CN111542281A - Temperature control of ultrasonic end effector and control system therefor - Google Patents
Temperature control of ultrasonic end effector and control system therefor Download PDFInfo
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Abstract
The invention discloses a generator, an ultrasonic device and a method for determining the temperature of an ultrasonic knife. A control circuit coupled to the memory determines an actual resonant frequency of an ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade through an ultrasonic waveguide. The actual resonant frequency is related to the actual temperature of the ultrasonic blade. The control circuit retrieves the reference resonant frequency of the ultrasound electromechanical system from the memory. The reference resonant frequency is related to a reference temperature of the ultrasonic blade. The control circuit then infers the temperature of the ultrasonic blade based on the difference between the actual resonant frequency and the reference resonant frequency.
Description
Cross Reference to Related Applications
The present patent application claims the benefit OF U.S. provisional patent application serial No. 16/115,205 entitled ULTRASONIC END EFFECTOR TEMPERATURE CONTROL AND CONTROL system THEREFOR (temparature CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL system tool), filed on 28.8.2018, the disclosure OF which is incorporated herein by reference in its entirety.
This patent application claims priority from U.S. provisional patent application 62/721,995 entitled control of ULTRASONIC surgical instruments (control AN ULTRASONIC surgical instrument TO TISSUE LOCATION) filed on 23.8.8.2018 under the provisions of section 119 (volume 35 of the U.S. code), the disclosure of which is incorporated herein by reference in its entirety.
This patent application claims the priority OF a situation AWARENESS for ELECTROSURGICAL SYSTEMS (patent architecture OF ELECTROSURGICAL SYSTEMS) U.S. provisional patent application 62/721,998 filed on 2018, 8, 23, in accordance with the provisions OF clause 119 (e) OF U.S. code 35, volume 35, the priority being incorporated herein by reference in its entirety.
This patent application claims priority from us provisional patent application 62/721,999 entitled ENERGY INTERRUPTION DUE to improper CAPACITIVE COUPLING (interim OF ENERGY DUE to ENERGY INTERRUPTION with access control coating) filed on 23.8.2018 as specified in title 119 (e) OF american code volume 35, the disclosure OF which is incorporated herein by reference in its entirety.
This patent application claims priority from U.S. provisional patent application 62/721,994 entitled BIPOLAR COMBINATION device for AUTOMATICALLY adjusting PRESSURE BASED ON ENERGY modalities (BIPOLAR COMBINATION device for use in conjunction with PRESSURE regulation) filed ON 23.8.8.2018 in accordance with the provisions of section 119 (volume 35 of the united states code), the disclosure of which is incorporated herein by reference in its entirety.
This patent application claims priority from U.S. provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device for delivering combined electrical SIGNALS (RADIO FREQUENCY resonance ENERGY DEVICE for RADIO interference communication SIGNALS) filed on 23.8.8.2018 in accordance with the provisions of clause 119 (volume 35) of the U.S. code, the disclosure of which is incorporated herein by reference in its entirety.
This patent application also claims the priority OF U.S. provisional patent application 62/692,747 entitled intelligent ACTIVATION OF an energy DEVICE by another DEVICE (SMART activity OF AN ENERGY DEVICE bypass DEVICE) filed on 30.6.2018, U.S. provisional patent application 62/692,748 entitled intelligent energy ARCHITECTURE (SMART ENERGY ARCHITECTURE) filed on 30.6.2018, and U.S. provisional patent application 62/692,768 entitled intelligent energy DEVICE (SMART ENERGY DEVICES) filed on 30.6.2018, the disclosures OF each OF which are incorporated herein by reference in their entirety, as specified in clause 119 (e) OF U.S. code 35.
This patent application also claims the benefit OF U.S. provisional patent application serial No. 62/640,417 entitled TEMPERATURE CONTROL in ultrasound devices AND a CONTROL SYSTEM THEREFOR (TEMPERATURE CONTROL input SYSTEM DEVICE AND CONTROL SYSTEM thermal) filed on 3, 8.2018 AND entitled priority OF U.S. provisional patent application serial No. 62/640,415 entitled estimating the state OF an ultrasound END EFFECTOR AND a CONTROL SYSTEM THEREFOR (ESTIMATING STATE OF ultra sound END EFFECTOR AND CONTROL SYSTEM thermal) filed on 3, 8.2018, the disclosures OF each OF which are incorporated herein by reference in their entirety, as specified in clause 119 (e) OF U.S. code 35.
This patent application also claims the benefit of priority of U.S. provisional patent application serial No. 62/650,898 entitled capacitively coupled return path pad with separable array elements (CAPACITIVE COUPLED RETURNPATH PAD WITH SEPARABLE ARRAY ELEMENTS) filed on 3/20.2018, U.S. provisional patent application serial No. 62/650,887 entitled SURGICAL system with optimized sensing capability (SURGICAL system with optimized sensing capability) filed on 3/30.2018, U.S. provisional patent application serial No. 62/650,882 entitled SMOKE EVACUATION MODULE FOR interactive SURGICAL PLATFORM (SMOKE EVACUATION system PLATFORM) filed on 3/30.2018, and U.S. provisional patent application serial No. 62/650,877 entitled SURGICAL SMOKE EVACUATION sensing and control (SURGICAL SMOKE EVACUATION system control SENSING AND) filed on 3/30.2018, the disclosure of each of these provisional patent applications is incorporated herein by reference in its entirety.
The present patent application further claims the benefit of priority from U.S. provisional patent application serial No. 62/611,341 entitled interactive SURGICAL PLATFORM (INTERACTIVE SURGICALPLATFORM) filed on 2017, 12, 28, date 35, the U.S. provisional patent application serial No. 62/611,340 entitled CLOUD-BASED medical analysis (CLOUD-BASED medical analysis) filed on 2017, 12, 28, date 12, 28, and U.S. provisional patent application serial No. 62/611,339 entitled robotically ASSISTED SURGICAL PLATFORM (ROBOT ASSISTED SURGICAL PLATFORM) filed on 2017, 12, 28, date, the disclosure of each of these provisional patent applications being incorporated herein by reference in its entirety.
Background
In a surgical environment, the smart energy device may be required in a smart energy architecture environment. Ultrasonic surgical devices, such as ultrasonic scalpels, are used in a variety of applications for surgical procedures due to their unique performance characteristics. Depending on the particular device configuration and operating parameters, the ultrasonic surgical device may provide transection of tissue and hemostasis by coagulation substantially simultaneously, thereby advantageously minimizing patient trauma. An ultrasonic surgical device may include a handpiece containing an ultrasonic transducer having a distally mounted end effector (e.g., a blade tip) to cut and seal tissue, and an instrument coupled to the ultrasonic transducer. In some cases, the instrument may be permanently attached to the handpiece. In other cases, the instrument may be detachable from the handpiece, as in the case of disposable instruments or interchangeable instruments. The end effector transmits ultrasonic energy to tissue in contact with the end effector to effect the cutting and sealing action. Ultrasonic surgical devices of this nature may be configured for open surgical use, laparoscopic or endoscopic surgical procedures, including robotically-assisted procedures.
Ultrasonic energy is used to cut and coagulate tissue using temperatures lower than those used in electrosurgical procedures, and ultrasonic energy may be transmitted to the end effector by an ultrasonic generator in communication with the handpiece. With high frequency vibration (e.g., 55,500 cycles per second), the ultrasonic blade denatures proteins in the tissue to form a viscous coagulum. The pressure exerted by the blade surface on the tissue collapses the vessel and causes the clot to form a hemostatic seal. The surgeon may control the cutting speed and coagulation by the force applied to the tissue by the end effector, the time that the force is applied, and the selected deflection level of the end effector.
The ultrasonic transducer can be modeled as an equivalent circuit comprising a first branch with a static capacitance and a second "dynamic" branch with an inductance, a resistance and a capacitance connected in series, which define the electromechanical properties of the resonator. The known ultrasonic generator may comprise a tuning inductor for detuning the static capacitance at the resonance frequency, so that substantially all of the generator's drive signal current flows into the dynamic branch. Thus, by using a tuning inductor, the generator's drive signal current is representative of the dynamic branch current, and thus the generator is able to control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductor may also transform the phase impedance map of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the particular static capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.
In addition, in some ultrasound generator architectures, the drive signal of the generator exhibits asymmetric harmonic distortion, which complicates impedance magnitude and phase measurements. For example, the accuracy of impedance phase measurements may be reduced due to harmonic distortion in the current and voltage signals.
Furthermore, electromagnetic interference in a noisy environment can reduce the generator's ability to maintain a lock on the resonant frequency of the ultrasonic transducer, thereby increasing the likelihood of invalid control algorithm inputs.
Electrosurgical devices for applying electrical energy to tissue to treat and/or destroy tissue are also finding increasingly widespread use 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 is positionable against tissue such that an electrical current is introduced into the tissue. The electrosurgical device may be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into and returned from the tissue through the active and return electrodes, respectively, of the end effector. During monopolar operation, current is introduced into tissue through the active electrode of the end effector and returned through a return electrode (e.g., a ground pad) separately positioned on the patient's body. The heat generated by the current flowing through the tissue may form a hemostatic seal within and/or between the tissues, and thus may be particularly useful, for example, in sealing blood vessels. The end effector of the electrosurgical device may also include a cutting member movable relative to the tissue and an electrode for transecting the tissue.
The electrical energy applied by the electrosurgical device may be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy may be in the form of Radio Frequency (RF) energy. The RF energy is in the form of electrical energy that can be in the frequency range of 300kHz to 1MHz as described in EN60601-2-2:2009+ a11:2011, definition 201.3.218-high frequency. For example, frequencies in monopolar RF applications are typically limited to less than 5 MHz. However, in bipolar RF applications, the frequency can be almost any value. Monopolar applications typically use frequencies above 200kHz in order to avoid unwanted stimulation of nerves and muscles due to the use of low frequency currents. Bipolar techniques may use lower frequencies if the risk analysis shows that the likelihood of neuromuscular stimulation has been mitigated to an acceptable level. Typically, frequencies above 5MHz are not used to minimize the problems associated with high frequency leakage currents. It is generally considered that 10mA is the lower threshold for tissue thermal effects.
During its operation, the electrosurgical device may transmit low frequency RF energy through tissue, which may cause ionic oscillations or friction and, in effect, resistive heating, thereby raising the temperature of the tissue. Because a sharp boundary may be formed between the affected tissue and the surrounding tissue, the surgeon is able to operate at a high level of accuracy and control without damaging adjacent non-target tissue. The low operating temperature of the RF energy may be suitable for removing soft tissue, contracting soft tissue, or sculpting soft tissue while sealing the vessel. RF energy may be particularly well suited for connective tissue, which is composed primarily of collagen and contracts when exposed to heat.
Ultrasonic and electrosurgical devices typically require different generators due to their unique drive signal, sensing and feedback requirements. In addition, in situations where the instrument is disposable or interchangeable with the handpiece, the ability of the ultrasound and electrosurgical generators to identify the particular instrument configuration used and to optimize the control and diagnostic procedures accordingly is limited. Furthermore, capacitive coupling between the non-isolated circuitry of the generator and the patient isolated circuitry, especially where higher voltages and frequencies are used, can result in exposure of the patient to unacceptable levels of leakage current.
Furthermore, ultrasonic and electrosurgical devices often require different user interfaces for different generators due to their unique drive signal, sensing and feedback requirements. In such conventional ultrasonic and electrosurgical devices, one user interface may be configured to be used with an ultrasonic instrument, while the other user interface may be configured to be used with an electrosurgical instrument. Such user interfaces include hand and/or foot activated user interfaces, such as hand activated switches and/or foot activated switches. Since various aspects of a combined generator for use with ultrasonic and electrosurgical instruments are contemplated in the ensuing disclosure, additional user interfaces configured to be operable with ultrasonic and/or electrosurgical instrument generators are also contemplated.
Additional user interfaces for providing feedback to a user or other machine are contemplated in subsequent disclosures to provide feedback indicative of the mode or state of operation of the ultrasonic and/or electrosurgical instrument. Providing user and/or machine feedback for operating a combination of ultrasonic and/or electrosurgical instruments would require providing sensory feedback to the user as well as providing 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 combining ultrasonic and/or electrosurgical instruments are contemplated in the subsequent disclosure.
Other electrosurgical instruments include, but are not limited to, irreversible and/or reversible electroporation, and/or microwave technology, among others. Accordingly, the techniques disclosed herein may be applicable to ultrasound, bipolar or monopolar RF (electrosurgical), irreversible and/or reversible electroporation, and/or microwave-based surgical instruments, among others.
Disclosure of Invention
In one aspect, a method of determining a temperature of an ultrasonic blade is provided. The method comprises the following steps: 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 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; and inferring, by a control circuit, a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
In another aspect, a generator for determining a temperature of an ultrasonic blade is provided. The generator comprises: a control circuit coupled to the memory, the control circuit configured to be capable of: determining 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 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; and inferring a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
In yet another aspect, an ultrasonic device for determining a temperature of an ultrasonic blade is provided. The ultrasonic device includes: a control circuit coupled to the memory, the control circuit configured to be capable of: determining 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 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; and inferring a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
Drawings
The features of the various aspects are set out with particularity in the appended claims. The various aspects (relating to the surgical tissues and methods) and further objects and advantages thereof, however, may best be understood by reference to the following description taken in conjunction with the accompanying drawings.
Fig. 1 is a block diagram of a computer-implemented interactive surgical system in accordance with at least one aspect of the present disclosure.
Fig. 2 is a surgical system for performing a surgical procedure in an operating room in accordance with at least one aspect of the present disclosure.
Fig. 3 is a surgical hub paired with a visualization system, a robotic system, and a smart instrument according to at least one aspect of the present disclosure.
Fig. 4 is a partial perspective view of a surgical hub housing and a composite generator module slidably receivable in a drawer of the surgical hub housing according to at least one aspect of the present disclosure.
Fig. 5 is a perspective view of a combined generator module having bipolar, ultrasonic and monopolar contacts and a smoke evacuation component according to at least one aspect of the present disclosure.
Fig. 6 illustrates a single power bus attachment for a plurality of lateral docking ports of a lateral modular housing configured to be capable of receiving a plurality of modules in accordance with at least one aspect of the present disclosure.
Fig. 7 illustrates a vertical modular housing configured to be capable of receiving a plurality of modules in accordance with at least one aspect of the present disclosure.
Fig. 8 illustrates a surgical data network including a modular communication hub configured to connect modular devices located in one or more operating rooms of a medical facility or any room in the medical facility dedicated to surgical procedures to a cloud in accordance with at least one aspect of the present disclosure.
Fig. 9 is a computer-implemented interactive surgical system according to at least one aspect of the present disclosure.
Fig. 10 illustrates a surgical hub including a plurality of modules coupled to a modular control tower according to at least one aspect of the present disclosure.
Fig. 11 illustrates one aspect of a Universal Serial Bus (USB) hub device in accordance with at least one aspect of the present disclosure.
Fig. 12 illustrates a logic diagram of a control system of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 13 illustrates a control circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 14 illustrates a combinational logic circuit configured to control various aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 15 illustrates sequential logic circuitry configured to control aspects of a surgical instrument or tool in accordance with at least one aspect of the present disclosure.
Fig. 16 illustrates 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.
Fig. 17 is a schematic view of a robotic surgical instrument configured to operate a surgical tool described herein, according to at least one aspect of the present disclosure.
Fig. 18 illustrates a block diagram of a surgical instrument programmed to control distal translation of a displacement member in accordance with at least one aspect of the present disclosure.
Fig. 19 is a schematic view of a surgical instrument configured to control various functions in accordance with at least one aspect of the present disclosure.
Fig. 20 is a system configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, according to at least one aspect of the present disclosure.
Fig. 21 illustrates an example of a generator in accordance with at least one aspect of the present disclosure.
Fig. 22 is a surgical system including a generator and various surgical instruments that may be used therewith according to at least one aspect of the present disclosure.
Fig. 23 is an end effector according to at least one aspect of the present disclosure.
Fig. 24 is an illustration of the surgical system of fig. 22 in accordance with at least one aspect of the present disclosure.
Fig. 25 is a model illustrating dynamic branch current in accordance with at least one aspect of the present disclosure.
Fig. 26 is a structural view of a generator architecture according to at least one aspect of the present disclosure.
Fig. 27A-27C are functional views of a generator architecture according to at least one aspect of the present disclosure.
Fig. 28A-28B are structural and functional aspects of a generator according to at least one aspect of the present disclosure.
FIG. 29 is a schematic diagram of one aspect of an ultrasonic drive circuit
Fig. 30 is a schematic diagram of a transformer coupled to the ultrasonic drive circuit shown in fig. 29, in accordance with at least one aspect of the present disclosure.
Fig. 31 is a schematic diagram of the transformer shown in fig. 30 coupled to a test circuit in accordance with at least one aspect of the present disclosure.
Fig. 32 is a schematic diagram of a control circuit according to at least one aspect of the present disclosure.
Fig. 33 illustrates a simplified electrical block diagram showing another electrical circuit included within the modular ultrasonic surgical instrument, in accordance with at least one aspect of the present disclosure.
Fig. 34 illustrates a generator circuit divided into a plurality of stages according to at least one aspect of the present disclosure.
Fig. 35 illustrates a generator circuit divided into a plurality of stages, wherein a first stage circuit is common to a second stage circuit, according to at least one aspect of the present disclosure.
Fig. 36 is a schematic diagram of one aspect of a drive circuit configured to drive high frequency current (RF) in accordance with at least one aspect of the present disclosure.
Fig. 37 is a schematic diagram of a transformer coupled to the RF drive circuit shown in fig. 34 in accordance with at least one aspect of the present disclosure.
FIG. 38 is a schematic diagram of a circuit including separate power sources for the high power energy/driver circuit and the low power circuit, according to one aspect of the present disclosure.
FIG. 39 illustrates a control circuit that allows the dual generator system to switch between RF generator and ultrasonic generator energy modalities of the surgical instrument.
Fig. 40 illustrates a schematic view 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.
Fig. 41 illustrates one aspect of a basic architecture of a digital synthesis circuit, such as a Direct Digital Synthesis (DDS) circuit, configured to generate a plurality of wave shapes for electrical signal waveforms in a surgical instrument, in accordance with at least one aspect of the present disclosure.
Fig. 42 illustrates one aspect of a Direct Digital Synthesis (DDS) circuit configured to generate a plurality of wave shapes for use in an electrical signal waveform in a surgical instrument, in accordance with at least one aspect of the present disclosure.
Fig. 43 illustrates one cycle of a discrete-time digital electrical signal according to at least one aspect of the present disclosure in terms of an analog waveform (shown superimposed over a discrete-time digital electrical signal waveform for comparison purposes), in accordance with at least one aspect of the present disclosure.
Fig. 44 is an illustration of a control system configured to provide gradual closure of the closure member as the closure member is advanced distally to close the clamp arms to apply a closing force load at a desired rate according to an aspect of the present disclosure.
FIG. 45 illustrates a proportional-integral-derivative (PID) controller feedback control system in accordance with an aspect of the present disclosure.
Fig. 46 is an exploded elevational view of the modular hand-held ultrasonic surgical instrument showing the left housing half removed from the handle assembly exposing a device identifier communicatively coupled to the multi-lead handle terminal assembly in accordance with one aspect of the present disclosure.
Fig. 47 is a detail view of a trigger portion and a switch of the ultrasonic surgical instrument shown in fig. 46, in accordance with at least one aspect of the present disclosure.
Fig. 48 is an enlarged partial perspective view of an end effector from a distal end having a jaw member in an open position according to at least one aspect of the present disclosure.
Fig. 49 is 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.
Fig. 50 is a circuit diagram of various components of a surgical instrument having motor control functionality in accordance with at least one aspect of the present disclosure.
Fig. 51 illustrates one aspect of an end effector including RF data sensors coupled to jaw members according to at least one aspect of the present disclosure.
Fig. 52 illustrates an aspect of the flexible circuit shown in fig. 51, wherein a sensor may be mounted to or integrally formed with the flexible circuit, in accordance with at least one aspect of the present disclosure.
FIG. 53 is an alternative system for controlling the frequency and detecting the impedance of an ultrasound electromechanical system according to at least one aspect of the present disclosure.
54A-54B are complex impedance spectra of the same ultrasonic device with a cool (blue) and warm (red) ultrasonic blade, according to at least one aspect of the present disclosure, wherein
FIG. 54A is a graphical representation of impedance phase angle as a function of resonant frequency for the same ultrasonic device having cold (blue) and warm (red) ultrasonic blades; and
FIG. 54B is a graphical representation of impedance magnitude as a function of resonant frequency for the same ultrasonic device with cold (blue) and warm (red) ultrasonic blades.
Fig. 55 is a schematic diagram of a kalman filter that improves a temperature estimator and a state space model based on impedances measured at various frequencies across an ultrasound transducer, in accordance with at least one aspect of the present disclosure.
Fig. 56 is a graph of three probability distributions employed by the state estimator of the kalman filter shown in fig. 55 to maximize the estimate, in accordance with at least one aspect of the present disclosure.
Figure 57A is a graphical representation of the temperature of an ultrasound device reaching a maximum temperature of 490 ℃ without temperature control versus time.
Fig. 57B is a graph of temperature versus time for an ultrasound device reaching a maximum temperature of 320 ℃ with temperature control, in accordance with at least one aspect of the present disclosure.
58A-58B are illustrations of feedback control for adjusting ultrasonic power applied to an ultrasonic transducer upon detection of a sudden drop in temperature of an ultrasonic blade, wherein
FIG. 58A is a graphical representation of ultrasonic power as a function of time; and
fig. 58B is a graph of ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure.
Fig. 59 is a logic flow diagram depicting a control program or logic configuration for controlling the temperature of an ultrasonic blade in accordance with a method of at least one aspect of the present disclosure.
Fig. 60 is a graphical representation of ultrasonic blade temperature as a function of time during vessel firing according to at least one aspect of the present disclosure.
Fig. 61 is a logic flow diagram of a method depicting a control program or logic configuration for controlling the temperature of an ultrasonic blade between two temperature set points in accordance with at least one aspect of the present disclosure.
Fig. 62 is a logic flow diagram of a method depicting a control program or logic configuration for determining an initial temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure.
Fig. 63 is a logic flow diagram of a method in accordance with at least one aspect of the present disclosure that depicts a control program or logic configuration for determining when an ultrasonic blade is approaching instability and when to adjust power to an ultrasonic transducer to prevent instability of the ultrasonic transducer.
Fig. 64 is a logic flow diagram of a method depicting a control program or logic configuration for providing ultrasonic sealing with temperature control in accordance with at least one aspect of the present disclosure.
Fig. 65 is a graphical representation of ultrasonic transducer current and ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure.
Fig. 66 is a graphical representation of the relationship between initial frequency and frequency change required to achieve a temperature of about 340 ℃ in accordance with at least one aspect of the present disclosure.
Fig. 67 illustrates a feedback control system including an ultrasound generator to adjust a current (i) set point applied to an ultrasound transducer of an ultrasound electromechanical system to prevent a frequency (f) of the ultrasound transducer from dropping below a predetermined threshold, in accordance with at least one aspect of the present disclosure.
Fig. 68 is a logic flow diagram depicting a control program or logic configuration for a controlled thermal management method for protecting an end effector pad, in accordance with at least one aspect of the present disclosure.
Fig. 69 is a graphical representation of temperature versus time comparing expected temperatures of an ultrasonic blade with a smart ultrasonic blade and a conventional ultrasonic blade in accordance with at least one aspect of the present disclosure.
Fig. 70 is a timeline depicting situational awareness for a surgical hub, according to at least one aspect of the present disclosure.
Detailed Description
The applicant of the present patent application owns the following U.S. patent applications filed on 28.8.2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. patent application Ser. No. END8536USNP2/180107-2 entitled estimating the state OF an ULTRASONIC END EFFECTOR and a control SYSTEM THEREFOR (ESTIMATING STATE OF ULTRASONIC END EFFECTOR ANDCONTROL SYSTEM THEREFOR);
U.S. patent application Ser. No. END8561USNP1/180144-1 entitled RADIO FREQUENCY energy device FOR DELIVERING combined electrical SIGNALS (RADIO FREQUENCY ENERGY DEVICE FOR DELIVERING COMMUNICATIONS SIGNALS);
U.S. patent application Ser. No. END8563USNP1/180139-1 entitled CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT (control AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUELOCATION) depending on tissue location;
U.S. patent application Ser. No. END8563USNP2/180139-2 entitled CONTROLLING the ACTIVATION OF AN ULTRASONIC surgical instrument based on the presence OF TISSUE (relating activity OF AN ULTRASONIC surgical instrument TO THE PRESENCE OF TISSUE);
U.S. patent application publication No. END8563USNP3/180139-3, entitled determination of tissue composition via ultrasound system (DETERMINING TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM);
U.S. patent application publication No. END8563USNP4/180139-4, entitled determining the state OF AN ultrasound ELECTROMECHANICAL system based on FREQUENCY SHIFT (DETERMINING THE STATE OF AN ultrasound ELECTROMECHANICAL system TO FREQUENCY SHIFT);
U.S. patent application Ser. No. END8563USNP5/180139-5, entitled determining ULTRASONIC END EFFECTOR status (DETERMINING THE STATE OF AN ULTRASONIC END EFFECTOR);
U.S. patent application Ser. No. END8564USNP1/180140-1 entitled SITUATIONAL AWARENESS for ELECTROSURGICAL SYSTEMS (SITUATIONAL AWARENESS OF ELECTROTROSURGICAL SYSTEMS);
U.S. patent application publication number END8564USNP2/180140-2 entitled mechanism for controlling different electromechanical systems of an electrosurgical instrument (MECHANISMS FOR CONTROLLING DIFFERENT ELECTROMECHANICALSYSTEMS OF AN ELECTROSURGICAL INSTRUMENT);
U.S. patent application Ser. No. END8564USNP3/180140-3 entitled detecting END EFFECTOR IMMERSION IN LIQUID (DETECTION OF END EFFECTOR IMMERSION IN LIQUID);
U.S. patent application publication No. END8565USNP1/180142-1 entitled ENERGY INTERRUPTION DUE TO improper capacitive coupling (INTERRUPTION OF ENERGY DUE TO inadequately capacitive coupling);
U.S. patent application publication number END8565USNP2/180142-2 entitled increasing radio frequency to create a PAD-LESS unipolar loop (PAD-LESS);
U.S. patent application publication No. END8566USNP1/180143-1 entitled BIPOLAR COMBINATION device for automatic pressure adjustment BASED ON ENERGY MODALITY (BIPOLAR COMBINATION DEVICE THAT automatic adjustment using pressure BASED ON ENERGY mode); and
U.S. patent application publication number END8573USNP1/180145-1, entitled ACTIVATION energy device (activity OF ENERGY DEVICES).
The applicant of the present patent application owns the following U.S. patent applications filed on 23.8.8.2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application 62/721,995 entitled CONTROLLING ULTRASONIC SURGICAL INSTRUMENTs (CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT) based on TISSUE LOCATION;
U.S. provisional patent application 62/721,998 entitled situational awareness for ELECTROSURGICAL SYSTEMS (SITUATIONALAWARENESS OF ELECTROROSURGICAL SYSTEMS);
us provisional patent application 62/721,999 entitled ENERGY INTERRUPTION DUE TO improper capacitive COUPLING (INTERRUPTION OF ENERGY TO INADVERTENT CAPACITIVE COUPLING);
U.S. provisional patent application bipolar combination device (bipolar combination DEVICE THAT automatic adjustment of PRESSURE) 62/721,994, titled, for automatic PRESSURE regulation BASED ON energy modality; and
us provisional patent application 62/721,996 entitled RADIO FREQUENCY energy device (RADIO FREQUENCY resonance ENERGY DEVICE FOR delayed coupling ELECTRICAL SIGNALS) FOR DELIVERING a COMBINED electrical signal.
The applicant of the present patent application owns the following U.S. patent applications filed on 30.6.2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application 62/692,747 entitled Smart ACTIVATION OF energy DEVICE BY ANOTHER DEVICE (SMART ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE);
U.S. provisional patent application 62/692,748 entitled SMART energy architecture (SMART energy architecture); and
us provisional patent application 62/692,768 entitled smart energy device (SMART ENERGYDEVICES).
