may be adjusted by block 2600 such 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.

[0319] 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 desired current is indirectly specified (for example, I d =V sp / 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 desired current is indirectly specified (for example, I d =P sp / V rms ).

[0320] 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, resulting in 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.

[0321] 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 rail voltage may be modulated according to the waveform envelope characterized by the minimum voltage sample as long as the value of the minimum voltage sample is less than the minimum target 2780 input into block 2720. For example, when the minimum voltage sample indicates a low envelope power level, block 2740 may cause a low rail voltage to be supplied to the power amplifier 1620, wherein the full rail 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 rail voltage to be maintained at a minimum value suitable for ensuring proper operation of the power amplifier 1620.

[0322] Fig.10 A control circuit 500 is shown, which is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 may be configured to implement various processes described herein. The control circuit 500 may include a microcontroller, which includes one or more processors 502 (e.g., microprocessors, microcontrollers) connected 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 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.

[0323] Fig.11Combinatorial logic circuit 510 is shown, which is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. Combinatorial logic circuit 510 can be configured to implement various processes described herein. Combinatorial logic circuit 510 may include a finite state machine that includes combinatorial logic 512 that is configured to receive data associated with a surgical instrument or tool at input 514, process the data through combinatorial logic 512, and provide output 516.

[0324] Fig.12 A sequential logic circuit 520 is shown that is configured to control various aspects of a surgical instrument or tool 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 various processes herein. In other aspects, the finite state machine may include a combinational logic circuit (e.g., combinational logic circuit 510, Fig.14 ) and a sequential logic circuit 520.

[0325] 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.13One 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.

[0326] 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 multiple 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 multiple 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 can be stored in an FPGA of the generator. The table may be addressed in any manner that facilitates the classification of the waveform shape. 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 multiple waveform shapes may be stored in the table as digital information.

[0327] 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, which may be stored in the generator circuit or the FPGA of the surgical instrument. The lookup table 4104 may be addressed by any method 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.

[0328] 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.13 In 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 coupled to the analog output signal 4110. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The phase noise is essentially the frequency response of the reference clock f. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The spectral noise is essentially the frequency response of the reference clock f. cThe 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 whose output terminal is connected to the output terminal of the generator circuit. The second analog output signal has a frequency f 输出 .

[0329] 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 .

[0330] The DDS circuit 4100 may include a plurality of lookup tables 4104, wherein the lookup table 4104 stores 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 during the tissue treatment process (e.g., "on-the-fly" or virtual real-time based on user or sensor input), switch between different waveform shapes stored in separate lookup tables 4104 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 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.

[0331] 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.

[0332] 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 used. 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 numbers in parallel incremental phase register 4204 are 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 32 bits wide, 232 clock cycles (over 4 billion) are required before phase accumulator 4206 returns to 00…00, and the cycle is repeated.

[0333] 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.

[0334] 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.

[0335] Table 1 specifies the waveform of an electrical signal digitized into a plurality of phase points.

[0336] N <![CDATA[Phase point number 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 … …

[0337] Table 1

[0338] 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, and fed to the tissue in the form of RF energy or fed to the ultrasonic transducer, and applied 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 tissue from the generator circuit.

[0339] 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.

[0340] 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:

[0341]

[0342] 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, not all bits from the phase accumulator 4206 are passed to the lookup table 4210, but 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.

[0343] The electrical signal waveform may be characterized by 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.

[0344] 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 a plurality of ultrasonic drive signals, a plurality of RF drive signals, and / or a combination of a plurality of ultrasonic drive signals and RF drive signals.

[0345] 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.

[0346] 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.

[0347] In addition to traditional sine / cosine wave shapes, the generator circuit can also be configured to generate one or more wave shapes (i.e., trapezoidal or square waves) that maximize the power entering the tissue in each cycle. The generator circuit can provide one or more wave shapes that are 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, customized wave shapes specific to the instrument and its tissue effect can be stored in 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.

[0348] 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. In general, 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 as used in many high crest factor "coagulation" waveforms, such as Fig.15 as shown in .

[0349] Fig.15 One cycle of a discrete-time digital electrical signal waveform 4300 in accordance with at least one aspect of the present disclosure of an analog waveform 4304 is shown (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 magnitude and phase points are digital words stored in memory circuits. Fig.13 , Fig.14 In the example shown in , the digital word is a six-bit word capable of storing amplitude and phase points with 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 point 4302 on the 4302 is 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 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. Fig.13 , Fig.14 The digital electrical signal waveform 4300 can be described by changing the amplitude phase point 4302 from 0 to T o Additional cycles are generated by repeatedly reading as many cycles or periods as desired. Fig.13 and Fig.14 ) Filter the outputs of DAC circuits 4108 and 4212 to achieve a smooth analog version of analog waveform 4304. The filtered analog output signals 4114 and 4222 ( Fig.13 and Fig.14 ) is applied to the input of the power amplifier.

[0350] Fig.16 12950 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.17 PID controller 12972 shown in FIG. Primary controller 12952 controls primary process 12958, and secondary controller 12955 controls secondary process 12960. Output 12966 of primary process 12958 is derived from primary set point SP1 The first summer 12962 is subtracted. The first summer 12962 produces a single sum output signal that is applied to the master controller 12952. The output of the master controller 12952 is the secondary set point SP 2 The output 12968 of the secondary process 12960 is the secondary set point SP 2 Subtract the second summer 12964.

[0351] 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).

[0352] 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.

[0353] 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.

[0354] 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. The system 132000 can 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 132016 (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.

[0355] The outputs of the voltage sensor 132018 and the current sensor 13020 are applied to another phase / frequency detector 132022 to determine the phase angle between the voltage and current as measured by the voltage sensor 132018 and the current sensor 13020. The output of the phase / frequency detector 132022 is applied to one channel of a high speed analog-to-digital converter 132024 (ADC) and provided thereto 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.

[0356] Optionally tune the voltage V t (This voltage and output frequency f oThe 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 .

[0357] Assess the condition of the jaws (burn-through pads, nails, broken blades, bone in the jaws, tissue in the jaws)

[0358] The challenge with ultrasonic energy delivery is that applying ultrasonic sound to the wrong material or the wrong tissue can lead to device failure, such as burn-through of the clamp arm pad or breakage of the ultrasonic blade. It is also desirable to detect what is in the jaws of the end effector of an ultrasonic device and the state of the jaws without adding additional sensors in the jaws. Positioning sensors in the jaws of an ultrasonic end effector has challenges in reliability, cost, and complexity.

[0359] According to at least one aspect of the present disclosure, an ultrasonic spectroscopy intelligent knife algorithm technology can be used to drive an ultrasonic transducer knife based on the impedance of the ultrasonic transducer configured to drive the ultrasonic transducer knife. To assess the condition of the jaws (burn through the clamp arm pad, nails, broken knife, bone in the jaws, tissue in the jaws, back cutting when the jaws are closed, etc.). Plot the impedance Z g (t), amplitude |Z| and phase as a function of frequency f.

