Smart blade and power pulsing
Through the intelligent ultrasonic knife control algorithm, the impedance of the ultrasonic transducer is monitored and adjusted in real time, the compatibility problems of ultrasonic and electrosurgical equipment is solved, the control accuracy and safety of the equipment are improved, and the compatibility of ultrasonic and electrosurgical equipment is achieved.
Patent Information
- Application Number
- JP2024191607
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2018-09-27
- Filing Date
- 2024-10-31
- Publication Date
- 2025-02-04
AI Technical Summary
The existing ultrasonic and electrosurgical equipment requires different driving signals and feedback mechanisms, resulting in the user interface and generator that need to be designed separately, which is incompatible, and there are current leakage and noise interference problems, which affects the control accuracy and safety of the equipment.
The intelligent ultrasonic knife control algorithm is adopted to monitor the impedance changes of the ultrasonic transducer in real time through processors or control circuits, adjust the power output to adapt to different tissue characteristics, and combine complex impedance measurement and frequency adjustment to achieve precise control of the ultrasonic knife.
It improves the operating accuracy and safety of ultrasonic surgical equipment, reduces current leakage and noise interference, realizes compatible use of ultrasonic and electrosurgical equipment, and improves the control and effect of surgery.
Smart Images

Figure 2025016647000001_ABST
Abstract
Description
[Technical field]
[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Nonprovisional Patent Application No. 16 / 144,405, entitled "SMART BLADE AND POWER PULSING," filed September 27, 2018, the entire disclosure of which is incorporated herein by reference.
[0002] This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 640,415, filed March 8, 2018, entitled “ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,” the entire disclosure of which is incorporated herein by reference. [Background technology]
[0003] In surgical environments, smart energy devices within a smart energy architecture environment may be required. Ultrasonic surgical devices, such as ultrasonic scalpels, are finding increasingly widespread use in surgical procedures due to their unique performance characteristics. With certain device configurations and operating parameters, ultrasonic surgical devices can provide homeostasis with substantially simultaneous ablation and coagulation of tissue, desirably minimizing patient trauma. Ultrasonic surgical devices may include a handpiece including an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer having a distally attached end effector (e.g., a blade tip) for cutting and sealing tissue. In some cases, the instrument may be permanently attached to the handpiece. In other cases, such as in the case of disposable or replaceable instruments, the instrument may be removable from the handpiece. The end effector transmits ultrasonic energy to tissue in contact with the end effector to achieve the cutting and sealing action. Such ultrasonic surgical devices may be configured for open surgical applications, laparoscopic or endoscopic procedures, including robotic-assisted procedures.
[0004] Ultrasonic energy cuts and coagulates tissue using lower temperatures than those used in electrosurgical procedures and may be transmitted to the end effector by an ultrasonic generator in communication with the handpiece. The ultrasonic blade vibrates at high frequencies (e.g., 55,500 cycles per second) to denature proteins in the tissue to form a sticky coagulant. Pressure applied by the blade surface against the tissue collapses blood vessels, allowing the coagulant to form a hemostatic seal. The surgeon can control the cutting speed and coagulation by the force applied to the tissue by the end effector, the time the force is applied, and the performance level of the selected end effector.
[0005] An ultrasonic transducer may be modeled as an equivalent circuit including a first branch with capacitance and a second "operational" branch with series-connected inductance, resistance, and capacitance that define the electromechanical properties of the resonator. Known ultrasonic generators may include tuning inductors for tuning out the capacitance at a certain resonant frequency so that substantially all of the generator drive signal current flows in the operational branch. Thus, by using a tuning inductor, the generator drive signal current represents the operational branch current, and thus the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency locking ability of the generator. However, the tuning inductor must be matched to the specific capacitance of the ultrasonic transducer at the operational resonant frequency. In other words, different ultrasonic transducers with different capacitances require different tuning inductors.
[0006] Additionally, in some ultrasonic generator configurations, the generator drive signal exhibits asymmetric harmonic distortion that complicates impedance magnitude and phase measurements. For example, the accuracy of impedance phase measurements can be reduced due to harmonic distortion of the current and voltage signals.
[0007] Additionally, electromagnetic interference in noisy environments reduces the generator's ability to maintain lock on the resonant frequency of the ultrasonic transducer, increasing the likelihood of invalid control algorithm inputs.
[0008] Electrosurgical devices for applying electrical energy to tissue to treat and / or destroy the tissue are also finding increasingly widespread use in surgical procedures. The electrosurgical device may include an instrument having a handpiece and a distally attached end effector (e.g., one or more electrodes). The end effector may be positioned relative to the tissue such that an electric current is introduced into the tissue. The electrosurgical device may be configured for bipolar or monopolar operation. During bipolar operation, the electric current is introduced into the tissue by the active electrode of the end effector and returned from the tissue by the return electrode of the end effector, respectively. During monopolar operation, the electric current is introduced into the tissue by the active electrode of the end effector and returned via a return electrode (e.g., a ground pad) separately located on the patient's body. Heat generated by the electric current flowing through the tissue may form a hemostatic seal in and / or between the tissue and may thus be particularly useful, for example, for sealing blood vessels. The end effector of the electrosurgical device may also include a cutting member that is movable relative to the tissue, and an electrode for resecting the tissue.
[0009] The electrical energy applied by the electrosurgical device may be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy may be in the form of radio frequency (RF) energy. RF energy is a form of electrical energy that may be in the frequency range of 300 kHz to 1 MHz, as described in EN60601-2-2:2009+A11:2011, Definition 201.3.218-HIGH FREQUENCY. For example, frequencies in monopolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, the frequency may be nearly any value. Frequencies above 200 kHz are typically used in monopolar applications to avoid unnecessary stimulation of nerves and muscles resulting from the use of low frequency currents. Lower frequencies may be used for bipolar techniques if risk analysis indicates that the potential for neuromuscular stimulation has been mitigated to an acceptable level. Frequencies above 5 MHz are not typically used to minimize problems associated with high frequency leakage currents. 10 mA is generally recognized as the lower threshold for thermal effects on tissue.
[0010] During its operation, the electrosurgical device can transmit low frequency RF energy through tissue, which causes ionic agitation or friction, i.e. resistive heating, increasing the temperature of the tissue. A sharp boundary can be formed between the tissue being treated and its surrounding tissue, allowing the surgeon to operate with a high level of precision and control without sacrificing adjacent non-target tissue. The low operating temperature of RF energy can be useful in simultaneously sealing blood vessels while removing, shrinking, or sculpting soft tissue. RF energy can work particularly well on connective tissue, which is primarily composed of collagen and contracts when in contact with heat.
[0011] Due to these unique drive signals, sensing and feedback requirements, ultrasonic and electrosurgical devices have typically required different generators. In addition, where the instruments are disposable or interchangeable with handpieces, ultrasonic and electrosurgical generators are limited in their ability to recognize the particular instrument configuration being used and therefore optimize the control and diagnostic process. Furthermore, capacitive coupling between the generator's non-isolated circuitry and the patient-isolated circuitry can result in exposing the patient to unacceptable levels of leakage current, especially when higher voltages and frequencies are used.
[0012] Moreover, due to these unique drive signal, sensing and feedback needs, ultrasonic and electrosurgical devices have typically required different user interfaces for the different generators. In such conventional ultrasonic and electrosurgical devices, one user interface may be configured for use with an ultrasonic instrument while another user interface is configured for use with an electrosurgical instrument. Such user interfaces include hand and / or foot activated user interfaces, such as hand and / or foot activated switches. As various aspects of combined generators for use with both ultrasonic and electrosurgical instruments are contemplated in the subsequent disclosure, additional user interfaces configured to operate with both ultrasonic and / or electrosurgical instrument generators are also contemplated.
[0013] Additional user interfaces for providing feedback to either a user or other machines to provide feedback indicative of the operating mode or status of either the ultrasonic and / or electrosurgical instruments are contemplated within the disclosure that follows. Providing user and / or machine feedback for operating a combination ultrasonic and / or electrosurgical instrument requires providing sensory feedback to the user and providing electrical / mechanical / electromechanical feedback to the machine. Feedback devices incorporating visual feedback devices (e.g., LCD display screens, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators) are contemplated within the disclosure that follows for use with combined ultrasonic and / or electrosurgical instruments.
[0014] Other electrosurgical instruments include, but are not limited to, irreversible and / or reversible electroporation, and / or microwave technology, among others. Thus, the technology disclosed herein is applicable to ultrasonic, bipolar or monopolar RF (electrosurgical), irreversible and / or reversible electroporation, and / or microwave based surgical instruments, among others. Summary of the Invention [Means for solving the problem]
[0015] An aspect of an ultrasonic device may include an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system further including an ultrasonic transducer coupled to the ultrasonic blade. An aspect of a method of controlling energy delivered to an ultrasonic device may include determining, by a processor or control circuitry, an impedance of the ultrasonic transducer coupled to the ultrasonic blade during an ablation process, analyzing, by the processor or control circuitry, the impedance of the ultrasonic transducer, profiling, by the processor or control circuitry, the ultrasonic blade based on the impedance of the ultrasonic transducer, and adjusting, by the processor or control circuitry, power delivered to the ultrasonic transducer during the ablation process based on the profile of the ultrasonic blade.
[0016] In one aspect, the method further includes pulsing, by a processor or control circuit, power delivered to the ultrasonic transducer, and determining, by the processor or control circuit, a change in tissue properties of tissue located within the end effector, the change in tissue properties being determined between pulses and adjusting, by the processor or control circuit, the power delivered to the ultrasonic transducer based on the tissue changes throughout the ablation.
[0017] In one aspect of the method, determining the change in tissue property by the processor or control circuitry includes measuring, by the processor or control circuitry, a complex impedance of an ultrasound transducer, the complex impedance being:
[0018]
number
[0019] In one aspect of the method, receiving, by the processor or control circuitry, the complex impedance measurement data points may include receiving, by the processor or control circuitry, the complex impedance measurement data points corresponding to the clamp arm pads, and adjusting, by the processor or control circuitry, power delivered to the ultrasonic transducer to a power value that prevents melting of the clamp arm pads.
[0020] In one aspect of the method, determining a change in tissue property by the processor or control circuitry includes applying, by the drive circuitry, a drive signal to the ultrasound transducer, the drive signal being a periodic signal defined by an amplitude and a frequency, sweeping, by the processor or control circuitry, a frequency of the drive signal from below to above resonance of the electromechanical ultrasound system, and determining, by the processor or control circuitry, an impedance / admittance circle variable R e , G e , X e , and B e and a processor or control circuit measures and records the measured impedance / admittance circle variable R e , G e , X e and B. e The reference impedance / admittance circle variable R ref , G ref , X ref , and B refand determining, by a processor or control circuitry, a state or status of the end effector based on results of the comparison analysis.
[0021] In one aspect of the method, determining by the processor or control circuitry a change in tissue property may include determining by the processor or control circuitry a change in tissue thickness.
[0022] One aspect of an ultrasonic surgical instrument may include an ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide and a generator configured to provide power to the ultrasonic transducer. In one aspect, the generator may include a control circuit configured to determine an impedance of the ultrasonic transducer coupled to the ultrasonic blade during a cutting process, analyze the impedance of the ultrasonic transducer, profile the ultrasonic blade based on the impedance of the ultrasonic transducer, and adjust power delivered to the ultrasonic transducer during the cutting process based on the profile of the ultrasonic blade.
[0023] In one aspect of the ultrasonic surgical instrument, the generator may include a control circuit further configured to pulse the power delivered to the ultrasonic transducer, determine a change in tissue properties of tissue located within the end effector, and adjust the power delivered to the ultrasonic transducer based on the tissue changes determined between pulses and the tissue properties throughout the ablation.
[0024] In one aspect of the ultrasonic surgical instrument, the generator measures a complex impedance of the ultrasonic transducer, the complex impedance being:
[0025]
number
[0026] In one aspect of the ultrasonic surgical instrument, the generator may include a control circuit further configured to receive complex impedance measurement data points corresponding to the clamp arm pads and adjust the power delivered to the ultrasonic transducer to a power value that prevents the clamp arm pads from melting.
[0027] In one aspect of the ultrasonic surgical instrument, the generator includes causing a driver circuit to apply a drive signal to an ultrasonic transducer, the drive signal being a periodic signal defined by an amplitude and a frequency, sweeping the frequency of the drive signal from below to above the resonance of the electromechanical ultrasonic system, and controlling an impedance / admittance circle parameter R. e , G e , X e , and B e and measuring and recording the measured impedance / admittance circle parameter R e , G e , X e , and B e The reference impedance / admittance circle variable R ref , G ref , X ref , and B ref and determining a state or status of the end effector based on a result of the comparison analysis.
[0028] In one aspect of the ultrasonic surgical instrument, the generator may include a control circuit further configured to determine a change in tissue thickness.
[0029] One aspect of a generator for an ultrasonic surgical instrument may include a control circuit configured to determine an impedance of an ultrasonic transducer coupled to an ultrasonic blade during a cutting process, analyze the impedance of the ultrasonic transducer, profile the ultrasonic blade based on the impedance of the ultrasonic transducer, and adjust power delivered to the ultrasonic transducer during the cutting process based on the profile of the ultrasonic blade.
[0030] In one aspect of the ultrasonic surgical instrument, the control circuitry is further configured to pulse power delivered to the ultrasonic transducer and determine a change in tissue properties of tissue located within the end effector, where the change in tissue properties is determined between pulses, and adjust the power delivered to the ultrasonic transducer based on the tissue changes throughout the ablation.
[0031] In one aspect of the ultrasonic surgical instrument, the control circuit measures a complex impedance of the ultrasonic transducer, the complex impedance being:
[0032]
number
[0033] In one aspect of the ultrasonic surgical instrument, the control circuit is further configured to receive complex impedance measurement data points corresponding to the clamp arm pads and adjust the power delivered to the ultrasonic transducer to a power value that prevents the clamp arm pads from melting.
[0034] In one aspect of the ultrasonic surgical instrument, the control circuitry causes the drive circuitry to apply a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by an amplitude and a frequency, sweeping the frequency of the drive signal from below to above resonance of the electromechanical ultrasonic system, and controlling an impedance / admittance circle parameter R. e , G e , X e , and B e and measuring and recording the measured impedance / admittance circle parameter R e , G e , X e , and B e The reference impedance / admittance circle variable R ref , G ref , X ref , and B ref and determining a state or status of the end effector based on a result of the comparison analysis.
[0035] In one aspect of the ultrasonic surgical instrument, the control circuitry is further configured to determine a change in tissue thickness.
[0036] One aspect of an ultrasonic surgical system may include a processor and a non-transitory memory. In one aspect, the non-transitory memory may include instructions that, when executed by the processor, cause the processor to determine an impedance of an ultrasonic transducer coupled to an ultrasonic blade during an ablation process, analyze the impedance of the ultrasonic transducer, profile the ultrasonic blade based on the impedance of the ultrasonic transducer, and adjust power delivered to the ultrasonic transducer during the ablation process based on the profile of the ultrasonic blade.
[0037] In one aspect of the ultrasonic surgical system, the non-transitory memory may include instructions that, when executed by the processor, further cause the processor to pulse the power delivered to the ultrasonic transducer; determine a change in tissue properties of tissue located within the end effector, where the change in tissue properties is determined between pulses; and adjust the power delivered to the ultrasonic transducer based on the tissue changes throughout the ablation. [Brief description of the drawings]
[0038] The features of the various aspects are set forth in detail in the appended claims, however the various aspects, both as to organization and method of operation, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings in which: [Figure 1] A system configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communications hub in accordance with at least one aspect of the present disclosure. [Diagram 2] 1 illustrates an example of a generator, according to at least one embodiment of the present disclosure. [Diagram 3] According to at least one aspect of the present disclosure, a surgical system includes a generator and various surgical instruments usable with the generator. [Figure 4] 1 is an end effector according to at least one aspect of the present disclosure. [Diagram 5] FIG. 4 is a diagram of the surgical system of FIG. 3, according to at least one embodiment of the present disclosure. [Figure 6] 1 is a model illustrating dynamic divided flow, according to at least one embodiment of the present disclosure. [Figure 7] FIG. 2 is a structural diagram of a generator architecture, in accordance with at least one embodiment of the present disclosure. [Figure 8A] FIG. 2 is a functional diagram of a generator architecture, in accordance with at least one embodiment of the present disclosure. [Figure 8B]FIG. 2 is a functional diagram of a generator architecture, in accordance with at least one embodiment of the present disclosure. [Figure 8C] FIG. 2 is a functional diagram of a generator architecture, in accordance with at least one embodiment of the present disclosure. [Figure 9A] 1 illustrates structural and functional aspects of a generator according to at least one embodiment of the present disclosure. [Figure 9B] 1 illustrates structural and functional aspects of a generator according to at least one embodiment of the present disclosure. [Figure 10] 1 illustrates a control circuit configured to control an aspect of a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 11] 1 illustrates a combinatorial logic circuit configured to control aspects of a surgical instrument or tool, according to at least one aspect of the present disclosure. [Figure 12] 1 illustrates a sequential logic circuit configured to control aspects of a surgical instrument or tool, in accordance with at least one aspect of the present disclosure. [Figure 13] 1 illustrates one embodiment of a basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms for an electrical signal waveform for use in a surgical instrument, in accordance with at least one embodiment of the present disclosure. [Figure 14] 1 illustrates one embodiment of a direct digital synthesis (DDS) circuit configured to generate a plurality of waveforms of an electrical signal waveform for use in a surgical instrument, in accordance with at least one embodiment of the present disclosure. [Figure 15] 1 illustrates one cycle of a discrete-time digital electrical signal waveform according to at least one embodiment of the present disclosure of an analog waveform (shown superimposed on the discrete-time digital electrical signal waveform for comparison); [Figure 16] FIG. 2 is a diagram of a control system according to one aspect of the present disclosure. [Figure 17]1 illustrates a proportional-integral-derivative (PID) controller feedback control system in accordance with at least one embodiment of the present disclosure. [Figure 18] 1 is an alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system in accordance with at least one embodiment of the present disclosure. [Figure 19] 1A-1C are spectra of the same ultrasonic device with various different states and conditions of the end effector, where the phase and magnitude of the impedance of the ultrasonic transducer are plotted as a function of frequency, in accordance with at least one embodiment of the present disclosure. [Figure 20] 1 is a graphical representation showing a plot of a set of 3D training data S in which impedance, magnitude, and phase of an ultrasound transducer are plotted as a function of frequency in accordance with at least one aspect of the present disclosure. [Figure 21] FIG. 13 is a logic flow diagram illustrating a control program or logic configuration for determining jaw condition based on a complex impedance characteristic pattern (fingerprint) in accordance with at least one aspect of the present disclosure. [Figure 22] 1 is a circle plot of complex impedance plotted as imaginary component versus real component of a piezoelectric transducer in accordance with at least one embodiment of the present disclosure. [Diagram 23] 1 is a circle plot of complex admittance plotted as imaginary component versus real component of a piezoelectric transducer, in accordance with at least one embodiment of the present disclosure. [Figure 24] 1 is a circular plot of the complex admittance of a 55.5 kHz ultrasonic piezoelectric transducer. [Diagram 25] FIG. 1 is a graphical representation of an impedance analyzer showing an impedance / admittance circle plot of an ultrasonic device with jaws open and no load, where complex admittance is plotted as a dashed line and complex impedance is plotted as a solid line, in accordance with at least one embodiment of the present disclosure. [Figure 26]FIG. 1 is a graphical representation of an impedance analyzer showing an impedance / admittance circle plot of an ultrasound device with jaws clamped to dry chamois, with complex admittance depicted as a dashed line and complex impedance depicted as a solid line, in accordance with at least one embodiment of the present disclosure. [Figure 27] FIG. 13 is a graphical representation of an impedance analyzer showing an impedance / admittance circle plot for an ultrasonic device with the jaw tips clamped in a wet chamois, with complex admittance depicted as a dashed line and complex impedance depicted as a solid line, in accordance with at least one embodiment of the present disclosure. [Figure 28] FIG. 13 is a graphical representation of an impedance analyzer showing an impedance / admittance circle plot of an ultrasound device with the jaws fully clamped in wet chamois, with complex admittance depicted as a dashed line and complex impedance depicted as a solid line, in accordance with at least one embodiment of the present disclosure. [Figure 29] 1 is a graphical representation of an impedance analyzer showing an impedance / admittance plot where the frequency is swept from 48 kHz to 62 kHz to capture multiple resonances of an ultrasonic device with the jaws open, with a dashed rectangular overlay making the circle easier to see, in accordance with at least one embodiment of the present disclosure. [Diagram 30] FIG. 13 is a logic flow diagram of a process illustrating a control program or logic configuration for determining jaw condition based on estimates of impedance / admittance circle radius and offset, in accordance with at least one aspect of the present disclosure. [Diagram 31] FIG. 1 is a logic flow diagram of a process illustrating a control program or logic configuration for monitoring an ultrasonic transducer, profiling an ultrasonic blade, and delivering power to the ultrasonic blade on the profile, according to one aspect of the present disclosure. [Figure 32A] 1 is a series of graphical representations for monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, according to one aspect of the present disclosure; FIG. 2 is a graphical representation of the initial impedance of the ultrasonic transducer as a function of time; [Figure 32B] 1 is a series of graphical representations for monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, according to one aspect of the present disclosure; and FIG. 2 is a graphical representation of power delivered to the ultrasonic blade as a function of time based on the initial impedance. [Figure 32C] 1 is a series of graphical representations for monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, according to one aspect of the present disclosure; and FIG. 2 is a graphical representation of the new impedance of the ultrasonic transducer as a function of time. [Fig. 32D] 1 is a series of graphical representations for monitoring the impedance of an ultrasonic transducer to profile an ultrasonic blade and deliver power to the ultrasonic blade on the profile, according to one aspect of the present disclosure; and a graphical representation of adjusted power delivered to the ultrasonic blade based on the new impedance. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0039] The applicant of this application also owns the following contemporaneously filed U.S. patent applications, each of which is incorporated herein by reference: U.S. Provisional Patent Application entitled "METHODS FOR CONTROLLING TEMPERATURE IN ULTRASONIC DEVICE," Attorney Docket No. END8560USNP1 / 180106-1M; · U.S. Provisional Patent Application entitled “ULTRASONIC SEALING ALGORITHM WITH TEMPERATURE CONTROL”, Attorney Docket No. END8560USNP3 / 180106-3; U.S. Provisional Patent Application entitled “APPLICATION OF SMART ULTRASONIC BLADE TECHNOLOGY,” Attorney Docket No. END8560USNP4 / 180106-4; U.S. Provisional Patent Application entitled “SMART BLADE TECHNOLOGY TO CONTROL BLADE INSTABILITY,” Attorney Docket No. END8560USNP6 / 180106-6; and · U.S. Provisional Patent Application entitled “START TEMPERATURE OF BLADE,” Attorney Docket No. END8560USNP7 / 180106-7.