The applicant of the present patent application owns the following U.S. patent applications filed on 29.6.2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. patent application serial No. 16/024,090, entitled capacitively coupled return path pad with SEPARABLE array elements (CAPACITIVE COUPLED RETURN PATH PAD WITH seperable ARRAY ELEMENTS);
U.S. patent application Ser. No. 16/024,057, entitled CONTROLLING SURGICAL INSTRUMENTs (control A SURGICAL INSTRUMENT) based on SENSED CLOSURE PARAMETERS;
U.S. patent application Ser. No. 16/024,067, entitled System FOR ADJUSTING END EFFECTOR PARAMETERS BASED on intraoperative INFORMATION (SYSTEM FOR ADJUSE END EFFECTOR PARAMETERS BASED ONPERIORATIVE INFORMATION);
U.S. patent application serial No. 16/024,075, entitled safety system FOR intelligently POWERED SURGICAL suturing (SAFETY SYSTEMS FOR SMART POWERED SURGICAL suturing);
U.S. patent application serial No. 16/024,083, entitled safety system FOR intelligently POWERED SURGICAL suturing (SAFETY SYSTEMS FOR SMART POWERED SURGICAL suturing);
U.S. patent application Ser. No. 16/024,094, entitled SURGICAL System FOR detecting end EFFECTOR TISSUE irregularities (SURGICAL SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGORATITIES);
U.S. patent application Ser. No. 16/024,138, entitled System FOR DETECTING the approach OF a SURGICAL END EFFECTOR to cancerous TISSUE (SYSTEM FOR DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS TISSUE);
U.S. patent application Ser. No. 16/024,150, entitled SURGICAL INSTRUMENT CARTRIDGE SENSOR Assembly (SURGICAL Instrument Cartridge SENSOR Assembly);
U.S. patent application serial No. 16/024,160, entitled VARIABLE OUTPUT CARTRIDGE SENSOR ASSEMBLY (VARIABLE OUTPUT SENSOR ASSEMBLY);
U.S. patent application Ser. No. 16/024,124, entitled SURGICAL Instrument with Flexible ELECTRODEs (SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE);
U.S. patent application Ser. No. 16/024,132, entitled SURGICAL Instrument with Flexible Circuit (SURGICAL INSTRUMENT HAVING A FLEXIBLE CICUIT);
U.S. patent application Ser. No. 16/024,141, entitled SURGICAL Instrument WITH TISSUE MARKING Assembly (SURGICAL Instrument WITH A TISSUE MARKING Assembly);
U.S. patent application serial No. 16/024,162, entitled SURGICAL system with PRIORITIZED DATA TRANSMISSION CAPABILITIES (SURGICAL SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES);
U.S. patent application Ser. No. 16/024,066 entitled SURGICAL EVACUATION sensing and Motor CONTROL (SURGICAL EVACUTION SENSING AND MOTOR CONTROL);
U.S. patent application Ser. No. 16/024,096, entitled SURGICAL EVACUATION SENSOR arrangement (SURGICAL EVACUTION SENSOR ARRANGEMENTS);
U.S. patent application Ser. No. 16/024,116, entitled surgical evacuation FLOW Path (SURGICALEVACUATION FLOW PATHS);
U.S. patent application Ser. No. 16/024,149, entitled SURGICAL EVACUATION sensing and Generator CONTROL (SURGICAL EVACUTION SENSING AND GENERATOR CONTROL);
U.S. patent application Ser. No. 16/024,180, entitled surgical evacuation sensing and display (SURGICALEVACUATION SENSING AND DISPLAY);
U.S. patent application Ser. No. 16/024,245, entitled System FOR conveying Smoke EVACUATION System parameters TO a HUB OR CLOUD IN a Smoke EVACUATION Module FOR an Interactive surgical PLATFORM (COMMUNICATION OF SMOKE EVACUATION SYSTEMPARAMETERS TO HUB OR CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATYING);
U.S. patent application serial No. 16/024,258, entitled SMOKE EVACUATION SYSTEM INCLUDING segmented control circuitry FOR an INTERACTIVE SURGICAL PLATFORM (SMOKE evacution SYSTEM in recording A SEGMENTED control computer program FOR INTERACTIVE SURGICAL PLATFORM);
U.S. patent application Ser. No. 16/024,265, entitled SURGICAL EVACUATION System with COMMUNICATION circuitry FOR COMMUNICATION BETWEEN Filter and fume extractor (SURGICAL EVACUTION SYSTEM WITH A COMMUNICATIONCIRCUIT FOR COMMUNICATIONBETWEEN A FILTER AND A SMOKE EVACUTION DEVICE); and
U.S. patent application Ser. No. 16/024,273, entitled Dual IN-line Large and Small DROPLET FILTERS (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2018, 6/28, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application serial No. 62/691,228, entitled METHOD OF USING an enhanced FLEX circuit having MULTIPLE SENSORS WITH an ELECTROSURGICAL device (a METHOD OF USING a recording flexible FLEX circuit WITH ELECTROSURGICAL device);
U.S. provisional patent application serial No. 62/691,227, entitled CONTROLLING a SURGICAL INSTRUMENT (control a SURGICAL INSTRUMENT TO sense closed closure parameters);
U.S. provisional patent application serial No. 62/691,230, entitled SURGICAL INSTRUMENT with FLEXIBLE ELECTRODEs (SURGICAL INSTRUMENT);
U.S. provisional patent application serial No. 62/691,219, entitled SURGICAL EVACUATION sensing and MOTOR CONTROL (SURGICAL EVACUTION SENSING AND MOTOR CONTROL);
U.S. provisional patent application serial No. 62/691,257, entitled system FOR delivering SMOKE EVACUATION system parameters TO a HUB OR CLOUD IN a SMOKE EVACUATION MODULE FOR an interactive surgical PLATFORM (composite OF SMOKE EVACUATION system TO HUB OR CLOUD IN SMOKE EVACUATION MODULE);
U.S. provisional patent application serial No. 62/691,262, entitled SURGICAL extraction system with COMMUNICATION CIRCUIT FOR COMMUNICATION BETWEEN filter and smoke exhaust (SURGICAL extraction system SYSTEM WITH optical extraction CIRCUIT FOR COMMUNICATION BETWEEN filter and smoke exhaust A FILTER AND A microwave extraction DEVICE); and
U.S. provisional patent application serial No. 62/691,251, entitled DUAL tandem macroand minidroplet FILTERS (DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS);
the applicant of the present patent application owns the following U.S. provisional patent applications filed on 2018, 4/19, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application serial No. 62/659,900, entitled hub COMMUNICATION METHOD (METHOD office COMMUNICATION);
the applicant of the present patent application owns the following U.S. provisional patent applications filed on 30/3/2018, the disclosures of each of which are incorporated herein by reference in their entirety:
us provisional patent application 62/650,898 filed 3, 30, 2018, entitled capacitively coupled return path pad (CAPACITIVE COUPLED RETURN PATH PAD WITHSEPARABLE ARRAY ELEMENTS) with separable array elements;
U.S. provisional patent application serial No. 62/650,887, entitled SURGICAL system with OPTIMIZED SENSING CAPABILITIES (SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES);
U.S. patent application Ser. No. 62/650,882, entitled Smoke EVACUATION Module FOR Interactive SURGICAL PLATFORM (SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATTOM); and
U.S. provisional patent application Ser. No. 62/650,877 entitled SURGICAL Smoke EVACUATION sensing and control (SURGICAL SMOKE EVACUTION SENSING AND CONTROLS)
The applicant of the present patent application owns the following U.S. patent applications filed on 29/3/2018, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. patent application serial No. 15/940,641, entitled interactive surgical system with encrypted COMMUNICATION capability (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES);
U.S. patent application serial No. 15/940,648, entitled interactive surgical system with conditional processing device and data CAPABILITIES (INTERACTIVE SURGICAL SYSTEMS WITH conditioning hand ling OF DEVICESAND DATA CAPABILITIES);
U.S. patent application Ser. No. 15/940,656, entitled SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION for operating room DEVICES (SURGICAL HUB COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING DEVICES);
U.S. patent application serial No. 15/940,666, entitled spatial perception OF a SURGICAL hub IN an OPERATING room (SPATIAL AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS);
U.S. patent application Ser. No. 15/940,670, entitled COOPERATIVE UTILIZATION OF data derived FROM secondary sources BY an Intelligent SURGICAL hub (COOPERATIVE diagnosis OF DATA DERIVED FROM SECONDARY OURCES BY INTELLIGENT SURGICAL HUBS);
U.S. patent application serial No. 15/940,677, entitled surgical hub control arrangement;
U.S. patent application Ser. No. 15/940,632, entitled data stripping METHOD for data interrogation of PATIENT RECORDS AND creation of anonymous RECORDS (DATA STRIPPING Metal to INTERROGATE PATIENT RECORD AND CreateNONYZED RECORD);
U.S. patent application Ser. No. 15/940,640, entitled COMMUNICATION HUB AND storage DEVICE FOR STORING parameters AND conditions OF a SURGICAL DEVICE TO BE shared with a CLOUD-BASED analysis system (COMMUNICATION HUB AND STORAGE EVICE FOR STORING PARAMETERS AND STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED ANALYTICS SYSTEMS);
U.S. patent application Ser. No. 15/940,645, entitled SELF DESCRIBING data packet generated at ISSUING INSTRUMENT (SELF description DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT);
U.S. patent application Ser. No. 15/940,649, entitled data pairing for interconnecting DEVICE measurement parameters with results (DATA PAIRING TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH ANOUTCOME);
U.S. patent application Ser. No. 15/940,654, entitled surgical hub SITUATIONAL AWARENESS (SURGICALHUB SITUATIONAL AWARENESS);
U.S. patent application Ser. No. 15/940,663, entitled surgical System DISTRIBUTED PROCESSING (SURGICAL SYSTEMS DISTRIBUTED PROCESSING);
U.S. patent application Ser. No. 15/940,668, entitled AGGREGATION AND REPORTING OF SURGICAL HUB DATA (AGGREGATION AND REPORTING OF SURGICAL HUB DATA);
U.S. patent application serial No. 15/940,671, entitled SURGICAL HUB spatial perception for determining devices in an operating room (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN operatingtheother);
U.S. patent application Ser. No. 15/940,686, entitled showing ALIGNMENT OF staple cartridges with a previously linear staple line (DISPLAY OF ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE);
U.S. patent application Ser. No. 15/940,700, entitled sterile field Interactive CONTROLs display (STERILEFIELD INTERACTIVE CONTROL DISPLAY);
U.S. patent application Ser. No. 15/940,629, entitled COMPUTER-implemented Interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);
U.S. patent application Ser. No. 15/940,704, entitled "determining characteristics OF backscattered light Using laser light and Red-Green-BLUE COLORATION" (USE OF LASER LIGHT ANDRED-GREEN-BLUE COLORATION TO DETERMINONEPIERTIES OF BACK SCATTERED LIGHT);
U.S. patent application Ser. No. 15/940,722, entitled "CHARACTERIZATION OF TISSUE IRREGULARITIES by USE OF monochromatic light refractive index" (CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHT REFRACTIVITY); and
U.S. patent application serial No. 15/940,742 entitled DUAL Complementary Metal Oxide Semiconductor (CMOS) array imaging (DUAL CMOS ARRAY IMAGING);
U.S. patent application Ser. No. 15/940,636, entitled ADAPTIVE CONTROL PROGRAM update FOR SURGICAL DEVICES (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);
U.S. patent application Ser. No. 15/940,653, entitled ADAPTIVE CONTROL PROGRAM update FOR SURGICAL hub (ADAPTIVE CONTROL PROGRAM update FOR SURGICAL hub);
U.S. patent application Ser. No. 15/940,660, entitled CLOUD-BASED medical analysis FOR CUSTOMIZATION AND recommendation to USERs (CLOOUD-BASED MEDICAL ANALYTICS FOR CURSTOMIZATION AND RECOMMENDITIONSTO A USER);
U.S. patent application Ser. No. 15/940,679, entitled CLOUD-BASED medical analysis for linking LOCAL USAGE trends with RESOURCE ACQUISITION behavior OF larger DATA SETs (CLOOUD-BASED MEDICAL ANALYTICS FORLINKING OF LOCAL USAGE TRENDS WITH THE RESOURCE ACQUISITION BEIORS OFLARGER DATA SET);
U.S. patent application serial No. 15/940,694, entitled CLOUD-BASED medical analysis OF medical facilities FOR personalizing INSTRUMENT FUNCTION segments (CLOUD-BASED MEDICAL ANALYTICS FOR MEDICAL FACILITYSEGMENTED differentiation OF inertial FUNCTIONs);
U.S. patent application Ser. No. 15/940,634, entitled CLOUD-BASED medical analysis FOR Security and certification trends and reactivity measurements (CLOOUD-BASED MEDICAL ANALYTICS FOR SECURITY ANDAUTHENTATION TRENDS AND REACTIVE MEASURES);
U.S. patent application serial No. 15/940,706 entitled data processing and priority IN cloud analysis NETWORKs (DATA HANDLING AND priority IN attached analysis NETWORK); and
U.S. patent application serial No. 15/940,675, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES (CLOUD INTERFACE FOR coated led DEVICES);
U.S. patent application Ser. No. 15/940,627, entitled drive arrangement FOR a robotic-ASSISTED SURGICAL platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLANTSS);
U.S. patent application Ser. No. 15/940,637, entitled COMMUNICATION arrangement FOR a robotic ASSISTED surgery platform (COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,642, entitled control FOR a robotically-ASSISTED SURGICAL platform (controlfor ROBOT-ASSISTED surgery PLATS);
U.S. patent application Ser. No. 15/940,676, entitled AUTOMATIC TOOL adjustment FOR robotically-ASSISTED SURGICAL PLATFORMS (AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,680, entitled controller FOR a robotic-ASSISTED SURGICAL platform (controlers FOR ROBOT-ASSISTED SURGICAL platform);
U.S. patent application Ser. No. 15/940,683, entitled collaborative SURGICAL action FOR a robotically ASSISTED SURGICAL platform (collaborative SURGICAL action FOR Robot-ASSISTED SURGICAL PLATFORMS);
U.S. patent application Ser. No. 15/940,690, entitled display arrangement FOR a robotic-ASSISTED SURGICAL platform (DISPLAY ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLANTSM); and
U.S. patent application serial No. 15/940,711, entitled sensing arrangement FOR a robotic-ASSISTED SURGICAL platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED surgery platformes).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2018, 3, 28, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application serial No. 62/649,302, entitled interactive surgical system with encrypted communication capability (INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED communicative capabilities);
U.S. provisional patent application serial No. 62/649,294, entitled data stripping METHOD for interrogating PATIENT RECORDS and creating anonymous RECORDS (DATA STRIPPING METHOD TO interface PATIENT RECORDS and anonymous RECORDS);
U.S. provisional patent application serial No. 62/649,300, entitled SURGICAL HUB SITUATIONAL AWARENESS (SURGICAL HUB SITUATIONAL aware);
U.S. provisional patent application serial No. 62/649,309, entitled SURGICAL HUB spatial perception for determining devices in an operating room (SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES INOPERATING THEATER);
U.S. patent application Ser. No. 62/649,310, entitled COMPUTER-implemented Interactive SURGICAL System (COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS);
U.S. provisional patent application Ser. No. 62/649291, entitled "method for determining the characteristics OF BACKSCATTERED LIGHT Using laser LIGHT and Red, Green, BLUE color development" (USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINEMOPERISTIES OF BACKSCATTERED LIGHT);
U.S. patent application Ser. No. 62/649,296, entitled ADAPTIVE CONTROL PROGRAM update FOR SURGICAL DEVICES (ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES);
U.S. provisional patent application serial No. 62/649,333, entitled CLOUD-BASED medical analysis FOR CUSTOMIZATION and recommendation TO USERs (CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION and computing services TO a USER);
U.S. provisional patent application serial No. 62/649,327, entitled CLOUD-BASED medical analysis FOR SECURITY and certification trends and reactivity measurements (CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY and identification TRENDS AND REACTIVE MEASURES);
U.S. provisional patent application serial No. 62/649,315 entitled data processing and priority IN CLOUD analysis NETWORKs (DATA HANDLING AND priority IN a CLOUD analysis NETWORK);
U.S. provisional patent application serial No. 62/649,313, entitled CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES (CLOUD INTERFACE FOR coated led DEVICES);
U.S. patent application Ser. No. 62/649,320, entitled drive arrangement FOR a robotic-ASSISTED SURGICAL platform (DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLANTSS);
U.S. provisional patent application serial No. 62/649,307, entitled AUTOMATIC TOOL adjustment FOR robotic ASSISTED SURGICAL platform (AUTOMATIC TOOL adjustment FOR ROBOT ASSISTED SURGICAL platform); and
U.S. provisional patent application serial No. 62/649,323, entitled sensing arrangement FOR a robotic-ASSISTED SURGICAL platform (SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL platform).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 8/3/2018, the disclosures of each of which are incorporated herein by reference in their entirety:
U.S. provisional patent application serial No. 62/640,417 entitled TEMPERATURE CONTROL IN an ultrasound device and CONTROL system therefor (temparature CONTROL IN ULTRASONIC DEVICE AND CONTROL system for); and
U.S. provisional patent application serial No. 62/640,415, entitled estimating the state OF an ULTRASONIC END EFFECTOR AND a control system THEREFOR (ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROLSYSTEM tool thermally).
The applicant of the present patent application owns the following U.S. provisional patent applications filed on 2017, 12, 28, the disclosure of each of which is incorporated herein by reference in its entirety:
U.S. provisional patent application serial No. 62/611,341, provisional patent application serial No. 62/611,341, entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM);
U.S. provisional patent application serial No. 62/611,340, entitled CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS); and
U.S. patent application serial No. 62/611,339, entitled robot-assisted SURGICAL PLATFORM (robot assisted surgery PLATFORM);
before explaining various aspects of the surgical device and generator in detail, it should be noted that the example illustrated application or use is not limited to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. The illustrative examples may be implemented alone or in combination with other aspects, variations and modifications, and may be practiced or carried out in various ways. Furthermore, unless otherwise indicated, the terms and expressions employed herein have been chosen for the purpose of describing the illustrative embodiments for the convenience of the reader and are not for the purpose of limiting the invention. Moreover, it is to be understood that expressions of one or more of the following described aspects, and/or examples may be combined with any one or more of the other below described aspects, and/or examples.
Aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of an ultrasonic surgical device may be configured to transect and/or coagulate tissue, for example, during a surgical procedure. Aspects of the electrosurgical device may be configured to transect, coagulate, target, weld, and/or desiccate tissue, for example, during a surgical procedure.
Referring to fig. 1, a computer-implemented interactive surgical system 100 includes one or more surgical systems 102 and a cloud-based system (e.g., cloud 104, which 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 cloud 104, which may include a remote server 113. In one example, as shown in fig. 1, the surgical system 102 includes a visualization system 108, a robotic system 110, and a handheld smart surgical instrument 112 configured to be able to communicate with each other and/or with the hub 106. In some aspects, 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.
Fig. 3 shows an example of a surgical system 102 for performing a surgical procedure on a patient lying on an operating table 114 in a surgical room 116. The robotic system 110 is used as part of the surgical system 102 in a surgical procedure. The robotic system 110 includes a surgeon's console 118, a patient side cart 120 (surgical robot), and a surgical robot hub 122. As 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. An image of the surgical site may be obtained by the medical imaging device 124, which may be manipulated by the patient side cart 120 to orient the imaging device 124. The robot hub 122 may be used to process images of the surgical site for subsequent display to the surgeon via the surgeon's console 118.
Other types of robotic systems may be readily adapted for use with the surgical system 102. Various examples of robotic systems and SURGICAL tools suitable for use in the present disclosure are described in U.S. provisional patent application serial No. 62/611,339 entitled ROBOT ASSISTED SURGICAL PLATFORM (ROBOT ASSISTED SURGICAL PLATFORM), filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.
Various examples of CLOUD-BASED analyses performed by the CLOUD 104 and suitable for use with the present disclosure are described in U.S. provisional patent application serial No. 62/611,340 entitled "CLOUD-BASED medical analysis (CLOUD-BASED MEDICAL ANALYTICS)" filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.
In various aspects, the 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.
The optical components of the imaging device 124 may include one or more illumination sources and/or one or more lenses. 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.
The one or more illumination sources may be configured to radiate electromagnetic energy in the visible spectrum as well as 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 simple light. A typical human eye will respond to wavelengths in air from about 380nm to about 750 nm.
The invisible spectrum (i.e., the non-luminescent spectrum) is the portion of the electromagnetic spectrum that lies below and above the visible spectrum (i.e., wavelengths below about 380nm and above about 750 nm). The human eye cannot detect the invisible spectrum. Wavelengths greater than about 750nm are longer than the red visible spectrum and they become invisible Infrared (IR), microwave and radio electromagnetic radiation. Wavelengths less than about 380nm are shorter than the violet spectrum and they become invisible ultraviolet, x-ray and gamma-ray electromagnetic radiation.
In various aspects, the imaging device 124 is configured for use in a minimally invasive procedure. Examples of imaging devices suitable for use in the present disclosure include, but are not limited to, arthroscopes, angioscopes, bronchoscopes, cholangioscopes, colonoscopes, cytoscopes, duodenoscopes, enteroscopes, esophago-duodenoscopes (gastroscopes), endoscopes, laryngoscopes, nasopharyngo-nephroscopes, sigmoidoscopes, thoracoscopes, and intrauterine scopes.
In one aspect, the imaging device employs multispectral monitoring to distinguish topography from underlying structures. A multispectral image is an image that captures image data across a particular range of wavelengths of the electromagnetic spectrum. The wavelengths may be separated by filters or by using instruments that are sensitive to specific wavelengths, including light from frequencies outside the visible range, such as IR and ultraviolet. Spectral imaging may allow extraction of additional information that the human eye fails to capture with its red, green, and blue receptors. Use of multispectral imaging is described in more detail under the heading "advanced imaging Acquisition Module" of U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICALPLATFORM)", filed 2017, 12, 28, the disclosure of which is incorporated herein by reference in its entirety. Multispectral monitoring may be a useful tool for repositioning the surgical site after completion of a surgical task to perform one or more of the previously described tests on the treated tissue.
It is self-evident that strict disinfection of the operating room and surgical equipment is required during any surgery. The stringent hygiene and disinfection conditions required in a "surgical room" (i.e., an operating room or a treatment room) require the highest possible sterility of all medical devices and equipment. Part of this sterilization process is any substance that needs to be sterilized, including the imaging device 124 and its attachments and components, in contact with the patient or penetrating the sterile field. It should be understood that a sterile field may be considered a designated area that is considered free of microorganisms, such as within a tray or within a sterile towel, or a sterile field may be considered an area around a patient that has been prepared for a surgical procedure. The sterile field may include a properly worn swabbed team member, as well as all furniture and fixtures in the area.
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 that are strategically arranged relative to the sterile field, as shown in fig. 2. In one aspect, the visualization system 108 includes interfaces for HL7, PACS, and EMR. Various components of the visualization system 108 are described under the heading "advanced imaging Acquisition Module" of U.S. provisional patent application Ser. No. 62/611,341 entitled "Interactive surgical platform (INTERACTIVE SURGICALPLATFORM)", filed 2017, 12, 28, the disclosure of which is incorporated herein by reference in its entirety.
As shown in fig. 2, a main display 119 is positioned in the sterile field to be visible to the operator at the surgical table 114. Further, the visualization tower 111 is positioned outside the sterile field. Visualization tower 111 includes a first non-sterile display 107 and a second non-sterile display 109 facing away from each other. Visualization system 108, guided by hub 106, is configured to be able to coordinate information flow to operators inside and outside the sterile field using displays 107, 109, and 119. For example, the hub 106 may 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. A snapshot on non-sterile display 107 or 109 may allow a non-sterile operator to, for example, perform diagnostic steps related to a surgical procedure.
In one aspect, hub 106 is further configured to be able to route diagnostic inputs or feedback entered by non-sterile operators at visualization tower 111 to main display 119 within the sterile field, where it can be viewed by sterile operators on the operating floor. In one example, the input may be a modified form of a snapshot displayed on non-sterile display 107 or 109, which may be routed through hub 106 to main display 119.
Referring to fig. 2, a surgical instrument 112 is used in a surgical procedure as part of the surgical system 102. Hub 106 is also configured to coordinate the flow of information to the display of surgical instrument 112. For example, U.S. provisional patent application serial No. 62/611,341 entitled "interactive surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety. Diagnostic inputs or feedback entered by non-sterile operators at visualization tower 111 may be routed by hub 106 to surgical instrument display 115 within the sterile field, where the inputs or feedback may be viewed by the operator of surgical instrument 112. Exemplary Surgical instruments suitable for use in Surgical system 102 are described under the heading Surgical Instrument Hardware (Surgical Instrument Hardware) of U.S. provisional patent application serial No. 62/611,341 entitled "interactive Surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on 28.12.2017, the disclosure of which is incorporated herein by reference in its entirety.
Referring now to fig. 3, hub 106 is depicted in communication with visualization system 108, robotic system 110, and handheld intelligent surgical instrument 112. Hub 106 includes a hub display 135, an imaging module 138, a generator module 140, a communication module 130, a processor module 132, and a storage array 134. In certain aspects, as shown in fig. 3, hub 106 further includes a smoke evacuation module 126 and/or a suction/irrigation module 128.
The application of energy to tissue for sealing and/or cutting during a surgical procedure is typically associated with smoke evacuation, aspiration of excess fluid, and/or irrigation of the tissue. Fluid lines, power lines, and/or data lines from different sources are often tangled during a surgical procedure. Valuable time may be lost in addressing the problem during a surgical procedure. Disconnecting the lines may require disconnecting the lines from their respective modules, which may require resetting the modules. The hub modular housing 136 provides a unified environment for managing power, data, and fluid lines, which reduces the frequency of tangling between such lines.
Aspects of the present disclosure provide a surgical hub for a surgical procedure involving application of energy to tissue at a surgical site. The surgical hub includes a hub housing and a composite generator module slidably receivable in a docking station of the hub housing. The docking station includes data contacts and power contacts. The combined generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component seated in a single cell. In one aspect, the combined generator module further comprises a smoke evacuation component for connecting the combined generator module to at least one energy delivery cable of the surgical instrument, at least one smoke evacuation component configured to evacuate smoke, fluids, and/or particles generated by application of the therapeutic energy to the tissue, and a fluid line extending from the remote surgical site to the smoke evacuation component.
In one aspect, the fluid line is a first fluid line and the second fluid line extends from the remote surgical site to a suction and irrigation module slidably received in the hub housing. In one aspect, the hub housing includes a fluid interface.
Certain surgical procedures may require more than one energy type to be applied to the tissue. One energy type may be more advantageous for cutting tissue, while a different energy type may be more advantageous for sealing tissue. For example, a bipolar generator may be used to seal tissue, while an ultrasonic generator may be used to cut the sealed tissue. Aspects of the present disclosure provide a solution in which the hub modular housing 136 is configured to accommodate different generators and facilitate interactive communication therebetween. One of the advantages of the hub modular housing 136 is the ability to quickly remove and/or replace various modules.
Aspects of the present disclosure provide a modular surgical housing for use in a surgical procedure involving application of energy to tissue. The modular surgical housing includes a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port including a first data contact and a first power contact, 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,
as further described above, the modular surgical housing further includes a second energy generator module configured to generate a second energy different from the first energy for application to tissue, and a second docking station including a second docking port including a second data contact and a second power contact, wherein the second energy generator module is slidably movable into and out of electrical contact with the power contact and the data contact, and wherein the second energy generator is slidably movable out of electrical contact with the second power contact and the second data contact.
In addition, the modular surgical housing further includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.
Referring to fig. 3-7, aspects of the present disclosure are presented as a hub modular housing 136 that allows for modular integration of the generator module 140, smoke evacuation module 126, and suction/irrigation module 128. The hub modular housing 136 also facilitates interactive communication between the modules 140, 126, 128. As shown in fig. 5, the generator module 140 may be a generator module with integrated monopolar, bipolar, and ultrasound components supported in a single housing unit 139 that is slidably inserted into the hub modular housing 136. As shown in fig. 5, the generator module 140 may be configured to be connectable to a monopolar device 146, a bipolar device 147, and an ultrasound device 148. Alternatively, the generator modules 140 may include a series of monopole generator modules, bipolar generator modules, and/or ultrasonic generator modules that interact through the hub modular housing 136. The hub modular housing 136 can be configured to facilitate the insertion of multiple generators and the interactive communication between generators docked into the hub modular housing 136 such that the generators will act as a single generator.
In one aspect, the hub modular housing 136 includes a modular power and communications backplane 149 having external and wireless communications connections to enable removable attachment of the modules 140, 126, 128 and interactive communications therebetween.
In one aspect, the hub modular housing 136 includes a docking cradle or drawer 151 (also referred to herein as a drawer) configured to slidably receive the modules 140, 126, 128. Fig. 4 illustrates a partial perspective view of the surgical hub housing 136 and the composite generator module 145 that can be slidably received in the docking station 151 of the surgical hub housing 136. The docking ports 152 having power and data contacts on the back of the combination generator module 145 are configured to engage the corresponding docking ports 150 with the power and data contacts of the corresponding docking station 151 of the hub module housing 136 when the combination generator module 145 is slid into place within the corresponding docking station 151 of the hub module housing 136. In one aspect, the combined generator module 145 includes bipolar, ultrasonic, and monopolar modules integrated together into a single housing unit 139, as shown in fig. 5.
In various aspects, the smoke evacuation module 126 includes a fluid line 154 that communicates captured/collected smoke and/or fluid from the surgical site to, for example, the smoke evacuation module 126. Vacuum suction from smoke evacuation module 126 may draw smoke into the opening of the common conduit at the surgical site. The utility conduit coupled to the fluid line may be in the form of a flexible tube terminating at the smoke evacuation module 126. The common conduit and fluid lines define a fluid path that extends toward the smoke evacuation module 126 received in the hub housing 136.
In various aspects, the suction/irrigation module 128 is coupled to a surgical tool that includes 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. The one or more drive systems may be configured to irrigate fluid to and aspirate fluid from the surgical site.
In one aspect, a surgical tool includes a shaft having an end effector at a distal end thereof and at least one energy treatment associated with the end effector, a suction tube, and an irrigation tube. The draft tube may have an inlet at a distal end thereof, and the draft tube extends through the shaft. Similarly, a draft tube may extend through the shaft and may have an inlet adjacent the energy delivery tool. The energy delivery tool is configured to deliver ultrasonic and/or RF energy to the surgical site and is coupled to the generator module 140 by a cable that initially extends through the shaft.
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, the fluid interface can connect the suction/irrigation module 128 to a fluid source and/or a vacuum source.
In one aspect, the modules 140, 126, 128 on the hub modular housing 136 and/or their corresponding docking stations may include alignment features configured to enable alignment of the docking ports of the modules into engagement with their corresponding ports in the docking stations of the hub modular housing 136. For example, as shown in fig. 4, the combined generator module 145 includes side brackets 155, the side brackets 155 configured to be slidably engageable with corresponding brackets 156 of corresponding docking mounts 151 of the hub modular housing 136. The brackets cooperate to guide the docking port contacts of the combined generator module 145 into electrical engagement with the docking port contacts of the hub modular housing 136.
In some aspects, the drawers 151 of the hub modular housing 136 are the same or substantially the same size, and the modules are sized to be received in the drawers 151. For example, the side brackets 155 and/or 156 may be larger or smaller depending on the size of the module. In other aspects, the drawers 151 are sized differently and are each designed to accommodate a particular module.
In addition, the contacts of a particular module may be keyed to engage the contacts of a particular drawer to avoid inserting the module into a drawer having unmatched contacts.
As shown in fig. 4, the docking port 150 of one drawer 151 may be coupled to the docking port 150 of another drawer 151 by 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 may be employed, such as, for example, Air Titan-Bluetooth.
Fig. 6 illustrates a single power bus attachment for multiple lateral docking ports of a lateral modular housing 160, the lateral modular housing 160 configured to receive multiple modules of a surgical hub 206. The lateral modular housing 160 is configured to laterally receive and interconnect the modules 161. The modules 161 are slidably inserted into docking feet 162 of a lateral modular housing 160, which lateral modular housing 160 includes a floor for interconnecting the modules 161. As shown in fig. 6, the modules 161 are arranged laterally in a lateral modular housing 160. Alternatively, the modules 161 may be arranged vertically in a lateral modular housing.
Fig. 7 illustrates a vertical modular housing 164 configured to receive a plurality of modules 165 of surgical hub 106. The modules 165 are slidably inserted into docking feet or drawers 167 of a vertical modular housing 164, which vertical modular housing 164 includes a floor 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 laterally arranged drawers. Further, the modules 165 may interact with each other through docking ports of the vertical modular housing 164. In the example of FIG. 7, a display 177 is provided for displaying data related to the operation of module 165. In addition, the vertical modular housing 164 includes a main module 178 that seats a plurality of sub-modules slidably received in the main module 178.
In various aspects, the imaging module 138 includes an integrated video processor and modular light source, and is adapted for use with a variety of imaging devices. In one aspect, the imaging device is constructed of a modular housing that can be fitted with a light source module and a camera module. The housing may be a disposable housing. In at least one example, the disposable housing is removably coupled to the reusable controller, the light source module, and the camera module. The light source module and/or the camera module may be selectively selected according to the type of surgical procedure. In one aspect, the camera module includes a CCD sensor. In another aspect, the camera module includes a CMOS sensor. In another aspect, the camera module is configured for scanning beam imaging. Also, the light source module may be configured to be capable of delivering white light or different light, depending on the surgical procedure.
During a surgical procedure, it may be inefficient to remove the surgical device from the surgical site and replace the surgical device with another surgical device that includes a different camera or a different light source. Temporary loss of vision at the surgical site can lead to undesirable consequences. The modular imaging apparatus of the present disclosure is configured to enable replacement of a light source module or a camera module during a surgical procedure without having to remove the imaging apparatus from the surgical site.
In one aspect, an imaging device includes a tubular housing including a plurality of channels. The first channel is configured to slidably receive a camera module, which may be configured to snap-fit engage with the first channel. The second channel is configured to slidably receive a light source module, which may be configured to snap-fit engage with the second channel. In another example, the camera module and/or the light source module may be rotated within their respective channels to a final position. Threaded engagement may be used instead of snap-fit engagement.
In various examples, multiple imaging devices are placed at different locations in a surgical field to provide multiple views. The imaging module 138 may be configured to be able to switch between imaging devices to provide an optimal view. In various aspects, the imaging module 138 may be configured to be able to integrate images from different imaging devices.
Various IMAGE PROCESSORs AND imaging devices suitable for use in the present disclosure are described in united states patent 7,995,045 entitled COMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR (COMBINED SBI AND associated IMAGE PROCESSOR) published on 9/8/2011, which is incorporated by reference herein in its entirety. Further, U.S. patent 7,982,776 entitled SBI MOTION ARTIFACT REMOVAL APPARATUS AND METHOD (SBI MOTION ARTIFACT REMOVAL MOTION ARTIFACT AND METHOD), published 7/19/2011, which is incorporated herein by reference in its entirety, describes various systems for removing MOTION ARTIFACTs from image data. Such a system may be integrated with the imaging module 138. Further, U.S. patent application publication 2011/0306840 entitled CONTROLLABLE magnetic source TO a fixture in-vivo device (CONTROLLABLE magnetic source TO fix tissue APPARATUS applied), published 2011, and U.S. patent application publication 2014/0243597 entitled SYSTEM FOR PERFORMING minimally invasive surgical PROCEDUREs (SYSTEM FOR patient protocol A MINIMALLY invasivisable protocol) published 2014, each of which is incorporated herein by reference in its entirety, are published 2011, 12-15.
Fig. 8 illustrates a surgical data network 201 including a modular communication hub 203, the modular communication hub 203 configured to enable connection of modular devices located in one or more operating rooms of a medical facility or any room in the medical facility specially 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, modular communication hub 203 includes a network hub 207 and/or a network switch 209 that communicate with network routers. Modular communication hub 203 may also be coupled to local computer system 210 to provide local computer processing and data manipulation. The surgical data network 201 may be configured to be passive, intelligent, or switched. The 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) as well as cloud computing resources. The intelligent surgical data network includes additional features to enable monitoring of traffic through the surgical data network and configuring each port in the 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.
The modular devices 1a-1n located in the operating room may be coupled to a modular communication hub 203. Network hub 207 and/or network switch 209 may be coupled to network router 211 to connect devices 1a-1n to cloud 204 or local computer system 210. Data associated with the devices 1a-1n may be transmitted via the router to the cloud-based computer for remote data processing and manipulation. Data associated with the devices 1a-1n may also be transmitted to the local computer system 210 for local data processing and manipulation. Modular devices 2a-2m located in the same operating room may also be coupled to the network switch 209. Network switch 209 may be coupled to network hub 207 and/or network router 211 to connect devices 2a-2m to cloud 204. Data associated with the devices 2a-2n may be transmitted via the network router 211 to the cloud 204 for data processing and manipulation. Data associated with the devices 2a-2m may also be transmitted to the local computer system 210 for local data processing and manipulation.
It should be understood that surgical data network 201 may be expanded by interconnecting multiple hubs 207 and/or multiple network switches 209 with multiple network routers 211. The modular communication hub 203 may be contained in a modular control tower configured to be capable of receiving a plurality of devices 1a-1n/2a-2 m. Local computer system 210 may also be contained in a 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, for example, during a surgical procedure. In various aspects, the devices 1a-1n/2a-2m may include, for example, various modules such as non-contact sensor modules in 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 memory array 134, a surgical device connected to a display, and/or other modular devices that may be connected to a modular communication hub 203 of a surgical data network 201.
In one aspect, the surgical data network 201 may include a combination of network hub(s), network switch (es), and network router(s) that connect the devices 1a-1n/2a-2m to the cloud. Any or all of the devices 1a-1n/2a-2m coupled to the hub or network switch may collect data in real time and transmit the data into the cloud computer for data processing and manipulation. It should be appreciated that cloud computing relies on shared computing resources rather than using local servers or personal devices to process software applications. The term "cloud" may be used as a metaphor for "internet," although the term is not so limited. Accordingly, the term "cloud computing" may be used herein to refer to a "type of internet-based computing" in which different services (such as servers, memory, and applications) are delivered to modular communication hub 203 and/or computer system 210 located in a surgical room (e.g., a fixed, mobile, temporary, or live operating room or space) and devices connected to modular communication hub 203 and/or computer system 210 over the internet. The cloud infrastructure may 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 the devices 1a-1n/2a-2m located in one or more operating rooms. Cloud computing services can perform a large amount of computing based on data collected by smart surgical instruments, robots, and other computerized devices located in the operating room. The hub hardware enables multiple devices or connections to connect to a computer in communication with the cloud computing resources and memory.
Applying cloud computer data processing techniques 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 may be employed to observe tissue conditions to assess leakage or perfusion of sealed tissue following a tissue sealing and cutting procedure. At least some of the devices 1a-1n/2a-2m may be employed to identify pathologies, such as the effects of disease, using cloud-based computing to examine data including images of body tissue samples for diagnostic purposes. This includes localization and edge confirmation of tissues and phenotypes. At least some of the devices 1a-1n/2a-2m may be employed to identify anatomical structures of the body using various sensors integrated with the imaging devices and techniques, such as overlaying images captured by multiple imaging devices. The data (including image data) collected by the devices 1a-1n/2a-2m may be transmitted to the cloud 204 or the local computer system 210 or both for data processing and manipulation, including image processing and manipulation. Such data analysis may further employ outcome analysis processing, and use of standardized methods may provide beneficial feedback to confirm or suggest modification of the behavior of the surgical treatment and surgeon.
In one implementation, the operating room devices 1a-1n may be connected to the modular communication hub 203 through a wired channel or a wireless channel, depending on the configuration of the devices 1a-1n to the network hub. In one aspect, hub 207 may be implemented as a local network broadcaster operating at the physical layer of the Open Systems Interconnection (OSI) model. The hub provides connectivity to devices 1a-1n located in the same operating room network. The hub 207 collects the data in the form of packets and transmits it to the router in half duplex mode. Hub 207 does not store any media access control/internet protocol (MAC/IP) used to transmit device data. Only one of the devices 1a-1n may transmit data through the hub 207 at a time. The hub 207 does not have routing tables or intelligence as to where to send information and broadcast all network data on each connection and to the remote server 213 (fig. 9) through the cloud 204. Hub 207 may detect basic network errors such as conflicts, but broadcasting all information to multiple ports may present a security risk and lead to bottlenecks.
In another implementation, the operating room devices 2a-2m may be connected to the network switch 209 via a wired channel or a wireless channel. Network switch 209 operates in the data link layer of the OSI model. The network switch 209 is a multicast device for connecting devices 2a-2m located in the same operating room to the network. Network switch 209 sends data in frames to network router 211 and operates in full duplex mode. Multiple devices 2a-2m may transmit 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.
In one example, hub 207 may be implemented as a USB hub, which allows multiple USB devices to be connected to a host. A USB hub may extend a single USB port to multiple tiers so that more ports are available for connecting devices to a host system computer. Hub 207 may include wired or wireless capabilities for receiving information over 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.
In other examples, the operating room devices 1a-1n/2a-2m may 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 of 2.4 to 2.485GHz in the ISM band) and building Personal Area Networks (PANs). In other aspects, the operating room devices 1a-1n/2a-2m may 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 (IEEE802.16 series), IEEE 802.20, Long Term Evolution (LTE) and Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and ethernet derivatives thereof, as well as any other wireless and wired protocols designated 3G, 4G, 5G, and above. The computing module may include a plurality of communication modules. For example, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and bluetooth, and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and the like.
The modular communication hub 203 may serve as a central connection for one or all of the operating room devices 1a-1n/2a-2m and handle a data type called a frame. The frames carry data generated by the devices 1a-1n/2a-2 m. When the modular communication hub 203 receives the frame, it is amplified and transmitted to the network router 211, which network router 211 transmits the data to the cloud computing resources using a plurality of wireless or wired communication standards or protocols as described herein.
Fig. 9 illustrates a computer-implemented interactive surgical system 200. The computer-implemented interactive surgical system 200 is similar in many respects to the computer-implemented interactive surgical system 100. For example, the computer-implemented interactive surgical system 200 includes one or more surgical systems 202 that are similar in many respects to the surgical system 102. Each surgical system 202 includes at least one surgical hub 206 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, the modular control tower 236 being connected to a plurality of operating room devices, such as, for example, intelligent surgical instruments, robots, and other computerized devices located in an operating room. As shown in fig. 10, the modular control tower 236 includes a modular communication hub 203 coupled to the computer system 210. As shown in the example of fig. 9, the modular control tower 236 is coupled to an imaging module 238 coupled to an endoscope 239, a generator module 240 coupled to an energy device 241, a smoke ejector 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 modular control tower 236. Robot hub 222 may also be connected to modular control tower 236 and cloud computing resources. The devices/instruments 235, visualization system 208, etc. may be coupled to the modular control tower 236 via wired or wireless communication standards or protocols, as described herein. The modular control tower 236 may be coupled to the 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 the image and the overlay image to display data received from devices connected to the modular control tower.
