Temperature control of ultrasonic end effector and control system therefor
By using control circuits to determine the resonant frequency and infer the temperature in an ultrasonic surgical device, and optimizing the energy mode in combination with a modular surgical hub, the problems of resonant frequency locking and noise interference are solved, and the automatic adjustment ability of temperature control and energy mode is improved.
Patent Information
- Application Number
- CN201910802581.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2018-08-28
- Filing Date
- 2019-08-28
- Publication Date
- 2025-01-17
- Estimated Expiration
- 2039-08-28
AI Technical Summary
The existing ultrasonic and electrosurgical devices have difficulty in locking resonant frequency during operation, asymmetric harmonic distortion leads to complex impedance magnitude and phase measurement, and electromagnetic interference in noise environment affects resonant frequency locking, resulting in reduced control accuracy. question.
By using a control circuit coupled to the memory in an ultrasonic surgical device, the actual resonance frequency of the ultrasonic electromechanical system is determined and compared with the reference resonance frequency to infer the temperature of the ultrasonic knife; at the same time, it is implemented using a modular surgical hub and a communication bus Interactive communication in multi-energy modes, optimizing energy modes and operating parameters of ultrasonic and electrosurgical devices.
The temperature control accuracy of the ultrasonic knife and the automatic adjustment ability of the energy mode are improved, the stability and control accuracy of the device in the noise environment are enhanced, and the input of the invalid control algorithm is reduced.
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Figure CN110859658B_ABST
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This patent application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 721,995, filed on August 23, 2018, entitled “CONTROLLING AN ULTRASONIC SURGICALINSTRUMENT ACCORDING TO TISSUE LOCATION,” the disclosure of which is incorporated herein by reference in its entirety.
[0003] This patent application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application No. 62 / 721,998, filed on August 23, 2018, entitled “SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS,” which is incorporated herein by reference in its entirety.
[0004] This patent application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 721,999, filed on August 23, 2018, entitled “INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING,” the disclosure of which is incorporated herein by reference in its entirety.
[0005] This patent application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 721,994, filed on August 23, 2018, entitled “BIPOLAR COMBINATION DEVICETHAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY,” the disclosure of which is incorporated herein by reference in its entirety.
[0006] This patent application claims priority under 35 U.S.C. 119(e) to U.S. Provisional Patent Application No. 62 / 721,996, filed on August 23, 2018, entitled “RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS,” the disclosure of which is incorporated herein by reference in its entirety.
[0007] This patent application also claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 62 / 692,747, filed on June 30, 2018, entitled “SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE,” U.S. Provisional Patent Application No. 62 / 692,748, filed on June 30, 2018, entitled “SMART ENERGY ARCHITECTURE,” and U.S. Provisional Patent Application No. 62 / 692,768, filed on June 30, 2018, entitled “SMART ENERGY DEVICES,” the disclosure of each of which is incorporated herein by reference in its entirety.
[0008] This patent application also claims the benefit of priority, pursuant to 35 U.S.C. § 119(e), to U.S. Provisional Patent Application Serial No. 62 / 640,417, filed on March 8, 2018, entitled “TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,” and to U.S. Provisional Patent Application Serial No. 62 / 640,415, filed on March 8, 2018, entitled “ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,” the disclosure of each of which is incorporated herein by reference in its entirety.
[0009] This patent application also claims, pursuant to 35 U.S.C. § 119(e), U.S. Provisional Patent Application No. 62 / 650,898, filed on March 20, 2018, entitled “CAPACITIVE COUPLED RETURNPATH PAD WITH SEPARABLE ARRAY ELEMENTS,” U.S. Provisional Patent Application No. 62 / 650,887, filed on March 30, 2018, entitled “SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES,” and U.S. Provisional Patent Application No. 62 / 650,887, filed on March 30, 2018, entitled “SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM,” and U.S. Provisional Patent Application No. 62 / 650,888, filed on March 30, 2018, entitled “SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM,” and U.S. Provisional Patent Application No. 62 / 650,887, filed on March 30, 2018, entitled “SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES,” and U.S. Provisional Patent Application No. 62 / 650,887 ...SURGICAL No. 62 / 650,882, filed on March 30, 2018, entitled “SURGICAL SMOKE EVACUATION SENSING AND CONTROLS,” and the disclosure of each of these provisional patent applications is incorporated herein by reference in its entirety.
[0010] This patent application also claims the benefit of priority, pursuant to 35 U.S.C. 119(e), to U.S. Provisional Patent Application Serial No. 62 / 611,341, filed on December 28, 2017, entitled “INTERACTIVE SURGICAL PLATFORM,” U.S. Provisional Patent Application Serial No. 62 / 611,340, filed on December 28, 2017, entitled “CLOUD-BASEDMEDICAL ANALYTICS,” and U.S. Provisional Patent Application Serial No. 62 / 611,339, filed on December 28, 2017, entitled “ROBOT ASSISTED SURGICAL PLATFORM,” the disclosure of each of which is incorporated herein by reference in its entirety. Background Art
[0011] In a surgical environment, smart energy devices may be needed in a smart energy architecture environment. Ultrasonic surgical devices, such as ultrasonic scalpels, are used in a variety of applications in surgical procedures due to their unique performance characteristics. Depending on the specific device configuration and operating parameters, the ultrasonic surgical device can substantially provide tissue transection and hemostasis by coagulation at the same time, thereby advantageously minimizing patient trauma. The ultrasonic surgical device may include a handpiece including an ultrasonic transducer, and an instrument coupled to the ultrasonic transducer, the ultrasonic transducer having an end effector (e.g., a knife tip) mounted at the distal end to cut and seal tissue. In some cases, the instrument may be permanently attached to the handpiece. In other cases, the instrument may be detachable from the handpiece, such as in the case of a disposable instrument or an interchangeable instrument. The end effector emits ultrasonic energy to the tissue in contact with the end effector to achieve cutting and sealing actions. Ultrasonic surgical devices with this property can be configured for open surgical use, laparoscopic or endoscopic surgical procedures, including robot-assisted procedures.
[0012] Ultrasonic energy uses a lower temperature than that used in electrosurgical procedures to cut and coagulate tissue, and can be transmitted to the end effector by an ultrasonic generator connected to the handpiece. Under high-frequency vibration (e.g., 55,500 cycles per second), the ultrasonic knife denatures the protein in the tissue to form a viscous coagulant. The pressure exerted by the surface of the knife on the tissue collapses the blood vessels and forms a hemostatic seal with the coagulant. The surgeon can control the cutting speed and coagulation by the force applied to the tissue by the end effector, the time of applying the force, and the selected offset level of the end effector.
[0013] The ultrasonic transducer can be modeled as an equivalent circuit including a first branch having a static capacitance and a second "dynamic" branch having an inductance, a resistance and a capacitance connected in series, which define the electromechanical characteristics of the resonator. A known ultrasonic generator may include a tuning inductor for detuning the static capacitance at the resonant frequency so that substantially all of the drive signal current of the generator flows into the dynamic branch. Thus, by using the tuning inductor, the drive signal current of the generator represents the dynamic branch current, and the generator is thus able to control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance diagram of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the specific static capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.
[0014] Additionally, in some ultrasonic generator architectures, the generator's drive signal exhibits asymmetric harmonic distortion, which complicates impedance magnitude and phase measurements. For example, the accuracy of impedance phase measurements can be reduced due to harmonic distortion in current and voltage signals.
[0015] Additionally, electromagnetic interference in noisy environments can degrade the generator's ability to maintain lock to the resonant frequency of the ultrasonic transducer, increasing the likelihood of invalid control algorithm inputs.
[0016] Electrosurgical devices for applying electrical energy to tissue to treat and / or destroy tissue are also increasingly used in surgical procedures. Electrosurgical devices include a handpiece and an instrument having a distally mounted end effector (e.g., one or more electrodes). The end effector can be positioned against the tissue so that current is introduced into the tissue. The electrosurgical device can be configured to be used for bipolar or monopolar operation. During bipolar operation, current is introduced into the tissue and returned from the tissue through the active electrode and return electrode of the end effector, respectively. During monopolar operation, current is introduced into the tissue through the active electrode of the end effector and returned through a return electrode (e.g., a ground pad) positioned separately on the patient's body. The heat generated by the current flowing through the tissue can form a hemostatic seal within the tissue and / or between the tissues, and can therefore be particularly suitable for, for example, sealing blood vessels. The end effector of the electrosurgical device can also include a cutting member movable relative to the tissue and an electrode for transecting the tissue.
[0017] 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 300kHz to 1MHz, as described in EN60601-2-2:2009+A11:2011, definition 201.3.218-high frequency. For example, the frequency in monopolar RF applications is typically limited to less than 5MHz. However, in bipolar RF applications, the frequency can be almost any value. Monopolar applications typically use frequencies above 200kHz in order to avoid unwanted stimulation of nerves and muscles due to the use of low-frequency currents. If a risk analysis shows that the potential for neuromuscular stimulation has been mitigated to an acceptable level, lower frequencies may be used with bipolar techniques. Typically, frequencies above 5MHz are not used to minimize problems associated with high-frequency leakage currents. It is generally believed that 10mA is the lower threshold for tissue thermal effects.
[0018] During its operation, an electrosurgical device may transmit low frequency RF energy through tissue, which may cause ion oscillation or friction and actually cause resistive heating, thereby raising the temperature of the tissue. Since a sharp boundary may be formed between the affected tissue and the surrounding tissue, the surgeon is able to operate with a high level of precision and control without damaging adjacent non-target tissue. The low operating temperature of RF energy may be useful for removing, shrinking, or shaping soft tissue while sealing blood vessels. RF energy may be particularly well suited for connective tissue, which is primarily composed of collagen and shrinks when exposed to heat.
[0019] Ultrasonic and electrosurgical devices typically require different generators due to their unique drive signal, sensing, and feedback requirements. In addition, in situations where the instruments are disposable or interchangeable with handpieces, the ability of ultrasonic and electrosurgical generators to identify the specific instrument configuration used and optimize control and diagnostic processes accordingly is limited. Furthermore, capacitive coupling between the non-isolated circuitry of the generator and the patient-isolated circuitry, especially when higher voltages and frequencies are used, can result in patient exposure to unacceptable levels of leakage current.
[0020] In addition, due to their unique drive signals, sensing and feedback requirements, ultrasonic and electrosurgical devices generally require different user interfaces for different generators. In such conventional ultrasonic and electrosurgical devices, one user interface is configured to be usable with an ultrasonic device, while another user interface may be configured to be usable with an electrosurgical instrument. Such user interfaces include hand and / or foot activated user interfaces, such as a hand activated switch and / or a foot activated switch. As various aspects of a combined generator for use with an ultrasonic surgical instrument and an electrosurgical instrument are contemplated in the subsequent disclosure, additional user interfaces configured to be operable with an ultrasonic and / or electrosurgical instrument generator are also contemplated.
[0021] Additional user interfaces for providing feedback to a user or other machine are contemplated in subsequent disclosures to provide feedback indicating the operating mode or state of the ultrasonic and / or electrosurgical instrument. Providing combined user and / or machine feedback for operating an ultrasonic and / or electrosurgical instrument will require providing sensory feedback to the user and electrical / mechanical / electromechanical feedback to the machine. Feedback devices incorporating visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., tactile actuators) for combined ultrasonic and / or electrosurgical instruments are contemplated in subsequent disclosures.
[0022] Other electrosurgical instruments include, but are not limited to, irreversible and / or reversible electroporation, and / or microwave technology, etc. Thus, the technology disclosed herein may be applicable to ultrasonic, bipolar or monopolar RF (electrosurgery), irreversible and / or reversible electroporation, and / or microwave-based surgical instruments, etc. Summary of the invention
[0023] In one aspect, a method for determining the temperature of an ultrasonic blade is provided. The method includes: determining, by a control circuit coupled to a memory, an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade through an ultrasonic waveguide, wherein the actual resonant frequency is related to the actual temperature of the ultrasonic blade; retrieving, by the control circuit, a reference resonant frequency of the ultrasonic electromechanical system from the memory, wherein the reference resonant frequency is related to a reference temperature of the ultrasonic blade; and inferring, by the control circuit, the temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
[0024] In another aspect, a generator for determining the temperature of an ultrasonic blade is provided. The generator includes a control circuit coupled to a memory, the control circuit being configured to: determine an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade through an ultrasonic waveguide, wherein the actual resonant frequency is related to the actual temperature of the ultrasonic blade; retrieve a reference resonant frequency of the ultrasonic electromechanical system from the memory, wherein the reference resonant frequency is related to a reference temperature of the ultrasonic blade; and infer the temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
[0025] In another aspect, an ultrasonic device for determining the temperature of an ultrasonic blade is provided. The ultrasonic device includes a control circuit coupled to a memory, the control circuit being configured to: determine an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade through an ultrasonic waveguide, wherein the actual resonant frequency is related to the actual temperature of the ultrasonic blade; retrieve a reference resonant frequency of the ultrasonic electromechanical system from the memory, wherein the reference resonant frequency is related to a reference temperature of the ultrasonic blade; and infer the temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency. BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The features of the various aspects are particularly described in the appended claims. However, the various aspects (relating to surgical organizations and methods) and further objects and advantages thereof may best be understood by reference to the following description taken in conjunction with the following drawings.
[0027] Figure 1 is a block diagram of a computer-implemented interactive surgical system according to at least one aspect of the present disclosure.
[0028] Figure 2A surgical system for performing surgical procedures in an operating room according to at least one aspect of the present disclosure.
[0029] Figure 3 A surgical hub is paired with a visualization system, a robotic system, and a smart instrument according to at least one aspect of the present disclosure.
[0030] Figure 4 A partial perspective view of a surgical hub housing and a combination generator module slidably received in a drawer of the surgical hub housing according to at least one aspect of the present disclosure.
[0031] Figure 5 is a perspective view of a combination generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation device according to at least one aspect of the present disclosure.
[0032] Figure 6 A single power bus attachment for multiple lateral docking ports of a lateral modular housing configured to accommodate multiple modules is shown in accordance with at least one aspect of the present disclosure.
[0033] Figure 7 A vertical modular housing configured to accommodate a plurality of modules according to at least one aspect of the present disclosure is shown.
[0034] Figure 8 A surgical data network including a modular communication hub configured to enable connecting modular devices located in one or more operating rooms of a medical facility or any room in a medical facility dedicated to surgical procedures to a cloud is shown in accordance with at least one aspect of the present disclosure.
[0035] Fig. 9 A computer-implemented interactive surgical system according to at least one aspect of the present disclosure.
[0036] Fig.10 A surgical hub comprising multiple modules coupled to a modular control tower is shown in accordance with at least one aspect of the present disclosure.
[0037] Fig.11 An aspect of a universal serial bus (USB) hub device in accordance with at least one aspect of the present disclosure is shown.
[0038] Fig.12 A logic diagram of a control system for a surgical instrument or tool according to at least one aspect of the present disclosure is shown.
[0039] Fig.13 Control circuitry configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure is shown.
[0040] Fig.14 Combinatorial logic circuits configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure are shown.
[0041] Fig.15 A sequential logic circuit configured to control various aspects of a surgical instrument or tool according to at least one aspect of the present disclosure is shown.
[0042] Fig.16 A surgical instrument or tool including multiple motors that can be activated to perform various functions in accordance with at least one aspect of the present disclosure is shown.
[0043] Fig.17 is a schematic diagram of a robotic surgical instrument configured to operate the surgical tools described herein according to at least one aspect of the present disclosure.
[0044] Fig.18 A block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure is shown.
[0045] Fig.19 is a schematic diagram of a surgical instrument configured to control various functions according to at least one aspect of the present disclosure.
[0046] Fig. 20 A system according to at least one aspect of the present disclosure is configured to be capable of executing an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub.
[0047] Fig.21 An example of a generator according to at least one aspect of the present disclosure is shown.
[0048] Fig. 22 A surgical system according to at least one aspect of the present disclosure includes a generator and various surgical instruments that can be used therewith.
[0049] Fig.23 An end actuator according to at least one aspect of the present disclosure.
[0050] Fig.24 According to at least one aspect of the present disclosure Fig. 22 Illustration of the surgical system.
[0051] Fig.25 A model showing dynamic branch current according to at least one aspect of the present disclosure is provided.
[0052] Fig.26 is a structural diagram of a generator architecture according to at least one aspect of the present disclosure.
[0053] Figures 27A-27C A functional view of a generator architecture according to at least one aspect of the present disclosure.
[0054] Figures 28A-28B Structural and functional aspects of a generator according to at least one aspect of the present disclosure.
[0055] Fig.29 A schematic diagram of an aspect of an ultrasonic drive circuit
[0056] Fig.30 According to at least one aspect of the present disclosure, coupled to Fig.29 Schematic diagram of the transformer of the ultrasonic drive circuit shown in .
[0057] Fig.31 A device coupled to a test circuit according to at least one aspect of the present disclosure Fig.30 Schematic diagram of the transformer shown in .
[0058] Fig.32 is a schematic diagram of a control circuit according to at least one aspect of the present disclosure.
[0059] Fig.33 A simplified circuit block diagram is shown illustrating another circuit included within a modular ultrasonic surgical instrument in accordance with at least one aspect of the present disclosure.
[0060] Fig.34 A generator circuit divided into a plurality of stages according to at least one aspect of the present disclosure is shown.
[0061] Fig.35 A generator circuit divided into a plurality of stages according to at least one aspect of the present disclosure is shown, wherein a first stage circuit is common to a second stage circuit.
[0062] Fig.36 A schematic diagram of one aspect of a driving circuit configured to drive a high frequency current (RF) according to at least one aspect of the present disclosure.
[0063] Fig.37 According to at least one aspect of the present disclosure, coupled to Fig.34 Schematic diagram of the transformer of the RF drive circuit shown in FIG.
[0064] Fig.38 is a schematic diagram of a circuit including independent power sources for high power energy / driver circuits and low power circuits according to one aspect of the present disclosure.
[0065] Fig.39 Control circuitry is shown that allows a dual generator system to switch between RF generator and ultrasonic generator energy modes of a surgical instrument.
[0066] Fig.40 A schematic diagram of one aspect of a surgical instrument including a feedback system for use with the surgical instrument according to one aspect of the present disclosure is shown.
[0067] Fig.41 An aspect of a basic architecture of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate multiple waveforms of electrical signal waveforms for use in a surgical instrument in accordance with at least one aspect of the present disclosure is shown.
[0068] Fig.42 An aspect of a direct digital synthesis (DDS) circuit configured to generate multiple waveform shapes of electrical signal waveforms for use in a surgical instrument in accordance with at least one aspect of the present disclosure is shown.
[0069] Fig.43 One cycle of a discrete-time digital electrical signal according to at least one aspect of the present disclosure is shown according to an analog waveform (shown superimposed on the discrete-time digital electrical signal waveform for comparison purposes) according to at least one aspect of the present disclosure.
[0070] Fig.44 is an illustration of a control system configured to provide gradual closing of a closure member as the closure member is advanced distally to close the clamp arms thereby applying a closing force load at a desired rate in accordance with one aspect of the present disclosure.
[0071] Fig.45 A proportional-integral-derivative (PID) controller feedback control system according to one aspect of the present disclosure is shown.
[0072] Fig.46 is a front exploded view of a modular handheld ultrasonic surgical instrument according to one aspect of the present disclosure showing a left housing half removed from a handle assembly, thereby exposing a device identifier communicatively coupled to a multi-lead handle terminal assembly.
[0073] Fig.47 According to at least one aspect of the present disclosure Fig.46 Detailed view of the trigger portion and switch of the ultrasonic surgical instrument shown in .
[0074] Fig.48 is a partially enlarged perspective view of an end effector according to at least one aspect of the present disclosure from a distal end with the jaw members in an open position.
[0075] Fig.49 A system diagram of a segmented circuit including a plurality of independently operating circuit segments according to at least one aspect of the present disclosure is provided.
[0076] Fig.50The present invention is a circuit diagram of various components of a surgical instrument with a motor control function according to at least one aspect of the present disclosure.
[0077] Fig.51 An aspect of an end effector according to at least one aspect of the present disclosure is shown, the end effector comprising an RF data sensor coupled to a jaw member.
[0078] Fig.52 According to at least one aspect of the present disclosure, Fig.51 One aspect of a flexible circuit is shown in , wherein a sensor may be mounted to or integrally formed with the flexible circuit.
[0079] Fig.53 An alternative system for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system according to at least one aspect of the present disclosure is provided.
[0080] Figures 54A-54B is a complex impedance spectrum of the same ultrasonic device with a cold (blue) and warm (red) ultrasonic blade according to at least one aspect of the present disclosure, wherein
[0081] Fig.54A is a graphical representation of the impedance phase angle as a function of the resonant frequency of the same ultrasonic device with a cool (blue) and warm (red) ultrasonic blade; and
[0082] Fig.54B Graph representation of impedance magnitude as a function of resonant frequency for the same ultrasonic device with a cool (blue) and warm (red) ultrasonic blade.
[0083] Fig.55 Schematic diagram of a Kalman filter that improves a temperature estimator and a state-space model based on impedance measured across an ultrasound transducer at multiple frequencies in accordance with at least one aspect of the present disclosure.
[0084] Fig.56 According to at least one aspect of the present disclosure, Fig.55 The state estimator of the Kalman filter shown in adopts three probability distributions to maximize the estimate.
[0085] Fig.57A A graphical representation of the temperature versus time of the ultrasonic device reaching a maximum temperature of 490°C without temperature control.
[0086] Fig.57B FIG. 1 is a graph of temperature versus time for an ultrasonic device reaching a maximum temperature of 320° C. under temperature control according to at least one aspect of the present disclosure.
[0087] Figures 58A-58Bis a diagram of feedback control for adjusting the ultrasonic power applied to the ultrasonic transducer when a sudden drop in the temperature of the ultrasonic blade is detected, wherein
[0088] Fig.58A is a graphical representation of ultrasound power as a function of time; and
[0089] Fig.58B is a graph of ultrasonic blade temperature as a function of time according to at least one aspect of the present disclosure.
[0090] Fig.59 The present invention is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control procedure or logic configuration for controlling the temperature of an ultrasonic blade.
[0091] Fig.60 is a graphical representation of ultrasonic blade temperature as a function of time during vessel firing in accordance with at least one aspect of the present disclosure.
[0092] Fig.61 is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control procedure or logic configuration for controlling the temperature of an ultrasonic blade between two temperature set points.
[0093] Fig.62 The present invention is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control procedure or logic configuration for determining an initial temperature of an ultrasonic blade.
[0094] Fig.63 The present invention is a logic flow diagram of a method according to at least one aspect of the present disclosure, which depicts a control program or logic configuration for determining when an ultrasonic blade is approaching instability and when to adjust the power to the ultrasonic transducer to prevent instability of the ultrasonic transducer.
[0095] Fig.64 SUMMARY OF THE INVENTION is a logic flow diagram of a method according to at least one aspect of the present disclosure that depicts a control procedure or logic configuration for providing ultrasonic sealing with temperature control.
[0096] Fig.65 is a graphical representation of ultrasonic transducer current and ultrasonic blade temperature as a function of time according to at least one aspect of the present disclosure.
[0097] Fig.66 A graphical representation of the relationship between the initial frequency and the change in frequency required to achieve a temperature of approximately 340° C. in accordance with at least one aspect of the present disclosure.
[0098] Fig.67A feedback control system according to at least one aspect of the present disclosure is shown, which includes an ultrasonic generator to adjust a current (i) set point applied to an ultrasonic transducer of an ultrasonic electromechanical system to prevent the frequency (f) of the ultrasonic transducer from decreasing below a predetermined threshold.
[0099] Fig.68 To illustrate a logic flow diagram of a method in accordance with at least one aspect of the present disclosure, a control routine or logic configuration is depicted for a controlled thermal management method for protecting an end effector pad.
[0100] Fig.69 is a graphical representation of temperature versus time comparing the expected temperature of an ultrasonic blade with an intelligent ultrasonic blade and a conventional ultrasonic blade according to at least one aspect of the present disclosure.
[0101] Fig.70 A timeline depicting situational awareness of a surgical hub according to at least one aspect of the present disclosure. DETAILED DESCRIPTION
[0102] The applicant of this patent application owns the following U.S. patent application filed on August 28, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0103] U.S. Patent Application Docket No. END8536USNP2 / 180107-2, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR;
[0104] U.S. Patent Application Docket No. END8561USNP1 / 180144-1, entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINEDELECTRICAL SIGNALS;
[0105] U.S. Patent Application Docket No. END8563USNP1 / 180139-1, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUELOCATION;
[0106] U.S. Patent Application Docket No. END8563USNP2 / 180139-2, entitled CONTROLLING ACTIVATION OF AN ULTRASONIC SURGICALINSTRUMENT ACCORDING TO THE PRESENCE OF TISSUE;
[0107] U.S. Patent Application Docket No. END8563USNP3 / 180139-3, entitled DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM;
[0108] U.S. Patent Application Docket No. END8563USNP4 / 180139-4, entitled DETERMINING THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO FREQUENCY SHIFT;
[0109] U.S. Patent Application Docket No. END8563USNP5 / 180139-5, entitled DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR;
[0110] U.S. Patent Application Docket No. END8564USNP1 / 180140-1, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;
[0111] U.S. Patent Application Docket No. END8564USNP2 / 180140-2, entitled MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN ELECTROSURGICAL INSTRUMENT;
[0112] U.S. Patent Application Docket No. END8564USNP3 / 180140-3, entitled DETECTION OF END EFFECTOR IMMERSION IN LIQUID;
[0113] U.S. Patent Application Docket No. END8565USNP1 / 180142-1, entitled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;
[0114] U.S. Patent Application Docket No. END8565USNP2 / 180142-2, entitled Adding Radio Frequency to Generate Padless Monopolar Loop (PAD-LESS);
[0115] U.S. Patent Application Docket No. END8566USNP1 / 180143-1, entitled BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTSPRESSURE BASED ON ENERGY MODALITY; and
[0116] US Patent Application Docket No. END8573USNP1 / 180145-1, entitled ACTIVATION OF ENERGY DEVICES.
[0117] The applicant of this patent application owns the following U.S. patent application filed on August 23, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0118] U.S. Provisional Patent Application No. 62 / 721,995, entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION;
[0119] U.S. Provisional Patent Application No. 62 / 721,998, entitled SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;
[0120] U.S. Provisional Patent Application No. 62 / 721,999, entitled INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;
[0121] U.S. Provisional Patent Application No. 62 / 721,994, entitled BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGY MODALITY; and
[0122] • U.S. Provisional Patent Application No. 62 / 721,996, entitled RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS.
[0123] The applicant of this patent application owns the following U.S. patent application filed on June 30, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0124] U.S. Provisional Patent Application No. 62 / 692,747, entitled SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;
[0125] U.S. Provisional Patent Application No. 62 / 692,748, entitled SMART ENERGY ARCHITURE; and
[0126] • U.S. Provisional Patent Application 62 / 692,768, entitled SMART ENERGY DEVICES.