[0040] The applicant of this application also owns the following contemporaneously filed U.S. patent applications, each of which is incorporated herein by reference: U.S. Provisional Patent Application entitled "METHODS FOR ESTIMATING AND CONTROLLING STATE OF ULTRASONIC END EFFECTOR," Attorney Docket No. END8536USNP1 / 180107-1M; U.S. Provisional Patent Application entitled “IN-THE-JAW CLASSIFIER BASED ON MODEL”, Attorney Docket No. END8536USNP3 / 180107-3; · U.S. Provisional Patent Application entitled “APPLICATION OF SMART BLADE TECHNOLOGY,” Attorney Docket No. END8536USNP4 / 180107-4; U.S. Provisional Patent Application entitled “ADJUSTMENT OF COMPLEX IMPEDEDANCE TO COMPENSATE FOR LOST POWER IN AN ARTICULATING ULTRASONIC DEVICE,” Attorney Docket No. END8536USNP6 / 180107-6; · U.S. Provisional Patent Application entitled “USING SPECTROSCOPY TO DETERMINE DEVICE USE STATE IN COMBO INSTRUMENT,” Attorney Docket No. END8536USNP7 / 180107-7; · U.S. Provisional Patent Application entitled "VESSEL SENSING FOR ADAPTIVE ADVANCED HEMOSTASIS," Attorney Docket No. END8536USNP8 / 180107-8; · U.S. Provisional Patent Application entitled “CALCIFIED VESSEL IDENTIFICATION,” Attorney Docket No. END8536USNP9 / 180107-9; U.S. Provisional Patent Application entitled “DETECTION OF LARGE VESSELS DURING PARENCHYMAL DISSECTION USING A SMART BLADE,” Attorney Docket No. END8536USNP10 / 180107-10; · U.S. Provisional Patent Application entitled "SMART BLADE APPLICATION FOR REUSABLE AND DISPOSABLE DEVICES," Attorney Docket No. END8536USNP11 / 180107-11; U.S. Provisional Patent Application entitled “LIVE TIME TISSUE CLASSIFICATION USING ELECTRICAL PARAMETERS”, Attorney Docket No. END8536USNP12 / 180107-12, and · U.S. Provisional Patent Application entitled “FINE DISSECTION MODE FOR TISSUE CLASSIFICATION”, Attorney Docket No. END8536USNP13 / 180107-13.
[0041] The applicant of this application owns the following U.S. patent applications, filed September 10, 2018, the entire disclosures of which are incorporated herein by reference: - U.S. Provisional Patent Application No. 62 / 729,177, entitled "AUTOMATED DATA SCALING, ALIGNMENT, AND ORGANIZING BASED ON PREDEFINED PARAMETERS WITHIN A SURGICAL NETWORK BEFORE TRANSMISSION"; - U.S. Provisional Patent Application No. 62 / 729,182, entitled "SENSING THE PATIENT POSITION AND CONTACT UTILIZING THE MONO POLAR RETURN PAD ELECTRODE TO PROVIDE SITUATIONAL AWARENESS TO THE HUB"; - U.S. Provisional Patent Application 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"; - U.S. Provisional Patent Application No. 62 / 729,183, entitled "SURGICAL NETWORK RECOMMENDATIONS FROM REAL TIME ANALYSIS OF PROCEDURE VARIABLES AGAINST A BASELINE HIGHLIGHTING DIFFERENCES FROM THE OPTIMAL SOLUTION"; - U.S. Provisional Patent Application No. 62 / 729,191, entitled "A CONTROL FOR A SURGICAL NETWORK OR SURGICAL NETWORK CONNECTED DEVICE THAT ADJUSTS ITS FUNCTION BASED ON A SENSED SITUATION OR USAGE"; - U.S. Provisional Patent Application No. 62 / 729,176, entitled "INDIRECT COMMAND AND CONTROL OF A FIRST OPERATING ROOM SYSTEM THROUGH THE USE OF A SECOND OPERATING ROOM SYSTEM WITHIN A STERILE FIELD WHERE THE SECOND OPERATING ROOM SYSTEM HAS PRIMARY AND SECONDARY OPERATING MODES"; U.S. Provisional Patent Application No. 62 / 729,186, entitled "WIRELESS PAIRING OF A SURGICAL DEVICE WITH ANOTHER DEVICE WITHIN A STERILE SURGICAL FIELD BASED ON THE USAGE AND SITUATIONAL AWARENESS OF DEVICES"; and U.S. Provisional Patent Application No. 62 / 729,185, entitled "POWERED STAPLING DEVICE THAT IS CAPABLE OF ADJUSTING FORCE, ADVANCEMENT SPEED, AND OVERALL STROKE OF CUTTING MEMBER OF THE DEVICE BASED ON SENSED PARAMETER OF FIRING OR CLAMPING".
[0042] The applicant of this application owns the following U.S. patent applications, filed August 28, 2018, the entire disclosures of which are incorporated herein by reference: - U.S. Patent Application No. 16 / 115,214, entitled "ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR"; - U.S. Patent Application No. 16 / 115,205, entitled "TEMPERATURE CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR"; U.S. Patent Application No. 16 / 115,233, entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS"; - U.S. Patent Application No. 16 / 115,208, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION"; U.S. Patent Application No. 16 / 115,220, entitled "CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE"; - U.S. Patent Application No. 16 / 115,232, entitled "DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM"; - U.S. Patent Application No. 16 / 115,239, entitled "DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT"; - U.S. Patent Application No. 16 / 115,247, entitled "DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR"; - U.S. Patent Application No. 16 / 115,211, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS"; - U.S. Patent Application No. 16 / 115,226, entitled "MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT"; - U.S. Patent Application No. 16 / 115,240, entitled "DETECTION OF END EFFECTOR EMERSION IN LIQUID"; - U.S. Patent Application No. 16 / 115,249, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING"; - U.S. Patent Application No. 16 / 115,256, entitled "INCREASING RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP"; U.S. Patent Application No. 16 / 115,223, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY"; and · U.S. Patent Application No. 16 / 115,238, entitled "ACTIVATION OF ENERGY DEVICES."
[0043] The applicant of this application owns the following U.S. patent applications, filed August 23, 2018, the entire disclosures of which are incorporated herein by reference: - U.S. Provisional Patent Application No. 62 / 721,995, entitled "CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION"; · U.S. Provisional Patent Application No. 62 / 721,998, entitled "SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS"; · U.S. Provisional Patent Application No. 62 / 721,999, entitled "INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING"; U.S. Provisional Patent Application No. 62 / 721,994, entitled "BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY"; and U.S. Provisional Patent Application No. 62 / 721,996 entitled "RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS."
[0044] The applicant of this application owns the following U.S. patent applications, filed June 30, 2018, the entire disclosures of which are incorporated herein by reference: - U.S. Provisional Patent Application No. 62 / 692,747, entitled "SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE"; · U.S. Provisional Patent Application No. 62 / 692,748, entitled "SMART ENERGY ARCHITECTURE"; and · U.S. Provisional Patent Application No. 62 / 692,768, entitled "SMART ENERGY DEVICES."
[0045] The applicant of this application owns the following U.S. patent applications, filed June 29, 2018, the entire disclosures of which are incorporated herein by reference: U.S. Patent Application No. 16 / 024,090, entitled "CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS"; U.S. Patent Application No. 16 / 024,057, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS"; U.S. Patent Application No. 16 / 024,067, entitled "SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION"; U.S. Patent Application No. 16 / 024,075, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING"; U.S. Patent Application No. 16 / 024,083, entitled "SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING"; - U.S. Patent Application No. 16 / 024,094, entitled "SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES"; U.S. Patent Application No. 16 / 024,138, entitled "SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE"; U.S. Patent Application No. 16 / 024,150, entitled "SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES"; - U.S. Patent Application No. 16 / 024,160, entitled "VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY"; - U.S. Patent Application No. 16 / 024,124, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE"; - U.S. Patent Application No. 16 / 024,132, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT"; U.S. Patent Application No. 16 / 024,141, entitled "SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY"; U.S. Patent Application No. 16 / 024,162, entitled "SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES"; - U.S. Patent Application No. 16 / 024,066, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL"; - U.S. Patent Application No. 16 / 024,096, entitled "SURGICAL EVACUATION SENSOR ARRANGEMENTS"; - U.S. Patent Application No. 16 / 024,116, entitled "SURGICAL EVACUATION FLOW PATHS"; - U.S. Patent Application No. 16 / 024,149, entitled "SURGICAL EVACUATION SENSING AND GENERATOR CONTROL"; - U.S. Patent Application No. 16 / 024,180, entitled "SURGICAL EVACUATION SENSING AND DISPLAY"; - U.S. Patent Application No. 16 / 024,245, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; - U.S. Patent Application No. 16 / 024,258, entitled "SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Patent Application No. 16 / 024,265, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE"; and · U.S. Patent Application No. 16 / 024,273, entitled "DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS"
[0046] The applicant of this application owns the following U.S. provisional patent applications, filed June 28, 2018, the entire disclosures of which are incorporated herein by reference: - U.S. Provisional Patent Application No. 62 / 691,228, entitled "A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES"; - U.S. Provisional Patent Application No. 62 / 691,227, entitled "CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS"; · U.S. Provisional Patent Application No. 62 / 691,230, entitled "SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE"; - U.S. Provisional Patent Application No. 62 / 691,219, entitled "SURGICAL EVACUATION SENSING AND MOTOR CONTROL"; - U.S. Provisional Patent Application No. 62 / 691,257, entitled "COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; U.S. Provisional Patent Application No. 62 / 691,262, entitled "SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE"; and Title of invention: “DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS”; U.S. Provisional Patent Application No. 62 / 691,251.
[0047] The applicant of this application owns the following U.S. provisional patent applications, filed April 19, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: · U.S. Provisional Patent Application No. 62 / 659,900, entitled “METHOD OF HUB COMMUNICATION.”
[0048] The applicant of this application owns the following U.S. provisional patent applications, filed March 30, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: U.S. Provisional Patent Application No. 62 / 650,898, filed March 30, 2018, entitled “CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS”; - U.S. Provisional Patent Application No. 62 / 650,887, entitled "SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES"; U.S. Provisional Patent Application No. 62 / 650,882, entitled "SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM"; and · U.S. Provisional Patent Application No. 62 / 650,877 entitled "SURGICAL SMOKE EVACUATION SENSING AND CONTROLS"
[0049] The applicant of this application owns the following U.S. patent applications, filed March 29, 2018, the entire disclosures of which are incorporated herein by reference: - U.S. Patent Application No. 15 / 940,641, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES"; - U.S. Patent Application No. 15 / 940,648, entitled "INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES"; - U.S. Patent Application No. 15 / 940,656, entitled "SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM DEVICES"; - U.S. Patent Application No. 15 / 940,666, entitled "SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS"; - U.S. Patent Application No. 15 / 940,670, entitled "COOPERATIVE UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS"; · U.S. Patent Application No. 15 / 940,677, entitled "SURGICAL HUB CONTROL ARRANGEMENTS"; - U.S. Patent Application No. 15 / 940,632, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD"; - U.S. Patent Application No. 15 / 940,640, entitled "COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS"; U.S. Patent Application No. 15 / 940,645, entitled "SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT"; U.S. Patent Application No. 15 / 940,649, entitled "DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME"; · U.S. Patent Application No. 15 / 940,654, entitled "SURGICAL HUB SITUATIONAL AWARENESS"; - U.S. Patent Application No. 15 / 940,663, entitled "SURGICAL SYSTEM DISTRIBUTED PROCESSING"; - U.S. Patent Application No. 15 / 940,668, entitled "AGGREGATION AND REPORTING OF SURGICAL HUB DATA"; - U.S. Patent Application No. 15 / 940,671, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER"; - U.S. Patent Application No. 15 / 940,686, entitled "DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE"; · U.S. Patent Application No. 15 / 940,700, entitled "STERILE FIELD INTERACTIVE CONTROL DISPLAYS"; · U.S. Patent Application No. 15 / 940,629, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS"; - U.S. Patent Application No. 15 / 940,704, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT"; U.S. Patent Application No. 15 / 940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY," and · U.S. Patent Application Serial No. 15 / 940,742, entitled “DUAL CMOS ARRAY IMAGING.” U.S. Patent Application No. 15 / 940,636, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES"; U.S. Patent Application No. 15 / 940,653, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS"; - U.S. Patent Application No. 15 / 940,660, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"; - U.S. Patent Application No. 15 / 940,679, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET"; - U.S. Patent Application No. 15 / 940,694, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION"; - U.S. Patent Application No. 15 / 940,634, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"; U.S. Patent Application No. 15 / 940,706, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK," and · U.S. Patent Application No. 15 / 940,675, entitled “CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES.” U.S. Patent Application No. 15 / 940,627, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Patent Application No. 15 / 940,637, entitled "COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Patent Application No. 15 / 940,642, entitled "CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; - "U.S. Patent Application No. 15 / 940,676, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Patent Application No. 15 / 940,680, entitled "CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; - U.S. Patent Application No. 15 / 940,683, entitled "COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Patent Application No. 15 / 940,690, entitled "DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and U.S. Patent Application No. 15 / 940,711, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS."
[0050] The applicant of this application owns the following U.S. provisional patent applications, filed March 28, 2018, the disclosures of each of which are incorporated by reference in their entirety herein: - U.S. Provisional Patent Application No. 62 / 649,302, entitled "INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES"; · U.S. Provisional Patent Application No. 62 / 649,294, entitled "DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD"; · U.S. Provisional Patent Application No. 62 / 649,300, entitled "SURGICAL HUB SITUATIONAL AWARENESS"; - U.S. Provisional Patent Application No. 62 / 649,309, entitled "SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER"; · U.S. Provisional Patent Application No. 62 / 649,310, entitled "COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS"; - U.S. Provisional Patent Application No. 62 / 649,291, entitled "USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT"; · U.S. Provisional Patent Application No. 62 / 649,296, entitled "ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES"; - U.S. Provisional Patent Application No. 62 / 649,333, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER"; - U.S. Provisional Patent Application No. 62 / 649,327, entitled "CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES"; - U.S. Provisional Patent Application No. 62 / 649,315, entitled "DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK"; - U.S. Provisional Patent Application No. 62 / 649,313, entitled "CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES"; - U.S. Provisional Patent Application No. 62 / 649,320, entitled "DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS"; U.S. Provisional Patent Application No. 62 / 649,307, entitled "AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS," and U.S. Provisional Patent Application No. 62 / 649,323, entitled "SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS."
[0051] The applicant of this application owns the following U.S. provisional patent applications, filed on December 28, 2017, the entire disclosures of each of which are incorporated herein by reference: · U.S. Provisional Patent Application No. U.S. Provisional Patent Application No. 62 / 611,341, Title of Invention: "INTERACTIVE SURGICAL PLATFORM"; U.S. Provisional Patent Application No. 62 / 611,340, entitled "CLOUD-BASED MEDICAL ANALYTICS," and - "U.S. Provisional Patent Application No. 62 / 611,339, entitled "ROBOT ASSISTED SURGICAL PLATFORM".
[0052] Before describing the various aspects of the surgical device and generator in detail, it should be noted that the illustrated embodiments are not limited in application or use to the details of construction and arrangement of parts shown in the accompanying drawings and description. The illustrative embodiments may be embodied or incorporated in other aspects, variations, and modifications and may be practiced or carried out in various ways. Moreover, unless otherwise specified, the terms and phrases used herein have been selected for the purpose of describing the illustrative embodiments for the convenience of the reader and not for the purpose of limiting them. Furthermore, it will be understood that one or more of the aspects, embodiment of the aspects, and / or embodiments described below can be combined with any one or more of the other aspects, embodiment of the aspects, and / or embodiments described below.
[0053] Various aspects are directed to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of the ultrasonic surgical devices may be configured, for example, to ablate and / or coagulate tissue during a surgical procedure. Aspects of the electrosurgical devices may be configured, for example, to ablate, coagulate, scale, weld, and / or desiccate tissue during a surgical procedure.
[0054] An adaptive ultrasonic blade control algorithm. In various aspects, the smart ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify the tissue type and adjust the device parameters. In one aspect, the ultrasonic blade control algorithm is configured to parameterize the tissue type. An algorithm for detecting the collagen / elasticity ratio of the tissue to adjust the amplitude of the distal tip of the ultrasonic blade is described in the following sections of this disclosure. Various aspects of the smart ultrasonic energy device are described herein, for example, in connection with Figures 1 and 2. Thus, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with Figures 1 and 2 and the associated description.
[0055] In certain surgical procedures, it is desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be used to adjust parameters of the ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of the ultrasonic device may be adjusted based on the location of the tissue within the jaws of the ultrasonic end effector, for example, the location of the tissue between the clamp arm and the ultrasonic blade. The impedance of the ultrasonic transducer may be used to identify which percentage of the tissue is located at the distal or proximal end of the end effector. The response of the ultrasonic device may be based on the tissue type or tissue compressibility. In another aspect, the parameters of the ultrasonic device may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be adjusted based on the ration of collagen to elastin tissue detected during the tissue identification procedure. The ratio of collagen to elastin tissue may be detected using various techniques including infrared (IR) surface reflectance and emissivity. The force applied to the tissue by the clamp arm and / or the stroke of the clamp arm to create gap and compression. Electrical continuity across the jaw with the electrodes can be used to determine what percentage of the jaw is covered with tissue.
[0056] 1 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communications hub, according to at least one embodiment of the present disclosure. In one embodiment, the generator module 240 is configured to execute the adaptive ultrasonic blade control algorithm(s) 802 described herein. In another embodiment, the device / instrument 235 is configured to execute the adaptive ultrasonic blade control algorithm(s) 804 described herein with reference to FIGS. 19-32. In another embodiment, both the device / instrument 235 and the device / instrument 235 are configured to execute the adaptive ultrasonic blade control algorithms 802, 804 described herein with reference to FIGS.
[0057] The generator module 240 may include a patient-isolated stage that communicates with the non-isolated stage via a power transformer. A secondary winding of the power transformer is housed within the isolated stage and may include a tap configuration (e.g., center-tapped or non-center-tapped configuration) to define a drive signal output for delivering drive signals to various surgical instruments, such as ultrasonic surgical instruments, RF electrosurgical instruments, and multifunction surgical instruments including ultrasonic and RF energy modes that can be delivered alone or simultaneously. Specifically, the drive signal output can output an ultrasonic drive signal (e.g., a 420V root-mean-square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output can output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument 241. Aspects of the generator module 240 are described herein with reference to FIGS. 7-12.
[0058] The generator module 240, or the device / instrument 235, or both, are coupled to a modular control tower 236 that is connected to multiple operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room. In some embodiments, the surgical data network may include a modular communication hub configured to connect modular devices located in one or more operating rooms of a medical facility, or any room in a medical facility equipped with specialized equipment for surgical procedures, to a cloud-based system (e.g., cloud 204, which may include a remote server 213 coupled to storage devices).
[0059] Modular devices located in the 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 devices to the cloud 204 or a local computer system. Data associated with the devices may be transferred to a cloud-based computer via the router for remote data processing and manipulation. Data associated with the devices may also be transferred to a local computer system for remote 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 devices to the cloud 204. Data associated with the devices may be transferred to the cloud 204 via the network router for data processing and manipulation. Data associated with the devices may also be transferred to a local computer system for remote data processing and manipulation.
[0060] It will be understood that cloud computing relies on shared computing resources rather than having local servers or personal devices to handle software applications. Although the term "cloud" may be used as a metaphor for the "internet," the term is not so limited. Thus, the term "cloud computing" may be used herein to refer to "a type of internet-based computing" where various services such as servers, storage, and applications are provided to a modular communication hub and / or computer system located in an operating room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and to devices connected to the modular communication hub and / or computer system via the internet. The cloud infrastructure may be maintained by a cloud service provider. In this context, a cloud service provider may be an entity that coordinates the use and control of devices located in one or more operating rooms. Cloud computing services may perform numerous calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware allows multiple devices or connections to connect to a computer that communicates with the cloud computing resources and storage.
[0061] FIG. 1 further illustrates some aspects of a computer-implemented interactive surgical system including a modular communication hub that may include a system 800 configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network. The surgical system may include at least one surgical hub in communication 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 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. The modular control tower 236 may include a modular communication hub coupled to a computer system. In some aspects, the modular control tower 236 is coupled to an imaging module coupled to an endoscope, a generator module 240 coupled to an energy device 241, and a smart device / instrument 235 optionally coupled to a display 237. The operating field devices are coupled to cloud computing resources and data storage via the modular control tower 236. The robot hub 222 may also be connected to the modular control tower 236 and cloud computing resources. Among other things, the devices / instruments 235, visualization system 208 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) for displaying and overlaying images received from the imaging modules, device / instrument displays, and / or other visualization system 208. The hub display 215 may also display data received from devices connected to the modular control tower along with images and overlay images.