[0360] Dynamic mechanical analysis (DMA, also known as dynamic mechanical spectroscopy or simply mechanical spectroscopy) is a technique used to study and characterize materials. Sinusoidal stress is applied to the material and the strain in the material is measured, so that the complex modulus of the material can be determined. Spectroscopy applied to ultrasonic devices includes exciting the end of the ultrasonic blade by frequency scanning (composite signal or traditional frequency scanning) and measuring the resulting complex impedance at each frequency. The complex impedance measurements of the ultrasonic transducer over a certain frequency range are used in a classifier or model to infer the characteristics of the ultrasonic end effector. In one aspect, the present disclosure provides a technology for determining the state of an ultrasonic end effector (clamping arm, jaws) to drive automation in an ultrasonic device (such as deactivating power to protect the device, executing an adaptive algorithm, retrieving information, identifying tissue, etc.).

[0361] Fig.19 132030 is a spectrum of an ultrasonic device having a plurality of different states and conditions of an end effector according to at least one aspect of the present disclosure, wherein the impedance Z g (t), amplitude |Z| and phase is plotted as a function of frequency f. The spectrum 132030 is plotted in three dimensions with frequency (Hz) plotted along the x-axis, phase (Rad) plotted along the y-axis, and amplitude (Ohms) plotted along the z-axis.

[0362] Spectral analysis of different jaw occlusions and device states produces different complex impedance signature patterns (fingerprints) over the frequency range of different conditions and states. When plotted, each state or condition has a different signature pattern in 3D space. These signature patterns can be used to evaluate the condition and state of the end effector. Fig.19 Shown are spectra of air 132032, clamp arm pad 132034, chamois leather 132036, nail 132038, and a broken knife 132040. Chamois leather 132036 can be used to characterize different types of tissue.

[0363] The spectrogram 132030 can be evaluated by applying a low power electrical signal to the ultrasonic transducer to produce non-therapeutic excitation of the ultrasonic blade. The low power electrical signal can be applied in the form of a sweep or complex Fourier series to measure the impedance on the ultrasonic transducer over a series (sweep) or parallel (complex signal) frequency range using FFT

[0364] Classification methods for new data

[0365] For each characteristic pattern, a parametric line can be fit to the data used for training using a polynomial, Fourier series, or any other form of parametric equation that is convenient. A new data point is then received and classified using the Euclidean perpendicular distance from the new data point to the track that has been fitted to the characteristic pattern training data. The perpendicular distance of the new data point to each track (each track represents a different state or condition) is used to assign the point to a certain state or condition.

[0366] The probability distribution of the distance from each point in the training data to the fitted curve can be used to estimate the probability of a new data point being correctly classified. This essentially constructs a two-dimensional probability distribution in a plane perpendicular to the fitted trajectory at each new data point in the fitted trajectory. The new data point can then be included in the training set based on its probability of correct classification to form an adaptive learning classifier that can easily detect high frequency changes in state but can adapt to slowly occurring deviations in system performance, such as dirty devices or worn pads.

[0367] Fig. 20 is a graphical representation of a graph 132042 of a set of 3D training data sets (S) according to at least one aspect of the present disclosure, wherein the ultrasonic transducer impedance Z g (t), amplitude |Z| and phase Plotted as a function of frequency f. The 3D training data set (S) curve 132042 is graphically depicted in three-dimensional space, where phase (Rad) is plotted along the x-axis, frequency (Hz) is plotted along the y-axis, amplitude (Ohms) is plotted along the z-axis, and a parameter Fourier series is fitted to the 3D training data set (S). The method for data classification is based on the 3D training data set (S0 used to generate the curve graph 132042).

[0368] The parameter Fourier series fitted to the 3D training dataset (S) is defined by:

[0369]

[0370] For new points from arrive The vertical distance is:

[0371]

[0372] when:

[0373]

[0374] but:

[0375] D=D ⊥

[0376] The probability distribution of D can be used to evaluate the data points belonging to group S probability.

[0377] control

[0378] Based on the classification of data measured before, during or after activating the ultrasonic transducer / ultrasonic blade, a variety of automated tasks and safety measures can be implemented. Similarly, the state of the tissue located in the end effector and the temperature of the ultrasonic blade can also be inferred to a certain extent, and used to better inform the user of the state of the ultrasonic device or protect critical structures, etc. The temperature control of the ultrasonic blade is described in the commonly owned U.S. Provisional Patent Application No. 62 / 640,417 filed on March 8, 2018 (titled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR", which is incorporated herein by reference in its entirety).

[0379] Similarly, power delivery can be reduced when the ultrasonic blade is most likely to be contacting the clamp arm pad (e.g., no tissue between them), or if the ultrasonic blade is likely to have broken or the ultrasonic blade is likely to contact metal (e.g., nails). In addition, if the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad, reverse cutting is not allowed.

[0380] Integrate additional data to improve classification

[0381] The system can be used in conjunction with other information provided by sensors, user, patient indicators, environmental factors, etc. by combining the data from the process with the above data using probability functions and Kalman filters. Given a large number of uncertain measurements with different confidence levels, the Kalman filter determines the most likely state or condition to have occurred. Since the method allows probabilities to be assigned to newly classified data points, the information of the algorithm can be implemented using other measurements or estimates in the Kalman filter.

[0382] Fig.21 A logic flow diagram 132044 of a control program or logic configuration for determining a jaw condition based on a complex impedance signature pattern (fingerprint) according to at least one aspect of the present disclosure. Before determining the jaw condition based on the complex impedance signature pattern (fingerprint), a reference complex impedance signature pattern or a training data set (S) characterizing various jaw conditions (including but not limited to the following) is used. Fig.19 The database is populated with air 132032, clamp arm pad 132034, chamois 132036, nail 132038, broken knife 132040, and various tissue types and conditions shown in . Chamois (dry or wet, full byte or end) can be used to characterize different types of tissue. The data points for generating a reference complex impedance signature pattern or training data set (S) are obtained as follows: by applying a sub-therapy drive signal to the ultrasonic transducer, scanning the drive frequency within a predetermined range of frequencies from below resonance to above resonance, measuring the complex impedance at each frequency and recording the data points. The data points are then fit to a curve using a variety of numerical methods (including polynomial curve fitting, Fourier series and / or parametric equations). This article describes a parametric Fourier series fitted to a reference complex impedance signature pattern or training data set (S).

[0383] Once the reference complex impedance signature pattern or training data set (S) is generated, the ultrasonic instrument measures new data points, classifies the new points, and determines whether the new data points should be added to the reference complex impedance signature pattern or training data set (S).

[0384] Now go to Fig.21 Logic flow chart, in one aspect, the control circuit measures the complex impedance of the ultrasonic transducer 132046, wherein the complex impedance is defined as The control circuit receives 132048 the complex impedance measurement data point and compares the complex impedance measurement data point to data points in a reference complex impedance signature pattern 132050. The control circuit classifies 132052 the complex impedance measurement data point based on the results of the comparative analysis and specifies 132054 a state or condition of the end effector based on the results of the comparative analysis.