[0127] The applicant of this patent application owns the following U.S. patent application filed on June 29, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0128] U.S. Patent Application Serial No. 16 / 024,090, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;
[0129] U.S. Patent Application Serial No. 16 / 024,057, entitled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;
[0130] U.S. Patent Application Serial No. 16 / 024,067, entitled SYSTEMS FOR ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE INFORMATION;
[0131] U.S. Patent Application Serial No. 16 / 024,075, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;
[0132] U.S. Patent Application Serial No. 16 / 024,083, entitled SAFETY SYSTEMS FOR SMART POWERED SURGICAL STAPLING;
[0133] U.S. Patent Application Serial No. 16 / 024,094, entitled SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES;
[0134] U.S. Patent Application Serial No. 16 / 024,138, entitled SYSTEMS FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE;
[0135] U.S. Patent Application Serial No. 16 / 024,150, entitled SURGICAL INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;
[0136] U.S. Patent Application Serial No. 16 / 024,160, entitled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY;
[0137] U.S. Patent Application Serial No. 16 / 024,124, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
[0138] U.S. Patent Application Serial No. 16 / 024,132, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE CIRCUIT;
[0139] U.S. Patent Application Serial No. 16 / 024,141, entitled SURGICAL INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;
[0140] U.S. Patent Application Serial No. 16 / 024,162, entitled SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;
[0141] U.S. Patent Application Serial No. 16 / 024,066, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;
[0142] U.S. Patent Application Serial No. 16 / 024,096, entitled SURGICAL EVACUATION SENSOR ARRANGEMENTS;
[0143] U.S. Patent Application Serial No. 16 / 024,116, entitled SURGICALEVACUATION FLOW PATHS;
[0144] U.S. Patent Application Serial No. 16 / 024,149, entitled SURGICAL EVACUATION SENSING AND GENERATOR CONTROL;
[0145] U.S. Patent Application Serial No. 16 / 024,180, entitled SURGICALEVACUATION SENSING AND DISPLAY;
[0146] U.S. Patent Application Serial No. 16 / 024,245, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
[0147] U.S. Patent Application Serial No. 16 / 024,258, entitled SMOKE EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROLCIRCUIT FOR INTERACTIVE SURGICAL PLATFORM;
[0148] U.S. Patent Application Serial No. 16 / 024,265, entitled SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and
[0149] - U.S. Patent Application Serial No. 16 / 024,273, entitled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.
[0150] The applicant of this patent application owns the following U.S. Provisional Patent Application filed on June 28, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0151] U.S. Provisional Patent Application Serial No. 62 / 691,228, entitled A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS WITH ELECTROSURGICAL DEVICES;
[0152] U.S. Provisional Patent Application Serial No. 62 / 691,227, entitled CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;
[0153] U.S. Provisional Patent Application Serial No. 62 / 691,230, entitled SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;
[0154] U.S. Provisional Patent Application Serial No. 62 / 691,219, entitled SURGICAL EVACUATION SENSING AND MOTOR CONTROL;
[0155] U.S. Provisional Patent Application Serial No. 62 / 691,257, entitled COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM;
[0156] U.S. Provisional Patent Application Serial No. 62 / 691,262, entitled SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN A FILTER AND A SMOKEEVACUATION DEVICE; and
[0157] U.S. Provisional Patent Application Serial No. 62 / 691,251, entitled DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS;
[0158] The applicant of this patent application owns the following U.S. Provisional Patent Application filed on April 19, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0159] U.S. Provisional Patent Application Serial No. 62 / 659,900, entitled METHOD OF HUB COMMUNICATION;
[0160] The applicant of this patent application owns the following U.S. Provisional Patent Application filed on March 30, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0161] U.S. Provisional Patent Application No. 62 / 650,898, filed on March 30, 2018, entitled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;
[0162] U.S. Provisional Patent Application Serial No. 62 / 650,887, entitled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;
[0163] U.S. Patent Application Serial No. 62 / 650,882, entitled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and
[0164] U.S. Patent Application Serial No. 62 / 650,877, entitled SURGICALSMOKE EVACUATION SENSING AND CONTROLS
[0165] The applicant of this patent application owns the following U.S. patent application filed on March 29, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0166] U.S. Patent Application Serial No. 15 / 940,641, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;
[0167] U.S. Patent Application Serial No. 15 / 940,648, entitled INTERACTIVE SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA CAPABILITIES;
[0168] U.S. Patent Application Serial No. 15 / 940,656, entitled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATINGROOM DEVICES;
[0169] U.S. Patent Application Serial No. 15 / 940,666, entitled SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;
[0170] U.S. Patent Application Serial No. 15 / 940,670, entitled COOPERATIVE UTILISATION OF DATA DERIVED FROM SECONDARY SOURCES BY INTELLIGENT SURGICAL HUBS;
[0171] U.S. Patent Application Serial No. 15 / 940,677, entitled SURGICAL HUB CONTROL ARRANGEMENT;
[0172] U.S. Patent Application Serial No. 15 / 940,632, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;
[0173] U.S. Patent Application Serial No. 15 / 940,640, entitled COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS;
[0174] U.S. Patent Application Serial No. 15 / 940,645, entitled SELF DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;
[0175] U.S. Patent Application Serial No. 15 / 940,649, entitled DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;
[0176] U.S. Patent Application Serial No. 15 / 940,654, entitled SURGICALHUB SITUATIONAL AWARENESS;
[0177] U.S. Patent Application Serial No. 15 / 940,663, entitled SURGICAL SYSTEM DISTRIBUTED PROCESSING; U.S. Patent Application Serial No. 15 / 940,668, entitled AGGREGATION AND REPORTING OF SURGICAL HUB DATA;
[0178] U.S. Patent Application Serial No. 15 / 940,671, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEEATER;
[0179] U.S. Patent Application Serial No. 15 / 940,686, entitled DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;
[0180] U.S. Patent Application Serial No. 15 / 940,700, entitled STERILEFIELD INTERACTIVE CONTROL DISPLAYS;
[0181] U.S. Patent Application Serial No. 15 / 940,629, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;
[0182] U.S. Patent Application Serial No. 15 / 940,704, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;
[0183] U.S. Patent Application Serial No. 15 / 940,722, entitled CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY; and
[0184] U.S. Patent Application Serial No. 15 / 940,742, entitled DUAL CMOS ARRAY IMAGING;
[0185] U.S. Patent Application Serial No. 15 / 940,636, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;
[0186] U.S. Patent Application Serial No. 15 / 940,653, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;
[0187] U.S. Patent Application Serial No. 15 / 940,660, entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER;
[0188] U.S. Patent Application Serial No. 15 / 940,679, entitled CLOUD-BASED MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;
[0189] U.S. Patent Application Serial No. 15 / 940,694, entitled CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED INDIVIDUALIZATION OF INSTRUMENT FUNCTION;
[0190] U.S. Patent Application Serial No. 15 / 940,634, entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES;
[0191] U.S. Patent Application Serial No. 15 / 940,706, entitled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and
[0192] U.S. Patent Application Serial No. 15 / 940,675, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;
[0193] U.S. Patent Application Serial No. 15 / 940,627, entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
[0194] U.S. Patent Application Serial No. 15 / 940,637, entitled COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
[0195] U.S. Patent Application Serial No. 15 / 940,642, entitled CONTROLS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
[0196] U.S. Patent Application Serial No. 15 / 940,676, entitled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
[0197] U.S. Patent Application Serial No. 15 / 940,680, entitled CONTROLLERS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
[0198] U.S. Patent Application Serial No. 15 / 940,683, entitled COOPERATIVE SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
[0199] U.S. Patent Application Serial No. 15 / 940,690, entitled DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and
[0200] • U.S. Patent Application Serial No. 15 / 940,711, entitled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.
[0201] The applicant of this patent application owns the following U.S. Provisional Patent Application filed on March 28, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0202] U.S. Provisional Patent Application Serial No. 62 / 649,302, entitled INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;
[0203] U.S. Provisional Patent Application Serial No. 62 / 649,294, entitled DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE ANONYMIZED RECORD;
[0204] U.S. Patent Application Serial No. 62 / 649,300, entitled SURGICALHUB SITUATIONAL AWARENESS;
[0205] U.S. Provisional Patent Application Serial No. 62 / 649,309, entitled SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER;
[0206] U.S. Patent Application Serial No. 62 / 649,310, entitled COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;
[0207] U.S. Provisional Patent Application Serial No. 62 / 649,291, entitled USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF BACK SCATTERED LIGHT;
[0208] U.S. Patent Application Serial No. 62 / 649,296, entitled ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;
[0209] U.S. Provisional Patent Application Serial No. 62 / 649,333, entitled CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A USER;
[0210] U.S. Provisional Patent Application Serial No. 62 / 649,327, entitled CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND REACTIVE MEASURES;
[0211] U.S. Provisional Patent Application Serial No. 62 / 649,315, entitled DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;
[0212] U.S. Patent Application Serial No. 62 / 649,313, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;
[0213] U.S. Patent Application Serial No. 62 / 649,320, entitled DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;
[0214] U.S. Provisional Patent Application Serial No. 62 / 649,307, entitled AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and
[0215] • U.S. Provisional Patent Application Serial No. 62 / 649,323, entitled SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.
[0216] The applicant of this patent application owns the following U.S. Provisional Patent Application filed on March 8, 2018, the disclosure of which is incorporated herein by reference in its entirety:
[0217] U.S. Provisional Patent Application Serial No. 62 / 640,417, entitled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR; and
[0218] • U.S. Provisional Patent Application Serial No. 62 / 640,415, entitled ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR.
[0219] The applicant of this patent application owns the following U.S. Provisional Patent Application filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety:
[0220] U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled INTERACTIVE SURGICAL PLATFORM;
[0221] U.S. Provisional Patent Application Serial No. 62 / 611,340, entitled CLOUD-BASED MEDICAL ANALYTICS; and
[0222] U.S. Patent Application Serial No. 62 / 611,339, entitled ROBOTASSISTED SURGICAL PLATFORM;
[0223] Before describing in detail various aspects of the surgical device and generator, it should be noted that the application or use of the illustrative examples is not limited to the details of the configuration and arrangement of the components shown in the drawings and detailed description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications, and may be practiced or performed in a variety of ways. In addition, unless otherwise indicated, the terms and expressions used herein are selected for the convenience of the reader to describe the exemplary embodiments and are not for limiting purposes. Moreover, it should be understood that one or more of the aspects, expressions of aspects and / or examples described below may be combined with any one or more of the other aspects, expressions of aspects and / or examples described below.
[0224] Various aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Various aspects of the ultrasonic surgical devices can be configured to enable use, for example, to transect and / or coagulate tissue during a surgical procedure. Various aspects of the electrosurgical devices can be configured to enable use, for example, to transect, coagulate, target, weld, and / or desiccate tissue during a surgical procedure.
[0225] See also Figure 1 , the computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., a cloud 104 that may include a remote server 113 coupled to a storage device 105). Each surgical system 102 includes at least one surgical hub 106 in communication with the cloud 104 that may include the remote server 113. In one example, as Figure 1 As shown in , the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld intelligent surgical instrument 112, which are configured to communicate with each other and / or with the hub 106. In some aspects, the surgical system 102 may include M number of hubs 106, N number of visualization systems 108, O number of robotic systems 110, and P number of handheld intelligent surgical instruments 112, where M, N, O, and P are integers greater than or equal to one.
[0226] Figure 3An example of a surgical system 102 is shown for performing a surgical procedure on a patient lying flat on an operating table 114 in a surgical operating room 116. A robotic system 110 is used as part of the surgical system 102 during a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robotic hub 122. While the surgeon views the surgical site through the surgeon's console 120, the patient side cart 117 can manipulate at least one removably coupled surgical tool 118 through a minimally invasive incision in the patient. Images of the surgical site can be obtained through a medical imaging device 124, which can be manipulated by the patient side cart 120 to orient the imaging device 124. The robotic hub 122 can be used to process images of the surgical site for subsequent display to the surgeon through the surgeon's console 118.
[0227] Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and surgical tools suitable for use with the present disclosure are described in U.S. Provisional Patent Application Serial No. 62 / 611,339, filed on December 28, 2017, entitled “ROBOT ASSISTED SURGICAL PLATFORM,” the disclosure of which is incorporated herein by reference in its entirety.
[0228] Various examples of cloud-based analytics performed by cloud 104 and suitable for use in the present disclosure are described in U.S. Provisional Patent Application Serial No. 62 / 611,340, entitled “CLOUD-BASED MEDICAL ANALYTICS,” filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety.
[0229] In various aspects, imaging device 124 includes at least one image sensor and one or more optical components. Suitable image sensors include, but are not limited to, charge coupled device (CCD) sensors and complementary metal oxide semiconductor (CMOS) sensors.
[0230] The optics of imaging device 124 may include one or more illumination sources and / or one or more lenses. The one or more illumination sources may be directed to illuminate portions of the surgical field. The one or more image sensors may receive light reflected or refracted from the surgical field, including light reflected or refracted from tissue and / or surgical instruments.
[0231] One or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as in the invisible spectrum. The visible spectrum (sometimes referred to as the optical spectrum or the luminescence spectrum) is that portion of the electromagnetic spectrum that is visible to (i.e., detectable by) the human eye and may be referred to as visible light or simply light. A typical human eye will respond to wavelengths in the range of about 380 nm to about 750 nm in air.
[0232] The invisible spectrum (i.e., non-luminescent spectrum) is the portion of the electromagnetic spectrum below and above the visible spectrum (i.e., wavelengths below about 380 nm and above about 750 nm). The invisible spectrum is not detectable by the human eye. Wavelengths greater than about 750 nm are longer than the red visible spectrum, and they become invisible infrared (IR), microwaves, and radio electromagnetic radiation. Wavelengths less than about 380 nm are shorter than the violet spectrum, and they become invisible ultraviolet, x-ray, and gamma-ray electromagnetic radiation.
[0233] In various aspects, the imaging device 124 is configured to be usable in minimally invasive procedures. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopy, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophago-duodenoscope (gastroscope), endoscope, laryngoscope, nasopharyngeal-renal endoscope, sigmoidoscope, thoracoscope, and hysteroscope.
[0234] In one aspect, the imaging device uses multispectral monitoring to distinguish topography and underlying structure. Multispectral images are images that capture image data within a specific wavelength range across the electromagnetic spectrum. The wavelengths can be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible light range, such as IR and ultraviolet. Spectral imaging allows the extraction of additional information that the human eye fails to capture with its red, green, and blue receptors. The use of multispectral imaging is described in more detail under the title "Advanced Imaging Acquisition Module" of U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled "INTERACTIVE SURGICALPLATFORM," filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. After completing the surgical task to perform one or more of the previously described tests on the treated tissue, multispectral monitoring can be a useful tool for repositioning the surgical site.
[0235] It is self-evident that during any surgical procedure, the operating room and surgical equipment need to be strictly sterilized. The strict sanitary and sterile conditions required in a "surgical room" (i.e., an operating room or treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is the need to sterilize any material that contacts the patient or penetrates the sterile field, including the imaging device 124 and its attachments and devices. It should be understood that the sterile field can be considered to be a designated area that is considered to be free of microorganisms, such as within a tray or sterile towels, or the sterile field can be considered to be an area around a patient that has been prepared for a surgical procedure. The sterile field can include a scrubbed team member that is appropriately dressed, as well as all furniture and fixtures in the area.
[0236] In various aspects, the visualization system 108 includes one or more imaging sensors, one or more image processing units, one or more storage arrays, and one or more displays strategically arranged relative to the sterile field, such as Figure 2 . In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described in U.S. Provisional Patent Application Serial No. 62 / 611,341, filed on December 28, 2017, entitled “INTERACTIVE SURGICAL PLATFORM,” under the title “Advanced Imaging Acquisition Module,” the disclosure of which is incorporated herein by reference in its entirety.
[0237] like Figure 2 , the main display 119 is positioned in the sterile field to be visible to the operator at the operating table 114. In addition, the visualization tower 111 is positioned outside the sterile field. The visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 that are separated from each other. The visualization system 108 guided by the hub 106 is configured to be able to coordinate the flow of information to operators inside and outside the sterile field using the displays 107, 109 and 119. For example, the hub 106 can cause the imaging system 108 to display a snapshot of the surgical site recorded by the imaging device 124 on the non-sterile display 107 or 109, while maintaining a real-time feed of the surgical site on the main display 119. The snapshot on the non-sterile display 107 or 109 can allow the non-sterile operator to perform, for example, a diagnostic step related to a surgical procedure.
[0238] In one aspect, the hub 106 is also configured to be able to route diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 to the primary display 119 within the sterile field, where it can be viewed by a sterile operator at the operating table. In one example, the input can be a modified form of a snapshot displayed on the non-sterile display 107 or 109, which can be routed to the primary display 119 via the hub 106.
[0239] See also Figure 2 , the surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. The hub 106 is also configured to coordinate the flow of information to the display of the surgical instrument 112. For example, U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled "INTERACTIVE SURGICAL PLATFORM," filed on December 28, 2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic input or feedback entered by a non-sterile operator at the visualization tower 111 can be routed by the hub 106 to the surgical instrument display 115 within the sterile field, where the operator of the surgical instrument 112 can observe the input or feedback. Exemplary surgical instruments suitable for use with surgical system 102 are described in U.S. provisional patent application serial number 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, under the title “Surgical Instrument Hardware,” the disclosure of which is incorporated herein by reference in its entirety.
[0240] See now Figure 3 , the hub 106 is depicted as communicating with the visualization system 108, the robotic system 110, and the handheld intelligent surgical instrument 112. The hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In certain aspects, as Figure 3 As shown in , the hub 106 also includes a smoke evacuation module 126 and / or a suction / rinsing module 128.
[0241] During surgical procedures, energy application to tissue for sealing and / or cutting is often associated with smoke evacuation, suction of excess fluid, and / or flushing of tissue. Fluid lines, power lines, and / or data lines from different sources often become tangled during surgical procedures. Valuable time can be lost in solving this problem during surgical procedures. Disconnecting a line may require disconnecting the line from its corresponding module, which may require resetting the module. The hub modular housing 136 provides a unified environment for managing power lines, data lines, and fluid lines, which reduces the frequency of tangling between such lines.
[0242] Aspects of the present disclosure provide a surgical hub for surgical procedures involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a combination generator module slidably accommodated in a docking base of the hub housing. The docking base includes data contacts and power contacts. The combination generator module includes two or more of an ultrasonic energy generator device, a bipolar RF energy generator device, and a monopolar RF energy generator device seated in a single unit. In one aspect, the combination generator module also includes a smoke exhaust device for connecting the combination generator module to at least one energy delivery cable of a surgical instrument, at least one smoke exhaust device configured to be able to exhaust smoke, fluid and / or particles generated by applying therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke exhaust device.
[0243] In one aspect, the fluid line is a first fluid line and the second fluid line extends from the remote surgical site to an aspiration and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.
[0244] Certain surgical procedures may require more than one energy type to be applied to tissue. One energy type may be more conducive to cutting tissue, while another different energy type may be more conducive to sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication between them. One of the advantages of the hub modular housing 136 is the ability to quickly remove and / or replace various modules.
[0245] Aspects of the present disclosure provide a modular surgical housing for use in surgical procedures involving application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking base including a first docking port including first data and power contacts, wherein the first energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the first energy generator module is slidably movable out of electrical engagement with the first power and data contacts,
[0246] Further describing the above, the modular surgical shell also includes a second energy generator module, which is configured to generate a second energy different from the first energy for application to tissue, and a second docking base, which includes a second docking port, the second docking port including second data and power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power and data contacts, and wherein the second energy generator is slidably movable out of electrical contact with the second power and data contacts.
[0247] Additionally, the modular surgical housing further includes a communication bus between the first docking port and the second docking port that is configured to facilitate communication between the first energy generator module and the second energy generator module.
[0248] See also Figure 3-7 , aspects of the present disclosure are presented as a hub modular housing 136 that allows modular integration of the generator module 140, the smoke evacuation module 126, and the suction / irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. Figure 5 As shown in , the generator module 140 may be a generator module having integrated monopolar devices, bipolar devices, and ultrasonic devices supported in a single housing unit 139 that is slidably inserted into the hub modular housing 136. Figure 5 As shown in , the generator module 140 may be configured to be connectable to a monopolar device 146, a bipolar device 147, and an ultrasonic device 148. Alternatively, the generator module 140 may include a series of monopolar generator modules, bipolar generator modules, and / or ultrasonic generator modules that interact through the hub modular housing 136. The hub modular housing 136 may be configured to facilitate the insertion of multiple generators and interactive communication between the generators docked into the hub modular housing 136 so that the generators will act as a single generator.
[0249] In one aspect, the hub modular housing 136 includes a modular power and communications backplane 149 with external and wireless communications connectors to enable removable attachment of the modules 140, 126, 128 and interactive communications therebetween.
[0250] In one aspect, the hub modular housing 136 includes a docking base or drawer 151 (also referred to herein as a drawer) that is configured to slidably accommodate the modules 140, 126, 128. Figure 4A partial perspective view of a surgical hub housing 136 and a combination generator module 145 slidably received in a docking station 151 of the surgical hub housing 136 is shown. A docking port 152 having power and data contacts on the back of the combination generator module 145 is configured to engage the corresponding docking port 150 with the power and data contacts of the corresponding docking station 151 of the hub modular housing 136 when the combination generator module 145 is slid into place within the corresponding docking station 151 of the hub modular housing 136. In one aspect, the combination generator module 145 includes bipolar, ultrasonic and monopolar modules and a smoke evacuation module integrated together into a single housing unit 139, such as Figure 5 as shown in .
[0251] In various aspects, the smoke evacuation module 126 includes a fluid line 154 that delivers captured / collected smoke and / or fluid from the surgical site to, for example, the smoke evacuation module 126. Vacuum suction from the smoke evacuation module 126 can draw smoke into an opening of a common conduit at the surgical site. The common conduit coupled to the fluid line can be in the form of a flexible tube that terminates at the smoke evacuation module 126. The common conduit and the fluid line define a fluid path that extends toward the smoke evacuation module 126 housed in the hub housing 136.
[0252] In various aspects, the suction / irrigation module 128 is coupled to a surgical tool including an aspiration fluid line and a suction fluid line. In one example, the aspiration fluid line and the suction fluid line are in the form of flexible tubes extending from the surgical site toward the suction / irrigation module 128. One or more drive systems can be configured to be able to flush fluid to the surgical site and to aspirate fluid from the surgical site.
[0253] In one aspect, the surgical tool comprises a shaft having an end effector at its distal end and at least one energy treatment associated with the end effector, a suction tube, and a flushing tube. The suction tube may have an inlet at its distal end, and the suction tube extends through the shaft. Similarly, the suction tube may extend through the shaft and may have an inlet adjacent to an energy delivery tool. The energy delivery tool is configured to be able to deliver ultrasonic energy and / or RF energy to a surgical site, and is coupled to a generator module 140 by a cable initially extending through the shaft.
[0254] The irrigation tube may be in fluid communication with a fluid source, and the aspiration tube may be in fluid communication with a vacuum source. The fluid source and / or vacuum source may be seated in the suction / irrigation module 128. In one example, the fluid source and / or vacuum source may be seated in the hub housing 136 independently of the suction / irrigation module 128. In such examples, a fluid interface is capable of connecting the suction / irrigation module 128 to the fluid source and / or vacuum source.
[0255] In one aspect, the modules 140, 126, 128 and / or their corresponding docking stations on the hub modular housing 136 may include alignment features configured to align the docking ports of the modules to engage with their corresponding ports in the docking stations of the hub modular housing 136. For example, Figure 4 As shown in , the combination generator module 145 includes a side bracket 155, which is configured to be slidably engaged with a corresponding bracket 156 of a corresponding docking base 151 of the hub modular housing 136. The bracket cooperates to guide the docking port contacts of the combination generator module 145 to electrically engage with the docking port contacts of the hub modular housing 136.
[0256] In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the size of the module is adjusted to be accommodated in the drawer 151. For example, the side brackets 155 and / or 156 can be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are different sizes and each is designed to accommodate a specific module.
[0257] Additionally, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting a module into a drawer with mismatched contacts.
[0258] like Figure 4 As shown in , the docking port 150 of one drawer 151 can be coupled to the docking port 150 of another drawer 151 via a communication link 157 to facilitate interactive communication between modules seated in the hub modular housing 136. Alternatively or additionally, the docking port 150 of the hub modular housing 136 can facilitate wireless interactive communication between modules seated in the hub modular housing 136. Any suitable wireless communication can be employed, such as, for example, Air Titan-Bluetooth.
[0259] Figure 6 A single power bus attachment is shown for multiple lateral docking ports of a lateral modular housing 160 that is configured to accommodate multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to accommodate and interconnect modules 161 laterally. The modules 161 are slidably inserted into docking bases 162 of the lateral modular housing 160 that includes a bottom plate for interconnecting the modules 161. Figure 6 As shown in FIG, the modules 161 are arranged transversely in the transverse modular housing 160. Alternatively, the modules 161 may be arranged vertically in the transverse modular housing.
[0260] Figure 7A vertical modular housing 164 is shown that is configured to accommodate multiple modules 165 of the surgical hub 106. The modules 165 can be slidably inserted into a docking base or drawer 167 of the vertical modular housing 164, which includes a bottom plate for interconnecting the modules 165. Although the drawers 167 of the vertical modular housing 164 are arranged vertically, in some cases, the vertical modular housing 164 may include drawers arranged horizontally. In addition, the modules 165 can interact with each other through the docking port of the vertical modular housing 164. Figure 7 In the example of FIG. 1 , a display 177 is provided for displaying data related to the operation of the module 165. In addition, the vertical modular housing 164 includes a main module 178 that seats a plurality of sub-modules that are slidably received in the main module 178.
[0261] In various aspects, the imaging module 138 includes an integrated video processor and a modular light source, and is suitable for use with various imaging devices. In one aspect, the imaging device is composed of a modular housing that can be equipped with a light source module and a camera module. The housing can be a disposable housing. In at least one example, the disposable housing is removably coupled to a reusable controller, light source module, and camera module. The light source module and / or camera module can be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. On the other hand, the camera module includes a CMOS sensor. On the other hand, the camera module is configured for scanning beam imaging. Similarly, the light source module can be configured to be able to deliver white light or different light, depending on the surgical procedure.
[0262] During a surgical procedure, it may be inefficient to remove a surgical device from the surgical field and replace the surgical device with another surgical device that includes a different camera or a different light source. Temporarily losing sight of the surgical field may lead to undesirable consequences. The modular imaging device of the present disclosure is configured to allow for mid-stream replacement of a light source module or a camera module during a surgical procedure without having to remove the imaging device from the surgical field.
[0263] In one aspect, an imaging device includes a tubular housing including a plurality of channels. A first channel is configured to slidably receive a camera module, which can be configured to snap-fit into engagement with the first channel. A second channel is configured to slidably receive a light source module, which can be configured to snap-fit into engagement with the second channel. In another example, the camera module and / or the light source module can be rotated into a final position within their respective channels. A threaded engagement can be used in place of a snap-fit engagement.