[0062] Generator Hardware FIG. 2 illustrates an embodiment of a generator 900, a form of generator configured to couple with an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm within a surgical data network with a modular communication hub as shown in FIG. 1. The generator 900 is configured to deliver multiple energy modalities to a surgical instrument. The generator 900 provides RF and ultrasonic signals, either alone or simultaneously, for delivering energy to the surgical instrument. The RF and ultrasonic signals may be provided alone or in combination, and may be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, which signals can be delivered individually or simultaneously to an end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to generate various signal waveforms based on information stored in a memory (not shown for clarity of disclosure) coupled to the processor 902. Digital information related to the waveforms is provided to the waveform generator 904, which includes one or more DAC circuits to convert the digital input to an analog output. The analog output is provided to an amplifier 906 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 906 is coupled to a power transformer 908. The signal is coupled across the power transformer 908 to a secondary side on the patient isolated side. A first signal of a first energy modality is provided between terminals labeled ENERGY1 and RETURN on the surgical instrument. A second signal of a second energy modality is coupled across a capacitor 910 and provided between terminals labeled ENERGY2 and RETURN on the surgical instrument. More than two energy modalities may be output, thus the subscript "n" indicates up to n ENERGY modalities. nIt will be understood that n is a positive integer greater than 1. n ) may be provided without departing from the scope of the present disclosure.
[0063] A first voltage sense circuit 912 is coupled across the terminals labeled ENERGY1 and RETURN paths and measures the output voltage therebetween. A second voltage sense circuit 924 is coupled across the terminals labeled ENERGY2 and RETURN paths and measures the output voltage therebetween. A current sense circuit 914 is disposed in series with the RETURN section of the secondary side of the illustrated power transformer 908 to measure the output current of either energy modality. If different return paths are provided for each energy modality, a separate current sense circuit must be provided in each return section. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to corresponding isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side (non-patient isolated side) of the power transformer 908 are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculations. Output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument and to calculate output impedance, among other parameters. Input / output communication between the processor 902 and the patient isolation circuitry is provided via an interface circuit 920. Sensors may also be in electrical communication with the processor 902 via the interface circuit 920.
[0064] In one aspect, the impedance may be determined by the processor 902 by dividing the output of either the first voltage sense circuit 912 coupled across the terminals labeled ENERGY1 / RETURN or the second voltage sense circuit 924 coupled across the terminals labeled ENERGY2 / RETURN by the output of a current sense circuit 914 placed in series with the RETURN section of the secondary side of the power transformer 908. The outputs of the first voltage sense circuit 912 and the second voltage sense circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sense circuit 914 is provided to another isolation transformer 916. Digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 to calculate the impedance. As an example, the first energy modality ENERGY1 may be ultrasound energy and the second energy modality ENERGY2 may be RF energy. Yet, in addition to ultrasound energy modalities and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, among others. Also, while in the example shown in FIG. 2 a single return path RETURN may be provided for two or more energy modalities, in other embodiments multiple return paths RETURN n Each energy modality ENERGY n Thus, as described herein, the impedance of the ultrasound transducer may be measured by dividing the output of the first voltage sense circuit 912 by the current sense circuit 914, and the impedance of the tissue may be measured by dividing the output of the second voltage sense circuit 924 by the current sense circuit 914.
[0065] As shown in FIG. 2, the generator 900, which includes at least one output port, may include a power transformer 908 with a single output and multiple taps to provide power, particularly to an end effector, in the form of one or more energy modalities, such as, for example, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, depending on the type of tissue treatment to be performed. For example, the generator 900 may deliver energy with either monopolar or bipolar RF electrosurgical electrodes, at high voltage and low current to drive an ultrasonic transducer, at low voltage and high current to drive an RF electrode for tissue sealing, or in a coagulation waveform for spot coagulation. The output waveform from the generator 900 may be directed, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 900 may preferably be located between the output labeled ENERGY1 and RETURN as shown in FIG. 2. In one example, the connection of the RF bipolar electrode to the output of the generator 900 would preferably be located between the output labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be the active electrode (e.g., pencil or other probe) to the ENERGY2 output and a suitable return pad connected to the RETURN output.
[0066] Further details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published March 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety.
[0067] As used throughout this description, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that may communicate data through the use of modulated electromagnetic radiation over a non-solid medium. This term does not imply that the associated devices do not include any wires, although in some aspects they may not be present. The communication modules may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G and beyond. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to short-range wireless communication such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to long-range wireless communication such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, and Ev-DO.
[0068] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually memory) or some other data stream. The term is used herein to refer to a system that combines many dedicated "processors" or a central processor (central processing unit) within a computer system, especially a system on a chip (SoC).
[0069] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also known as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It can include digital, analog, mixed-signal and often high-frequency functions, all on a single substrate. An SoC integrates a microcontroller (or microprocessor) with modern peripherals such as a graphics processing unit (GPU), Wi-Fi module or co-processor. An SoC may or may not include built-in memory.
[0070] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for microcontroller unit) may be implemented as a small computer on a single integrated circuit. This may be similar to an SoC, which may include a microcontroller as one of its components. A microcontroller may house one or more core processing units (CPUs) along with memory and programmable input / output peripherals. Program memory and a small amount of RAM in the form of ferroelectric RAM, NOR flash or OTP ROM are often also included on the chip. Microcontrollers may be employed for embedded applications, as opposed to microprocessors used in personal computers or other general-purpose applications that are made up of various separate chips.
[0071] As used herein, the term controller or microcontroller may be a standalone IC or chip device that interfaces with a peripheral device. It may also be the link between two parts of a computer or controller on an external device that manages the operation of (and connections with) that device.
[0072] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one embodiment, the processor may be, for example, an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments. The processor core includes on-chip memory of 256KB of single-cycle flash memory or other non-volatile memory up to 40MHz, a pre-fetch buffer to improve performance beyond 40MHz, 32KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® 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) analogs, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which are available in the product data sheet.
[0073] In one aspect, the processor may include a safety controller, including two controller families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, manufactured by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while offering scalable performance, connectivity, and memory options.
[0074] Modular devices include modules that are receivable within a surgical hub (e.g., as described in connection with FIG. 3) and surgical devices or instruments that can be connected to various modules to connect or pair with corresponding surgical hubs. Modular devices include, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, aspirators, and displays. The modular devices described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on the surgical hub to which the particular modular device is paired, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data can be related to the patient during surgery (e.g., tissue characteristics or insufflation pressure) or related to the modular device itself (e.g., advancing knife speed, motor current, or energy level). For example, the control algorithm of a surgical stapling and severing instrument may control the speed at which the instrument's motor drives the knife through tissue based on the resistance offered by the knife as it advances.
[0075] 3 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multi-function surgical instrument 1108 is a combination ultrasonic / RF electrosurgical instrument. The generator 1100 is configurable for use with a variety of surgical instruments. According to various forms, the generator 1100 may be configurable for use with a variety of different surgical devices including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. 3, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, however, in one form the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on a front panel of a console for the generator 1100. The input device 1110 may include any suitable device for generating signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured for wired or wireless communication.
[0076] The generator 1100 is configured to drive a number of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a hand piece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 acoustically coupled to the ultrasonic transducer 1120 and a clamp arm 1140. The hand piece 1105 includes a trigger 1143 for actuating the clamp arm 1140 and a combination of toggle buttons 1134a, 1134b, 1134c for energizing and actuating the ultrasonic blade 1128 or other functions. The toggle buttons 1134a, 1134b, 1134c can be configured to energize the ultrasonic transducer 1120 using the generator 1100.
[0077] The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a hand piece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in clamp arms 1142a, 1142b and return through a conductor portion of the shaft 1127. The electrodes are coupled to and energized by a bipolar energy source in the generator 1100. The hand piece 1107 includes a trigger 1145 for operating the clamp arms 1142a, 1142b and an energy button 1135 for actuating an energy switch to energize the electrodes in the end effector 1124.
[0078] The generator 1100 is also configured to drive a multifunction surgical instrument 1108. The multifunction surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to an ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 that operates the clamp arm 1146, and a combination of toggle buttons 1137a, 1137b, 1137c to energize and activate the ultrasonic blade 1149 or other functions. The toggle buttons 1137 a , 1137 b , 1137 c can be configured to energize the ultrasonic transducer 1120 using the generator 1100 , and to energize the ultrasonic blade 1149 using a bipolar energy source also housed within the generator 1100 .
[0079] The generator 1100 is configurable for use with a variety of surgical instruments. According to various configurations, the generator 1100 may be configurable for use with a variety of different surgical devices including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument 1108 that integrates RF and ultrasonic energy delivered simultaneously from the generator 1100. In the configuration of FIG. 3, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, but in another configuration, the generator 1100 may be integrally formed with any one of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As mentioned above, the generator 1100 includes an input device 1110 located on a front panel of the console of the generator 1100. The input device 1110 may include any suitable device that generates a signal suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Further aspects of the generator and the surgical instrument for digitally generating an electrical signal waveform are described in U.S. Patent Application Publication No. 2017-0086914-A1, which is incorporated herein by reference in its entirety.
[0080] 4 is an end effector 1122 of an example ultrasonic device 1104 according to at least one embodiment of the present disclosure. The end effector 1122 may include a blade 1128 that may be coupled to an ultrasonic transducer 1120 via a waveguide. When driven by the ultrasonic transducer 1120, the blade 1128 may vibrate and, upon contact with tissue, may cut and / or coagulate the tissue, as described herein. According to various embodiments and as illustrated in FIG. 4, the end effector 1122 may further include a clamp arm 1140 that may be configured to cooperate with the blade 1128 of the end effector 1122. Along with the blade 1128, the clamp arm 1140 may include a series of jaws. The clamp arm 1140 may be pivotally connected to a distal end of the shaft 1126 of the instrument portion 1104. The clamp arm 1140 may include a clamp arm tissue pad 1163, which may be formed from TEFLON® or other suitable low friction material. The pad 1163 is mounted to cooperate with the blade 1128 such that pivotal movement of the clamp arm 1140 may position the clamp pad 1163 in a substantially parallel relationship with and in contact with the blade 1128. With this configuration, a piece of tissue to be clamped may be grasped between the tissue pad 1163 and the blade 1128. The tissue pad 1163 may include a sawtooth-like configuration including a plurality of axially spaced apart and proximally extending grasping teeth 1161 to cooperate with the blade 1128 to improve the gripping of the tissue. The clamp arm 1140 may transition from an open position, shown in FIG. 4, to a closed position (where the clamp arm 1140 is in contact with or in close proximity to the blade 1128) in any suitable manner. For example, the handpiece 1105 may include a jaw closure trigger. When actuated by the clinician, the jaw closure trigger may pivot the clamp arm 1140 in any suitable manner.
[0081] The generator 1100 may be activated to provide a drive signal to the ultrasonic transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 (FIG. 5) coupled to the generator 1100 via a foot switch cable 1432. A clinician may activate the ultrasonic transducer 1120, and thereby the ultrasonic transducer 1120 and the blade 1128, by depressing the foot switch 1430. In addition to or instead of the foot switch 1430, some embodiments of the device 1104 may employ one or more switches positioned on the hand piece 1105 that, when activated, can cause the generator 1100 to operate the ultrasonic transducer 1120. In one embodiment, for example, the one or more switches may include a pair of toggle buttons 1134, 1134a, 1134b (FIG. 3), for example, to determine the operating mode of the device 1104. For example, when the toggle button 1134a is depressed, the ultrasonic generator 1100 can provide a maximum drive signal to the ultrasonic transducer 1120 to cause the ultrasonic transducer 1120 to generate a maximum ultrasonic energy output. Pressing the toggle button 1134b can cause the ultrasonic generator 1100 to provide a user-selectable drive signal to the ultrasonic transducer 1120 to cause the ultrasonic transducer 1120 to generate a less than maximum ultrasonic energy output. The device 1104 may additionally or alternatively include a second switch to indicate a position of a jaw closing trigger, for example, to manipulate the jaws via the clamp arm 1140 of the end effector 1122. Also, in some aspects, the ultrasonic generator 1100 can be activated based on the position of the jaw closing trigger (e.g., ultrasonic energy can be applied when a clinician depresses the jaw closing trigger to close the jaws via the clamp arm 1140).
[0082] Additionally or alternatively, one or more of the switches may include a toggle button 1134 that, when depressed, causes the generator 1100 to provide a pulsed output (FIG. 3). The pulses may be provided, for example, at any suitable frequency and classification. In certain aspects, the power level of the pulses may be, for example, a power level (maximum, less than maximum) associated with a toggle button 1134a, 1134b.
[0083] It will be appreciated that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134 (FIG. 3). For example, the device 1104 may be configured with only two toggle buttons, a toggle button 1134a for generating maximum ultrasonic energy output, and a toggle button 1134 for generating a pulsed output at either a maximum or less than maximum power level each time. In this manner, the drive signal output configuration of the generator 1100 may be five continuous signals, or any discrete number of individual pulse signals (1, 2, 3, 4, or 5 times). In certain aspects, the particular drive signal configuration may be controlled based on, for example, an EEPROM setting of the generator 1100 and / or a user's power level selection(s).
[0084] In certain aspects, a two-position switch may be provided as an alternative to the toggle button 1134 (FIG. 3). For example, the device 1104 may include a toggle button 1134a for generating 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 generate a continuous output at less than the maximum power level, and in a second detent position, the toggle button 1134b may generate a pulsed output (e.g., at either the maximum or less than maximum power level, depending on an EEPROM setting).
[0085] In some embodiments, the RF electrosurgical end effector 1124, 1125 (FIG. 3) may also include a pair of electrodes. The electrodes may be in communication with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of a tissue fragment present between the clamp arm 1142a, 1146 and the blade 1142b, 1149. The generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. The impedance of the tissue fragment may be found, for example, by monitoring the current, voltage, etc. of the signal.
[0086] In various aspects, the generator 1100 may comprise several separate functional elements, such as modules and / or blocks, as shown in FIG. 5, which is a diagram of the surgical system 1000 of FIG. 3. The various functional elements or modules may be configured to drive various types of surgical devices 1104, 1106, 1108. For example, an ultrasonic generator module may drive an ultrasonic device, such as the ultrasonic device 1104. An electrosurgical / RF generator module may drive the electrosurgical device 1106. The modules may generate corresponding drive signals to drive the surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and / or the electrosurgical / RF generator module may each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as separate circuit modules electrically coupled to the generator 1100. (The modules are shown in phantom to illustrate this option.) Also, in some aspects the electrosurgical / RF generator module may be integrally formed with the ultrasonic generator module, or vice versa.
[0087] According to the described aspects, the ultrasonic generator module may generate a drive signal or signals of a particular voltage, current, and frequency (e.g., 55,500 cycles / second, or Hz). The drive signal or signals may be provided to the ultrasonic device 1104, and in particular to the transducer 1120, which may operate, for example, as described above. In one aspect, the generator 1100 may be configured to generate drive signals of particular voltage, current, and / or frequency output signals that may be stepped with high resolution, precision, and repeatability.
[0088] According to the described embodiment, the electrosurgical / RF generator module may use radio frequency (RF) energy to generate a drive signal or multiple drive signals at an output power sufficient to perform a bipolar electrosurgical procedure. In a bipolar electrosurgical application, for example, the drive signal may be provided to, for example, electrodes of the electrosurgical device 1106, as described above. Thus, the generator 1100 may be configured for therapeutic purposes by applying electrical energy to tissue sufficient to treat the tissue (e.g., coagulation, cauterization, tissue welding, etc.).
[0089] The generator 1100 may include an input device 2150 (FIG. 8B) located, for example, on a front panel of the generator 1100's console. The input device 2150 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. During 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 may be used by the generator (e.g., by one or more processors housed within the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasonic generator module and / or the electrosurgical / RF generator module). In various embodiments, the input device 2150 includes one or more of a button, a switch, a thumb wheel, 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 include a suitable user interface, such as, for example, one or more user interface screens displayed on a touch screen monitor. The input device 2150 thus enables a user to set or program various operating parameters of the generator, such as, for example, the current (I), voltage (V), frequency (f), and / or duration (T) of the drive signal or signals generated by the ultrasonic generator module and / or the electrosurgical / RF generator module.
[0090] The generator 1100 may also include output devices 2140 (FIG. 8B), located, for example, on the front panel of the generator 1100 console. The output devices 2140 include one or more devices for providing sensory feedback to a user. Such devices may include, for example, visual feedback devices (e.g., LCD display screen, LED indicators), audible feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., haptic actuators).
[0091] While certain modules and / or blocks of generator 1100 may be described as examples, it will be understood that a greater or lesser number of modules and / or blocks may be used and still be within the scope of the aspects. Additionally, while various aspects may be described in terms of modules and / or blocks for ease of explanation, such modules and / or blocks may be implemented by one or more hardware components, e.g., processors, digital signal processors (DSPs), programmable logic devices (PLDs), application specific integrated circuits (ASICs), circuits, registers, and / or software components, e.g., programs, subroutines, logic, and / or combinations of hardware and software components.
[0092] In one aspect, the ultrasonic generator drive module and the electrosurgical / RF drive module 1110 (FIG. 3) may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may comprise various executable modules such as software, programs, data, drivers, application program interfaces (APIs), and the like. The firmware may be stored in a non-volatile memory (NVM) such as a bit-masked read-only memory (ROM) or a flash memory. In various implementations, storing the firmware in a ROM may preserve 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).
[0093] In one aspect, the module includes hardware components implemented as a processor for executing program instructions for monitoring various measurable properties of the devices 1104, 1106, 1108 and generating a corresponding output drive signal or signals for operating the devices 1104, 1106, 1108. In an aspect where the generator 1100 is used with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in a cutting and / or coagulation mode of operation. The electrical properties of the device 1104 and / or tissue may be measured and used to control aspects of the operation of the generator 1100 and / or provided as feedback to the user. In an aspect where the generator 1100 is used with the device 1106, the drive signal may provide electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation and / or desiccation mode. The electrical properties of the device 1106 and / or tissue may be measured and used to control aspects of the operation of the generator 1100 and / or provided as feedback to the user. In various aspects, the hardware components may be implemented as DSPs, PLDs, ASICs, circuits, and / or registers, as described above. In one aspect, the processor may be configured to store and execute computer software program instructions to generate step function output signals for driving various components of the devices 1104, 1106, 1108, such as the ultrasonic transducer 1120 and the end effectors 1122, 1124, 1125.
[0094] The electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide, and an ultrasonic blade. The electromechanical ultrasonic system has an initial resonant frequency defined by the physical properties of the ultrasonic transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is coupled to an alternating voltage V equal to the resonant frequency of the electromechanical ultrasonic system. g (t) and current I g (t) signal. When the electromechanical ultrasonic system resonates, the voltage V g (t) Signal and current I gThe phase difference between the (t) signal is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, the compliance of the ultrasonic blade (modeled as an equivalent capacitance) changes the resonant frequency of the electromechanical ultrasonic system. Thus, the inductive impedance is no longer equal to the capacitive impedance, which causes a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasonic system. The system is now operated "off-resonance". The mismatch between the drive frequency and the resonant frequency is determined by the voltage V applied to the ultrasonic transducer. g (t) Signal and current I g (t) signal. The generator electronics produces a voltage V g (t) Signal and current I g The phase difference between the (t) signal can be easily monitored and the drive frequency can be continuously adjusted until the phase difference is again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. The change in phase and / or frequency can be used as an indirect measure of the ultrasonic blade temperature.
[0095] As shown in FIG. 6, the electromechanical properties of an ultrasonic transducer may be modeled as an equivalent circuit including a first branch with a capacitance and a second "operational" branch with series-connected inductance, resistance, and capacitance that define the electromechanical properties of the resonator. Known ultrasonic generators may include a tuning inductor to tune out the capacitance at a certain resonant frequency so that substantially all of the generator drive signal current flows in the operational branch. Thus, by using a tuning inductor, the generator drive signal current represents the operational branch current, and thus the generator can control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance plot of the ultrasonic transducer to improve the frequency locking ability of the generator. However, the tuning inductor must be matched to the specific capacitance of the ultrasonic transducer at the operational resonant frequency. In other words, different ultrasonic transducers with different capacitances require different tuning inductors.
[0096] 6 illustrates an equivalent circuit 1500 of an ultrasonic transducer, such as ultrasonic transducer 1120, according to one embodiment. The circuit 1500 includes a series-connected inductance L that defines the electromechanical properties of the resonator. s , resistance R s , and capacity C s and a second capacitive branch having a capacitance C0. The operating current I m (t) flows through the first branch, and the current I g (t)~I m With (t) flowing through the capacitive branch, the drive current I g (t) is the driving voltage V g The control of the electromechanical properties of the ultrasonic transducer may be performed by I g (t) and V g This may be achieved by suitably controlling the current output I(t) of the generator. As mentioned above, known generator architectures gA tuning inductor L in the parallel resonant circuit for tuning the capacitance C0 at the resonant frequency so that substantially all of (t) flows through the operating branch. t (shown in phantom in FIG. 6 ). In this method, the motional branch current I m The control of (t) is the generator current output I g This is achieved by controlling the tuning inductor L t is specific to the static capacitance C0 of the ultrasonic transducer, but different ultrasonic transducers with different static capacitances require different tuning inductors L t In addition, the adjustment inductor L t corresponds to the nominal value of the capacitance C0 at a single resonant frequency, so that the operating branch current I m Accurate control of (t) is only guaranteed at that frequency. If the frequency is reduced by the temperature of the transducer, accurate control of the motional branch current is lost.