[0385] In one aspect, the control circuit receives a reference complex impedance signature pattern from a database or memory connected to the processor. In one aspect, the control circuit generates the reference complex impedance signature pattern as follows. A drive circuit connected to the control circuit applies a non-therapeutic drive signal to the ultrasonic transducer, the non-therapeutic drive signal starting with an initial frequency, ending with a final frequency, and being at multiple frequencies between the initial frequency and the final frequency. The control circuit measures the impedance of the ultrasonic transducer at each frequency and stores a data point corresponding to each impedance measurement. The control circuit curve fits the multiple data points to generate a three-dimensional curve representing the reference complex impedance signature pattern, where the amplitude |Z| and phase is plotted as a function of frequency f. Curve fitting includes polynomial curve fitting, Fourier series and / or parametric equations.

[0386] In one aspect, the control circuit receives a new impedance measurement data point and uses the Euclidean perpendicular distance from the new impedance measurement data point to the trajectory that has been fitted to the reference complex impedance characteristic pattern to classify the new impedance measurement data point. The control circuit evaluates the probability of correctly classifying the new impedance measurement data point. The control circuit adds the new impedance measurement data point to the reference complex impedance characteristic pattern based on the evaluated probability of correctly classifying the new impedance measurement data point. In one aspect, the control circuit classifies the data based on a training data set (S), wherein the training data set (S) includes a plurality of complex impedance measurement data, and the curve fits the training data set (S) using a parameter Fourier series, wherein S is defined herein, and wherein a probability distribution is used to evaluate the probability of a new impedance measurement data point belonging to group S.

[0387] Model-based jaw classifier status

[0388] There has been interest in classifying material located within the jaws of an ultrasound device, including the type and condition of tissue. In various aspects, it has been shown that with high data sampling and fine pattern recognition, such classification is possible. The method is based on impedance as a function of frequency (where amplitude, phase, and frequency are plotted in 3D, and the pattern looks like Fig.19 and Fig. 20 ) and Fig.21 The present disclosure provides an alternative smart knife algorithm approach based on a mature model for piezoelectric transducers.

[0389] For example, the equivalent electrical lumped parameter model is known to be an accurate model of the physical piezoelectric transducer. It is based on the Mittag-Leffler expansion of the tangent line near the mechanical resonance. When the complex impedance or complex admittance is plotted as the relationship between the imaginary component and the real component, a circle is formed. Fig. 22 132056 is a circular graph of complex impedance plotted as a relationship between imaginary and real components of a piezoelectric vibrator according to at least one aspect of the present disclosure. Fig.23 132058 is a circular graph of the complex admittance plotted as a relationship between an imaginary component and a real component of a piezoelectric vibrator according to at least one aspect of the present disclosure. Fig. 22 and Fig.23 The circles depicted in are taken from the IEEE 177 standard, which is incorporated herein by reference in its entirety. Tables 1-4 are taken from the IEEE 177 standard and are disclosed herein for completeness.

[0390] As the frequency is scanned from below resonance to above resonance, a circle is formed. Rather than stretching the circle in 3D, the circle is identified and the radius (r) and offset (a, b) of the circle are evaluated. These values ​​are then compared to established values ​​for a given condition. These conditions may be: 1) the jaws are open and nothing is in them, 2) the ends are occluded, 3) the jaws are fully occluded and there are nails. If the scan generates multiple resonances, there will be circles with different characteristics for each resonance. If the resonances are separated, each circle will be drawn before the next circle. Rather than fitting a 3D curve with a series of approximate values, a circle is fitted to the data. The radius (r) and offset (a, b) can be calculated using a processor that is programmed to perform a variety of mathematical or digital techniques described below. These values ​​can be evaluated by capturing an image of the circle, and image processing techniques are used to evaluate the radius (r) and offset (a, b) that define the circle.

[0391] Fig.24 Circular plot 132060 of the complex admittance of a 55.5kHz ultrasonic piezoelectric transducer for the lumped parameter input and output specified below. The values ​​of the lumped parameter model are used to generate the complex admittance. A moderate load is applied to the model. The resulting admittance circle generated in MathCad is shown in Fig.24 When the frequency is scanned from 54kHz to 58kHz, a circular diagram 132060 is formed.

[0392] The lumped parameter input values ​​are:

[0393] Co=3.0nF

[0394] Cs=8.22pF

[0395] Ls=1.0H

[0396] Rs=450Ω

[0397] The output of the model based on the input is:

[0398]

[0399] The output values ​​are used to plot the Fig.24 Circular figure 132060 in . Circular figure 132060 has a radius (r) and a center 132062 offset from an origin 132064 by (a, b) as shown below:

[0400] r=1.012*10 3

[0401] a=1.013*10 3

[0402] b=-954.585

[0403] According to at least one aspect of the present disclosure, the sum AE specified below is required to evaluate Fig.24 A circle diagram of the example given in 132060 Figure. There are several algorithms to compute a fit to a circle. A circle is defined by its radius (r) and its center offset from the origin (a, b):

[0404] r 2 =(x a) 2 +(yb) 2

[0405] The modified least squares method (Umbach and Jones) is convenient because there are simple closed-form solutions for a, b, and r.

[0406]

[0407] The caret on the variable "a" indicates the evaluation of the true value. A, B, C, D, and E are the sums of various products calculated from the data. For completeness, they are included in this article as follows:

[0408]

[0409] Z1,i is the first vector of the real component, called the conductance;

[0410] Z2,i is the second vector of the imaginary component, called susceptance; and

[0411] Z3,i is the third vector, indicating the frequency at which the admittance is calculated.

[0412] The present disclosure will be applicable to ultrasonic systems and potentially to electrosurgical systems even though electrosurgical systems do not rely on resonance.

[0413] Figure 25 to Figure 29An image obtained from an impedance analyzer is shown, which shows an impedance / admittance circular graph of an ultrasonic device with an end effector jaw in various open or closed configurations and with a load. According to at least one aspect of the present disclosure, the circular graph in solid line form depicts impedance, while the circular graph in dashed line form depicts admittance. For example, the impedance / admittance circular graph is generated by connecting an ultrasonic device to an impedance analyzer. The display of the impedance analyzer is set to complex impedance and complex admittance, which can be selected from the front panel of the impedance analyzer. For example, as described below in conjunction with Fig.25 As described above, the initial display can be obtained with the jaws of the ultrasonic end effector in the open position and the ultrasonic device in an unloaded state. The automatic scaling display function of the impedance analyzer can be used to generate complex impedance and admittance circle graphs. The same display is used for subsequent runs of the ultrasonic device with different loading conditions, such as subsequent Figure 25 to Figure 29 . The data file can be uploaded using a LabVIEW application. In another technique, a camera, such as a smartphone camera (like an iPhone or Android), can be used to capture the display image. As such, the image of the display may include some "keystone distortion" and may generally not appear parallel to the screen. Using this technique, the circular pattern traces on the display will appear distorted in the captured image. Using this method, the material located in the jaws of the ultrasonic end effector can be classified.