[0264] In various examples, multiple imaging devices are placed at different locations in the surgical field to provide multiple views. The imaging module 138 can be configured to be able to switch between imaging devices to provide the best view. In various aspects, the imaging module 138 can be configured to be able to integrate images from different imaging devices.
[0265] Various image processors and imaging devices suitable for use with the present disclosure are described in U.S. Pat. No. 7,995,045, entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, issued on August 9, 2011, which is incorporated herein by reference in its entirety. In addition, U.S. Pat. No. 7,982,776, entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD, issued on July 19, 2011, describes various systems for removing motion artifacts from image data, which is incorporated herein by reference in its entirety. Such systems may be integrated with imaging module 138. In addition, U.S. patent application publication 2011 / 0306840, entitled CONTROLLABLE MAGNETIC SOURCE TO FIXTUREINTRACORPOREAL APPARATUS, published on December 15, 2011, and U.S. patent application publication 2014 / 0243597, entitled SYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, published on August 28, 2014, each of the above patents is incorporated herein by reference in its entirety.
[0266] Figure 8A surgical data network 201 is shown that includes a modular communication hub 203 that is configured to connect modular devices located in one or more operating rooms of a medical facility or any room in a medical facility that is specifically equipped for surgical operations to a cloud-based system (e.g., a cloud 204 that may include a remote server 213 coupled to a storage device 205). In one aspect, the modular communication hub 203 includes a network hub 207 and / or a network switch 209 that communicates with a network router. The modular communication hub 203 may also be coupled to a local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured as passive, intelligent, or switched. A passive surgical data network acts as a conduit for data, enabling it to be transferred from one device (or segment) to another device (or segment) and to cloud computing resources. An intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuration of each port in the network hub 207 or network switch 209. The intelligent surgical data network may be referred to as a manageable hub or switch. The switching hub reads the destination address of each packet and then forwards the packet to the correct port.
[0267] Modular devices 1a-1n located in an operating room may be coupled to a modular communication hub 203. A network hub 207 and / or a network switch 209 may be coupled to a network router 211 to connect devices 1a-1n to a cloud 204 or a local computer system 210. Data associated with devices 1a-1n may be transmitted to a cloud-based computer via a router for remote data processing and manipulation. Data associated with devices 1a-1n may also be transmitted to a local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to a network switch 209. A network switch 209 may be coupled to a network hub 207 and / or a network router 211 to connect devices 2a-2m to a cloud 204. Data associated with devices 2a-2n may be transmitted to a cloud 204 via a network router 211 for data processing and manipulation. Data associated with devices 2a-2m may also be transmitted to a local computer system 210 for local data processing and manipulation.
[0268] It should be understood that the surgical data network 201 can be expanded by interconnecting multiple network hubs 207 and / or multiple network switches 209 with multiple network routers 211. The modular communication hub 203 can be included in a modular control tower that is configured to accommodate multiple devices 1a-1n / 2a-2m. A local computer system 210 can also be included in the modular control tower. The modular communication hub 203 is connected to a display 212 to display images obtained by some of the devices 1a-1n / 2a-2m during a surgical procedure, for example. In various aspects, devices 1a-1n / 2a-2m may include, for example, various modules, such as an imaging module 138 coupled to an endoscope, a generator module 140 coupled to an energy-based surgical device, a smoke evacuation module 126, a suction / irrigation module 128, a communication module 130, a processor module 132, a storage array 134, a surgical device connected to a display, and / or a non-contact sensor module in other modular devices that can be connected to a modular communication hub 203 of a surgical data network 201.
[0269] In one aspect, the surgical data network 201 may include a combination of (one or more) network hubs, (one or more) network switches, and (one or more) network routers that connect the devices 1a-1n / 2a-2m to the cloud. Any or all of the devices 1a-1n / 2a-2m coupled to the network hub or network switch can collect data in real time and transmit the data to the cloud computer for data processing and manipulation. It should be understood that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" can be used as a metaphor for "Internet", although the term is not limited to this. Therefore, the term "cloud computing" can be used herein to refer to "a type of Internet-based computing", in which different services (such as servers, storage, and applications) are delivered to a modular communication hub 203 and / or a computer system 210 located in a surgical room (e.g., a fixed, mobile, temporary, or on-site operating room or space) and a device connected to the modular communication hub 203 and / or the computer system 210 via the Internet. The cloud infrastructure can be maintained by a cloud service provider. In this case, the cloud service provider may be an entity that coordinates the use and control of devices 1a-1n / 2a-2m located in one or more operating rooms. Cloud computing services may perform a large number of calculations based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. Hub hardware enables multiple devices or connections to connect to a computer that communicates with cloud computing resources and storage.
[0270] Applying cloud computer data processing technology to the data collected by the devices 1a-1n / 2a-2m, the surgical data network provides improved surgical results, reduced costs and improved patient satisfaction. At least some of the devices 1a-1n / 2a-2m can be used to observe tissue status to evaluate leakage or perfusion of sealed tissue after tissue sealing and cutting procedures. At least some of the devices 1a-1n / 2a-2m can be used to identify pathology, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes positioning and edge confirmation of tissue and phenotype. At least some of the devices 1a-1n / 2a-2m can be used to identify the anatomical structure of the body using various sensors integrated with imaging devices and technologies (such as overlapping images captured by multiple imaging devices). The data collected by the devices 1a-1n / 2a-2m (including image data) can be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. The data can be analyzed to improve surgical procedure outcomes by determining whether further treatment can be pursued, such as endoscopic interventions, emerging technologies, targeted radiation, targeted interventions, and precision robotic applications to tissue-specific sites and conditions. Such data analysis can be further processed using outcome analysis, and using standardized methods can provide helpful feedback to confirm surgical treatments and surgeon behavior, or suggest modifications to surgical treatments and surgeon behavior.
[0271] In one specific implementation, operating room devices 1a-1n may be connected to the modular communication hub 203 via a wired channel or a wireless channel, depending on the configuration of the devices 1a-1n to the network hub. In one aspect, the network hub 207 may be implemented as a local network broadcast device that operates on the physical layer of the open system interconnection (OSI) model. The network hub provides connections to devices 1a-1n located in the same operating room network. The network hub 207 collects data in the form of packets and sends it to a router in half-duplex mode. The network hub 207 does not store any media access control / Internet protocol (MAC / IP) for transmitting device data. Only one of the devices 1a-1n can send data through the network hub 207 at a time. The network hub 207 has no knowledge of where to send information and broadcasts all network data on each connection and to the remote server 213 ( Fig. 9 ) Routing tables or intelligence that broadcasts all network data. The network hub 207 can detect basic network errors such as collisions, but broadcasting all information to multiple ports can pose security risks and cause bottlenecks.
[0272] In another specific implementation, the operating room devices 2a-2m can be connected to the network switch 209 through a wired channel or a wireless channel. The network switch 209 operates in the data link layer of the OSI model. The network switch 209 is a multicast device for connecting the devices 2a-2m located in the same operating room to the network. The network switch 209 sends data to the network router 211 in the form of a frame and operates in full-duplex mode. Multiple devices 2a-2m can send data simultaneously through the network switch 209. The network switch 209 stores and uses the MAC addresses of the devices 2a-2m to transmit data.
[0273] The network hub 207 and / or the network switch 209 are coupled to a network router 211 to connect to the cloud 204. The network router 211 operates in the network layer of the OSI model. The network router 211 creates a route for transmitting data packets received from the network hub 207 and / or the network switch 211 to cloud-based computer resources to further process and manipulate data collected by any or all of the devices 1a-1n / 2a-2m. The network router 211 can be used to connect two or more different networks located in different locations, such as, for example, different operating rooms in the same medical facility or different networks located in different operating rooms in different medical facilities. The network router 211 sends data to the cloud 204 in the form of packets and operates in full-duplex mode. Multiple devices can send data simultaneously. The network router 211 uses IP addresses to transmit data.
[0274] In one example, the network hub 207 may be implemented as a USB hub that allows multiple USB devices to be connected to a host computer. The USB hub may expand a single USB port to multiple levels so that more ports are available to connect devices to a host system computer. The network hub 207 may include wired or wireless capabilities for receiving information through a wired channel or a wireless channel. In one aspect, a wireless USB short-range, high-bandwidth wireless radio communication protocol may be used for communication between devices 1a-1n and devices 2a-2m located in an operating room.
[0275] In other examples, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via the Bluetooth wireless technology standard for exchanging data from fixed and mobile devices over short distances (using short wavelength UHF radio waves in the ISM band of 2.4 to 2.485 GHz) and building a personal area network (PAN). In other aspects, the operating room devices 1a-1n / 2a-2m can communicate with the modular communication hub 203 via a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE) and Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivatives thereof, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.
[0276] The modular communication hub 203 can serve as a central connection for one or all of the operating room devices 1a-1n / 2a-2m and handles data types called frames. The frames carry data generated by the devices 1a-1n / 2a-2m. When the modular communication hub 203 receives a frame, it is amplified and transmitted to the network router 211, which transmits the data to the cloud computing resources using multiple wireless or wired communication standards or protocols as described herein.
[0277] Modular communication hub 203 can be used as a standalone device or connected to compatible network hubs and network switches to form a larger network. Modular communication hub 203 is generally easy to install, configure and maintain, making it a good option for networking operating room devices 1a-1n / 2a-2m.
[0278] Fig. 9A computer-implemented interactive surgical system 200 is shown. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 in communication with a cloud 204, which may include a remote server 213. In one aspect, the computer-implemented interactive surgical system 200 includes a modular control tower 236 that is connected to a plurality of operating room devices, such as, for example, smart surgical instruments, robots, and other computerized devices located in the operating room. Fig.10 As shown in FIG, modular control tower 236 includes modular communication hub 203 coupled to computer system 210. Fig. 9 As shown in the example of , the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke evacuator module 226, a suction / irrigation module 228, a communication module 230, a processor module 232, a storage array 234, a smart device / instrument 235 optionally coupled to a display 237, and a non-contact sensor module 242. The operating room devices are coupled to cloud computing resources and data storage via the modular control tower 236. The robotic hub 222 can also be connected to the modular control tower 236 and cloud computing resources. The devices / instruments 235, the visualization system 208, etc. can be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 can be coupled to a hub display 215 (e.g., monitor, screen) to display and overlay images received from the imaging module, device / instrument display, and / or other visualization system 208. The hub display may also combine graphics and overlay images to display data received from devices connected to the modular control tower.
[0279] Fig.10 A surgical hub 206 is shown comprising a plurality of modules coupled to a modular control tower 236. The modular control tower 236 comprises a modular communication hub 203 (e.g., network connectivity means) and a computer system 210 to provide, for example, local processing, visualization, and imaging. Fig.10 As shown in , the modular communication hub 203 can be hierarchically configured to expand the number of modules (e.g., devices) that can be connected to the modular communication hub 203 and transmit data associated with the modules to the computer system 210, cloud computing resources, or both. Fig.10As shown in , each of the network hubs / switches in the modular communication hub 203 includes three downstream ports and one upstream port. The upstream network hub / switch is connected to the processor to provide communication connections with cloud computing resources and local display 217. Communication with the cloud 204 can be carried out through wired or wireless communication channels.
[0280] The surgical hub 206 employs a non-contact sensor module 242 to measure the size of the operating room and generates a map of the surgical room using an ultrasound or laser-based non-contact measurement device. The ultrasound-based non-contact sensor module scans the operating room by emitting a burst of ultrasound waves and receiving the echoes as they bounce off the walls of the operating room, as described in U.S. Provisional Patent Application Serial No. 62 / 611,341, entitled “INTERACTIVE SURGICAL PLATFORM,” filed on December 28, 2017, under the title “Surgical Hub Spatial Awareness Within an Operating Room,” which is incorporated herein by reference in its entirety, wherein the sensor module is configured to be able to determine the size of the operating room and adjust the Bluetooth pairing distance limit. The laser-based non-contact sensor module scans the operating room by emitting laser pulses, receiving laser pulses that bounce off the walls of the operating room, and comparing the phase of the emitted pulses with the received pulses to determine the size of the operating room and adjust the Bluetooth pairing distance limit.
[0281] The computer system 210 includes a processor 244 and a network interface 245. The processor 244 is coupled to a communication module 247, a storage device 248, a memory 249, a non-volatile memory 250, and an input / output interface 251 via a system bus. The system bus may be any of several types of bus structures including a memory bus or memory controller, a peripheral bus or external bus, and / or a local bus using any of a variety of available bus architectures including, but not limited to, a 9-bit bus, Industry Standard Architecture (ISA), Micro Charmel Architecture (MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI), USB, Advanced Graphics Port (AGP), Personal Computer Memory Card International Association bus (PCMCIA), Small Computer System Interface (SCSI), or any other peripheral bus.
[0282] Controller 244 may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be a commercially available ARM Cortex-M4F processor core, such as the Texas Instruments LM4F230H5QR, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle sequential random access memory (SRAM), a 32KB MCU loaded with Internal read-only memory (ROM) for software, 2KB electrically erasable programmable read-only memory (EEPROM), and / or one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, details of which can be found in the product data sheet.
[0283] In one aspect, the processor 244 may include a safety controller including two families based on controllers such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by Texas Instruments. The safety controller may be configured to be specialized for IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
[0284] System memory includes volatile memory and non-volatile memory. The basic input / output system (BIOS), which contains basic routines such as transferring information between elements within the computer system during startup, is stored in non-volatile memory. For example, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes random access memory (RAM) that acts as external cache memory. In addition, RAM is available in a variety of forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM) enhanced SDRAM (ESDRAM), synchronous link DRAM (SLDRAM), and direct Rambus RAM (DRRAM).
[0285] Computer system 210 also includes removable / non-removable, volatile / non-volatile computer storage media, such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as disk drives, floppy disk drives, tape drives, Jaz drives, Zip drives, LS-60 drives, flash memory cards, or memory sticks. In addition, disk storage may include storage media individually or in combination with other storage media, including but not limited to optical disk drives such as optical disk ROM devices (CD-ROM), optical disk recordable drives (CD-R drives), optical disk rewritable drives (CD-RW drives), or digital universal disk ROM drives (DVD-ROM). In order to facilitate the connection of the disk storage device to the system bus, a removable or non-removable interface may be used.
[0286] It should be understood that the computer system 210 includes software that acts as an intermediary between a user and the basic computer resources described in a suitable operating environment. Such software includes an operating system. An operating system that can be stored on a disk storage device is used to control and allocate the resources of the computer system. System applications use the operating system to manage resources through program modules and program data stored in system memory or disk storage devices. It should be understood that the various devices described herein can be implemented with various operating systems or combinations of operating systems.
[0287] The user inputs commands or information into the computer system 210 through (one or more) input devices coupled to the I / O interface 251. Input devices include, but are not limited to, pointing devices such as a mouse, a touch ball, a stylus, a touch pad, a keyboard, a microphone, a joystick, a game pad, a satellite dish, a scanner, a TV tuner card, a digital camera, a digital video camera, a web camera, etc. These and other input devices are connected to the processor through the system bus via (one or more) interface ports. (One or more) interface ports include, for example, serial ports, parallel ports, game ports, and USB. (One or more) output devices use the same type of port as (one or more) input devices. Thus, for example, a USB port can be used to provide input to the computer system and output information from the computer system to an output device. Output adapters are provided to illustrate that there are some output devices (such as monitors, displays, speakers, and printers) that require special adapters among other output devices. Output adapters include, by way of example, but are not limited to, video and sound cards that provide connection means between output devices and the system bus. It should be noted that other devices or systems of devices such as (one or more) remote computers provide both input capabilities and output capabilities.
[0288] The computer system 210 can operate in a networked environment using a logical connection with one or more remote computers (such as (one or more) cloud computers) or local computers. (One or more) remote cloud computers can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other public network nodes, etc., and generally include many or all of the elements described relative to the computer system. For simplicity, only a memory storage device with (one or more) remote computers is shown. (One or more) remote computers are logically connected to the computer system through a network interface, and then physically connected via a communication connection. The network interface covers communication networks such as local area networks (LANs) and wide area networks (WANs). LAN technologies include fiber distributed data interface (FDDI), copper distributed data interface (CDDI), Ethernet / IEEE 802.3, token ring / IEEE 802.5, etc. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks such as integrated services digital networks (ISDN) and their variants, packet switching networks, and digital subscriber lines (DSL).
[0289] In various aspects, Fig.10 computer system 210, imaging module 238 and / or visualization system 208, and / or Figure 9-10 The processor module 232 may include an image processor, an image processing engine, a media processor, or any dedicated digital signal processor (DSP) for processing digital images. The image processor may employ parallel computing with single instruction, multiple data (SIMD) or multiple instructions, multiple data (MIMD) techniques to improve speed and efficiency. The digital image processing engine may perform a range of tasks. The image processor may be a system on a chip with a multi-core processor architecture.
[0290] The communication connection(s) refers to the hardware / software used to connect the network interface to the bus. Although the communication connections are shown for exemplary clarification within the computer system, they may also be located external to the computer system 210. The hardware / software necessary to connect to the network interface includes internal and external technologies such as modems, including conventional telephone grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards for exemplary purposes only.
[0291] Fig.11A functional block diagram of one aspect of a USB network hub 300 device according to at least one aspect of the present disclosure is shown. In the illustrated aspect, the USB network hub device 300 employs the TUSB2036 integrated circuit hub of Texas Instruments. The USB network hub 300 is a CMOS device that provides an upstream USB transceiver port 302 and up to three downstream USB transceiver ports 304, 306, 308 according to the USB 2.0 specification. The upstream USB transceiver port 302 is a differential root data port that includes a differential data negative (DP0) input paired with a differential data positive (DM0) input. The three downstream USB transceiver ports 304, 306, 308 are differential data ports, each of which includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.
[0292] The USB network hub 300 device is implemented with a digital state machine rather than a microcontroller, and does not require firmware programming. A fully compatible USB transceiver is integrated into the circuit for the upstream USB transceiver port 302 and all downstream USB transceiver ports 304, 306, 308. The downstream USB transceiver ports 304, 306, 308 support both full-speed devices and low-speed devices by automatically setting the conversion rate according to the speed of the device attached to the port. The USB network hub 300 device can be configured to be in bus-powered mode or self-powered mode, and includes a hub power logic 312 for managing power.
[0293] The USB network hub 300 device includes a serial interface engine 310 (SIE). The SIE 310 is the front end of the USB network hub 300 hardware and handles most of the protocols described in Chapter 8 of the USB specification. The SIE 310 generally includes up to transaction-level signaling. The functions it handles may include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection / generation, clock / data separation, non-return to zero inversion (NRZI) data encoding / decoding and digit filling, CRC generation and verification (token and data), packet ID (PID) generation and verification / decoding, and / or serial-to-parallel / parallel-to-serial conversion. The 310 receives a clock input 314 and is coupled to a pause / resume logic and frame timer 316 circuit and a hub repeater circuit 318 to control the communication between the upstream USB transceiver port 302 and the downstream USB transceiver port 304, 306, 308 through the port logic circuit 320, 322, 324. SIE 310 is coupled to command decoder 326 via interface logic to control commands from the serial EEPROM via serial EEPROM interface 330 .
[0294] In various aspects, the USB network hub 300 can connect 127 functions configured in up to six logical layers (hierarchies) to a single computer. In addition, the USB network hub 300 can be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power is configured as a bus-powered mode and a self-powered mode. The USB network hub 300 can be configured to support four power management modes: a bus-powered hub with individual port power management or a complete set of port power management, and a self-powered hub with individual port power management or a complete set of port power management. In one aspect, the USB network hub 300, the upstream USB transceiver port 302 is inserted into the USB host controller using a USB cable, and the downstream USB transceiver ports 304, 306, 308 are exposed for connecting USB compatible devices, etc.
[0295] Surgical Instrument Hardware
[0296] Fig.12 A logic diagram of a control system 470 of a surgical instrument or tool according to one or more aspects of the present disclosure is shown. The system 470 includes a control circuit. The control circuit includes a microcontroller 461 including a processor 462 and a memory 468. For example, one or more of the sensors 472, 474, 476 provide real-time feedback to the processor 462. A motor 482 driven by a motor driver 492 is operably coupled to a longitudinally movable displacement member to drive a clamp arm closing member. The tracking system 480 is configured to be able to determine the position of the longitudinally movable displacement member. The position information is provided to the processor 462, which can be programmed or configured to be able to determine the position of the longitudinally movable drive member and the position of the closing member. Additional motors can be provided at the tool driver interface to control the closure tube travel, shaft rotation, joint movement, or clamp arm closure, or a combination of the above. The display 473 displays a variety of operating conditions of the instrument and may include a touch screen function for data input. The information displayed on the display 473 may be superimposed with an image acquired via an endoscopic imaging module.
[0297] In one aspect, the microprocessor 461 can be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In one aspect, the microcontroller 461 can be a LM4F230H5QR ARM Cortex-M4F processor core available from, for example, Texas Instruments, which includes 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle SRAM, a 32-bit MCU, and a 32-bit MCU. Internal ROM for software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADC with 12 analog input channels, details of which can be found in the product data sheet.
[0298] In one aspect, the microcontroller 461 may include a safety controller including two families based on controllers such as TMS570 and RM4x, known under the trade name Hercules ARM Cortex R4 also produced by Texas Instruments. The safety controller may be configured to be capable of being specifically used for IEC 61508 and ISO26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
[0299] Microcontroller 461 can be programmed to perform various functions, such as accurately controlling the speed and position of a knife, articulation system, clamping arm or a combination thereof. In one aspect, microcontroller 461 includes processor 462 and memory 468. Electric motor 482 can be a brushed DC (DC) motor having a gearbox and a mechanical link to an articulation or knife system. In one aspect, motor driver 492 can be an A3941 available from Allegro Microsystems, Inc. Other motor drivers can be easily replaced for use in tracking system 480 including an absolute positioning system. A detailed description of the absolute positioning system is described in U.S. Patent Application Publication 2017 / 0296213 entitled SYSTEMS AND METHODS FOR CONTROLLING A SURGICAL STAPLING AND CUTTING INSTRUMENT published on October 19, 2017, which is incorporated herein by reference in its entirety.
[0300] The microcontroller 461 can be programmed to provide precise control of the speed and position of the displacement member and articulation system. The microcontroller 461 can be configured to be able to calculate the response in the software of the microcontroller 461. The calculated response is compared with the measured response of the actual system to obtain the "observed" response, which is used for actual feedback decisions. The observed response is a favorable tuning value that balances the smooth continuous nature of the simulated response with the measured response, which can detect external influences on the system.
[0301] In one aspect, the motor 482 can be controlled by a motor driver 492 and can be adopted by the firing system of a surgical instrument or tool. In various forms, the motor 482 can be a brushed DC drive motor with a maximum rotation speed of about 25,000 RPM. In other arrangements, the motor 482 can include a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 can include, for example, an H-bridge driver including a field effect transistor (FET). The motor 482 can be powered by a power assembly that can be releasably mounted to a handle assembly or a tool housing for supplying control power to a surgical instrument or tool. The power assembly can include a battery that can include a plurality of battery cells connected in series that can be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cell of the power assembly can be a replaceable and / or rechargeable battery cell. In at least one example, the battery cell can be a lithium-ion battery that can be coupled to the power assembly and can be separated from the power assembly.
[0302] Driver 492 may be an A3941 available from Allegro Microsystems, Inc. A3941 492 is a full-bridge controller for use with external N-channel power metal oxide semiconductor field effect transistors (MOSFETs) specifically designed for inductive loads such as brushed DC motors. Driver 492 includes a unique charge pump regulator that provides full (>10V) gate drive for battery voltages as low as 7V and allows the A3941 to operate at reduced gate drive as low as 5.5V. A bootstrap capacitor may be used to provide the above-mentioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side driver allows DC (100% duty cycle) operation. A diode or synchronous rectification may be used to drive the full bridge in fast decay mode or slow decay mode. In slow decay mode, current recirculation may pass through the high-side FET or the low-side FET. The power FET is protected from breakdown by a resistor-adjustable dead time. The overall diagnostics provide indications of undervoltage, overtemperature, and power bridge faults, and can be configured to protect the power MOSFETs under most short circuit conditions.Other motor drivers can be easily substituted for use in the tracking system 480 including the absolute positioning system.
[0303] Tracking system 480 includes a controlled motor drive circuit arrangement including position sensor 472 according to one aspect of the present disclosure. Position sensor 472 for absolute positioning system provides a unique position signal corresponding to the position of displacement member. In one aspect, displacement member represents a longitudinally movable drive member, which includes a rack of drive teeth for meshing engagement with a corresponding drive gear of a gear reducer assembly. In other aspects, displacement member represents a firing member, which can be adapted and configured to include a rack of drive teeth. In another aspect, displacement member represents a longitudinal displacement member for opening and closing clamping arms, which can be adapted and configured to include a rack of drive teeth. In other aspects, displacement member represents a clamping arm closing member, which is configured to be able to close and open the clamping arm of a stapler, the clamping arm of an ultrasonic or electrosurgical device, or a combination of the above. Therefore, as used herein, the term displacement member is generally used to refer to any movable member of a surgical instrument or tool (such as a drive member, a clamping arm, or any element that can be displaced). Thus, the absolute positioning system can actually track the displacement of the clamping arm by tracking the linear displacement of the longitudinally movable drive member.
[0304] In other aspects, the absolute positioning system can be configured to track the position of the clamping arm during closing or opening. In various other aspects, the displacement member can be coupled to any position sensor 472 suitable for measuring linear displacement. Therefore, the longitudinally movable drive member, or the clamping arm, or a combination thereof can be coupled to any suitable linear displacement sensor. The linear displacement sensor may include a contact displacement sensor or a non-contact displacement sensor. The linear displacement sensor may include a linear variable differential transformer (LVDT), a differential variable reluctance transducer (DVRT), a sliding potentiometer, a magnetic sensing system including a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system including a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical sensing system including a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system including a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
[0305] The electric motor 482 may include a rotatable shaft operably interfaced with a gear assembly that is mounted on the displacement member in meshing engagement with a set or rack of drive teeth. The sensor element may be operably coupled to the gear assembly so that a single rotation of the position sensor 472 element corresponds to some linear longitudinal translation of the displacement member. The arrangement of the transmission and sensor may be connected to a linear actuator via a rack and pinion arrangement, or to a rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system, and the output indicator may display the output of the absolute positioning system. The displacement member represents a longitudinally movable drive member that includes a rack of drive teeth formed thereon for meshing engagement with a corresponding drive gear of the gear reducer assembly. The displacement member represents a longitudinally movable firing member for opening and closing the clamping arm.
[0306] A single rotation of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement d of the displacement member. 1 , where d 1 is the longitudinal linear distance the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. The sensor arrangement may be connected via a gear reduction that enables the position sensor 472 to complete only one or more rotations for a full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.
[0307] A series of switches (where n is an integer greater than one) may be employed alone or in conjunction with gear reduction to provide unique position signals for more than one rotation of the position sensor 472. The state of the switches is fed back to the microcontroller 461 which applies logic to determine the position corresponding to the longitudinal linear displacement d of the displacement member. 1 +d 2 +…d n The output of the position sensor 472 is provided to the microcontroller 461. The position sensor 472 of the sensor arrangement may include a magnetic sensor, an analog rotation sensor (such as a potentiometer), an array of analog Hall effect elements that output a unique combination of position signals or values.