Fig. 10 shows the surgical hub 206 including a plurality of modules coupled to a modular control tower 236. The modular control tower 236 includes a modular communication hub 203 (e.g., a network connectivity device) and a computer system 210 to provide, for example, local processing, visualization, and imaging. As shown in fig. 10, the modular communication hub 203 may be connected in a hierarchical configuration to expand the number of modules (e.g., devices) that may 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. As shown in fig. 10, each of the network hubs/switches in modular communication hub 203 includes three downstream ports and one upstream port. The upstream hub/switch is connected to the processor to provide a communication connection with the cloud computing resources and the local display 217. Communication with the cloud 204 may be through a wired or wireless communication channel.
The surgical hub 206 employs the non-contact sensor module 242 to measure dimensions of the operating room and uses ultrasound or laser type non-contact measurement devices to generate a map of the operating room. An ultrasound-based non-contact sensor module scans an Operating Room by emitting a burst of ultrasound waves and receiving echoes as they bounce off the enclosure of the Operating Room, as described under U.S. provisional patent application serial No. 62/611,341 entitled "interactive Surgical platform (INTERACTIVE SURGICAL PLATFORM)" filed on 12/28 2017, entitled "Surgical Hub space sensing in 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 bouncing off the enclosure of the operating room, and comparing the phase of the emitted pulses to the received pulses to determine the size of the operating room and adjust the bluetooth paired distance limit.
The controller 244 may be any single-core or multi-core processor, such as those provided by Texas instruments under the tradename ARM Cortex. In one aspect, the processor may be a processor core available from, for example, Texas Instruments LM4F230H5QR ARM Cortex-M4F processor core, which includes 256KB of on-chip memory of single cycle flash or other non-volatile memory (up to 40MHZ), a prefetch buffer for improved performance above 40MHz, 32KB of single cycle Sequential Random Access Memory (SRAM), loaded with Stellaris
Software internal Read Only Memory (ROM), 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) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, the details of which can be seen in the product data sheet.
In one aspect, the processor 244 may comprise a safety controller comprising two series controller-based controllers (such as TMS570 and RM4x), also known under the trade name Hercules ARM Cortex R4, also manufactured by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety critical applications, etc., to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
The system memory includes volatile memory and non-volatile memory. The basic input/output system (BIOS), containing the basic routines to transfer information between elements within the computer system, such as during start-up, is stored in nonvolatile memory. For example, nonvolatile memory can include ROM, Programmable ROM (PROM), Electrically Programmable ROM (EPROM), EEPROM, or flash memory. Volatile memory includes Random Access Memory (RAM), which acts as external cache memory. Further, RAM may be 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).
The computer system 210 also includes removable/non-removable, volatile/nonvolatile computer storage media such as, for example, disk storage. Disk storage includes, but is not limited to, devices such as a magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zip drive, LS-60 drive, flash memory card, or memory stick. In addition, disk storage can include storage media separately or in combination with other storage media including, but not limited to, an optical disk drive such as a compact disk ROM device (CD-ROM), compact disk recordable drive (CD-R drive), compact disk rewritable drive (CD-RW drive) or a digital versatile disk ROM drive (DVD-ROM). To facilitate connection of the disk storage devices to the system bus, a removable or non-removable interface may be used.
It is to be appreciated that the computer system 210 includes software that acts as an intermediary between users and the basic computer resources described in suitable operating environments. Such software includes an operating system. An operating system, which may be stored on disk storage, is used to control and allocate resources of the computer system. System applications utilize the operating system to manage resources through program modules and program data stored in system memory or on disk storage. It is to be appreciated that the various components described herein can be implemented with various operating systems or combinations of operating systems.
A user enters commands or information into the computer system 210 through input device(s) coupled to the I/O interface 251. Input devices include, but are not limited to, a pointing device such as a mouse, trackball, stylus, touch pad, keyboard, microphone, joystick, game pad, satellite dish, scanner, TV tuner card, digital camera, digital video camera, web camera, and the like. These and other input devices are connected to the processor through the system bus via interface port(s). The interface port(s) include, for example, a serial port, a parallel port, a game port, and a USB. The output device(s) use the same type of port as the input device(s). Thus, for example, a USB port may be used to provide input to a computer system and to 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.
The computer system 210 may operate in a networked environment using logical connections to one or more remote computers, such as a cloud computer(s), or a local computer. The remote cloud computer(s) can be personal computers, servers, routers, network PCs, workstations, microprocessor-based appliances, peer devices or other common network nodes and the like, and typically includes many or all of the elements described relative to the computer system. For purposes of brevity, only a memory storage device with remote computer(s) is illustrated. The remote computer(s) is logically connected to the computer system through a network interface and then physically connected via a communications connection. Network interfaces encompass communication networks such as Local Area Networks (LANs) and Wide Area Networks (WANs). LAN technologies include Fiber Distributed Data Interface (FDDI), Copper Distributed Data Interface (CDDI), Ethernet/IEEE 802.3, token Ring/IEEE 802.5, and the like. WAN technologies include, but are not limited to, point-to-point links, circuit switching networks like Integrated Services Digital Networks (ISDN) and variations thereon, packet switching networks, and Digital Subscriber Lines (DSL).
In various aspects, the computer system 210, imaging module 238, and/or visualization system 208 of fig. 10, and/or the processor module 232 of fig. 9-10 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 instruction, multiple data (MIMD) techniques to increase speed and efficiency. The digital image processing engine may perform a series of tasks. The image processor may be a system on a chip having a multi-core processor architecture.
Communication connection(s) refers to the hardware/software used to interface the network to the bus. While a communication connection is shown for exemplary clarity within the computer system, it can also be external to computer system 210. The hardware/software necessary for connection to the network interface includes, for exemplary purposes only, internal and external technologies such as, modems including regular telephone grade modems, cable modems and DSL modems, ISDN adapters, and Ethernet cards.
Fig. 11 illustrates a functional block diagram of one aspect of a USB hub 300 device in accordance with at least one aspect of the present disclosure. In the illustrated aspect, the USB hub device 300 employs a TUSB2036 integrated circuit hub from texas instruments. The USB 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, where each port includes a differential data positive (DP1-DP3) output paired with a differential data negative (DM1-DM3) output.
The USB hub 300 device is implemented with a digital state machine rather than a microcontroller and does not require firmware programming. Fully compatible USB transceivers are integrated into the circuitry 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 slew rate according to the speed of the device attached to the port. The USB hub 300 device may be configured to be capable of being in a bus-powered mode or a self-powered mode and includes hub power logic 312 for managing power.
The USB hub 300 device includes a serial interface engine 310 (SIE). SIE 310 is the front end of the USB hub 300 hardware and handles most of the protocols described in section 8 of the USB specification. The SIE 310 typically includes signaling up to the transaction level. The processing functions thereof may include: packet identification, transaction ordering, SOP, EOP, RESET and RESUME signal detection/generation, clock/data separation, no return to zero inversion (NRZI) data encoding/decoding and digit stuffing, CRC generation and verification (token and data), packet id (pid) generation and verification/decoding, and/or serial-parallel/parallel-serial conversion. 310 receives a clock input 314 and is coupled to pause/resume logic and frame timer 316 circuitry and hub repeater circuitry 318 to control communications between the upstream USB transceiver port 302 and the downstream USB transceiver ports 304, 306, 308 through port logic circuitry 320, 322, 324. The SIE 310 is coupled to a command decoder 326 via interface logic to control commands from the serial EEPROM via a serial EEPROM interface 330.
In various aspects, the USB hub 300 may connect 127 functions configured in up to six logical layers (tiers) to a single computer. Further, the USB hub 300 may be connected to all external devices using a standardized four-wire cable that provides both communication and power distribution. The power configuration is a bus powered mode and a self-powered mode. The USB hub 300 may be configured to support four power management modes: bus-powered hubs with individual port power management or package port power management, and self-powered hubs with individual port power management or package port power management. In one aspect, the USB hub 300, upstream USB transceiver port 302, are plugged into the USB host controller using a USB cable, and downstream USB transceiver ports 304, 306, 308 are exposed for connection of USB compatible devices, or the like.
Surgical instrument hardware
Fig. 12 illustrates a logic diagram for a control system 470 for a surgical instrument or tool according to one or more aspects of the present disclosure. The system 470 includes control circuitry. The control circuit includes a microcontroller 461 that includes 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 operatively coupled to the longitudinally movable displacement member to drive the clamp arm closure 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 a processor 462, which processor 462 may be programmed or configured to be able to determine the position of the longitudinally movable drive member and the position of the closure member. Additional motors may be provided at the tool driver interface to control closure tube travel, shaft rotation, articulation, or gripper arm closure, or combinations thereof. The display 473 displays a variety of operating conditions of the instrument and may include touch screen functionality for data entry. The information displayed on the display 473 may be overlaid with the image acquired via the endoscopic imaging module.
In one aspect, the microprocessor 461 can be any single microprocessorCore or multi-core processors such as those known under the trade name ARM Cortex manufactured by Texas Instruments (Texas Instruments). In one aspect, microcontroller 461 may be an LM4F230H5QR ARM Cortex-M4F processor core available from Texas Instruments, Inc. (Texas Instruments), for example, that includes on-chip memory of 256KB single-cycle flash memory or other non-volatile memory (up to 40MHZ), prefetch buffers for improved performance above 40MHz, 32KB single-cycle SRAM, Stellaris loaded, Stellaris
Internal ROM of software, 2KB electrical EEPROM, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels, the details of which can be seen in the product data sheet.
In one aspect, microcontroller 461 may comprise a safety controller comprising two controller-based families such as TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4, also manufactured by Texas Instruments. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety critical applications, etc., to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
The microcontroller 461 may be programmed to perform various functions such as precisely controlling the speed and position of the knife, the articulation system, the clamp arm, or a combination of the above. In one aspect, microcontroller 461 includes processor 462 and memory 468. The electric motor 482 may be a brushed Direct Current (DC) motor having a gear box and a mechanical link to an articulation or knife system. In one aspect, the motor driver 492 may be a3941 available from Allegro Microsystems, Inc. Other motor drives can be readily substituted for use in tracking system 480, including an absolute positioning system. Detailed description of absolute positioning system U.S. patent application publication 2017/0296213 entitled system and method FOR CONTROLLING a SURGICAL stapling and severing instrument (SYSTEMS AND METHODS FOR CONTROLLING a SURGICAL stapling a SURGICAL STAPLING AND cutting system), which is published on 19/10/2017, is incorporated herein by reference in its entirety.
The microcontroller 461 may be programmed to provide precise control of the speed and position of the displacement member and the articulation system. The microcontroller 461 may be configured to be able to calculate a response in the software of the microcontroller 461. The calculated response is compared to the measured response of the actual system to obtain an "observed" response, which is used for the actual feedback decision. 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 effects on the system.
In one aspect, the motor 482 can be controlled by a motor driver 492 and can be employed by a firing system of a surgical instrument or tool. In various forms, the motor 482 may be a brushed DC drive motor having a maximum rotational speed of about 25,000 RPM. In other arrangements, the motor 482 may comprise a brushless motor, a cordless motor, a synchronous motor, a stepper motor, or any other suitable electric motor. The motor driver 492 may comprise, for example, an H-bridge driver including a Field Effect Transistor (FET). The motor 482 may be powered by a power assembly releasably mounted to the handle assembly or tool housing for supplying control power to the surgical instrument or tool. The power assembly may include a battery, which may include a plurality of battery cells connected in series that may be used as a power source to provide power to a surgical instrument or tool. In some cases, the battery cells of the power assembly may be replaceable and/or rechargeable battery cells. In at least one example, the battery cell may be a lithium ion battery that is capable of being coupled to and separable from the power assembly.
The driver 492 may be a3941 available from Allegro Microsystems, Inc. A 3941492 is a full-bridge controller for use with an external N-channel power Metal Oxide Semiconductor Field Effect Transistor (MOSFET) 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 a3941 to operate with reduced gate drive as low as 5.5V. A bootstrap capacitor may be employed to provide the aforementioned battery supply voltage required for the N-channel MOSFET. The internal charge pump of the high-side drive allows for direct current (100% duty cycle) operation. The full bridge may be driven in fast decay mode or slow decay mode using diodes or synchronous rectification. In the slow decay mode, current recirculation may pass through either the high-side FET or the low-side FET. The power FET is protected from breakdown by a resistor adjustable dead time. The integral diagnostics provide an indication of undervoltage, overheating, and power bridge faults, and may be configured to protect the power MOSFETs under most short circuit conditions. Other motor drives can be readily substituted for use in tracking system 480, including an absolute positioning system.
The tracking system 480 includes a controlled motor drive circuit arrangement including a position sensor 472 according to one aspect of the present disclosure. The position sensor 472 for the absolute positioning system provides a unique position signal corresponding to the position of the displacement member. In one aspect, the displacement member represents a longitudinally movable drive member including a rack of drive teeth for meshing engagement with a corresponding drive gear of the gear reducer assembly. In other aspects, the displacement member represents a firing member that may be adapted and configured as a rack including drive teeth. In a further aspect, the displacement member represents a longitudinal displacement member for opening and closing the clamp arm, which may be adapted and configured as a rack comprising drive teeth. In other aspects, the displacement member represents a clamp arm closure member configured to be capable of closing and opening a clamp arm of a stapler, a clamp arm of an ultrasonic or electrosurgical device, or a combination thereof. Accordingly, as used herein, the term displacement member is used generically to refer to any movable member of a surgical instrument or tool (such as a drive member, a clamp arm, or any element that can be displaced). Thus, the absolute positioning system can in fact track the displacement of the gripping arm by tracking the linear displacement of the longitudinally movable drive member.
In other aspects, the absolute positioning system can be configured to track the position of the clamp arm during closing or opening. In various other aspects, the displacement member may be coupled to any position sensor 472 suitable for measuring linear displacement. Thus, the longitudinally movable drive member, or the clamp arm, or a combination thereof, may be coupled to any suitable linear displacement sensor. The linear displacement sensor may comprise a contact displacement sensor or a non-contact displacement sensor. The linear displacement sensor may comprise a Linear Variable Differential Transformer (LVDT), a Differential Variable Reluctance Transducer (DVRT), a sliding potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photodiodes or photodetectors, an optical sensing system comprising a fixed light source and a series of movable linearly arranged photodiodes or photodetectors, or any combination thereof.
The electric motor 482 may include a rotatable shaft that operatively interfaces with a gear assembly mounted on the displacement member in meshing engagement with the set or rack of drive teeth. The sensor element may be operatively coupled to the gear assembly such 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 the linear actuator via a rack and pinion arrangement, or to the rotary actuator via a spur gear or other connection. The power source powers the absolute positioning system and the output indicator may display an output of the absolute positioning system. The displacement member represents a longitudinally movable drive member including 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 clamp arm.
A single rotation of the sensor element associated with the position sensor 472 is equivalent to a longitudinal linear displacement d of the displacement member1Wherein d is1Is the longitudinal linear distance that the displacement member moves from point "a" to point "b" after a single rotation of the sensor element coupled to the displacement member. Can be connected and transmitted by gear reductionThe sensor arrangement, the gear reduction, causes the position sensor 472 to complete only one or more rotations for the full stroke of the displacement member. The position sensor 472 may complete multiple rotations for a full stroke of the displacement member.
A series of switches (where n is an integer greater than one) may be employed alone or in conjunction with the gear reduction to provide unique position signals for more than one rotation of the position sensor 472. The state of the switch is fed back to the microcontroller 461, which microcontroller 461 applies logic to determine a longitudinal linear displacement d corresponding to the displacement member1+d2+…dnA unique position signal of. The output of the position sensor 472 is provided to a microcontroller 461. The position sensor 472 of the sensor arrangement may include a magnetic sensor, an analog rotation sensor (e.g., a potentiometer), an array of analog hall effect elements that output a unique combination of position signals or values.
In one aspect, the position sensor 472 for the tracking system 480 including an absolute positioning system comprises a magnetic rotary absolute positioning system. The position sensor 472 can be implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from australia 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 component and includes four hall effect elements located in the area of the position sensor 472 on the magnet. A high resolution ADC and an intelligent power management controller are also provided on the chip. Coordinate rotation digital computer (CORDIC) processors (also known as bitwise and Volder algorithms) are provided to perform simple and efficient algorithms to compute hyperbolic and trigonometric functions, which require only addition, subtraction, digital displacement and table lookup operations. The angular position, alarm bits and magnetic field information are transmitted to the microcontroller 461 through 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 × 0.85mm package.
The tracking system 480, including an absolute positioning system, may include and/or may be programmed to implement feedback controllers such as PID, state feedback, and adaptive controllers. 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 location measured by the location 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 a sensor arrangement such as those described in U.S. patent 9,345,481 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE TISSUE thicknes) issued 5, 24, 2016, which is incorporated herein by reference in its entirety; U.S. patent application publication 2014/0263552 entitled staple cartridge TISSUE THICKNESS sensor system (STAPLE CARTRIDGE TISSUE thicknes) published 9, 18, 2014, which is incorporated herein by reference in its entirety; and us patent application serial No. 15/628,175 entitled technique FOR ADAPTIVE CONTROL OF motor speed FOR SURGICAL stapling and CUTTING INSTRUMENTs (TECHNIQUES FOR ADAPTIVE CONTROL OF A SURGICAL STAPLING AND CUTTING INSTRUMENT) filed 2017, 8, 20, which is hereby incorporated by reference in its entirety. In a digital signal processing system, an absolute positioning system is coupled to a digital data acquisition system, wherein the output of the absolute positioning system will have a finite resolution and sampling frequency. The absolute positioning system may include comparison and combination circuitry to combine the calculated response with the measured response using an algorithm (such as a weighted average and a 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, inductive resistance to predict the state and output of the physical system by knowing the inputs.
Thus, the absolute positioning system provides an absolute position of the displacement member upon power-up of the instrument, and does not retract or advance the displacement member to a reset (clear or home) position as may be required by 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.
The sensor 474 (such as, for example, a strain gauge or a micro-strain gauge) is configured to measure one or more parameters of the end effector, such as, for example, the amplitude of the strain exerted on the anvil during a clamping operation, which may be indicative of the closing force applied to the anvil. The measured strain is converted to a digital signal and provided to the processor 462. Alternatively or in addition to sensor 474, sensor 476 (such as, for example, a load sensor) may measure the closing force applied by the closure drive system to an anvil in a stapler or clamping arm in an ultrasonic or electrosurgical instrument. The sensor 476 (such as, for example, a load sensor) may measure a firing force applied to a closure member coupled to a clamp arm of a surgical instrument or tool or a force applied by the clamp arm to tissue located in a jaw of an ultrasonic or electrosurgical instrument. Alternatively, a current sensor 478 may be employed to measure the current drawn by the motor 482. The displacement member may also be configured to be able to engage the clamp arm to open or close the clamp arm. The force sensor may be configured to measure a 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 to a digital signal and provided to the processor 462.
In one form, the strain gauge sensor 474 may be used to measure the force applied to tissue by the end effector. A strain gauge may be coupled to the end effector to measure force on tissue being treated by the end effector. The system for measuring force applied to tissue grasped by the end effector includes a strain gauge sensor 474, such as, for example, a micro-strain gauge, configured to be capable of measuring one or more parameters of, for example, the end effector. In one aspect, strain gauge sensor 474 can measure the amplitude or magnitude of the strain exerted on the jaw members of the end effector during a clamping operation, which can indicate tissue compression. The measured strain is converted to a digital signal and provided to the processor 462 of the microcontroller 461. Load sensor 476 may measure a force used to operate the knife member, for example, to cut tissue captured between the anvil and the staple cartridge. The load cell 476 may measure a force used to operate the clamp arm member, for example, to capture tissue between the clamp arm and the ultrasonic blade or to capture tissue between the clamp arm and the jaws of the electrosurgical instrument. A magnetic field sensor may be employed to measure the thickness of the trapped tissue. The measurements of the magnetic field sensors may also be converted to digital signals and provided to the processor 462.
The microcontroller 461 can use measurements of tissue compression, tissue thickness, and/or force required to close the end effector, as measured by the sensors 474, 476, respectively, to characterize selected positions of the firing member and/or corresponding values of the velocity of the firing member. In one example, the memory 468 may store techniques, formulas, and/or look-up tables that may be employed by the microcontroller 461 in the evaluation.
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, as shown in fig. 8-11.
Fig. 13 illustrates a control circuit 500, the control circuit 500 configured to control aspects of a surgical instrument or tool according to an aspect of the present disclosure. The control circuitry 500 may be configured to enable the various processes described herein. The circuit 500 may include a microcontroller including one or more processors 502 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 504. The memory circuitry 504 stores machine-executable instructions that, when executed by the processor 502, cause the processor 502 to execute machine instructions to implement the various processes described herein. 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 volatile storage media and non-volatile storage media. Processor 502 may include an instruction processing unit 506 and an arithmetic unit 508. The instruction processing unit may be configured to be able to receive instructions from the memory circuit 504 of the present disclosure.
Fig. 14 illustrates a combinational logic circuit 510, the combinational logic circuit 510 configured to control aspects of a surgical instrument or tool according to an aspect of the present disclosure. The combinational logic circuit 510 may be configured to enable the various processes described herein. The combinational logic circuit 510 may include a finite state machine including combinational logic 512, the combinational logic 512 configured to receive data associated with a surgical instrument or tool at input 514, process the data through the combinational logic 512 and provide output 516.
Fig. 15 illustrates a sequential logic circuit 520 configured to control various aspects of a surgical instrument or tool according to one aspect of the present disclosure. Sequential logic circuitry 520 or combinational logic 522 may be configured to enable the various processes described herein. Sequential logic circuit 520 may comprise a finite state machine. Sequential logic circuitry 520 may include, for example, combinatorial logic 522, at least one memory circuit 524, and a clock 529. The at least one memory circuit 524 may store a current state of the finite state machine. In some cases, the sequential logic circuit 520 may be synchronous or asynchronous. The combinational logic 522 is configured to receive data associated with a surgical instrument or tool from the inputs 526, process the data through the combinational logic 522, and provide the outputs 528. In other aspects, a circuit may comprise a combination of a processor (e.g., 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 combination of combinational logic circuitry (e.g., combinational logic circuitry 510, FIG. 14) and sequential logic circuitry 520.
Fig. 16 illustrates a surgical instrument or tool including multiple motors that can be activated to perform various functions. In some cases, the first motor may be activated to perform a first function, the second motor may be activated to perform a second function, and the third motor may be activated to perform a third function. In some instances, multiple motors of the robotic surgical instrument 600 may be individually activated to cause firing, closing, and/or articulation motions in the end effector. Firing motions, closing motions, and/or articulation motions can be transmitted to the end effector, for example, via a shaft assembly.
In certain instances, a surgical instrument system or tool may include a firing motor 602. The firing motor 602 is operatively coupled to a firing motor drive assembly 604, which firing motor drive assembly 604 may be configured to emit a firing motion generated by the motor 602 to the end effector, in particular 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 gripper arms to open.
In some cases, the surgical instrument or tool may include a closure motor 603. The closure motor 603 may be operatively coupled to a closure motor drive assembly 605, the closure motor drive assembly 605 being configured to emit closure motions generated by the motor 603 to the end effector, in particular for displacing a closure tube to close the anvil and compress tissue between the anvil and staple cartridge. The closure motor 603 can be operatively coupled to a closure motor drive assembly 605 configured to transmit the closure motions generated by the motor 603 to the end effector, in particular for displacing the closure tube to close the clamp arm and compress tissue between the clamp arm and the ultrasonic blade or jaw member of the electrosurgical device. The closing motion can transition, for example, the end effector from an open configuration to an approximated configuration to capture tissue. The end effector may be transitioned to the open position by reversing the direction of the motor 603.
In some cases, the surgical instrument or tool may include, for example, one or more articulation motors 606a, 606 b. The motors 606a, 606b can be operatively coupled to respective articulation motor drive assemblies 608a, 608b, which can be configured to transmit articulation motions generated by the motors 606a, 606b to the end effector. In some cases, the articulation can articulate the end effector relative to the shaft, for example.
As described above, a surgical instrument or tool may include multiple motors that may be configured to perform various independent functions. In some cases, multiple motors of a surgical instrument or tool may be activated individually or independently to perform one or more functions while other motors remain inactive. For example, the articulation motors 606a, 606b may be activated to articulate the end effector while the firing motor 602 remains inactive. Alternatively, the firing motor 602 may be activated to fire a plurality of staples and/or advance the cutting edge while the articulation motor 606 remains inactive. Further, the closure motor 603 may be activated simultaneously with the firing motor 602 to advance the closure tube or closure member distally, as described in more detail below.
In some instances, a surgical instrument or tool may include a common control module 610, which common control module 610 may be used with multiple motors of the surgical instrument or tool. In some cases, the common control module 610 may regulate one of the plurality of motors at a time. For example, the common control module 610 can be individually coupled to and separable from multiple motors of the surgical instrument. In some cases, multiple motors of a surgical instrument or tool may share one or more common control modules, such as common control module 610. In some instances, multiple motors of a surgical instrument or tool may independently and selectively engage a common control module 610. In some cases, the common control module 610 may switch from interfacing with one of the plurality of motors of the surgical instrument or tool to interfacing with another of the plurality of motors of the surgical instrument or tool.
In at least one example, the common control module 610 can be selectively switched between operatively engaging the articulation motors 606a, 606b and operatively engaging the firing motor 602 or the closure motor 603. In at least one example, as shown in fig. 16, the switch 614 may be moved or transitioned between a plurality of positions and/or states. In the first position 616, the switch 614 may electrically couple the common control module 610 to the firing motor 602; in a second position 617, the switch 614 may electrically couple the common control module 610 to the close motor 603; in a third position 618a, switch 614 may electrically couple common control module 610 to first articulation motor 606 a; and in the fourth position 618b, the switch 614 may electrically couple the common control module 610 to, for example, the second articulation motor 606 b. In some instances, a single common control module 610 may be electrically coupled to the firing motor 602, the closure motor 603, and the articulation motors 606a, 606b simultaneously. In some cases, the switch 614 may be a mechanical switch, an electromechanical switch, a solid state switch, or any suitable switching mechanism.
Each of the motors 602, 603, 606a, 606b may include a torque sensor to measure the output torque on the shaft of the motor. The force on the end effector can be sensed in any conventional manner, such as by a force sensor on the outside of the jaws or by a torque sensor of a motor used to actuate the jaws.
In various instances, as shown in fig. 16, the common control module 610 may include a motor driver 626, which motor driver 626 may include one or more H-bridge FETs. The motor driver 626 may regulate power transmitted from a power source 628 to the motors coupled to the common control module 610, for example, based on input from a microcontroller 620 ("controller"). In some cases, the microcontroller 620 may be employed, for example, to determine the current drawn by the motors when they are coupled to the common control module 610, as described above.
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 various functions and/or computations as described herein. In some cases, one or more of the memory units 624 may be coupled to the processor 622, for example. In various aspects, microcontroller 620 can communicate over a wired or wireless channel, or a combination thereof.
In some cases, power source 628 may be used, for example, to power microcontroller 620. In some cases, the power source 628 may include a battery (or "battery pack" or "power pack"), such as a lithium ion battery, for example. In some instances, the battery pack may be configured to be releasably mountable to the handle for powering the surgical instrument 600. A plurality of series-connected battery cells may be used as the power source 628. In some cases, the power source 628 may be replaceable and/or rechargeable, for example.
In various instances, the processor 622 may control the motor driver 626 to control the position, rotational direction, and/or speed of the motors coupled to the common controller 610. In some cases, the processor 622 may signal the motor driver 626 to stop and/or disable the motors coupled to the common controller 610. It is to be understood that the term "processor" as used herein includes any suitable microprocessor, microcontroller, or other basic computing device that combines the functions of a computer's Central Processing Unit (CPU) on one integrated circuit or at most several integrated circuits. Processor 622 is a multipurpose programmable device that receives digital data as input, processes the input according to instructions stored in its memory, and then provides the result as output. Because the processor has internal memory, it is an example of sequential digital logic. The operands of the processor are numbers and symbols represented in a binary numerical system.
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 (Texas Instruments). In some cases, microcontroller 620 may be, for example, LM4F230H5QR, which is commercially available from Texas Instruments. In at least one example, the Texas instruments LM4F230H5QR is an ARM Cortex-M4F processor core that includes: 256KB of on-chip memory of Single cycle flash or other non-volatile memory (up to 40MHz), prefetch buffers to improve performance above 40MHz, 32KB of Single cycle SRAM, Stellaris loaded
Internal ROM of software, EEPROM of 2KB, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Can be easily exchanged for other microcontrollers to be used with the moduleBlock 4410 is used together. Accordingly, the present disclosure should not be limited to this context.
In certain instances, 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 closure motor 603, and the articulation motors 606a, 606 b. Such program instructions may cause the processor 622 to control firing, closure, and articulation functions in accordance with input from an algorithm or control program of the surgical instrument or tool.
In some cases, one or more mechanisms and/or sensors (such as sensor 630) may be used to alert processor 622 of program instructions that should be used in a particular setting. For example, the sensor 630 may alert the processor 622 to use program instructions associated with firing, closing, and articulating the end effector. In some cases, sensor 630 may include, for example, a position sensor that may be used to sense the position of switch 614. Thus, the processor 622 can use program instructions associated with firing a closure member of a clamp arm coupled to the end effector when the switch 614 is detected in the first position 616, for example, by the sensor 630; the processor 622 can use the program instructions associated with closing the anvil when the switch 614 is in the second position 617, for example, as detected by the sensor 630; and the processor 622 may use the program instructions associated with articulating the end effector when the switch 614 is in the third position 618a or the fourth position 618b, for example, as detected by the sensor 630.
Fig. 17 is a schematic illustration of a robotic surgical instrument 700 configured to operate a surgical tool described herein, according to one aspect of the present disclosure. The robotic surgical instrument 700 may be programmed or configured to control distal/proximal translation of the displacement member, distal/proximal displacement of the closure tube, shaft rotation, and articulation with single or multiple articulation drive links. In one aspect, the surgical instrument 700 can be programmed or configured to control the firing member, the closure member, the shaft member, or one or more articulation members individually, or in combinations thereof. The surgical instrument 700 includes a control circuit 710, the control circuit 710 configured to control a motor driven firing member, a closure member, a shaft member, or one or more articulation members, or a combination thereof.
In one aspect, the robotic surgical instrument 700 includes a control circuit 710, the control circuit 710 configured to control the clamp arm 716 and closure member 714 portions of the end effector 702, an ultrasonic blade 718 coupled to an ultrasonic transducer 719 excited by an ultrasonic generator 721, a shaft 740, and one or more articulation members 742a, 742b via a plurality of motors 704a-704 e. The position sensor 734 may be configured to provide position feedback of the closure member 714 to the control circuit 710. The other sensors 738 may be configured to provide feedback to the control circuit 710. The timer/counter 731 provides timing and count 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 by the control circuit 710 in open loop or closed loop feedback control.
In one aspect, 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, such as a elapsed time or a digital count, to the control circuit 710 to correlate the position of the closure 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 closure member 714 at a particular time (t) relative to a starting position or at a time (t) when the closure member 714 is at a particular position relative to a starting position. The timer/counter 731 may be configured to be able to measure elapsed time, count external events, or time external events.
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 may be programmed to sense a tissue condition, such as thickness, directly or indirectly, as described herein. The control circuit 710 may be programmed to select a firing control program or a closing control program based on tissue conditions. The firing control routine may describe distal movement of the displacement member. Different firing control programs may be selected to better address different tissue conditions. For example, when thicker tissue is present, the control circuit 710 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 710 may be programmed to translate the displacement member at a higher speed and/or at a higher power. The closure control program can control the closure force applied to the tissue by the clamp arms 716. Other control programs control the rotation of the shaft 740 and the articulation members 742a, 742 b.
In one aspect, the control circuit 710 may generate a motor set point signal. The motor set point signals may be provided to various motor controllers 708a-708 e. 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 speeds of the motors 704a-704e may be proportional to the respective motor drive signals. In some examples, the motors 704a-704e can be brushless DC motors, and the respective motor drive signals can include PWM signals provided to one or more stator windings of the motors 704a-704 e. Also, in some examples, the motor controllers 708a-708e may be omitted and the control circuit 710 may generate the motor drive signals directly.
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 stroke of the displacement member. Based on the response of the robotic surgical instrument 700 during the open-loop portion of the stroke, the control circuit 710 may select a firing control program 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 elapsed during the open loop portion, the energy provided to one of the motors 704a-704e during the open loop portion, the sum of the pulse widths of the motor drive signals, and so forth. After the open loop portion, the control circuit 710 may implement the selected firing control routine for a second portion of the displacement member stroke. For example, during the closed-loop portion of the stroke, the control circuit 710 may modulate one of the motors 704a-704e based on translation data that describes the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed.
In one aspect, the motors 704a-704e may receive power from an energy source 712. The energy source 712 may be a DC power source driven by a main ac power source, a battery, a super capacitor, or any other suitable energy source. The motors 704a-704e may be mechanically coupled to separate movable mechanical elements, such as the closure member 714, the clamp arm 716, the shaft 740, the articulation 742a, and the articulation 742b, via respective transmissions 706a-706 e. The actuators 706a-706e may include one or more gears or other linkage components to couple the motors 704a-704e to the movable mechanical elements. The position sensor 734 may sense the position of the closure member 714. The position sensor 734 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 714. In some examples, the position sensor 734 may include an encoder configured to provide a series of pulses to the control circuit 710 as the closure member 714 is translated distally and proximally. The control circuit 710 may track the pulses to determine the position of the closure member 714. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the movement of the closure member 714. Also, in some examples, position sensor 734 may be omitted. Where the motors 704a-704e are stepper motors, the control circuit 710 may track the position of the closure member 714 by aggregating the number and direction of steps that the motor 704 has been commanded to perform. The position sensor 734 may be located in the end effector 702 or at any other portion of the instrument. The output of each of the motors 704a-704e includes a torque sensor 744a-744e for sensing force and has an encoder for sensing rotation of the drive shaft.
In one aspect, the control circuit 710 is configured to drive a closure member 714 portion of a firing member, such as the end effector 702. The control circuit 710 provides a motor set point to the motor control 708a, which provides a drive signal to the motor 704 a. The output shaft of motor 704a is coupled to a torque sensor 744 a. The torque sensor 744a is coupled to the transmission 706a, which transmission 706a is coupled to the closure member 714. The transmission 706a includes movable mechanical elements, such as rotating elements and firing members, to control the distal and proximal movement of the closure member 714 along the longitudinal axis of the end effector 702. In one aspect, the motor 704a may be coupled to a knife gear assembly that includes a knife gear reduction set that 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 closure member 714. The position sensor 734 may be configured to provide the position of the closure 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 708 a. In response to the firing signal, the motor 704a can drive the firing member distally along the longitudinal axis of the end effector 702 from a proximal stroke start position to an end of stroke position distal of the stroke start position. As the closure member 714 translates distally, the clamp arm 716 closes toward the ultrasonic blade 718.
In one aspect, the control circuit 710 is configured to drive a closure member, such as a clamp arm 716 portion of the end effector 702. The control circuit 710 provides a motor set point to the motor control 708b, which motor control 708b provides a drive signal to the motor 704 b. The output shaft of motor 704b is coupled to a torque sensor 744 b. The torque sensor 744b is coupled to the transmission 706b that is coupled to the clamp arm 716. The actuator 706b includes movable mechanical elements, such as rotating elements and closing members, to control the movement of the clamp arms 716 from the open and closed positions. In one aspect, the motor 704b is coupled to a closure gear assembly that includes a closure reduction gear set supported in meshing engagement with a closure spur gear. The torque sensor 744b provides a closing force feedback signal to the control circuit 710. The closing force feedback signal is representative of the closing force applied to the clamp arm 716. The position sensor 734 may be configured to provide the position of the closure member as a feedback signal to the control circuit 710. An additional sensor 738 in the end effector 702 may provide a closing force feedback signal to the control circuit 710. Pivotable clamp arm 716 is positioned opposite ultrasonic blade 718. When ready for use, the control circuit 710 may provide a close signal to the motor control 708 b. In response to the closure signal, the motor 704b advances the closure member to grasp tissue between the clamp arm 716 and the ultrasonic blade 718.