[0414] Complex impedance and complex admittance are simply the reciprocals of each other. No new information can be added by looking at both. Another consideration includes deciding how sensitive the evaluation is to noise when using complex impedance or complex admittance.

[0415] exist Figure 25 to Figure 29 In the example shown, the range of the impedance analyzer is set to capture only the main resonance. By sweeping over a wider range of frequencies, more resonances may be encountered and multiple circular plots may be formed. The equivalent circuit of the ultrasonic transducer can be modeled by a first "dynamic" branch with a series connection of inductance Ls, resistance Rs and capacitance Cs (which define the electromechanical characteristics of the resonator) and a second capacitive branch with a static capacitance C0. In the following Figure 25 to Figure 29 In the impedance / admittance diagram shown in , the values ​​of the components of the equivalent circuit are:

[0416] Ls=L1=1.1068H

[0417] Rs=R1=311.352Ω

[0418] Cs=C1=7.43265pF

[0419] C0=C0=3.64026nF

[0420] The oscillator voltage applied to the ultrasonic transducer is 500mV, sweeping the frequency from 55kHz to 56kHz. The impedance (Z) scale is 200Ω / div, and the admittance (Y) scale is 500μS / div. Measurement results that characterize the values ​​of the impedance (Z) and admittance (Y) circular graphs can be obtained at the positions indicated by the impedance cursor and the admittance cursor on the circular graph.

[0421] Jaw state: open and without load

[0422] Fig.25 132066 is a graphical display of an impedance analyzer according to at least one aspect of the present disclosure, showing complex impedance (Z) / admittance (Y) graphs 132068, 132070 of an ultrasonic device with jaws open and no load, wherein the graph 132068 in solid form depicts the complex impedance and the graph 132070 in dashed form depicts the complex admittance. The oscillator voltage applied to the ultrasonic transducer is 500 mV, sweeping the frequency from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div, and the admittance (Y) scale is 500 μS / div. Measurements that can characterize the values ​​of the complex impedance (Z) and complex admittance (Y) graphs 132068, 132070 can be obtained at the locations indicated by the impedance cursor 132072 and the admittance cursor 132074 on the graphs 132068, 132070. Thus, the impedance cursor 132072 is located at a portion of the impedance circle 132068 equal to approximately 55.55 kHz, and the admittance cursor 132074 is located at a portion of the admittance circle 132070 equal to approximately 55.29 kHz. Fig.25 As depicted, the position of the impedance cursor 132072 corresponds to the following values:

[0423] R=1.66026Ω

[0424] X=-697.309Ω

[0425] Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of the admittance cursor 132074 corresponds to the following values:

[0426] G=64.0322μS

[0427] B=1.63007mS

[0428] where G is the conductance (real value) and B is the susceptance (imaginary value).

[0429] The state of the jaws: clamped on dry tanned leather

[0430] Fig.26A graphical display 132076 of an impedance analyzer according to at least one aspect of the present disclosure shows complex impedance (Z) / admittance (Y) graphs 132078, 132080 of an ultrasonic device with the jaws of the end effector clamped on dry chamois leather, wherein the impedance graph 132078 is shown in solid lines and the admittance graph 132080 is shown in dashed lines. The voltage applied to the ultrasonic transducer is 500 mV, and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div, and the admittance (Y) scale is 500 μS / div.

[0431] Measurement results that may characterize the values ​​of the complex impedance (Z) and complex admittance (Y) graphs 132078, 132080 may be obtained at the locations indicated by the impedance cursor 132082 and the admittance cursor 132084 on the graphs 132078, 132080. Thus, the impedance cursor 132082 is located at a portion of the impedance graph 132078 equal to approximately 55.68 kHz, and the admittance cursor 132084 is located at a portion of the admittance graph 132080 equal to approximately 55.29 kHz. Fig.26 As depicted, the position of the impedance cursor 132082 corresponds to the following values:

[0432] R=434.577Ω

[0433] X=-758.772Ω

[0434] Where R is the resistance (real value) and X is the reactance (imaginary value).

[0435] Similarly, the position of admittance cursor 132084 corresponds to the following values:

[0436] G=85.1712μS

[0437] B=1.49569mS

[0438] where G is the conductance (real value) and B is the susceptance (imaginary value).

[0439] The jaws are clamped on wet chamois leather.

[0440] Fig. 27 A graphical display 132086 of an impedance analyzer according to at least one aspect of the present disclosure shows complex impedance (Z) / admittance (Y) graphs 132098, 132090 of an ultrasonic device with the jaws tip clamped on wet chamois leather, wherein the impedance graph 132088 is shown in solid lines and the admittance graph 132090 is shown in dashed lines. The voltage applied to the ultrasonic transducer is 500 mV, and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div, and the admittance (Y) scale is 500 μS / div.

[0441] Measurement results that may characterize values ​​of the complex impedance (Z) and complex admittance (Y) graphs 132088, 132090 may be obtained at locations on the graphs 132088, 132090 indicated by the impedance cursor 132092 and the admittance cursor 132094. Thus, the impedance cursor 132092 is located at a portion of the impedance graph 132088 equal to approximately 55.68 kHz, and the admittance cursor 132094 is located at a portion of the admittance graph 132090 equal to approximately 55.29 kHz. Fig.28 As depicted, the impedance cursor 132092 corresponds to the following values:

[0442] R=445.259Ω

[0443] X=-750.082Ω

[0444] Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the admittance cursor 132094 corresponds to the following values:

[0445] G=96.2179μS

[0446] B=1.50236mS

[0447] where G is the conductance (real value) and B is the susceptance (imaginary value).

[0448] Jaws: Fully clamped on wet chamois leather

[0449] Fig.28 A graphical display 132096 of an impedance analyzer according to at least one aspect of the present disclosure shows complex impedance (Z) / admittance (Y) graphs 132098, 132100 of an ultrasonic device with its jaws fully clamped on wet chamois leather, wherein the impedance graph 132098 is shown in solid lines and the admittance graph 132100 is shown in dashed lines. The voltage applied to the ultrasonic transducer is 500 mV, and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div, and the admittance (Y) scale is 500 μS / div.

[0450] Measurements that may characterize the values ​​of the impedance and admittance graphs 132098, 132100 may be obtained at locations on the graphs 132098, 132100 indicated by the impedance cursor 13212 and the admittance cursor 132104. Thus, the impedance cursor 132102 is located at a portion of the impedance graph 132098 equal to approximately 55.63 kHz, and the admittance cursor 132104 is located at a portion of the admittance graph 132100 equal to approximately 55.29 kHz. Fig.28As depicted, the impedance cursor 132102 corresponds to the value of the resistance R (real value, not shown) and the value of the reactance X (imaginary value, also not shown).