[0308] Position sensor 472 may include any number of magnetic sensing elements, such as, for example, magnetic sensors classified according to whether they measure the total magnetic field or the vector component of the magnetic field. The technologies used to produce the above two types of magnetic sensors cover many aspects of physics and electronics. Technologies for magnetic field sensing include probe coils, fluxgates, optical pumps, nuclear spins, superconducting quantum interference devices (SQUIDs), Hall effects, anisotropic magnetoresistance, giant magnetoresistance, magnetic tunnel junctions, giant magnetoimpedance, magnetostrictive / piezoelectric composites, magnetosensitive diodes, magnetosensitive transistors, optical fibers, magneto-optics, and magnetic sensors based on micro-electromechanical systems, among others.
[0309] In one aspect, the position sensor 472 for the tracking system 480 including the absolute positioning system includes a magnetic rotation absolute positioning system. The position sensor 472 can be implemented as an AS5055EQFT monolithic magnetic rotation position sensor, which can be purchased from Austria Microsystems, AG. The position sensor 472 interfaces with the microcontroller 461 to provide an absolute positioning system. The position sensor 472 is a low voltage and low power device and includes four Hall effect elements in the area of the position sensor 472 located on the magnet. A high resolution ADC and an intelligent power management controller are also provided on the chip. A coordinate rotation digital computer (CORDIC) processor (also known as the bitwise method and Volder algorithm) is provided to perform a simple and efficient algorithm to calculate hyperbolic and trigonometric functions, which only requires addition, subtraction, digit shift and table lookup operations. The angular position, alarm bit and magnetic field information are transmitted to the microcontroller 461 via a standard serial communication interface (such as a serial peripheral interface (SPI) interface). The position sensor 472 provides 12 or 14 bit resolution. The position sensor 472 may be an AS5055 chip provided in a small QFN 16-pin 4×4×0.85 mm package.
[0310] The tracking system 480 including the absolute positioning system may include and / or may be programmed to implement a feedback controller such as a PID, state feedback, and an adaptive controller. The power source converts the signal from the feedback controller into a physical input to the system: in this case, a voltage. Other examples include PWM of voltage, current, and force. In addition to the position measured by the position sensor 472, other sensor(s) may be provided to measure physical parameters of the physical system. In some aspects, the other sensor(s) may include sensor arrangements such as those described in U.S. Patent 9,345,481, entitled STAPLE CARTRIDGE TISSUE THICKNESS, issued on May 24, 2016, which is incorporated herein by reference in its entirety; U.S. Patent Application Publication 2014 / 0263552, entitled STAPLE CARTRIDGE TISSUE THICKNESS, issued on September 18, 2014, which is incorporated herein by reference in its entirety; and U.S. Patent Application Serial No. 15 / 628,175, entitled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICAL STAPLING AND CUTTING INSTRUMENT, filed on June 20, 2017, which is incorporated herein by reference in its entirety. In a digital signal processing system, the absolute positioning system is coupled to a digital data acquisition system, where the output of the absolute positioning system will have a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuits to combine the calculated response with the measured response using an algorithm (such as weighted average and theoretical control loop) that drives the calculated response toward the measured response. The calculated response of the physical system takes into account characteristics such as mass, inertia, viscous friction, inductance and resistance to predict the state and output of the physical system by knowing the input.
[0311] Thus, the absolute positioning system provides the absolute position of the displacement member when the instrument is powered on, and does not retract or advance the displacement member to a reset (zero or home) position as may be required with conventional rotary encoders, which simply count the number of forward or backward steps taken by the motor 482 to infer the position of the device actuator, drive rod, knife, etc.
[0312] The sensor 474 (such as, for example, a strain gauge or a micro strain gauge) is configured to be able to measure one or more parameters of the end effector, such as, for example, the magnitude of the strain applied to the anvil during the clamping operation, which can indicate the closing force applied to the anvil. The measured strain is converted into a digital signal and provided to the processor 462. Alternatively or in addition to the sensor 474, the sensor 476 (such as, for example, a load sensor) can measure the closing force of the anvil in the stapler or clamping arm applied by the closed drive system to the ultrasonic or electrosurgical instrument. The sensor 476 (such as, for example, a load sensor) can measure the firing force applied to the closing member of the clamping arm coupled to the surgical instrument or tool or the force applied by the clamping arm to the tissue in the jaws of the ultrasonic or electrosurgical instrument. Alternatively, a current sensor 478 can be used to measure the current consumed by the motor 482. The displacement member can also be configured to engage the clamping arm to open or close the clamping arm. The force sensor can be configured to be able to measure the clamping force on the tissue. The force required to advance the displacement member may correspond to, for example, the current consumed by the motor 482. The measured force is converted into a digital signal and provided to the processor 462.
[0313] In one form, a strain gauge sensor 474 can be used to measure the force applied to the tissue by the end effector. A strain gauge can be coupled to the end effector to measure the force on the tissue processed by the end effector. A system for measuring the force applied to the tissue grasped by the end effector includes a strain gauge sensor 474, such as, for example, a micro strain gauge, which is configured to be able to measure, for example, one or more parameters of the end effector. In one aspect, the strain gauge sensor 474 can measure the amplitude or magnitude of the strain applied to the jaw member of the end effector during the clamping operation, which can indicate tissue compression. The measured strain is converted into a digital signal and provided to the processor 462 of the microcontroller 461. The load sensor 476 can measure the force used to operate the knife element, for example, to cut the tissue captured between the anvil and the nail magazine. The load sensor 476 can measure the force used to operate the clamp arm element, for example, to capture the tissue between the clamp arm and the ultrasonic blade or the tissue between the clamp arm and the jaws of the electrosurgical instrument. A magnetic field sensor can be used to measure the thickness of the captured tissue. The measurement value of the magnetic field sensor can also be converted into a digital signal and provided to the processor 462.
[0314] The microcontroller 461 can characterize the corresponding values of the selected position of the firing member and / or the velocity of the firing member using the measurements of tissue compression, tissue thickness, and / or the force required to close the end effector measured by the sensors 474, 476, respectively. In one example, the memory 468 can store techniques, formulas, and / or lookup tables that can be used by the microcontroller 461 in the evaluation.
[0315] The control system 470 of the surgical instrument or tool may also include wired or wireless communication circuitry to communicate with the modular communication hub, such as Figure 8-11 as shown in .
[0316] Fig.13 A control circuit 500 is shown, which is configured to be able to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. The control circuit 500 may be configured to be able to implement various processes described herein. The circuit 500 may include a microcontroller, which 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 cause the processor 502 to execute machine instructions to implement various processes described herein when executed by the processor 502. The processor 502 may be any of a variety of single-core or multi-core processors known in the art. The memory circuit 504 may include a volatile storage medium and a non-volatile storage medium. The processor 502 may include an instruction processing unit 506 and an operation unit 508. The instruction processing unit may be configured to be able to receive instructions from the memory circuit 504 of the present disclosure.
[0317] Fig.14 Combinatorial logic circuit 510 is shown, which is configured to be able to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. Combinatorial logic circuit 510 can be configured to be able to implement various processes described herein. Combinatorial logic circuit 510 may include a finite state machine that includes combinatorial logic 512 that is configured to be able to receive data associated with a surgical instrument or tool at input 514, process the data through combinatorial logic 512, and provide output 516.
[0318] Fig.15 A sequential logic circuit 520 is shown that is configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. The sequential logic circuit 520 or the combinatorial logic 522 may be configured to implement the various processes described herein. The sequential logic circuit 520 may include a finite state machine. The sequential logic circuit 520 may include, for example, the combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store the current state of the finite state machine. In some cases, the sequential logic circuit 520 may be synchronous or asynchronous. The combinatorial logic 522 is configured to receive data associated with a surgical instrument or tool from an input 526, process the data through the combinatorial logic 522, and provide an output 528. In other aspects, the circuit may include a processor (e.g., the processor 502, Fig.13) and a finite state machine to implement the various processes herein. In other embodiments, the finite state machine may include a combinational logic circuit (e.g., combinational logic circuit 510, Fig.14 ) and a sequential logic circuit 520.
[0319] Fig.16 A surgical instrument or tool is shown that includes multiple motors that can be activated to perform various functions. In some cases, a first motor can be activated to perform a first function, a second motor can be activated to perform a second function, and a third motor can be activated to perform a third function. In some cases, multiple motors of the robotic surgical instrument 600 can be individually activated to cause a firing motion, a closing motion, and / or an articulation motion in an end effector. The firing motion, the closing motion, and / or the articulation motion can be transmitted to the end effector, for example, via a shaft assembly.
[0320] In some cases, the surgical instrument system or tool may include a firing motor 602. The firing motor 602 may be operably coupled to a firing motor drive assembly 604, which may be configured to transmit the firing motion generated by the motor 602 to the end effector, specifically for displacing the clamp arm closure member. The closure member may be retracted by reversing the direction of the motor 602, which also causes the clamp arm to open.
[0321] In some cases, the surgical instrument or tool may include a closing motor 603. The closing motor 603 may be operably coupled to a closing motor drive assembly 605, which is configured to be able to transmit the closing motion generated by the motor 603 to the end effector, specifically for displacing the closing tube to close the anvil and compressing the tissue between the anvil and the staple cartridge. The closing motor 603 may be operably coupled to a closing motor drive assembly 605, which is configured to be able to transmit the closing motion generated by the motor 603 to the end effector, specifically for displacing the closing tube to close the clamping arm and compressing the tissue between the clamping arm and the ultrasonic blade or jaw member of the electrosurgical device. The closing motion may, for example, cause the end effector to transition from an open configuration to a close configuration to capture tissue. The end effector may be transitioned to an open position by reversing the direction of the motor 603.
[0322] In some cases, a surgical instrument or tool may include, for example, one or more articulation motors 606a, 606b. The motors 606a, 606b may be operably coupled to respective articulation motor drive assemblies 608a, 608b, which may be configured to transmit articulation generated by the motors 606a, 606b to an end effector. In some cases, articulation may cause the end effector to articulate relative to an axis, for example.
[0323] As described above, the surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of the surgical instrument or tool may be individually or independently activated to perform one or more functions, while other motors remain inactive. For example, articulation motors 606a, 606b may be activated to articulate the end effector, while firing motor 602 remains inactive. Alternatively, firing motor 602 may be activated to fire multiple nails and / or advance the cutting edge, while articulation motor 606 remains inactive. In addition, closing motor 603 may be activated simultaneously with firing motor 602 to advance the closing tube or closing member toward the distal side, as described in more detail below.
[0324] In some cases, a surgical instrument or tool may include a common control module 610 that can be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 can adjust one of the multiple motors at a time. For example, the common control module 610 can be individually coupled to multiple motors of the surgical instrument and can be separated from the multiple motors of the surgical instrument. In some cases, multiple motors of the surgical instrument or tool can share one or more common control modules such as the common control module 610. In some cases, multiple motors of the surgical instrument or tool can independently and selectively engage the common control module 610. In some cases, the common control module 610 can switch from interfacing with one of the multiple motors of the surgical instrument or tool to interfacing with another of the multiple motors of the surgical instrument or tool.
[0325] In at least one example, the common control module 610 can selectively switch between operably engaging the articulation motors 606a, 606b and operably engaging the firing motor 602 or the closing motor 603. Fig.16 As shown in , the switch 614 can move or change between multiple positions and / or states. In the first position 616, the switch 614 can electrically couple the common control module 610 to the firing motor 602; in the second position 617, the switch 614 can electrically couple the common control module 610 to the closing motor 603; in the third position 618a, the switch 614 can electrically couple the common control module 610 to the first joint motion motor 606a; and in the fourth position 618b, the switch 614 can electrically couple the common control module 610 to, for example, the second joint motion motor 606b. In some cases, a separate common control module 610 can be electrically coupled to the firing motor 602, the closing motor 603, and the joint motion motors 606a, 606b at the same time. In some cases, the switch 614 can be a mechanical switch, an electromechanical switch, a solid-state switch, or any suitable switch mechanism.
[0326] Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector may be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of the motor used to actuate the jaws.
[0327] In various cases, such as Fig.16 As shown in , the common control module 610 may include a motor driver 626, which may include one or more H-bridge field effect FETs. The motor driver 626 may regulate the power transmitted from a power source 628 to a motor coupled to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In some cases, when a motor is coupled to the common control module 610, the microcontroller 620 may be used, for example, to determine the current consumed by the motor, as described above.
[0328] In some cases, microcontroller 620 may include a microprocessor 622 ("processor") and one or more non-transitory computer-readable media or storage units 624 ("memory"). In some cases, memory 624 may store various program instructions that, when executed, may cause processor 622 to perform a number of functions and / or calculations described herein. In some cases, one or more of storage units 624 may be coupled to processor 622, for example. In various aspects, microcontroller 620 may communicate via wired or wireless channels, or a combination thereof.
[0329] In some cases, the power source 628 can be used, for example, to power the microcontroller 620. In some cases, the power source 628 can include a battery (or "battery pack" or "power pack"), such as a lithium-ion battery, for example. In some cases, the battery pack can be configured to be releasably mounted to the handle for powering the surgical instrument 600. Multiple battery cells connected in series can be used as the power source 628. In some cases, the power source 628 can be, for example, replaceable and / or rechargeable.
[0330] In various cases, the processor 622 may control the motor driver 626 to control the position, rotation direction, and / or speed of the motor coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and / or deactivate the motor coupled to the common controller 610. It should be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functions of the central processing unit (CPU) of a computer on one integrated circuit or at most several integrated circuits. The processor 622 is a multi-purpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides a result as output. Because the processor has internal memory, it is an example of sequential digital logic. The operating objects of the processor are numbers and symbols represented in the binary number system.
[0331] In one example, processor 622 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex produced by Texas Instruments. In some cases, microcontroller 620 may be, for example, LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improved performance above 40 MHz, 32KB of single-cycle SRAM, a 32-bit MCU loaded with Internal ROM for software, 2KB of EEPROM, one or more PWM modules, one or more QEI simulations, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Other microcontrollers can be easily substituted for use with module 4410. Therefore, the present disclosure should not be limited to this context.
[0332] In some cases, the memory 624 may include program instructions for controlling each of the motors of the surgical instrument 600 that may be coupled to the common controller 610. For example, the memory 624 may include program instructions for controlling the firing motor 602, the closing motor 603, and the articulation motors 606a, 606b. Such program instructions may cause the processor 622 to control the firing, closing, and articulation functions based on input from an algorithm or control program of the surgical instrument or tool.
[0333] In some cases, one or more mechanisms and / or sensors (such as, for example, sensor 630) can be used to alert the processor 622 of program instructions that should be used in a particular setting. For example, the sensor 630 can alert the processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In some cases, the sensor 630 can include, for example, a position sensor that can be used to sense the position of the switch 614. Thus, the processor 622 can use program instructions associated with firing a closing member of a clamping arm coupled to the end effector when, for example, the sensor 630 detects that the switch 614 is in the first position 616; the processor 622 can use program instructions associated with closing the anvil when, for example, the sensor 630 detects that the switch 614 is in the second position 617; and the processor 622 can use program instructions associated with articulating the end effector when, for example, the sensor 630 detects that the switch 614 is in the third position 618a or the fourth position 618b.
[0334] Fig.17 7 is a schematic diagram of a robotic surgical instrument 700 configured to operate the surgical tools described herein according to one aspect of the present disclosure. The robotic surgical instrument 700 can be programmed or configured to control distal / proximal translation of a displacement member, distal / proximal displacement of a closure tube, shaft rotation, and articulation with a single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to control a firing member, a closure member, an axis member, or one or more articulation members, or a combination thereof, individually. The surgical instrument 700 includes a control circuit 710 that is configured to control a motor-driven firing member, a closure member, an axis member, or one or more articulation members, or a combination thereof.
[0335] In one aspect, the robotic surgical instrument 700 includes a control circuit 710 configured to control the clamping arm 716 and the closing member 714 portion of the end effector 702, the ultrasonic blade 718 coupled to the ultrasonic transducer 719 excited by the ultrasonic generator 721, the shaft 740, and one or more joint motion members 742a, 742b via a plurality of motors 704a-704e. The position sensor 734 may be configured to provide position feedback of the closing member 714 to the control circuit 710. Other sensors 738 may be configured to provide feedback to the control circuit 710. The timer / counter 731 provides timing and counting information to the control circuit 710. An energy source 712 may be provided to operate the motors 704a-704e, and a current sensor 736 provides motor current feedback to the control circuit 710. The motors 704a-704e may be operated individually in open-loop or closed-loop feedback control by the control circuit 710.
[0336] In one aspect, the control circuit 710 may include one or more microcontrollers, microprocessors, or other suitable processors for executing instructions that cause the one or more processors to perform one or more tasks. In one aspect, the timer / counter 731 provides an output signal to the control circuit 710, such as an elapsed time or a digital count, to correlate the position of the closing member 714 as determined by the position sensor 734 with the output of the timer / counter 731, so that the control circuit 710 can determine the position of the closing member 714 at a specific time (t) relative to the starting position or the time (t) when the closing member 714 is in a specific position relative to the starting position. The timer / counter 731 can be configured to be able to measure elapsed time, count external events, or time external events.
[0337] In one aspect, the control circuit 710 can be programmed to control the function of the end effector 702 based on one or more tissue conditions. The control circuit 710 can be programmed to sense tissue conditions, such as thickness, directly or indirectly, as described herein. The control circuit 710 can be programmed to select a firing control program or a closing control program based on the tissue conditions. The firing control program can describe the distal movement of the displacement member. Different firing control programs can be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 710 can be programmed to translate the displacement member at a lower speed and / or at a lower power. When thinner tissue is present, the control circuit 710 can be programmed to translate the displacement member at a higher speed and / or at a higher power. The closing control program can control the closing force applied to the tissue by the clamping arm 716. Other control programs control the rotation of the shaft 740 and the articulation members 742a, 742b.
[0338] In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point signal may be provided to various motor controllers 708a-708e. The motor controllers 708a-708e may include one or more circuits configured to provide motor drive signals to the motors 704a-704e to drive the motors 704a-704e as described herein. In some examples, the motors 704a-704e may be brushed DC electric motors. For example, the speed of the motors 704a-704e may be proportional to the corresponding motor drive signals. In some examples, the motors 704a-704e may be brushless DC motors, and the corresponding motor drive signals may include PWM signals provided to one or more stator windings of the motors 704a-704e. Moreover, in some examples, the motor controllers 708a-708e may be omitted, and the control circuit 710 may directly generate the motor drive signals.
[0339] In some examples, the control circuit 710 may initially operate each of the motors 704a-704e in an open-loop configuration for a first open-loop portion of the travel of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the travel, the control circuit 710 may select a firing control program in a closed-loop configuration. The response of the instrument may include the translation distance of the displacement member during the open-loop portion, the time consumed during the open-loop portion, the energy provided to one of the motors 704a-704e during the open-loop portion, the sum of the pulse widths of the motor drive signal, etc. After the open-loop portion, the control circuit 710 may implement the selected firing control program for a second portion of the travel of the displacement member. For example, during the closed-loop portion of the travel, the control circuit 710 may modulate one of the motors 704a-704e based on the translation data describing the position of the displacement member in a closed-loop manner to cause the displacement member to translate at a constant speed.
[0340] In one aspect, the motors 704a-704e may receive power from the energy source 712. The energy source 712 may be a DC power source driven by a main AC power source, a battery, a supercapacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to separate movable mechanical elements, such as the closing member 714, the clamping arm 716, the shaft 740, the articulation 742a, and the articulation 742b, via corresponding transmissions 706a-706e. The transmissions 706a-706e may include one or more gears or other linkage devices to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the closing member 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicating the position of the closing member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 when the closing member 714 is translated toward the distal and proximal sides. The control circuit 710 can track the pulses to determine the position of the closing member 714. Other suitable position sensors can be used, including, for example, proximity sensors. Other types of position sensors can provide other signals indicating the movement of the closing member 714. Moreover, in some examples, the position sensor 734 can be omitted. In the case where the motors 704a-704e are stepper motors, the control circuit 710 can track the position of the closing member 714 by aggregating the number and direction of steps that the motor 704 has been commanded to perform. The position sensor 734 can be located in the end effector 702 or at any other part of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force, and has an encoder for sensing the rotation of the drive shaft.
[0341] In one aspect, the control circuit 710 is configured to be able to drive a firing member such as a closing member 714 portion of the end effector 702. The control circuit 710 provides a motor set point to a motor control 708a, which provides a drive signal to the motor 704a. The output shaft of the motor 704a is coupled to a torque sensor 744a. The torque sensor 744a is coupled to a transmission 706a, which is coupled to the closing member 714. The transmission 706a includes a movable mechanical element such as a rotating element and a firing member to control the movement of the closing member 714 along the longitudinal axis of the end effector 702 to the distal and proximal sides. In one aspect, the motor 704a can be coupled to a knife gear assembly, which includes a knife gear reduction group, and the knife gear reduction group includes a first knife drive gear and a second knife drive gear. The torque sensor 744a provides a firing force feedback signal to the control circuit 710. The firing force signal represents the force required to fire or displace the closing member 714. The position sensor 734 may be configured to provide the position of the closing member 714 along the firing stroke or the position of the firing member as a feedback signal to the control circuit 710. The end effector 702 may include an additional sensor 738 configured to provide a feedback signal to the control circuit 710. When ready for use, the control circuit 710 may provide a firing signal to the motor control 708a. In response to the firing signal, the motor 704a may drive the firing member from the proximal stroke start position toward the distal end of the stroke start position along the longitudinal axis of the end effector 702. When the closing member 714 translates toward the distal side, the clamping arm 716 closes toward the ultrasonic blade 718.
[0342] In one aspect, the control circuit 710 is configured to be able to drive a closing member, such as the clamping arm 716 portion of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708b, which provides a drive signal to the motor 704b. The output shaft of the motor 704b is coupled to a torque sensor 744b. The torque sensor 744b is coupled to a transmission 706b coupled to the clamping arm 716. The transmission 706b includes a movable mechanical element such as a rotating element and a closing member to control the movement of the clamping arm 716 from an open position and a closed position. In one aspect, the motor 704b is coupled to a closing gear assembly, which includes a closing reduction gear set supported to mesh with a closing spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal represents the closing force applied to the clamping arm 716. The position sensor 734 can be configured to be able to provide the position of the closing member as a feedback signal to the control circuit 710. The additional sensor 738 in the end effector 702 can provide a closing force feedback signal to the control circuit 710. The pivotable clamp arm 716 is positioned opposite the ultrasonic blade 718. When ready for use, the control circuit 710 can provide a closing signal to the motor control 708b. In response to the closing signal, the motor 704b advances the closing member to grasp the tissue between the clamp arm 716 and the ultrasonic blade 718.
[0343] In one aspect, the control circuit 710 is configured to enable a shaft member such as shaft 740 to rotate so that the end effector 702 rotates. The control circuit 710 provides a motor set point to the motor control 708c, which provides a drive signal to the motor 704c. The output shaft of the motor 704c is coupled to a torque sensor 744c. The torque sensor 744c is coupled to a transmission 706c coupled to the shaft 740. The transmission 706c includes a movable mechanical element such as a rotating element to control the shaft 740 to rotate clockwise or counterclockwise more than 360°. In one aspect, the motor 704c is coupled to a rotation transmission assembly, which includes a tube gear section formed on (or attached to) the proximal end of the proximal closure tube to be operably engaged by a rotation gear assembly operably supported on the tool mounting plate. The torque sensor 744c provides a rotational force feedback signal to the control circuit 710. The rotational force feedback signal represents the rotational force applied to the shaft 740. The position sensor 734 may be configured to provide the position of the closing member as a feedback signal to the control circuit 710. An additional sensor 738 such as a shaft encoder may provide the rotational position of the shaft 740 to the control circuit 710.
[0344] In one aspect, the control circuit 710 is configured to enable the end effector 702 to articulate. The control circuit 710 provides a motor set point to a motor control 708d, which provides a drive signal to a motor 704d. The output of the motor 704d is coupled to a torque sensor 744d. The torque sensor 744d is coupled to a transmission 706d coupled to the articulation member 742a. The transmission 706d includes a movable mechanical element such as an articulation element to control the articulation of the end effector 702 ± 65°. In one aspect, the motor 704d is coupled to an articulation nut that is rotatably journaled on a proximal end portion of the distal spine and rotatably driven thereon by an articulation gear assembly. The torque sensor 744d provides an articulation force feedback signal to the control circuit 710. The articulation force feedback signal represents the articulation force applied to the end effector 702. A sensor 738 , such as an articulation encoder, may provide the articulation position of the end effector 702 to the control circuit 710 .
[0345] On the other hand, the joint motion function of the robotic surgical system 700 may include two joint motion components or connecting rods 742a, 742b. These articulated components 742a, 742b are driven by a separate disk on the robot interface (rack) driven by two motors 708d, 708e. When a separate firing motor 704a is provided, each of the joint motion connecting rods 742a, 742b can be driven in an antagonistic manner relative to another connecting rod so as to provide resistance to the head to maintain motion and load when the head is not moving, and to provide joint motion when the head is articulated. When the head rotates, the joint motion components 742a, 742b are attached to the head with a fixed radius. Therefore, when the head rotates, the mechanical advantage of the push-pull connecting rod changes. This change in mechanical advantage can be more obvious for other joint motion connecting rod drive systems.
[0346] In one aspect, one or more motors 704a-704e may include a brushed DC motor with a gearbox and a mechanical link with a firing member, a closing member, or an articulation member. Another example includes an electric motor 704a-704e that operates a movable mechanical element such as a displacement member, an articulation link, a closing tube, and an axis. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body, and friction on a physical system. Such external influences may be referred to as drag, which acts relative to one of the electric motors 704a-704e. External influences such as drag may cause the operation of a physical system to deviate from the desired operation of the physical system.
[0347] In one aspect, the position sensor 734 can be implemented as an absolute positioning system. In one aspect, the position sensor 734 can include a magnetic rotation absolute positioning system implemented as an AS5055EQFT monolithic magnetic rotation position sensor, which can be purchased from Austria Microsystems, AG. The position sensor 734 can interface with the control circuit 710 to provide an absolute positioning system. The position can include a Hall effect element located above the magnet and coupled to a CORDIC processor, which is also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions, which only require addition operations, subtraction operations, digit shift operations, and table lookup operations.
[0348] In one aspect, the control circuit 710 can communicate with one or more sensors 738. The sensor 738 can be positioned on the end effector 702 and is adapted to operate with the robotic surgical instrument 700 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensor 738 can include a magnetic sensor, a magnetic field sensor, a strain gauge, a force sensor, a pressure sensor, a force sensor, a torque sensor, an inductive sensor such as an eddy current sensor, a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 702. The sensor 738 can include one or more sensors. The sensor 738 can be located on the clamping arm 716 to determine tissue position using segmented electrodes. The torque sensors 744a-744e can be configured to sense forces such as firing force, closing force, and / or joint motion force, etc. Thus, the control circuit 710 can sense (1) the closure load experienced by the distal closure tube and its position, (2) the firing member at the rack and its position, (3) the portion of the ultrasonic blade 718 on which the tissue is located, and (4) the loads and positions on the two articulation rods.