In one aspect, the control circuit 710 is configured to rotate a shaft member, such as the shaft 740, to rotate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708c, which motor control 708c provides a drive signal to the motor 704 c. The output shaft of motor 704c is coupled to a torque sensor 744 c. The torque sensor 744c is coupled to the transmission 706c coupled to the shaft 740. Actuator 706c includes a movable mechanical element, such as a rotating element, to control rotation of shaft 740 more than 360 ° clockwise or counterclockwise. In one aspect, the motor 704c is coupled to a rotary drive assembly that includes a tube gear section formed on (or attached to) the proximal end of the proximal closure tube for operative engagement by a rotary gear assembly operatively 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 closure member as a feedback signal to the control circuit 710. An additional sensor 738, such as a shaft encoder, may provide the control circuit 710 with the rotational position of the shaft 740.
In one aspect, the control circuit 710 is configured to articulate the end effector 702. The control circuit 710 provides a motor set point to the motor control 708d, which motor control 708d provides a drive signal to the motor 704 d. The output of the motor 704d is coupled to a torque sensor 744 d. The torque sensor 744d is coupled to the transmission 706d that is coupled to the articulation member 742 a. The actuator 706d includes a movable mechanical element, such as an articulation element, to control the + -65 deg. articulation of the end effector 702. In one aspect, the motor 704d is coupled to an articulation nut that is rotatably journaled on the 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 control circuit 710 with the articulated position of the end effector 702.
In another aspect, the articulation function of the robotic surgical system 700 may include two articulation members or links 742a, 742 b. These hinge members 742a, 742b are driven by separate disks on the robotic interface (rack) driven by two motors 708d, 708 e. When a separate firing motor 704a is provided, each of the articulation links 742a, 742b can be driven antagonistic to the other link to provide resistance holding motion and load to the head when the head is not moving and to provide articulation when the head is articulating. When the head is rotated, the articulation members 742a, 742b are attached to the head at a fixed radius. Thus, the mechanical advantage of the push-pull link changes as the head rotates. This variation in mechanical advantage may be more apparent for other articulation link drive systems.
In one aspect, one or more of the motors 704a-704e can include a brushed DC motor having a gearbox and a mechanical link to a firing member, a closure member, or an articulation member. Another example includes electric motors 704a-704e that operate movable mechanical elements such as displacement members, articulation links, closure tubes, and shafts. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on the physical system. Such external influences may be referred to as drag forces, which act against one of the electric motors 704a-704 e. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.
In one aspect, position sensor 734 may be implemented as an absolute positioning system. In one aspect, the position sensor 734 may include a magnetic rotary absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotary position sensor, available from australia Microsystems, AG. Position sensor 734 may interface with controller 710 to provide an absolute positioning system. The location may include a hall effect element located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and a Volder algorithm, which is provided to implement a simple and efficient algorithm for computing hyperbolic and trigonometric functions that require only an addition operation, a subtraction operation, a digit shift operation and a table lookup operation.
In one aspect, the control circuit 710 may be in communication with one or more sensors 738. The sensors 738 can be positioned on the end effector 702 and adapted to operate with the robotic surgical instrument 700 to measure various derivative parameters such as gap distance versus time, tissue compression versus time, and anvil strain versus time. The sensors 738 may include magnetic sensors, magnetic field sensors, strain gauges, load sensors, pressure sensors, force sensors, torque sensors, inductive sensors such as eddy current sensors, resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors for measuring one or more parameters of the end effector 702. The sensors 738 may include one or more sensors. A sensor 738 may be located on the clamp arm 716 to determine tissue location using segmented electrodes. The torque sensors 744a-744e may be configured to be able to sense forces such as firing forces, closing forces, and/or articulation forces, among others. Thus, the control circuit 710 may 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 having tissue thereon, and (4) the load and position on the two articulation bars.
In one aspect, the one or more sensors 738 may include a strain gauge, such as a micro-strain gauge, configured to be able to measure a magnitude of strain in the clamp arm 716 during a clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. Sensor 738 may include a pressure sensor configured to detect pressure generated by the presence of compressed tissue between clamp arm 716 and ultrasonic blade 718. Sensor 738 may be configured to detect an impedance of a tissue section located between clamp arm 716 and ultrasonic blade 718, which impedance is indicative of a thickness and/or degree of filling of tissue located therebetween.
In one aspect, the sensors 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 so forth. Also, the switch may be a solid state device, such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensors 738 may include a non-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.
In one aspect, the sensor 738 may be configured to measure the force exerted on the clamp arm 716 by the closure drive system. For example, one or more sensors 738 may be located at the point of interaction between the closure tube and the clamp arm 716 to detect the closing force applied to the clamp arm 716 by the closure tube. The force exerted on clamp arm 716 may be indicative of tissue compression experienced by a section of tissue captured between clamp arm 716 and ultrasonic blade 718. One or more sensors 738 may be positioned at various interaction points along the closure drive system to detect the closure force applied to the clamp arm 716 by the closure drive system. The one or more sensors 738 may be sampled in real time by a processor of the control circuit 710 during a clamping operation. The control circuit 710 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to the gripping arm 716 in real-time.
In one aspect, the current sensor 736 can be used to measure the current consumed by each of the motors 704a-704 e. The force required to advance any of the movable mechanical elements, such as the closure member 714, corresponds to the current consumed by one of the motors 704a-704 e. The force is converted to a digital signal and provided to the control circuit 710. The control circuit 710 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the closure member 714 in the end effector 702 at or near a 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 signals from a feedback controller into physical inputs, such as housing voltages, PWM voltages, frequency modulated voltages, currents, torques, and/or forces. Additional details are disclosed in U.S. patent application serial No. 15/636,829 entitled CLOSED LOOP VELOCITY CONTROL technology FOR ROBOTIC SURGICAL INSTRUMENTs (CLOSED LOOP VELOCITY CONTROL FOR ROBOTIC SURGICAL INSTRUMENTs) filed on 29.6.2017, which is incorporated herein by reference in its entirety.
Fig. 18 illustrates a schematic view of a surgical instrument 750 configured to control distal translation of a displacement member according to one aspect of the present disclosure. In one aspect, the surgical instrument 750 is programmed to control distal translation of a displacement member, such as the closure member 764. The surgical instrument 750 includes an end effector 752, which end effector 752 may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
The position, movement, displacement, and/or translation of a linear displacement member, such as the closure member 764, may be measured by an absolute positioning system, sensor arrangement, and position sensor 784. Since the closure member 764 is coupled to the longitudinally movable drive member, the position of the closure member 764 can be determined by measuring the position of the longitudinally movable drive member with the position sensor 784. Thus, in the following description, the position, displacement, and/or translation of the closure member 764 may be achieved by the position sensor 784 described herein. The control circuit 760 may be programmed to control the translation of a displacement member, such as the closure member 764. In some examples, the control circuitry 760 may 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 closure member 764) in the manner described. In one aspect, the timer/counter 781 provides an output signal, such as a elapsed time or a digital count, to the control circuit 760 to correlate the position of the closure 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 closure member 764 at a particular time (t) relative to the starting position. The timer/counter 781 may be configured to be able to measure elapsed time, count external events or time external events.
The control circuit 760 may generate a motor set point signal 772. The motor set point signal 772 may be provided to the motor controller 758. The motor controller 758 may include one or more circuits configured to be capable of providing a motor drive signal 774 to the motor 754 to drive the motor 754, as described herein. In some examples, the motor 754 may be a brushed DC electric motor. For example, the speed of motor 754 may be proportional to the voltage of motor drive signal 774. In some examples, the motor 754 may be a brushless DC electric motor, and the motor drive signals 774 may include PWM signals provided to one or more stator windings of the motor 754. Also, in some examples, the motor controller 758 may be omitted and the control circuitry 760 may generate the motor drive signal 774 directly.
The motor 754 may receive power from an 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 closure member 764 via a transmission 756. The transmission 756 can include one or more gears or other linkage devices to couple the motor 754 to the closure member 764. The position sensor 784 may sense the position of the closure member 764. The position sensor 784 may be or include any type of sensor capable of generating position data indicative of the position of the closure member 764. In some examples, the position sensor 784 may include an encoder configured to provide a series of pulses to the control circuit 760 as the closure member 764 is translated distally and proximally. The control circuit 760 may track the pulses to determine the position of the closure member 764. Other suitable position sensors may be used, including, for example, proximity sensors. Other types of position sensors may provide other signals indicative of the motion of the closure member 764. Also, in some examples, position sensor 784 may be omitted. In the case 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 754 has been commanded to perform. The position sensor 784 may be located in the end effector 752 or at any other portion of the instrument.
The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 752 and adapted to operate with the surgical instrument 750 to measure various derivative parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensors 788 may include, for example, magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors for measuring one or more parameters of the end effector 752. The sensor 788 may include one or more sensors.
In certain instances, the one or more sensors 788 may include a strain gauge, such as a micro-strain gauge, configured to be capable of measuring a magnitude of strain in the clamp arm 766 during a clamping condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensor 788 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the clamp arm 766 and the ultrasonic blade 768. The sensor 788 may be configured to detect an impedance of a section of tissue located between the clamp arm 766 and the ultrasonic blade 768, which impedance is indicative of a thickness and/or degree of filling of the tissue located therebetween.
The sensor 788 may be configured to measure the force exerted by the closure drive system on the clamp arm 766. For example, one or more sensors 788 may be located at the point of interaction 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 exerted on the clamp arm 766 may be representative of the tissue compression experienced by a section of tissue captured between the clamp arm 766 and the ultrasonic blade 768. One or more sensors 788 may be positioned at various interaction points along the closure drive system to detect the closure force applied by the closure drive system to the clamp arm 766. The one or more sensors 788 may be sampled in real time by the processor of the control circuitry 760 during the clamping operation. The control circuitry 760 receives real-time sample measurements to provide and analyze time-based information and evaluates the closing force applied to the gripping arm 766 in real-time.
A current sensor 786 may be employed to measure the current drawn 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 to a digital signal and provided to the processor 760.
The control circuit 760 may be configured to simulate the response of the actual system of the instrument in the software of the controller. The displacement member may be actuated to move the closure member 764 in the end effector 752 at or near a 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, a PID, status feedback, LQR, and/or adaptive controller. The surgical instrument 750 may include a power source to, for example, convert signals from the feedback controller into physical inputs such as housing voltage, PWM voltage, frequency modulated voltage, current, torque, and/or force.
The actual drive system of the surgical instrument 750 is configured to drive the displacement, cutting or closure member 764 through a brushed DC motor having a gearbox and mechanical link to the articulation and/or knife system. Another example is an electric motor 754 that operates a displacement member and articulation driver, for example, of an interchangeable shaft assembly. External influences are unmeasured, unpredictable effects of things such as tissue, surrounding body and friction on the physical system. This external influence may be referred to as a drag force acting against the electric motor 754. External influences such as drag forces may cause the operation of the physical system to deviate from the desired operation of the physical system.
Various example aspects relate to a surgical instrument 750 including an end effector 752 having a motorized surgical sealing and cutting implementation. For example, the motor 754 can drive the displacement member distally and proximally along a longitudinal axis of the end effector 752. The end effector 752 may include a pivotable clamp arm 766, and when configured for use, the ultrasonic blade 768 is positioned opposite the clamp arm 766. The clinician may grasp tissue between the clamp arm 766 and the ultrasonic blade 768, as described herein. When the instrument 750 is ready for use, the clinician may provide a firing signal, for example, by depressing a trigger of the instrument 750. In response to the firing signal, the motor 754 can drive the displacement member distally along the longitudinal axis of the end effector 752 from a proximal stroke start position to an end of stroke position distal to the stroke start position. The closure member 764, having a cutting element positioned at the distal end, may cut tissue between the ultrasonic blade 768 and the clamp arm 766 as the displacement member is translated distally.
In various examples, the surgical instrument 750 can include a control circuit 760, the control circuit 760 programmed to control distal translation of a displacement member (such as the closure member 764) based on one or more tissue conditions. The control circuitry 760 may be programmed to sense a tissue condition, such as thickness, directly or indirectly, as described herein. The control circuit 760 may be programmed to select a control program based on tissue conditions. The control program may describe distal movement of the displacement member. Different control programs may be selected to better address different tissue conditions. For example, when thicker tissue is present, the control circuitry 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 circuitry 760 may be programmed to translate the displacement member at a higher speed and/or at a higher power.
In some examples, the control circuit 760 may initially operate the motor 754 in an open loop configuration for a first open loop portion of the stroke of the displacement member. Based on the response of the instrument 750 during the open loop portion of the stroke, the control circuit 760 may select a firing control routine. The response of the instrument may include the translation distance of the displacement member during the open loop portion, the time elapsed during the open loop portion, the energy provided to the motor 754 during the open loop portion, the sum of the pulse widths of the motor drive signals, and the like. After the open loop portion, the control circuit 760 may implement the selected firing control routine for a second portion of the displacement member travel. For example, during the closed-loop portion of the stroke, the control circuit 760 may adjust the motor 754 based on translation data describing the position of the displacement member in a closed-loop manner to translate the displacement member at a constant speed. Additional details are disclosed in U.S. patent application serial No. 15/720,852 entitled system and method FOR controlling a DISPLAY OF a SURGICAL INSTRUMENT (SYSTEM AND METHODS FOR controlling DISPLAY OF a SURGICAL INSTRUMENT), filed 2017, 9,29, which is incorporated herein by reference in its entirety.
Fig. 19 is a schematic view of a surgical instrument 790 configured to control various functions in accordance with an aspect of the present disclosure. In one aspect, the surgical instrument 790 is programmed to control distal translation of a displacement member, such as the closure member 764. The surgical instrument 790 includes an end effector 792 that may include a clamp arm 766, a closure member 764, and an ultrasonic blade 768 that may be interchanged with or work in conjunction with one or more RF electrodes 796 (shown in phantom). The ultrasonic blade 768 is coupled to an ultrasonic transducer 769 driven by an ultrasonic generator 771.
In one aspect, the sensor 788 can 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, or 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 so forth. Also, the switch may be a solid state device, such as a transistor (e.g., FET, junction FET, MOSFET, bipolar transistor, etc.). In other implementations, the sensors 788 may include a non-conductor switch, an ultrasonic switch, an accelerometer, an inertial sensor, and so forth.
In one aspect, the position sensor 784 may be implemented AS an absolute positioning system including a magnetic rotary absolute positioning system implemented AS an AS5055EQFT monolithic magnetic rotary position sensor available from australia Microsystems, AG. The position sensor 784 may interface with the control circuitry 760 to provide an absolute positioning system. The location may include a hall effect element located above the magnet and coupled to a CORDIC processor, also known as a bitwise method and a Volder algorithm, which is provided to implement a simple and efficient algorithm for computing hyperbolic and trigonometric functions that require only an addition operation, a subtraction operation, a digit shift operation and a table lookup operation.
In some examples, the position sensor 784 may be omitted. In the case 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.
The control circuitry 760 may be in communication with one or more sensors 788. The sensors 788 may be positioned on the end effector 792 and adapted to operate with the surgical instrument 790 to measure various derivative parameters such as gap distance and time, tissue compression and time, and anvil strain and time. The sensors 788 may include magnetic sensors, magnetic field sensors, strain gauges, pressure sensors, force sensors, inductive sensors (such as eddy current sensors), resistive sensors, capacitive sensors, optical sensors, and/or any other suitable sensors for measuring one or more parameters of the end effector 792. The sensor 788 may include one or more sensors.
An RF energy source 794 is coupled to the end effector 792 and, when an RF electrode 796 is disposed in the end effector 792 to operate in place of the ultrasonic blade 768 or in conjunction with the ultrasonic blade 768, the RF energy source 794 is applied to the RF electrode 796. For example, the ultrasonic blade is made of a conductive metal and can be used as a return path for electrosurgical RF current. Control circuitry 760 controls the delivery of RF energy to RF electrode 796.
Additional details are disclosed in U.S. patent application serial No. 15/636,096 filed on 28.6.2017, entitled SURGICAL SYSTEM capable OF coupling with a staple cartridge and a radiofrequency cartridge and METHOD OF USING the SAME (SURGICAL SYSTEM on shelf WITHSTAPLE CARTRIDGE AND RADIO FREQUENCY resonance CARTRIDGE, AND METHOD OF USING SAME), which is incorporated herein by reference in its entirety.
Self-adaptive ultrasonic knife control algorithm
In various aspects, the smart ultrasonic energy device may include an adaptive algorithm for controlling the operation of the ultrasonic blade. In one aspect, the ultrasonic blade adaptive control algorithm is configured to identify tissue type and adjust device parameters. In one aspect, the ultrasonic blade control algorithm is configured to be capable of parameterizing tissue type. The following sections of the present disclosure describe an algorithm for detecting the collagen/elasticity ratio of tissue to tune the amplitude of the distal tip of an ultrasonic blade. Various aspects of a smart ultrasonic energy device are described herein in connection with, for example, fig. 1-94. Accordingly, the following description of the adaptive ultrasonic blade control algorithm should be read in conjunction with fig. 1-94 and the description associated therewith.
Tissue type identification and device parameter adjustment
In certain surgical procedures, it is desirable to employ an adaptive ultrasonic blade control algorithm. In one aspect, an adaptive ultrasonic blade control algorithm may be employed to adjust parameters of an ultrasonic device based on the type of tissue in contact with the ultrasonic blade. In one aspect, parameters of the ultrasonic device can be adjusted based on the position of tissue within the jaws of the ultrasonic end effector (e.g., the position of tissue between the clamp arm and the ultrasonic blade). The impedance of the ultrasound transducer can be used to distinguish the percentage of tissue in the distal or proximal end of the end effector. The response of the ultrasound device may be based on the tissue type or compressibility of the tissue. In another aspect, parameters of the ultrasound device may be adjusted based on the identified tissue type or parameterization. For example, the mechanical displacement amplitude of the distal tip of the ultrasonic blade may be 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 reflectance and specific radiance. The force applied to the tissue by the clamp arm and/or the stroke of the clamp arm creates the gap and compression. Electrical continuity across the electrode-equipped jaws may be employed to determine the percentage of jaw coverage by tissue.
Fig. 20 is a system 800 configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, according to at least one aspect of the present disclosure. In one aspect, the generator module 240 is configured to be capable of executing the adaptive ultrasonic blade control algorithm(s) 802 as described herein with reference to fig. 53-105. In another aspect, the device/instrument 235 is configured to be capable of executing an adaptive ultrasonic blade control algorithm(s) 804 as described herein with reference to fig. 53-105. In another aspect, both the device/instrument 235 and the device/instrument 235 are configured to be capable of executing the adaptive ultrasonic blade control algorithms 802, 804 as described herein with reference to fig. 53-105.
The generator module 240 may include a patient isolation stage in communication with a non-isolation stage via a power transformer. The secondary winding of the power transformer is contained in an isolation stage and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define a drive signal output for delivering drive signals to different surgical instruments, such as, for example, ultrasonic surgical instruments, RF electrosurgical instruments, and multi-functional surgical instruments including ultrasonic energy modes and RF energy modes that can be delivered separately or simultaneously. In particular, 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. Aspects of the generator module 240 are described herein with reference to fig. 21-28B.
The generator module 240 or the device/instrument 235 or both are coupled to a modular control tower 236, which modular control tower 236 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, as described with reference to fig. 8-11, for example.
Generator hardware
FIG. 21 shows an example of a generator 900, which is one form of a generator configured to be couplable to an ultrasonic instrument and further configured to execute an adaptive ultrasonic blade control algorithm in a surgical data network including a modular communication hub, as shown in FIG. 20Shown in the figure. The generator 900 is configured to deliver a plurality of energy modalities to the surgical instrument. The generator 900 provides RF and ultrasonic signals for independently or simultaneously delivering energy to the surgical instrument. The RF and ultrasound signals may be provided separately or in combination, and may be provided simultaneously. As described above, at least one generator output may deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or microwave energy, etc.) through a single port, and these signals may be delivered separately or simultaneously to the end effector to treat tissue. The generator 900 includes a processor 902 coupled to a waveform generator 904. The processor 902 and waveform generator 904 are configured to be capable of generating various signal waveforms based on information stored in a memory coupled to the processor 902, which memory is not shown for clarity of the present disclosure. Digital information associated with the waveform is provided to a waveform generator 904, which waveform generator 904 includes one or more DAC circuits to convert a digital input to an analog output. The analog output is fed to an amplifier 1106 for signal conditioning and amplification. The regulated 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 a power transformer 908. A first signal of a first ENERGY mode is provided to a first ENERGY mode labeled ENERGY1And a terminal of the RETURN. A second signal of a second ENERGY mode is coupled across capacitor 910 and provided to a second terminal labeled ENERGY2And a terminal of the RETURN. It will be appreciated that more than two ENERGY modes may be output, and thus the subscript "n" may be used to specify that up to n ENERGY may be providednA terminal, wherein 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 this disclosuren。
The first voltage sensing circuit 912 is coupled to a voltage source labeled ENERGY1And across the terminals of the RETURN path to measure the output voltage therebetween. A second voltage sense circuit 924 is coupled to the voltage sense circuit labeled ENERGY2And across the terminals of the RETURN path to measure the output voltage therebetween. As shown, the current sensing circuit 914 and the power transformer908 are placed in series with the "return" legs on the secondary side to measure the output current of either energy mode. If a different return path is provided for each energy modality, a separate current sensing circuit should be provided in each return branch. The outputs of the first 912 and second 924 voltage sensing circuits are provided to respective isolation transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 918. The output of the isolation transformers 916, 928, 922 on the primary side of the power transformer 908 (not the patient isolation side) is 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 computation. Output voltage and output current feedback information may be employed to adjust the output voltage and current provided to the surgical instrument and calculate parameters such as output impedance. Input/output communication between the processor 902 and the patient isolation circuitry is provided through an interface circuit 920. The sensors may also be in electrical communication with the processor 902 through an interface 920.
In one aspect, the impedance may be determined by the processor 902 by coupling at a coupling labeled ENERGY1First voltage sense circuit 912 coupled across terminals of/RETURN or otherwise labeled ENERGY2The output of the second voltage sensing circuit 924 across the terminals of the/RETURN is divided by the output of the current sensing circuit 914 arranged in series with the RETURN leg on the secondary side of the power transformer 908. The outputs of the first 912 and second 924 voltage sensing circuits are provided to separate isolation transformers 916, 922 and the output of the current sensing circuit 914 is provided to another isolation transformer 916. The digitized voltage and current sense measurements from the ADC circuit 926 are provided to the processor 902 for use in calculating the impedance. For example, the first ENERGY modality ENERGY1May be ultrasonic ENERGY and the second ENERGY modality ENERGY2May 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, among others. Also, while the example shown in fig. 21 illustrates that a single RETURN path RETURN may be provided for two or more energy modalities, in other aspects, a single RETURN path RETURN may be provided for each energy modality ENERGYnProviding multiple RETURN paths RETURNn. Thus, as described herein, the 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 the tissue impedance may be measured by dividing the output of the second voltage sensing circuit 924 by the output of the current sensing circuit 914.
As shown in fig. 21, the 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 the 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 ultrasound transducer, with a lower voltage and higher current to drive an RF electrode for sealing tissue, or with a coagulation waveform for using 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 at what is labelled ENERGY1And the output of RETURN, as shown in fig. 21. In one example, the connection of the RF bipolar electrode to the output of generator 900 will preferably be at what is labeled ENERGY2And the output of RETURN. In the case of a unipolar output, the preferred connection would be an active electrode (e.g. a light cone (pencil) or other probe) to ENERGY2The sum of the outputs is connected to a suitable RETURN pad of the RETURN output.
Additional details are disclosed in U.S. patent application publication 2017/0086914 entitled technique FOR OPERATING a GENERATOR AND housing instrument FOR digitally generating electrical signal WAVEFORMS (TECHNIQUES FOR OPERATING GENERATITOR FOR DIGITALLYGENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS), published 3, 30, 2017, which is incorporated herein by reference in its entirety.
As used throughout this specification, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated organization does not contain any wires, although in some aspects they may not. The communication module may implement any of a number of wireless or wired communication standards or protocols, including but not limited to Wi-Fi (IEEE 802.11 series), WiMAX (IEEE802.16 series), IEEE 802.20, Long Term Evolution (LTE), Ev-DO, HSPA +, HSDPA +, HSUPA +, EDGE, GSM, GPRS, CDMA, TDMA, DECT, bluetooth, and ethernet derivatives thereof, and any other wireless and wired protocol computing module designated as 3G, 4G, 5G, and above may include a plurality of communication modules. For example, a first communication module may be dedicated to shorter range wireless communications such as Wi-Fi and bluetooth, and a second communication module may be dedicated to longer range wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and the like.
As used herein, a processor or processing unit is an electronic circuit that performs operations on some external data source, typically a memory or some other data stream. The term is used herein to refer to a central processing unit (cpu) in one or more systems, especially systems on a chip (SoC), that combine multiple specialized "processors".
As used herein, a system-on-chip or system-on-chip (SoC or SoC) is an integrated circuit (also referred to as an "IC" or "chip") that integrates all of the components of a computer or other electronic system. It may contain digital, analog, mixed signal, and often radio frequency functions-all on a single substrate. The SoC integrates a microcontroller (or microprocessor) with advanced peripherals such as a Graphics Processing Unit (GPU), Wi-Fi modules, or coprocessors. The SoC may or may not contain built-in memory.
As used herein, a microcontroller or controller is a system that integrates a microprocessor with peripheral circuitry and memory. The microcontroller (or MCU of the microcontroller unit) may be implemented as a small computer on a single integrated circuit. It may be similar to a SoC; the SoC may include a microcontroller as one of its components. Microcontrollers 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 are often included on the chip. In contrast to microprocessors used in personal computers or other general-purpose applications composed of various discrete chips, microcontrollers may be used in embedded applications.
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 two components of a computer or a controller on an external device for managing the operation of (and connection to) the device.
Any of the processors or microcontrollers as described herein may be any single-core or multi-core processor, such as those provided by Texas Instruments under the trade name ARM Cortex. In one aspect, the processor may be, for example, an LM4F230H5QR ARMCortex-M4F processor core available from Texas Instruments (Texas Instruments), which includes: 256KB of single cycle flash or other non-volatile memory (up to 40MHZ) on-chip memory, prefetch buffers to improve performance by over 40MHz, 32KB of single cycle Serial Random Access Memory (SRAM), Stellaris loaded
Internal Read Only Memory (ROM) in software, Electrically Erasable Programmable Read Only Memory (EEPROM) in 2KB, one or more Pulse Width Modulation (PWM) modules, one or more Quadrature Encoder Input (QEI) analog, one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, and other features readily available.
In one example, the processor may include a safety controller that includes two series based controllers, such as TMS570 and RM4x, also available from Texas Instruments under the trade name Hercules ARMCortex R4. The safety controller may be configured specifically for IEC 61508 and ISO26262 safety critical applications, etc., to provide advanced integrated safety features while delivering scalable performance, connectivity, and memory options.
The modular device includes modules (as described in connection with fig. 3 and 9) that can be received within a surgical hub and surgical devices or instruments that can be connected to the various modules for connection or mating with a corresponding surgical hub. Modular devices include, for example, smart surgical instruments, medical imaging devices, suction/irrigation devices, smoke ejectors, energy generators, respirators, insufflators, and displays. The modular devices described herein may be controlled by a control algorithm. The control algorithms may be executed on the modular devices themselves, on a surgical hub paired with a particular modular device, or on both the modular devices and the surgical hub (e.g., via a distributed computing architecture). In some examples, the control algorithm of the modular device controls the device based on data sensed by the modular device itself (i.e., by sensors in, on, or connected to the modular device). This data may be related to the patient being operated on (e.g., tissue characteristics or insufflation pressure) or the modular device itself (e.g., rate at which the knife is advanced, motor current, or energy level). For example, the control algorithm of a surgical stapling and severing instrument may control the rate at which the motor of the instrument drives its knife through tissue based on the resistance encountered by the knife as it advances.
Fig. 22 illustrates one form of a surgical system 1000 including a generator 1100 and various surgical instruments 1104, 1106, 1108 that may be used therewith, wherein the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunctional surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument. The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, 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 the front panel of the console of the generator 1100. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of generator 1100. The generator 1100 may be configured for wired or wireless communication.
The generator 1100 is configured to drive a plurality of surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and includes a handpiece 1105(HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 includes an ultrasonic blade 1128 and a clamp arm 1140 acoustically coupled to an ultrasonic transducer 1120. The handpiece 1105 includes a combination of a trigger 1143 for operating the clamp arm 1140 and toggle buttons 1134a, 1134b, 1134c for energizing the ultrasonic blade 1128 and driving the ultrasonic blade 1128 or other functions. Toggle buttons 1134a, 1134b, 1134c may be configured to enable the generator 1100 to power the ultrasound transducer 1120.
The generator 1100 is also configured to drive a second surgical instrument 1106. The second surgical instrument 1106 is an RF electrosurgical instrument and includes a hand piece 1107(HP), a shaft 1127, and an end effector 1124. The end effector 1124 includes electrodes in the clamp arms 1142a, 1142b and returns through the electrical conductor portion of the shaft 1127. The 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 clamp arms 1142a, 1142b and an energy button 1135 for actuating an energy switch to energize the electrodes in the end effector 1124.
The generator 1100 is also configured to drive a multi-function surgical instrument 1108. The multifunctional surgical instrument 1108 includes a hand piece 1109(HP), a shaft 1129, and an end effector 1125. The end effector 1125 includes an ultrasonic blade 1149 and a clamp arm 1146. The ultrasonic blade 1149 is acoustically coupled to the ultrasonic transducer 1120. The handpiece 1109 includes a combination of a trigger 1147 for operating the clamp arm 1146 and switch buttons 1137a, 1137b, 1137c for energizing the ultrasonic blade 1149 and driving the ultrasonic blade 1149 or other functions. The toggle buttons 1137a, 1137b, 1137c may be configured to enable the generator 1100 to power the ultrasonic transducer 1120, and the bipolar energy source also contained within the generator 1100 to power the ultrasonic blade 1149.
The generator 1100 may be configured for use with a variety of surgical devices. According to various forms, the generator 1100 may be configurable for use with different types of surgical instruments including, for example, an ultrasonic surgical instrument 1104, an RF electrosurgical instrument 1106, and a multifunctional surgical instrument 1108 that integrates RF energy and ultrasonic energy delivered simultaneously from the generator 1100. Although in the form of fig. 22, the generator 1100 is shown separate from the surgical instruments 1104, 1106, 1108, 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 console of the generator 1100. Input device 1110 may include any suitable device that generates signals suitable for programming the operation of 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.
Fig. 23 is an end effector 1122 of an example ultrasonic device 1104 in accordance with at least one aspect of the present disclosure. The end effector 1122 may include a blade 1128, which blade 1128 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 the tissue, as described herein. In accordance with various aspects, and as shown in fig. 23, the end effector 1122 may further comprise a clamp arm 1140, which clamp arm 1140 may be configured to act in cooperation with a blade 1128 of the end effector 1122. With the blade 1128, the clamp arm 1140 can include a set of jaws. The clamp arm 1140 may be pivotally connected at a distal end of the shaft 1126 of the instrument portion 1104. Clamp arm 1140 can comprise a clamp arm tissue pad 1163, and clamp arm tissue pad 1163 can be formed from
Or other suitable low friction material. A pad 1163 may be mounted for cooperation with the knife 1128, wherein pivotal movement of the clamp arm 1140 positions the clamp pad 1163 generally parallel to and in contact with the blade 1128. With this arrangement, tissue to be clamped can be grasped between the tissue pad 1163 and the blade 1128. Tissue pad 1163 may have a serrated configuration including a plurality of axially spaced proximally extending gripping teeth 1161 to cooperate with blade 1128 to enhance the grip of tissue. The clamp arm 1140 may be transitioned from the open position shown in fig. 23 to the closed position (where the clamp arm 1140 is in contact with or proximate to the blade 1128) in any suitable manner. For example, the handpiece 1105 can include a jaw closure trigger. When actuated by the clinician, the jaw closure trigger may pivot the clamp arm 1140 in any suitable manner.
The generator 1100 may be activated to provide a drive signal to the transducer 1120 in any suitable manner. For example, the generator 1100 can include a foot switch 1430 (fig. 24), the foot switch 1430 being coupled to the generator 1100 via a foot switch cable 1432. The clinician may activate the ultrasonic transducer 1120, and thereby the ultrasonic transducer 1120 and the blade 1128, by depressing the foot switch 1430. In addition, or in lieu of the foot switch 1430, some aspects of the apparatus 1104 may utilize one or more switches positioned on the handpiece 1105 that, when activated, may 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), e.g., to determine the operating mode of device 1104. When the toggle button 1134a is depressed, for example, the ultrasonic generator 1100 may provide a maximum drive signal to the transducer 1120, causing it to produce a maximum ultrasonic energy output. Depressing the toggle button 1134b may cause the ultrasound generator 1100 to provide a user selectable drive signal to the ultrasound transducer 1120, causing it to produce an ultrasound energy output that is less than a 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 clamp arm 1140 of the end effector 1122. Further, in some aspects, the sonicator 1100 may be activated based on the position of the jaw closure trigger (e.g., ultrasonic energy may be applied when the clinician depresses the jaw closure trigger to close the jaws via the clamp arm 1140).
Additionally or alternatively, the one or more switches can include a toggle button 1134c, which toggle button 1134c, when depressed, causes generator 1100 to provide a pulsed output (fig. 22). The pulses may be provided, for example, at any suitable frequency and grouping. In certain aspects, for example, the power level of the pulse may be the power level associated with the toggle buttons 1134a, 1134b (maximum, less than maximum).
It should be appreciated that the device 1104 may include any combination of toggle buttons 1134a, 1134b, 1134c (FIG. 22). For example, the device 1104 may be configured to be able to have only two toggle buttons: a toggle button 1134a for producing a maximum ultrasonic energy output and a toggle button 1134c for producing a pulsed output at or below a maximum power level. Thus, the drive signal output configuration of generator 1100 may be five continuous signals, or any discrete number of single pulse signals (1, 2, 3, 4, or 5). In certain aspects, the particular drive signal configuration may be controlled, for example, based on EEPROM settings and/or user power level selection(s) in the generator 1100.
In some aspects, an on/off switch may be provided in place of toggle button 1134c (FIG. 22). For example, the device 1104 may include a toggle button 1134a and a dual toggle button 1134b for producing a continuous output at a maximum power level. In the first detent position, the switch button 1134b may produce a continuous output at less than the maximum power level, and in the second detent position, the switch button 1134b may produce a pulsed output (e.g., at or less than the maximum power level, depending on the EEPROM setting).
In some aspects, the RF electrosurgical end effector 1124, 1125 (fig. 22) can also include a pair of electrodes. The electrodes may be in communication with the generator 1100, for example, via a cable. The electrodes may be used, for example, to measure the impedance of a tissue bite existing between the clamping arms 1142a, 1146 and the blades 1142b, 1149. Generator 1100 may provide a signal (e.g., a non-therapeutic signal) to the electrodes. For example, the impedance of tissue occlusion can be found by monitoring the current, voltage, etc. of the signal.