[0451] Similarly, the admittance cursor 132104 corresponds to the following values:

[0452] G=137.272μS

[0453] B=1.48481mS

[0454] where G is the conductance (real value) and B is the susceptance (imaginary value).

[0455] Jaw state: open and without load

[0456] Fig.29 A graphical display 132106 of an impedance analyzer according to at least one aspect of the present disclosure shows an impedance (Z) / admittance (Y) graph, wherein the frequency is swept from 48 kHz to 62 kHz to capture multiple resonances of the ultrasonic device with the jaws open and no load, wherein the area represented by the rectangle 132108 shown in dashed lines is to facilitate visualization of the impedance graphs 132110a, 132110b, 132110c and the admittance graphs 132112a, 132112b, 132112c shown in solid lines. The voltage applied to the ultrasonic transducer is 500 mV, and the frequency is swept from 48 kHz to 62 kHz. The impedance (Z) scale is 500 Ω / div, and the admittance (Y) scale is 500 μS / div.

[0457] Measurements that may characterize the values ​​of the impedance and admittance graphs 132110a-c, 132112a-c may be obtained at locations on the impedance and admittance graphs 132110a-c, 132112a-c indicated by the impedance cursor 132114 and the admittance cursor 132116. Thus, the impedance cursor 132114 is located at a portion of the impedance graphs 132110a-c equal to approximately 55.52 kHz, and the admittance cursor 132116 is located at a portion of the admittance graphs 132112a-c equal to approximately 59.55 kHz. Fig.29 As depicted, the impedance cursor 132114 corresponds to the following values:

[0458] R=1.86163kΩ

[0459] X=-536.229Ω

[0460] Where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the admittance cursor 132116 corresponds to the following values:

[0461] G=649.956μS

[0462] B=2.51975mS

[0463] where G is the conductance (real value) and B is the susceptance (imaginary value).

[0464] Because there are only 400 samples over the full sweep range of the impedance analyzer, there are only a few points about resonance. Therefore, the circle on the right becomes irregular. But this is only because of the impedance analyzer and the settings used to cover multiple resonances.

[0465] When multiple resonances are present, more information is available to improve the classifier. A circle graph 132110a-c, 132112a-c fit can be calculated for each resonance encountered to keep the algorithm running fast. Thus, once there is an intersection of the complex admittances (representing a circle) during a scan, a fit can be calculated.

[0466] Benefits include a well-known model of the classifier in the jaws and the ultrasonic system based on the data. The count and characteristics of the circle are well known in the vision system. Therefore, data processing is easy. For example, there is a closed form solution that can calculate the radius and axis offset of the circle. The technique can be relatively fast.

[0467] Table 2 is a list of symbols for the lumped parameter model for piezoelectric transducers (from the IEEE 177 standard).

[0468]

[0469]

[0470] Table 2 Table 3 is a list of symbols for the transmission network (from the IEEE 177 standard).

[0471]

[0472]

[0473] * refers to real roots; complex roots are ignored.

[0474] Table 3

[0475] Table 4 is a list of solutions for various characteristic frequencies (from IEEE 177 standard).

[0476] Solutions for various characteristic frequencies

[0477]

[0478] * refers to real roots; complex roots are ignored

[0479] Table 4Table 5 shows the losses of three types of piezoelectric materials.

[0480]

[0481] Expected ratio Q for various types of piezoelectric vibrators r Minimum value of / r

[0482] Table 5

[0483] Table 6 shows the jaw conditions, i.e. the evaluation parameters of the circle based on the real-time measurements of the complex impedance / admittance, radius (re) and offset (ae and be) of the circle represented by the measured variables Re, Ge, Xe, Be, and the parameters of the reference circle diagram based on the real-time measurements of the complex impedance / admittance, radius (rr) and offset (ar, br) of the reference circle represented by the reference variables Rref, Gref, Xref, Bref, as shown in Table 6. Figure 25 to Figure 29 These values ​​are then compared to established values ​​for given conditions. These conditions may be: 1) jaws open and nothing in them, 2) end bite, 3) jaws fully bite with nails in place. The equivalent circuit of the ultrasonic transducer is modeled as follows and the frequency is swept from 55kHz to 56kHz:

[0484] Ls=L1=1.1068H

[0485] Rs=R1=311.352Ω

[0486] Cs = C1 = 7.43265pF and

[0487] C0=C0=3.64026nF

[0488]

[0489] Table 6

[0490] In use, the ultrasonic generator sweeps the frequency, records the measured variables, and determines the evaluation values ​​Re, Ge, Xe, Be. These evaluation values ​​are then compared with the reference variables Rref, Gref, Xref, Bref stored in the memory (e.g., stored in a lookup table), and the jaw condition is determined. The reference jaw conditions shown in Table 6 are only examples. More or fewer reference jaw conditions can be classified and stored in the memory. These variables can be used to evaluate the radius and offset of the impedance / admittance circle.

[0491] Fig.30132120 is a logic flow diagram of a process for a control program or logic configuration to determine a jaw condition based on an estimate of the radius (r) and offset (a, b) of an impedance / admittance circle according to at least one aspect of the present disclosure. Initially, based on the combination of Figure 25 to Figure 29 The reference jaw condition described in Table 6 is populated with reference values ​​in a database or lookup table. The reference jaw condition is set and the frequency is swept from below resonance to above resonance. The reference values ​​Rref, Gref, Xref, Bref defining the corresponding impedance / admittance circle are stored in the database or lookup table. During use, under the control of a control program or logic configuration, the control circuit of the generator or instrument causes the frequency to be swept 132122 from below resonance to above resonance. The control circuit measures and records 132124 the variables Re, Ge, Xe, Be defining the corresponding impedance / admittance circle (e.g., storing them in a memory) and compares 132126 them to the reference values ​​Rref, Gref, Xref, Bref stored in the database or lookup table. The control circuit determines 132128 (e.g., evaluates) the end effector jaw condition based on the comparison result.

[0492] Using spectroscopy to determine device usage status in combination devices

[0493] Fig.31 A system 132210 according to at least one aspect of the present disclosure is used to measure the complex impedance (Z) of an ultrasonic transducer 132212 in real time to determine the action being performed by an ultrasonic blade 132214. Current surgical instruments include three functions (seal+cut, seal only, and spot coagulation). These functions can be performed by activating two buttons. It would be very useful if the surgeon only had to press one button and could receive only a sealing or spot coagulation algorithm depending on the desired action to be performed. Ultrasonic spectroscopy can be used to measure the complex impedance (Z) of an ultrasonic blade 132214 in real time. The real-time measurement can be compared with predefined data to determine the action being performed. The different complex impedance (Z) patterns between spot coagulation and seal only enable the generator 132216 to determine which action is being performed and execute the appropriate algorithm.