[0097] Various aspects of the generator 1100 include a tuning inductor L t Operation without relying on branch current I m Rather, the generator 1100 can use measurements of static capacitance C0 (along with drive signal voltage and current feedback data) during application of power to a particular ultrasonic surgical device 1104 to dynamically and continuously (e.g., in real time) measure the dynamic current I m (t) may be determined. Thus, such an embodiment of the generator 1100 can provide virtual tuning to simulate a system that is tuned or resonates with any value of capacitance C0 at any frequency, rather than only at a single resonant frequency determined by a nominal value of capacitance C0.
[0098] FIG 7 is a simplified block diagram of one embodiment of a generator 1100 for providing, among other advantages, inductorless regulation as described above. FIGS 8A-8C show the architecture of the generator 1100 of FIG 7 according to one embodiment. With reference to FIG 7, the generator 1100 may include a patient-isolated stage 1520 in communication with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is included in the isolated stage 1520 and may include a tapped configuration (e.g., center-tapped or non-center-tapped configuration) and defines drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to various surgical devices, such as, for example, an ultrasonic surgical device 1104 and an electrosurgical device 1106. In particular, 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, where output 1600b corresponds to a center tap of the power transformer 1560. The non-isolated stage 1540 may include a power amplifier 1620 having an output connected to the primary winding 1640 of the power transformer 1560. In certain aspects, the power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may further include a programmable logic 1660 for providing a digital output to a digital-to-analog converter (DAC) 1680, which in turn provides a corresponding analog signal to the input of the power amplifier 1620. In certain embodiments, the programmable logic 1660 may include, for example, a field programmable gate array (FPGA). The programmable logic 1660 may control the input of the power amplifier 1620 via the DAC 1680, thereby controlling any of a number of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal appearing at the drive signal outputs 1600a, 1600b, 1600c.In certain aspects, and as described below, the programmable logic 1660, in conjunction with a processor (e.g., processor 1740, described below), can execute a number of digital signal processing (DSP)-based and / or other control algorithms to control parameters of the drive signal output by the generator 1100.
[0099] Power can be provided to the bus of the power amplifier 1620 by a switch mode regulator 1700. In a particular aspect, the switch mode regulator 1700 can include, for example, an adjustable buck regulator. As mentioned above, the non-isolated stage 1540 can further include a processor 1740, which in one aspect can include, for example, a DSP processor, such as an ADSP-21469 SHARC DSP available from Analog Devices, Norwood, Mass. In a particular aspect, the processor 1740 can control the operation of the switch mode power converter 1700 in response to voltage feedback data received by the processor 1740 from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. For example, in one aspect, the processor 1740 can receive as an input via the ADC 1760 the waveform envelope of a signal (e.g., an RF signal) being amplified by the power amplifier 1620. The processor 1740 can then control the switch mode regulator 1700 (e.g., via a pulse-width modulated (PWM) output) so that the rail voltages supplied to the power amplifier 1620 track the waveform envelope of the amplified signal. By dynamically modulating the rail voltages of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved compared to a fixed rail voltage amplifier scheme. The processor 1740 may be configured for wired or wireless communication.
[0100] In certain aspects, and as described in more detail in connection with FIGS. 9A and 9B, the programmable logic 1660, in cooperation with the processor 1740, may execute a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency and / or amplitude of the drive signal output by the generator 1100. In one aspect, for example, the programmable logic 1660 may execute a DDS control algorithm 2680 (FIG. 9A) by calling waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT, which may be embedded in an FPGA. This control algorithm is particularly useful in ultrasonic applications, where an ultrasonic transducer, such as the ultrasonic transducer 1120, may be driven by a well-defined sinusoidal current at its resonant frequency. Undesirable resonant effects may be minimized or reduced because other frequencies may excite parasitic resonances, and correspondingly, the total distortion of the operating branch current is minimized or reduced. Because the waveform shape of the drive signal output by the generator 1100 may be affected by various distortion sources present in the output drive circuit (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal may be input to an algorithm, such as an error control algorithm executed by the processor 1740, to appropriately pre-distort or modify the waveform samples stored in the LUT to compensate for the distortion on a dynamic, ongoing basis (e.g., in real time). In one aspect, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated motional branch current and the desired current waveform shape, the error being determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed through the drive circuit, may result in a motional branch drive signal having a desired waveform shape (e.g., sinusoidal) to optimally drive an ultrasonic transducer. Thus, in such an aspect, the LUT waveform samples represent not the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately generate the motional branch drive signal of the desired waveform when considering distortion effects.
[0101] The non-isolated stage 1540 may further include ADC 1780 and ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for sampling the voltage and current, respectively, of the drive signal output by the generator 1100. In certain aspects, the ADC 1780, 1800 may be configured to sample at a high speed (e.g., 80 Msps) to allow for oversampling of the drive signal. In one aspect, for example, the sampling rate of the ADC 1780, 1800 may allow for oversampling of the drive signal by approximately 200 times (depending on the drive frequency). In certain aspects, the sampling operation of the ADC 1780, 1800 may be performed by a single ADC that receives the input voltage and current signals via a bidirectional multiplexer. The use of high speed sampling in embodiments of the generator 1100 can enable, among other things, the calculation of complex currents flowing through the motional branches (which may be used in certain embodiments to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and highly accurate calculation of actual power consumption. The voltage and current feedback data output by the ADCs 1780, 1800 may be received by the programmable logic 1660 and processed (e.g., FIFO buffering, multiplexing), and may be stored in a data memory, for subsequent retrieval, for example, by the processor 1740. As noted above, the voltage and current feedback data may be used as input to an algorithm to pre-distort or modify the LUT waveform samples on a dynamic and ongoing basis. In certain embodiments, this may require that each stored voltage and current feedback data pair be indexed or otherwise associated with the corresponding LUT sample output by the programmable logic 1660 as the voltage and current feedback data pair is acquired. Synchronizing the LUT samples with the voltage and current feedback data in this manner contributes to precise timing and stability of the predistortion algorithm.
[0102] In certain aspects, the voltage and current feedback data can be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, the voltage and current feedback data can be used to determine the impedance phase, e.g., the phase difference between the voltage drive signal and the current drive signal. The frequency of the drive signal can then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the measurement accuracy of the impedance phase. The determination of the phase impedance and frequency control signal can be performed, for example, by the processor 1740, with the frequency control signal being provided as an input to a DDS control algorithm executed by the programmable logic 1660.
[0103] The impedance phase may be determined by Fourier analysis. In one aspect, the phase difference between the generator voltage Vg(t) and generator current Ig(t) drive signals may be determined using a Fast Fourier Transform (FFT) or Discrete Fourier Transform (DFT) as follows:
[0104]
number
[0105] Evaluating the Fourier transform at the frequency of the sine wave gives:
[0106]
number
[0107] Other approaches include weighted least squares estimation, Kalman filtering, and space vector based techniques. Substantially all of the processing in the FFT or DFT technique may be performed in the digital domain, for example using a two channel high speed ADC 1780, 1800. In one technique, digital signal samples of the voltage and current signals are Fourier transformed with an FFT or DFT. The phase angle φ at any time can be calculated by the following formula: φ=2πft+φ0 where φ is the phase angle, f is the frequency, t is the time, and φ0 is the phase at t=0.
[0108] Voltage V g (t) Signal and current I g Another technique for determining the phase difference between a (t) signal and a voltage V g (t) Signal and current I g For the (t) signal, the voltage signal V g Each negative to positive zero crossing of (t) triggers the start of a pulse, while the current signal I g Each negative to positive zero crossing of (t) triggers the end of a pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train can be passed through an averaging filter to obtain a measure of the phase difference. Additionally, positive to negative zero crossings can also be used in a similar manner and any effects of DC and harmonic content can be reduced when the result is averaged. In one implementation, the analog voltage V g (t) Signal and current I g The (t) signal is converted to a high digital signal when the analog signal is positive and a low digital signal when the analog signal is negative. High accuracy phase estimation requires a sharp transition between high and low. In one embodiment, a Schmitt trigger can be used in conjunction with an RC stabilization network to convert the analog signal to a digital signal. In other embodiments, an edge-triggered RS flip-flop and supporting circuitry may be used. In yet another embodiment, the zero-crossing technique may use an eXclusive OR (XOR) gate.
[0109] Other techniques for determining the phase difference between voltage and current signals include Lissajous figures and image monitoring, three-voltmeter method, crossed coil method, vector voltmeter and vector impedance methods, as well as phase standard instruments, phase-locked loops, and Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http: / / www.engnetbase.com> and the use of other techniques, such as those described in, which are incorporated herein by reference.
[0110] In another aspect, for example, current feedback data can be monitored to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point can be directly specified or indirectly determined based on specified voltage amplitude and power set points. In certain aspects, control of the current amplitude can be performed by a control algorithm, such as, for example, a proportional-integral-derivative (PID) control algorithm in the processor 1740. Variables controlled by the control algorithm to appropriately control the current amplitude of the drive signal can include, for example, the scaling of the LUT waveform samples stored in the programmable logic 1660 and / or the full-scale output voltage of the DAC 1680 (which provides an input to the power amplifier 1620) via the DAC 1860.
[0111] The non-isolated stage 1540 may further include a processor 1900 to provide, among other things, user interface (UI) functions. In one embodiment, the processor 1900 may include, for example, an Atmel AT91 SAM9263 processor with an ARM926EJ-S core available from Atmel Corporation, San Jose, Calif. Examples of UI functions supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a Universal Serial Bus (USB) interface), communication with a foot switch 1430, communication with an input device 2150 (e.g., a touch screen display), and communication with an output device 2140 (e.g., a speaker). The processor 1900 may communicate with the processor 1740 and the programmable logic (e.g., via a serial peripheral interface (SPI) bus). While the processor 1900 may primarily support UI functions, it may also cooperate with the processor 1740 in certain embodiments to provide hazard mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user input and / or other inputs (e.g., touch screen input 2150, foot switch 1430 input, temperature sensor input 2160) and can disable the drive output of the generator 1100 if an erroneous condition is detected.
[0112] In certain aspects, both processor 1740 (FIGS. 7 and 8A) and processor 1900 (FIGS. 7 and 8B) may determine and monitor the operating state of generator 1100. In the case of processor 1740, the operating state of generator 1100 may determine, for example, which control and / or diagnostic processes are executed by processor 1740. In the case of processor 1900, the operating state of generator 1100 may determine, for example, which elements of a user interface (e.g., display screen, sound) are provided to a user. Processors 1740, 1900 may separately maintain the current operating state of generator 1100 and recognize and evaluate possible transitions from the current operating state. Processor 1740 acts as a master in this relationship and may determine when transitions between operating states occur. Processor 1900 may recognize valid transitions between operating states and may verify that a particular transition is appropriate. For example, when processor 1740 commands processor 1900 to transition to a particular state, processor 1900 may verify that the requested transition is valid. If a transition between states requested by processor 1900 is determined to be invalid, processor 1900 may place generator 1100 in a failure mode.
[0113] The non-isolated stage 1540 may further include a controller 1960 (FIGS. 7 and 8B) for monitoring the input device 2150 (e.g., a capacitive touch sensor, a capacitive touch screen used to turn the generator 1100 on and off). In certain aspects, the controller 1960 may comprise at least one processor and / or other controller device in communication with the processor 1900. In one aspect, for example, the controller 1960 may comprise a processor (e.g., a Mega168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, the controller 1960 may comprise a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) for controlling and managing acquisition of touch data from a capacitive touch screen.
[0114] In certain aspects, when the generator 1100 is in the "power off" state, the controller 1960 may continue to receive operating power (e.g., via a line from a power source of the generator 1100, such as the power source 2110 (FIG. 7) described below). In this manner, the controller 1960 may continue to monitor an input device 2150 (e.g., a capacitive touch sensor located on the front panel of the generator 1100) for turning the generator 1100 on and off. When the generator 1100 is in the "power off" state, the controller 1960 may activate the power source (e.g., enable operation of one or more DC / DC voltage converters 2130 (FIG. 7) of the power source 2110) upon detection of activation of the "on / off" input device 2150 by a user. Thus, the controller 1960 may initiate a sequence to transition the generator 1100 to the "power on" state. Conversely, when activation of the "on / off" input device 2150 is detected while the generator 1100 is in the "power on" state, the controller 1960 can initiate a sequence to transition the generator 1100 to the "power off" state. In certain aspects, for example, the controller 1960 can report activation of the "on / off" input device 2150 to the processor 1900, which then executes the processing sequence necessary to transition the generator 1100 to the "power off" state. In such aspects, the controller 1960 may not have the independent capability to cause the removal of power from the generator 1100 after its "power on" state has been established.
[0115] In certain aspects, the controller 1960 may cause the generator 1100 to provide auditory or other sensory feedback to alert a user that a "power on" or "power off" sequence has begun. Such an alert may be provided at the start of a "power on" or "power off" sequence and prior to the start of other processes associated with the sequence.
[0116] In certain aspects, the isolated stage 1520 may include an instrument interface circuit 1980, for example, to provide a communication interface between the surgical device's control circuitry (e.g., control circuitry including handpiece switches) and the components of the non-isolated stage 1540 (e.g., programmable logic 1660, processor 1740, and / or processor 1900, etc.). The instrument interface circuit 1980 may exchange information with the components of the non-isolated stage 1540 via a communication link that maintains an appropriate degree of electrical isolation between the stages 1520, 1540, such as, for example, an infrared (IR) based communication link. For example, the instrument interface circuit 1980 may be powered using a low dropout voltage regulator powered by an isolation transformer driven from the non-isolated stage 1540.
[0117] In one aspect, the instrument interface circuit 1980 may comprise a programmable logic 2000 (e.g., an FPGA) in communication with a signal conditioning circuit 2020 (FIGS. 7 and 8C). The signal conditioning circuit 2020 may be configured to receive a periodic signal (e.g., a 2 kHz square wave) from the programmable logic 2000 and generate a bipolar interrogation signal having the same frequency. The interrogation signal may be generated, for example, using a bipolar current source fed by a differential amplifier. The interrogation signal may be communicated 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 number of switches, resistors, and / or diodes to modify one or more characteristics (e.g., amplitude, rectification) of the interrogation signal such that the state or configuration of the control circuit is individually identifiable based on the one or more characteristics. For example, in one aspect, the signal conditioning circuitry 2020 may include an ADC to generate samples of a voltage signal appearing across an input of the control circuitry caused by the interrogation signal passing through it. The programmable logic 2000 (or a component of the non-isolated stage 1540) may then determine a state or configuration of the control circuitry based on the ADC samples.
[0118] In one embodiment, the instrument interface circuit 1980 can comprise a first data circuit interface 2040 that allows for the exchange of information between the programmable logic 2000 (or other elements of the instrument interface circuit 1980) and a first data circuit disposed within or otherwise associated with the surgical device. In certain embodiments, for example, the first data circuit 2060 may be disposed in a cable integrally attached to a handpiece of the surgical device, or in an adapter for interfacing a particular surgical device type or model with the generator 1100. In certain embodiments, the first data circuit can comprise a non-volatile storage device, such as an electrically erasable programmable read only memory (EEPROM) device. In certain embodiments, and referring back to FIG. 7, the first data circuit interface 2040 can be implemented separately from the programmable logic 2000 and can comprise suitable circuitry (e.g., discrete logic, processor) that allows for communication between the programmable logic 2000 and the first data circuit. In other embodiments, the first data circuit interface 2040 may be integral to the programmable logic device 2000 .
[0119] In certain aspects, the first data circuit 2060 can store information regarding the particular surgical device with which it is associated. Such information can include, for example, a model number, a serial number, a number of operations the surgical device has been used in, and / or other types of information. This information can be read by the instrument interface circuit 1980 (e.g., by the programmable logic 2000) and transferred to components of the non-isolated stage 1540 (e.g., the programmable logic 1660, the processor 1740, and / or the processor 1900) for presentation to a user via the output device 2140 and / or for controlling the functions or operations of the generator 1100. Additionally, any type of information can be communicated to the first data circuit 2060 via the first data circuit interface 2040 (e.g., using the programmable logic 2000) for storage within the first data circuit 2060. Such information can include, for example, the most recent number of operations the surgical device has been used in, and / or the date and / or time of its use.
[0120] As noted above, the surgical instruments may be removable from the handpiece to facilitate interchangeability and / or disposability of the instruments (e.g., instrument 1106 may be removable from handpiece 1107). In such cases, known generators may be limited in their ability to recognize the particular instrument configuration being used and optimize their control and diagnostic processes accordingly. However, adding readable data circuitry to the surgical device instrument to address this issue is problematic from a compatibility standpoint. For example, designing a surgical device to be backward compatible with generators that lack the necessary data read capabilities may not be practical due to, for example, different signaling schemes, design complexity, and expense. Other aspects of the instrument address these concerns by economically using data circuitry that may be implemented in existing surgical instruments and minimizing design changes to maintain compatibility of the surgical device with modern generator platforms.
[0121] Additionally, aspects of the generator 1100 may enable communication with an instrument-based data circuit. For example, the generator 1100 may be configured to communicate with a second data circuit (e.g., a data circuit) housed within an instrument (e.g., instrument 1104, 1106, or 1108) of a surgical device. The instrument interface circuit 1980 may include a second data circuit interface 2100 to enable this communication. In one aspect, the second data circuit interface 2100 may include a tri-state digital interface, although other interfaces may be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and / or receiving data. In one aspect, for example, the second data circuit may store information regarding the particular surgical instrument with which it is associated. Such information may include, for example, a model number, a serial number, the number of operations the surgical instrument has been used in, and / or any other type of information. Additionally or alternatively, any type of information can be communicated to the second data circuit via the second data circuit interface 2100 (e.g., using the programmable logic 2000) for storage in the second data circuit. Such information may include, for example, the most recent number of operations the instrument was used for and / or the date and / or time of its use. In certain aspects, the second data circuit can transmit data obtained by one or more sensors (e.g., instrument-based temperature sensors). In certain aspects, the second data circuit can receive data from the generator 1100 and provide an indication (e.g., an LED indication or other visual indication) to the user based on the received data.
[0122] In certain aspects, the second data circuit and the second data circuit interface 2100 can be configured such that communication between the programmable logic 2000 and the second data circuit can be achieved without the need to provide additional conductors for this purpose (e.g., dedicated conductors in the cable connecting the handpiece to the generator 1100). In one aspect, a one-wire bus communication scheme implemented on existing cable wiring can be used to convey information to and from the second data circuit, for example, with one of the conductors used transmitting an interrogation signal from the signal conditioning circuit 2020 to the control circuitry in the handpiece. In this manner, design changes or modifications to the surgical device that may otherwise be required are minimized or reduced. Furthermore, because various types of communication can be implemented over a common physical channel (either with or without frequency band separation), the presence of the second data circuit can be "invisible" to generators that do not have the necessary data reading capabilities, thus enabling backward compatibility of surgical device tools.
[0123] In certain embodiments, the isolation stage 1520 may include at least one blocking capacitor 2960-1 (FIG. 8C) connected to the drive signal output 1600b to prevent DC current from passing through the patient. A single blocking capacitor may be required, for example, to comply with medical regulations or standards. Although failure in a single capacitor design is relatively rare, such failure may still have negative consequences. In one embodiment, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1 to monitor current leakage from a point between the blocking capacitors 2960-1, 2960-2, for example, by an ADC 2980 for sampling a voltage induced by the leakage current. The samples may be received, for example, by the programmable logic 2000. Based on the change in leakage current (shown by a voltage sample in the embodiment of FIG. 7), the generator 1100 may determine when at least one of the blocking capacitors 2960-1, 2960-2 has failed. Thus, the embodiment of FIG. 7 can provide benefits over single capacitor designs that have a single point of failure.
[0124] In certain aspects, the non-isolated stage 1540 may comprise a power supply 2110 for outputting DC power at a suitable voltage and current. The power supply may comprise, for example, a 400 W power supply for outputting a 48 VDC system voltage. As mentioned above, the power supply 2110 may further comprise one or more DC / DC voltage converters 2130 for receiving the output of the power supply and generating a DC output at the voltage and current required by the various components of the generator 1100. As described above in connection with the controller 1960, one or more of the DC / DC voltage converters 2130 may receive input from the controller 1960 when activation of an “on / off” input device 2150 by a user is detected by the controller 1960 to enable operation or activation of the DC / DC voltage converters 2130.
[0125] 9A and 9B show certain functional and structural aspects of one embodiment of the generator 1100. Feedback indicative of the current and voltage output from the secondary winding 1580 of the power transformer 1560 is received by ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 may be implemented as two-channel ADCs and may sample the feedback signal at a high speed (e.g., 80 Msps) to allow for oversampling of the drive signal (e.g., approximately 200 times oversampling). The current and voltage feedback signals may be appropriately conditioned (e.g., amplified, filtered) in the analog domain prior to processing by the ADCs 1780, 1800. The current and voltage feedback samples from the ADCs 1780, 1800 may be individually buffered and then multiplexed or interleaved into a single data stream in block 2120 of the programmable logic 1660. In the embodiment of FIGS. 9A and 9B, the programmable logic 1660 comprises an FPGA.
[0126] The multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented in block 2144 of the processor 1740. The PDAP may include a packing unit for implementing any of a number of methods for correlating the multiplexed feedback samples with memory addresses. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by the programmable logic 1660 may be stored at one or more memory addresses that are associated with or indexed to the LUT address of the LUT sample. In another aspect, feedback samples corresponding to a particular LUT sample output by the programmable logic 1660 may be stored in a common memory location along with the LUT address of the LUT sample. In either case, the feedback samples may be stored such that the address of the LUT sample from which a particular set of feedback samples originates may subsequently be ascertained. As noted above, synchronization of the LUT sample addresses and feedback samples thus contributes to the precise timing and stability of the predistortion algorithm. A direct memory access (DMA) controller implemented in block 2166 of the processor 1740 can store the feedback samples (and any LUT sample address data, if applicable) in a specified memory location 2180 (e.g., internal RAM) of the processor 1740.