[0349] In one aspect, one or more sensors 738 may include a strain gauge, such as a micro strain gauge, which is configured to measure the magnitude of the strain in the clamping arm 716 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 738 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the clamping arm 716 and the ultrasonic blade 718. The sensor 738 may be configured to detect the impedance of the tissue section between the clamping arm 716 and the ultrasonic blade 718, which indicates the thickness and / or filling degree of the tissue located therebetween.
[0350] In one aspect, the sensor 738 may be implemented as one or more limit switches, electromechanical devices, solid-state switches, Hall effect devices, magnetoresistive (MR) devices, giant magnetoresistive (GMR) devices, magnetometers, and the like. In other implementations, the sensor 738 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switch may be a solid-state device, such as a transistor (e.g., a FET, a junction FET, a MOSFET, a bipolar transistor, and the like). In other implementations, the sensor 738 may include a non-electrical conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and the like.
[0351] In one aspect, the sensor 738 may be configured to be able to measure the force applied by the closure drive system to the clamp arm 716. For example, one or more sensors 738 may be located at the interaction point between the closure tube and the clamp arm 716 to detect the closing force applied by the closure tube to the clamp arm 716. The force applied to the anvil 716 may represent the tissue compression experienced by the tissue segment captured between the clamp arm 716 and the ultrasonic blade 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closing force applied by the closure drive system to the clamp arm 716. One or more sensors 738 may be sampled in real time by the processor of the control circuit 710 during the clamping operation. The control circuit 710 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to the clamp arm 716 in real time.
[0352] In one aspect, the current sensor 736 can be used to measure the current consumed by each of the motors 704a-704e. The force required to propel any of the movable mechanical elements (such as the closing member 714) corresponds to the current consumed by one of the motors 704a-704e. The force is converted into a digital signal and provided to the processor 710. The control circuit 710 can be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member can be actuated to move the closing member 714 in the end effector 702 at a target speed or close to the target speed. The robotic surgical system 700 may include a feedback controller, which may be one of any feedback controllers, including but not limited to, for example, PID, state feedback, linear square (LQR) and / or adaptive controllers. The robotic surgical instrument 700 may include a power source to, for example, convert a signal from the feedback controller into a physical input, such as a housing voltage, a PWM voltage, a frequency modulated voltage, a current, a torque and / or a force. Additional details are disclosed in U.S. patent application serial number 15 / 636,829, filed on June 29, 2017, entitled CLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT, which is incorporated herein by reference in its entirety.
[0353] Fig.18 A schematic diagram of a surgical instrument 750 configured to control distal translation of a displacement member according to one aspect of the present disclosure is shown. In one aspect, the surgical instrument 750 is programmed to control distal translation of a displacement member such as a closure member 764. The surgical instrument 750 includes an end effector 752, which may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
[0354] The position, movement, displacement and / or translation of a linear displacement member such as the closing member 764 can be measured by an absolute positioning system, a sensor arrangement and a position sensor 784. Since the closing member 764 is coupled to a longitudinally movable drive member, the position of the closing member 764 can be determined by measuring the position of the longitudinally movable drive member using the position sensor 784. Therefore, in the following description, the position, displacement and / or translation of the closing member 764 can be achieved by the position sensor 784 described herein. The control circuit 760 can be programmed to control the translation of a displacement member such as the closing member 764. In some examples, the control circuit 760 can include one or more microcontrollers, microprocessors or other suitable processors for executing instructions that cause the one or more processors to control the displacement member (e.g., the closing member 764) in the manner described. In one aspect, the timer / counter 781 provides an output signal, such as an elapsed time or a digital count, to the control circuit 760 to correlate the position of the closing member 764 as determined by the position sensor 784 with the output of the timer / counter 781 so that the control circuit 760 can determine the position of the closing member 764 at a particular time (t) relative to the starting position. The timer / counter 781 can be configured to be able to measure elapsed time, count external events, or time external events.
[0355] The control circuit 760 can generate a motor set point signal 772. The motor set point signal 772 can be provided to the motor controller 758. The motor controller 758 can include one or more circuits configured to provide a motor drive signal 774 to the motor 754 to drive the motor 754 as described herein. In some examples, the motor 754 can be a brushed DC electric motor. For example, the speed of the motor 754 can be proportional to the voltage of the motor drive signal 774. In some examples, the motor 754 can be a brushless DC electric motor, and the motor drive signal 774 can include a PWM signal provided to one or more stator windings of the motor 754. Moreover, in some examples, the motor controller 758 can be omitted, and the control circuit 760 can directly generate the motor drive signal 774.
[0356] The motor 754 may receive power from the energy source 762. The energy source 762 may be or include a battery, a supercapacitor, or any other suitable energy source. The motor 754 may be mechanically coupled to the closing member 764 via the transmission 756. The transmission 756 may include one or more gears or other connecting rod devices to couple the motor 754 to the closing member 764. The position sensor 784 may sense the position of the closing member 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicating the position of the closing member 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 when the closing member 764 is translated toward the distal and proximal sides. The control circuit 760 may track the pulses to determine the position of the closing member 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicating the movement of the closing member 764. Moreover, in some examples, the position sensor 784 may be omitted. Where motor 754 is a stepper motor, control circuit 760 can track the position of closure member 764 by summing the number and direction of steps motor 754 has been commanded to perform. Position sensor 784 may be located in end effector 752 or at any other portion of the instrument.
[0357] The control circuit 760 may communicate with one or more sensors 788. The sensor 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensor 788 may include a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 752. The sensor 788 may include one or more sensors.
[0358] In some cases, one or more sensors 788 may include a strain gauge, such as a micro strain gauge, which is configured to measure the magnitude of the strain in the clamping arm 766 during the clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may include a pressure sensor configured to detect the pressure generated by the presence of compressed tissue between the clamping arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect the impedance of the tissue section between the clamping arm 766 and the ultrasonic blade 768, which indicates the thickness and / or filling degree of the tissue located therebetween.
[0359] The sensor 788 may be configured to be able to measure the force applied by the closure drive system to the clamp arm 766. For example, one or more sensors 788 may be located at the interaction point between the closure tube and the clamp arm 766 to detect the closing force applied by the closure tube to the clamp arm 766. The force applied to the clamp arm 766 may represent the tissue compression experienced by the tissue segment captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closing force applied by the closure drive system to the clamp arm 766. One or more sensors 788 may be sampled in real time by the processor of the control circuit 760 during the clamping operation. The control circuit 760 receives real-time sample measurements to provide and analyze time-based information and evaluate the closing force applied to the clamp arm 766 in real time.
[0360] A current sensor 786 may be employed to measure the current consumed by the motor 754. The force required to advance the closure member 764 may correspond to, for example, the current consumed by the motor 754. The force is converted into a digital signal and provided to the processor 760.
[0361] The control circuit 760 can be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member can be actuated to move the closing member 764 in the end effector 752 at a target speed or close to the target speed. The surgical instrument 750 may include a feedback controller, which may be one of any feedback controllers, including but not limited to, for example, PID, state feedback, LQR and / or adaptive controllers. The surgical instrument 750 may include a power source to, for example, convert a signal from the feedback controller into a physical input, such as a housing voltage, a PWM voltage, a frequency modulated voltage, a current, a torque and / or a force.
[0362] The actual drive system of the surgical instrument 750 is configured to be able to drive the displacement member, cutting member or closing member 764 through a brushed DC motor with a gear box and a mechanical link to the joint motion and / or knife system. Another example is an electric motor 754 that operates the displacement member and joint motion drive of, for example, an interchangeable shaft assembly. External influences are the unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on the physical system. Such external influences can be referred to as drag forces acting relative to the electric motor 754. External influences such as drag forces can cause the operation of the physical system to deviate from the desired operation of the physical system.
[0363] Various exemplary aspects relate to a surgical instrument 750, which includes an end effector 752 with a motor-driven surgical sealing and cutting embodiment. For example, a motor 754 can drive a displacement member distally and proximally along the longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamping arm 766, and when configured to be usable, an ultrasonic blade 768 is positioned relative to the clamping arm 766. The clinician can grasp the tissue between the clamping arm 766 and the ultrasonic blade 768, as described herein. When the instrument 750 is ready to be used, the clinician can provide a firing signal, such as by pressing the trigger of the instrument 750. In response to the firing signal, the motor 754 can drive the displacement member from the proximal stroke start position distally along the longitudinal axis of the end effector 752 to the stroke end position distal to the stroke start position. When the displacement member is translated distally, a closing member 764 having a cutting element positioned at the distal end can cut the tissue between the ultrasonic blade 768 and the clamping arm 766.
[0364] In various examples, the surgical instrument 750 may include a control circuit 760 that is programmed to control the distal translation of a displacement member, such as a closure member 764, based on one or more tissue conditions. The control circuit 760 may be programmed to sense tissue conditions, such as thickness, directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on the tissue condition. The control program may describe the distal movement of the displacement member. Different control programs may be selected to better handle different tissue conditions. For example, when thicker tissue is present, the control circuit 760 may be programmed to translate the displacement member at a lower speed and / or at a lower power. When thinner tissue is present, the control circuit 760 may be programmed to translate the displacement member at a higher speed and / or at a higher power.
[0365] In some examples, the control circuit 760 can initially operate the motor 754 in an open-loop configuration for a first open-loop portion of the displacement member's travel. Based on the response of the instrument 750 during the open-loop portion of the travel, the control circuit 760 can select a firing control program. The response of the instrument can include the distance the displacement member is translated during the open-loop portion, the time elapsed during the open-loop portion, the energy provided to the motor 754 during the open-loop portion, the sum of the pulse widths of the motor drive signal, etc. After the open-loop portion, the control circuit 760 can implement the selected firing control program for a second portion of the displacement member's travel. For example, during the closed-loop portion of the travel, the control circuit 760 can modulate the motor 754 based on the translation data describing the position of the displacement member in a closed-loop manner to cause the displacement member to translate at a constant speed. Additional details are disclosed in U.S. patent application serial number 15 / 720,852, filed on September 29, 2017, entitled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICAL INSTRUMENT, which is incorporated herein by reference in its entirety.
[0366] Fig.19 Schematic diagram of a surgical instrument 790 configured to control various functions according to one aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control the distal translation of a displacement member such as a closure member 764. The surgical instrument 790 includes an end effector 792, which may include a clamping arm 766, a closure member 764, and an ultrasonic blade 768, which may be interchangeable with or in conjunction with one or more RF electrodes 796 (shown in dotted lines). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
[0367] In one aspect, the sensor 788 may be implemented as a limit switch, an electromechanical device, a solid-state switch, a Hall effect device, an MR device, a GMR device, a magnetometer, and the like. In other implementations, the sensor 638 may be implemented as a solid-state switch that operates under the influence of light, such as an optical sensor, an IR sensor, an ultraviolet sensor, and the like. Likewise, the switch may be a solid-state device, such as a transistor (e.g., a FET, a junction FET, a MOSFET, a bipolar transistor, and the like). In other implementations, the sensor 788 may include a non-electrical conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and the like.
[0368] In one aspect, the position sensor 784 can be implemented as an absolute positioning system including a monolithic magnetic rotary position sensor implemented as an AS5055EQFT, available from Austria Microsystems, AG. The position sensor 784 interfaces with the controller 760 to provide an absolute positioning system. The position can include a Hall effect element located above a magnet and coupled to a CORDIC processor, also known as a bitwise method and Volder algorithm, which is provided to implement a simple and efficient algorithm for calculating hyperbolic and trigonometric functions, which only require addition operations, subtraction operations, bit shift operations, and table lookup operations.
[0369] In some examples, the position sensor 784 may be omitted. Where the motor 754 is a stepper motor, the control circuit 760 may track the position of the closure member 764 by aggregating the number and direction of steps the motor has been commanded to perform. The position sensor 784 may be located in the end effector 792 or at any other portion of the instrument.
[0370] The control circuit 760 may communicate with one or more sensors 788. The sensor 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derived parameters, such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensor 788 may include, for example, a magnetic sensor, a magnetic field sensor, a strain gauge, a pressure sensor, a force sensor, an inductive sensor (such as an eddy current sensor), a resistive sensor, a capacitive sensor, an optical sensor, and / or any other suitable sensor for measuring one or more parameters of the end effector 792. The sensor 788 may include one or more sensors.
[0371] The RF energy source 794 is coupled to the end effector 792 and is applied to the RF electrode 796 when the RF electrode 796 is disposed in the end effector 792 to replace the ultrasonic blade 768 or to work in conjunction with the ultrasonic blade 768. For example, the ultrasonic blade is made of a conductive metal and can be used as a return path for the electrosurgical RF current. The control circuit 760 controls the delivery of RF energy to the RF electrode 796.
[0372] Additional details are disclosed in U.S. patent application serial number 15 / 636,096 filed on June 28, 2017, entitled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE AND RADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, which is incorporated herein by reference in its entirety.
[0373] Adaptive ultrasonic knife control algorithm
[0374] In various aspects, the intelligent ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic scalpel. In one aspect, the ultrasonic scalpel adaptive control algorithm is configured to be able to identify tissue types and adjust device parameters. In one aspect, the ultrasonic scalpel control algorithm is configured to be able to parameterize tissue types. The following section of the present disclosure describes an algorithm for detecting the collagen / elasticity ratio of tissue to tune the amplitude of the distal end of the ultrasonic scalpel. This article is combined with, for example, Figure 1-9 4 describes various aspects of the intelligent ultrasonic energy device. Therefore, the following description of the adaptive ultrasonic knife control algorithm should be combined with Figure 1-9 4 and the description associated with it.
[0375] Tissue type identification and device parameter adjustment
[0376] In certain surgical procedures, it is desirable to use an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm can be used to adjust the parameters of an ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, the parameters of an ultrasonic device can be adjusted based on the position of the tissue in the jaws of an ultrasonic end effector (e.g., the position of the tissue between the clamping arm and the ultrasonic blade). The impedance of an ultrasonic transducer can be used to distinguish the percentage of tissue in the distal end or proximal end of the end effector. The response of the ultrasonic device can be based on the type of tissue or the compressibility of the tissue. On the other hand, the parameters of the ultrasonic device can be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal end of the ultrasonic blade can be tuned based on the ratio of collagen to elastin tissue detected during the tissue identification process. The ratio of collagen to elastin tissue can be detected using a variety of techniques, including infrared (IR) surface reflectivity and specific emissivity. The force applied to the tissue by the clamping arm and / or the stroke of the clamping arm to produce gaps and compression. The electrical continuity across the jaws equipped with electrodes can be used to determine the percentage of the jaws covered by tissue.
[0377] Fig. 20The system 800 is configured to be capable of executing an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to be capable of executing the adaptive ultrasonic blade control algorithm as described herein with reference to Figure 53-10 5. In another aspect, the device / instrument 235 is configured to be able to perform the adaptive ultrasonic blade control algorithm(s) 802 described herein. Figure 53-10 5. In another aspect, both the device / instrument 235 and the device / instrument 235 are configured to be able to perform the adaptive ultrasonic blade control algorithm 804 described herein. Figure 53-10 5. The adaptive ultrasonic knife control algorithm 802, 804 described in FIG.
[0378] The generator module 240 may include a patient isolation stage that communicates with a non-isolated stage via a power transformer. The secondary winding of the power transformer is contained in the isolation stage and may include a tapping configuration (e.g., a center tap or a non-center tap configuration) to define a drive signal output that is used to deliver the drive signal to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multifunctional surgical instruments that include ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. Specifically, the drive signal output may output an ultrasonic drive signal (e.g., a 420V root mean square (RMS) drive signal) to the ultrasonic surgical instrument 241, and the drive signal output may output an RF electrosurgical drive signal (e.g., a 100V RMS drive signal) to the RF electrosurgical instrument 241. Reference is made herein to Figure 21-28B Aspects of the generator module 240 are described.
[0379] The generator module 240 or the device / instrument 235 or both are coupled to a modular control tower 236 that is connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in the operating room, as described with reference to FIG. Figure 8-11 Said, for example.
[0380] Generator Hardware
[0381] Fig.21 An example of a generator 900 is shown, which is a form of a generator that is configured to be coupled to an ultrasonic device and further configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, such as Fig. 20As shown in . Generator 900 is configured to be able to deliver multiple energy modes to surgical instruments. Generator 900 provides RF signals and ultrasonic signals for independently or simultaneously delivering energy to surgical instruments. RF signals and ultrasonic signals can be provided separately or in combination, and can be provided simultaneously. As described above, at least one generator output can deliver multiple energy modes (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation and / or microwave energy, etc.) through a single port, and these signals can be delivered to the end effector separately or simultaneously to treat tissue. Generator 900 includes a processor 902 coupled to a waveform generator 904. Processor 902 and waveform generator 904 are configured to be able to generate various signal waveforms based on information stored in a memory coupled to processor 902, and the memory is not shown for clarity of this disclosure. Digital information associated with the waveform is provided to waveform generator 904, which includes one or more DAC circuits to convert digital input into analog output. The analog output is fed to amplifier 1106 for signal conditioning and amplification. The conditioned and amplified output of amplifier 906 is coupled to power transformer 908. The signal is coupled to the secondary side in the patient isolation side through power transformer 908. The first signal of the first energy modality is provided to the secondary side labeled ENERGY 1 A second signal of the second energy mode is coupled across capacitor 910 and provided to a terminal labeled ENERGY 2 and RETURN terminals of the surgical instrument. It should be understood that more than two energy modes may be output, and thus the subscript "n" may be used to specify that up to n ENERGY modes may be provided. n Terminal, where n is a positive integer greater than 1. It should also be understood that up to n return paths RETURN may be provided without departing from the scope of the present disclosure. n .
[0382] The first voltage sensing circuit 912 is coupled to a voltage labeled ENERGY 1 and RETURN paths to measure the output voltage therebetween. The second voltage sensing circuit 924 is coupled to the terminals labeled ENERGY 2and RETURN path terminals to measure the output voltage therebetween. As shown, the current sensing circuit 914 is arranged in series with the RETURN branch of the secondary side of the power transformer 908 to measure the output current of any energy mode. If a different return path is provided for each energy mode, a separate current sensing circuit should be provided in each return branch. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to the corresponding isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The outputs of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (non-patient isolation side) are provided to one or more ADC circuits 926. The digitized output of the ADC circuit 926 is provided to the processor 902 for further processing and calculation. The output voltage and output current feedback information can be used to adjust the output voltage and current provided to the surgical instrument, and calculate parameters such as output impedance. The input / output communication between the processor 902 and the patient isolation circuit is provided by the interface circuit 920. The sensor may also be in electrical communication with the processor 902 via the interface 920 .
[0383] In one aspect, the impedance may be determined by processor 902 by coupling the 1 A first voltage sensing circuit 912 across the / RETURN terminal or coupled to the terminal labeled ENERGY 2 The output of the second voltage sensing circuit 924 across the terminals of / RETURN is determined by dividing the output of the current sensing circuit 914 arranged in series with the RETURN branch on the secondary side of the power transformer 908. The outputs of the first voltage sensing circuit 912 and the second voltage sensing circuit 924 are provided to separate isolation transformers 916, 922, and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for use in calculating the impedance. For example, the first energy mode ENERGY 1 It can be ultrasonic energy, and the second energy mode ENERGY 2 It may be RF energy. However, in addition to ultrasound and bipolar or monopolar RF energy modalities, other energy modalities include irreversible and / or reversible electroporation and / or microwave energy, etc. Moreover, although Fig.21 The example shown in FIG. 1 shows that a single return path RETURN may be provided for two or more energy modes, but in other aspects, a single return path RETURN may be provided for each energy mode ENERGY n Provide multiple return paths RETURN nThus, as described herein, ultrasound transducer impedance may be measured by dividing the output of the first voltage sensing circuit 912 by the output of the current sensing circuit 914 , and tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914 .
[0384] like Fig.21 As shown in , a generator 900 including at least one output port may include a power transformer 908 having a single output and multiple taps to provide power to an end effector in the form of one or more energy modalities (such as ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, etc.), for example, depending on the type of tissue treatment being performed. For example, the generator 900 may deliver energy with a higher voltage and lower current to drive an ultrasonic transducer, deliver energy with a lower voltage and higher current to drive an RF electrode for sealing tissue, or deliver energy with a coagulation waveform for use with monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 900 may be manipulated, switched, or filtered to provide a frequency to the end effector of the surgical instrument. The connection of the ultrasonic transducer to the output of the generator 900 will preferably be located at the position marked as ENERGY 1 and RETURN output, such as Fig.21 In one example, the connection of the RF bipolar electrodes to the generator 900 output will preferably be located at the position marked ENERGY 2 In the case of a unipolar output, the preferred connection would be from the active electrode (e.g., pencil or other probe) to the ENERGY 2 output and connect to a suitable return pad for the RETURN output.
[0385] Additional details are disclosed in U.S. patent application publication 2017 / 0086914, entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS, published on March 30, 2017, which is incorporated herein by reference in its entirety.
[0386] As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communication channels, etc. that can transmit data through a non-solid medium using modulated electromagnetic radiation. The term does not mean that the associated organization does not contain any wires, although in some aspects they may not. The communication module may implement any of a variety of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE 802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, Bluetooth, and its Ethernet derivatives, and any other wireless and wired protocols designated as 3G, 4G, 5G and above. The computing module may include multiple communication modules. For example, the first communication module may be dedicated to shorter-range wireless communications such as Wi-Fi and Bluetooth, and the second communication module may be dedicated to longer-range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, etc.
[0387] As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source (usually a memory or some other data stream). The term is used herein to refer to a central processing unit (Central Processing Unit) in one or more systems (especially System on Chip (SoC)) that combine multiple specialized "processors".
[0388] As used herein, a system on a chip or system on a chip (SoC or SOC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all the components of a computer or other electronic system. It can contain digital, analog, mixed signal, and often radio frequency functions - all on a single substrate. A SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a graphics processing unit (GPU), a Wi-Fi module, or a coprocessor. A SoC may or may not include built-in memory.
[0389] As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuits and memory. A microcontroller (or MCU for a microcontroller unit) can be implemented as a small computer on a single integrated circuit. It can be similar to a SoC; an SoC may include a microcontroller as one of its devices. A microcontroller may include one or more core processing units (CPUs) as well as memory and programmable input / output peripherals. Program memory in the form of ferroelectric RAM, NOR flash memory, or OTP ROM, as well as a small amount of RAM, is also often included on the chip. Compared to microprocessors used in personal computers or other general-purpose applications consisting of various discrete chips, microcontrollers can be used for embedded applications.
[0390] As used herein, the term controller or microcontroller may be a stand-alone IC or chip device that interfaces with peripheral devices. This may be a link between the two components of a computer or a controller on an external device that manages the operation of the device (and the connection to the device).
[0391] Any of the processors or microcontrollers described herein may be any single-core or multi-core processor, such as those offered by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be, for example, the LM4F230H5QR ARMCortex-M4F processor core available from Texas Instruments, which includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improving performance beyond 40 MHz, 32KB of single-cycle serial random access memory (SRAM), a 32-bit MCU loaded with 128-bit MCUs, and a 32-bit MCU. Internal read-only memory (ROM) for software, 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder input (QEI) simulations, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features that are readily available.
[0392] In one example, the processor may include a safety controller including two families based on controllers such as the TMS570 and RM4x also offered by Texas Instruments under the trade name Hercules ARMCortex R4. The safety controller may be configured to be capable of being specifically used for IEC 61508 and ISO 26262 safety critical applications, among others, to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
[0393] The modular device includes a module that can be accommodated in a surgical hub (such as a combination of Figure 3 and Fig. 9The invention relates to a surgical device or instrument that can be connected to various modules so as to be connected or paired with a corresponding surgical hub. The modular device includes, for example, intelligent surgical instruments, medical imaging devices, suction / irrigation devices, smoke evacuators, energy generators, ventilators, insufflators, and displays. The modular device described herein can be controlled by a control algorithm. The control algorithm can be executed on the modular device itself, on a surgical hub paired with a specific modular device, or on both the modular device and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device through the modular device). The data can be related to the patient being operated on (e.g., tissue properties or insufflation pressure) or the modular device itself (e.g., the rate at which the knife is advanced, the motor current, or the energy level). For example, the control algorithm of a surgical suturing and cutting instrument can control the rate at which the motor of the instrument drives its knife through the tissue according to the resistance encountered by the knife as it advances.
[0394] Fig. 22 One form of a surgical system 1000 is shown that includes a generator 1100 and various surgical instruments 1104, 1106, 1108 that can be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination ultrasonic / RF electrosurgical instrument. The generator 1100 may be configured to be capable of use with a variety of surgical devices. According to various forms, the generator 1100 may be configured to be capable of use with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates simultaneous delivery of RF energy and ultrasonic energy from the generator 1100. Although in Fig. 22 In one form, the generator 1100 is shown as being separate from the surgical instruments 1104, 1106, 1108, however in one form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. The generator 1100 includes an input device 1110 located on a front panel of the console of the generator 1100. The input device 1110 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. The generator 1100 may be configured to enable wired or wireless communication.
[0395] The generator 1100 is configured to be able to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 acoustically coupled to the ultrasonic transducer 1120. The handpiece 1105 includes a trigger 1143 for operating the clamp arm 1140 and a combination of switch buttons 1134a, 1134b, 1134c for energizing the ultrasonic blade 1128 and driving the ultrasonic blade 1128 or other functions. The switch buttons 1134a, 1134b, 1134c can be configured to be able to energize the ultrasonic transducer 1120 with the generator 1100.
[0396] The generator 1100 is also configured to be able to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a handpiece 1107 (HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamping arms 1142a, 1142b and returns through the electrical conductor portion of the shaft 1127. These electrodes are coupled to and powered by a bipolar energy source within the generator 1100. The handpiece 1107 includes a trigger 1145 for operating the clamping arms 1142a, 1142b and an energy button 1135 for actuating an energy switch to power the electrodes in the end effector 1124.
[0397] The generator 1100 is also configured to be able to drive a multifunctional surgical instrument 1108. The multifunctional surgical instrument 1108 includes a handpiece 1109 (HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a trigger 1147 for operating the clamp arm 1146 and a combination of switch buttons 1137a, 1137b, 1137c for energizing the ultrasonic blade 1149 and driving the ultrasonic blade 1149 or other functions. The switch buttons 1137a, 1137b, 1137c can be configured to be able to energize the ultrasonic transducer 1120 with the generator 1100, and to energize the ultrasonic blade 1149 with a bipolar energy source also included in the generator 1100.
[0398] The generator 1100 may be configured to be usable with a variety of surgical devices. According to various forms, the generator 1100 may be configurable to be usable with different surgical instruments of different types, including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multi-function surgical instrument 1108 that integrates simultaneous delivery of RF energy and ultrasonic energy from the generator 1100. Although Fig. 22 In one form, the generator 1100 is shown as being separate from the surgical instruments 1104, 1106, 1108, however in another form, the generator 1100 may be integrally formed with any of the surgical instruments 1104, 1106, 1108 to form an integrated surgical system. As discussed above, the generator 1100 includes an input device 1110 located on the front panel of the generator 1100 console. The input device 1110 may include any suitable device that generates a signal suitable for programming the operation of the generator 1100. The generator 1100 may also include one or more output devices 1112. Additional aspects of generators and surgical instruments for digitally generating electrical signal waveforms are described in U.S. Patent Publication US-2017-0086914-A1, which is incorporated herein by reference in its entirety.