In various aspects, the generator 1100 may include several separate functional elements, such as modules and/or blocks, as shown in the illustrations of the surgical system 1000 of fig. 24, 22. Different functional elements or modules may be configured to drive different kinds of surgical devices 1104, 1106, 1108. For example, the ultrasonic generator module may drive an ultrasonic device, such as ultrasonic surgical device 1104. The electrosurgical/RF generator module may drive an electrosurgical device 1106. For example, the modules may generate respective drive signals for driving the surgical devices 1104, 1106, 1108. In various aspects, the ultrasonic generator module and/or the electrosurgical/RF generator module can each be integrally formed with the generator 1100. Alternatively, one or more of the modules may be provided as a separate circuit module electrically coupled to the generator 1100. (the module is shown in phantom to illustrate this portion.) furthermore, in some aspects, the electrosurgical/RF generator module may be integrally formed with the ultrasonic generator module, or vice versa.
According to the aspects, the ultrasonic generator module may generate one or more drive signals of a particular voltage, current, and frequency (e.g., 55,500 cycles per second or Hz). The one or more drive signals may be provided to ultrasound device 1104, in particular transducer 1120, which may operate, for example, as described above. In one aspect, the generator 1100 may be configured to generate drive signals of specific voltage, current, and/or frequency output signals that may be modified in terms of high resolution, accuracy, and reproducibility.
According to the aspects, the electrosurgical/RF generator module may generate one or more drive signals having an output power sufficient to perform bipolar electrosurgery using Radio Frequency (RF) energy. In a bipolar electrosurgical application, the drive signal may be provided to, for example, an electrode of the electrosurgical device 1106, as described above. Accordingly, the generator 1100 may be configured for therapeutic purposes by applying electrical energy to tissue sufficient to treat the tissue (e.g., coagulate, cauterize, tissue weld, etc.).
The generator 1100 may also include an input device 2140 located, for example, on the front panel of the generator 1100 console (fig. 27B). Output devices 2140 include one or more devices for providing sensory feedback to a user. Such devices may include, for example, visual feedback devices (e.g., LCD display screens, LED indicators), audio feedback devices (e.g., speakers, buzzers), or tactile feedback devices (e.g., haptic actuators).
Although certain modules and/or blocks of generator 1100 may be described by way of example, it may be appreciated that a greater or lesser number of modules and/or blocks may be used and still fall within the scope of the described aspects. Furthermore, although various aspects may be described in terms of modules and/or blocks for ease of illustration, 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 and software devices.
In one aspect, the ultrasonic generator driver module and the electrosurgical/RF driver module 1110 (fig. 22) can include one or more embedded applications implemented as firmware, software, hardware, or any combination thereof. The modules may include various executable modules such as software, programs, data, drivers, Application Program Interfaces (APIs), and so forth. The firmware may be stored in a non-volatile memory (NVM), such as a bit-mask read-only memory (ROM) or flash memory. In various implementations, storing firmware in ROM may protect flash memory. NVM may include other types of memory including, for example, programmable rom (prom), erasable programmable rom (eprom), electrically erasable programmable rom (eeprom), or battery backed Random Access Memory (RAM) (such as dynamic RAM (dram), double data rate dram (ddram), and/or synchronous dram (sdram)).
In one aspect, the modules include hardware devices implemented as processors 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 in which the generator 1100 is used in conjunction with the device 1104, the drive signal may drive the ultrasonic transducer 1120 in a cutting and/or coagulation mode of operation. Electrical characteristics of the device 1104 and/or tissue may be measured and used to control aspects of the operation of the generator 1100 and/or may be provided as feedback to a user. In aspects in which 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 dehydration 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 described previously, the hardware devices may be implemented as DSPs, PLDs, ASICs, circuits and/or registers. In one aspect, the processor may be configured to store and execute computer software program instructions to generate step function output signals for driving various components of the apparatus 1104, 1106, 1108 (e.g., the ultrasonic transducer 1120 and the end effectors 1122, 1124, 1125).
An electromechanical ultrasound system includes an ultrasound transducer, a waveguide, and an ultrasonic blade. The electromechanical ultrasound system has an initial resonant frequency defined by the physical characteristics of the ultrasound transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer being excited by an alternating voltage Vg(t) and current Ig(t) the resonant frequency of the signal is equal to the electromechanical ultrasound system. When the ultrasonic electromechanical system is at resonance, the voltage Vg(t) and current Ig(t) the phase difference between the signals is zero. In other words, at resonance, the inductive impedance is equal to the capacitive impedance. As the ultrasonic blade heats up, the compliance of the ultrasonic blade (modeled as an equivalent capacitance) causes the resonant frequency of the electromechanical ultrasonic system to shift. As a result, 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 ultrasound 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) and current Ig(t) phase difference between the signals. The generator electronics can easily monitor the voltage Vg(t) and current Ig(t) the phase difference between the signals and the drive frequency may be continuously adjusted until the phase difference is again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. The change in phase and/or frequency can be used as an indirect measure of the temperature of the ultrasonic blade.
As shown in fig. 25, the electromechanical properties of the ultrasound transducer can be modeled as an equivalent circuit comprising a first branch with a static capacitance and a second "dynamic" branch with series-connected inductance, resistance and capacitance defining the electromechanical properties of the resonator. The known ultrasonic generator may comprise a tuning inductor for detuning the static capacitance at the resonance frequency, such that substantially all of the driving signal current of the generator flows into the dynamic branch. Thus, by using a tuning inductor, the generator's drive signal current is representative of the dynamic branch current, and thus the generator is able to control its drive signal to maintain the resonant frequency of the ultrasound transducer. The tuning inductor may also transform the phase impedance map of the ultrasonic transducer to improve the frequency locking capability of the generator. However, the tuning inductor must be matched to the particular static capacitance of the ultrasound transducer at the operating resonant frequency. In other words, different ultrasonic transducers with different static capacitances require different tuning inductors.
Fig. 25 illustrates an equivalent circuit 1500 of an ultrasound transducer, such as ultrasound transducer 1120, according to an aspect. The circuit 1500 includes a series-connected inductor L having electromechanical properties defining a resonatorsResistance RsAnd a capacitor CsAnd a first "dynamic" branch C having a static capacitance0. Can be driven at a voltage Vg(t) receiving a drive current I from a generatorg(t) wherein the dynamic current Im(t) flows through the first branch and a current Ig(t)-Im(t) flows through the capacitive branch. Can be controlled by properly controlling Ig(t) and Vg(t) to enable control of the electromechanical properties of the ultrasound transducer. As mentioned above, known generator architectures may include a tuned inductor L in a parallel resonant circuitt(shown in dashed lines in fig. 25), the tuning inductor is used to couple the static capacitance C0Tuned to the resonance frequency so that substantially the current output I of the generatorgAll of (t) flow through the dynamic leg. In this way, by controlling the generator current output Ig(t) to realize the dynamic branch current Im(t) control. However, the tuning inductor LtStatic capacitance C to ultrasonic transducer0Are specific and different ultrasonic transducers with different static capacitances require different tuning inductors Lt. Furthermore, because the inductor L is tunedtWith static capacitance C at a single resonant frequency0So that the dynamic branch current I is only guaranteed at this frequencym(t) precise control. As the frequency shifts downward with transducer temperature, precise control of the dynamic branch current is compromised.
Various aspects of the generator 1100 may not rely on tuning the inductor LtTo monitor the dynamic branch current Im(t) of (d). Instead, generator 1100 may be such thatWith a static capacitance C between applications of power for a particular ultrasonic surgical device 11040Along with drive signal voltage and current feedback data to determine dynamic branch current I on a dynamic travel basis (e.g., in real time)mThe value of (t). Thus, such aspects of the generator 1100 can provide virtual tuning to simulate a tuned system or static capacitance C at any frequency0Is resonant, rather than only at the static capacitance C0Is resonant at a single resonant frequency as indicated by the nominal value of (a).
Fig. 26 is a simplified block diagram of an aspect of a generator 1100 that provides inductorless tuning, as described above, among other benefits. Fig. 27A-27C illustrate an architecture of the generator 1100 of fig. 26, according to one aspect. Referring to fig. 26, generator 1100 may include a patient isolation stage 1520 in communication with a non-isolation stage 1540 via a power transformer 1560. Secondary winding 1580 of power transformer 1560 is included in isolation stage 1520 and may include a tapped configuration (e.g., a center-tapped or non-center-tapped configuration) to define drive signal outputs 1600a, 1600b, 1600c for outputting drive signals to different surgical devices, such as, for example, ultrasonic surgical device 1104 and electrosurgical device 1106. Specifically, drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 420V RMS drive signal) to ultrasonic surgical device 1104, and drive signal outputs 1600a, 1600b, 1600c may output a drive signal (e.g., a 100V RMS drive signal) to electrosurgical device 1106, with output 1060b corresponding to a center tap of power transformer 1560. Non-isolated stage 1540 may include power amplifier 1620 having an output connected to primary winding 1640 of power transformer 1560. In certain aspects, the power amplifier 1620 may comprise a push-pull amplifier, for example. The non-isolation stage 1540 may also include a programmable logic device 1660, the programmable logic device 1660 being configured to supply a digital output to a digital-to-analog converter (DAC)1680, which digital-to-analog converter 1680 in turn supplies a corresponding analog signal to the input of the power amplifier 1620. In certain aspects, the programmable logic device 1660 may comprise a Field Programmable Gate Array (FPGA), for example. As a result of controlling the input of power amplifier 1620 via DAC1680, programmable logic device 1660 may thus control any of a plurality of parameters (e.g., frequency, waveform shape, waveform amplitude) of the drive signals present at drive signal outputs 1600a, 1600b, 1600 c. In certain aspects and as described below, programmable logic device 1660 in conjunction with a processor (e.g., processor 1740 described below) can implement a plurality of Digital Signal Processing (DSP) based algorithms and/or other control algorithms to control parameters of the drive signals output by generator 1100.
Power may be supplied to the power rails of power amplifier 1620 by switch-mode regulator 1700. In certain aspects, the switch mode regulator 1700 may comprise, for example, an adjustable buck regulator. As described above, non-isolation stage 1540 may further include a processor 1740, which processor 1740 in one aspect may include a DSP processor such as ADSP-21469 arc DSP, available from Analog Devices, Norwood, Mass, for example. In certain aspects, processor 1740 may control the operation of switch-mode power converter 1700 in response to voltage feedback data received by processor 1740 from power amplifier 1620 via analog-to-digital converter (ADC) 1760. In one aspect, for example, processor 1740 can receive as input via ADC 1760 a waveform envelope of a signal (e.g., an RF signal) being amplified by power amplifier 1620. Processor 1740 may then control switch-mode regulator 1700 (e.g., via a Pulse Width Modulation (PWM) output) so that the rail voltage supplied to 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 may be significantly increased relative to a fixed rail voltage amplifier scheme. The processor 1740 may be configured for wired or wireless communication.
In certain aspects and as discussed in more detail in connection with fig. 28A-28B, programmable logic device 1660 in conjunction with processor 1740 can implement a Direct Digital Synthesizer (DDS) control scheme to control the waveform shape, frequency, and/or amplitude of the drive signals output by generator 1100. In one aspect, for example, the programmable logic device 1660 may implement the DDS control algorithm 2680 (fig. 28A) by retrieving (recall) waveform samples stored in a dynamically updated look-up table (LUT), such as a RAM LUT that may be embedded in an FPGA. The control algorithm is particularly useful for ultrasound applications where an ultrasound transducer, such as ultrasound transducer 1120, may be driven by a purely sinusoidal current at its resonant frequency. Because other frequencies may excite parasitic resonances, minimizing or reducing the total distortion of the dynamic branch current may correspondingly minimize or reduce adverse resonance effects. Because the waveform shape of the drive signal output by generator 1100 is affected by various sources of distortion present in the output drive circuitry (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 the distortion by pre-distorting or modifying the waveform samples stored in the LUT, as appropriate, on a dynamic 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 dynamic 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 dynamic branch drive signal to have a desired waveform shape (e.g., sinusoidal shape) to optimally drive the ultrasound transducer. Thus, in such aspects, when 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 dynamic branch drive signal.
In certain aspects, 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, voltage and current feedback data may be used to determine an impedance phase, such as a phase difference between voltage and current drive signals. The frequency of the drive signal may then be controlled to minimize or reduce the difference between the determined impedance phase and the impedance phase set point (e.g., 0 °), thereby minimizing or reducing the effects of harmonic distortion and correspondingly improving impedance phase measurement accuracy. The determination of the phase impedance and frequency control signals may be implemented in processor 1740, for example, where the frequency control signals are supplied as inputs to a DDS control algorithm implemented by programmable logic device 1660.
The impedance phase may be determined by fourier analysis. In one aspect, a Fast Fourier Transform (FFT) or discrete fourier transform may be used as follows(DFT) to determine the generator voltage Vg(t) sum generator current Ig(t) phase difference between drive signals:
evaluating the fourier transform at sinusoidal frequencies yields:
other methods include weighted least squares estimation, kalman filtering, and space vector based techniques. For example, almost all processing in the FFT or DFT techniques may be performed in the digital domain with the aid of, for example, a 2-channel high speed ADC 1780, 1800. In one technique, digital signal samples of the voltage and current signals are fourier transformed using an FFT or DFT. The phase angle at any point in time can be calculated by the following formula
Wherein
Is a phase angle, f is a frequency, t is a time, and
is the phase at t-0.
For determining the voltage Vg(t) and current Ig(t) another technique for phase difference between signals is the zero crossing method and produces very accurate results. For voltages V having the same frequencyg(t) and current Ig(t) signal, voltage signal Vg(t) alternately triggering pulsed boiling water at each negative to positive zero point, and current signal IgEach negative to positive zero crossing of (t) triggers the end of a pulse. The result is a pulse train having a pulse width proportional to the phase angle between the voltage and current signals. In one aspect, the pulse train may be passed through an averaging filter to obtain a measure of the phase difference. Furthermore, if positive-to-negative zero crossings are also used in a similar manner, and the results averaged, any effects of DC and harmonic components may be reduced. In one implementation, the analog voltage Vg(t) and current Ig(t) the signal is converted to a digital signal which is high if the analog signal is positive and low if the analog signal is negative. High precision phase estimation requires sharp transitions between high and low values. In one aspect, Schmitt triggers and RC stabilization networks may be employed to convert analog signals to digital signals. In other aspects, edge-triggered RS flip-flops (flip-flops) and ancillary circuits may be employed. In yet another aspect, the zero crossing technique may employ exclusive or (XOR) gates.
Other techniques for determining the phase difference between the voltage and current signals include Lissajous diagrams and monitoring of images; methods such as the three volt method, the cross-coil method, the vector voltmeter, and the vector impedance method; and the use of phase-standard instruments, phase-locked loops, and "phase measurements" (Peter O 'Shea, 2000CRC Press LLC, < http:// www.engnetbase.com >) as by Peter O' Shea,2000CRC Press, Inc. < http:// www.engnetbase.com >, which are incorporated herein by reference.
In another aspect, for example, current feedback data can be monitored in order to maintain the current amplitude of the drive signal at a current amplitude setpoint. 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 processor 1740, such as, for example, a proportional-integral-derivative (PID) control algorithm. Variables controlled by the control algorithm for appropriately controlling the current amplitude of the drive signal may include, for example, scaling of LUT waveform samples stored in programmable logic device 1660 and/or full-scale output voltage via DAC1680 of DAC 1860 (which supplies an input to power amplifier 1620).
In certain aspects, processor 1740 (fig. 26, 27A) and processor 1900 (fig. 26, 27B) may determine and monitor an operating state of generator 1100. With respect to processor 1740, the operational state of generator 1100 may, for example, indicate to processor 1740 which control and/or diagnostic processes are being implemented. For processor 1900, the operational state of generator 1100 may, for example, indicate which elements of a user interface (e.g., display screen, sound) are presented to the user. Processors 1740, 1900 may independently maintain the current operating state of generator 1100 and identify and evaluate possible transitions of the current operating state. Processor 1740 may serve as a master in this relationship and determine when transitions between operating states may occur. The processor 1900 may note valid transitions between operating states and may verify that a particular transition is appropriate. For example, when processor 1740 instructs processor 1900 to transition to a particular state, processor 1900 may verify that the requested transition is valid. In the event that processor 1900 determines that the requested inter-state transition is invalid, processor 1900 may cause generator 1100 to enter a failure mode.
In certain aspects, the controller 1960 may continue to receive operating power (e.g., via a line from a power source of the generator 1100, such as the power source 2110 (fig. 26) discussed below) when the generator 1100 is in a "power off state. In this way, controller 1960 may continue to monitor input device 2150 (e.g., a capacitive touch sensor located on the front panel of generator 1100) for turning generator 1100 on and off. When the generator 1100 is in the "power off" state, if activation of the user "on/off input device 2150 is detected, the controller 1960 can wake up the power source (e.g., enable operation of one or more DC/DC voltage converters 2130 (fig. 26) of the power source 2110). Controller 1960 may thus begin a sequence that transitions generator 1100 to a "power on" state. Conversely, when generator 1100 is in a "power on" state, if activation of "on/off input device 2150 is detected, controller 1960 may begin a sequence that transitions generator 1100 to a" power off "state. In certain aspects, for example, controller 1960 may report activation of "on/off input device 2150 to processor 1900, which in turn implements the desired sequence of processes to transition generator 1100 to a" power off "state. In such aspects, the controller 1960 may not have the independent ability to remove power from the generator 1100 after the "power off" state has been established.
In certain aspects, the controller 1960 can cause the generator 1100 to provide audible or other sensory feedback for alerting a user that a "power on" or "power off sequence has begun. This alert may be provided at the beginning of a "power on" or "power off" sequence and before the beginning of other processes associated with that sequence.
In certain aspects, the isolation stage 1520 may include instrument interface circuitry 1980 to provide a communication interface, for example, between control circuitry of the surgical device (e.g., control circuitry including a handpiece switch) and devices of the non-isolation stage 1540 (such as, for example, programmable logic device 1660, processor 1740, and/or processor 1900). The instrument interface circuit 1980 may exchange information with devices of the non-isolated stage 1540 via a communication link that maintains a suitable degree of electrical isolation between the stages 1520, 1540, such as, for example, an Infrared (IR) based communication link. For example, instrument interface circuit 1980 may be supplied with power using a low-dropout voltage regulator powered by an isolation transformer, which is driven from non-isolated stage 1540.
In one aspect, the instrument interface circuit 1980 may include a programmable logic device 2000 in communication with a signal conditioning circuit 2020 (fig. 26 and 27C). 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 the surgical device control circuit (e.g., by using a conductive pair in a cable connecting the generator 1100 to the surgical device) and monitored to determine the state or configuration of the control circuit. For example, the control circuit may include a plurality of switches, resistors, and/or diodes to modify one or more characteristics (e.g., amplitude, correction) of the interrogation signal such that the state or configuration of the control circuit may be uniquely discerned based on the one or more characteristics. In one aspect, for example, the signal conditioning circuit 2020 may include an ADC for generating samples of a voltage signal that appears in the input of the control circuit as a result of an interrogation signal passing through the control circuit. Programmable logic device 2000 (or a device of non-isolation stage 1540) may then determine the state or configuration of the control circuit based on the ADC samples.
In one aspect, the instrument interface circuit 1980 may include a first data circuit interface 2040 to enable the exchange of information 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 provided in a cable integrally attached to the surgical device handpiece or provided in an adapter for interfacing 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 referring again to fig. 26, the first data circuit interface 2040 may be implemented separately from the programmable logic device 2000 and include suitable circuitry (e.g., discrete logic devices, processors) to enable communication between the programmable logic device 2000 and the first data circuit. In other aspects, the first data circuit interface 2040 may be integral to the logic device 2000.
In certain aspects, the first data circuit 2060 may store information relating to the particular surgical device associated. 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 instrument interface circuitry 1980 (e.g., by programmable logic device 2000), transmitted to devices of non-isolation stage 1540 (e.g., to programmable logic device 1660, processor 1740, and/or processor 1900), presented to a user via output device 2140, and/or to control functions or operations of generator 1100. Additionally, 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, the updated number of operations in which the surgical device is used and/or the date and/or time of its use.
As previously discussed, the surgical instrument is detachable from the handpiece (e.g., the instrument 1106 is detachable from the handpiece 1107) to facilitate instrument interchangeability and/or disposability. In such cases, the ability of the known generator to identify the particular instrument configuration used and to optimize the control and diagnostic procedures accordingly may be limited. However, from a compatibility perspective, solving this problem by adding readable data circuitry to the surgical device instrument is problematic. For example, designing a surgical device to remain backward compatible with a generator lacking the requisite data reading functionality may be impractical due to, for example, different signal schemes, design complexity, and cost. Other aspects of the instrument address these issues by using a data circuit that can be economically implemented in existing surgical instruments with minimal design changes to maintain compatibility of the surgical device with current generator platforms.
In addition, aspects of the generator 1100 may enable communication with instrument-based data circuitry. For example, the generator 1100 may be configured to communicate with a second data circuit included in an instrument (e.g., instruments 1104, 1106, or 1108) of the surgical device. The instrument interface circuit 1980 may include a second data circuit interface 2100 for enabling this communication. In one aspect, second data circuit interface 2100 may comprise a tri-state digital interface, although 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 the particular surgical instrument associated. 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, the number of updates to the operation in which the surgical instrument is used and/or the date and/or time of its use. In certain aspects, the second data circuit may transmit data collected by one or more sensors (e.g., instrument-based temperature sensors). In certain aspects, the second data circuit may receive data from the generator 1100 and provide an indication (e.g., an LED indication or other visual indication) to a user based on the received data.
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 (e.g., dedicated conductors of a cable connecting the handpiece to the generator 1100). In one aspect, 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 interrogation signals from signal conditioning circuit 2020 to control circuitry in the handpiece, for example. In this way, design changes or modifications to the surgical device that may otherwise be necessary may be minimized or reduced. Furthermore, because different types of communication may be implemented on a common physical channel (with or without band splitting), the presence of the second data circuit may be "invisible" to generators that do not have the requisite data reading functionality, thus enabling backwards compatibility of surgical device instruments.
In certain aspects, the isolation stage 1520 may include at least one blocking capacitor 2960-1 (fig. 27C) that 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. While relatively few faults occur in single capacitor designs, such faults can have undesirable 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, 2960-2 is detected by, for example, the ADC 2980 for sampling the voltage induced by the leakage current. The sample may be received by programmable logic device 2000, for example. Based on the change in leakage current (as indicated by the voltage samples in the aspect of FIG. 26), the generator 1100 may determine when at least one of the blocking capacitors 2960-1, 2960-2 fails. Thus, the aspect of fig. 26 has benefits over a single capacitor design with a single point of failure.
In certain aspects, the non-isolated stage 1540 may include a power source 2110 for outputting DC power at appropriate voltages and currents. The power source may comprise, for example, a 400W power source for outputting a system voltage of 48 VDC. 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 produce a DC output at the voltage and current required by the various devices of the generator 1100. As described above in connection with controller 1960, one or more of DC/DC voltage converters 2130 may receive input from controller 1960 when controller 1960 detects a user activation of "on/off input device 2150 to enable operation of DC/DC voltage converter 2130 or to wake up DC/DC voltage converter 2130.
Fig. 28A-28B illustrate certain functional and structural aspects of an aspect of the generator 1100. Feedback indicative of the current and voltage output from the secondary winding 1580 of power transformer 1560 is received by ADCs 1780, 1800, respectively. As shown, ADCs 1780, 1800 may be implemented as 2-channel ADCs, and the feedback signal may be sampled at high speed (e.g., 80Msps) to allow oversampling (e.g., approximately 200x oversampling) of the drive signal. The current and voltage feedback signals may be appropriately conditioned (e.g., amplified, filtered) in the analog domain prior to processing by the ADC 1780, 1800. Current and voltage feedback samples from ADCs 1780, 1800 may be individually buffered and then multiplexed or interleaved into a single data stream within block 2120 of programmable logic device 1660. In the aspect of fig. 28A-28B, programmable logic device 1660 comprises an FPGA.
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 comprise an encapsulation 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 particular LUT samples output by programmable logic device 1660 can be stored at one or more memory addresses that correlate to or index LUT addresses of the LUT samples. In another aspect, feedback samples corresponding to particular LUT samples output by programmable logic device 1660 can be stored at a common memory location along with LUT addresses for the LUT samples. In any case, the feedback samples may be stored such that the address of the LUT sample from which the particular set of feedback samples originated may be subsequently determined. As described above, synchronizing the LUT sample addresses and the feedback samples in this manner facilitates correct timing and stability of the predistortion algorithm. A Direct Memory Access (DMA) controller implemented at block 2166 of processor 1740 may store the feedback samples (and any LUT sample address data, if applicable) at a designated memory location 2180 (e.g., internal RAM) of processor 1740.
At block 2220 of the predistortion algorithm, the current through the dynamic branch of the ultrasound transducer is determined. May be based on, for example, current and voltage feedback samples stored at memory location 2180 (which, when properly calibrated, may represent I in the model of FIG. 25 discussed abovegAnd Vg) Static capacitance C of ultrasonic transducer0And a known value of the drive frequency, using kirchhoff's current law to determine the dynamic branch current. Dynamic branch current samples for each set of stored current and voltage feedback samples associated with LUT samples may be determined.
At block 2240 of the predistortion algorithm, each dynamic leg current sample determined at block 2220 is compared to a sample of the desired current waveform shape to determine a difference or sample amplitude error between the compared samples. For this determination, samples of the desired current waveform shape may be supplied, for example, from waveform shape LUT2260, which waveform shape LUT2260 contains amplitude samples for one cycle of the desired current waveform shape. The particular sample of the desired current waveform shape from LUT2260 used for comparison may be determined by the LUT sample address associated with the dynamic branch current sample used for comparison. Thus, the input of the motion leg current to block 2240 may be synchronized to the input of its associated LUT sample address to block 2240. Thus, the number of LUT samples stored in programmable logic device 1660 and LUT samples stored in waveform shape LUT2260 may be equal. In certain aspects, the desired current waveform shape represented by the LUT samples stored in waveform shape LUT2260 may be a basic sine wave. Other waveform shapes may be desired. For example, it is contemplated that a basic sine wave for driving the main longitudinal motion of the ultrasound transducer superimposed with one or more other drive signals at other frequencies may be used, such as a third harmonic for driving at least two mechanical resonances for advantageous vibrations in the transverse or other modes.
Each value of the sample amplitude error determined at block 2240 is transmitted to the LUT of the programmable logic device 1660 (shown at block 2280 in fig. 28A) along with an indication of its associated LUT address. Based on the value of the sample amplitude error and its associated address (and optionally, the previously received value of the sample amplitude error for the same LUT address), the LUT2280 (or other control block of the programmable logic device 1660) can predistort or modify the value of the LUT sample stored at the LUT address such that the sample amplitude error is reduced or minimized. It will be appreciated that such predistortion or modification of each LUT sample in an iterative manner over the entire LUT address range will result in the waveform shape of the generator's output current matching or conforming to the desired current waveform shape represented by the samples of waveform shape LUT 2260.
The current and voltage amplitude measurements, power measurements, and impedance measurements may be determined at block 2300 of 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 some 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 substantially represent the fundamental frequency of the generator's drive output signal. 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 some aspects, the resulting frequency 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.
At block 2340 (fig. 28B), a Root Mean Square (RMS) calculation may be applied to current feedback samples representing a sample size of the drive signal for an integer cycle to generate a measurement I representing the drive signal output currentrms。
At block 2360, a Root Mean Square (RMS) calculation may be applied to the voltage feedback samples representing a sample size of the drive signal for an integer cycle to determine a measurement V representing the output voltage of the drive signalrms。
At block 2380, the current and voltage feedback samples may be multiplied point-by-point and the samples representing the integer-cycle drive signal may be averaged to determine a measure P of the true output power of the generatorr。
At block 2400, a measure P of the apparent output power of the generatoraCan be determined as the product Vrms·Irms。
At block 2420, the measured value of the load resistance value ZmCan be determined as a quotientNumber Vrms/Irms。
In certain aspects, the amount I determined at blocks 2340, 2360, 2380, 2400, and 2420rms、Vrms、Pr、PaAnd ZmCan 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, output device 2140 integral to generator 1100 or output device 2140 connected to generator 1100 through a suitable communication interface (e.g., a USB interface). For example, various diagnostic procedures may include, but are not limited to, handpiece integrity, instrument attachment integrity, instrument overload, approaching instrument overload, frequency lock fault, over current condition, over power condition, voltage sensing fault, current sensing fault, audio indicating fault, visual indicating fault, short circuit condition, power delivery fault, or blocking capacitor fault.
The phase control algorithm receives as inputs the current and voltage feedback samples stored in memory location 2180. The feedback samples may be appropriately scaled and processed in some respects by a suitable filter 2460 (which may be the same as filter 2320) to remove noise generated by, for example, the data acquisition process and induced harmonic components, before being used in the phase control algorithm. Thus, the filtered voltage and current samples may substantially represent the fundamental frequency of the generator's drive output signal.
At block 2480 of the phase control algorithm, the current through the dynamic branch of the ultrasound transducer is determined. This determination may be the same as the determination described above in connection with block 2220 of the predistortion algorithm. Thus, for each set of stored current and voltage feedback samples associated with LUT samples, the output of block 2480 may be a dynamic branch current sample.
At block 2500 of the phase control algorithm, the impedance phase is determined based on the synchronous input of the dynamic 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 the impedance phase measured at the rising edge of the waveform and the impedance phase measured at the falling edge of the waveform.
At block 2520 of the phase control algorithm, the impedance phase value determined at block 2220 is compared to the phase set point 2540 to determine a difference or phase error between the compared values.
At block 2560 (fig. 28A) of the phase control algorithm, a frequency output for controlling the frequency of the drive signal is determined based on the value of the phase error determined at block 2520 and the impedance magnitude determined at block 2420. The value of the frequency output may be continuously adjusted by the block 2560 and transmitted to the DDS control block 2680 (discussed below) in order to maintain the impedance phase determined at block 2500 at a phase set point (e.g., zero phase error). In certain aspects, the impedance phase may be adjusted to a 0 ° phase setpoint. In this way, any harmonic distortion will be centered around the peak of the voltage waveform, thereby enhancing the accuracy of the phase impedance determination.
In terms of driving signal voltage as a control variable, current demand IdMay be based, for example, on maintaining the load impedance magnitude Z measured at block 2420mGiven a desired voltage set point 2620B (V)sp) The required current is indirectly specified (e.g. I)d＝Vsp/Zm). Similarly, in terms of driving signal power as a control variable, current demand IdMay be based, for example, on the voltage V measured at block 2360rmsGiven a desired setpoint 2620C (P)sp) The required current is indirectly specified (e.g. I)d＝Psp/Vrms)。
Block 2680 (fig. 28A) may implement a DDS control algorithm for controlling the 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) -skip technique. The NCO algorithm may implement a phase accumulator or frequency-to-phase converter that is used as an address pointer for retrieving LUT samples from the LUT 2280. In one aspect, the phase accumulator may be a D step, modulus N phase accumulator, where D is a positive integer representing the 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 LUT2280, resulting in a waveform output that replicates the waveform stored in LUT 2280. When D >1, the phase accumulator may skip addresses in LUT2280, producing a waveform output with a higher frequency. Accordingly, the frequency of the waveform generated by the DDS control algorithm can thus be controlled by appropriately changing the frequency control value. In certain aspects, the frequency control value may be determined based on the output of the phase control algorithm implemented at block 2440. The output of block 2680 may supply an input of DAC1680, which DAC1680 in turn supplies a corresponding analog signal to an input of power amplifier 1620.
Fig. 29 is a schematic diagram of one aspect of a circuit 2900 suitable for driving an ultrasonic transducer, such as ultrasonic transducer 1120, in accordance with at least one aspect of the present disclosure. Circuit 2900 includes an analog multiplexer 2980. The analog multiplexer 2980 multiplexes various signals from the upstream channel SCL-A, SDA-A such as ultrasound, battery, and power control circuitry. A current sensor 2982 is coupled in series with the return or ground branch of the power source circuit to measure the current provided by the power source. A Field Effect Transistor (FET) temperature sensor 2984 provides ambient temperature. If the main program ignores maintenance on it periodically, a Pulse Width Modulation (PWM) watchdog timer 2988 automatically generates a system reset. Which is set to auto-reset circuit 2900 when it stalls or freezes due to a software or hardware failure. It should be understood that circuit 2900 may be configured as an RF driver circuit, e.g., for driving an ultrasound transducer or for driving an RF electrode such as circuit 3600 shown in fig. 36. Thus, referring now back to fig. 29, circuit 2900 may be used to interchangeably drive both the ultrasound transducer and the RF electrode. If driven simultaneously, filter circuits can be provided in the corresponding first stage circuit 3404 (FIG. 34) to select the ultrasonic or RF waveform. Such filtering TECHNIQUES are described in commonly owned U.S. patent publication US-2017-0086910-A1, entitled technique FOR circuit topology FOR a combinational GENERATOR (TECHNIQUES FOR COMMUNICED GENERATOR), which is incorporated herein by reference in its entirety.
The drive circuit 2986 provides a left ultrasonic energy output and a right ultrasonic energy output. Digital signals representing the signal waveforms are provided from a control circuit, such as control circuit 3200 (FIG. 32), to the SCL-A, SDA-A input of analog multiplexer 2980. A digital-to-analog converter 2990(DAC) converts a digital input to 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. A voltage sensor 2999 is coupled between the ultrasonic LEFT/RIGHT output terminals to measure the output voltage. The driver circuit 2986, the first and second driver circuits 2996a and 2996b, and the first and second transistor output stages 2998a and 2998b define a first stage amplifier circuit. In operation, the control circuit 3200 (fig. 32) generates the digital waveform 4300 (fig. 43) using circuitry such as Direct Digital Synthesis (DDS) circuits 4100, 4200 (fig. 41 and 42). The DAC 2990 receives the digital waveform 4300 and converts it to an analog waveform that is received and amplified by the first stage amplifier circuit.
Fig. 30 is a schematic diagram of a transformer 3000 coupled to the circuit 2900 shown in fig. 29, in accordance with at least one aspect of the present disclosure. 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 3074 b. Positive and negative electrodes 3074a and 3074b of transformer 3000 are coupled to positive and negative terminals (stack 1 and 2) of the ultrasonic transducer. In one aspect, transformer 3000 has a turns ratio n of 1:501:n2。
Fig. 31 is a schematic diagram of the transformer 3000 shown in fig. 30 coupled to a test circuit 3165, according to at least one aspect of the present disclosure. Test circuit 3165 is coupled to positive electrode 3074a and negative electrode 3074 b. Switch 3167 is placed in series with an inductor/capacitor/resistor (LCR) load that simulates the load of the ultrasonic transducer.
Fig. 32 is a schematic diagram of a control circuit 3200 (such as the 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 the various local power sources 3215. The control circuit includes a main processor 3214, the main processor 3214 being coupled to various downstream circuits via an interface host (interface master)3218 by, for example, the outputs SCL-A and SDA-A, SCL-B and SDA-B, SCL-C and SDA-C. In one aspect, the interface host 3218 is a universal serial interface, such as I2And C, serial interface. The main processor 3214 is further configured to be able to drive the switches 3224 through general purpose input/output (GPIO)3220, the display 3226 (e.g., and LCD display) and various indicators 3228 through GPIO 3222. The watchdog processor 3216 is arranged to control the main processor 3214. A switch 3230 is provided in series with the battery 3211 to activate the control when the battery assembly is inserted into the handle assembly of the surgical instrumentA circuit 3212 is formed.
In one aspect, the main processor 3214 is coupled to the circuit 2900 (FIG. 29) through the output terminals SCL-A, SDA-A. The main processor 3214 includes a memory for storing, for example, a table of digitized drive signals or waveforms transmitted to the circuit 2900 to drive the ultrasonic transducer 1120. In other aspects, the main processor 3214 may generate and transmit digital waveforms to the circuit 2900, or may store digital waveforms for later transmission to the circuit 2900. The main processor 3214 may also provide RF drive through the output terminals SCL-B, SDA-B, and may provide various sensors (e.g., Hall effect sensors, magneto-rheological fluid (MRF) sensors, etc.) through the output terminals SCL-C, SDA-C. In one aspect, the main processor 3214 is configured to be able to sense the presence of the ultrasound drive circuitry and/or RF drive circuitry to enable appropriate software and user interface functionality.