[0494] The following techniques can be used to measure the complex impedance (Z) of the ultrasonic transducer 132212 in real time to determine the action being performed by the ultrasonic knife 132214: Figure 19-21 The title of the description is "ESTIMATING THE STATE OF THE JAW (PADBURN THROUGH, STAPLES, BROKEN BLADE, BONE IN JAW, TISSUE IN JAW) and / or Figure 22-30and / or the technology for evaluating the temperature of an ultrasonic knife described in related U.S. Provisional Patent Application No. 62 / 640,417 to Nott et al., entitled “TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR,” which is incorporated herein by reference in its entirety.

[0495] Table 7 is a graph of ultrasonic knife motion and corresponding complex impedance. This information is stored in a memory lookup table or database.

[0496] Ultrasonic knife action Impedance (Z) Seal only <![CDATA[Z 1 ]]> Spot condensation <![CDATA[Z 2 ]]>

[0497] Table 7

[0498] Fig.32 132220 is a logic flow diagram of a process according to at least one aspect of the present disclosure, the process depicting a method for determining an ultrasonic blade 132214 ( Fig.31 ) The control program or logic configuration of the action being performed. Fig.32 Combined Fig.31 Prior to the described process, a database or memory lookup table is populated with data of the ultrasonic blade 132214 action and the observed complex impedance (Z) associated with the ultrasonic blade 132214 action. The ultrasonic instrument 132218 or the generator 132216 can access the database or lookup table when performing the ultrasonic blade 132214 action. Therefore, during the hemostasis process, the control circuit of the generator 132216 or the instrument 13218 determines 132222 the complex impedance (Z) of the ultrasonic blade 132214. The control circuit compares 132224 the measured complex impedance (Z) with the stored value of the complex impedance pattern associated with the ultrasonic blade 132214 function. Based on the comparison, the control circuit controls the generator 132216 to apply 132226 the output power algorithm to the ultrasonic transducer 132212.

[0499] 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.

[0500] The above specific embodiments have been described in various forms of devices and / or methods 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 hardware 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 the exemplary forms of the subject matter described herein are applicable regardless of the specific type of signal-bearing medium used to actually distribute.

[0501] 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.

[0502] 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)), 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 devices described herein, or a microprocessor configured by a computer program to at least partially implement the methods and / or devices described herein), electronic circuitry forming a memory device (e.g., forming a 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.

[0503] 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 memory device.

[0504] 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.

[0505] 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, transferred, 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.

[0506] 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 the 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 the 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 the 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" published by the ATM Forum in August 2001 and / or later versions of the standard. Of course, different and / or later developed connection-oriented network communication protocols are also contemplated herein.

[0507] 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.

[0508] One or more components may be referred to herein as "configured to be able to", "configurable to be able to", "operable / operably", "suitable / adaptable to", "able to", "conformable / conform to", etc. Those skilled in the art will recognize that, unless the context indicates otherwise, "configured to be able to" may generally cover components in an active state and / or components in an inactive state and / or components in a standby state.

[0509] 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.

[0510] 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.

[0511] 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".

[0512] For the appended claims, those skilled in the art will appreciate that the operations described therein may generally be performed in any order. In addition, although various operational flow charts are presented in one or more sequences, it should be understood that the various operations may be performed in other orders than the order shown, or the various operations may be performed simultaneously. Unless the context otherwise dictates, examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preparatory, supplementary, simultaneous, reverse, or other altered orderings. In addition, unless the context otherwise dictates, terms such as "responsive to," "related to," or other past tense adjectives are generally not intended to exclude such variants.

[0513] 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 various places throughout the specification do not necessarily refer to the same aspect. In addition, specific features, structures, or characteristics may be combined in any suitable manner in one or more aspects.

[0514] 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 set forth 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 set forth herein will be incorporated only to the extent that there is no conflict between the incorporated material and the existing public material.

[0515] 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 various forms and various modifications suitable for the intended specific use. The claims submitted herewith are intended to define the full scope.

[0516] Various aspects of the subject matter described herein are set forth in the following numbered examples:

[0517] Embodiment 1. A method of delivering energy to an ultrasonic device, the ultrasonic device comprising an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system further comprising an ultrasonic transducer coupled to an ultrasonic blade, the method comprising:

[0518] Measuring, by a processor or control circuit, the complex impedance of the ultrasonic blade coupled to the ultrasonic transducer;

[0519] comparing, by the processor or the control circuit, the measured complex impedance with a stored value of a complex impedance pattern associated with an ultrasonic blade function; and

[0520] An algorithm is applied by the processor or the control circuit based on the comparison to control power output to the ultrasound transducer.

[0521] Example 2. The method of Example 1, further comprising delivering energy to the ultrasonic device by the processor or the control circuit based on a state or condition of an end effector, wherein determining the state or condition of the end effector comprises:

[0522] The complex impedance of the ultrasonic transducer is measured by the processor or the control circuit, wherein the complex impedance is defined as

[0523] receiving, by the processor or the control circuit, complex impedance measurement data points;

[0524] comparing, by the processor or the control circuit, the complex impedance measurement data points with data points in a reference complex impedance signature pattern;

[0525] classifying, by the processor or the control circuit, the complex impedance measurement data points based on the results of the comparative analysis; and

[0526] The state or condition of the end effector is designated by the processor or the control circuit based on the results of the comparative analysis.

[0527] Example 3. A method according to Example 2, wherein the state or condition of the end actuator is specified by the processor or the control circuit based on the results of the comparative analysis, including: the state or condition of the end actuator corresponding to the state of only sealing tissue is specified by the processor or the control circuit.

[0528] Example 4. A method according to Example 2, wherein the state or condition of the end actuator is specified by the processor or the control circuit based on the results of the comparative analysis, including: the state or condition of the end actuator corresponding to the state of coagulating the tissue spot is specified by the processor or the control circuit.

[0529] Example 5. The method of any one or more of Examples 1 to 4, further comprising delivering energy to the ultrasonic device by the processor or the control circuit based on a state or condition of the end effector, wherein determining the state or condition of the end effector comprises:

[0530] applying a drive signal to the ultrasonic transducer by a drive circuit, wherein the drive signal is a periodic signal defined by amplitude and frequency;

[0531] sweeping, by a processor or control circuit, the frequency of the drive signal from below resonance to above resonance of the electromechanical ultrasonic system;

[0532] The impedance / admittance circle variable R is measured and recorded by the processor or the control circuit. e , G e , X e and B e ;

[0533] The processor or the control circuit converts the measured impedance / admittance circle variable R e , G e , X e and B e With reference impedance / admittance circle variable R ref , G ref , Xref and B ref Make comparisons;

[0534] as well as

[0535] The state or condition of the end effector is determined by the processor or the control circuit based on the results of the comparative analysis.

[0536] Example 6. A method according to Example 5, wherein the state or condition of the end actuator is specified by the processor or the control circuit based on the results of the comparative analysis, including: the state or condition of the end actuator corresponding to the state of only sealing tissue is specified by the processor or the control circuit.

[0537] Example 7. A method according to Example 5, wherein the state or condition of the end actuator is specified by the processor or the control circuit based on the result of the comparative analysis, including: the state or condition of the end actuator corresponding to the state of coagulating the tissue spot is specified by the processor or the control circuit.