[0127] Block 2200 of the processor 1740 can implement a pre-distortion algorithm to pre-distort or modify on a dynamic, ongoing basis the LUT samples stored in the programmable logic 1660. As described above, pre-distortion of the LUT samples can compensate for various sources of distortion present in the output drive circuitry of the generator 1100. The pre-distorted LUT samples thus, when processed by the drive circuitry, produce a drive signal having a desired waveform shape (e.g., a sine wave) to optimally drive an ultrasonic transducer.
[0128] In block 2220 of the predistortion algorithm, the current flowing through the motional branch of the ultrasonic transducer is determined. The motional branch current may be determined, for example, from the current and voltage feedback samples stored in memory location 2180 (which, when appropriately scaled, corresponds to I in the model of FIG. 6 described above). g and V g The LUT sample may be determined using Kirchhoff's current law based on the LUT sample's capacitance C0 (which may represent the LUT sample's capacitance C0), the value of the ultrasonic transducer's capacitance C0 (measured or known a priori), and the known value of the drive frequency. The motional branch current samples in each set of stored current and voltage feedback samples associated with the LUT samples may be determined.
[0129] In block 2240 of the predistortion algorithm, each motional branch current sample determined in block 2220 is compared to a sample of the desired current waveform shape to determine the difference or sample amplitude error between the compared samples. For this determination, the current waveform shape sample may be provided from a waveform shape LUT 2260, which may include, for example, amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT 2260 used for the comparison may be determined by the LUT sample address associated with the motional branch current sample used for the comparison. Thus, the input of the motional branch current to block 2240 may be synchronized with the input of its associated LUT sample address to block 2240. Thus, the LUT samples stored in programmable logic 1660 and the LUT samples stored in waveform shape LUT 2260 may be numerically equivalent. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT 2260 may be a fundamental sine wave. Other waveform shapes may be desirable. For example, it is contemplated that a fundamental sine wave may be used to drive the primary longitudinal motion of an ultrasonic transducer overlapped with one or more other drive signals at other wavelengths, such as the third harmonic, to drive at least two mechanical resonances for beneficial vibration in the lateral or other modes.
[0130] Each value of sample amplitude error determined in block 2240 may be sent to a LUT (shown in block 2280 of FIG. 9A) of programmable logic 1660 along with an indication of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and, optionally, a previously received value of sample amplitude error for the same LUT address), LUT 2280 (or other control block of programmable logic 1660) may pre-distort or modify the value of the LUT sample stored at the LUT address, thereby reducing or minimizing the sample amplitude error. It will be appreciated that such pre-distortion or modification of each LUT sample in an iterative manner across the entire range of LUT addresses causes the waveform shape of the generator output current to match or conform to the desired current waveform shape represented by the samples of waveform shape LUT 2260.
[0131] Current and voltage amplitude measurements, power measurements, and impedance measurements may be determined in block 2300 of processor 1740 based on the current and voltage feedback samples stored in memory location 2180. Prior to the determination of these values, the feedback samples may be appropriately scaled and, in certain embodiments, processed through a suitable filter 2320 to remove, for example, noise and induced harmonic components caused by the data acquisition process. The filtered voltage and current samples may thus substantially represent the fundamental frequency of the generator's drive output signal. In certain embodiments, filter 2320 may be a finite impulse response (FIR) filter applied in the frequency domain. Such embodiments may use a fast Fourier transform (FFT) of the output drive signal current and voltage signals. In certain embodiments, the resulting frequency spectrum may be used to provide additional generator functions. In one embodiment, for example, the ratio of second and / or third harmonic components to the fundamental frequency component may be used as a diagnostic indicator.
[0132] At block 2340 (FIG. 9B), a root-mean-square (RMS) calculation is applied to a sample size of the current feedback samples that represents an integer number of cycles of the drive signal to obtain a measurement I that represents the drive signal output current. rms may be generated.
[0133] At block 2360, a measurement V representing the drive signal output voltage is rms To determine, a root mean square (RMS) calculation may be applied to a sample size of voltage feedback samples that represents an integer number of cycles of the drive signal.
[0134] In block 2380, the current and voltage feedback samples may be multiplied point by point and an averaging calculation applied to samples representing an integer number of cycles of the drive signal to obtain a measure of the actual output power of the generator, P r is determined.
[0135] In block 2400, the measured apparent output power of the generator P a is the product V rms I rms It can be determined as:
[0136] At block 2420, a measured load impedance magnitude Z m is the quotient V rms / I rms It can be determined as:
[0137] In certain embodiments, the values I determined in blocks 2340, 2360, 2380, 2400, and 2420 rms , V rms , P r , P a , and Z mmay be used by the generator 1100 to implement any of a number of control and / or diagnostic processes. In certain aspects, any of these values may be communicated to a user through a suitable communications interface (e.g., a USB interface), for example, via an output device 2140 integral with the generator 1100 or connected to the generator 1100. The various diagnostic processes may include, but are not limited to, for example, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock failure, overvoltage condition, overcurrent condition, overpower condition, voltage sense failure, current sense failure, audible indicator failure, visual indicator failure, short circuit condition, power supply failure, or blocking capacitor failure.
[0138] Block 2440 of processor 1740 may implement a phase control algorithm to determine and control the impedance phase of an electrical load (e.g., an ultrasonic transducer) driven by generator 1100. As described above, the frequency of the drive signal may be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and improving the accuracy of the phase measurement.
[0139] The phase control algorithm receives as input the current and voltage feedback samples stored in memory location 2180. Before using them in the phase control algorithm, the feedback samples may be appropriately scaled and, in certain aspects, processed through a suitable filter 2460 (which may be the same as filter 2320) to remove, for example, noise resulting from the data acquisition process and induced harmonic components. The filtered voltage and current samples may thus substantially represent the fundamental frequency of the generator drive output signal.
[0140] In block 2480 of the phase control algorithm, the current through the motional branch of the ultrasonic transducer is determined. This determination may be the same as that described above in connection with block 2220 of the predistortion algorithm. Thus, the output of block 2480 may be a motional branch current sample for each set of stored current and voltage feedback samples associated with a LUT sample.
[0141] In block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronized input of the motional branch current samples and corresponding voltage feedback samples determined in block 2480. In a particular aspect, the impedance phase is determined as the average of the impedance phase measured at the rising edge of the waveform and the impedance phase measured at the falling edge of the waveform.
[0142] In block 2520 of the phase control algorithm, the value of the impedance phase determined in block 2220 is compared to a phase set point 2540 to determine the difference or phase error between the compared values.
[0143] In phase control algorithm block 2560 (FIG. 9A), a frequency output is determined for controlling the frequency of the drive signal based on the value of the phase error determined in block 2520 and the magnitude of the impedance determined in block 2420. The frequency output value may be continuously adjusted by block 2560 and forwarded to DDS control block 2680 (described below) to maintain the impedance phase determined in block 2500 at the phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0° phase set point. In this manner, any amount of harmonic distortion is centered around the top of the voltage waveform, improving the accuracy of the phase impedance determination.
[0144] Block 2580 of processor 1740 may implement algorithms for modulating the current amplitude of the drive signal to control the drive signal current, voltage, and power according to user-specified set points or requirements specified by other processes or algorithms implemented by generator 1100. Control of these values may be achieved, for example, by scaling LUT samples in LUT 2280 and / or by adjusting the full-scale output voltage of DAC 1680 (which provides an input to power amplifier 1620) via DAC 1860. Block 2600 (which in certain aspects may be implemented as a PID controller) may receive as input from memory location 2180 a current feedback sample (which may be appropriately scaled and filtered). The current feedback sample may be used to calculate a "current demand" I, determined by the controlled variable (e.g., current, voltage, or power), to determine if the drive signal is providing the required current. d In embodiments where the drive signal current is the controlled variable, the current demand I d The current setting is 2620A (I sp ) directly. For example, the RMS value of the current feedback data (determined in block 2340) may be used in conjunction with a user-specified RMS current setpoint I to determine the appropriate controller action. sp For example, the current feedback data can be compared to the current setpoint I sp If the current feedback data indicates an RMS value lower than the current setpoint I, then the LUT scaling and / or the full-scale output voltage of the DAC 1680 may be adjusted by block 2600 such that the drive signal current is increased. sp If the signal indicates a higher RMS value than 1, block 2600 may adjust the LUT scaling and / or the full-scale output voltage of the DAC 1680 to reduce the drive signal current.
[0145] In the embodiment where the drive signal voltage is the controlled variable, the current demand I d is, for example, the magnitude of the load impedance Z measured in block 2420. mGiven the desired voltage set point 2620B (V sp ) may be indirectly specified based on the current required to maintain the d =V sp / Z m Similarly, in embodiments where drive signal power is the controlled variable, the current demand I d is, for example, the voltage V measured in block 2360. rms Given the desired power setting 2620C(P sp ) may be indirectly specified based on the current required to maintain d =P sp / V rms ).
[0146] Block 2680 (FIG. 9A) can implement a DDS control algorithm to control the drive signal by recalling the LUT samples stored in LUT 2280. In a particular embodiment, the DDS control algorithm can be a numerically controlled oscillator (NCO) algorithm to generate samples of a waveform at a fixed clock rate using a point (memory location) skip technique. The NCO algorithm can implement a phase accumulator, or a frequency / phase converter, that acts as an address pointer to recall the LUT samples from LUT 2280. In one embodiment, the phase accumulator can be a D step size, modulo N phase accumulator, where D is a positive integer representing a frequency control value and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D=1 can cause the phase accumulator to sequentially address all of LUT 2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. If D>1, the phase accumulator may skip addresses of the LUT 2280 resulting in a waveform output having a higher frequency. This allows the frequency of the waveform generated by the DDS control algorithm to be controlled accordingly by appropriately changing the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented in block 2440. The output of block 2680 may provide an input to the DAC 1680, which in turn provides a corresponding analog signal to the input of the power amplifier 1620.
[0147] Block 2700 of processor 1740 may implement a switch mode converter control algorithm to dynamically modulate the rail voltage of power amplifier 1620 based on the waveform envelope of the signal being amplified, thereby improving the efficiency of power amplifier 1620. In certain aspects, the characteristics of the waveform envelope may be determined by monitoring one or more signals included in power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope may be determined by monitoring a minimum value of a drain voltage (e.g., a MOSFET drain voltage) that is modulated according to the envelope of the amplified signal. The minimum voltage signal may be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal may be sampled by ADC 1760, and the output minimum voltage sample may be received at block 2720 of the switch mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 may control the PWM signal output by PWM generator 2760, which in turn controls the rail voltage supplied to power amplifier 1620 by switch mode regulator 1700. In certain aspects, the rail voltage may be modulated according to the waveform envelope characterized by the minimum voltage sample as long as the value of the minimum voltage sample is less than the minimum target 2780 input to block 2720. For example, a low rail voltage may be provided by block 2740 to the power amplifier 1620 when the minimum voltage sample indicates a low envelope power level, and full rail voltage may be provided only when the minimum voltage sample indicates a maximum envelope power level. When the minimum voltage sample falls below the minimum target 2780, the rail voltage may be maintained by block 2740 at a minimum value suitable to ensure proper operation of the power amplifier 1620.
[0148] FIG. 10 illustrates a control circuit 500 configured to control an embodiment of a surgical instrument or tool according to one embodiment of the present disclosure. The control circuit 500 can be configured to implement various processes described herein. The control circuit 500 can include a microcontroller that includes one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuit 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement various processes described herein. The processor 502 can be any one of a number of single or multi-core processors known in the art. The memory circuit 504 can include volatile and non-volatile storage media. The processor 502 can include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit can be configured to receive instructions from the memory circuit 504 of the present disclosure.
[0149] 11 illustrates a combinational logic circuit 510 configured to control an aspect of a surgical instrument or tool, according to one aspect of the present disclosure. The combinational logic circuit 510 can be configured to implement various processes described herein. The combinational logic circuit 510 can include a finite state machine including combinational logic 512 configured to receive data associated with the surgical instrument or tool at an input 514, process the data through the combinational logic 512, and provide an output 516.
[0150] FIG. 12 illustrates a sequential logic circuit 520 configured to control aspects of a surgical instrument or tool according to one aspect of the disclosure. The sequential logic circuit 520 or the combinatorial logic 522 can be configured to implement various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 can store a current state of the finite state machine. In certain examples, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with the surgical instrument or tool from an input 526, process the data through the combinatorial logic 522, and provide an output 528. In other aspects, the circuit may include a combination of a processor (e.g., processor 502 of FIG. 13) and a finite state machine that performs various processes herein. In other aspects, the finite state machine may include a combination of combinational logic (eg, combinational logic 510 of FIG. 14) and sequential logic 520.
[0151] In one aspect, the ultrasonic or radio frequency current generator of the surgical system 1000 may be configured to digitally generate the electrical signal waveform, desirably using a predetermined number of phase points stored in a look-up table to digitize the waveform. The phase points may be stored in a table defined in a memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 13 shows one aspect of a basic architecture for a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 4100, configured to generate multiple waveforms for the electrical signal waveform. The generator software and digital control may instruct the FPGA to scan addresses in the look-up table 4104, which in turn provides various digital input values to a DAC circuit 4108 that feeds the power amplifier. The addresses may be scanned according to the desired frequency. Using such a look-up table 4104 allows for the generation of various types of waveforms that can be delivered into tissue, or into a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasonic instruments. Additionally, multiple look-up tables 4104 representing multiple waveforms can be created, stored, and applied to the tissue from the generator.
[0152] The waveform signal may be configured to control at least one of an output current, an output voltage, or an output power of an ultrasonic transducer and / or an RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). Furthermore, if the surgical instrument comprises an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Thus, the generator may be configured to provide a waveform signal to at least one surgical instrument, the waveform signal being responsive to at least one waveform of a plurality of waveforms in a table. It is noted that the waveform signal provided to the two surgical instruments may include two or more waveforms. The table may include information related to the plurality of waveforms, and the table may be stored in the generator. In one aspect or embodiment, the table may be a direct digital synthesis table and may be stored in an FPGA of the generator. The table may be addressed by any method that is convenient to categorize the waveforms. According to one aspect, the table, which may be a direct digital synthesis table, is addressed according to the frequency of the waveform signal. Additionally, information relating to multiple waveforms may be stored as digital information in a table.
[0153] The analog electrical signal waveform may be configured to control at least one of an output current, an output voltage, or an output power of an ultrasonic transducer and / or an RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). Furthermore, if the surgical instrument comprises an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Thus, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, where the analog electrical signal waveform corresponds to at least one waveform of the plurality of waveforms stored in the lookup table 4104. It should be noted that the analog electrical signal waveform provided to the two surgical instruments may include two or more waveforms. The lookup table 4104 may include information related to the plurality of waveforms, and the lookup table 4104 may be stored in either the generator circuit or the surgical instrument. In one aspect or embodiment, the lookup table 4104 may be a direct digital synthesis table, which may be stored in the generator circuitry or the FPGA of the surgical instrument. The lookup table 4104 may be addressed by any method that is convenient for categorizing waveforms. According to one aspect, the lookup table 4104, which may be a direct digital synthesis table, is addressed according to the frequency of the desired analog electrical signal waveform. Additionally, information related to multiple waveforms may be stored in the lookup table 4104 as digital information.
[0154] With the widespread use of digital technology in instrumentation and communication systems, a digitally controlled method of generating multiple frequencies from a reference frequency has been developed and is called direct digital synthesis. The basic architecture is shown in Figure 13. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic of the generator circuit and a memory circuit located within the generator circuit of the surgical system 1000. The DDS circuit 4100 includes an address counter 4102, a look-up table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. A stable clock f c is received by an address counter 4102, which drives a programmable read only memory (PROM) that stores one or more integer numbers of cycles of a sine wave (or any other waveform) in a look-up table 4104. As the address counter 4102 steps through the memory locations, the values stored in the look-up table 4104 are written to a register 4106 that is coupled to a DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location of the look-up table 4104 drives the DAC circuit 4108 which in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. Phase noise is essentially a function of the phase of a reference clock f c The first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal has a frequency f out has.
[0155] Because the DDS circuit 4100 is a sampled data system, it must consider problems associated with sampling, such as quantization noise, aliasing, filtering, etc. For example, whereas the higher harmonics of the output of a phase-locked-loop (PLL)-based synthesizer can be filtered, the higher harmonics of the DAC circuit 4108 output frequency fold back into the Nyquist bandwidth, making them unfilterable. The look-up table 4104 contains signal data for an integer number of cycles. The final output frequency f out is the reference clock frequency f c or by reprogramming the PROM.
[0156] The DDS circuitry 4100 may include multiple lookup tables 4104, which store waveforms represented by a predetermined number of samples, which define a predetermined waveform shape. Thus, multiple waveforms having unique shapes can be stored in the multiple lookup tables 4104 to provide various tissue treatments based on tool settings or tissue feedback. Examples of waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuitry 4100 can create multiple waveform lookup tables 4104 and can switch between various waveforms stored in the individual lookup tables 4104 during a tissue treatment procedure (e.g., "on the fly" or in real time based on user or sensor input) based on the desired tissue effect and / or tissue feedback. Thus, switching between waveforms can be based on tissue impedance and other factors, for example. In other aspects, the lookup table 4104 can store electrical signal waveforms that are shaped to maximize the power delivered into tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the lookup table 4104 can store synchronized waveforms that maximize power delivery by the multifunction surgical instrument of the surgical system 1000 while delivering RF and ultrasonic drive signals. In yet other aspects, the lookup table 4104 can store electrical signal waveforms that simultaneously drive ultrasonic and RF therapeutic and / or sub-therapeutic energies while maintaining ultrasonic frequency lock. Custom waveforms specific to various instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (e.g., EEPROM) of the surgical system 1000 and fetched upon connecting the multifunction surgical instrument to the generator circuit. An example of an exponentially decaying sinusoidal curve, as used in many high crest factor "coagulation" waveforms, is shown in FIG. 15.
[0157] A more flexible and efficient implementation of the DDS circuit 4100 uses a digital circuit called a Numerically Controlled Oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as a DDS circuit 4200, is shown in FIG. 14. In this simplified block diagram, the DDS circuit 4200 is coupled to a processor, controller, or logic of the generator and to a memory circuit located either in the generator or in the surgical instrument of the surgical system 1000. The DDS circuit 4200 includes a load resistor 4202, a parallel delta phase register 4204, a summer circuit 4216, a phase register 4208, a look-up table 4210 (phase to amplitude converter), a DAC circuit 4212, and a filter 4214. The summer circuit 4216 and the phase register 4208 form part of a phase accumulator 4206. The clock frequency f c is applied to the phase register 4208 and the DAC circuit 4212. The load resistor 4202 receives the reference clock frequency signal f c The output of the load register 4202, along with the adjustment word M, is provided to a parallel delta phase register 4204.
[0158] The DDS circuit 4200 operates at a clock frequency f c The phase accumulator 4206 includes a sample clock that generates a phase accumulator 4206, and a lookup table 4210 (e.g., a phase-to-amplitude converter). The contents of the phase accumulator 4206 are stored in a phase accumulator 4206 every clock cycle f cThe phase accumulator 4206 is updated once every clock cycle. Once the phase accumulator 4206 is updated, the digital number M stored in the parallel delta phase register 4204 is added to the number in the phase register 4208 by an adder circuit 4216. Assume the number in the parallel delta phase register 4204 is 00...01 and the initial contents of the phase accumulator 4206 are 00...00. The phase accumulator 4206 is updated with 00...01 every clock cycle. If the phase accumulator 4206 is 32-bits wide, it will take 232 clock cycles (over 4 billion) for the phase accumulator 4206 to return to 00...00, and the cycle will repeat.
[0159] 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 to a sine (or cosine) lookup table. The addresses in the lookup table correspond to phase points from 0° to 360° in the sine wave. The lookup table 4210 contains the corresponding digital amplitude information of 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, which 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.
[0160] In one embodiment, the electrical signal waveform may be digitized to 1024 (210) phase points, although the waveform that may be digitized may be any suitable number of 2n phase points ranging from 256 (28) to 281, 474, 976, 710, 656 (248), where n is a positive integer, as shown in Table 1. n (θ n ), where the normalized amplitude A at point n isn Phase angle θ n is referred to as a phase point at point n. The number n of discrete phase points determines the adjustment resolution of DDS circuit 4200 (and DDS circuit 4100 shown in FIG. 13).
[0161] Table 1 specifies the electrical signal waveform that has been digitized into a number of phase points.
[0162] [Table 1]
[0163] The generator circuit algorithm and digital control circuit scans the addresses in the lookup table 4210, which in turn provides various digital input values to the DAC circuit 4212 that feeds the filter 4214 and the power amplifier. The addresses may be scanned according to the desired frequency. Using the lookup table, it is possible to generate different types of shapes that can be converted to an analog output signal by the DAC circuit 4212, filtered by the filter 4214, amplified by a power amplifier coupled to the output of the generator circuit, and applied to the tissue in the form of RF energy or to an ultrasonic transducer and in the form of ultrasonic vibrations that deliver energy to the tissue in the form of heat. The output of the amplifier can be applied to, for example, a single RF electrode, multiple RF electrodes simultaneously, a single ultrasonic transducer, multiple ultrasonic transducers simultaneously, or a combination of RF and ultrasonic transducers. Furthermore, multiple waveform tables can be created, stored, and applied to the tissue from the generator circuit.