In one aspect, primary processor 3214 may be, for example, LM4F230H5QR, available from texas instruments (texas instruments). In at least one example, LM4F230H5QR, Texas instruments (Texas instruments), is an ARM Cortex-M4F processor core that includes: 256KB of single cycle flash or other non-volatile memory (up to 40MHZ) on-chip memory, prefetch buffers to improve performance by over 40MHz, 32KB of single cycle Serial Random Access Memory (SRAM), Stellaris loaded
Software internal Read Only Memory (ROM), 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.
Fig. 33 illustrates a simplified circuit block diagram showing another circuit 3300 included within a modular ultrasonic surgical instrument 3334, in accordance with at least one aspect of the present disclosure. 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 sense circuit 3314, a transducer 1120, and a shaft assembly (e.g., shaft assemblies 1126, 1129) that includes an ultrasonic transmission waveguide terminated at an ultrasonic blade (e.g., ultrasonic blade 1128, 1149), which may be referred to herein simply as a waveguide.
One feature of the present disclosure that cuts off the dependence on high voltage (120 volts ac) input power (a feature of typical ultrasonic cutting devices) is the utilization of low voltage switches during the entire wave forming process, and the amplification of the drive signal only immediately prior to the transformer stage. Thus, in one aspect of the present disclosure, power is sourced from only one battery or a group of batteries that are small enough to fit within the handle assembly. The battery technology in the art provides high power batteries with a height and width of a few centimeters and a depth of a few millimeters. By combining features of the present disclosure to provide self-contained and self-powered ultrasound devices, a reduction in manufacturing costs can be achieved.
The output of power source 3304 is fed to and powers 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, circuit 3300 can also include memory 3326, preferably Random Access Memory (RAM), which stores computer-readable instructions and data.
The output of power source 3304 is also directed to switch 3306, which has a duty cycle controlled by processor 3302. By controlling the on-time of the switch 3306, the processor 3302 can specify the total amount of power that is ultimately delivered to the transducer 1120. In one aspect, the switch 3306 is a MOSFET, but other switches and switch configurations are also adaptable. The output of the switch 3306 is fed to a drive circuit 3308, which drive circuit 3308 comprises, 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) of the output signal, respectivelyINAnd IIN). These values are used in a feedback architecture to adjust the pulse width modulation of the switch 3306. For example, the duty cycle of the switch 3306 may vary in a range of about 20% to about 80%, depending on the desired and actual outputs from the switch 3306.
The drive circuit 3308, which receives signals from the switch 3306, includes an oscillating 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, this smoothed version of the ultrasonic waveform is ultimately fed to the ultrasonic transducer 1120 to produce a resonant sine wave along the ultrasonic transmission waveguide.
The output of the driver circuit 3308 is a transformer 3310 capable of boosting the low voltage signal(s) 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 heretofore not been possible with ultrasonic cutting and cauterization devices. This is due at least in part to the fact that the device advantageously uses low on-resistance MOSFET switching devices. Low on-resistance MOSFET switches are advantageous because they produce lower switching losses and less heat than conventional MOSFET devices and allow higher currents to pass. Thus, the switching stage (pre-transformer) can be characterized as low voltage/high current. To ensure low on-resistance of the amplifier MOSFET(s), the MOSFET(s) operate at, for example, 10V. In this case, a separate 10VDC power source may be used to power the MOSFET gate, which ensures that the MOSFET is fully on and a relatively low on-resistance is achieved. In one aspect of the present disclosure, the transformer 3310 boosts the battery voltage to 120 volts Root Mean Square (RMS). Transformers are known in the art and are therefore not described in detail herein.
In such circuit configurations, circuit device degradation can negatively impact 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, as MOSFET design technology advances and the corresponding size decreases, MOSFET temperature is no longer a valid indicator of circuit loading and heat. Thus, according to at least one aspect of the present disclosure, the sensing circuit 3314 senses the temperature of the transformer 3310. This temperature sensing is advantageous because transformer 3310 operates at or very near its maximum temperature during device use. The 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 transformer 3310 by, for example, reducing drive power in transformer 3310, signaling a user, shutting down power, pulsing power, or other suitable response.
In one aspect of the present disclosure, the processor 3302 is communicatively coupled to an end effector (e.g., 1122, 1125) for placing a material in physical contact with an ultrasonic blade (e.g., 1128, 1149). A sensor is provided that measures a clamping force value (existing within a known range) at the end effector, and based on the clamping force value received, the processor 3302 changes the dynamic voltage VM. Since high force values in combination with set rates of motion may result in high blade temperatures, the temperature sensor 3332 may be communicatively coupled to the processor 3302, where the processor 3302 may be operable to receive and interpret signals indicative of the current temperature of the blade from the temperature sensor 3336 and determine a target frequency of blade movement based on the received temperature. In another aspect, a force sensor, such as a strain sensor or a pressure sensor, may 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, may be coupled to the switch button such that the displacement strength corresponds to a force applied to the switch button by a user.
According to at least one aspect of the present disclosure, the PLL portion of the drive circuit 3308 coupled to the processor 3302 can determine the frequency of the waveguide movement and communicate 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 is turned off and retrieve the last waveguide movement frequency if the elapsed time is less than a predetermined value. The device can then be started at more than one frequency, which is probably the optimum frequency for the current load.
Modular battery-powered hand-held surgical instrument with multi-stage generator circuit
In another aspect, the present disclosure provides a modular battery-powered hand-held surgical instrument having a multi-stage generator circuit. A surgical instrument includes 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 to 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 the load.
In one aspect, the present disclosure provides a surgical instrument comprising: a battery assembly comprising control circuitry 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 comprising a first stage circuit coupled to a processor, the first stage circuit comprising 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 to an analog waveform, wherein the first stage amplifier circuit is configured to receive and amplify the analog waveform; and a shaft assembly including a second stage circuit coupled to the first stage amplifier circuit to receive the analog waveform, amplify the analog waveform, and apply the analog waveform to a load; wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly.
The load may include any of the ultrasound transducer, the electrode, or the 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 capable of independently or simultaneously driving the first stage ultrasonic drive circuit and the first stage high frequency current drive circuit. The first stage ultrasonic drive circuit may be configured to be coupleable to the second stage ultrasonic drive circuit. The second stage ultrasonic drive circuit may be configured to be coupleable to an ultrasonic transducer. The first stage high frequency current drive circuit may be configured to be coupleable to the second stage high frequency drive circuit. The second stage high frequency drive circuit may be configured to be capable of being coupled to the electrode.
The first stage circuitry may include first stage sensor drive circuitry. The first stage sensor drive circuit may be configured to enable the second stage sensor drive circuit. The second stage sensor drive circuit may be configured to be coupleable to the sensor.
In another aspect, the present disclosure provides a surgical instrument comprising: a battery assembly comprising control circuitry 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 comprising a common first stage circuit coupled to the processor, the common first stage circuit comprising 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 to an analog waveform, wherein the common first stage amplifier circuit is configured to receive and amplify the analog waveform; and a shaft assembly comprising 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 the load; wherein the battery assembly and the shaft assembly are configured to be mechanically and electrically connected to the handle assembly.
The load may include any of the ultrasound transducer, the electrode, or the sensor, or any combination thereof. The common first stage circuit may be configured to be capable of driving ultrasound, high frequency current, or sensor circuits. The common first stage drive circuit may be configured to be coupleable 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 coupleable to an ultrasonic transducer, the second stage high frequency drive circuit configured to be coupleable to an electrode, and the second stage sensor drive circuit configured to be coupleable to a sensor.
In another aspect, 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 configured to be capable of receiving a digital waveform, converting the digital waveform to an analog waveform, and amplifying the analog waveform; and a shaft assembly comprising a second stage circuit coupled to the common first stage circuit to receive and amplify the analog waveform; wherein the shaft assembly is configured to be mechanically and electrically connected to the handle assembly.
The common first stage circuit may be configured to be capable of driving ultrasound, high frequency current, or sensor circuits. The common first stage drive circuit may be configured to be coupleable 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 coupleable to an ultrasonic transducer, the second stage high frequency drive circuit configured to be coupleable to an electrode, and the second stage sensor drive circuit configured to be coupleable to a sensor.
Fig. 34 illustrates a generator circuit 3400 divided into a first stage circuit 3404 and a second stage circuit 3406 in accordance with at least one aspect of the present disclosure. In one aspect, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3400 divided into a plurality of stages. For example, the surgical instrument of the surgical system 1000 can include a generator circuit 3400 divided into at least two circuits: first and second stage circuits 3404, 3406 that enable RF energy operation only, ultrasonic energy operation only, and/or a combination of RF energy and ultrasonic energy operation. Modular shaft assembly 3414 may be powered by a common first stage circuit 3404 located within handle assembly 3412 and a modular second stage circuit 3406 integrally formed with modular shaft assembly 3414. As previously discussed throughout this specification in connection 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 effector assembly is configured to mechanically and electrically connect shaft assembly 3414.
Turning now to fig. 34, the generator circuit 3400 is divided into a plurality of stages located in a plurality of modular assemblies of a surgical instrument (such as the surgical instruments of the surgical system 1000 described herein). In one aspect, the control stage circuitry 3402 may be located in the battery assembly 3410 of the surgical instrument. The control stage circuit 3402 is a control circuit 3200 as described in connection with fig. 32. The control circuit 3200 includes a processor 3214, the processor 3214 including internal memory 3217 (fig. 34) (e.g., volatile and non-volatile memory), and 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 the circuits and techniques described in connection with fig. 41 and 42 to generate the digital waveform 4300 (fig. 43). Returning to fig. 34, the digital waveform 4300 may be configured to be capable of independently or simultaneously driving an ultrasound transducer, high frequency (e.g., RF) electrodes, or a combination thereof. If driven simultaneously, a filter circuit may be provided in the corresponding first stage circuit 3404 to select an ultrasonic waveform or an RF waveform. Such filtering TECHNIQUES are described in commonly owned U.S. patent publication US-2017-0086910-a1, entitled CIRCUIT topology FOR a COMBINED GENERATOR (TECHNIQUES FOR CIRCUIT TOPOLOGIESFOR COMMUNICED GENERATOR), which is incorporated herein by reference in its entirety.
The first stage circuitry 3404 (e.g., first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, and first stage transducer 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 output SCL-A, SDA-A of the control circuit 3200. The first stage ultrasonic drive circuit 3420 is described in detail in connection with fig. 29. Control circuit 3200 provides the RF drive signal to first stage RF drive circuit 3422 via output SCL-B, SDA-B of control circuit 3200. The first stage RF driver circuit 3422 is described in detail in connection with fig. 36. The control circuit 3200 provides sensor drive signals to the first level sensor drive circuit 3424 via the output SCL-C, SDA-C of the control circuit 3200. Generally, each of the first stage circuits 3404 includes a digital-to-analog (DAC) converter and a first stage amplifier section to drive the second stage circuit 3406. The output of the first stage 3404 is provided to the input 3406 of the second stage.
The control circuit 3200 is configured to be able to detect which modules are inserted into the control circuit 3200. For example, control circuit 3200 is configured to be able to detect whether first stage ultrasonic drive circuit 3420, first stage RF drive circuit 3422, or first stage sensor drive circuit 3424 located in handle assembly 3412 is connected to battery assembly 3410. Likewise, each of the first stage circuits 3404 may detect which of the second stage circuits 3406 are connected to, 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 may detect which third stage circuit 3408 or which devices are connected thereto, and this information is provided back to the control circuit 3200 to determine the type of signal waveform to generate.
In one aspect, the second stage circuitry 3406 (e.g., ultrasonic drive second stage circuitry 3430, RF drive second stage circuitry 3432, and sensor drive second stage circuitry 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 described in detail in connection with fig. 30 and 31. The second stage ultrasonic drive circuit 3430 may include filters, amplifiers, and signal conditioning circuits in addition to the transformer (fig. 30 and 31). The first stage high frequency (RF) current drive circuit 3422 provides signals to the second stage RF drive circuit 3432 via output RF-Left/RF-Right. In addition to the transformer and blocking capacitor, the second stage RF driver circuit 3432 may also include filters, amplifiers, and signal conditioning circuits. First stage Sensor drive circuit 3424 provides signals to second stage Sensor drive circuit 3434 via outputs 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.
In one aspect, the third stage circuit 3408 (e.g., the ultrasound transducer 1120, the RF electrodes 3074a, 3074b, and the sensor 3440) may be located in various components 3416 of the surgical instrument. In one aspect, the second stage 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 an ultrasonic transducer assembly of a surgical instrument. However, in other aspects, the ultrasonic transducer 1120 may be located in the handle assembly 3412, the shaft assembly 3414, or the end effector. In one aspect, second stage RF drive circuit 3432 provides drive signals to RF electrodes 3074a, 3074b, which are typically located in the end effector portion of the surgical instrument. In one aspect, the second stage sensor drive circuit 3434 provides drive signals to various sensors 3440 located throughout the surgical instrument.
Fig. 35 illustrates a generator circuit 3500 divided into a plurality of stages, 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, the surgical instrument of the surgical system 1000 described herein can include a generator circuit 3500 divided into a plurality of stages. For example, the 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 enable high frequency (RF) energy operation only, ultrasonic energy operation only, and/or a combination of RF energy and ultrasonic energy operation. The modular shaft assembly 3514 may be powered by a common first stage circuit 3504 located within the handle assembly 3512 and a modular second stage circuit 3506 integrally formed with the modular shaft assembly 3514. As previously discussed throughout this specification in connection 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 effector assembly is configured to mechanically and electrically connect the shaft assembly 3514.
As shown in the example of fig. 35, the battery assembly 3510 portion of the surgical instrument includes a first control circuit 3502, which first control circuit 3502 includes the previously described control circuit 3200. A handle assembly 3512 connected to a battery assembly 3510 includes a common first stage drive circuit 3420. As previously described, the first stage drive circuit 3420 is configured to be capable of driving ultrasound, high frequency (RF) currents, and sensor loads. The output of common first stage drive circuit 3420 may drive any of second stage circuits 3506, such as second stage ultrasonic drive circuit 3430, second stage high frequency (RF) current drive circuit 3432, and/or 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 sensor drive circuit 3434) is located in the shaft assembly 3514. This information is provided to the control circuit 3200 located in the handle assembly 3512 in order to provide the appropriate digital waveform 4300 (fig. 43) to the second stage circuit 3506 to drive an appropriate load, such as ultrasonic, RF or a sensor. It is to be understood that the identification circuit can be included in various components 3516 in the third stage circuit 3508, such as the ultrasonic transducer 1120, the electrodes 3074a, 3074b, or the sensor 3440. Therefore, when the third stage circuit 3508 is connected to the second stage circuit 3506, the second stage circuit 3506 knows the type of load required based on the identification information.
Fig. 36 is a schematic diagram of one aspect of a circuit 3600 configured to be capable of driving high frequency current (RF) in accordance with at least one aspect of the present disclosure. Circuit 3600 includes analog multiplexer 3680. Analog multiplexer 3680 multiplexes the various signals from upstream channels SCL-A, SDA-A such as RF, battery, and power control circuitry. A current sensor 3682 is coupled in series with the return or ground leg of the power source circuit to measure the current provided by the power source. A Field Effect Transistor (FET) temperature sensor 3684 provides ambient temperature. Pulse Width Modulation (PWM) watchdog timer 3688 automatically generates a system reset if the main program ignores maintenance on it periodically. Which is set to auto-reset circuit 3600 when it stalls or freezes due to a software or hardware failure. It should be understood that circuit 3600 may be configured for driving RF electrodes or for driving ultrasound transducer 1120, for example, as described in connection with fig. 29. Thus, referring back now to fig. 36, circuit 3600 may be used to interchangeably drive both ultrasound and RF electrodes.
Fig. 37 is a schematic diagram of a transformer 3700 coupled to circuit 3600 shown in fig. 36, in accordance with at least one aspect of the present disclosure. The RF +/RF input terminal (primary winding) of transformer 3700 is electrically coupled to the RFLEft/RF output terminal of circuit 3600. One side of the secondary winding is coupled in series with a first barrier capacitor 3706 and a second barrier capacitor 3708. The second blocking capacitor is coupled to the positive terminal of the second stage RF driver circuit 3774 a. The other side of the secondary winding is coupled to the negative terminal of second stage RF driver circuit 3774 b. The positive output of the second stage RF drive circuit 3774a is coupled to the ultrasonic blade and the second stage RF drive circuit negative ground terminal 3774b is coupled to the outer tube. In one aspect, the transformer has a turns ratio n of 1:501:n2。
Fig. 38 is a schematic diagram of a circuit 3800 in accordance with at least one aspect of the present disclosure, the circuit 3800 including separate power sources for the high power energy/driver circuit and the low power circuit. The power source 3812 includes a primary battery pack including a first main battery 3815 and a second main battery 3817 (e.g., lithium ion batteries) connected to the circuit 3800 through a switch 3818, and a secondary battery pack including a secondary battery 3820, the secondary battery 3820 being connected to the circuit through a switch 3823 when the power source 3812 is inserted into the battery assembly. The secondary battery 3820 is a drop-resistant battery having a device portion that is resistant to gamma or other radiation sterilization. For example, a switch-mode power supply 3827 and optional charging circuitry within the battery assembly may be incorporated to allow the secondary battery 3820 to reduce the voltage sag of the primary batteries 3815, 3817. This ensures that the surgery is initially easy to introduce into a fully charged unit in a sterile field. Primary batteries 3815, 3817 may be used to directly power the motor control circuitry 3826 and the energy circuitry 3832. The motor control circuit 3826 is configured to be able to control a motor, such as the motor 3829. The power source/battery pack 3812 may include a dual-type battery assembly including primary Li- ion batteries 3815, 3817 and secondary NiMH batteries 3820 with dedicated energy cells 3820 to control the handle electronic circuitry 3830 from the dedicated energy cells 3815, 3817 to run motor control circuitry 3826 and energy circuitry 3832. In this case, when the primary batteries 3815, 3817 involved in driving the energy circuit 3832 and/or the motor control circuit 3826 are dropped, the circuit 3810 is pulled from the secondary battery 3820 involved in driving the handle electronic circuit 3830. In one various aspect, the circuit 3810 may include a unidirectional diode that will not allow current to flow in the opposite direction (e.g., from a battery related to the drive energy circuit and/or the motor control circuit to the motor control circuit related to the drive electronics circuit).
Additionally, a gamma friendly charging circuit may be provided that includes a switch mode power supply 3827 that uses diodes and vacuum tube devices to minimize voltage sag at predetermined levels. The switch mode power supply 3827 may be eliminated with the inclusion of a separate minimum drop voltage for the NiMH voltage (3 NiMH cells). In addition, a modular system may be provided in which the radiation-hardening devices are located in the modules such that the modules may be sterilized by radiation sterilization. Other non-radiation hardened devices may be included in other modular devices and connections made between modular devices such that the device portions operate together as if the devices were located together on the same circuit board. A diode and vacuum tube based switch mode power supply 3827 allows for sterilizable electronics within a disposable primary battery pack if only two NiMH cells are desired.
Turning now to fig. 39, there is shown a control circuit 3900 for operating a battery 3901-powered RF generator circuit 3902 for use with a surgical instrument in accordance with at least one aspect of the present disclosure. The surgical instrument is configured to be capable of performing a surgical coagulation/cutting process on living tissue using both ultrasonic vibration and a high-frequency current, and performing a surgical coagulation process on the living tissue using the high-frequency current.
Fig. 39 shows a control circuit 3900 that allows the dual generator system to switch between an RF generator circuit 3902 modality and an ultrasound generator circuit 3920 modality of a surgical instrument of the surgical system 1000. In one aspect, a current threshold in the RF signal is detected. When the impedance of the tissue is low, the high frequency current through the tissue is high when the RF energy is used as a therapeutic source for the tissue. According to one aspect, the visual indicator 3912 or light located on the surgical instrument of the surgical system 1000 may be configured to be in an on state during this high current period. When the current is below the threshold, the visual indicator 3912 is in an off state. Thus, the phototransistor 3914 may be configured to be able to detect a transition from an on state to an off state and dissociate the RF energy, as shown in the control circuit 3900 shown in fig. 39. Thus, when the energy button is released and the energy switch 3926 is turned on, the control circuit 3900 is reset and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are kept off.
Referring to fig. 39, in one aspect, a method of managing an RF generator circuit 3902 and an ultrasonic generator circuit 3920 is provided. The RF generator circuit 3902 and/or the ultrasonic generator circuit 3920 can be located in, for example, the handle assembly 1109, the ultrasonic transducer/RF generator assembly 1120, the battery assembly, the shaft assembly 1129, and/or the nozzle of the multi-function electrosurgical instrument 1108. If the energy switch 3926 is off (e.g., open), the control circuit 3900 remains in the reset state. Thus, when the energy switch 3926 is open, the control circuit 3900 is reset and both the RF generator circuit 3902 and the ultrasonic generator circuit 3920 are turned off. When the energy switch 3926 is squeezed and the energy switch 3926 is engaged (e.g., closed), RF energy is delivered to the tissue and the visual indicator 3912 operated by the current sensing step-up transformer 3904 will illuminate when the tissue impedance is low. Light from the visual indicator 3912 provides a logic signal to maintain the ultrasonic generator circuit 3920 in the off state. Once the tissue impedance increases above the threshold and the high frequency current through the tissue decreases below the threshold, the visual indicator 3912 turns off and the light transitions to the off state. The logic signal generated by this transition turns off the relay 3908, thereby turning off the RF generator circuit 3902 and turning on the ultrasonic generator circuit 3920 to complete the coagulation and cutting cycle.
Still referring to fig. 39, in one aspect, a dual generator circuit configuration employs a battery 3901 powered, on-board RF generator circuit 3902 for one modality, and a second, on-board ultrasonic generator circuit 3920, which ultrasonic generator circuit 3920 may be on-board a handle assembly 1109, a battery assembly, a shaft assembly 1129, a nozzle, and/or an ultrasonic transducer/RF generator assembly 1120 of the multifunctional electrosurgical instrument 1108. The ultrasonic generator circuit 3920 is also battery 3901 operational. In various aspects, the RF generator circuit 3902 and the ultrasonic generator circuit 3920 can be integrated or separable components of the handle assembly 1109. According to various aspects, having the dual RF generator circuit 3902/ultrasonic generator circuit 3920 as part of the handle assembly 1109 may eliminate the need for complex wiring. The RF generator circuit 3902/ultrasonic generator circuit 3920 can be configured to provide the full capabilities of existing generators while simultaneously utilizing the capabilities of a cordless generator system.
Either type of system may have independent controls for modalities that do not communicate with each other. The surgeon activates RF and ultrasound separately and at their discretion. Another approach would be to provide a fully integrated communication scheme that shares buttons, tissue state, instrument operating parameters (such as jaw closure, force, etc.), and algorithms for managing tissue processing. Various combinations of this integration may be implemented to provide appropriate levels of functionality and performance.
As described above, in one aspect, the control circuit 3900 includes a battery 3901 powered RF generator circuit 3902 that includes a battery as an energy source. As shown, RF generator circuit 3902 is coupled to two conductive surfaces referred to herein as electrodes 3906a, 3906b (i.e., active electrode 3906a and return electrode 3906b), and is configured to be capable of driving electrodes 3906a, 3906b with RF energy (e.g., high frequency current). The first winding 3910a of the step-up transformer 3904 is connected in series with one pole of the bipolar RF generator circuit 3902 and the return electrode 3906 b. In one aspect, the first winding 3910a and the return electrode 3906b are connected to the negative pole of the bipolar RF generator circuit 3902. The other pole of the bipolar RF generator circuit 3902 is connected to the active electrode 3906a through a switch contact 3909 of the relay 3908, or any suitable electromagnetic switching device that includes an armature that is moved by an electromagnet 3936 to operate the switch contact 3909. When the electromagnet 3936 is energized, the switch contact 3909 is closed, and when the electromagnet 3936 is de-energized, the switch contact 3909 is opened. When the switch contacts are closed, RF current flows through conductive tissue (not shown) located between electrodes 3906a, 3906 b. It should be appreciated that in one aspect, the active electrode 3906a is connected to the anode of the bipolar RF generator circuit 3902.
The visual indication circuit 3905 includes a step-up transformer 3904, a series resistor R2, and a visual indicator 3912. The visual indicator 3912 may be adapted for use with the surgical instrument 1108 and other electrosurgical systems and tools, such as those described herein. The first winding 3910a of the step-up transformer 3904 is connected in series with the return electrode 3906b, and the second winding 3910b of the step-up transformer 3904 is connected in series with the resistor R2, and the visual indicator 3912 comprises, for example, an NE-2 type neon bulb.
In operation, when the switch contact 3909 of the relay 3908 is opened, the active electrode 3906a is disconnected from the anode of the bipolar RF generator circuit 3902 and no current flows through the tissue, the return electrode 3906b, and the first winding 3910a of the step-up transformer 3904. Thus, the visual indicator 3912 is not energized and does not emit light. When the switch contacts 3909 of the relay 3908 are closed, the active electrode 3906a is connected to the anode of the bipolar RF generator circuit 3902, thereby enabling current to flow through the tissue, the return electrode 3906b, and the first winding 3910a of the step-up transformer 3904 to operate on the tissue, such as to cut and cauterize the tissue.
A first current flows through the first winding 3910a as a function of the impedance of the tissue located between the active electrode 3906a and the return electrode 3906b, thereby providing a first voltage across the first winding 3910a of the step-up transformer 3904. The boosted second voltage is induced on the second winding 3910b of the boost transformer 3904. A secondary voltage appears across resistor R2 and energizes visual indicator 3912 when the current through the tissue is greater than a predetermined threshold, causing the neon bulb to light up. It should be understood that the circuit and device values are exemplary and not limiting. When the switch contact 3909 of the relay 3908 is closed, current flows through the tissue and turns on the visual indicator 3912.
Turning now to the energy switch 3926 portion of the control circuit 3900, when the energy switch 3926 is in the open position, a logic high is applied to the input of the first inverter 3928 and a logic low is applied to one of the two inputs of the and gate 3932. Therefore, the output of the and gate 3932 is low and the transistor 3934 is turned off to prevent current from flowing through the windings of the electromagnet 3936. When the electromagnet 3936 is in the de-energized state, the switch contacts 3909 of the relay 3908 remain open and prevent current from flowing through the electrodes 3906a, 3906 b. The logic low output of the first inverter 3928 is also applied to the second inverter 3930, causing the output to go high and resetting the flip-flop 3918 (e.g., a D-type flip-flop). At this time, the Q output goes low to turn off the ultrasonic generator circuit 3920 circuit and
the output goes high and is applied to the other input of and gate 3932.
When the user presses the energy switch 3926 on the instrument handle to apply energy to the tissue between the electrodes 3906a, 3906b, the energy switch 3926 is closed and applies a logic low at the input of the first inverter 3928, which first inverter 3928 applies a logic high to the other input of the and gate 3932, causing the output of the and gate 3932 to go high and turn on the transistor 3934. In the on state, the transistor 3934 conducts and sinks current through the windings of the electromagnet 3936 to energize the electromagnet 3936 and close the switch contact 3909 of the relay 3908. As described above, when the switch contact 3909 is closed, current can flow through the electrodes 3906a, 3906b and the first winding 3910a of the step-up transformer 3904 when tissue is located between the electrodes 3906a, 3906 b.
As described above, the magnitude of the current flowing through electrodes 3906a, 3906b depends on the impedance of the tissue located between electrodes 3906a, 3906 b. Initially, the tissue impedance is low and the magnitude of the current through the tissue and the first winding 3910a is high. Therefore, the voltage applied across the second winding 3910b is high enough to turn on the visual indicator 3912. The light emitted by the visual indicator 3912 turns on the phototransistor 3914, which pulls the input of the inverter 3916 low and the output of the inverter 3916 high. The high input of CLK applied to flip-flop 3918 does not affect the Q OR of flip-flop 3918
Output, and Q output remains low, and
the output remains high. Thus, when the visual indicator 3912 remains energized, the ultrasonic generator circuit 3920 is turned off and the ultrasonic transducer 3922 and the ultrasonic blade 3924 of the multifunctional electrosurgical instrument are not activated.
When the tissue between electrodes 3906a, 3906b dries out, the impedance of the tissue increases and the current through the tissue decreases due to the heat generated by the current flowing through the tissue. As the current through the first winding 3910a decreases, the voltage across the second winding 3910b also decreases, and when the voltage drops below a minimum threshold required to operate the visual indicator 3912, the visual indicator 3912 and the phototransistor 3914 are turned off. When phototransistor 3914 is off, a logic high is applied to the input of inverter 3916 and a logic low is applied to the CLK input of flip-flop 3918 as a logic high to the Q output and to
Of the outputLogic low is clocked. The logic high at the Q output turns on the ultrasonic generator circuit 3920 to activate the ultrasonic transducer 3922 and ultrasonic blade 3924 to begin cutting tissue located between the electrodes 3906a, 3906 a. Which is simultaneously or near simultaneously turned on by the ultrasonic generator circuit 3920,
the output flip-flop 3918 goes low and causes the output of the and gate 3932 to go low and turn off the transistor 3934, thereby de-energizing the electromagnet 3936 and opening the switch contact 3909 of the relay 3908 to cut off the current flowing through the electrodes 3906a, 3906 b.
When the switch contact 3909 of the relay 3908 is open, there is no current flowing through the electrodes 3906a, 3906b, the tissue, and the first winding 3910a of the step-up transformer 3904. Therefore, no voltage is generated across the second winding 3910b and no current flows through the visual indicator 3912.
The Q output of the trigger 3918 and when the user squeezes the energy switch 3926 on the instrument handle to hold the energy switch 3926 closed
The output remains the same. Thus, when no current flows from the bipolar RF generator circuit 3902 through the electrodes 3906a, 3906b, the ultrasonic blade 3924 remains activated and continues to cut tissue between the jaws of the end effector. When the user releases the energy switch 3926 on the instrument handle, the energy switch 3926 opens and the output of the first inverter 3928 goes low and the output of the second inverter 3930 goes high to reset the trigger 3918, causing the Q output to go low and turn off the ultrasonic generator circuit 3920. At the same time as this is done,
the output goes high and the circuit is now in the open state and ready for actuation of the energy switch 3926 on the instrument handle by the user to close the energy switch 3926, apply current to the tissue between the electrodes 3906a, 3906b, and repeat the cycle of applying RF energy and ultrasonic energy to the tissue as described above.
Fig. 40 shows a diagram of a surgical system 4000, the surgical system 4000 representing one aspect of the surgical system 1000, including a feedback system for use with any of the surgical instruments of the surgical system 1000, which may include or implement many of the features described herein. The surgical system 4000 can include a generator 4002 coupled to a surgical instrument that includes an end effector 4006, the end effector 4006 can be activated when a clinician operates the trigger 4010. In various aspects, the end effector 4006 can comprise an ultrasonic blade to deliver ultrasonic vibrations to perform a surgical coagulation/cutting process on living tissue. In other aspects, the end effector 4006 can comprise an electrically conductive element coupled to an electrosurgical high frequency current source to perform a surgical coagulation or cauterization process on living tissue, and a mechanical blade having a sharp edge or an ultrasonic blade for performing a cutting process on living tissue. When the trigger 4010 is actuated, the force sensor 4012 can generate a signal indicative of an amount of force applied to the trigger 4010. In addition to or in lieu of the force sensor 4012, the surgical instrument can include a position sensor 4013, the position sensor 4013 can generate a signal indicative of the position of the trigger 4010 (e.g., the extent to which the trigger has been pressed or otherwise actuated). In one aspect, the position sensor 4013 can be a sensor positioned with an outer tubular sheath or a reciprocating tubular actuation member that is located within an outer tubular sheath of the surgical instrument. In one aspect, the sensor may be a hall effect sensor or any suitable transducer that changes its output voltage in response to a magnetic field. Hall effect sensors may be used for proximity switching, positioning, speed detection, and current sensing applications. In one aspect, the hall effect sensor operates as an analog transducer, returning voltage directly. Using the known magnetic field, its distance from the hall plate can be determined.
According to various aspects, the end effector 4006 can comprise a clamp or a clamping mechanism. When the trigger 4010 is initially actuated, the clamping mechanism can close, thereby clamping tissue between the clamp arms and the end effector 4006. As the force applied to the trigger increases (e.g., as sensed by force sensor 4012), control circuit 4008 can increase the power delivered by transducer 4004 to end effector 4006 and/or the generator level or ultrasonic blade amplitude generated in end effector 4006. In one aspect, the trigger position as sensed by position sensor 4013 or the clamp or clamp arm position as sensed by position sensor 4013 (e.g., with a hall effect sensor) can be used by control circuit 4008 to set the power and/or amplitude of end effector 4006. For example, as the trigger moves further toward the fully actuated position, or the clamp or clamp arm moves further toward the ultrasonic blade (or end effector 4006), the power and/or amplitude of the end effector 4006 may increase.
According to various aspects, the surgical instrument of the surgical system 4000 may further comprise one or more feedback devices for indicating the amount of power delivered to the end effector 4006. For example, the speaker 4014 can emit a signal indicative of the power of the end effector. According to various aspects, the speaker 4014 may emit a series of pulsed sounds, and the frequency of the sounds may be indicative of power. In addition to or in lieu of the speaker 4014, the surgical instrument can include a visual display 4016. The visual display 4016 may indicate end effector power according to any suitable method. For example, the visual display 4016 may comprise a series of LEDs, and the end effector power is indicated by the number of LEDs that are illuminated. The speaker 4014 and/or the visual display 4016 can be driven by the control circuit 4008. According to various aspects, a surgical instrument can include a ratchet device connected to the trigger 4010. The ratchet device may generate an audible sound as more force is applied to the trigger 4010, providing an indirect indication of end effector power. The surgical instrument may include other features that may enhance safety. For example, the control circuit 4008 can be configured to prevent power exceeding a predetermined threshold from being delivered to the end effector 4006. Further, the control circuit 4008 may implement a delay between the time that the change in end effector power is indicated (e.g., by the speaker 4014 or the visual display 4016) and the time that the change in end effector power is delivered. This gives the clinician sufficient warning: the level of ultrasonic power to be transmitted to the end effector 4006 will change.
In one aspect, the ultrasonic or high frequency current generator of the surgical system 1000 may be configured to digitally generate an electrical signal waveform such that it is desirable to digitize the waveform using a predetermined number of phase points stored in a look-up table. The phase points may be stored in tables defined in memory, a Field Programmable Gate Array (FPGA), or any suitable non-volatile memory. Fig. 41 illustrates one aspect of the basic architecture of a digital synthesis circuit, such as a Direct Digital Synthesis (DDS) circuit 4100, the DDS circuit 4100 configured to be capable of generating multiple wave shapes of electrical signal waveforms. The generator software and digital controls may command the FPGA to scan for addresses in a lookup table 4104, which lookup table 4104 in turn provides varying digital input values to the DAC circuit 4108 feeding the power amplifier. The addresses may be scanned according to the frequency of interest. Various types of waveforms can be generated using this lookup table 4104, which can be fed simultaneously into tissue or transducers, RF electrodes, multiple transducers, multiple RF electrodes, or a combination of RF and ultrasonic instruments. Further, multiple lookup tables 4104 representing multiple wave shapes can be created, stored, and applied to the tissue from the generator.