[0538] Embodiment 8. An ultrasonic surgical instrument, comprising:

[0539] an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide; and

[0540] a generator configured to supply power to the ultrasonic transducer, wherein the generator comprises a control circuit configured to:

[0541] measuring the complex impedance of an ultrasonic blade connected to an ultrasonic transducer;

[0542] comparing the measured complex impedance to a stored value of a complex impedance pattern associated with an ultrasonic blade function; and

[0543] An algorithm is applied based on the comparison to control power output to the ultrasound transducer.

[0544] Example 9. The ultrasonic surgical instrument of Example 8, wherein the generator comprises a control circuit further configured to deliver energy to the ultrasonic device based on a state or condition of the end effector when the control circuit is further configured to:

[0545] The complex impedance of the ultrasonic transducer is measured, wherein the complex impedance is defined as

[0546]

[0547] receiving complex impedance measurement data points;

[0548] comparing the complex impedance measurement data points with data points in a reference complex impedance signature pattern;

[0549] classifying the complex impedance measurement data points based on the results of the comparative analysis; and

[0550] A state or condition of the end effector is assigned based on the results of the comparative analysis.

[0551] Example 10. According to the ultrasonic surgical instrument of Example 9, the state or condition of the end actuator corresponds to a state of sealing only tissue.

[0552] Example 11. An ultrasonic surgical instrument according to Example 9, wherein the state or condition of the end effector corresponds to a state of coagulating the tissue spot.

[0553] Embodiment 12. An ultrasonic surgical instrument according to any one or more of Embodiments 8 to 11, wherein the generator comprises a control circuit further configured to deliver energy to the ultrasonic device based on a state or condition of an end effector when the control circuit is further configured to:

[0554] causing a drive circuit to apply a drive signal to the ultrasonic transducer, wherein the drive signal is a periodic signal defined by an amplitude and a frequency;

[0555] sweeping the frequency of the drive signal from below resonance to above resonance of the electromechanical ultrasonic system;

[0556] Measure and record the impedance / admittance circle variable R e , G e , X e and B e ;

[0557] The measured impedance / admittance circle variable R e , G e , X e and B e With reference impedance / admittance circle variable R ref , G ref , X ref and B ref Make a comparison; and

[0558] A state or condition of the end effector is determined based on the results of the comparative analysis.

[0559] Example 13. An ultrasonic surgical instrument according to Example 12, wherein the state or condition of the end actuator corresponds to a state of sealing only tissue.

[0560] Example 14. An ultrasonic surgical instrument according to Example 12, wherein the state or condition of the end effector corresponds to a state of coagulating the tissue spot.

[0561] Embodiment 15. A generator for an ultrasonic surgical instrument, the generator comprising:

[0562] A control circuit configured to:

[0563] measuring the complex impedance of an ultrasonic blade connected to an ultrasonic transducer;

[0564] comparing the measured complex impedance to a stored value of a complex impedance pattern associated with an ultrasonic blade function; and

[0565] An algorithm is applied based on the comparison to control power output to the ultrasound transducer.

[0566] Example 16. The generator of Example 15, wherein the control circuit is further configured to enable energy to be delivered to the ultrasonic surgical instrument based on a state or condition of an end effector when the control circuit is further configured to enable:

[0567] The complex impedance of the ultrasonic transducer is measured, wherein the complex impedance is defined as

[0568]

[0569] receiving complex impedance measurement data points;

[0570] comparing the complex impedance measurement data points with data points in a reference complex impedance signature pattern;

[0571] classifying the complex impedance measurement data points based on the results of the comparative analysis; and

[0572] A state or condition of the end effector is assigned based on the results of the comparative analysis.

[0573] Example 17. The generator of Example 16, wherein the state or condition of the end effector corresponds to a state in which only tissue is sealed.

[0574] Example 18. The generator of Example 16, wherein the state or condition of the end effector corresponds to a state in which the tissue spot is coagulated.

[0575] Example 19. The generator of any one or more of Examples 15 to 18, wherein the control circuit is further configured to deliver energy to the ultrasonic surgical instrument based on a state or condition of an end effector when the control circuit is further configured to:

[0576] causing a drive circuit to apply a drive signal to the ultrasonic transducer, wherein the drive signal is a periodic signal defined by an amplitude and a frequency;

[0577] sweeping the frequency of the drive signal from below resonance to above resonance of the electromechanical ultrasonic system;

[0578] Measure and record the impedance / admittance circle variable R e , G e , X e and B e ;

[0579] The measured impedance / admittance circle variable R e , G e , X e and B e With reference impedance / admittance circle variable R ref , G ref , X ref and B ref Make a comparison; and

[0580] A state or condition of the end effector is determined based on the results of the comparative analysis.

[0581] Example 20. The generator of Example 19, wherein the state or condition of the end effector corresponds to a state of sealing tissue only.

[0582] Example 21. The generator of Example 19, wherein the state or condition of the end effector corresponds to a state in which the tissue spot is coagulated.

Claims

1. A computer readable medium for storing or transmitting electronic instructions for executing a method of delivering energy to an ultrasonic device, the ultrasonic device comprising an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system also comprising an ultrasonic transducer coupled to an ultrasonic blade, the method comprising: The complex impedance of the ultrasonic blade coupled to the ultrasonic transducer is measured by a processor or control circuit, wherein the complex impedance is defined as Among them, Z g (t) represents the complex impedance of the ultrasonic blade connected to the ultrasonic transducer, V g (t) represents the alternating voltage applied to the ultrasonic transducer, I g (t) represents an alternating current applied to the ultrasonic transducer; comparing, by the processor or the control circuit, the measured complex impedance with a stored value of a complex impedance pattern associated with an ultrasonic knife function; applying, by the processor or the control circuit, an algorithm based on the comparison to control power output to the ultrasonic transducer; energy is delivered to the ultrasonic device by the processor or the control circuit based on the state and condition of the end effector, and The complex impedance pattern is a spectrum diagram of an ultrasonic device with a plurality of different states and conditions of an end effector plotted in three-dimensional space, wherein the complex impedance, amplitude and phase are plotted as a function of frequency; and / or the complex impedance pattern is an impedance diagram or an admittance diagram formed by scanning the frequency of the drive signal applied to the ultrasonic transducer within a predetermined range of frequencies from below the resonance to above the resonance of the electromechanical ultrasonic system.

2. The computer-readable medium of claim 1 , wherein determining the state and condition of the end effector comprises: Measuring, by the processor or the control circuit, the complex impedance of the ultrasonic transducer; receiving, by the processor or the control circuit, complex impedance measurement data points; comparing, by the processor or the control circuit, the complex impedance measurement data points with data points in a reference complex impedance signature pattern; classifying, by the processor or the control circuit, the complex impedance measurement data points based on the results of the comparative analysis; as well as The state and condition of the end effector is designated by the processor or the control circuit based on the results of the comparative analysis.