[0164] 13, for n=32 and M=1, the phase accumulator 4206 steps through 232 possible outputs before overflowing and restarting. The corresponding output wave frequency is equal to the input clock frequency divided by 232. For M=2, the phase register 1708 "rolls over" twice as fast and the output frequency doubles. This can be generalized as follows:
[0165] For a phase accumulator 4206 configured to accumulate n-bits (where n typically ranges from 24 to 32 in most DDS systems, but as noted above, n may be selected from a wide range of options), 2 n There are f possible phase points. The digital word M in the delta phase register represents the amount by which the phase accumulator increments every clock cycle. c If is the clock frequency, then the frequency of the output sine wave is equal to:
[0166]
number
[0167] The above equation is known as the DDS "tuning equation." The frequency resolution of the system is given by:
[0168]
number
[0169] The electrical signal waveform may be characterized by a current, voltage, or power at a predetermined frequency. Furthermore, if any one 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 an ultrasonic transducer of the at least one surgical instrument. Thus, the generator circuit may be configured to provide an electrical signal waveform to the at least one surgical instrument, the electrical signal waveform being characterized by a predetermined waveform stored in the lookup table 4210 (or the lookup table 4104 of FIG. 13). It should be noted that the electrical signal waveform may be a combination of two or more waveforms. The lookup table 4210 may include information related to multiple waveforms. In one aspect or embodiment, the lookup table 4210 may be generated by the DDS circuit 4200 and may be referred to as a direct digital synthesis table. The DDS operates by first storing a large repetitive waveform in an on-board memory. A cycle of a waveform (sine, triangle, square, any) may be represented by a predetermined number of phase points and stored in memory, as shown in Table 1. Once the waveform is stored in memory, the waveform may be generated at a very accurate frequency. The direct digital synthesis table may be stored in a non-volatile memory of the generator circuit and / or implemented with an FPGA circuit in the generator circuit. The lookup table 4210 may be addressed by any suitable technique that is convenient for categorizing waveforms. According to one embodiment, the lookup table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, information related to multiple waveforms may be stored as digital information in memory or as part of the lookup table 4210.
[0170] In one aspect, the generator circuit may be configured to provide electrical signal waveforms to at least two surgical instruments simultaneously. The generator circuit may also be configured to provide electrical signal waveforms (which may be characterized by two or more waveforms) to two surgical instruments simultaneously via a single output channel of the generator circuit. For example, in one aspect, the electrical signal waveform includes a first electrical signal (e.g., an ultrasonic drive signal) that drives an ultrasonic transducer, a second RF drive signal, and / or a combination thereof. Furthermore, the electrical signal waveform may include multiple ultrasonic drive signals, multiple RF drive signals, and / or a combination of multiple ultrasonic and RF drive signals.
[0171] Further, a method of operating a generator circuit according to the present disclosure includes generating an electrical signal waveform and providing the generated electrical signal waveform to any one of the surgical instruments of the surgical system 1000, where generating the electrical signal waveform includes receiving information related to the electrical signal waveform from a memory. The generated electrical signal waveform includes at least one waveform. Further, providing the generated electrical signal waveform to the at least one surgical instrument includes providing the electrical signal waveform to at least two surgical instruments simultaneously.
[0172] The generator circuitry described herein may enable the generation of various types of direct digital synthesis tables. Examples of waveforms of RF / electrosurgical signals generated by the generator circuitry suitable for treating various tissues include RF signals with high crest factors (which may be used for superficial coagulation in RF mode), RF signals with low crest factors (which may be used for deeper tissue penetration), and waveforms that promote efficient modified coagulation. The generator circuitry may also generate multiple waveforms using the direct digital synthesis lookup table 4210 and may switch between specific waveforms on the fly based on the desired tissue effect. The switching may be based on tissue impedance and / or other factors.
[0173] In addition to traditional sine / cosine waveforms, the generator circuit may be configured to generate a waveform(s) (i.e., trapezoidal or square wave) that maximizes the power to the tissue per cycle. If the generator circuit includes a circuit topology that allows for driving RF and ultrasonic signals simultaneously, the generator circuit can provide a waveform(s) that is synchronized to maximize the power delivered to the load and maintain ultrasonic frequency lock when driving RF and ultrasonic signals simultaneously. Additionally, custom waveforms specific to the instrument and its tissue effect can be stored in non-volatile memory (NVM) or in the EEPROM of the instrument and fetched upon connecting any one of the surgical instruments of the surgical system 1000 to the generator circuit.
[0174] The DDS circuitry 4200 may include multiple lookup tables 4104, where the lookup table 4210 stores waveforms represented by a predetermined number of phase points (sometimes referred to as samples), which define the shape of the predetermined waveform. Thus, multiple waveforms having unique shapes may be stored in the multiple lookup tables 4210 to provide different tissue treatments based on tool settings or tissue feedback. Examples of waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuitry 4200 may create multiple waveform lookup tables 4210 and during a tissue treatment procedure (e.g., "on the fly" or in real time based on user or sensor input), switch between different waveforms stored in the different lookup tables 4210 based on the desired tissue effect and / or tissue feedback. Thus, switching between waveforms may be based on tissue impedance and other factors, for example. In other aspects, the lookup table 4210 can store electrical signal waveforms that are shaped to maximize the power delivered into tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the lookup table 4210 can store synchronized waveforms that maximize power delivery by any one of the surgical instruments of the surgical system 1000 when delivering RF and ultrasonic drive signals. In yet other aspects, the lookup table 4210 can store electrical signal waveforms that simultaneously drive ultrasonic and RF therapeutic and / or sub-therapeutic energy while maintaining ultrasonic frequency lock. In general, the output waveforms may be in the form of sine waves, cosine waves, pulse waves, square waves, etc. Nevertheless, more complex custom waveforms specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (e.g., EEPROM) of the surgical instrument and can be fetched upon connecting the surgical instrument to the generator circuit.An example of a custom waveform is an exponentially decaying sine waveform used in many high crest factor "coagulation" waveforms, as shown in FIG.
[0175] 15 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 according to at least one embodiment of the present disclosure of an analog waveform 4304 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison purposes). The horizontal axis represents time (t) and the vertical axis represents digital phase points. The digital electrical signal waveform 4300 is, for example, a digital discrete-time version of a desired analog waveform 4304. The digital electrical signal waveform 4300 is a digital discrete-time version of a desired analog waveform 4304 over one cycle or period T o T clock cycles clk The digital electrical signal waveform 4300 is generated by storing amplitude phase points 4302 representing the amplitude of each period T o The amplitude phase points are digital words stored in a memory circuit. In the embodiment shown in Figs. 13 and 14, the digital words are 6-bit words capable of storing the amplitude phase points with 26 or 64-bit resolution. It will be understood that the embodiment shown in Figs. 13 and 14 is for illustrative purposes only and that in an actual implementation the resolution may be much higher. One cycle T o The digital amplitude phase points 4302 spanning a period T are stored in memory as strings of string words in lookup tables 4104, 4210, for example, as described with respect to Figures 13 and 14. Also, as described with respect to Figures 13 and 14, to generate an analog version of the analog waveform 4304, the amplitude phase points 4302 are clk Every 0~T o are sequentially read out of memory and converted by DAC circuits 4108, 4212. Additional cycles are read out from 0 to T for as many cycles or periods as may be desired. o4222 (FIGS. 13 and 14)。 Analog waveform 4304 can be generated by repeatedly reading the amplitude phase points 4302 of the digital electrical signal waveform 4300. A smooth analog version of the analog waveform 4304 is achieved by filtering the output of the DAC circuits 4108, 4212 with filters 4112, 4214 (FIGS. 13 and 14). The filtered analog output signals 4114, 4222 (FIGS. 13 and 14) are applied to the input of the power amplifier.
[0176] 16 is a diagram of a control system 12950 that may be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) for continuously calculating an error value as the difference between a desired set point and a measured process variable, and applies corrections based on proportional, integral, and derivative terms (which may be denoted P, I, and D, respectively). The nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12956. The primary controller 12952 may be a PID controller 12972 as shown in FIG. 17, and the secondary controller 12955 may also be a PID controller 12972 as shown in FIG. 17. The primary controller 12952 controls a primary process 12958, and the secondary controller 12955 controls a secondary process 12960. The output 12966 of the primary process 12958 is subtracted from the primary setpoint SP1 by a first summer 12962. The first summer 12962 generates a single sum output signal that is applied to the primary controller 12952. The output of the primary controller 12952 is the secondary setpoint SP2. The output 12968 of the secondary process 12960 is subtracted from the secondary setpoint SP2 by a second summer 12964.
[0177] 17 illustrates a PID feedback control system 12970 according to one embodiment of the disclosure. The primary controller 12952 or the secondary controller 12955, or both, may be implemented as a PID controller 12972. In one embodiment, the PID controller 12972 may include a proportional element 12974 (P), an integral element 12976 (I), and a derivative element 12978 (D). The outputs of the P element 12974, the I element 12976, and the D element 12978 are summed by a summer 12986, which provides a control variable μ(t) to a process 12980. The output of the process 12980 is a process variable y(t). The summer 12984 calculates the difference between the desired set point r(t) and the measured process variable y(t). The PID controller 12972 continuously calculates an error value e(t) (e.g., the difference between the closing force threshold and the measured closing force) as the difference between a desired set point r(t) (e.g., the closing force threshold) and a measured process variable y(t) (e.g., the speed and direction of the closing tube) and applies a correction based on the proportional, integral, and derivative terms calculated by proportional element 12974 (P), integral element 12976 (I), and derivative element 12978 (D), respectively. The PID controller 12972 attempts to minimize the error e(t) over time by adjusting the control variables μ(t) (e.g., the speed and direction of the closing tube).
[0178] According to the PID algorithm, the "P" element 12974 corresponds to the current value of the error. For example, if the error is large and positive, the control output will also be large and positive. According to the present disclosure, the error term e(t) is the difference between the desired and measured closing force of the closing tube. The "I" element 12976 corresponds to the past value of the error. For example, if the current output is not strong enough, the integral of the error will accumulate over time and the controller will respond by applying stronger action. The "D" element 12978 corresponds to the possible future trend of the error based on its current rate of change. For example, going back to the P example above, if a large positive control output succeeds in bringing the error closer to zero, it also puts the process on a path that will lead to a large negative error in the near future. In this case, the derivative will become negative and the D module will reduce the strength of the action to prevent this overshoot.
[0179] It will be appreciated that other variables and set points may also be monitored and controlled in accordance with the feedback control systems 12950, 12970. For example, the adaptive closure member velocity control algorithm described herein may measure at least two of the following parameters, among others: firing member stroke position, firing member load, cutting element displacement, cutting element velocity, closure tube stroke position, closure tube load.
[0180] 18 is an alternative system 132000 for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system 132002, according to at least one embodiment of the present disclosure. The system 132000 may be incorporated into a generator. A processor 132004 coupled to a memory 132026 programs a programmable counter 132006 to control the output frequency f of the ultrasonic electromechanical system 132002. oThe input frequency is generated by a crystal oscillator 132008 and input to a fixed counter 132010 for scaling the frequency to a suitable value. The output 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 VCO which is applied to a voltage controlled oscillator 132016 (VCO). t The VCO 132016 provides an output frequency f to the ultrasonic transducer portion of the ultrasonic electromechanical system 132002, which is shown modeled here as an equivalent electrical circuit. o The voltage and current signals applied to the ultrasonic transducer are monitored by a voltage sensor 132018 and a current sensor 132020.
[0181] The outputs of the voltage sensor 132018 and the current sensor 13020 are applied to another phase / frequency detector 132022 to determine the phase angle between the voltage and current measured by the voltage sensor 132018 and the current sensor 13020. The output of the phase / frequency detector 132022 is applied to one channel of a high-speed analog-to-digital converter 132024 (ADC) and provided therethrough to the processor 132004. Optionally, to determine the phase angle between the voltage and current signals applied to the ultrasonic electromechanical system 132002, the outputs of the voltage sensor 132018 and the current sensor 132020 may be applied to respective channels of a two-channel ADC 132024 and provided to the processor 132004 for zero crossing, FFT, or other algorithms described herein.
[0182] Optionally, the output frequency f o Adjustment voltage V proportional to t may be fed back to the processor 132004 via the ADC 132024. This is oto the processor 132004 and uses this feedback to output a frequency f o can be adjusted and controlled.
[0183] Prediction of jaw condition (burnt pads, staples, broken blades, bone in jaw, tissue in jaw) A challenge with ultrasonic energy delivery is that ultrasonic sounds may be applied to the wrong material or the wrong tissue, which can result in device failure, for example, burning of clamp arm pads or breaking of the ultrasonic blade. It is also desirable to detect what is located in the jaws of an ultrasonic device's end effector and the condition of the jaws without adding additional sensors in the jaws. Positioning sensors in the jaws of an ultrasonic end effector poses reliability, cost, and complexity challenges.
[0184] The ultrasonic spectroscopy smart blade algorithm technique may include, in accordance with at least one embodiment of the present disclosure, detecting an impedance of an ultrasonic transducer configured to drive an ultrasonic transducer blade.
[0185]
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[0186] Dynamic Mechanical Analysis (DMA), also known as Dynamic Mechanical Spectroscopy or simply Mechanical Spectroscopy, is a technique used to study and characterize materials. Applying a sinusoidal stress to a material and measuring the strain in the material allows the complex modulus of the material to be determined. Spectroscopy as applied to ultrasonic devices involves exciting the tip of an ultrasonic blade with a sweep of frequencies (compound signal or conventional frequency sweep) and measuring the resulting complex impedance at each frequency. Complex impedance measurements of the ultrasonic transducer over a range of frequencies are used in a classifier or model to infer the properties of the ultrasonic end effector. In one aspect, the present disclosure provides techniques for determining the state of the ultrasonic end effector (clamp arm, jaws) to drive automation within the ultrasonic device (e.g., disabling power to protect the device, implementing adaptive algorithms, acquiring information, identifying tissue, etc.).
[0187] FIG. 19 is a spectrum 132030 of an ultrasonic device in various different states and situations of the end effector, in accordance with at least one embodiment of the present disclosure, and shows the impedance Z g (t), magnitude |Z|, and phase φ are plotted as functions of frequency f. The spectrum 132030 is plotted in three-dimensional space, where frequency (Hz) is plotted along the x-axis, phase (rad) is plotted along the y-axis, and magnitude (Ohms) is plotted along the z-axis.
[0188] Spectral analysis of different jaw occlusion and instrument conditions produces different complex impedance signature patterns (fingerprints) across a range of frequencies for different situations and conditions. Each situation or condition has a different signature pattern in 3D space when plotted. These signature patterns can be used to estimate the situation and condition of the end effector. FIG. 19 shows the spectra of air 132032, clamp arm pad 132034, chamfer 132036, staple 132038, and broken blade 132040. Chamfer 132036 may be used to characterize different types of tissue.
[0189] The spectrum 132030 can be evaluated by applying a low power electrical signal across the ultrasound transducer to produce a non-therapeutic excitation of the ultrasound blade. The low power electrical signal is impedance scaled across the ultrasound transducer at a range of frequencies in series (swept) or parallel (compound signal) using an FFT.
[0190]
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[0191] New ways to classify data For each characteristic pattern, a parametric line may be fitted to the data used for training using a polynomial, a Fourier series, or any other form of parametric equation, as may be conveniently determined. A new data point is received and classified by using the Euclidean perpendicular distance from the new data point to the trajectory fitted to the characteristic pattern training data. The perpendicular distance of the new data point to each trajectory (each trajectory representing a different state or condition) is used to assign the point to a state or condition.
[0192] 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 builds a two-dimensional probability distribution in the plane perpendicular to the fitted trajectory at each new data point of the fitted trajectory. New data points can then be included in the training set based on their probability of correct classification, creating an adaptive learning classifier that easily detects high frequency changes in conditions but adapts to slow deviations that occur in system performance, such as dirty equipment or worn out pads.
[0193] FIG. 20 is a graphical representation of a plot 132042 of a set of 3D training data sets (S) showing impedance Z of an ultrasound transducer according to at least one embodiment of the present disclosure. g (t), magnitude |Z|, and phase φ are plotted as a function of frequency f. The 3D training data set (S) plot 132042 is graphed in three dimensional space where phase (rad) is plotted along the x-axis, frequency (Hz) is plotted along the y-axis, and magnitude (ohms) is plotted along the z-axis, and a parametric Fourier series is fitted to the 3D training data set. A method for classifying the data is based on the 3D training data set (S0 is used to generate the plot 132042).
[0194] The parametric Fourier series that is fitted to the 3D training data set (S) is defined by:
[0195]
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[0196] What's new
[0197]
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[0198]
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[0199]
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[0200]
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[0201]
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[0202] Using the probability distribution of D, we can determine which data points belong to group S.
[0203]
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[0204] control Based on the classification of data measured before, during, or after activation of the ultrasonic transducer / blade, various automated tasks and safety measures can be implemented. Similarly, the condition of the tissue located in the end effector and the temperature of the ultrasonic blade can also be estimated to some extent and used to better inform the user of the condition of the ultrasonic device or to protect critical structures, etc. Ultrasonic blade temperature control is described in commonly owned U.S. Provisional Patent Application No. 62 / 640,417, filed March 8, 2018, entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," which is incorporated herein by reference in its entirety.
[0205] Similarly, power delivery can be reduced when the ultrasonic blade is likely to contact the clamp arm pad (e.g., no tissue between), or if the ultrasonic blade is likely to be broken or touching metal (e.g., staples). Additionally, backcutting can be disabled when the jaws are closed and no tissue is detected between the ultrasonic blade and the clamp arm pad.
[0206] Integrating other data to improve classification The system can use the data from this process in conjunction with other information provided by sensors, user and patient metrics, environmental factors, etc., by combining the aforementioned data using probability functions and a Kalman filter. The Kalman filter determines the maximum likelihood of the occurring state or situation, taking into account a variety of uncertain measurements of reliability. This method allows for the assignment of probabilities to newly classified data points, so that the information of this algorithm can be implemented with other measurements or estimates in the Kalman filter.
[0207] FIG. 21 is a logic flow diagram 132044 illustrating a control program or logic configuration for determining jaw conditions based on a complex impedance characteristic pattern (fingerprint) according to at least one embodiment of the present disclosure. Prior to determining jaw conditions based on a complex impedance characteristic pattern (fingerprint), a database is populated with reference complex impedance characteristic patterns or training data sets (S) characterizing various jaw conditions including, but not limited to, air 132032, clamp arm pads 132034, chamfer 132036, staples 132038, broken blades 132040, and various tissue types and conditions, as shown in FIG. 82. Chamfers, whether dry or wet, full bite or tip, may be used to characterize different types of tissue. The data points used to generate the reference complex impedance characteristic pattern or training data set (S) are obtained by applying a sub-therapeutic drive signal to an ultrasonic transducer, sweeping the drive frequency over a predetermined frequency range from below resonance to above resonance, measuring the complex impedance at each of the frequencies, and recording the data points. The data points are then fitted to a curve using various numerical methods including polynomial curve fitting, Fourier series, and / or parametric equations. A parametric Fourier series fitted to a reference complex impedance characteristic pattern or training data set (S) is described herein.
[0208] Once the reference complex impedance characteristic pattern or training data set (S) is generated, the ultrasonic instrument measures new data points, classifies these new data points, and determines whether the new data points should be added to the reference complex impedance characteristic pattern or training data set (S).
[0209] Referring now to the logic flow diagram of FIG. 21, in one embodiment, the control circuit measures the complex impedance of the ultrasonic transducer 132046, the complex impedance being:
[0210]
number
[0211] In one aspect, the control circuit receives the reference complex impedance characteristic pattern from a database or memory coupled to the processor. In one aspect, the control circuit generates the reference complex impedance characteristic pattern as follows: A drive circuit coupled to the control circuit applies a non-therapeutic drive signal to the ultrasound transducer at multiple frequencies, beginning with an initial frequency and ending with a final frequency, and in between. The control circuit measures the impedance of the ultrasound transducer at each frequency and stores a data point corresponding to each impedance measurement. The control circuit curve fits the multiple data points to generate a three-dimensional curve representing the reference complex impedance characteristic pattern, where magnitude |Z| and phase φ are plotted as a function of frequency f. The curve fit includes polynomial curve fit, Fourier series, and / or parametric equations.
[0212] In one aspect, the control circuit receives a new impedance measurement data point and classifies the new impedance measurement data point using a Euclidean perpendicular distance from the new impedance measurement data point to a locus fitted to a reference complex impedance characteristic pattern. The control circuit estimates a probability that the new impedance measurement data point will be correctly classified. The control circuit adds the new impedance measurement data point to the reference complex impedance characteristic pattern based on the estimated probability of correct classification of the new impedance measurement data point. In one aspect, the control circuit classifies the data based on a training data set (S), the training data set (S) comprising a plurality of complex impedance measurement data, a curve is fitted to the training data set (S) using a parametric Fourier series, S being defined herein, and a probability distribution is used to estimate the probability of the new impedance measurement data point belonging to group S.
[0213] Model-based Joe Classifier State There is an existing interest in classifying materials located within the jaws of an ultrasound device, including tissue types and conditions. In various embodiments, this classification can be shown to be possible using advanced data sampling and sophisticated pattern recognition. The approach is based on impedance as a function of frequency, where magnitude, phase, and frequency are plotted in 3D, and the pattern appears as a ribbon, as shown in Figures 19 and 20, and the logic flow diagram in Figure 21. The present disclosure provides an alternative smart blade algorithm approach based on a well-established model of the piezoelectric transducer.