The waveform signal may be configured to be capable of controlling at least one of an output current, an output voltage, or an output power of the ultrasound transducer and/or the RF electrode or multiples thereof (e.g., two or more ultrasound transducers and/or two or more RF electrodes). Additionally, where the surgical instrument includes an ultrasound device, the waveform signal may be configured to drive at least two vibration modes of an ultrasound transducer of the at least one surgical instrument. Accordingly, the generator may be configured to provide a waveform signal to the at least one surgical instrument, wherein the waveform signal corresponds to at least one wave shape of the plurality of wave shapes in the table. In addition, the waveform signals provided to the two surgical instruments may include two or more wave shapes. The table may include information associated with a plurality of waveform shapes, and the table may be stored within the generator. In one aspect or example, the table may be a direct digital synthesis table that may be stored in the FPGA of the generator. The table may be addressed in any manner that facilitates classification of waveform shapes. According to one aspect, the table (which may be a direct digital synthesis table) is addressed according to the frequency of the waveform signal. Additionally, information associated with the plurality of waveform shapes may be stored as digital information in a table.
The analog electrical signal waveform can be configured to be capable of controlling at least one of an output current, an output voltage, or an output power of the ultrasound transducer and/or the RF electrode or multiples thereof (e.g., two or more ultrasound transducers and/or two or more RF electrodes). Additionally, where the surgical instrument includes an ultrasound device, the analog electrical signal waveform may be configured to drive at least two vibration modes of an ultrasound transducer of the at least one surgical instrument. Accordingly, the generator circuit may be configured to provide an analog electrical signal waveform to the at least one surgical instrument, wherein the analog electrical signal waveform corresponds to at least one wave shape of the plurality of wave shapes stored in the lookup table 4104. In addition, the analog electrical signal waveforms provided to the two surgical instruments may include two or more wave shapes. The lookup table 4104 may include information associated with a plurality of waveform shapes, and the lookup table 4104 may be stored within the generator circuit or the surgical instrument. In one aspect or example, the lookup table 4104 can be a direct digital synthesis table that can be stored in the generator circuit or FPGA of the surgical instrument. The lookup table 4104 may be addressed in any manner that facilitates classification of waveform shapes. According to one aspect, the lookup table 4104 (which may be a direct digital synthesis table) is addressed according to the frequency of the desired analog electrical signal waveform. In addition, information associated with the plurality of waveform shapes may be stored as digital information in the lookup table 4104.
As digital technology is widely used in instruments and communication systems, digital control methods for generating multiple frequencies from a reference frequency source have evolved and are referred to as direct digital synthesis. The infrastructure is shown in fig. 41. In this simplified block diagram, the DDS circuit is coupled to a processor, controller, or logic device of the generator circuit and to a memory circuit located in the generator circuit of the surgical system 1000. The DDS circuit 4100 includes an address counter 4102, a lookup table 4104, a register 4106, a DAC circuit 4108, and a filter 4112. Stable clock fcIs received by an address counter 4102, and register 4106 drives a Programmable Read Only Memory (PROM) that stores one or more integer cycles of a sine wave (or other arbitrary waveform) in a lookup table 4104. As the address counter 4102 steps through memory locations, the values stored in the lookup table 4104 are written to a register 4106, which register 4106 is coupled to a DAC circuit 4108. The corresponding digital amplitude of the signal at the memory location of the lookup table 4104 drives the DAC circuit 4108, which DAC circuit 4108 in turn generates an analog output signal 4110. The spectral purity of the analog output signal 4110 is primarily determined by the DAC circuit 4108. The phase noise being substantially the reference clock fcPhase noise of (2). The first analog output signal 4110 output from the DAC circuit 4108 is filtered by a filter 4112, and the second analog output signal 4114 output by the filter 4112 is provided to an amplifier having an output coupled to the output of the generator circuit. The second analog output signal having a frequency fOutput of。
Because the DDS circuit 4100 is a sampled data system, the problems involved in sampling must be considered: quantization noise, aliasing, filtering, etc. For example, higher order harmonics of the DAC circuit 4108 output frequency are folded back into the Nyquist bandwidth so that they are not filterable, while higher order harmonics of the output of a Phase Locked Loop (PLL) based synthesizer may be filtered. Lookup table 4104 contains an integer number of cyclesThe signal data of (1). By varying the frequency f of the reference clockcOr by reprogramming the PROM to change the final output frequency fOutput of。
The DDS circuit 4100 may include a plurality of lookup tables 4104, wherein the lookup tables 4104 store waveforms represented by a predetermined number of samples, wherein the samples define a predetermined shape of the waveform. Accordingly, multiple waveforms having unique shapes may be stored in multiple lookup tables 4104 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4100 may create multiple waveform-shaped look-up tables 4104 and switch between different wave shapes stored in the individual look-up tables 4104 based on desired tissue effects and/or tissue feedback during the tissue treatment process (e.g., based on "on-the-fly" or virtual real-time of user or sensor input).
Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4104 can store electrical signal waveforms shaped to maximize the power delivered into the tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the lookup table 4104 can store waveforms synchronized in a manner that maximizes power delivery for the multifunctional surgical instrument of the surgical system 1000 when delivering RF and ultrasonic drive signals. In other aspects, the lookup table 4104 can store electrical signal waveforms to drive ultrasound energy and RF therapy energy, and/or sub-therapy energy, simultaneously while maintaining ultrasound frequency lock. The customized waveforms and their tissue effects specific to the different instruments may be stored in non-volatile memory of the generator circuit or in non-volatile memory (e.g., EEPROM) of the surgical system 1000 and extracted when the multifunctional surgical instrument is connected to the generator circuit. An example of an exponentially decaying sinusoid as used in many high crest factor "coag" waveforms is shown in FIG. 43.
More flexible and efficient implementation of DDS circuit 4100Digital circuits known as Numerically Controlled Oscillators (NCO) are employed. A block diagram of a more flexible and efficient digital synthesis circuit, such as DDS circuit 4200, is shown in fig. 42. In this simplified block diagram, the DDS circuit 4200 is coupled to a processor, controller, or logic device of the generator and connected to a memory circuit located in the generator or in any of the surgical instruments of the surgical system 1000. The DDS circuit 4200 includes a load register 4202, a parallel delta phase register 4204, an adder circuit 4216, a phase register 4208, a look-up table 4210 (phase to amplitude converter), a DAC circuit 4212, and a filter 4214. The adder circuit 4216 and phase register 4208 form part of the phase accumulator 4206. Clock frequency fcIs applied to the phase register 4208 and the DAC circuit 4212. The load register 4202 receives the signal f designating the output frequency as the reference clock frequencycFractional tuning words of (a). The output of load register 4202 is provided to parallel delta phase register 4204 as a tuning word M.
The truncated output 4218 of the phase accumulator 4206 is provided to a phase-to-amplitude converter look-up table 4210, and the output of the look-up table 4210 is coupled to a DAC circuit 4212. The truncated output 4218 of the phase accumulator 4206 serves as the address for the sine (or cosine) look-up table. The addresses in the look-up table correspond to phase points on the sine wave from 0 deg. to 360 deg.. The look-up table 4210 contains the corresponding digital amplitude information for one complete cycle of the sine wave. Thus, the lookup table 4210 maps the phase information from the phase accumulator 4206 to a digital amplitude word, which in turn drives the DAC circuit 4212. The output of the DAC circuit is a first analog signal 4220 and is filtered by a filter 4214. The output of the filter 4214 is a second analog signal 4222, which is provided to a power amplifier coupled to the output of the generator circuit.
In one aspect, the electrical signal waveform may be digitized as 1024(210) phase points, but the wave shape may be digitized as any suitable number of 2n phase points in the range 256(28) to 281,474,976,710,656(248), where n is a positive integer, as shown in table 1. The electrical signal waveform can be represented as An(θn) Where the normalized amplitude A at point n is defined by the phase angle θ referred to as the phase point at point nnAnd (4) showing. The number of discrete phase points, n, determines the tuning resolution of the DDS circuit 4200 (and the DDS circuit 4100 shown in fig. 41).
Table 1 specifies the waveform of an electrical signal digitized into a plurality of phase points。
| Whether or not | Number of |
| 8 | 256 |
| 10 | 1,024 |
| 12 | 4,096 |
| 14 | 16,384 |
| 16 | 65,536 |
| 18 | 262,144 |
| 20 | 1,048,576 |
| 22 | 4,194,304 |
| 24 | 16,777,216 |
| 26 | 67,108,864 |
| 28 | 268,435,456 |
| ... | ... |
| 32 | 4,294,967,296 |
| ... | ... |
| 48 | 281,474,976,710,656 |
| ... | ... |
TABLE 1
The generator circuit algorithm and digital control circuit scan for addresses in a look-up table 4210, which look-up table 4210 in turn provides varying digital input values to a DAC circuit 4212 feeding a filter 4214 and a power amplifier. The addresses may be scanned according to the frequency of interest. Using a look-up table, various types of shapes can be generated that can be converted to analog output signals by the DAC circuit 4212, filtered by a filter 4214, amplified by a power amplifier coupled to the output of the generator circuit, or fed to tissue in the form of RF energy, or fed to tissue in the form of ultrasonic vibrations that deliver energy to tissue in the form of heat. The output of the amplifier may be applied to, for example, an RF electrode, to multiple RF electrodes simultaneously, to an ultrasound transducer, to multiple ultrasound transducers simultaneously, or to a combination of RF and ultrasound transducers. In addition, multiple waveform tables may be created, stored, and applied to tissue from the generator circuit.
Referring back to fig. 41, for n-32 and M-1, the phase accumulator 4206 steps through 232 possible outputs before it overflows and restarts. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M is 2, the phase register 1708 "rolls over" twice as fast and the output frequency is doubled. This can be summarized as follows.
For a phase configured to be able to accumulate n bits, the accumulator 4206 (n is typically in the range of 24 to 32 in most DDS systems, but as previously mentioned n can be selected from a wide range of options), there is 2nA possible phase point. The digital word M in the increment phase register represents the amount by which the phase accumulator increments per clock cycle. If f iscAt the clock frequency, the frequency of the output sinusoid is equal to:
the above formula is referred to as the DDS "tuning formula". Note that the frequency resolution of the system is equal to
For n-32, theThe resolution is greater than forty parts per billion. In one aspect of the DDS circuit 4200, not all bits from the phase accumulator 4206 are passed to the lookup table 4210, but are truncated leaving only the first 13 to 15 Most Significant Bits (MSBs), for example. This reduces the size of the look-up table 4210 and does not affect the frequency resolution. Phase truncation adds only a small but acceptable amount of phase noise to the final output.
The electrical signal waveform may be characterized by current, voltage, or power at a predetermined frequency. Additionally, where any of the surgical instruments of the surgical system 1000 includes an ultrasound device, the electrical signal waveform may be configured to drive at least two vibration modes of the ultrasound transducer of at least one of the surgical instruments. Accordingly, the generator circuit may be configured to provide an electrical signal waveform to at least one surgical instrument, wherein the electrical signal waveform is characterized by a predetermined waveform shape stored in the look-up table 4210 (or look-up table 4104 of fig. 41). Further, the electrical signal waveform may be a combination of two or more wave shapes. The lookup table 4210 may include information associated with a plurality of waveform shapes. In one aspect or example, the look-up table 4210 may be generated by the DDS circuit 4200 and may be referred to as a direct digital synthesis table. The DDS works by first storing a large number of repeating waveforms in on-board memory. The cycles of the waveform (sine, triangle, square, arbitrary) may be represented by a predetermined number of phase points as shown in table 1 and stored into memory. Once the waveform is stored in memory, it can be generated at a very precise frequency. The direct digital synthesis table may be stored in a non-volatile memory of the generator circuit and/or may be implemented with FPGA circuitry in the generator circuit. The lookup table 4210 may be addressed by any suitable technique that facilitates classification of waveform shapes. According to one aspect, the look-up table 4210 is addressed according to the frequency of the electrical signal waveform. Additionally, information associated with the plurality of waveform shapes may be stored in memory as digital information or as part of the lookup table 4210.
In one aspect, the generator circuit can be configured to provide electrical signal waveforms to at least two surgical instruments simultaneously. The generator circuit may also be configured to simultaneously provide an electrical signal waveform to two surgical instruments via an output channel of the generator circuit, the electrical signal waveform being characterizable by two or more waveforms. For example, in one aspect, the electrical signal waveform includes a first electrical signal (e.g., an ultrasonic drive signal) for driving the ultrasonic transducer, a second RF drive signal, and/or combinations thereof. Further, the electrical signal waveforms may include a plurality of ultrasonic drive signals, a plurality of RF drive signals, and/or a combination of a plurality of ultrasonic and RF drive signals.
Further, a method of operating a generator circuit according to the present disclosure includes generating an electrical signal waveform and providing the generated electrical signal waveform to any of the surgical instruments of the surgical system 1000, wherein generating the electrical signal waveform includes receiving information associated with the electrical signal waveform from a memory. The generated electrical signal waveform includes at least one wave shape. Further, providing the generated electrical signal waveform to at least one surgical instrument includes providing the electrical signal waveform to at least two surgical instruments simultaneously.
A generator circuit as described herein may allow for the generation of various types of direct digital synthesis tables. Examples of wave shapes of RF/electrosurgical signals generated by the generator circuit suitable for treating a variety of tissues include RF signals with high crest factors (which can be used for surface coagulation in RF mode), low crest factor RF signals (which can be used for deeper tissue penetration), and waveforms that promote effective touch coagulation. The generator circuit may also employ a direct digital synthesis look-up table 4210 to generate a plurality of wave shapes, and may rapidly switch between particular wave shapes based on desired tissue effects. Switching may be based on tissue impedance and/or other factors.
In addition to the traditional sine/cosine wave shape, the generator circuit may also be configured to be capable of producing wave shape(s) (i.e., trapezoidal or square waves) that maximize the power into the tissue in each cycle. The generator circuit may provide wave shape(s) that are synchronized to maximize power delivered to the load and maintain ultrasonic lock when the RF and ultrasonic signals are driven simultaneously, provided that the generator circuit includes a circuit topology that is capable of driving the RF and ultrasonic signals simultaneously. Additionally, customized waveform shapes specific to the instrument and its tissue effects may be stored in non-volatile memory (NVM) or instrument EEPROM and may be extracted when any of the surgical instruments of surgical system 1000 are connected to the generator circuit.
The DDS circuit 4200 may include a plurality of lookup tables 4104, where the lookup tables 4210 store waveforms represented by a predetermined number of phase points (which may also be referred to as samples), where the phase points define a predetermined shape of the waveform. Accordingly, multiple waveforms having unique shapes may be stored in multiple look-up tables 4210 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include high crest factor RF electrical signal waveforms for surface tissue coagulation, low crest factor RF electrical signal waveforms for deeper tissue penetration, and electrical signal waveforms that promote effective touch coagulation. In one aspect, the DDS circuit 4200 may create multiple waveform-shaped look-up tables 4210 and switch between different wave shapes stored in different look-up tables 4210 based on desired tissue effects and/or tissue feedback during a tissue treatment process (e.g., "on-the-fly" or virtual real-time based on user or sensor input).
Thus, switching between waveforms may be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 4210 may store electrical signal waveforms shaped to maximize the power delivered into the tissue per cycle (i.e., trapezoidal or square wave). In other aspects, the look-up table 4210 may store waveform shapes that are synchronized in such a way that they maximize power delivery by either of the surgical instruments of the surgical system 1000 when delivering RF and ultrasonic drive signals. In other aspects, the lookup table 4210 may store electrical signal waveforms to drive the ultrasound energy and the RF therapy energy, and/or sub-therapy energy simultaneously, while maintaining ultrasound lock. Generally, the output wave shape may be in the form of a sine wave, cosine wave, pulse wave, square wave, or the like. However, more complex and customized waveforms specific to different instruments and their tissue effects may be stored in non-volatile memory of the generator circuit or non-volatile memory (e.g., EEPROM) of the surgical instrument and extracted upon connecting the surgical instrument to the generator circuit. One example of a custom wave shape is an exponentially decaying sinusoid as used in many high crest factor "coag" waveforms, as shown in fig. 43.
Fig. 43 illustrates one cycle of a discrete-time digital electrical signal waveform 4300 (shown superimposed on the discrete-time digital electrical signal waveform 4300 for comparison) of an analog waveform 4304, in accordance with at least one aspect of the present disclosure. The horizontal axis represents time (t), while the vertical axis represents digital phase points. The digital electrical signal waveform 4300 is a digital discrete-time version of, for example, a desired analog waveform 4304. A digital electrical signal waveform 4300 is generated by storing an amplitude phase point 4302, the amplitude phase point 4302 representing one cycle or period ToPer clock cycle TclkThe amplitude of (d). Digital electrical signal waveform 4300 is passed through any suitable digital processing circuitry for one period ToThe above is generated. The amplitude phase points are digital words stored in a memory circuit. In the examples shown in fig. 41, 42, the digital word is a six-bit word capable of storing amplitude phase points at a resolution of 26 bits or 64 bits. It should be understood that the examples shown in fig. 41, 42 are for exemplary purposes, and in actual implementations, the resolution may be higher. In a cycle ToThe digital amplitude phase points 4302 are stored in memory as a string in the lookup tables 4104, 4210, as described in connection with fig. 41, 42, for example. To generate an analog version of analog waveform 4304, clock cycle T from memoryclkFrom 0 to ToThe amplitude phase points 4302 are read in turn and converted by DAC circuits 4108, 4212, also described in connection with fig. 41, 42. The amplitude phase point 4302 of the digital electrical signal waveform 4300 may be adjusted from 0 to ToReading as many cycles or periods as possible is repeated to generate additional cycles. A smoothed analog version of the analog waveform 4304 is achieved by filtering the outputs of the DAC circuits 4108, 4212 with filters 4112, 4214 (fig. 41 and 42). The filtered analog output signals 4114, 4222 (fig. 41 and 42) are applied to the input of the power amplifier.
FIG. 44 is a schematic illustration of a control system 12950, the control system 12950 configured to enableProviding gradual closure of the closure member (e.g., closure tube) as the displacement member is advanced distally and coupled to the clamp arm (e.g., anvil) to reduce the closure force load on the closure member and reduce the firing force load on the firing member at a desired rate. In one aspect, the control system 12950 can be implemented as a nested PID feedback controller. A PID controller is a control loop feedback mechanism (controller) that is used to continuously calculate an error value as the difference between a desired set point and a measured process variable and apply corrections based on proportional, integral, and derivative terms (sometimes denoted P, I and D, respectively). The nested PID controller feedback control system 12950 includes a primary controller 12952 in a primary (outer) feedback loop 12954 and a secondary controller 12955 in a secondary (inner) feedback loop 12956. The primary controller 12952 can be a PID controller 12972 as shown in fig. 45 and the secondary controller 12955 can also be a PID controller 12972 as shown in fig. 45. The main controller 12952 controls the main process 12958 and the secondary controller 12955 controls the secondary process 12960. The output 12966 of the master process 12958 is the slave master set point SP1The first summer 12962 is subtracted. First summer 12962 generates a single sum output signal that is applied to main controller 12952. The output of the main controller 12952 is the secondary setpoint SP2. The output 12968 of the secondary process 12960 is a slave secondary set point SP2The second summer 12964 is subtracted.
In the case of controlling the displacement of the closure tube, the control system 12950 may be configured to enable a main set point SP1Is a desired closing force value, and the main controller 12952 is configured to receive the closing force from a torque sensor coupled to the output of the closing motor and determine a set point SP for the closing motor2The motor speed. In other aspects, the closing force may be measured with a strain gauge, load cell, or other suitable force sensor. Will close the motor speed set point SP2Compared to the actual speed of the closure tube, as determined by the secondary controller 12955. The actual velocity of the closure tube may be measured by comparing the measured closure tube displacement with a position sensor and measuring the elapsed time with a timer/counter. Other techniques such as linear encoder or rotary encoding may be employedThe apparatus measures the displacement of the closure tube. The output 12968 of the secondary process 12960 is the actual speed of the closed tube. The closure tube velocity output 12968 is provided to a preliminary process 12958, which preliminary process 12958 determines the force acting on the closure tube and feeds back to an adder 12962, which adder 12962 derives from a main set point SP1The measured closing force is subtracted. Main set point SP1May be an upper threshold or a lower threshold. Based on the output of adder 12962, main controller 12952 controls the speed and direction of the closing motor. The secondary controller 12955 bases the actual speed of the closed tube as measured by the secondary process 12960 and the secondary set point SP2To control the speed of the closure motor based on a comparison of the actual firing force to upper and lower firing force thresholds.
Fig. 45 illustrates a PID feedback control system 12970 in accordance with an aspect of the present disclosure. Either the primary controller 12952 or the secondary controller 12955, or both, can be implemented as a PID controller 12972. In one aspect, the PID controller 12972 may include a proportional element 12974(P), an integral element 12976(I), and a derivative element 12978 (D). The outputs of the P element 12974, I element 12976, and D element 12978 are summed by a summer 12986, which summer 12986 provides a control variable μ (t) to the process 12980. The output of process 12980 is a process variable y (t). Summer 12984 calculates the difference between the desired set point r (t) and the measured process variable y (t). The PID controller 12972 continuously calculates an error value e (t) (e.g., the difference between the closing force threshold and the measured closing force) as the difference between the desired set point r (t) (e.g., the closing force threshold) and the measured process variable y (t) (e.g., the speed and direction of the closed tube), and applies corrections based on the proportional, integral, and derivative terms calculated by the proportional element 12974(P), the integral element 12976(I), and the derivative element 12978(D), respectively. The PID controller 12972 attempts to minimize the error e (t) over time by adjusting the control variable μ (t) (e.g., the speed and direction of the closed tube).
The "P" element 12974 calculates the current value of the error according to a PID algorithm. For example, if the error is large and positive, then the control output will also be large and positive. According to the present disclosure, the error term e (t) is different between the desired closing force and the measured closing force of the closure tube. The "I" element 12976 calculates a past value of the error. For example, if the current output is not strong enough, the integral of the error will accumulate over time and the controller will respond by applying a stronger action. The "D" element 12978 calculates the future probable trend for this error based on its current rate of change. For example, continuing the above P example, when a large positive control output successfully brings the error closer to zero, it also places the process in the path of the most recent future large negative error. In this case, the derivative becomes negative and the D module reduces the strength of the action to prevent this overshoot.
It should be understood that other variables and set points may be monitored and controlled according to the feedback control systems 12950, 12970. For example, the adaptive closing member speed control algorithm described herein may measure at least two of the following parameters: firing member travel position, firing member load, cutting element displacement, cutting element velocity, closure tube travel position, closure tube load, and the like.
Aspects relate to improved ultrasonic surgical devices, electrosurgical devices, and generators for use therewith. Aspects of an ultrasonic surgical device may be configured to transect and/or coagulate tissue, for example, during a surgical procedure. Aspects of the electrosurgical device may be configured to transect, coagulate, target, weld, and/or desiccate tissue, for example, during a surgical procedure.
Aspects of the generator utilize high-speed analog-to-digital sampling (e.g., approximately 200 oversampling, depending on frequency) of the generator drive signal current and voltage, as well as digital signal processing, to provide a number of advantages and benefits over known generator architectures. In one aspect, for example, the generator may determine a dynamic branch current of the ultrasonic transducer based on current and voltage feedback data, a value of a static capacitance of the ultrasonic transducer, and a value of a drive signal frequency. This provides the benefits of a substantially tuned system and simulates the presence of a system tuned or resonating at any frequency and any value of static capacitance (e.g., C0 in fig. 4). Thus, control of the dynamic branch current may be achieved by tuning the effect of the static capacitance without the need to tune the inductor. Additionally, eliminating the tuning inductor may not degrade the frequency locking capability of the generator, as frequency locking may be achieved by properly processing current and voltage feedback data.
High-speed analog-to-digital sampling of the generator drive signal current and voltage, and digital signal processing may also enable accurate digital filtering of the samples. For example, aspects of the generator may utilize a low-pass digital filter (e.g., a Finite Impulse Response (FIR) filter) that attenuates between the fundamental drive signal frequency and the second order harmonics to reduce asymmetric harmonic distortion and EMI induced noise in the current and voltage feedback samples. The filtered current and voltage feedback samples are substantially representative of the fundamental drive signal frequency, thus enabling more accurate impedance phase measurements relative to the fundamental drive signal frequency and improving the generator's ability to maintain resonant frequency lock. The accuracy of the impedance phase measurement can be further enhanced by averaging the falling edge measurement and the rising edge phase measurement, and by adjusting the measured impedance phase to 0 °.
Aspects of the generator may also utilize high-speed analog-to-digital sampling of the generator drive signal current and voltage, as well as digital signal processing, to determine the actual power consumption and other quantities with high accuracy. This may allow the generator to implement a variety of available algorithms, such as, for example, controlling the amount of power delivered to the tissue as the impedance of the tissue changes and controlling the power delivery to maintain a constant rate of increase of the tissue impedance. Some of these algorithms are used to determine the phase difference between the generator drive signal current and voltage signals. At resonance, the phase difference between the current and voltage signals is zero. When the ultrasound system comes out of resonance, the phase changes. Various algorithms may be employed to detect the phase difference and adjust the drive frequency until the ultrasound system returns to resonance, i.e., the phase difference between the current and voltage signals is zero. The phase information may also be used to infer the condition of the ultrasonic blade. As discussed in detail below, the phase changes as a function of the temperature of the ultrasonic blade. Thus, the phase information may be employed to control the temperature of the ultrasonic blade. This may be accomplished, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade is running too hot, and increasing the power delivered to the ultrasonic blade when the ultrasonic blade is running too cold.
Various aspects of the generator may have a wide frequency range and increased output power necessary to drive both the ultrasonic and electrosurgical devices. The lower voltage, higher current requirements of electrosurgical devices can be met by dedicated taps on broadband power transformers, eliminating the need for separate power amplifiers and output transformers. In addition, the sensing and feedback circuitry of the generator can support a large dynamic range that meets the needs of both ultrasonic and electrosurgical applications with minimal distortion.
The various aspects may provide a simple, economical means for the generator to read and optionally write to a data circuit (e.g., a single Wire bus device, such as a single Wire protocol EEPROM known under the trade name "1-Wire") disposed in an instrument attached to the handpiece using existing multi-conductor generator/handpiece cables. In this way, the generator is able to retrieve and process instrument specific data from the instrument attached to the handpiece. This may enable the generator to provide better control and improved diagnostics and error detection. In addition, the ability of the generator to write data to the instrument provides potentially new functionality in, for example, tracking instrument usage and capturing operational data. Furthermore, the use of frequency bands allows the appliance containing the bus device to be backward compatible with existing generators.
The disclosed aspects of the generator provide for active cancellation of leakage currents caused by unintended capacitive coupling between the generator's non-isolated circuitry and the patient isolated circuitry. In addition to reducing patient risk, the reduction in leakage current may also reduce electromagnetic radiation. These and other benefits of the various aspects of the present disclosure will be apparent from the detailed description below.
It should be understood that the terms "proximal" and "distal" are used herein with respect to a clinician gripping a handpiece assembly. Thus, the end effector is distal relative to the more proximal handpiece. It should also be understood that spatial terms such as "top" and "bottom" are also used herein with respect to the clinician gripping the handpiece assembly for convenience and clarity. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
Fig. 46 is an exploded elevational view of a modular hand-held ultrasonic surgical instrument 6480 showing the left housing half removed from the handle assembly 6482, exposing a device identifier communicatively coupled to a multi-lead handle terminal assembly according to one aspect of the present disclosure. In additional aspects of the present disclosure, the modular handheld ultrasonic surgical instrument 6480 is powered using smart or smart batteries. However, the smart battery is not limited to the modular handheld ultrasonic surgical instrument 6480 and, as will be explained, may be used in a variety of devices that may or may not have different power requirements (e.g., current and voltage) from one another. According to one aspect of the present disclosure, the smart battery assembly 6486 is advantageously capable of identifying the particular device to which it is electrically coupled. It performs this operation by means of an encrypted or unencrypted identification method. For example, smart battery assembly 6486 may have a connection portion, such as connection portion 6488. The handle assembly 6482 may also be provided with a device identifier communicatively coupled to the multi-lead handle terminal assembly 6491 and operable to communicate at least one piece of information about the handle assembly 6482. This information may relate to the number of times the handle assembly 6482 has been used, the number of times the ultrasonic transducer/generator assembly 6484 (currently disconnected from the handle assembly 6482) has been used, the number of times the waveguide shaft assembly 6490 (currently connected to the handle assembly 6482) has been used, the type of waveguide shaft assembly 6490 currently connected to the handle assembly 6482, the type or identity of the ultrasonic transducer/generator assembly 6484 currently connected to the handle assembly 6482, and/or many other characteristics. When the smart battery assembly 6486 is inserted into the handle assembly 6482, the connection portion 6488 within the smart battery assembly 6486 is in communicative contact with the device identifier of the handle assembly 6482. The handle assembly 6482, through hardware, software, or a combination thereof, is capable of transmitting information to the smart battery assembly 6486 (whether by self-activation or in response to a request from the smart battery assembly 6486). The communication identifier is received by the connection portion 6488 of the smart battery assembly 6486. In one aspect, once the smart battery assembly 6486 receives the information, the communications portion may be operated to control the output of the smart battery assembly 6486 to meet the specific power requirements of the device.
In one aspect, the communications portion includes a processor 6493 and a memory 6497, which may be separate devices or a single device. The processor 6493 in combination with the memory can provide intelligent power management for the modular handheld ultrasonic surgical instrument 6480. This aspect is particularly advantageous because the ultrasonic device (such as the modular handheld ultrasonic surgical instrument 6480) has power requirements (frequency, current, and voltage) that may be unique to the modular handheld ultrasonic surgical instrument 6480. Indeed, the modular handheld ultrasonic surgical instrument 6480 may have particular power requirements or limitations for one size or type of outer tube 6494, and may have a second, different power requirement for a second type of waveguide having a different size, shape, and/or configuration.
Thus, the smart battery assembly 6486 in accordance with at least one aspect of the present disclosure allows the battery assembly to be used between several surgical instruments. Because the smart battery assembly 6486 is able to identify to which device it is attached and to change its output accordingly, operators of various different surgical instruments that utilize the smart battery assembly 6486 no longer need to worry about the power source they are trying to install within the electronic device being used. This is particularly advantageous in operating environments where the battery assembly needs to be replaced or interchanged with another surgical instrument during complex surgical procedures.
In another aspect of the disclosure, the smart battery assembly 6486 stores a record of each use of a particular device in the memory 6497. The record may be useful for assessing the end of useful life or allowable life of the device. For example, once the device is used 20 times, such a battery in the smart battery assembly 6486 connected to the device will refuse to power it because the device is defined as a "no longer reliable" surgical instrument. Reliability is determined based on a number of factors. One factor may be wear, which may be estimated in a number of ways, including the number of times the device has been used or activated. After a certain number of uses, the components of the device may become worn and exceed the tolerances between the components. For example, the smart battery assembly 6486 may sense the number of button pushes received by the handle assembly 6482, and may determine when a maximum number of button pushes has been reached or exceeded. The smart battery assembly 6486 may also monitor the impedance of the button mechanism, which may change, for example, when the handle is contaminated with, for example, saline.
Such wear can lead to unacceptable failure during the procedure. In some aspects, the smart battery assembly 6486 may identify which components are grouped together in a device, and even how many uses the component has undergone. For example, if the smart battery assembly 6486 is a smart battery according to the present disclosure, it may well identify the handle assembly 6482, the waveguide shaft assembly 6490, and the ultrasonic transducer/generator assembly 6484 before the user attempts to use the composite device. A memory 6497 within the smart battery assembly 6486 may, for example, record the time the ultrasound transducer/generator assembly 6484 was operated and the manner in which it operated, when it was operated, and the duration of the operation. If the ultrasound transducer/generator assembly 6484 has a separate identifier, the smart battery assembly 6486 may track the usage of the ultrasound transducer/generator assembly 6484 and deny power to the ultrasound transducer/generator assembly 6484 once either the handle assembly 6482 or the ultrasound transducer/generator assembly 6484 exceeds their maximum number of uses. The ultrasonic transducer/generator assembly 6484, handle assembly 6482, waveguide shaft assembly 6490, or other device may also include a memory chip to record this information. In this way, any number of smart batteries in the smart battery assembly 6486 may be used with any number of ultrasound transducer/generator assemblies 6484, staplers, vascular sealers, etc., and still be able to determine the total number of uses or total time of use, or total actuation time, etc., or charge or discharge cycles of the ultrasound transducer/generator assemblies 6484, staplers, vascular sealers, etc. The intelligent functionality may reside external to the battery assembly 6486, and may reside, for example, in the handle assembly 6482, the ultrasonic transducer/generator assembly 6484, and/or the shaft assembly 6490.
When counting the use of the ultrasonic transducer/generator assembly 6484 to intelligently terminate the life of the ultrasonic transducer/generator assembly 6484, the surgical instrument accurately distinguishes between completion of actual use of the ultrasonic transducer/generator assembly 6484 in a surgical procedure and momentary loss of actuation of the ultrasonic transducer/generator assembly 6484 due to, for example, a battery replacement or temporary delay in the surgical procedure. Thus, as an alternative to simply counting the number of activations of the ultrasound transducer/generator assembly 6484, a real-time clock (RTC) circuit may be implemented to track the amount of time that the ultrasound transducer/generator assembly 6484 is actually turned off. From the measured length of time, if the shut down is significant enough to be considered the end of an actual use, or the shut down time is too short to be considered the end of a use, then it can be determined by appropriate logic. Thus, in some applications, the method may determine the useful life of the ultrasound transducer/generator assembly 6484 more accurately than a simple "activation-based" algorithm, which may provide, for example, that ten "activations" occurred in a surgical procedure, and thus the ten activations should indicate that the counter is incremented by one. Generally, the internal clock of this type and system will prevent misuse of devices designed to fool simple "activation-based" algorithms, and will prevent incorrect logging of full use in the event that simple decommissioning of the ultrasound transducer/generator assembly 6484 or smart battery assembly 6486 is required for only legitimate reasons.
While the ultrasonic transducer/generator assembly 6484 of the surgical instrument 6480 is reusable, in one aspect, a limited number of uses may be set because the surgical instrument 6480 is subjected to harsh conditions during cleaning and sterilization. More specifically, the battery pack is configured to be sterilized. Regardless of the material used for the outer surface, the actual material used has a limited life expectancy. The life is determined by various characteristics that may include, for example, the number of times the battery pack has actually been sterilized, the time the battery pack was manufactured, and the number of times the battery pack has been recharged. In addition, the life of the battery cell itself is limited. The software of the present disclosure employs the algorithms of the present disclosure that verify the number of uses of the ultrasonic transducer/generator assembly 6484 and the smart battery assembly 6486 and disable the device when the number of uses is reached or exceeded. The analysis can be performed outside the battery with each of the possible sterilization methods. Based on the most rigorous sterilization process, a maximum number of allowed sterilizations may be defined, and this number may be stored in memory of the smart battery assembly 6486. If the charger is assumed to be non-sterile and the smart battery assembly 6486 is used after charging, then the charge count may be defined to be equal to the number of sterilizations encountered for that particular battery pack.
In one aspect, hardware in the battery pack may be disabled to minimize or eliminate safety issues due to continuous draining from the battery cells after the software disables the battery pack. Under certain low voltage conditions, there may be situations where the battery internal hardware cannot disable the battery. In this case, in one aspect, the charger may be used to "kill" the battery. Due to the fact that the battery microcontroller is in a shutdown state in its charger, non-sterile, System Management Bus (SMB) based Electrically Erasable Programmable Read Only Memory (EEPROM) may be used to exchange information between the battery microcontroller and the charger. Thus, the serial EEPROM can be used to store information that can be written and read even when the battery microcontroller is turned off, which is beneficial when attempting to exchange information with a charger or other peripheral device. The example EEPROM can be configured to contain sufficient memory registers to store at least (a) a usage count limit (battery usage count) when the battery should be disabled, (b) a number of procedures the battery has undergone (battery procedure count), and/or (c) a number of charges the battery has undergone (charge count), among other things. Some of the information stored in the EEPROM (such as the usage count register and the charge count register) is stored in a write-protected portion of the EEPROM to prevent a user from altering the information. In one aspect, the secondary detector storage usage and counters are inverted with corresponding bits to detect data corruption.