[0399] Fig.23 1 is an end effector 1122 of an example ultrasonic device 1104 according to at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128, which may be coupled to an ultrasonic transducer 1120 via a waveguide. When driven by the ultrasonic transducer 1120, the blade 1128 may vibrate and, when in contact with tissue, may cut and / or coagulate tissue, as described herein. According to various aspects, and as Fig.23 As shown in FIG. 1 , the end effector 1122 may also include a clamp arm 1140 that may be configured to cooperate with the knife 1128 of the end effector 1122. With the knife 1128, the clamp arm 1140 may include a set of jaws. The clamp arm 1140 may be pivotally connected at the distal end of the shaft 1126 of the instrument portion 1104. The clamp arm 1140 may include a clamp arm tissue pad 1163, which may be provided by or other suitable low friction material. Pad 1163 may be mounted for cooperation with knife 1128, wherein pivotal movement of clamp arm 1140 positions clamp pad 1163 substantially parallel to and in contact with knife 1128. With this configuration, tissue to be clamped may be grasped between tissue pad 1163 and knife 1128. Tissue pad 1163 may have a serrated configuration including a plurality of axially spaced proximally extending grasping teeth 1161 to enhance the grasping of tissue in cooperation with knife 1128. Clamp arm 1140 may be moved from Fig.23 1128 to a closed position (wherein the clamp arm 1140 is in contact with or proximate to the knife 1128) in any suitable manner. For example, the handpiece 1105 may include a jaw closure trigger. When actuated by the clinician, the jaw closure trigger may pivot the clamp arm 1140 in any suitable manner.
[0400] The generator 1100 may be activated to provide a drive signal to the transducer 1120 in any suitable manner. For example, the generator 1100 may include a foot switch 1430 ( Fig.24 ), the foot switch 1430 is coupled to the generator 1100 via a foot switch cable 1432. The clinician can activate the ultrasonic transducer 1120 by depressing the foot switch 1430, and thereby activate the ultrasonic transducer 1120 and the blade 1128. In addition, or as an alternative to the foot switch 1430, some aspects of the device 1104 can utilize one or more switches located on the handpiece 1105, which, when activated, can cause the generator 1100 to activate the transducer 1120. In one aspect, for example, the one or more switches can include a pair of toggle buttons 1134a, 1134b, 1134c ( Fig. 22 ) For example, to determine the operating mode of the device 1104. When the toggle button 1134a is pressed, for example, the ultrasonic generator 1100 may provide a maximum drive signal to the transducer 1120, thereby causing it to produce a maximum ultrasonic energy output. Pressing the toggle button 1134b may cause the ultrasonic generator 1100 to provide a user-selectable drive signal to the ultrasonic transducer 1120, thereby causing it to produce an ultrasonic energy output less than the maximum value. Additionally or alternatively, the device 1104 may include a second switch to, for example, indicate the position of a jaw closure trigger for operating the jaws via the clamping arm 1140 of the end effector 1122. In addition, in some aspects, the ultrasonic generator 1100 may be activated based on the position of the jaw closure trigger (e.g., when the clinician presses the jaw closure trigger to close the jaws via the clamping arm 1140, ultrasonic energy may be applied).
[0401] Additionally or alternatively, the one or more switches may include a toggle button 1134c that, when depressed, causes the generator 1100 to provide a pulsed output ( Fig. 22 ). The pulses may be provided, for example, at any suitable frequency and grouping. In some aspects, for example, the power level of the pulses may be the power level (maximum, less than maximum) associated with the toggle buttons 1134a, 1134b.
[0402] It should be understood that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c ( Fig. 22). For example, the device 1104 can be configured to have only two toggle buttons: a toggle button 1134a for generating maximum ultrasonic energy output and a toggle button 1134c for generating pulsed output at or less than the maximum power level. In this way, the drive signal output configuration of the generator 1100 can be five continuous signals, or any discrete number of single pulse signals (1, 2, 3, 4, or 5). In certain aspects, for example, a specific drive signal configuration can be controlled based on an EEPROM setting in the generator 1100 and / or (one or more) user power level selections.
[0403] In some aspects, a two-position switch may be provided to replace the toggle button 1134c ( Fig. 22 ). For example, the device 1104 may include a toggle button 1134a for producing a continuous output at a maximum power level and a two-position toggle button 1134b. In a first detent position, the toggle button 1134b may produce a continuous output at a power level less than the maximum power level, and in a second detent position, the toggle button 1134b may produce a pulsed output (e.g., at a maximum power level or less than the maximum power level, depending on the EEPROM setting).
[0404] In some aspects, the RF electrosurgical end effectors 1124, 1125 ( Fig. 22 ) may also include a pair of electrodes. The electrodes may communicate with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of tissue engagement between the clamp arms 1142a, 1146 and the blades 1142b, 1149. The generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. For example, the impedance of tissue engagement may be found by monitoring the current, voltage, etc. of the signal.
[0405] In various aspects, the generator 1100 may include several independent functional elements, such as modules and / or blocks, such as Fig.24 , Fig. 22 100. Different functional elements or modules can be configured to drive different kinds of surgical devices 1104, 1106, 1108. For example, an ultrasonic generator module can drive an ultrasonic device, such as ultrasonic surgical device 1104. An electrosurgery / RF generator module can drive an electrosurgery device 1106. For example, the module can generate a corresponding drive signal for driving surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and / or the electrosurgery / RF generator module can each be integrally formed with the generator 1100. Alternatively, one or more of the modules can be configured as a separate circuit module electrically coupled to the generator 1100. (The modules are shown in dashed lines to illustrate the portion.) In addition, in some aspects, the electrosurgery / RF generator module can be integrally formed with the ultrasonic generator module, or vice versa.
[0406] According to the described aspects, the ultrasonic generator module can generate one or more drive signals of a specific voltage, current, and frequency (e.g., 55,500 cycles per second or Hz). The one or more drive signals can be provided to the ultrasonic device 1104, in particular the transducer 1120, which can be operated, for example, as described above. In one aspect, the generator 1100 can be configured to generate a drive signal of a specific voltage, current, and / or frequency output signal that can be modified in terms of high resolution, accuracy, and reproducibility.
[0407] According to the described aspects, the electrosurgery / RF generator module can generate one or more drive signals having an output power sufficient to perform bipolar electrosurgery using radio frequency (RF) energy. In bipolar electrosurgery applications, the drive signals can be provided to, for example, electrodes of an electrosurgical device 1106, as described above. Thus, the generator 1100 can be configured to be used to achieve a therapeutic purpose by applying electrical energy to tissue sufficient to treat the tissue (e.g., coagulation, cauterization, tissue welding, etc.).
[0408] The generator 1100 may include an input device 2150 ( Fig.27B ). The input device 2150 may include any suitable device that generates signals suitable for programming the operation of the generator 1100. In operation, a user may use the input device 2150 to program or otherwise control the operation of the generator 1100. The input device 2150 may include any suitable device that generates signals that can be used by the generator (e.g., by one or more processors contained in the generator) to control the operation of the generator 1100 (e.g., the operation of the ultrasonic generator module and / or the electrosurgery / RF generator module). In various aspects, the input device 2150 includes one or more of the following: a button, a switch, a thumbwheel, a keyboard, a keypad, a touch screen monitor, a pointing device, a remote connection to a general purpose or special purpose computer. In other aspects, the input device 2150 may, for example, include a suitable user interface, such as one or more user interface screens displayed on a touch screen monitor, for example. Thus, through the input device 2150, a user can set or program various operating parameters of the generator, such as, for example, the current (I), voltage (V), frequency (f) and / or period (T) of one or more drive signals generated by the ultrasonic generator module and / or the electrosurgery / RF generator module.
[0409] The generator 1100 may also include an input device 2140 ( Fig.27B). Output device 2140 includes one or more devices for providing sensory feedback to the user. Such devices may include, for example, visual feedback devices (e.g., LCD display, LED indicator), audio feedback devices (e.g., speaker, buzzer) or tactile feedback devices (e.g., tactile actuator).
[0410] Although certain modules and / or blocks of the generator 1100 may be described by way of example, it is understood that a greater or lesser number of modules and / or blocks may be used and still fall within the scope of the aspects. In addition, although various aspects may be described in terms of modules and / or blocks for ease of description, such modules and / or blocks may be implemented by one or more hardware devices (e.g., processors, digital signal processors (DSPs), programmable logic devices (PLDs), application specific integrated circuits (ASICs), circuits, registers) and / or software devices (e.g., programs, subroutines, logic), and / or a combination of hardware devices and software devices.
[0411] In one aspect, the ultrasonic generator drive module and the electrosurgery / RF drive module 1110 ( Fig. 22 ) may include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. Modules may include various executable modules, such as software, programs, data, drivers, application programming interfaces (APIs), etc. The firmware may be stored in a non-volatile memory (NVM) such as a bit-masked read-only memory (ROM) or flash memory. In various implementations, storing the firmware in ROM may protect the flash memory. The NVM may include other types of memory, including, for example, a programmable ROM (PROM), an erasable programmable ROM (EPROM), an electrically erasable programmable ROM (EEPROM), or a battery-backed random access memory (RAM) such as a dynamic RAM (DRAM), a double data rate DRAM (DDRAM), and / or a synchronous DRAM (SDRAM)).
[0412] In one aspect, the module comprises a hardware device implemented as a processor for executing program instructions for monitoring various measurable characteristics of the devices 1104, 1106, 1108 and generating corresponding output drive signals for operating the devices 1104, 1106, 1108. In aspects where the generator 1100 is used in conjunction with the device 1104, the drive signal can drive the ultrasonic transducer 1120 in a cutting and / or coagulation mode of operation. Electrical characteristics of the device 1104 and / or tissue can be measured and used to control operational aspects of the generator 1100 and / or can be provided as feedback to a user. In aspects where the generator 1100 is used in conjunction with the device 1106, the drive signal can supply electrical energy (e.g., RF energy) to the end effector 1124 in a cutting, coagulation, and / or desiccation mode. Electrical characteristics of the device 1106 and / or tissue can be measured and used to control operational aspects of the generator 1100 and / or can be provided as feedback to a user. In various aspects, as previously described, the hardware device can be implemented as a DSP, PLD, ASIC, circuit and / or register. In one aspect, the processor can be configured to store and execute computer software program instructions to generate a step function output signal for driving various components of the apparatus 1104, 1106, 1108 (e.g., the ultrasonic transducer 1120 and the end effectors 1122, 1124, 1125).
[0413] The electromechanical ultrasonic system includes an ultrasonic transducer, a waveguide and an ultrasonic scalpel. The electromechanical ultrasonic system has an initial resonant frequency defined by the physical properties of the ultrasonic transducer, the waveguide and the ultrasonic scalpel. The ultrasonic transducer is excited by an alternating voltage V g (t)Signal and current I g (t) The resonant frequency of the signal is equal to the electromechanical ultrasonic system. When the ultrasonic electromechanical system is in resonance, the voltage V g (t)Signal and current I g (t) The phase difference between the signals is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. When the ultrasonic blade is heated, the compliance of the ultrasonic blade (modeled as an equivalent capacitor) causes the resonant frequency of the electromechanical ultrasonic system to shift. Therefore, the inductive impedance is no longer equal to the capacitive impedance, resulting in a mismatch between the drive frequency and the resonant frequency of the electromechanical ultrasonic system. The system now operates "off-resonance". The mismatch between the drive frequency and the resonant frequency is manifested as a voltage V applied to the ultrasonic transducer. g (t)Signal and current I g (t) The phase difference between the signals. The generator electronics can easily monitor the voltage V g (t)Signal and current I gThe phase difference between the (t) signals and the drive frequency can be continuously adjusted until the phase difference is zero again. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system. The change in phase and / or frequency can be used as an indirect measurement of the temperature of the ultrasonic knife.
[0414] like Fig.25 As shown in , the electromechanical characteristics of an ultrasonic transducer can be modeled as an equivalent circuit including a first branch having a static capacitance and a second "dynamic" branch having a series connection of an inductance, a resistance and a capacitance that define the electromechanical characteristics of the resonator. A known ultrasonic generator may include a tuning inductor for detuning the static capacitance at the resonant frequency so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using the tuning inductor, the generator's drive signal current represents the dynamic branch current, and the generator is thus able to control its drive signal to maintain the resonant frequency of the ultrasonic transducer. The tuning inductor can also transform the phase impedance diagram of the ultrasonic transducer to improve the generator's frequency locking capability. However, the tuning inductor must be matched to the specific static capacitance of the ultrasonic transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.
[0415] Fig.25 An equivalent circuit 1500 of an ultrasonic transducer such as ultrasonic transducer 1120 according to one aspect is shown. Circuit 1500 includes a series-connected inductor L having electromechanical properties defining a resonator. s , resistor R s and capacitor C s The first "dynamic" branch and the second capacitive branch with static capacitance C 0 . The driving voltage V g (t) receives the driving current I from the generator g (t), where the dynamic current I m (t) flows through the first branch and the current I g (t)-I m (t) flows through the capacitor branch. This can be achieved by properly controlling I g (t) and V g (t) to achieve control of the electromechanical characteristics of the ultrasonic transducer. As described above, a known generator architecture may include a tuned inductor L in a parallel resonant circuit. t (exist Fig.25 The tuning inductor is used to adjust the static capacitance C 0 is tuned to the resonant frequency so that the current output of the generator is substantially g All of (t) flows through the dynamic branch. In this way, by controlling the generator current output I g (t) to realize the dynamic branch current Im (t) is controlled. However, the tuning inductor L t The static capacitance C of the ultrasonic transducer 0 is specific, and different ultrasonic transducers with different static capacitances require different tuning inductors L t In addition, because the tuning inductor L t With the static capacitance C at a single resonant frequency 0 The nominal value of the dynamic branch current I is matched, so only at this frequency is the dynamic branch current I m As the frequency shifts downward with the temperature of the transducer, precise control of the motional branch current is compromised.
[0416] Various aspects of the generator 1100 may not rely on the tuning inductor L t To monitor the dynamic branch current I m (t). Instead, the generator 1100 may use a static capacitance C between the power applied for a particular ultrasonic surgical device 1104 0 The measured values of (together with the drive signal voltage and current feedback data) are used to determine the dynamic branch current I on a dynamic ongoing basis (e.g., in real time) m (t). Thus, such aspects of the generator 1100 are able to provide virtual tuning to simulate a tuned system or with a static capacitance C at any frequency. 0 resonance at any value, not just at the static capacitance C 0 The nominal value resonates at a single resonant frequency as indicated.
[0417] Fig.26 1100 is a simplified block diagram of one aspect of a generator 1100 that provides inductorless tuning as described above, among other benefits. Figures 27A-27C According to one aspect Fig.26 The architecture of the generator 1100. Fig.26, the generator 1100 may include a patient isolation stage 1520 that communicates with a non-isolated stage 1540 via a power transformer 1560. A secondary winding 1580 of the power transformer 1560 is included in the isolation stage 1520 and may include a tapping configuration (e.g., a center tap or a non-center tap configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to different surgical devices (such as, for example, an ultrasonic surgical device 1104 and an electrosurgical device 1106). Specifically, the drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to the ultrasonic surgical device 1104, and the drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to the electrosurgical device 1106, wherein the output 1060b corresponds to the center tap of the power transformer 1560. The non-isolated stage 1540 may include a power amplifier 1620 having an output connected to a primary winding 1640 of a power transformer 1560. In some aspects, the power amplifier 1620 may include, for example, a push-pull amplifier. The non-isolated stage 1540 may also include a programmable logic device 1660 for supplying a digital output to a digital-to-analog converter (DAC) 1680, which in turn supplies a corresponding analog signal to an input of the power amplifier 1620. In some aspects, the programmable logic device 1660 may include, for example, a field programmable gate array (FPGA). Since the input of the power amplifier 1620 is controlled via the DAC 1680, the programmable logic device 1660 may thus control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signal appearing at the drive signal outputs 1600a, 1600b, 1600c. In certain aspects and as described below, the programmable logic device 1660 in conjunction with a processor (e.g., the processor 1740 described below) may implement a plurality of digital signal processing (DSP) based algorithms and / or other control algorithms to control parameters of the drive signal output by the generator 1100.
[0418] Power may be supplied to the power rail of the power amplifier 1620 by the switch-mode regulator 1700. In certain aspects, the switch-mode regulator 1700 may include, for example, an adjustable buck regulator. As described above, the non-isolated stage 1540 may further include a processor 1740, which in one aspect may include a DSP processor such as an ADSP-21469 SHARC DSP, which is available from, for example, Analog Devices, Norwood, Mass. In certain aspects, the processor 1740 may control the operation of the switch-mode power converter 1700 in response to voltage feedback data received by the processor 1740 from the power amplifier 1620 via an analog-to-digital converter (ADC) 1760. In one aspect, for example, the processor 1740 may receive as input via the ADC 1760 a waveform envelope of a signal (e.g., an RF signal) being amplified by the power amplifier 1620. The processor 1740 can then control the switch mode regulator 1700 (e.g., via a pulse width modulation (PWM) output) so that the rail voltage supplied to the power amplifier 1620 tracks the waveform envelope of the amplified signal. By dynamically modulating the rail voltage of the power amplifier 1620 based on the waveform envelope, the efficiency of the power amplifier 1620 can be significantly improved relative to a fixed rail voltage amplifier solution. The processor 1740 can be configured to enable wired or wireless communications.
[0419] In some respects and as combined Figures 28A-28B As discussed in more detail, the programmable logic device 1660 in conjunction with the processor 1740 may implement a direct digital synthesizer (DDS) control scheme to control the waveform shape, frequency, and / or amplitude of the drive signal output by the generator 1100. In one aspect, for example, the programmable logic device 1660 may implement the DDS control algorithm 2680 by recalling waveform samples stored in a dynamically updated lookup table (LUT), such as a RAM LUT that may be embedded in an FPGA. Fig.28A). The control algorithm is particularly useful for ultrasonic applications in which an ultrasonic transducer such as ultrasonic transducer 1120 may be driven by a pure sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the overall distortion of the motional branch current may correspondingly minimize or reduce adverse resonant effects. Because the waveform shape of the drive signal output by the generator 1100 is affected by various sources of distortion present in the output drive circuit (e.g., power transformer 1560, power amplifier 1620), voltage and current feedback data based on the drive signal may be input into an algorithm (such as an error control algorithm implemented by processor 1740) that compensates for distortion by appropriately pre-distorting or modifying waveform samples stored in the LUT on a dynamically ongoing basis (e.g., in real time). In one form, the amount or degree of pre-distortion applied to the LUT samples may be based on the error between the calculated motional branch current and the desired current waveform shape, where the error may be determined on a sample-by-sample basis. In this manner, the pre-distorted LUT samples, when processed by the drive circuit, can cause the motional branch drive signal to have a desired waveform shape (e.g., a sinusoidal shape) to optimally drive the ultrasonic transducer. Thus, in such aspects, when the distortion effects are taken into account, the LUT waveform samples will therefore not represent the desired waveform shape of the drive signal, but rather the waveform shape required to ultimately produce the desired waveform shape of the motional branch drive signal.
[0420] The non-isolated stage 1540 may further include an ADC 1780 and an ADC 1800 coupled to the output of the power transformer 1560 via respective isolation transformers 1820, 1840 for respectively sampling the voltage and current of the drive signal output by the generator 1100. In certain aspects, the ADCs 1780, 1800 may be configured to be capable of sampling at a high speed (e.g., 80Msps) to enable oversampling of the drive signal. In one aspect, for example, the sampling speed of the ADCs 1780, 1800 may enable oversampling of the drive signal by approximately 200X (depending on the frequency). In certain aspects, the sampling operation of the ADCs 1780, 1800 may be performed by a single ADC that receives the input voltage signal and the current signal via a two-way multiplexer. By using high speed sampling in aspects of the generator 1100, among other things, calculations of complex currents flowing through the motional branches (which in some aspects can be used to implement the DDS-based waveform shape control described above), accurate digital filtering of the sampled signals, and calculation of actual power consumption with high accuracy can be achieved. The voltage and current feedback data output by the ADCs 1780, 1800 can be received and processed (e.g., FIFO buffering, multiplexing) by the programmable logic device 1660 and stored in a data memory for subsequent retrieval by, for example, the DSP processor 1740. As described above, the voltage and current feedback data can be used as input to an algorithm for pre-distorting or modifying LUT waveform samples in a dynamic and ongoing manner. In some aspects, when voltage and current feedback data pairs are acquired, this may require indexing each stored voltage and current feedback data pair based on or otherwise associated with a corresponding LUT sample output by the programmable logic device 1660. Synchronizing the LUT samples and the voltage and current feedback data in this manner facilitates accurate timing and stability of the pre-distortion algorithm.
[0421] In certain aspects, the voltage and current feedback data may be used to control the frequency and / or amplitude (e.g., current amplitude) of the drive signal. In one aspect, for example, the voltage and current feedback data may be used to determine the impedance phase, such as the phase difference between the voltage and current drive signals. Subsequently, the frequency of the drive signal may be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving the impedance phase measurement accuracy. The determination of the phase impedance and frequency control signal may be implemented in the processor 1740, for example, where the frequency control signal is supplied as an input to a DDS control algorithm implemented by the programmable logic device 1660.
[0422] The impedance phase can be determined by Fourier analysis. In one aspect, the generator voltage V can be determined using a Fast Fourier Transform (FFT) or a Discrete Fourier Transform (DFT) as follows g (t) Drive signal and generator current I g (t) Phase difference between driving signals:
[0423]
[0424]
[0425]
[0426]
[0427] Evaluating the Fourier transform at sinusoidal frequencies yields:
[0428]
[0429]
[0430] Other methods include weighted least squares estimation, Kalman filtering, and space vector based techniques. For example, almost all of the processing in the FFT or DFT techniques can be performed in the digital domain with the assistance of, for example, a 2-channel high speed ADC 1780, 1800. In one technique, digital signal samples of the voltage signal and the current signal are Fourier transformed using an FFT or DFT. The phase angle at any point in time can be calculated by the following formula
[0431]
[0432] in is the phase angle, f is the frequency, t is the time, and is the phase at t=0.
[0433] To determine the voltage V g (t)Signal and current I g Another technique for measuring the phase difference between the (t) signals is the zero crossing method and produces very accurate results. For voltages V with the same frequency g (t)Signal and current I g (t) signal, voltage signal V g (t) each negative to positive zero crossing triggers the water boiling pulse, and the current signal I gEach negative to positive zero crossing of (t) triggers the end of the pulse. The result is a pulse train with a pulse width proportional to the phase angle between the voltage signal and the current signal. In one aspect, the pulse train can be passed through an averaging filter to obtain a measurement of the phase difference. In addition, if positive to negative zero crossings are also used in a similar manner and the results are averaged, any effects of DC and harmonic components can be reduced. In one specific implementation, the analog voltage V g (t)Signal and current I g The (t) signal is converted to a digital signal that is high when the analog signal is positive and low when the analog signal is negative. High-precision phase estimation requires sharp transitions between high and low values. In one aspect, a Schmitt trigger and an RC stabilization network can be used to convert the analog signal to a digital signal. In other aspects, an edge-triggered RS flip-flop and auxiliary circuits can be used. In yet another aspect, the zero-crossing technique can use an exclusive-OR (XOR) gate.
[0434] Other techniques for determining the phase difference between the voltage and current signals include Lissajous plots and monitoring of images; methods such as the trivoltmeter method, the cross-coil method, the vector voltmeter, and the vector impedance method; and the use of phase standard devices, phase-locked loops, and methods such as Peter O'Shea, 2000 CRC Publishing Co., Ltd.<http: / / www.engnetbase.com> "Phase Measurement" (Peter O'Shea, 2000CRC Press LLC,<http: / / www.engnetbase.com> ), which is incorporated herein by reference.
[0435] In another aspect, for example, current feedback data may be monitored in order to maintain the current amplitude of the drive signal at a current amplitude set point. The current amplitude set point may be specified directly or determined indirectly based on a particular voltage amplitude and power set point. In certain aspects, control of the current amplitude may be achieved by a control algorithm in the processor 1740, such as, for example, a proportional integral derivative (PID) control algorithm. The variables controlled by the control algorithm in order to properly control the current amplitude of the drive signal may include, for example, scaling of LUT waveform samples stored in the programmable logic device 1660 and / or a full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via the DAC 1860.
[0436] The non-isolated stage 1540 may further include a processor 1900 for providing, among other things, user interface (UI) functions. In one aspect, the processor 1900 may include, for example, an Atmel AT91SAM9263 processor with an ARM 926EJ-S core purchased from Atmel Corporation, San Jose, Calif. Examples of UI functions supported by the processor 1900 may include audible and visual user feedback, communication with peripheral devices (e.g., via a universal serial bus (USB) interface), communication with a foot switch 1430, communication with an input device 2150 (e.g., a touch screen display), and communication with an output device 2140 (e.g., a speaker). The processor 1900 may communicate with the processor 1740 and a programmable logic device (e.g., via a serial peripheral interface (SPI) bus). Although the processor 1900 may primarily support UI functions, in some aspects, it may also cooperate with the processor 1740 to achieve risk mitigation. For example, the processor 1900 may be programmed to monitor various aspects of user input and / or other inputs (e.g., touch screen input 2150, foot switch 1430 input, temperature sensor input 2160) and disable the drive output of the generator 1100 when an error condition is detected.
[0437] In some aspects, the processor 1740 ( Fig.26 , Fig.27A ) and processor 1900( Fig.26 , Fig.27B ) can determine and monitor the operating state of the generator 1100. For the processor 1740, the operating state of the generator 1100 can indicate, for example, which control and / or diagnostic processes are implemented by the processor 1740. For the processor 1900, the operating state of the generator 1100 can indicate, for example, which elements of the user interface (e.g., display screen, sound) are presented to the user. The processors 1740, 1900 can independently maintain the current operating state of the generator 1100 and identify and evaluate possible transitions of the current operating state. The processor 1740 can act as the subject in this relationship and determine when a transition between operating states will occur. The processor 1900 can notice valid transitions between operating states and can verify whether a particular transition is appropriate. For example, when the processor 1740 commands the processor 1900 to transition to a particular state, the processor 1900 can verify that the requested transition is valid. In the event that the processor 1900 determines that the requested transition between states is invalid, the processor 1900 can cause the generator 1100 to enter a failure mode.
[0438] The non-isolated stage 1540 may further include a controller 1960 ( Fig.26 , Fig.27B) for monitoring input devices 2150 (e.g., capacitive touch sensors, capacitive touch screens for turning generator 1100 on and off). In certain aspects, controller 1960 may include at least one processor and / or other controller devices in communication with processor 1900. In one aspect, for example, controller 1960 may include a processor (e.g., a Mega168 8-bit controller available from Atmel) configured to monitor user input provided via one or more capacitive touch sensors. In one aspect, controller 1960 may include a touch screen controller (e.g., a QT5480 touch screen controller available from Atmel) to control and manage the collection of touch data from a capacitive touch screen.