[0214] As an example, the equivalent electrical lumped parameter model is known to be an accurate model of a physical piezoelectric transducer. It is based on a Mitta-Leffler expansion of the tangent near the mechanical resonance. When complex impedance or admittance is plotted as imaginary component versus real component, a circle is formed. FIG. 22 is a circle plot 132056 of complex impedance plotted as imaginary component versus real component of a piezoelectric transducer, according to at least one embodiment of the present disclosure. FIG. 23 is a circle plot 132058 of complex admittance plotted as imaginary component versus real component of a piezoelectric transducer, according to at least one embodiment of the present disclosure. The circles shown in FIGS. 22 and 23 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.
[0215] The circle is created as the frequency is swept from below resonance to above resonance. Rather than unfolding the circle in 3D, the circle is identified and the radius (r) and offsets (a, b) of the circle are estimated. These values are then compared to values established for given conditions. These conditions may be 1) open and nothing in the jaws, 2) tip occlusion, 3) full occlusion and staples in the jaws. If the sweep produces multiple resonances, there will be a circle of different characteristics for each resonance. Each circle will be drawn before moving on to the next if the resonance is isolated. Rather than fitting a 3D curve with a series of approximations, a circle is fitted to the data. The radius (r) and offsets (a, b) can be calculated using a processor programmed to implement various mathematical or numerical techniques described below. These values can be estimated by capturing an image of the circle and image processing techniques are used to estimate the radius (r) and offsets (a, b) that define the circle.
[0216] Figure 24 is a circle plot 132060 of the complex admittance of a 55.5 kHz ultrasonic piezoelectric transducer for lumped parameter inputs and outputs specified below. The values for the lumped parameter model were used to generate the complex admittance. The model was moderately loaded. The resulting admittance circle generated in MathCad is shown in Figure 24. The circle plot 132060 is formed as the frequency is swept from 54 to 58 kHz.
[0217] The lumped constant input values are as follows: Co=3.0nF Cs=8.22pF Ls=1.0H Rs=450Ω
[0218] The output of the model based on the input is:
[0219]
number
[0220] The output values are used to plot the circle plot 132060 shown in Figure 24. The circle plot 132060 has a radius (r) and a center 132062 that is offset (a, b) from the origin 132064. r=1.012 * 10 3 a=1.013 * 10 3 b=-954.585
[0221] The sums A-E specified below are necessary to estimate the example circle plot 132060 plot given in FIG. 24, according to at least one embodiment of the present disclosure. Several algorithms exist for computing the fit to a circle. A circle is defined by its radius (r) and the offset (a, b) of its center from the origin. r 2 =(xa) 2 +(yb) 2
[0222] The modified least squares method (Umbach and Jones) is convenient in that there exists a simple closed-form solution for a, b, and r.
[0223]
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[0224] The caret above the variable "a" indicates an estimate of the true value. A, B, C, D, and E are sums of various products calculated from the data. These are included here for completeness as follows:
[0225]
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[0226] The present disclosure works for ultrasonic systems and may be applicable to electrosurgical systems even though the electrosurgical systems do not rely on resonance.
[0227] 25-29 are images taken from an impedance analyzer showing impedance / admittance circle plots of an ultrasonic device with the end effector jaws in various open or closed configurations and loads. In accordance with at least one embodiment of the present disclosure, the solid circle plots show impedance and the dashed circle plots show admittance. By way of example, the impedance / admittance circle plots are generated by connecting an ultrasonic device to an impedance analyzer. The impedance analyzer display is set to complex impedance and complex admittance, which may be selectable from the impedance analyzer front panel. An initial display may be obtained when the ultrasonic end effector jaws are in the open position and the ultrasonic device is in an unloaded state, for example as described below in connection with FIG. 25. An autoscale display feature of the impedance analyzer may be used to generate both the complex impedance circle plot and the complex admittance circle plot. The same display is used for subsequent runs of the ultrasonic device at different load conditions, as shown in subsequent FIGS. 25-29. A LabVIEW application may be used to upload data files. In another technique, the display image may be captured with a camera, such as a smartphone camera, such as an iPhone or Android. The image on the display may therefore contain some "keystone distortion" and may not generally appear parallel to the screen. Using this technique, a circle plot trace on the display will appear distorted in the captured image. This approach allows for classification of materials located within the jaws of an ultrasonic end effector.
[0228] Complex impedance and complex admittance are exact reciprocals of each other. No new information should be added by looking at both. Another consideration includes determining how sensitive the estimate is to noise when using complex impedance or admittance.
[0229] In the example shown in Figures 25-29, the impedance analyzer is set in a range that only captures the dominant resonance. By scanning over a wider range of frequencies, more resonances can be encountered and multiple circle plots can be formed. The equivalent circuit of the ultrasonic transducer may be modeled by a first "motional" branch with series-connected inductance Ls, resistance Rs, and capacitance Cs, and a second capacitive branch with capacitance C0, which define the electrosurgical characteristics of the resonator. In the impedance / admittance plots shown in the following Figures 25-29, the component values of the equivalent circuit are as follows: Ls = L1 = 1.1068H Rs = R1 = 311.352 Ω Cs = C1 = 7.43265pF C0 = C0 = 3.64026 nF
[0230] The oscillator voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div. Measurements of values that may characterize the impedance (Z) and admittance (Y) circle plots may be taken at locations on the circle plot indicated by the impedance and admittance cursors.
[0231] Jaw status: Open with no load 25 is a graphical representation 132066 of an impedance analyzer showing complex impedance (Z) / admittance (Y) circle plots 132068, 132070 for an ultrasonic device with jaws released and no load, where the solid circle plot 132068 shows the complex impedance and the dashed circle plot 132070 shows the complex admittance, according to at least one embodiment of the present disclosure. The oscillator voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div. Measurements of values that may characterize the complex impedance (Z) and admittance (Y) circle plots 132068, 132070 may be taken at locations on the circle plots 132068, 132070 indicated by the impedance cursor 132072 and the admittance cursor 132074. Thus, the impedance cursor 132072 is located on a portion of the impedance circle plot 132068 equal to approximately 55.55 kHz, and the admittance cursor 132074 is located on a portion of the admittance circle plot 132070 equal to approximately 55.29 kHz. As shown in FIG. 25, the positions of the impedance cursor 132072 correspond to the following values: R=1.66026Ω X=-697.309Ω where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the position of the admittance cursor 132074 corresponds to the following values: G = 64.0322μS B=1.63007mS where G is the conductance (real value) and B is the susceptance (imaginary value).
[0232] Jaw condition: clamped on dry chamois 26 is a graphical representation 132076 of an impedance analyzer showing complex impedance (Z) / admittance (Y) circle plots 132078, 132080 of an ultrasonic device with the jaws of the end effector clamped on a dry chamois, with the impedance circle plot 132078 shown as a solid line and the admittance circle plot 132080 shown as a dashed line, in accordance with at least one embodiment of the present disclosure. 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.
[0233] Measurements of values that may characterize the complex impedance (Z) and admittance (Y) circle plots 132078, 132080 may be taken at locations on the circle plots 132078, 132080 indicated by the impedance cursor 132082 and the admittance cursor 132084. Thus, the impedance cursor 132082 is located on a portion of the impedance circle plot 132078 equal to approximately 55.68 kHz, and the admittance cursor 132084 is located on a portion of the admittance circle plot 132080 equal to approximately 55.29 kHz. As shown in FIG. 26, the positions of the impedance cursor 132082 correspond to the following values: R=434.577Ω X=-758.772Ω where R is the resistance (real value) and X is the reactance (imaginary value).
[0234] Similarly, the position of the admittance cursor 132084 corresponds to the following values: G = 85.1712μS B=1.49569mS where G is the conductance (real value) and B is the susceptance (imaginary value).
[0235] Jaw condition: Tips clamped onto damp chamois 27 is a graphical representation 132086 of an impedance analyzer showing complex impedance (Z) / admittance (Y) circle plots 132098, 132090 of an ultrasonic device with jaw tips clamped on a wet chamois, according to at least one embodiment of the present disclosure, where the impedance circle plot 132088 is shown in solid line and the admittance circle plot 132090 is shown in dashed line. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div.
[0236] Measurements of values that may characterize the complex impedance (Z) and complex admittance (Y) circle plots 132088, 132090 may be taken at locations on the circle plots 132088, 132090 indicated by the impedance cursor 132092 and the admittance cursor 132094. Thus, the impedance cursor 132092 is located on a portion of the impedance circle plot 132088 equal to approximately 55.68 kHz, and the admittance cursor 132094 is located on a portion of the admittance circle plot 132090 equal to approximately 55.29 kHz. As shown in FIG. 28, the impedance cursor 132092 corresponds to the following values: R=445.259Ω X=-750.082Ω where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the admittance cursor 132094 corresponds to the following values: G = 96.2179 μS B=1.50236mS where G is the conductance (real value) and B is the susceptance (imaginary value).
[0237] Jaw Condition: Fully clamped on damp chamois 28 is a graphical representation 132096 of an impedance analyzer showing complex impedance (Z) / admittance (Y) circle plots 132098, 132100 of an ultrasonic device with jaws fully clamped on a wet chamois, according to at least one embodiment of the present disclosure, where the impedance circle plot 132098 is shown as a solid line and the admittance circle plot 132100 is shown as a dashed line. The voltage applied to the ultrasonic transducer is 500 mV and the frequency is swept from 55 kHz to 56 kHz. The impedance (Z) scale is 200 Ω / div and the admittance (Y) scale is 500 μS / div.
[0238] Measurements of values that may characterize the impedance and admittance circle plots 132098, 132100 may be taken at locations on the circle plots 132098, 1332100 indicated by the impedance cursor 13212 and the admittance cursor 132104. Thus, the impedance cursor 132102 is located on a portion of the impedance circle plot 132098 equal to approximately 55.63 kHz, and the admittance cursor 132104 is located on a portion of the admittance circle plot 132100 equal to approximately 55.29 kHz. As shown in Figure 28, the impedance cursor 132102 corresponds to values of resistance R (real value, not shown) and reactance X (imaginary value, not shown).
[0239] Similarly, the admittance cursor 132104 corresponds to the following values: G = 137.272μS B=1.48481mS where G is the conductance (real value) and B is the susceptance (imaginary value).
[0240] Jaw status: Open with no load 29 is a graphical representation 132106 of an impedance analyzer showing impedance (Z) / admittance (Y) circle plots, according to at least one embodiment of the present disclosure, where the frequency is swept from 48 kHz to 62 kHz to capture multiple resonances of an unloaded ultrasonic device with jaws open, and the area designated by the dashed rectangle 132108 is for better viewing of the impedance circle plots 132110a, 132110b, 132110c, and the admittance circle plots 132112a, 132112b, 132112c, shown in solid lines. The voltage applied to the ultrasonic transducer is 500 mV, and the frequency is swept from 48 kHz to 62 kHz. The impedance (Z) scale is 500 Ω / div, and the admittance (Y) scale is 500 μS / div.
[0241] Measurements of values that may characterize the impedance and admittance circle plots 132110a-c, 132112a-c may be taken at locations on the impedance and admittance circle plots 132110a-c, 132112a-c indicated by the impedance cursor 132114 and the admittance cursor 132116. Thus, the impedance cursor 132114 is located on a portion of the impedance circle plots 132110a-c equal to approximately 55.52 kHz, and the admittance cursor 132116 is located on a portion of the admittance circle plots 132112a-c equal to approximately 59.55 kHz. As shown in FIG. 29, the impedance cursor 132114 corresponds to the following values: R=1.86163Ω X=-536.229Ω where R is the resistance (real value) and X is the reactance (imaginary value). Similarly, the admittance cursor 132116 corresponds to the following values: G = 649.956 μS B=2.51975mS where G is the conductance (real value) and B is the susceptance (imaginary value).
[0242] Since there are only 400 samples across the sweep range of the impedance analyzer, there are only a few points on the resonances, which makes the circle on the right hand side choppy, but this is only due to the impedance analyzer and the settings used to cover multiple resonances.
[0243] When multiple resonances are present, there is more information to improve the classifier. Fits of the circle plots 132110a-c, 132112a-c can be calculated for each one as they are encountered to keep the algorithm running fast. So, once there is a crossing of the complex admittances that represent the circles during the sweep, a fit can be calculated.
[0244] Benefits include an in-jaw classifier based on the data and on well-known models for ultrasound systems. Counting and characterizing circles in vision systems is well-known, so data processing is readily available. For example, closed-form solutions exist for calculating the radius and axial offsets for a circle. This technique can be relatively fast.
[0245] Table 2 lists the symbols used in the lumped parameter model of piezoelectric transducers (from the IEEE 177 standard).
[0246] [Table 2-1]
[0247] [Table 2-2]
[0248] Table 3 lists the symbols for transmission networks (from the IEEE 177 standard).
[0249] [Table 3] * Complex roots that refer to real solutions are ignored.
[0250] Table 4 lists the various characteristic frequency solutions (from the IEEE 177 standard).
[0251] [Table 4] * Refers to real solutions, ignores complex roots
[0252] Table 5 lists the losses for three types of piezoelectric materials.
[0253] [Table 5]
[0254] Table 6 shows the jaw conditions, estimated parameters of the circle based on the real-time measurements of complex impedance / admittance, the radius (rr) and offset (ar, br) of the reference circle represented by the reference variables Rref, Gref, Xref, Bref, as described in Figures 25-29, the 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 plot. These values are then compared to values established for the given conditions. These conditions may be 1) nothing in the jaws and open, 2) tip occlusion, 3) full occlusion and staple in the jaws. The equivalent circuit of the ultrasonic transducer was modeled as follows and the frequency was swept from 55 kHz to 56 kHz. Ls = L1 = 1.1068H Rs = R1 = 311.352 Ω Cs = C1 = 7.43265pF and C0 = C0 = 3.64026 nF
[0255] [Table 6]
[0256] In use, the ultrasonic generator sweeps the frequency and records the measured variables to determine estimated Re, Ge, Xe, Be. These estimates are then compared to reference variables Rref, Gref, Xref, Bref stored in memory (e.g., stored in a look-up table) to determine the jaw conditions. The reference jaw conditions shown in Table 6 are merely examples. Additional or fewer reference jaw conditions may be classified and stored in memory. These variables can be used to estimate the radius and offset of the impedance / admittance circle.
[0257] FIG. 30 is a logic flow diagram 132120 of a process illustrating a control program or logic configuration configured to determine jaw conditions based on a prediction of impedance / admittance circle radius (r) and offset (a, b), according to at least one embodiment of the present disclosure. Initially, a database or lookup table is populated with reference values based on reference jaw conditions, as described in connection with FIGS. 25-29 and Table 6. The reference jaw conditions are set and the frequency is swept from below resonance to above resonance. The reference values Rref, Gref, Xref, Bref that define the corresponding impedance / admittance circle plot are stored in the database or lookup table. In use, under the control of the control program or logic configuration, the generator or instrument's control circuitry causes the frequency to be swept from below resonance to above resonance 132122. The control circuit measures and records 132124 (e.g., stores in memory) the variables Re, Ge, Xe, Be that define the corresponding impedance / admittance circle plot and compares them to reference values Rref, Gref, Xref, Bref stored in a database or look-up table 132126. The control circuit determines, e.g., estimates, 132128 the jaw condition of the end effector based on the results of the comparison.
[0258] Smart Blades and Power Pulsing During surgery with an ultrasonic shearing device, the power delivered to the tissue is set at a predetermined level. This predetermined level is used to ablate the tissue throughout the ablation procedure. Certain tissues may seal better or cut better / quicker if the power delivered is varied throughout the ablation procedure. A solution is required to vary the power delivered to the tissue through the blade during the ablation process. In various aspects, the type of tissue and changes to the tissue during the ablation process may be determined using techniques described in Figures 19-21 entitled "ESTIMATING THE STATE OF THE JAW (PAD BURN THROUGH, STAPLES, BROKEN BLADE, BONE IN JAW, TISSUE IN JAW" and / or Figures 22-30 entitled "STATE OF JAW CLASSIFIER BASED ON MODEL" and / or techniques for estimating the temperature of the ultrasonic blade described in related U.S. Provisional Patent Application No. 62 / 640,417 by Nott et al. entitled "TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR," which is incorporated herein by reference in its entirety.
[0259] One solution to provide better ultrasonic ablation employs ultrasonic blade impedance feedback. As previously mentioned, the impedance of the ultrasonic blade is related to the impedance of the electromechanical ultrasonic system and can be determined by measuring the phase angle between the voltage and current signals applied to the ultrasonic transducer as described herein. This technique can be used to measure the magnitude and phase of the impedance of the ultrasonic transducer. The impedance of the ultrasonic transducer can be used to profile factors that may affect the ultrasonic blade during use (e.g., force, temperature, vibration, force over time, etc.). This information can be used to affect the power delivered to the ultrasonic blade during the ablation process.
[0260] FIG. 31 is a logic flow diagram 132170 of a process illustrating a control program or logic configuration for monitoring an ultrasonic transducer, profiling an ultrasonic blade, and delivering power to the ultrasonic blade on the profile, according to one embodiment of the disclosure. According to this process, the control circuit determines 132172 (e.g., measures) the impedance (Z) of the ultrasonic transducer during the tissue ablation process. Based on the determined 132172 impedance (Z), the control circuit analyzes and profiles 132174 the ultrasonic blade immediately after the tissue is fully clamped within the jaws of the end effector of the ultrasonic device. The control circuit adjusts 132176 the power output level based on the ultrasonic blade profile (e.g., high power for thick tissue, low power for thin tissue). The control circuit controls the generator to momentarily drive the ultrasonic transducer and ultrasonic blade and then stop. The control circuit again determines 132172 the impedance (Z) of the ultrasonic blade and profiles 132174 the ultrasonic blade based on the determined impedance (Z) 132172. The control circuit controls the generator to adjust or maintain the output power level based on the profile of the ultrasonic blade. The control circuit again controls the generator to momentarily activate the ultrasonic transducer and ultrasonic blade and then stop. This process is repeated to determine the impedance (Z) 132172, measure the ultrasonic blade profile 132174, adjust the power level 132176 until the detected impedance profile matches the impedance profile of the clamp arm pad, and adjust the output so that the clamp arm pad does not melt.
[0261] The process discussed in connection with FIG. 31 allows the power level of the ultrasonic transducer to be adjusted on the fly as the tissue changes from being heated and cut. Thus, if the tissue is initially hard and then becomes weak, or if different layers of tissue are encountered during the ablation process, the power level can be optimally adjusted to match the profile of the ultrasonic blade. This method can eliminate the need for the user to set the power level. The ultrasonic device adapts and selects the appropriate power level based on the current tissue condition and ablation process.
[0262] This technique provides intelligent control for power level setting based on tissue feedback. This technique can eliminate the need for generator power settings and result in faster ablation times. In one aspect, in an ultrasonic ablation medical device that includes a jaw with an ultrasonic blade, the impedance of the ultrasonically driven blade is used to profile the ultrasonic blade characteristics (force, heat, vibration, etc.) and the profile is used to affect the power output of the transducer during the ablation process. The power can be pulsed intermittently and adjusted during the ablation process so that changes in the tissue can be read for feedback between pulses.
[0263] 32A-32D are a series of graphical representations of ultrasonic transducer impedance for profiling an ultrasonic blade and delivering power to the ultrasonic blade based on the profile, according to at least one embodiment of the present disclosure. FIG. 32A is a graphical representation 132180 of ultrasonic transducer impedance versus time. The generator control circuit reads an initial impedance Z1 based on the jaw content and applies a pulsed power P1 to the ultrasonic transducer as shown in FIG. 32B, which is a graphical representation 132182 of pulsed power versus time. FIG. 32C is a graphical representation 132184 of new impedance Z2 versus time. The generator control circuit reads the new impedance Z2 and applies a pulsed power P2 to the ultrasonic transducer as plotted in FIG. 32D, which is a graphical representation 132186 of pulsed power P2.
[0264] While several embodiments have been illustrated and described, it is not the applicant's intention to restrict or limit the appended claims to such details. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these embodiments can be implemented and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described embodiments can be alternatively described as a means for providing the function performed by the element. Also, although materials are disclosed with respect to specific components, other materials may be used. It is therefore to be understood that the above description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.
[0265] The above detailed description has set forth various forms of apparatus and / or processes via block diagrams, flow charts, and / or examples. To the extent that such block diagrams, flow charts, and / or examples include one or more functions and / or operations, those skilled in the art will appreciate that each function and / or operation included in such block diagrams, flow charts, and / or examples can be implemented individually and / or collectively by various hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will understand that some aspects of the embodiments disclosed herein may be equivalently implemented in whole or in part 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 virtually any combination thereof, and that designing circuitry and / or writing software and / or firmware code is within the skill of those skilled in the art in light of this disclosure. Furthermore, those skilled in the art will understand that the subject mechanisms described herein may be distributed in a variety of forms as one or more program products, and that the illustrative embodiments of the subject matter described herein apply regardless of the particular type of signal-bearing medium used to actually effect the distribution.
[0266] The instructions used to program the logic to execute the various disclosed aspects may be stored in memory within the system, such as dynamic random access memory (DRAM), cache, flash memory, or other storage device. Additionally, the instructions may be distributed over a network or by other computer-readable media. Machine-readable media may thus include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including, but not limited to, floppy diskettes, optical disks, compact disks, read-only memories (CD-ROMs), as well as magneto-optical disks, read-only memories (ROMs), random access memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memories, or tangible machine-readable storage devices used to transmit information over the Internet via electrical, optical, acoustical, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Non-transitory computer-readable media may thus include any type of tangible machine-readable media suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
[0267] The term "control circuitry" as used in any aspect of the present specification can refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual 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), or a field programmable gate array (FPGA)), a state machine circuit, firmware that stores instructions executed by the programmable circuit, and any combination thereof. The control circuitry can be embodied collectively or individually as circuits that form part of a larger system, such as, for example, an integrated circuit (IC), an application-specific integrated circuit (ASIC), a system-on-a-chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, a "control circuit" includes, but is not limited to, an electrical circuit having at least one discrete electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application specific integrated circuit, an electrical circuit forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially executes the processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially executes the processes and / or devices described herein), an electrical circuit forming a memory device (e.g., a form of random access memory), and / or an electrical circuit forming a communication device (e.g., a modem, a communication switch, or an opto-electrical 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.