3. The computer readable medium of claim 1 , wherein determining the state and condition of the end effector comprises: applying a drive signal to the ultrasonic transducer by a drive circuit, wherein the drive signal is a periodic signal defined by amplitude and frequency; sweeping, by a processor or control circuit, the frequency of the drive signal within a predetermined range of frequencies from below resonance to above resonance of the electromechanical ultrasonic system; The processor or the control circuit measures and records the impedance circle or admittance circle variable R e , G e , X e and B e ; The processor or the control circuit converts the measured impedance circle or admittance circle variable R e , G e , X e and B e With reference impedance circle or admittance circle variable R ref , G ref , X ref and B ref Make comparisons; as well as The state and condition of the end effector is determined by the processor or the control circuit based on the results of the comparative analysis.

4. An ultrasonic surgical instrument, comprising: An electromechanical ultrasonic system, the electromechanical ultrasonic system comprising an ultrasonic transducer coupled to an ultrasonic scalpel via an ultrasonic waveguide; as well as a generator configured to supply power to the ultrasonic transducer, wherein the generator comprises a control circuit configured to: The complex impedance of the ultrasonic blade coupled to the ultrasonic transducer is measured, where the complex impedance is defined as Among them, Z g (t) represents the complex impedance of the ultrasonic blade connected to the ultrasonic transducer, V g (t) represents the alternating voltage applied to the ultrasonic transducer, I g (t) represents an alternating current applied to the ultrasonic transducer; comparing the measured complex impedance to a stored value of a complex impedance pattern associated with an ultrasonic knife function; applying an algorithm based on the comparison to control power output to the ultrasonic transducer; as well as delivering energy to the ultrasonic surgical instrument based on the state and condition of the end effector, and wherein the complex impedance pattern is a spectrum diagram of an ultrasonic surgical instrument with a plurality of different states and conditions of an end effector plotted in three-dimensional space, wherein the complex impedance, amplitude and phase are plotted as a function of frequency; and / or the complex impedance pattern is an impedance diagram or an admittance diagram formed by scanning the frequency of a drive signal applied to the ultrasonic transducer within a predetermined range of frequencies from below resonance to above resonance of the electromechanical ultrasonic system.

5. The ultrasonic surgical instrument according to claim 4, wherein: The control circuit is configured to enable energy to be delivered to the ultrasonic surgical instrument based on a state and condition of the end effector when the control circuit is further configured to enable: measuring the complex impedance of the ultrasonic transducer; receiving complex impedance measurement data points; comparing the complex impedance measurement data points with data points in a reference complex impedance signature pattern; classifying the complex impedance measurement data points based on the results of the comparative analysis; and A state and condition of the end effector is assigned based on the results of the comparative analysis.

6. The ultrasonic surgical instrument of claim 5, the state and condition of the end effector corresponding to a state of sealing tissue only.

7. The ultrasonic surgical instrument according to claim 5, wherein: The state and condition of the end effector corresponds to a state in which the tissue spot is coagulated.

8. The ultrasonic surgical instrument according to claim 4, wherein: The control circuit is configured to enable energy to be delivered to the ultrasonic surgical instrument based on a state and condition of the end effector when the control circuit is further configured to enable: causing a drive circuit to apply a drive signal to the ultrasonic transducer, wherein the drive signal is a periodic signal defined by an amplitude and a frequency; sweeping the frequency of the drive signal within a predetermined range of frequencies from below resonance to above resonance of the electromechanical ultrasonic system; Measure and record the impedance circle or admittance circle variable R e , G e , X e and B e ; The measured impedance circle or admittance circle variable R e , G e , X e and B e With reference impedance circle or admittance circle variable R ref , G ref , X ref and B ref Make a comparison; and The state and condition of the end effector is determined based on the results of the comparative analysis.

9. The ultrasonic surgical instrument according to claim 8, wherein: The state and condition of the end effector corresponds to a state in which only tissue is sealed.

10. The ultrasonic surgical instrument according to claim 8, wherein: The state and condition of the end effector corresponds to a state in which the tissue spot is coagulated.

11. A generator for an ultrasonic surgical instrument, the ultrasonic surgical instrument comprising an electromechanical ultrasonic system, the generator comprising: A control circuit configured to: The complex impedance of the ultrasonic blade coupled to the ultrasonic transducer is measured, where the complex impedance is defined as Among them, Z g (t) represents the complex impedance of the ultrasonic blade connected to the ultrasonic transducer, V g (t) represents the alternating voltage applied to the ultrasonic transducer, I g (t) represents an alternating current applied to the ultrasonic transducer; comparing the measured complex impedance to a stored value of a complex impedance pattern associated with an ultrasonic knife function; applying an algorithm based on the comparison to control power output to the ultrasonic transducer; and delivering energy to the ultrasonic surgical instrument based on the state and condition of the end effector, and wherein the complex impedance pattern is a spectrum diagram of an ultrasonic surgical instrument with a plurality of different states and conditions of an end effector plotted in three-dimensional space, wherein the complex impedance, amplitude and phase are plotted as a function of frequency; and / or the complex impedance pattern is an impedance diagram or an admittance diagram formed by scanning the frequency of a drive signal applied to the ultrasonic transducer within a predetermined range of frequencies from below resonance to above resonance of the electromechanical ultrasonic system.

12. The generator according to claim 11, wherein The control circuit is configured to enable energy to be delivered to the ultrasonic surgical instrument based on a state and condition of the end effector when the control circuit is further configured to enable: measuring the complex impedance of the ultrasonic transducer; receiving complex impedance measurement data points; comparing the complex impedance measurement data points with data points in a reference complex impedance signature pattern; classifying the complex impedance measurement data points based on the results of the comparative analysis; and A state and condition of the end effector is assigned based on the results of the comparative analysis.

13. The generator according to claim 12, wherein The state and condition of the end effector corresponds to a state in which only tissue is sealed.

14. The generator according to claim 12, wherein: The state and condition of the end effector corresponds to a state in which the tissue spot is coagulated.

15. The generator according to claim 11, wherein The control circuit is configured to enable energy to be delivered to the ultrasonic surgical instrument based on a state and condition of the end effector when the control circuit is further configured to enable: causing a drive circuit to apply a drive signal to the ultrasonic transducer, wherein the drive signal is a periodic signal defined by an amplitude and a frequency; sweeping the frequency of the drive signal within a predetermined range of frequencies from below resonance to above resonance of the electromechanical ultrasonic system; Measure and record the impedance circle or admittance circle variable R e , G e , X e and B e ; The measured impedance circle or admittance circle variable R e , G e , X e and B e With reference impedance circle or admittance circle variable R ref , G ref , X ref and B ref Make a comparison; and The state and condition of the end effector is determined based on the results of the comparative analysis.

16. The generator according to claim 15, wherein The state and condition of the end effector corresponds to a state in which only tissue is sealed.

17. The generator according to claim 15, wherein The state and condition of the end effector corresponds to a state in which the tissue spot is coagulated.

Images