[0439] In certain aspects, when the generator 1100 is in the “power off” state, the controller 1960 may continue to receive operating power (e.g., via a power source from the generator 1100 (such as the power source 2110 discussed below). Fig.26 )) pipeline). In this way, the controller 1960 can continue to monitor the input device 2150 (e.g., a capacitive touch sensor located on the front panel of the generator 1100) for turning the generator 1100 on and off. When the generator 1100 is in the "power off" state, if the user's activation of the "on / off" input device 2150 is detected, the controller 1960 can wake up the power source (e.g., enable one or more DC / DC voltage converters 2130 ( Fig.26 ) operation). The controller 1960 may thus initiate a sequence to transition the generator 1100 to the "power on" state. Conversely, when the generator 1100 is in the "power on" state, if activation of the "on / off" input device 2150 is detected, the controller 1960 may initiate a sequence to transition the generator 1100 to the "power off" state. In certain aspects, for example, the controller 1960 may report the activation of the "on / off" input device 2150 to the processor 1900, which in turn implements the required sequence of processes to transition the generator 1100 to the "power off" state. In such aspects, the controller 1960 may not have an independent ability to remove power from the generator 1100 after the "power off" state has been established.
[0440] In certain aspects, the controller 1960 can cause the generator 1100 to provide audible or other sensory feedback to alert the user that a "power on" or "power off" sequence has begun. This alert can be provided when a "power on" or "power off" sequence begins and before other processes associated with the sequence begin.
[0441] In certain aspects, the isolation stage 1520 may include an instrument interface circuit 1980 to provide, for example, a communication interface between control circuitry of a surgical device (e.g., control circuitry including a handpiece switch) and components of the non-isolated stage 1540 (such as, for example, the programmable logic device 1660, the processor 1740, and / or the processor 1900). The instrument interface circuit 1980 may exchange information with components of the non-isolated stage 1540 via a communication link (such as, for example, an infrared (IR)-based communication link) that maintains a suitable degree of electrical isolation between the stages 1520, 1540. For example, the instrument interface circuit 1980 may be powered using a low-dropout voltage regulator powered by an isolation transformer that is driven from the non-isolated stage 1540.
[0442] In one aspect, the instrument interface circuit 1980 may include a signal conditioning circuit 2020 ( Fig.26 and Fig.27C ) communication with a programmable logic device 2000. The signal conditioning circuit 2020 may be configured to receive a periodic signal (e.g., a 2kHz square wave) from the programmable logic circuit 2000 to generate a bipolar interrogation signal having the same frequency. For example, the interrogation signal may be generated using a bipolar current source fed by a differential amplifier. The interrogation signal may be sent to a surgical device control circuit (e.g., by using a conductive pair in a cable connecting the generator 1100 to the surgical device) and monitored to determine the state or configuration of the control circuit. For example, the control circuit may include a plurality of switches, resistors, and / or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal so that the state or configuration of the control circuit can be uniquely identified based on the one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating a sample of a voltage signal that appears at the input of the control circuit due to the interrogation signal passing through the control circuit. The programmable logic device 2000 (or a device of the non-isolated stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.
[0443] In one aspect, the instrument interface circuit 1980 may include a first data circuit interface 2040 to enable information exchange between the programmable logic device 2000 (or other elements of the instrument interface circuit 1980) and a first data circuit disposed in or otherwise associated with the surgical device. In certain aspects, for example, the first data circuit 2060 may be disposed in a cable integrally attached to a surgical device handpiece, or in an adapter used to interface a particular surgical device type or model with the generator 1100. In certain aspects, the first data circuit may include a non-volatile storage device, such as an electrically erasable programmable read-only memory (EEPROM) device. In certain aspects and again referring to Fig.26, the first data circuit interface 2040 can be implemented separately from the programmable logic device 2000 and include suitable circuit systems (e.g., discrete logic devices, processors) to implement communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 can be integrated with the logic device 2000.
[0444] In certain aspects, the first data circuit 2060 may store information related to the associated particular surgical device. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical device has been used, and / or any other type of information. This information may be read by the instrument interface circuit 1980 (e.g., via the programmable logic device 2000), transmitted to a device of the non-isolated stage 1540 (e.g., to the programmable logic device 1660, the processor 1740, and / or the processor 1900) for presentation to a user via the output device 2140 and / or to control the function or operation of the generator 1100. In addition, any type of information may be sent to the first data circuit 2060 via the first data circuit interface 2040 (e.g., using the programmable logic device 2000) for storage therein. Such information may include, for example, an updated number of operations in which the surgical device has been used and / or the date and / or time of its use.
[0445] As previously discussed, surgical instruments may be detachable from handpieces (e.g., instrument 1106 may be detachable from handpiece 1107) to facilitate instrument interchangeability and / or disposability. In such cases, it is known that the ability of a generator to identify the particular instrument configuration being used and to optimize control and diagnostic processes accordingly may be limited. However, addressing this issue by adding readable data circuits to surgical device instruments is problematic from a compatibility perspective. For example, designing a surgical device to maintain backward compatibility with a generator that lacks the requisite data reading functionality may be impractical due to, for example, different signal schemes, design complexity, and cost. Other aspects of the instrument address these issues by using data circuits that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical device with current generator platforms.
[0446] In addition, aspects of the generator 1100 can enable communication with instrument-based data circuits. For example, the generator 1100 can be configured to communicate with a second data circuit included in an instrument (e.g., instrument 1104, 1106, or 1108) of a surgical device. The instrument interface circuit 1980 may include a second data circuit interface 2100 for enabling such communication. In one aspect, the second data circuit interface 2100 may include a tri-state digital interface, however other interfaces may also be used. In certain aspects, the second data circuit may generally be any circuit for transmitting and / or receiving data. In one aspect, the second data circuit may store information related to an associated specific surgical instrument. Such information may include, for example, a model number, a serial number, a number of operations in which the surgical instrument has been used, and / or any other type of information. Additionally or alternatively, any type of information may be sent to the second data circuit via the second data circuit interface 2100 (e.g., using the programmable logic device 2000) for storage therein. Such information may include, for example, an updated number of operations in which the surgical instrument is used and / or the date and / or time of its use. In certain aspects, the second data circuit can transmit data acquired by one or more sensors (e.g., an instrument-based temperature sensor). In certain aspects, the second data circuit can receive data from the generator 1100 and provide an indication to the user (e.g., an LED indication or other visual indication) based on the received data.
[0447] In certain aspects, the second data circuit and the second data circuit interface 2100 may be configured to enable communication between the programmable logic device 2000 and the second data circuit without providing additional conductors for this purpose (e.g., dedicated conductors of a cable connecting the hand piece to the generator 1100). In one aspect, for example, information may be sent to and from the second data circuit using a single bus communication scheme implemented on an existing cable (such as one of the conductors used to transmit an interrogation signal from the signal conditioning circuit 2020 to the control circuit in the hand piece). In this way, design changes or modifications to the surgical device that may otherwise be necessary may be minimized or reduced. In addition, because different types of communications may be achieved on a common physical channel (with or without frequency band separation), the presence of the second data circuit may be "invisible" to a generator that does not have the requisite data reading function, thereby enabling backward compatibility of surgical device instruments.
[0448] In some aspects, the isolation stage 1520 may include at least one blocking capacitor 2960-1 ( Fig.27C), the at least one blocking capacitor 2096-1 is connected to the drive signal output 1600b to prevent DC current from flowing to the patient. For example, the signal blocking capacitor may be required to comply with medical regulations or standards. Although errors are relatively rare in single capacitor designs, such errors may have adverse consequences. In one aspect, a second blocking capacitor 2960-2 may be provided in series with the blocking capacitor 2960-1, wherein current leakage from a point between the blocking capacitors 2960-1 and 2960-2 is detected by, for example, an ADC 2980 to sample a voltage induced by the leakage current. The sample may be received, for example, by the programmable logic device 2000. Based on changes in the leakage current (such as Fig.26 ), the generator 1100 may determine when at least one of the blocking capacitors 2960-1, 2960-2 fails. Fig.26 The aspect of has benefits over a single capacitor design with a single failure point.
[0449] In certain aspects, the non-isolated stage 1540 may include a power source 2110 for outputting DC power at an appropriate voltage and current. The power source may include, for example, a 400W power source for outputting a system voltage of 48VDC. As described above, the power source 2110 may further include one or more DC / DC voltage converters 2130 for receiving the output of the power source to generate a DC output at the voltage and current required by the various components of the generator 1100. As described above in conjunction with the controller 1960, when the controller 1960 detects that the user activates the "on / off" input device 2150 to enable operation of the DC / DC voltage converter 2130 or wake up the DC / DC voltage converter 2130, one or more of the DC / DC voltage converters 2130 may receive input from the controller 1960.
[0450] Figures 28A-28B Certain functional and structural aspects of one aspect of the generator 1100 are shown. Feedback indicative of the current and voltage outputs from the secondary winding 1580 of the power transformer 1560 is received by ADCs 1780, 1800, respectively. As shown, the ADCs 1780, 1800 may be implemented as 2-channel ADCs, and the feedback signals may be sampled at a high speed (e.g., 80Msps) to allow the drive signals to be oversampled (e.g., approximately 200x oversampling). Prior to being processed by the ADCs 1780, 1800, the current feedback signal and the voltage feedback signal may be appropriately conditioned (e.g., amplified, filtered) in the analog domain. The current and voltage feedback samples from the ADCs 1780, 1800 may be buffered separately and subsequently multiplexed or interleaved into a single data stream within block 2120 of the programmable logic device 1660. In Figures 28A-28BIn some aspects, programmable logic device 1660 includes an FPGA.
[0451] The multiplexed current and voltage feedback samples may be received by a parallel data acquisition port (PDAP) implemented within block 2144 of the processor 1740. The PDAP may include a packaging unit for implementing any of a variety of methods for associating multiplexed feedback samples with memory addresses. In one aspect, for example, feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored at one or more memory addresses associated with or indexed to the LUT address of the LUT sample. On the other hand, feedback samples corresponding to a particular LUT sample output by the programmable logic device 1660 may be stored at a common memory location together with the LUT address of the LUT sample. In any case, the feedback samples may be stored so that the address of the LUT sample of a particular set of feedback samples derived therefrom can be subsequently determined. As described above, synchronizing the LUT sample addresses and feedback samples in this manner facilitates the correct timing and stability of the pre-distortion algorithm. A direct memory access (DMA) controller implemented at block 2166 of the processor 1740 may store the feedback samples (and any LUT sample address data, if applicable) at a designated memory location 2180 (eg, internal RAM) of the processor 1740 .
[0452] Block 2200 of the processor 1740 may implement a predistortion algorithm for predistorting or modifying the LUT samples stored in the programmable logic device 1660 on a dynamic, ongoing basis. As described above, predistortion of the LUT samples may compensate for various sources of distortion present in the output drive circuit of the generator 1100. The predistorted LUT samples, when processed by the drive circuit, will thus cause the drive signal to have a desired waveform shape (e.g., a sinusoidal shape) to optimally drive the ultrasonic transducer.
[0453] At block 2220 of the predistortion algorithm, the current through the motional branch of the ultrasonic transducer is determined. This may be based on, for example, current and voltage feedback samples stored at memory location 2180 (which, when properly scaled, may represent the above-discussed Fig.25 I in the model g and V g ), ultrasonic transducer static capacitance C 0 The motional branch current is determined using Kirchhoff's current law with the value of , and the known value of the drive frequency. A motional branch current sample may be determined for each set of stored current and voltage feedback samples associated with a LUT sample.
[0454] At block 2240 of the predistortion algorithm, each motional branch current sample determined at block 2220 is compared with a sample of the desired current waveform shape to determine the difference or sample amplitude error between the compared samples. For this determination, a sample of the desired current waveform shape may be supplied, for example, from a waveform shape LUT 2260, which contains amplitude samples of one cycle of the desired current waveform shape. The specific sample of the desired current waveform shape from LUT 2260 for comparison may be determined by the LUT sample address associated with the motional branch current sample for comparison. Therefore, the input of the motional branch current to block 2240 may be synchronized to the input of the LUT sample address associated with it to block 2240. Therefore, the number of LUT samples stored in the programmable logic device 1660 and the number of LUT samples stored in the waveform shape LUT 2260 may be equal. In some aspects, the desired current waveform shape represented by the LUT samples stored in the waveform shape LUT 2260 may be a basic sine wave. Other waveform shapes may be desired. For example, it is contemplated that a fundamental sine wave for driving the primary longitudinal motion of the ultrasonic transducer may be used superimposed with one or more other drive signals at other frequencies, such as a third harmonic for driving at least two mechanical resonances for beneficial vibration in transverse or other modes.
[0455] Each value of the sample amplitude error determined at block 2240 is transmitted to the LUT of the programmable logic device 1660 (at Fig.28A 2280 in FIG. 10 ). Based on the value of the sample amplitude error and its associated address (and optionally, the value of the sample amplitude error of the same LUT address previously received), the LUT 2280 (or other control block of the programmable logic device 1660) may pre-distort or modify the value of the LUT sample stored at the LUT address so that the sample amplitude error is reduced or minimized. It should be understood that performing such pre-distortion or modification on each LUT sample in an iterative manner over the entire LUT address range will result in the waveform shape of the output current of the generator matching or conforming to the desired current waveform shape represented by the samples of the waveform shape LUT 2260.
[0456] Current and voltage amplitude measurements, power measurements, and impedance measurements may be determined at block 2300 of the processor 1740 based on current and voltage feedback samples stored at memory location 2180. Prior to determining these quantities, the feedback samples may be appropriately scaled and, in certain aspects, processed through a suitable filter 2320 to remove noise generated by, for example, the data acquisition process and induced harmonic components. Thus, the filtered voltage and current samples may generally represent the fundamental frequency of the drive output signal of the generator. In certain aspects, the filter 2320 may be a finite impulse response (FIR) filter applied to the frequency domain. Such aspects may use a fast Fourier transform (FFT) of the output drive signal current and voltage signals. In certain aspects, the resulting spectrum may be used to provide additional generator functionality. In one aspect, for example, the ratio of the second order harmonic component and / or the third order harmonic component relative to the fundamental frequency component may be used as a diagnostic indicator.
[0457] In block 2340 ( Fig.28B ), a root mean square (RMS) calculation may be applied to a sample size of current feedback samples representing an integer number of cycles of the drive signal to generate a measurement value I representing the output current of the drive signal rms .
[0458] At block 2360, a root mean square (RMS) calculation may be applied to a sample size of the voltage feedback samples representing an integer number of cycles of the drive signal to determine a measured value V representing the output voltage of the drive signal. rms .
[0459] At block 2380, the current and voltage feedback samples may be multiplied point by point, and the samples representing an integer number of cycles of the drive signal may be averaged to determine a measure of the true output power of the generator, P r .
[0460] At block 2400, a measurement of the apparent output power of the generator, P a can be determined as the product V rms I rms .
[0461] At block 2420, the measured value Z of the load resistance magnitude is m can be determined as the quotient V rms / I rms .
[0462] In some aspects, the amount I determined at blocks 2340, 2360, 2380, 2400, and 2420 rms 、V rms , P r , P a and Z mmay be used by the generator 1100 to implement any of a number of control and / or diagnostic processes. In certain aspects, any of these quantities may be communicated to a user via, for example, an output device 2140 integral to the generator 1100 or connected to the generator 1100 via a suitable communication interface (e.g., a USB interface). For example, various diagnostic processes may include, but are not limited to, handpiece integrity, instrument integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock fault, overcurrent condition, overpower condition, voltage sensing fault, current sensing fault, audio indication fault, visual indication fault, short circuit condition, power delivery fault, or blocking capacitor fault.
[0463] Block 2440 of the processor 1740 may implement a phase control algorithm for determining and controlling the impedance phase of an electrical load (e.g., an ultrasonic transducer) driven by the generator 1100. As described above, by controlling the frequency of the drive signal to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0°), the effects of harmonic distortion may be minimized or reduced, and the accuracy of the phase measurement increased.
[0464] The phase control algorithm receives as input the current and voltage feedback samples stored in memory location 2180. Before being used in the phase control algorithm, the feedback samples may be appropriately scaled and processed in some aspects by a suitable filter 2460 (which may be identical to filter 2320) to remove noise generated by, for example, the data acquisition process and induced harmonic components. Thus, the filtered voltage and current samples may generally represent the fundamental frequency of the drive output signal of the generator.
[0465] At block 2480 of the phase control algorithm, the current through the motional branch of the ultrasonic transducer is determined. This determination may be the same as that described above in connection with block 2220 of the predistortion algorithm. Thus, for each set of stored current and voltage feedback samples associated with the LUT samples, the output of block 2480 may be a motional branch current sample.
[0466] At block 2500 of the phase control algorithm, an impedance phase is determined based on the synchronized input of the motional branch current samples and the corresponding voltage feedback samples determined at block 2480. In certain aspects, the impedance phase is determined as an average of an impedance phase measured at a rising edge of the waveform and an impedance phase measured at a falling edge of the waveform.
[0467] At block 2520 of the phase control algorithm, the impedance phase value determined at block 2520 is compared to a phase set point 2540 to determine the difference or phase error between the compared values.
[0468] In block 2560 of the phase control algorithm ( Fig.28A), based on the value of the phase error determined at block 2520 and the impedance magnitude determined at block 2420, a frequency output for controlling the frequency of the drive signal is determined. The value of the frequency output may be continuously adjusted by block 2560 and transmitted to a DDS control block 2680 (discussed below) to maintain the impedance phase determined at block 2500 at a phase set point (e.g., zero phase error). In some aspects, the impedance phase may be adjusted to a 0° phase set point. In this way, any harmonic distortion will be centered around the peaks of the voltage waveform, thereby enhancing the accuracy of the phase impedance determination.
[0469] Block 2580 of processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal so as to control the drive signal current, voltage, and power according to a user specified set point or according to requirements specified by other processes or algorithms implemented by generator 1100. Control of these quantities may be achieved, for example, by scaling LUT samples in LUT 2280 and / or by adjusting the full-scale output voltage of DAC 1680 (which supplies input to power amplifier 1620) via DAC 1860. Block 2600 (which may be implemented as a PID controller in some aspects) may receive as input current feedback samples (which may be appropriately scaled and filtered) from memory location 2180. The current feedback samples may be compared to a “current demand” I specified by a controlled variable (e.g., current, voltage, or power). d The current requirement I is compared with the drive signal current to determine whether the drive signal supplies the necessary current. d The current setting point 2620A (I sp ) is directly specified. For example, the RMS value of the current feedback data (as determined in block 2340) can be compared with the user-specified RMS current set point I sp A comparison is made to determine the appropriate controller action. For example, if the current feedback data indicates that the RMS value is less than the current set point I sp , then the LUT calibration and / or full-scale output voltage of DAC 1680 can be adjusted by block 2600 so that the drive signal current increases. Conversely, when the current feedback data indicates that the RMS value is greater than the current set point I sp When , block 2600 may adjust the LUT scaling and / or full-scale output voltage of DAC 1680 to reduce the drive signal current.
[0470] In terms of the driving signal voltage as the controlled variable, the current demand I d The load impedance magnitude Z measured at block 2420 may be maintained, for example, based on m Given the desired voltage set point 2620B (V sp ) The required current is specified indirectly (for example, I d =V sp / Z m ). Similarly, in terms of the driving signal power being the controlled variable, the current demand I d The voltage V measured at block 2360 may be, for example, based on rms Given the desired set point 2620C (P sp ) The required current is specified indirectly (for example, I d =P sp / V rms ).
[0471] Block 2680( Fig.28A ) may implement a DDS control algorithm for controlling a drive signal by retrieving LUT samples stored in LUT 2280. In certain aspects, the DDS control algorithm may be a digitally controlled oscillator (NCO) algorithm for generating samples of a waveform at a fixed clock rate using a point (memory location)-skipping technique. The NCO algorithm may implement a phase accumulator or a frequency-to-phase converter that serves as an address pointer for retrieving LUT samples from LUT 2280. In one aspect, the phase accumulator may be a phase accumulator of D steps and modulus N, where D is a positive integer representing a frequency control value, and N is the number of LUT samples in LUT 2280. For example, a frequency control value of D=1 may cause the phase accumulator to sequentially point to each address of LUT 2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. When D>1, the phase accumulator may skip addresses in LUT 2280, thereby producing a waveform output with a higher frequency. Thus, the frequency of the waveform generated by the DDS control algorithm can be controlled by appropriately changing the frequency control value. In some aspects, the frequency control value can be determined based on the output of the phase control algorithm implemented at block 2440. The output of block 2680 can supply the input of DAC 1680, which in turn supplies the corresponding analog signal to the input of power amplifier 1620.
[0472] Block 2700 of processor 1740 may implement a switch-mode converter control algorithm for dynamically modulating the rail voltage of power amplifier 1620 based on the waveform envelope of the amplified signal, thereby improving the efficiency of power amplifier 1620. In some aspects, the characteristics of the waveform envelope may be determined by monitoring one or more signals included in power amplifier 1620. In one aspect, for example, the characteristics of the waveform envelope may be determined by monitoring the minimum value of the drain voltage (e.g., MOSFET drain voltage) modulated according to the envelope of the amplified signal. A minimum voltage signal may be generated, for example, by a voltage minimum detector coupled to the drain voltage. The minimum voltage signal may be sampled by ADC 1760, where the output minimum voltage sample is received at block 2720 of the switch-mode converter control algorithm. Based on the value of the minimum voltage sample, block 2740 may control a PWM signal output by PWM generator 2760, which in turn controls the rail voltage supplied to power amplifier 1620 by switch-mode regulator 1700. In certain aspects, the mains voltage may be modulated according to the waveform envelope characterized by the minimum voltage sample as long as the value of the minimum voltage sample is less than the minimum target 2780 input into block 2720. For example, when the minimum voltage sample indicates a low envelope power level, block 2740 may cause a low mains voltage to be supplied to the power amplifier 1620, wherein the full mains voltage is supplied only when the minimum voltage sample indicates a maximum envelope power level. When the minimum voltage sample falls below the minimum target 2780, block 2740 may cause the mains voltage to be maintained at a minimum value suitable for ensuring proper operation of the power amplifier 1620.
[0473] Fig.29 Schematic diagram of one aspect of a circuit 2900 suitable for driving an ultrasonic transducer (such as the ultrasonic transducer 1120) according to at least one aspect of the present disclosure. The circuit 2900 includes an analog multiplexer 2980. The analog multiplexer 2980 multiplexes various signals from upstream channels SCL-A, SDA-A such as ultrasound, battery, and power control circuits. A current sensor 2982 is coupled in series with a return leg or ground leg of the power source circuit to measure the current supplied by the power source. A field effect transistor (FET) temperature sensor 2984 provides the ambient temperature. A pulse width modulation (PWM) watchdog timer 2988 automatically generates a system reset if the main program neglects to maintain it periodically. It is configured to automatically reset the circuit 2900 when it stalls or freezes due to a software or hardware failure. It should be understood that the circuit 2900 can be configured to be capable of driving an ultrasonic transducer or for driving an RF electrode such as Fig.36 The RF driver circuit of the circuit 3600 shown in FIG. 3600 is shown in FIG. 3600 , for example. Therefore, now returning to reference Fig.29, the circuit 2900 can be used to drive both the ultrasound transducer and the RF electrode interchangeably. If driven simultaneously, the filter circuit can be set in the corresponding first stage circuit 3404 ( Fig.34 ) to select an ultrasonic waveform or an RF waveform. Such filtering techniques are described in commonly owned U.S. Patent Publication No. US-2017-0086910-A1, entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein by reference in its entirety.
[0474] The drive circuit 2986 provides left and right ultrasonic energy outputs. A digital signal representing the signal waveform is sent from a control circuit (such as the control circuit 3200 ( Fig.32 ) is provided to the SCL-A, SDA-A inputs of the analog multiplexer 2980. The digital-to-analog converter 2990 (DAC) converts the digital input into an analog output to drive a pulse width modulation (PWM) circuit 2992 coupled to an oscillator 2994. The PWM circuit 2992 provides a first signal to a first gate drive circuit 2996a coupled to a first transistor output stage 2998a to drive a first ultrasonic (LEFT) energy output. The PWM circuit 2992 also provides a second signal to a second gate drive circuit 2996b coupled to a second transistor output stage 2998b to drive a second ultrasonic (RIGHT) energy output. The voltage sensor 2999 is coupled between the ultrasonic LEFT / RIGHT output terminals to measure the output voltage. The drive circuit 2986, the first drive circuit 2996a and the second drive circuit 2996b, and the first transistor output stage 2998a and the second transistor output stage 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 ( Fig.32 ) using circuits such as direct digital synthesis (DDS) circuits 4100, 4200 ( Fig.41 and Fig.42 ) generates a digital waveform 4300( Fig.43 ). DAC 2990 receives digital waveform 4300 and converts it into an analog waveform, which is received and amplified by the first stage amplifier circuit.
[0475] Fig.30 is coupled to at least one aspect of the present disclosure Fig.29Schematic diagram of transformer 3000 of circuit 2900 is shown in FIG. The ultrasonic LEFT / RIGHT input terminal (primary winding) of transformer 3000 is electrically coupled to the ultrasonic LEFT / RIGHT output terminal of circuit 2900. The secondary winding of transformer 3000 is coupled to positive electrode 3074a and negative electrode 3074b. The positive electrode 3074a and negative electrode 3074b of transformer 3000 are coupled to the positive terminal (stack 1) and negative terminal (stack 2) of the ultrasonic transducer. In one aspect, transformer 3000 has a turns ratio n of 1:50. 1 :n 2 .
[0476] Fig.31 is coupled to the test circuit 3165 according to at least one aspect of the present disclosure Fig.30 Schematic diagram of transformer 3000 is shown in . Test circuit 3165 is coupled to positive electrode 3074a and negative electrode 3074b. Switch 3167 is placed in series with an inductor / capacitor / resistor (LCR) load that simulates the load of an ultrasonic transducer.
[0477] Fig.32 32 is a schematic diagram of a control circuit 3200 (such as control circuit 3212) according to at least one aspect of the present disclosure. The control circuit 3200 is located within the housing of the battery assembly. The battery assembly is an energy source for various local power sources 3215. The control circuit includes a main processor 3214, which is coupled to various downstream circuits via an interface master 3218 through, for example, outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. In one aspect, the interface master 3218 is a universal serial interface, such as an I 2 C serial interface. The main processor 3214 is also configured to be able to drive a switch 3224 through a general purpose input / output (GPIO) 3220, a display 3226 (e.g., and LCD display) and various indicators 3228 through a GPIO 3222. A watchdog processor 3216 is configured to control the main processor 3214. A switch 3230 is provided in series with the battery 3211 to activate the control circuit 3212 when the battery assembly is inserted into the handle assembly of the surgical instrument.