[0268] As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or instruction sets, and / or hard-coded (e.g., non-volatile) data in a memory device.
[0269] As used in any aspect of this specification, the terms "component," "system," "module," etc. may refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.
[0270] As used in any aspect of the present specification, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result, and the "steps" refer to the manipulation of physical quantities and / or logical states, which may, but need not, be in the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms can be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.
[0271] The network may include a packet-switched network. The communication devices may communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include an Ethernet communication protocol that may enable communication using Transmission Control Protocol / Internet Protocol (TCP / IP). The Ethernet protocol may conform to or be compatible with the Ethernet standard entitled "IEEE 802.3 Standard" published in December 2008 by the Institute of Electrical and Electronics Engineers (IEEE), and / or later versions of this standard. Alternatively or additionally, the communication devices may communicate with each other using an X.25 communication protocol. The X.25 communication protocol may conform to or be compatible with standards promulgated by the International Telecommunication Union-Telecommunication Standardization Sector (ITU-T). Alternatively or additionally, the communication devices may communicate with each other using a Frame Relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and / or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published in August 2001 by the ATM Forum entitled "ATM-MPLS Network Interworking 2.0" and / or later versions of this standard.Of course, different and / or later developed connection-oriented network communication protocols are equally contemplated herein.
[0272] Unless expressly specified otherwise, as will be apparent from the foregoing disclosure, discussions throughout the foregoing disclosure using terms such as "processing," "calculating," "computing," "determining," "displaying," and the like will be understood to refer to the operations and processing of a computer system or similar electronic computing device that manipulates and transforms data represented as physical (electronic) quantities in the computer system's registers and memory into other data similarly represented as physical quantities in the computer system's memory or registers or such information storage, transmission, or display devices.
[0273] One or more components may be referred to herein as being "configured to," "configurable to," "operable / operative to," "adapted / adaptable," "able to," "conformable / conformed to," etc. Those skilled in the art will understand that "configured to" may generally encompass active and / or inactive and / or standby components, unless the context requires otherwise.
[0274] The terms "proximal" and "distal" are used herein with reference to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further understood that for convenience and clarity, spatial terms such as "vertical," "horizontal," "upper," and "lower" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[0275] Those of skill in the art will understand that the terms used herein in general, and in the appended claims in particular (e.g., the body of the appended claims), are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including, but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "including, but not limited to," etc.). Moreover, those of skill in the art will understand that where a specific number is intended in an introduced claim recitation, such intention will be clearly recited in the claim, and in the absence of such recitation, no such intention exists. For example, as an aid to understanding, the appended claims below may include the introductory phrases "at least one" and "one or more" to introduce the claim recitation. However, the use of such phrases should not be construed as suggesting that when a claim statement is introduced by the indefinite article "a" or "an," any particular claim containing such an introduced claim statement is limited to claims containing only one such statement, even if the same claim contains an introductory phrase such as "one or more" or "at least one" and the indefinite article "a" or "an" (e.g., "a" and / or "an" should ordinarily be construed to mean "at least one" or "one or more"). The same applies when a definite article is used to introduce a claim statement.
[0276] Further, even when specific numbers are specified in an introduced claim recitation, those of skill in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., a recitation of simply "two items" without other qualifiers typically means at least two items, or two or more items). Furthermore, when a notation similar to "at least one of A, B, and C, etc." is used, such syntax is generally intended in the sense that a person of skill in the art would understand the notation (e.g., "a system having at least one of A, B, and C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). When a notation similar to "at least one of A, B, or C, etc." is used, such syntax is generally intended in the sense that one of ordinary skill in the art would understand the notation (e.g., "a system having at least one of A, B, or C" includes, but is not limited to, systems having only A, only B, only C, both A and B, both A and C, both B and C, and / or all of A, B, and C, etc.). Typically, one of ordinary skill in the art will further appreciate that any disjunctive word and / or phrase expressing two or more alternative terms, whether in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of those terms, either of those terms, or both of those terms, unless the context requires otherwise. For example, the phrase "A or B" will typically be understood to include the possibility of "A" or "B" or "A and B."
[0277] With respect to the appended claims, one of ordinary skill in the art will appreciate that the operations recited herein may generally be performed in any order. Also, while flow diagrams of various operations are shown in sequence(s), it should be understood that the various operations may be performed in orders other than those illustrated, or may be performed simultaneously. Examples of such alternative orderings may include overlapping, interleaving, interrupting, reordering, progressive, preliminary, supplementary, simultaneous, reverse, or other different orderings, unless the context requires otherwise. Moreover, terms such as "responsive to," "related to," or other past tense adjectives are generally not intended to exclude such variations, unless the context requires otherwise.
[0278] It is worth noting that any reference to "one embodiment," "an embodiment," "an example," "an example," or the like means that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment," "in an embodiment," "in an example," and "in one example" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
[0279] Any patent application, patent, non-patent publication, or other disclosure material referenced herein and / or listed in any Application Data Sheet is incorporated herein by reference to the extent that the incorporated material is not inconsistent with this specification. As such, and to the extent necessary, the disclosure material explicitly set forth in this specification shall take precedence over any conflicting statements incorporated herein by reference. Any content, or portions thereof, that conflicts with current definitions, opinions, or other disclosure material set forth herein shall be incorporated herein by reference, but only to the extent that no conflict arises between the reference material and the current disclosure material.
[0280] In summary, many benefits have been described that result from using the concepts described herein. The foregoing description of one or more embodiments has been presented for purposes of illustration and description. It is not intended to be exhaustive or to be limited to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The one or more embodiments have been selected and described in order to illustrate the principles and practical applications, thereby enabling those skilled in the art to utilize various embodiments, with various modifications, as suitable for the particular use contemplated. It is intended that the claims presented herewith define the overall scope.
[0281] Various aspects of the subject matter described herein are illustrated in the following numbered examples. Example 1. A method of controlling energy delivered to an ultrasound device, the ultrasound device comprising an electromechanical ultrasound system defined by a predetermined resonant frequency, the electromechanical ultrasound system comprising an ultrasound transducer coupled to an ultrasonic blade, the method comprising: determining, by a processor or control circuitry, an impedance of an ultrasonic transducer coupled to the ultrasonic blade during the ablation process; analyzing, by a processor or control circuit, the impedance of the ultrasonic transducer; profiling the ultrasonic blade based on the impedance of the ultrasonic transducer by a processor or control circuit; and adjusting, by a processor or control circuit, the power delivered to the ultrasonic transducer during the ablation process based on a profile of the ultrasonic blade.
[0282] Example 2. pulsing power delivered to the ultrasonic transducer by a processor or control circuit; determining, by a processor or control circuitry, a change in a tissue property of tissue located within the end effector, the change in tissue property being determined between pulses; The method of example 1, further comprising adjusting, by a processor or control circuit, the power delivered to the ultrasound transducer based on changes in tissue throughout the ablation.
[0283] Example 3. Determining, by a processor or control circuitry, a change in tissue property, measuring a complex impedance of the ultrasonic transducer by a processor or control circuit,
[0284]
number
[0285] Example 4. Receiving, by a processor or control circuitry, a complex impedance measurement data point may include receiving, by the processor or control circuitry, a complex impedance measurement data point corresponding to a clamp arm pad; and adjusting, by a processor or control circuit, the power delivered to the ultrasonic transducer to a power value that prevents the clamp arm pad from melting.
[0286] Example 5. Determining, by a processor or control circuitry, a change in tissue characteristic. applying a drive signal to the ultrasonic transducer by a drive circuit, the drive signal being a periodic signal defined by a magnitude and a frequency; sweeping, by a processor or control circuit, a frequency of the drive signal from below resonance to above resonance of the electromechanical ultrasonic system; The processor or control circuit determines the impedance / admittance circle variable R e , G e , X e , and B e Measuring and recording The processor or control circuit measures the impedance / admittance parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with 3. The method of claim 2, further comprising: determining, by a processor or control circuit, a state or status of the end effector based on the results of the comparative analysis.
[0287] Example 6. The method of one or more of Examples 2-5, wherein determining, by the processor or control circuitry, a change in tissue characteristic includes determining, by the processor or control circuitry, a change in tissue thickness.
[0288] Example 7. An ultrasonic surgical instrument comprising: an ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide; a generator configured to provide power to the ultrasonic transducer, the generator comprising: determining an impedance of an ultrasonic transducer coupled to the ultrasonic blade during the ablation process; Analyzing the impedance of an ultrasonic transducer; profiling the ultrasonic blade based on an impedance of the ultrasonic transducer; and adjusting power delivered to an ultrasonic transducer during a cutting process based on a profile of an ultrasonic blade.
[0289] Example 8. The generator comprises: pulsing the power delivered to the ultrasonic transducer; determining a change in a tissue property of tissue located within the end effector, the change in the tissue property being determined between pulses; The ultrasonic surgical instrument of Example 7, further comprising a control circuit configured to adjust power delivered to the ultrasonic transducer based on tissue changes throughout the resection.
[0290] Example 9. The generator comprises: Measuring the complex impedance of an ultrasonic transducer,
[0291]
number
[0292] Example 10. A generator receiving complex impedance measurement data points corresponding to clamp arm pads; The ultrasonic surgical instrument of Example 9, further comprising a control circuit configured to adjust the power delivered to the ultrasonic transducer to a power value that prevents the clamp arm pad from melting.
[0293] Example 11. The generator comprises: causing a drive circuit to apply a drive signal to an ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency; Sweeping the frequency of the drive signal from below to above resonance of the electromechanical ultrasonic system; Impedance / admittance circle variable R e , G e , X e , B e Measuring and recording Measured impedance / admittance circular parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with An ultrasonic surgical instrument as described in any one or more of Examples 8-10, further comprising a control circuit configured to determine a state or status of the end effector based on the results of the comparative analysis.
[0294] Example 12. An ultrasonic surgical instrument according to any one or more of Examples 8-11, wherein the generator comprises a control circuit further configured to determine a change in tissue thickness.
[0295] Example 13. A generator for an ultrasonic surgical instrument, the generator comprising: a control circuit, the control circuit comprising: determining an impedance of an ultrasonic transducer coupled to the ultrasonic blade during the ablation process; Analyzing the impedance of an ultrasonic transducer; profiling the ultrasonic blade based on an impedance of the ultrasonic transducer; and adjusting the power delivered to the ultrasonic transducer during the ablation process based on a profile of the ultrasonic blade.
[0296] Example 14. A control circuit comprising: pulsing the power delivered to the ultrasonic transducer; determining a change in a tissue property of tissue located within the end effector, the change in the tissue property being determined between pulses; The ultrasonic surgical instrument of Example 13, further configured to adjust the power delivered to the ultrasonic transducer based on tissue changes throughout the resection.
[0297] Example 15. A control circuit comprising: Measuring the complex impedance of an ultrasonic transducer,
[0298]
number
[0299] Example 16. A control circuit receives complex impedance measurement data points corresponding to clamp arm pads; The ultrasonic surgical instrument of Example 15, further configured to adjust the power delivered to the ultrasonic transducer to a power value that prevents the clamp arm pad from melting.
[0300] Example 17. A control circuit comprising: causing a drive circuit to apply a drive signal to an ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency; Sweeping the frequency of the drive signal from below to above resonance of the electromechanical ultrasonic system; Impedance / admittance circle variable R e , G e , X e , and B e Measuring and recording Measured impedance / admittance circular parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with The ultrasonic surgical instrument of any one or more of Examples 14-16, further configured to determine a state or status of the end effector based on the results of the comparative analysis.
[0301] Example 18. An ultrasonic surgical instrument according to any one or more of Examples 14-17, wherein the control circuitry is further configured to determine a change in tissue thickness.
[0302] Example 19. An ultrasonic surgical system comprising: a processor and a non-transitory memory, the non-transitory memory, when executed by the processor, causing the processor to: determining an impedance of an ultrasonic transducer coupled to the ultrasonic blade during the ablation process; Analyzing the impedance of an ultrasonic transducer; profiling the ultrasonic blade based on an impedance of the ultrasonic transducer; and adjusting power delivered to an ultrasonic transducer during a cutting process based on a profile of an ultrasonic blade.
[0303] Example 20. The non-transitory memory, when executed by the processor, further causes the processor to: pulsing the power delivered to the ultrasonic transducer; determining a change in a tissue property of tissue located within the end effector, the change in the tissue property being determined between pulses; The ultrasonic surgical system of Example 19, further comprising instructions for adjusting the power delivered to the ultrasonic transducer based on tissue changes throughout the resection.
[0304] [Embodiment] (1) A method of controlling energy delivered to an ultrasound device, the ultrasound device including an electromechanical ultrasound system defined by a predetermined resonant frequency, the electromechanical ultrasound system including an ultrasound transducer coupled to an ultrasonic blade, the method comprising: determining, by a processor or control circuitry, an impedance of the ultrasonic transducer coupled to the ultrasonic blade during an ablation process; analyzing, by the processor or the control circuitry, the impedance of the ultrasonic transducer; profiling, by the processor or the control circuitry, the ultrasonic blade based on the impedance of the ultrasonic transducer; and adjusting, by the processor or control circuitry, power delivered to the ultrasonic transducer during the ablation process based on the profile of the ultrasonic blade. (2) pulsing the power delivered to the ultrasonic transducer by the processor or the control circuitry; and determining, by the processor or the control circuitry, a change in a tissue property of tissue located within the end effector, the change in tissue property being determined between pulses; 2. The method of claim 1, further comprising adjusting, by the processor or control circuitry, power delivered to the ultrasound transducer based on the tissue changes across the ablation. (3) determining, by the processor or the control circuitry, a change in tissue characteristic; measuring a complex impedance of the ultrasonic transducer by the processor or the control circuit, the complex impedance being
[0305]
number
[0306] (6) The method of embodiment 2, wherein determining a change in tissue characteristic by the processor or control circuitry includes determining a change in tissue thickness by the processor or control circuitry. (7) An ultrasonic surgical instrument, comprising: an ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide; a generator configured to provide power to the ultrasonic transducer, the generator comprising: determining an impedance of the ultrasonic transducer coupled to the ultrasonic blade during an ablation process; Analyzing the impedance of the ultrasonic transducer; profiling the ultrasonic blade based on the impedance of the ultrasonic transducer; and adjusting power delivered to the ultrasonic transducer during the cutting process based on the profile of the ultrasonic blade. (8) The generator comprises: pulsing the power delivered to the ultrasonic transducer; determining a change in a tissue property of tissue located within the end effector, the change in tissue property being determined between pulses; 8. The ultrasonic surgical instrument of claim 7, further comprising a control circuit configured to: adjust power delivered to the ultrasonic transducer based on the tissue changes throughout the resection. (9) The generator comprises: Measuring a complex impedance of the ultrasonic transducer, the complex impedance being
[0307]
number
[0308] (11) The generator, causing a drive circuit to apply a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency; Sweeping the frequency of the drive signal from below to above resonance of the electromechanical ultrasonic system; Impedance / admittance circle variable R e , G e , X e , and B e Measuring and recording Measured impedance / admittance circular parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with 9. The ultrasonic surgical instrument of claim 8, further comprising a control circuit configured to: determine a state or status of the end effector based on the results of the comparative analysis. (12) The ultrasonic surgical instrument of claim 8, wherein the generator includes a control circuit further configured to determine a change in tissue thickness. (13) A generator for an ultrasonic surgical instrument, said generator comprising: a control circuit, the control circuit comprising: determining an impedance of an ultrasonic transducer coupled to the ultrasonic blade during the ablation process; Analyzing the impedance of the ultrasonic transducer; profiling the ultrasonic blade based on the impedance of the ultrasonic transducer; and adjusting power delivered to the ultrasonic transducer during the ablation process based on the profile of the ultrasonic blade. (14) The control circuit pulsing the power delivered to the ultrasonic transducer; determining a change in a tissue property of tissue located within the end effector, the change in tissue property being determined between pulses; 14. The generator of claim 13, further configured to adjust power delivered to the ultrasound transducer based on the tissue changes across the ablation. (15) The control circuit Measuring a complex impedance of the ultrasonic transducer, the complex impedance being
[0309]
number
[0310] (16) The control circuit receiving a complex impedance measurement data point corresponding to a clamp arm pad; 16. The generator of claim 15, further configured to adjust the power delivered to the ultrasonic transducer to a power value that prevents the clamp arm pad from melting. (17) The control circuit causing a drive circuit to apply a drive signal to the ultrasonic transducer, the drive signal being a periodic signal defined by a magnitude and a frequency; Sweeping the frequency of the drive signal from below to above resonance of the electromechanical ultrasonic system; Impedance / admittance circle variable R e , G e , X e , and B e Measuring and recording Measured impedance / admittance circular parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with 15. The generator of claim 14, further configured to determine a state or status of the end effector based on the results of the comparative analysis. (18) The generator of claim 14, wherein the control circuitry is further configured to determine a change in tissue thickness. (19) An ultrasonic surgical system, comprising: a processor; and a non-transitory memory, the non-transitory memory, when executed by the processor, causing the processor to: determining an impedance of an ultrasonic transducer coupled to the ultrasonic blade during the ablation process; Analyzing the impedance of the ultrasonic transducer; profiling the ultrasonic blade based on the impedance of the ultrasonic transducer; and adjusting power delivered to the ultrasonic transducer during the cutting process based on the profile of the ultrasonic blade. (20) The non-transitory memory, when executed by the processor, further causes the processor to: pulsing the power delivered to the ultrasonic transducer; determining a change in a tissue property of tissue located within the end effector, the change in tissue property being determined between pulses; 20. The ultrasonic surgical system of claim 19, further comprising instructions to adjust power delivered to the ultrasonic transducer based on the tissue changes throughout the ablation.
Claims
1. 1. A method for determining a clamping state of an end effector in a system having an electromechanical ultrasonic system defined by a predetermined resonant frequency, the electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade, the method comprising: a processor or control circuit determining an impedance of the ultrasonic transducer coupled to the ultrasonic blade during an ablation process; and determining a clamping state of the end effector based on an impedance of the ultrasonic transducer, the processor or the control circuitry determining a clamping state of the end effector based on an impedance of the ultrasonic transducer; Determining a clamping state of the end effector, Applying a periodic drive signal to the ultrasonic transducer by a drive circuit; determining an impedance of the ultrasonic transducer while the processor or control circuit sweeps a frequency of the drive signal from below to above a resonant frequency of the electromechanical ultrasonic system; The processor or the control circuit calculates an impedance / admittance circle parameter R based on the impedance of the ultrasonic transducer. e , G e , X e , and B e and determining The processor or the control circuitry determines the impedance / admittance circle parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with and determining a clamping status of the end effector based on a result of the comparison, The impedance circle variables Re and Xe are the real and imaginary components of the impedance of the ultrasonic transducer, respectively, and the admittance circle variables Ge and Be are the real and imaginary components of the admittance of the ultrasonic transducer, respectively.
2. 1. An ultrasonic surgical instrument comprising: an electromechanical ultrasonic system including an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide; a generator configured to provide power to the ultrasonic transducer, the generator comprising: applying a periodic drive signal to the ultrasonic transducer by a drive circuit during an ablation process; determining an impedance of the ultrasonic transducer while sweeping a frequency of the drive signal from below to above a resonant frequency of an electromechanical ultrasonic system; Based on the impedance of the ultrasonic transducer, an impedance / admittance circle parameter R e , G e , X e , and B e and determining The impedance / admittance circle parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with and determining a clamping state of the end effector based on a result of the comparison; The impedance circle variables Re and Xe are the real and imaginary components of the impedance of the ultrasonic transducer, respectively, and the admittance circle variables Ge and Be are the real and imaginary components of the admittance of the ultrasonic transducer, respectively.
3. 1. A generator for an ultrasonic surgical instrument, said generator comprising: a control circuit, the control circuit comprising: causing a drive circuit to apply a drive signal to an ultrasonic transducer during an ablation process, the drive signal being a periodic signal; determining an impedance of the ultrasonic transducer while sweeping a frequency of the drive signal from below to above a resonant frequency of an electromechanical ultrasonic system; Based on the impedance of the ultrasonic transducer, an impedance / admittance circle parameter R e , G e , X e , and B e and determining The impedance / admittance circle parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with determining a clamping state of the end effector based on a result of the comparison; and The device is configured to: The impedance circle variables Re and Xe are the real and imaginary components of the impedance of the ultrasonic transducer, respectively, and the admittance circle variables Ge and Be are the real and imaginary components of the admittance of the ultrasonic transducer, respectively.
4. 1. An ultrasonic surgical system comprising: a processor; and a non-transitory memory, the non-transitory memory, when executed by the processor, causing the processor to: causing a drive circuit to apply a drive signal to an ultrasonic transducer during an ablation process, the drive signal being a periodic signal; determining an impedance of the ultrasonic transducer while sweeping a frequency of the drive signal from below to above a resonant frequency of an electromechanical ultrasonic system; Based on the impedance of the ultrasonic transducer, an impedance / admittance circle parameter R e , G e , X e , and B e and determining The impedance / admittance circle parameter R e , G e , X e , and B e , the reference impedance / admittance circle variable R ref , G ref , X ref , and B ref Compare with determining a clamping status of the end effector based on a result of the comparison; An ultrasonic surgical system, wherein the impedance circle variables Re and Xe are the real and imaginary components of the impedance of the ultrasonic transducer, respectively, and the admittance circle variables Ge and Be are the real and imaginary components of the admittance of the ultrasonic transducer, respectively.