[0478] In one aspect, the host processor 3214 is coupled to the circuit 2900 ( Fig.29). The main processor 3214 includes a memory for storing, for example, a table of digitized drive signals or waveforms transmitted to the circuit 2900 to drive the ultrasonic transducer 1120. In other aspects, the main processor 3214 may generate a digital waveform and transmit it to the circuit 2900, or may store the digital waveform for later transmission to the circuit 2900. The main processor 3214 may also provide RF drive through output terminals SCL-B, SDA-B, and may provide various sensors (e.g., Hall effect sensors, magnetorheological fluid (MRF) sensors, etc.) through output terminals SCL-C, SDA-C. In one aspect, the main processor 3214 is configured to be able to sense the presence of the ultrasonic drive circuit system and / or the RF drive circuit system to enable appropriate software and user interface functions.
[0479] In one aspect, the main processor 3214 can be, for example, the LM 4F230H5QR available from Texas Instruments. In at least one example, the LM4F230H5QR from Texas Instruments is an ARM Cortex-M4F processor core that includes: 256KB of single-cycle flash or other non-volatile memory (up to 40 MHz) on-chip memory, a pre-fetch buffer for improving performance beyond 40 MHz, 32KB of single-cycle serial random access memory (SRAM), a 32-bit SPI interface, and a 32-bit SPI interface. The processor is an internal read-only memory (ROM) for software, 2KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse width modulation (PWM) modules, one or more quadrature encoder inputs (QED analog), one or more 12-bit analog-to-digital converters (ADC) with 12 analog input channels, and other features readily available. Other processors may be readily substituted, and thus, the present disclosure should not be limited to this context.
[0480] Fig.33 A simplified circuit block diagram in accordance with at least one aspect of the present disclosure is shown illustrating another circuit 3300 included within a modular ultrasonic surgical instrument 3334. The circuit 3300 includes a processor 3302, a clock 3330, a memory 3326, a power source 3304 (e.g., a battery), a switch 3306 (such as a metal oxide semiconductor field effect transistor (MOSFET) power switch), a drive circuit 3308 (PLL), a transformer 3310, a signal smoothing circuit 3312 (also referred to as a matching circuit, and may be, for example, a tank circuit), a sensing circuit 3314, a transducer 1120, and a shaft assembly (e.g., shaft assemblies 1126, 1129) including an ultrasonic transmission waveguide, which may be referred to herein simply as a waveguide, terminated at an ultrasonic blade (e.g., ultrasonic blades 1128, 1149).
[0481] One feature of the present disclosure that cuts off the reliance on high voltage (120 volts AC) input power (a feature of typical ultrasonic cutting devices) is to utilize low voltage switches during the entire wave forming process and only amplify the drive signal directly before the transformer stage. Thus, in one aspect of the present disclosure, power is derived from only one battery or a group of batteries that are small enough to fit within the handle assembly. Battery technology in the art provides high power batteries that are several centimeters in height and width and several millimeters in depth. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasonic device, a reduction in manufacturing costs can be achieved.
[0482] The output of the power source 3304 is fed to and powers the processor 3302. The processor 3302 receives and outputs signals, and as will be described below, the processor 3302 operates according to custom logic or according to a computer program executed by the processor 3302. As described above, the circuit 3300 may also include a memory 3326, preferably a random access memory (RAM), which stores computer readable instructions and data.
[0483] The output of power source 3304 is also directed to switch 3306 having a duty cycle controlled by processor 3302. By controlling the on-time of switch 3306, processor 3302 is able to specify the total amount of power ultimately delivered to transducer 1120. In one aspect, switch 3306 is a MOSFET, but other switches and switch configurations are also adaptable. The output of switch 3306 is fed to a drive circuit 3308, which includes, for example, a phase detection phase-locked loop (PLL) and / or a low-pass filter and / or a voltage controlled oscillator. The output of switch 3306 is sampled by processor 3302 to determine the voltage and current (V IN and I IN ). These values are used in a feedback architecture to adjust the pulse width modulation of switch 3306. For example, the duty cycle of switch 3306 can vary from about 20% to about 80%, depending on the desired output and the actual output from switch 3306.
[0484] The drive circuit 3308 receiving the signal from the switch 3306 includes an oscillator circuit (VCO) that converts the output of the switch 3306 into an electrical signal having an ultrasonic frequency (e.g., 55 kHz). As described above, the smoothed version of the ultrasonic waveform is ultimately fed to the ultrasonic transducer 1120 to generate a resonant sine wave along the ultrasonic transmission waveguide.
[0485] The output of the drive circuit 3308 is a transformer 3310 capable of boosting (one or more) low voltage signals to a higher voltage. It should be noted that the upstream switching before the transformer 3310 is performed at a low (e.g., battery-driven) voltage, which has not been possible for ultrasonic cutting and cauterization devices to date. This is at least partially due to the fact that the device advantageously uses low on-resistance MOSFET switch devices. Low on-resistance MOSFET switches are advantageous because they produce lower switching losses and less heat than traditional MOSFET devices and allow higher currents to pass. Therefore, the switching stage (pre-transformer) can be characterized as low voltage / high current. In order to ensure a low on-resistance of the (one or more) amplifier MOSFETs, the (one or more) MOSFETs are operated at, for example, 10V. In this case, a separate 10VDC power source can be used to power the MOSFET gate, which ensures that the MOSFET is fully turned on and a fairly low on-resistance is achieved. In one aspect of the present disclosure, the transformer 3310 boosts the battery voltage to 120V root mean square (RMS). Transformers are known in the art and are therefore not described in detail herein.
[0486] In the circuit configuration, degradation of the circuit device may have a negative impact on the circuit performance of the circuit. One factor that directly affects device performance is heat. Known circuits typically monitor switch temperature (e.g., MOSFET temperature). However, due to technological advances in MOSFET design and corresponding size reductions, MOSFET temperature is no longer an effective indication of circuit load and heat. Therefore, according to at least one aspect of the present disclosure, the sensing circuit 3314 senses the temperature of the transformer 3310. This temperature sensing is advantageous because the transformer 3310 operates at or very close to its maximum temperature during device use. Additional temperature will cause the core material (e.g., ferrite) to crack and permanent damage may occur. The present disclosure may respond to the maximum temperature of the transformer 3310 by, for example, reducing the drive power in the transformer 3310, signaling the user, shutting off the power, pulsing the power, or other appropriate responses.
[0487] In one aspect of the present disclosure, the processor 3302 is communicatively coupled to an end effector (e.g., 1122, 1125) that is used to place a material in physical contact with an ultrasonic blade (e.g., 1128, 1149). A sensor is provided that measures a clamping force value (within a known range) at the end effector, and based on the received clamping force value, the processor 3302 changes the dynamic voltage V M. Since a high force value combined with a set rate of motion can result in a high knife temperature, the temperature sensor 3332 can be communicatively coupled to the processor 3302, wherein the processor 3302 can be operated to receive and interpret a signal indicating the current temperature of the knife from the temperature sensor 3336 and determine a target frequency of knife movement based on the received temperature. In another aspect, a force sensor such as a strain sensor or a pressure sensor can be coupled to the trigger (e.g., 1143, 1147) to measure the force applied to the trigger by the user. In another aspect, a force sensor such as a strain sensor or a pressure sensor can be coupled to a switch button so that the displacement intensity corresponds to the force applied to the switch button by the user.
[0488] In accordance with at least one aspect of the present disclosure, the PLL portion of the driver circuit 3308 coupled to the processor 3302 can determine the frequency of the waveguide movement and transmit the frequency to the processor 3302. When the device is turned off, the processor 3302 stores the frequency value in the memory 3326. By reading the clock 3330, the processor 3302 can determine the elapsed time after the device was turned off, and if the elapsed time is less than a predetermined value, retrieve the last waveguide movement frequency. The device can then start up at the last frequency, which is presumably the optimal frequency for the current load.
[0489] Modular battery-powered handheld surgical instrument with multi-stage generator circuit
[0490] In another aspect, the present disclosure provides a modular battery-powered handheld surgical instrument with a multi-stage generator circuit. The present disclosure discloses a surgical instrument comprising a battery assembly, a handle assembly, and a shaft assembly, wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly. The battery assembly includes a control circuit configured to generate a digital waveform. The handle assembly includes a first-stage circuit configured to receive a digital waveform, convert the digital waveform into an analog waveform, and amplify the analog waveform. The shaft assembly includes a second-stage circuit coupled to the first-stage circuit to receive, amplify, and apply the analog waveform to a load.
[0491] In one aspect, the present disclosure provides a surgical instrument comprising: a battery assembly, the battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured to generate a digital waveform; a handle assembly, the handle assembly including a first-stage circuit coupled to the processor, the first-stage circuit including a digital-to-analog (DAC) converter and a first-stage amplifier circuit, wherein the DAC is configured to receive a digital waveform and convert the digital waveform into an analog waveform, wherein the first-stage amplifier circuit is configured to receive and amplify the analog waveform; and an axis assembly, the axis assembly including a second-stage circuit coupled to the first-stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load; wherein the battery assembly and the axis assembly are configured to be mechanically and electrically connected to the handle assembly.
[0492] The load may include any one of an ultrasonic transducer, an electrode or a sensor, or any combination thereof. The first stage circuit may include a first stage ultrasonic drive circuit and a first stage high frequency current drive circuit. The control circuit may be configured to be able to drive the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit independently or simultaneously. The first stage ultrasonic drive circuit may be configured to be able to couple to a second stage ultrasonic drive circuit. The second stage ultrasonic drive circuit may be configured to be able to couple to an ultrasonic transducer. The first stage high frequency current drive circuit may be configured to be able to couple to a second stage high frequency drive circuit. The second stage high frequency drive circuit may be configured to be able to couple to an electrode.
[0493] The first stage circuit may include a first stage sensor driving circuit. The first stage sensor driving circuit may be configured as a second stage sensor driving circuit. The second stage sensor driving circuit may be configured to be coupled to the sensor.
[0494] On the other hand, the present disclosure provides a surgical instrument comprising: a battery assembly, the battery assembly including a control circuit including a battery, a memory coupled to the battery, and a processor coupled to the memory and the battery, wherein the processor is configured to generate a digital waveform; a handle assembly, the handle assembly including a common first-stage circuit coupled to the processor, the common first-stage circuit including a digital-to-analog (DAC) converter and a common first-stage amplifier circuit, wherein the DAC is configured to receive a digital waveform and convert the digital waveform into an analog waveform, wherein the common first-stage amplifier circuit is configured to receive and amplify the analog waveform; and an axis assembly, the axis assembly including a second-stage circuit coupled to the common first-stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load; wherein the battery assembly and the axis assembly are configured to be mechanically and electrically connected to the handle assembly.
[0495] The load may include any one of an ultrasonic transducer, an electrode, or a sensor, or any combination thereof. The common first stage circuit may be configured to drive an ultrasonic, high frequency current, or sensor circuit. The common first stage drive circuit may be configured to be coupled to a second stage ultrasonic drive circuit, a second stage high frequency drive circuit, or a second stage sensor drive circuit. The second stage ultrasonic drive circuit may be configured to be coupled to an ultrasonic transducer, the second stage high frequency drive circuit may be configured to be coupled to an electrode, and the second stage sensor drive circuit may be configured to be coupled to a sensor.
[0496] On the other hand, the present disclosure provides a surgical instrument comprising a control circuit comprising a memory coupled to a processor, wherein the processor is configured to generate a digital waveform; a handle assembly comprising a common first-stage circuit coupled to the processor, the common first-stage circuit being configured to receive the digital waveform, convert the digital waveform into an analog waveform, and amplify the analog waveform; and an axis assembly comprising a second-stage circuit coupled to the common first-stage circuit to receive and amplify the analog waveform; wherein the axis assembly is configured to be mechanically and electrically connected to the handle assembly.
[0497] The common first stage circuit may be configured to drive an ultrasound, high frequency current or sensor circuit. The common first stage drive circuit may be configured to be coupled to a second stage ultrasound drive circuit, a second stage high frequency drive circuit or a second stage sensor drive circuit. The second stage ultrasound drive circuit may be configured to be coupled to an ultrasound transducer, the second stage high frequency drive circuit may be configured to be coupled to an electrode, and the second stage sensor drive circuit may be configured to be coupled to a sensor.
[0498] Fig.34 A generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 according to at least one aspect of the present disclosure is shown. In one aspect, a surgical instrument of the surgical system 1000 described herein may include a generator circuit 3400 divided into a plurality of stages. For example, a surgical instrument of the surgical system 1000 may include a generator circuit 3400 divided into at least two circuits: a first stage circuit 3404 and a second stage circuit 3406 that implement only RF energy operations, only ultrasonic energy operations, and / or a combination of RF energy operations and ultrasonic energy operations. The combined modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within the handle assembly 3412 and a modular second stage circuit 3406 integrally formed with the modular shaft assembly 3414. As previously discussed throughout this specification in conjunction with the surgical instruments of the surgical system 1000, the battery assembly 3410 and the shaft assembly 3414 are configured to be mechanically and electrically connected to the handle assembly 3412. The end actuator assembly is configured to be mechanically and electrically coupled to the shaft assembly 3414 .
[0499] Now go to Fig.34 , the generator circuit 3400 is divided into multiple stages, which are located in multiple modular components of a surgical instrument (such as the surgical instrument of the surgical system 1000 described herein). In one aspect, the control stage circuit 3402 can be located in the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is as shown in combination with Fig.32 The control circuit 3200 includes a processor 3214, which includes an internal memory 3217 ( Fig.34 ) (e.g., volatile and non-volatile memory), and is electrically coupled to a battery 3211. The battery 3211 supplies power to the first stage circuit 3404, the second stage circuit 3406, and the third stage circuit 3408, respectively. As previously described, the control circuit 3200 uses a combination of Fig.41 and Fig.42 The circuit and technique described herein are used to generate digital waveform 4300 ( Fig.43 ). Back to Fig.34 , the digital waveform 4300 can be configured to be able to drive an ultrasonic transducer, a high frequency (e.g., RF) electrode, or a combination thereof independently or simultaneously. If driven simultaneously, a filtering circuit can be provided in the corresponding first stage circuit 3404 to select an ultrasonic waveform or an RF waveform. Such filtering techniques are described in the commonly owned U.S. Patent Publication US-2017-0086910-A1 entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein by reference in its entirety.
[0500] The first stage circuit 3404 (e.g., the first stage ultrasonic drive circuit 3420, the first stage RF drive circuit 3422, and the first stage sensor drive circuit 3424) is located in the handle assembly 3412 of the surgical instrument. The control circuit 3200 provides an ultrasonic drive signal to the first stage ultrasonic drive circuit 3420 via the outputs SCL-A and SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 combines Fig.29 The control circuit 3200 provides an RF drive signal to the first-stage RF drive circuit 3422 via the outputs SCL-B and SDA-B of the control circuit 3200. The first-stage RF drive circuit 3422 combines Fig.36Detailed description. The control circuit 3200 provides a sensor drive signal to the first stage sensor drive circuit 3424 via the outputs SCL-C, SDA-C of the control circuit 3200. Generally speaking, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section to drive the second stage circuit 3406. The output of the first stage circuit 3404 is provided to the input 3406 of the second stage circuit.
[0501] The control circuit 3200 is configured to be able to detect which modules are inserted into the control circuit 3200. For example, the control circuit 3200 is configured to be able to detect whether the first-stage ultrasonic drive circuit 3420, the first-stage RF drive circuit 3422, or the first-stage sensor drive circuit 3424 located in the handle assembly 3412 is connected to the battery assembly 3410. Similarly, each of the first-stage circuits 3404 can detect which second-stage circuits 3406 are connected to it, and this information is provided back to the control circuit 3200 to determine the type of signal waveform to be generated. Similarly, each of the second-stage circuits 3406 can detect which third-stage circuits 3408 or which devices are connected to it, and this information is provided back to the control circuit 3200 to determine the type of signal waveform to be generated.
[0502] In one aspect, the second stage circuit 3406 (e.g., the ultrasonic drive second stage circuit 3430, the RF drive second stage circuit 3432, and the sensor drive second stage circuit 3434) is located in the shaft assembly 3414 of the surgical instrument. The first stage ultrasonic drive circuit 3420 provides a signal to the second stage ultrasonic drive circuit 3430 via the output US-Left / US-Right. The second stage ultrasonic drive circuit 3430 is combined with Fig.30 and Fig.31 Detailed description. In addition to the transformer ( Fig.30 and Fig.31 ), the second-stage ultrasonic drive circuit 3430 may also include filters, amplifiers, and signal conditioning circuits. The first-stage high-frequency (RF) current drive circuit 3422 provides a signal to the second-stage RF drive circuit 3432 via the output RF-Left / RF-Right. In addition to the transformer and the locking capacitor, the second-stage RF drive circuit 3432 may also include filters, amplifiers, and signal conditioning circuits. The first-stage sensor drive circuit 3424 provides a signal to the second-stage sensor drive circuit 3434 via the output Sensor-1 / Sensor-2. Depending on the type of sensor, the second-stage sensor drive circuit 3434 may include filters, amplifiers, and signal conditioning circuits. The output of the second-stage circuit 3406 is provided to the input of the third-stage circuit 3408.
[0503] In one aspect, the third level circuit 3408 (e.g., ultrasonic transducer 1120, RF electrodes 3074a, 3074b, and sensor 3440) can be located in various components 3416 of the surgical instrument. In one aspect, the second level ultrasonic drive circuit 3430 provides a drive signal to the ultrasonic transducer 1120 piezoelectric stack. In one aspect, the ultrasonic transducer 1120 is located in the ultrasonic transducer assembly of the surgical instrument. However, in other aspects, the ultrasonic transducer 1120 can be located in the handle assembly 3412, the shaft assembly 3414, or the end effector. In one aspect, the second level RF drive circuit 3432 provides a drive signal to the RF electrodes 3074a, 3074b, which are typically located in the end effector portion of the surgical instrument. In one aspect, the second level sensor drive circuit 3434 provides a drive signal to various sensors 3440 located throughout the surgical instrument.
[0504] Fig.35 A generator circuit 3500 divided into multiple stages is shown, wherein a first stage circuit 3504 is common to a second stage circuit 3506, in accordance with at least one aspect of the present disclosure. In one aspect, a surgical instrument of the surgical system 1000 described herein may include a generator circuit 3500 divided into multiple stages. For example, a surgical instrument of the surgical system 1000 may include a generator circuit 3500 divided into at least two circuits: a first stage amplifier circuit 3504 and a second stage amplifier circuit 3506 that implement only high frequency (RF) energy operation, only ultrasonic energy operation, and / or a combination of RF energy operation and ultrasonic energy operation. The combined modular shaft assembly 3514 may be powered by the common first stage circuit 3504 located within the handle assembly 3512 and the modular second stage circuit 3506 formed integrally with the modular shaft assembly 3514. As previously discussed throughout this specification in conjunction with the surgical instruments of the surgical system 1000, the battery assembly 3510 and the shaft assembly 3514 are configured to be mechanically and electrically connected to the handle assembly 3512. The end actuator assembly is configured to be able to mechanically and electrically connect to the shaft assembly 3514.
[0505] like Fig.35As shown in the example of , the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502, which includes the control circuit 3200 previously described. The handle assembly 3512 connected to the battery assembly 3510 includes a common first-stage drive circuit 3420. As previously described, the first-stage drive circuit 3420 is configured to be able to drive ultrasound, high-frequency (RF) current, and sensor loads. The output of the common first-stage drive circuit 3420 can drive any of the second-stage circuits 3506, such as the second-stage ultrasonic drive circuit 3430, the second-stage high-frequency (RF) current drive circuit 3432, and / or the second-stage sensor drive circuit 3434. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first-stage drive circuit 3420 detects which second-stage circuit 3506 is located in the shaft assembly 3514. When the shaft assembly 3514 is connected to the handle assembly 3512, the common first stage drive circuit 3420 determines which of the second stage circuits 3506 (e.g., the second stage ultrasonic drive circuit 3430, the second stage RF drive circuit 3432, and / or the second stage transducer drive circuit 3434) is located in the shaft assembly 3514. This information is provided to the control circuit 3200 located in the handle assembly 3512 to provide the appropriate digital waveform 4300 to the second stage circuit 3506 ( Fig.43 ) to drive an appropriate load, such as ultrasound, RF, or a sensor. It should be understood that the identification circuit may be included in various components 3516 in the third-level circuit 3508, such as the ultrasonic transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. Therefore, when the third-level circuit 3508 is connected to the second-level circuit 3506, the second-level circuit 3506 knows...
Claims
1. A method for determining the temperature of an ultrasonic knife, the method comprising: determining, by a control circuit coupled to a memory, an actual resonant frequency of an ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide, wherein the actual resonant frequency is related to an actual temperature of the ultrasonic blade; Retrieving, by the control circuit, a reference resonant frequency of the ultrasonic electromechanical system from the memory, wherein the reference resonant frequency is related to a reference temperature of the ultrasonic blade; The control circuit infers the temperature of the ultrasonic blade based on the difference between the actual resonant frequency and the reference resonant frequency, and The control circuit determines whether the actual resonant frequency is within a certain buffer distance from the lower frequency limit, and if the determination is yes, reduces the current set point of the specified current demand of the ultrasonic transducer, The method further comprises generating, by the control circuit, a temperature estimate and a state-space model of the inferred temperature of the ultrasonic blade as a function of the resonant frequency of the ultrasonic electromechanical system based on a set of nonlinear state-space formulas, wherein the state-space model is defined by the following formula: The state space model represents the natural frequency F n(t) , temperature T(t), energy E(t) and time t of the electromechanical ultrasonic system The rate of change and the temperature of the ultrasonic knife The rate of change, represents the measured and observable natural frequency F of the electromechanical ultrasonic system n(t) , the observability of the temperature T(t) of the ultrasonic knife, the energy E(t) applied to the ultrasonic knife and the time t.
2. The method according to claim 1, wherein: Determining the actual resonant frequency of the ultrasonic electromechanical system by the control circuit includes: The voltage V applied to the ultrasonic transducer is determined by the control circuit g (t)Signal and current I g (t) Phase angle between signals 3 . The method of claim 1 , further comprising applying, by the control circuit, a Kalman filter to improve the temperature estimator and the state-space model.
4. The method according to claim 3, further comprising: applying, by the control circuit, a state estimate in a feedback loop of the Kalman filter; controlling, by the control circuit, the power applied to the ultrasonic transducer; as well as The temperature of the ultrasonic knife is adjusted by the control circuit.
5. The method according to claim 4, wherein: The state variance of the state estimator of the Kalman filter is defined by the following equation: and The gain K of the Kalman filter is defined by the following equation: Among them, the state variance It is used to predict the next state of the system, and the next state is represented by the predicted state probability distribution, σ m is the observed variance.
6. The method according to claim 1, wherein: The control circuit and the memory are located at a surgical hub that communicates with the ultrasonic electromechanical system.
7. A generator for determining the temperature of an ultrasonic scalpel, the generator comprising: a control circuit coupled to the memory, the control circuit being configured to: determining an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide, wherein the actual resonant frequency is related to an actual temperature of the ultrasonic blade; retrieving a reference resonant frequency of the ultrasonic electromechanical system from the memory, wherein the reference resonant frequency is related to a reference temperature of the ultrasonic blade; inferring the temperature of the ultrasonic blade based on the difference between the actual resonant frequency and the reference resonant frequency; and determining whether the actual resonant frequency is within a certain buffer distance from a lower frequency limit, and if the determination structure is yes, reducing the current set point of the specified current demand of the ultrasonic transducer, wherein the control circuit generates a temperature estimate and a state space model of the inferred temperature of the ultrasonic blade as a function of the resonant frequency of the ultrasonic electromechanical system based on a set of nonlinear state space formulas, and the state space model is defined by the following formula: The state space model represents the natural frequency F n(t) , temperature T(t), energy E(t) and time t of the electromechanical ultrasonic system The rate of change and the temperature of the ultrasonic knife The rate of change, The natural frequency F of the electromechanical ultrasonic system can be measured and observed. n(t) , the observability of the temperature T(t) of the ultrasonic knife, the energy E(t) applied to the ultrasonic knife and the time t.
8. The generator according to claim 7, wherein In order to determine the actual resonant frequency of the ultrasonic electromechanical system, the control circuit is further configured to: Determine the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals 9. The generator according to claim 7, wherein The control circuit is further configured to apply a Kalman filter to improve the temperature estimator and the state-space model.
10. The generator according to claim 9, wherein The control circuit is further configured to: applying a state estimator in a feedback loop of the Kalman filter; controlling power applied to the ultrasonic transducer; and Adjust the temperature of the ultrasonic scalpel.
11. The generator according to claim 10, wherein The state variance of the state estimator of the Kalman filter is defined by the following equation: and The gain K of the Kalman filter is defined by the following formula: Among them, the state variance It is used to predict the next state of the system, and the next state is represented by the predicted state probability distribution, σ m is the observed variance.
12. The generator according to claim 7, wherein: The control circuit and the memory are located at a surgical hub in communication with the generator.
13. An ultrasonic device for determining the temperature of an ultrasonic knife, the ultrasonic device comprising: a control circuit coupled to the memory, the control circuit being configured to: determining an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade via an ultrasonic waveguide, wherein the actual resonant frequency is related to an actual temperature of the ultrasonic blade; retrieving a reference resonant frequency of the ultrasonic electromechanical system from the memory, wherein the reference resonant frequency is related to a reference temperature of the ultrasonic blade; inferring the temperature of the ultrasonic blade based on the difference between the actual resonant frequency and the reference resonant frequency; and Determine whether the actual resonant frequency is within a certain buffer distance from a lower frequency limit, and if the determination structure is yes, reduce the current set point of the specified current demand of the ultrasonic transducer, wherein the control circuit is further configured to generate a temperature estimate and a state space model of the inferred temperature of the ultrasonic blade as a function of the resonant frequency of the ultrasonic electromechanical system based on a set of nonlinear state space formulas, and the state space model is defined by the following formula: The state space model represents the natural frequency F n(t) , temperature T(t), energy E(t) and time t of the electromechanical ultrasonic system The rate of change and the temperature of the ultrasonic knife The rate of change, represents the measured and observable natural frequency F of the electromechanical ultrasonic system n(t) , the observability of the temperature T(t) of the ultrasonic knife, the energy E(t) applied to the ultrasonic knife and the time t.
14. The ultrasound device according to claim 13, wherein In order to determine the actual resonant frequency of the ultrasonic electromechanical system, the control circuit is further configured to: Determine the voltage V applied to the ultrasonic transducer g (t)Signal and current I g (t) Phase angle between signals 15. The ultrasonic device according to claim 13, wherein: The control circuit is further configured to apply a Kalman filter to improve the temperature estimator and the state-space model.
16. The ultrasound device according to claim 15, wherein The control circuit is further configured to: applying a state estimator in a feedback loop of the Kalman filter; controlling power applied to the ultrasonic transducer; and Adjust the temperature of the ultrasonic scalpel.
17. The ultrasound device according to claim 16, wherein The state variance of the state estimator of the Kalman filter is defined by the following equation: and The gain K of the Kalman filter is defined by the following equation: Among them, the state variance It is used to predict the next state of the system, and the next state is represented by the predicted state probability distribution, σ m is the observed variance.
18. The ultrasonic device according to claim 13, wherein: The control circuit and the memory are located at a surgical hub that communicates with the ultrasound device.
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