Any residual voltage in the SMBus pipeline may damage the microcontroller and damage the SMBus signal. Thus, to ensure that the SMBus line of the battery controller does not carry voltage when the microcontroller is shut down, a relay is provided between the external SMBus line and the battery microcontroller board.
During charging of smart battery assembly 6486, an "end-of-charge" condition of the battery within smart battery assembly 6486 is determined when, for example, when a constant current/constant voltage charging scheme is employed, the current flowing into the battery falls below a given threshold in a tapered manner. To accurately detect this "end of charge" condition, the battery microcontroller and buck board are powered down and shut down during battery charging to reduce any current drain that may be caused by the board and that may interfere with the taper current detection. In addition, the microcontroller and buck board are powered down during charging to prevent any damage to the SMBus signal.
With respect to the charger, in one aspect, the smart battery assembly 6486 is prevented from being inserted into the charger in any manner other than a properly inserted position. Thus, the exterior of the smart battery assembly 6486 is provided with a charger retention feature. The cup for holding the smart battery assembly 6486 securely in the charger is configured to be able to have a profile that matches the taper geometry to prevent accidental insertion of the smart battery assembly 6486 in any way other than the correct (intended) way. It is also contemplated that the presence of the smart battery assembly 6486 may be detected by the charger itself. For example, the charger may be configured to be able to detect the presence of an SMBus transformer from the battery protection circuit and a resistor located in the protection board. In such cases, the charger will be able to control the voltage exposed at the pins of the charger until the smart battery assembly 6486 is properly seated or in place on the charger. This is because the exposed voltage at the pins of the charger will present a risk and risk of an electrical short occurring across the possible pins and cause the charger to inadvertently start charging.
In some aspects, the smart battery assembly 6486 may communicate to the user through audio and/or visual feedback. For example, the smart battery assembly 6486 may cause the LED to light up in a predetermined manner. In this case, even if the microcontroller in the ultrasound transducer/generator assembly 6484 controls the LEDs, the microcontroller receives instructions to be executed directly from the smart battery assembly 6486.
In yet another aspect of the present disclosure, the microcontroller in the ultrasound transducer/generator assembly 6484 enters a sleep mode when not in use for a predetermined period of time. Advantageously, when in sleep mode, the clock speed of the microcontroller is reduced, thereby significantly curtailing current consumption. Some current continues to be consumed as the processor continues to ping wait to sense the input. Advantageously, the microcontroller and battery controller can directly control the LEDs when the microcontroller is in the power-saving sleep mode. For example, a decoder circuit may be built into the ultrasound transducer/generator assembly 6484 and connected to the communication pipeline such that when the ultrasound transducer/generator assembly 6484 microcontroller is "off" or in "sleep mode," the LEDs may be independently controlled by the processor 6493. This is a power saving feature that does not require waking up the microcontroller in the ultrasound transducer/generator assembly 6484. Power is conserved by allowing the generator to be turned off while still being able to effectively control the user interface indicator.
On the other hand, when not in use, one or more microcontrollers are slowed down to save power. For example, the clock frequency of both microcontrollers may be reduced to save power. To maintain synchronous operation, the microcontroller coordinates changes in its respective clock frequency to decrease at about the same time and subsequently increase in frequency when full speed operation is required. For example, when entering idle mode, the clock frequency is decreased, and when exiting idle mode, the frequency is increased.
In another aspect, the smart battery assembly 6486 is able to determine the amount of available power remaining in its unit and is programmed to operate only the surgical instrument attached thereto if it determines that there is sufficient battery power to predictably operate the device throughout the intended protocol. For example, if there is not enough power within the cell to operate the surgical instrument for 20 seconds, the smart battery assembly 6486 can remain in an inoperative state. According to one aspect, the smart battery assembly 6486 determines the amount of power remaining in the battery at the end of its most recent previous function (e.g., surgical incision). Thus, in this regard, if, for example, during this procedure, the smart battery assembly 6486 determines that the power of the cell is insufficient, it will not allow the subsequent function to be performed. Alternatively, if the smart battery assembly 6486 determines that there is sufficient power for a subsequent procedure during the procedure and is below the threshold, it will not interrupt the ongoing procedure, but will allow it to complete, and then prevent additional procedures from occurring.
The following explains the advantages of using the device with the smart battery assembly 6486 of the present disclosure to its fullest extent. In this example, a set of different devices have different ultrasonic transmission waveguides. By definition, the waveguide may have a corresponding maximum allowable power limit beyond which the waveguide is over-stressed and eventually broken. One waveguide from the set of waveguides will naturally have the smallest maximum power tolerance. Because of the lack of intelligent battery power management of prior art batteries, the output of prior art batteries must be limited by the value of the minimum maximum allowable power input of the smallest/thinnest/weakest waveguide in the setting envisioned and used with the device/battery. Even if a larger, thicker waveguide could later be attached to the shank and by definition allow for the application of a greater force. This limitation also exists for maximum battery power. For example, if a battery is designed for use in multiple devices, its maximum output power will be limited by the lowest maximum power level of any of the devices that are to use the battery. With this configuration, one or more devices or device configurations will not be able to utilize the battery to the maximum extent, as the battery is not aware of the specific limitations of a particular device.
In one aspect, the smart battery assembly 6486 may be used to intelligently bypass the ultrasound device limitations described above. The smart battery assembly 6486 may produce one output for one device or particular device configuration, and the same smart battery assembly 6486 may later produce a different output for a second device or device configuration. The universal smart battery surgical system is well suited for modern operating rooms where space and time are at a premium. By having an intelligent battery pack operate many different devices, a nurse can easily manage the storage, retrieval, and inventory of these battery packs. Advantageously, in one aspect, a smart battery system according to the present disclosure may employ one type of charging station, thereby increasing ease and efficiency of use and reducing the cost of a surgical room charging device.
In addition, other surgical instruments (such as powered staplers) may have different power requirements than the modular handheld ultrasonic surgical instrument 6480. According to various aspects of the present disclosure, the smart battery assembly 6486 may be used with any of a range of surgical instruments and may be manufactured to customize its own power output to the particular device in which it is installed. In one aspect, this power regulation is performed by controlling the duty cycle of the switch-mode power source (such as buck, buck-boost, or other configuration that is integrally formed with or otherwise coupled to and controlled by smart battery assembly 6486. in other aspects, smart battery assembly 6486 may dynamically change its power output during device operation. for example, in vascular sealing devices, power management provides improved tissue sealing, in these devices, large constant current values are required, the total power output needs to be dynamically adjusted, because when tissue is sealed, aspects of the present disclosure provide a smart battery assembly 6486 with a variable maximum current limit the current limit may change from one application (or device) to another based on the requirements of the application or device.
Fig. 47 is a detailed view of a trigger 6483 portion and a switch of the ultrasonic surgical instrument 6480 illustrated in fig. 46, in accordance with at least one aspect of the present disclosure. The trigger 6483 is operatively coupled to a jaw member 6495 of the end effector 6492. The ultrasonic blade 6496 is powered by the ultrasonic transducer/generator assembly 6484 when the activation switch 6485 is activated. Continuing now with fig. 46 and referring also to fig. 47, a trigger 6483 and activation switch 6485 are shown as components of a handle assembly 6482. The trigger 6483 activates the end effector 6492, which has a cooperative association with the ultrasonic blade 6496 of the waveguide shaft assembly 6490, to enable various types of contact between the end effector jaw member 6495 and the ultrasonic blade 6496 with tissue and/or other matter. The jaw member 6495 of the end effector 6492 is typically a pivoting jaw that is used to grasp or clamp onto tissue disposed between the jaw and the ultrasonic blade 6496. In one aspect, audible feedback is provided in the trigger when the trigger is fully depressed. Noise may be generated by the thin metal part of the trigger snap when closed. This feature adds an audible component to the user feedback that informs the user that the jaws are fully compressed against the waveguide and that sufficient clamping pressure is being applied to complete the vessel seal. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the trigger 6483 to measure the force applied to the trigger 6483 by the user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, may be coupled to the switch 6485 button such that the displacement strength corresponds to a force applied to the switch 6485 button by a user.
When depressed, the activation switch 6485 places the modular handheld ultrasonic surgical instrument 6480 in an ultrasonic mode of operation that causes ultrasonic motion at the waveguide shaft assembly 6490. In one aspect, depressing the activation switch 6485 causes electrical contacts within the switch to close, completing a circuit between the smart battery assembly 6486 and the ultrasonic transducer/generator assembly 6484 for applying electrical energy to the ultrasonic transducer, as previously described. On the other hand, depressing the activation switch 6485 closes the electrical contact to the smart battery assembly 6486. Of course, the description of closing electrical contacts in an electrical circuit herein is merely an exemplary general description of the operation of a switch. There are many alternative aspects that may include opening contacts or processor controlled power delivery that receive information from the switch and direct the corresponding circuit reaction based on the information.
Fig. 48 is an enlarged, partial perspective view of the end effector 6492 with the jaw member 6495 in an open position, as viewed from the distal end, according to at least one aspect of the present disclosure. Referring to fig. 48, a perspective partial view of the distal end 6498 of the waveguide shaft assembly 6490 is shown. The waveguide shaft assembly 6490 includes an outer tube 6494 surrounding a portion of the waveguide. The ultrasonic blade 6496 portion of the waveguide 6499 protrudes from the distal end 6498 of the outer tube 6494. Contacting tissue and transferring its ultrasonic energy to the tissue during a medical procedure is the portion of the ultrasonic blade 6496. The waveguide shaft assembly 6490 also includes a jaw member 6495 coupled to an outer tube 6494 and an inner tube (not visible in this view). The jaw member 6495, along with the inner and outer tubes of the waveguide 6499 and the portion of the ultrasonic blade 6496, can be referred to as an end effector 6492. As will be explained below, outer tube 6494 and the inner tube, not shown, slide longitudinally relative to each other. As relative movement between the outer tube 6494 and the inner tube, not shown, occurs, the jaw member 6495 pivots on a pivot point, causing the jaw member 6495 to open and close. When closed, the jaw member 6495 exerts a clamping force on the tissue between the jaw member 6495 and the ultrasonic blade 6496, thereby ensuring positive and effective blade-to-tissue contact.
Fig. 49 is a system diagram 7400 of a segmented circuit 7401 comprising a plurality of independently operating circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 in accordance with at least one aspect of the present disclosure. A circuit section of the plurality of circuit sections of the segmented circuit 7401 comprises one or more circuits and one or more sets of machine executable instructions stored in one or more memory devices. One or more circuits of the circuit section are coupled to communicate electrically over one or more wired or wireless connection mediums. The plurality of circuit segments are configured to be capable of transitioning between three modes, including a sleep mode, a standby mode, and an operational mode.
In one aspect shown, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 are first activated in a standby mode, second transitioned to a sleep mode, and again transitioned to an operational mode. However, in other aspects, the plurality of circuit sections may transition from any of the three modes to any other of the three modes. For example, the plurality of circuit sections may transition directly from the standby mode to the operating mode. Based on the execution of the machine-executable instructions by the processor, the voltage control circuitry 7408 may place individual circuit segments into particular states. The states include a power-off state, a low energy state, and a power-on state. The power-off state corresponds to a sleep mode, the low energy state corresponds to a standby mode, and the power-on state corresponds to an operational mode. The transition to the low energy state may be achieved by, for example, using a potentiometer.
In one aspect, the plurality of circuit segments 7402, 7414, 7416, 7420, 7424, 7428, 7434, 7440 may transition from a sleep mode or a standby mode to an operational mode according to a power-on sequence. The plurality of circuit segments may also transition from an operational mode to a standby mode or a sleep mode according to a power-down sequence. The power-up sequence and the power-down sequence may be different. In some aspects, the power-up sequence includes powering up only a subset of the circuit segments of the plurality of circuit segments. In some aspects, the power down sequence includes powering down only a subset of the circuit segments of the plurality of circuit segments.
Referring back to the system diagram 7400 in fig. 49, the segmented circuit 7401 includes a plurality of circuit segments including a transition circuit segment 7402, a processor circuit segment 7414, a handle circuit segment 7416, a communication circuit segment 7420, a display circuit segment 7424, a motor control circuit segment 7428, an energy processing circuit segment 7434, and a shaft circuit segment 7440. The transition circuit section includes a wake-up circuit 7404, a boost current circuit 7406, a voltage control circuit 7408, a safety controller 7410, and a POST controller 7412. Transition circuit section 7402 is configured to enable power-off and power-on sequences, safety detection protocol, and POST.
In some aspects, the wake-up circuit 7404 includes an accelerometer button sensor 7405. In various aspects, the transition circuit segment 7402 is configured to be capable of being in a powered on state, while other circuit segments of the plurality of circuit segments of the segmented circuit 7401 are configured to be capable of being in a low energy state, a powered off state, or a powered on state. The accelerometer button sensor 7405 can monitor the movement or acceleration of the surgical instrument 6480 described herein. For example, the movement may be a change in orientation or rotation of the surgical instrument. The surgical instrument can be moved in any direction relative to the three-dimensional Euclidean space by, for example, a user of the surgical instrument. When the accelerometer button sensor 7405 senses movement or acceleration, the accelerometer button sensor 7405 sends a signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to apply a voltage to the processor circuit section 7414 to transition the processor and volatile memory to a powered-on state. In aspects, the processor and volatile memory are in a powered-on state before the voltage control circuit 7409 applies a voltage to the processor and volatile memory. In the operating mode, the processor may begin a power-on sequence or a power-off sequence. In various aspects, the accelerometer button sensor 7405 can also send a signal to the processor to cause the processor to begin a power-up sequence or a power-down sequence. In some aspects, the processor begins a power-up sequence when most of the individual circuit sections are in a low-energy state or a power-down state. In other aspects, the processor begins a power-down sequence when a majority of the individual circuit segments are in a power-on state.
Additionally or alternatively, the accelerometer button sensor 7405 can sense external movement within a predetermined proximity of the surgical instrument. For example, the accelerometer button sensor 7405 may sense that a user of the surgical instrument 6480 described herein is moving the user's hand in a predetermined proximity. When the accelerometer button sensor 7405 senses this external movement, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor, as previously described. After receiving the transmitted signal, the processor may begin a power-on sequence or a power-off sequence to transition one or more circuit segments between the three modes. In aspects, a signal sent to the voltage control circuit 7408 is sent to verify whether the processor is in an operating mode. In some aspects, the accelerometer button sensor 7405 can sense when the surgical instrument has been dropped and send a signal to the processor based on the sensed drop. For example, the signal may indicate an error in the operation of the individual circuit segments. One or more sensors may sense damage or failure of the affected individual circuit segments. Based on the sensed damage or failure, POST controller 7412 may perform POST on the corresponding individual circuit segment.
The power-up sequence or power-down sequence may be defined based on the accelerometer button sensor 7405. For example, the accelerometer button sensor 7405 may sense a particular motion or sequence of motions indicative of selection of a particular circuit segment of the plurality of circuit segments. Based on the sensed motion or series of sensed motions, the accelerometer button sensor 7405 can transmit a signal to the processor including an indication of one or more of the plurality of circuit segments when the processor is in a powered state. Based on the signal, the processor determines a power-on sequence that includes the selected one or more circuit segments. Additionally or alternatively, a user of the surgical instrument 6480 described herein may select the number and order of circuit segments to define a power-up sequence or a power-down sequence based on interaction with a Graphical User Interface (GUI) of the surgical instrument.
In various aspects, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor only when the accelerometer button sensor 7405 detects movement of the surgical instrument 6480 described herein or an external motion within a predetermined proximity above a predetermined threshold. For example, a signal may be sent only if movement is sensed for 5 or more seconds or if the surgical instrument is moved 5 or more inches. In other aspects, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor only when the accelerometer button sensor 7405 detects an oscillating motion of the surgical instrument. The predetermined threshold reduces accidental transitioning of the circuit section of the surgical instrument. As previously described, the transition may include transitioning to an operational mode according to a power-up sequence, transitioning to a low energy mode according to a power-down sequence, or transitioning to a sleep mode according to a power-down sequence. In some aspects, a surgical instrument includes an actuator actuatable by a user of the surgical instrument. The actuation is sensed by accelerometer button sensor 7405. The actuator may be a slider, a toggle switch, or a momentary contact switch. Based on the sensed actuation, the accelerometer button sensor 7405 may send a signal to the voltage control circuit 7408 and a signal to the processor.
The boost current circuit 7406 is coupled to the battery. The boost current circuit 7406 is a current amplifier (such as a relay or a transistor) and is configured to be able to amplify the magnitude of the current of the individual circuit section. The initial magnitude of the current corresponds to the source voltage provided by the battery to the segmented circuit 7401. Suitable relay systems include solenoids. Suitable transistors include Field Effect Transistors (FETs), MOSFETs and Bipolar Junction Transistors (BJTs). The boost current circuit 7406 may amplify a magnitude of current corresponding to an independent circuit segment or circuit that requires more current consumption during operation of the surgical instrument 6480 described herein. For example, when the motor of the surgical instrument requires more input power, an increase in current to the motor control circuit section 7428 may be provided. An increase in the current provided to an individual circuit segment may result in a corresponding decrease in the current of another circuit segment or circuit segments. Additionally or alternatively, the increase in current may correspond to a voltage provided by an additional voltage source operating in conjunction with the battery.
The voltage control circuit 7408 is coupled to the battery. The voltage control circuit 7408 is configured to be capable of providing voltages to or removing voltages from a plurality of circuit segments. The voltage control circuit 7408 is also configured to be able to increase or decrease the voltage provided to the plurality of circuit segments of the segmented circuit 7401. In various aspects, the voltage control circuit 7408 includes combinational logic circuitry, such as a Multiplexer (MUX) for selecting the input, the plurality of electronic switches, and the plurality of voltage converters. The electronic switch of the plurality of electronic switches may be configured to be switchable between an open and a closed configuration to disconnect the individual circuit segment from the battery or to connect the individual circuit segment to the battery. The plurality of electronic switches may be solid state devices such as transistors or other types of switches such as wireless switches, ultrasonic switches, accelerometers, inertial sensors, and the like. The combinational logic circuit is configured to be able to select individual electronic switches for switching to an open configuration to enable application of a voltage to the corresponding circuit segment. The combinational logic circuit is further configured to enable selection of individual electronic switches for switching to a closed configuration to enable removal of voltage from the corresponding circuit segment. By selecting a plurality of individual electronic switches, the combinational logic circuit can implement a power-down sequence or a power-up sequence. The plurality of voltage converters may provide a boosted voltage or a reduced voltage to the plurality of circuit sections. The voltage control circuit 7408 may also include a microprocessor and a memory device.
The security controller 7410 is configured to be able to perform security checks on the circuit segments. In some aspects, the security controller 7410 performs a security check when one or more individual circuit segments are in an operational mode. A security check may be performed to determine if there are any errors or defects in the function or operation of the circuit segment. The safety controller 7410 may monitor one or more parameters of a plurality of circuit segments. The security controller 7410 may verify the identity and operation of the plurality of circuit segments by comparing one or more parameters to predefined parameters. For example, if an RF energy modality is selected, the safety controller 7410 may verify whether the articulation parameters of the shaft match predefined articulation parameters to verify operation of the RF energy modality of the surgical instrument 6480 described herein. In some aspects, the safety controller 7410 may monitor a predetermined relationship between one or more characteristics of the surgical instrument via sensors to detect a fault. A fault may occur when one or more characteristics are inconsistent with a predetermined relationship. When the safety controller 7410 determines that there is a fault, that there is an error, or that some operation of the plurality of circuit segments is not verified, the safety controller 7410 prevents or disables operation of the particular circuit segment that caused the fault, error, or verification failure.
POST controller 7412 executes POST to verify proper operation of the various circuit segments. In some aspects, POST is performed on individual ones of the plurality of circuit segments before the voltage control circuit 7408 applies a voltage to the individual circuit segments to transition the individual circuit segments from a standby mode or a sleep mode to an operational mode. If a single circuit segment fails POST, the particular circuit segment will not transition from a standby mode or sleep mode to an operational mode. The POST of the handle circuit segment 7416 may include, for example, testing whether the handle control sensor 7418 senses actuation of a handle control of the surgical instrument 6480 described herein. In some aspects, the POST controller 7412 may transmit signals to the accelerometer button sensor 7405 to verify the operation of the individual circuit segments that are part of the POST. For example, after receiving the signal, the accelerometer button sensor 7405 can prompt a user of the surgical instrument to move the surgical instrument to a plurality of varying positions to ensure operation of the surgical instrument. The accelerometer button sensor 7405 may also monitor the output of a circuit segment or a circuit of a circuit segment that is part of the POST. For example, the accelerometer button sensor 7405 may sense incremental motor pulses generated by the motor 7432 to verify operation. A motor controller of the motor control circuit 7430 may be used to control the motor 7432 to generate incremental motor pulses.
In various aspects, the surgical instrument 6480 described herein may include additional accelerometer button sensors. POST controller 7412 may also execute control programs stored in a memory device of voltage control circuit 7408. The control program may cause POST controller 7412 to transmit signals requesting matching encryption parameters from multiple circuit segments. Failure to receive a matching encryption parameter from an individual circuit segment indicates to POST controller 7412 that the corresponding circuit segment has been damaged or failed. In some aspects, if POST controller 7412 determines based on POST that a processor has been damaged or has failed, POST controller 7412 may send a signal to one or more secondary processors to cause the one or more secondary processors to perform a critical function that the processor is unable to perform. In some aspects, if the POST controller 7412 determines based on POST that one or more circuit segments are not functioning properly, the POST controller 7412 may begin a reduced performance mode for those circuit segments that are operating properly while locking those circuit segments that are not passing POST or are not operating properly. The locked circuit section may function similar to a circuit section in a standby mode or a sleep mode.
The processor circuit section 7414 includes a processor and volatile memory. The processor is configured to be able to initiate a power-up sequence or a power-down sequence. To begin the power-on sequence, the processor transmits a power-on signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to apply voltages to multiple or a subset of the multiple circuit segments according to the power-on sequence. To begin a power down sequence, the processor transmits a power down signal to the voltage control circuit 7408 to cause the voltage control circuit 7408 to remove voltage from multiple or a subset of the multiple circuit segments according to the power down sequence.
The handle circuit section 7416 includes a handle control sensor 7418. The handle control sensor 7418 may sense actuation of one or more handle controls of the surgical instrument 6480 described herein. In various aspects, the one or more handle controls include a clamp control, a release button, an articulation switch, an energy activated button, and/or any other suitable handle control. The user may activate an energy activation button to select between an RF energy mode, an ultrasonic energy mode, or a combination of an RF energy mode and an ultrasonic energy mode. The handle control sensor 7418 may also facilitate attachment of the modular handle to a surgical instrument. For example, the handle control sensor 7418 may sense the proper attachment of the modular handle to the surgical instrument and indicate the sensed attachment to a user of the surgical instrument. The LCD display 7426 may provide a graphical indication of the sensed attachment. In some aspects, the handle control sensor 7418 senses actuation of one or more handle controls. Based on the sensed actuation, the processor may begin a power-on sequence or a power-off sequence.
The communication circuit section 7420 includes a communication circuit 7422. The communication circuitry 7422 includes a communication interface to facilitate communication of signals between individual ones of the plurality of circuit segments. In some aspects, the communication circuitry 7422 provides a path for electrical communication for the modular components of the surgical instrument 6480 described herein. For example, when the modular shaft and modular transducer are attached together to the handle of a surgical instrument, the control program may be uploaded to the handle through the communication circuitry 7422.
The display circuit section 7424 includes an LCD display 7426. The LCD display 7426 may include a liquid crystal display, LED indicators, or the like. In some aspects, the LCD display 7426 is an Organic Light Emitting Diode (OLED) screen. The display may be placed on, embedded in, or located remotely from the surgical instrument 6480 described herein. For example, the display may be placed on a handle of the surgical instrument. The display is configured to provide sensory feedback to the user. In various aspects, the LCD display 7426 also includes a backlight. In some aspects, the surgical instrument may further comprise an audio feedback device such as a speaker or buzzer and a haptic feedback device such as a haptic actuator.
The motor control circuit section 7428 includes a motor control circuit 7430 coupled to a motor 7432. The motor 7432 is coupled to the processor through a driver and a transistor (such as a FET). In various aspects, the motor control circuitry 7430 includes a motor current sensor in signal communication with the processor to provide a signal indicative of a measure of current consumption of the motor to the processor. The processor transmits the signal to the display. The display receives the signal and displays a measurement of the current draw of the motor 7432. The processor may monitor, for example, using the signal, whether the current draw of the motor 7432 is within an acceptable range, to compare the current draw to one or more parameters of the plurality of circuit segments, and to determine one or more parameters of the patient treatment site. In various aspects, the motor control circuitry 7430 includes a motor controller for controlling the operation of the motor. For example, the motor control circuitry 7430 controls various motor parameters, such as by adjusting the speed, torque, and acceleration of the motor 7432. This adjustment is done based on measuring the current through the motor 7432 by a motor current sensor.
In various aspects, the motor control circuitry 7430 includes force sensors to measure the force and torque generated by the motor 7432. The motor 7432 is configured to actuate a mechanism of the surgical instrument 6480 described herein. For example, the motor 7432 is configured to control actuation of a shaft of the surgical instrument to achieve clamping, rotation, and articulation functions. For example, the motor 7432 may actuate the shaft to effect a clamping motion with the jaws of the surgical instrument. The motor controller can determine whether the material gripped by the jaws is tissue or metal. The motor controller may also determine the degree to which the jaws grip the material. For example, the motor controller may determine how the jaws are opened or closed based on a derivative of the sensed motor current or motor voltage. In some aspects, the motor 7432 is configured to actuate the transducer to cause the transducer to apply torque to the handle or to control articulation of the surgical instrument. The motor current sensor may interact with the motor controller to set the motor current limit. When the current meets a predefined threshold limit, the motor controller initiates a corresponding change in motor control operation. For example, exceeding the motor current limit causes the motor controller to reduce the current consumption of the motor.
The energy processing circuit section 7434 includes RF amplifier and safety circuits 7436 and ultrasonic signal generator circuits 7438 to enable energy modular functionality of the surgical instrument 6480 described herein. In various aspects, the RF amplifier and safety circuit 7436 is configured to be able to control the RF modality of the surgical instrument by generating RF signals. The ultrasonic signal generator circuit 7438 is configured to be able to control the ultrasonic energy modality by generating an ultrasonic signal. The RF amplifier and safety circuitry 7436 and the ultrasonic signal generator circuitry 7438 may operate in conjunction to control the combination of RF energy mode and ultrasonic energy mode.
The shaft circuit section 7440 includes a shaft module controller 7442, a modular control actuator 7444, one or more end effector sensors 7446, and a non-volatile memory 7448. The axle module controller 7442 is configured to be able to control a plurality of axle modules including a control program to be executed by the processor. The plurality of shaft modules implement shaft modalities such as ultrasound, a combination of ultrasound and RF, RF I-blade and RF opposable jaws. The axis module controller 7442 may select an axis modality for execution by the processor by selecting a corresponding axis module. The modular control actuators 7444 are configured to actuate the shafts according to a selected shaft mode. After actuation is initiated, the shaft articulates the end effector according to one or more parameters, routines, or programs specific to the selected shaft modality and the selected end effector modality. The one or more end effector sensors 7446 at the end effector may include a force sensor, a temperature sensor, a current sensor, or a motion sensor. The one or more end effector sensors 7446 transmit data regarding one or more operations of the end effector based on the energy modality achieved by the end effector. In various aspects, the energy modality comprises an ultrasonic energy modality, an RF energy modality, or a combination of an ultrasonic energy modality and an RF energy modality. The nonvolatile memory 7448 stores a spindle control program. The control program includes one or more parameters, routines or programs that are specific to the shaft. In various aspects, the non-volatile memory 7448 may be ROM, EPROM, EEPROM, or flash memory. The non-volatile memory 7448 stores a shaft module corresponding to a selected shaft of the surgical instrument 6480 described herein. The shaft module may be changed or upgraded in the non-volatile memory 7448 by the shaft module controller 7442 depending on the surgical instrument shaft to be used in operation.
FIG. 50 is a schematic diagram of circuitry 7925 of various components of a surgical instrument having motor control functionality in accordance with at least one aspect of the present disclosure. In various aspects, the surgical instrument 6480 described herein includes a drive mechanism 7930, the drive mechanism 7930 configured to drive a shaft and/or a gear device in order to perform various operations associated with the surgical instrument 6480. In one aspect, the drive mechanism 7930 includes a rotary drive train (drivetrain)7932 configured to rotate the end effector relative to the handle housing, e.g., about a longitudinal axis. The drive mechanism 7930 also includes a closure drivetrain 7934 configured to close the jaw members to grasp tissue with the end effector. In addition, the drive mechanism 7930 includes a firing power transmission 7936 configured to open and close the clamp arm portions of the end effector to grasp tissue with the end effector.
The drive mechanism 7930 includes a selector gearbox assembly 7938 that may be located in a handle assembly of the surgical instrument. Adjacent to the selector gearbox assembly 7938 is a function selection module that includes a first motor 7942 for selectively moving a gear element within the selector gearbox assembly 7938 to selectively position one of the drivelines 7932, 7934, 7936 into engagement with an input drive member of an optional second motor 7944 and motor drive circuit 7946 (shown in dotted lines to indicate that the second motor 7944 and motor drive circuit 7946 are optional members).
Still referring to fig. 50, the motors 7942, 7944 are coupled to motor control circuits 7946, 7948, respectively, which are configured to control the operation of the motors 7942, 7944, including the flow of electrical energy from the power source 7950 to the motors 7942, 7944. The power source 7950 may be a DC battery (e.g., a rechargeable lead-based, nickel-based, lithium ion-based battery, etc.), or any other power source suitable for providing electrical energy to a surgical instrument.
The surgical instrument also includes a microcontroller 7952 ("controller"). In some cases, the controller 7952 can include a microprocessor 7954 ("processor") and one or more computer-readable media or memory units 7956 ("memory"). In some cases, memory 7956 may store various program instructions that, when executed, may cause processor 7954 to perform various functions and/or computations described herein. The power source 7950 may be configured to be capable of supplying power to the controller 7952, for example.
The processor 7954 may be in communication with a motor control circuit 7946. Additionally, the memory 7956 may store program instructions that, when executed by the processor 7954 in response to the user input 7958 or the feedback element 7960, may cause the motor control circuit 7946 to actuate the motor 7942 to generate at least one rotational motion to selectively move a gear element within the selector gearbox assembly 7938 to selectively position one of the drivelines 7932, 7934, and 7936 and move it into engagement with the input drive of the second motor 7944. Further, the processor 7954 may be in communication with the motor control circuitry 7948. The memory 7956 may also store program instructions that, when executed by the processor 7954 in response to the user input 7958, may cause the motor control circuit 7948 to actuate the motor 7944 to generate at least one rotational motion to drive, for example, a drivetrain engaged with an input drive device of the second motor 7948.
The controller 7952 and/or other controllers of the present disclosure may be implemented using integrated and/or discrete hardware elements, software elements, and/or a combination of both. Examples of integrated hardware elements may include processors, microprocessors, microcontrollers, integrated circuits, ASICs, PLDs, DSPs, FPGAs, logic gates, registers, semiconductor devices, chips, microchips, chipsets, microcontrollers, systems on a chip (SoC), and/or single in-line packages (SIP). Examples of discrete hardware elements may include circuits and/or circuit elements, such as logic gates, field effect transistors, bipolar transistors, resistors, capacitors, inductors, and/or relays. In some cases, for example, the controller 7952 may include a hybrid circuit that includes discrete and integrated circuit elements or components on one or more substrates.
In certain examples, controller 7952 and/or other controllers of the present disclosure may be, for example, LM4F230H5QR, available from Texas Instruments, inc (Texas Instruments). In some cases, the Texas instruments LM4F230H5QR is an ARM Cortex-M4F processor core, which includes: 256KB of on-chip memory of Single cycle flash or other non-volatile memory (up to 40MHz), prefetch buffers to improve performance above 40MHz, 32KB of Single cycle SRAM, Stellaris loaded
SoftwareAn internal ROM of 2KB, one or more PWM modules, one or more QEI analog, one or more 12-bit ADCs with 12 analog input channels, and other features readily available. Other microcontrollers may be readily substituted for use in conjunction with the present disclosure. Accordingly, the present disclosure should not be limited to this context.
In various examples, one or more of the various steps described herein may be performed by a finite state machine comprising combinational or sequential logic circuitry coupled to at least one storage circuit. At least one memory circuit stores a current state of the finite state machine. Combinational or sequential logic circuitry is configured to enable the finite state machine to reach these steps. Sequential logic circuits may be synchronous or asynchronous. In other examples, one or more of the various steps described herein may be performed by circuitry that includes a combination of the processor 7958 and a finite state machine, for example.
In various instances, it may be advantageous to be able to assess the functional status of a surgical instrument to ensure that it is functioning properly. For example, the drive mechanisms (configured to include various motors, power trains, and/or gear devices to perform various operations of the surgical instrument) as described above may wear out over time. This can occur during normal use and in some cases the drive mechanism may wear out faster due to abuse conditions. In certain instances, the surgical instrument may be configured to perform a self-assessment to determine the status (e.g., health) of the drive mechanism and its various components.
For example, self-evaluation may be used to determine when a surgical instrument is able to perform its function or when some of the devices should be replaced and/or repaired before being re-sterilized. Evaluation of the drive mechanism and its components (including, but not limited to, the rotary power transmission system 7932, the closure power transmission system 7934, and/or the firing power transmission system 7936) may be accomplished in various ways. The magnitude of the deviation from the predicted performance may be used to determine the likelihood of a sensed fault and the severity of such a fault. A number of metrics may be used, including: periodic analysis of the predicted event, peaks or dips above expected thresholds, and the width of the fault may be repeated.
In various examples, the condition of the drive mechanism or one or more components thereof may be evaluated using a signature of a properly functioning drive mechanism or one or more components thereof. One or more vibration sensors may be arranged relative to the normally operating drive mechanism or one or more components thereof to record various vibrations occurring during operation of the normally operating drive mechanism or one or more components thereof. The recorded vibrations may be used to create a signature. The future waveform may be compared to the signature waveform to assess the state of the drive mechanism and its components.
Still referring to fig. 50, the surgical instrument 7930 includes a driveline failure detection module 7962 configured to record and analyze one or more acoustic outputs of one or more of the drivelines 7932, 7934, and/or 7936. The processor 7954 may communicate with or otherwise control the module 7962. As described in more detail below, the module 7962 may be embodied as various means, such as circuitry, hardware, a computer program product including a computer-readable medium (e.g., the memory 7956) storing computer-readable program instructions that are executable by a processing device (e.g., the processor 7954), or some combination thereof. In some aspects, processor 36 may include or otherwise control module 7962.
Turning now to fig. 51, the end effector 8400 includes RF data sensors 8406, 8408a, 8408b on the jaw member 8402. The end effector 8400 includes a jaw member 8402 and an ultrasonic blade 8404. The jaw member 8402 is shown gripping tissue 8410 positioned between the jaw member 8402 and the ultrasonic blade 8404. The first sensor 8406 is located at a central portion of the jaw member 8402. A second sensor 8408a and a third sensor 8408b are located on a lateral portion of the jaw member 8402. The sensors 8406, 8408a, 8408b are mounted or integrally formed with a flexible circuit 8412 (shown more particularly in fig. 52) that is configured to be fixedly mounted to the jaw member 8402.
The end effector 8400 is an example end effector for a surgical instrument. The sensors 8406, 8408a, 8408b are electrically connected to control circuitry, such as control circuitry 7400 (fig. 63), via interface circuitry. The sensors 8406, 8408a, 8408b are battery powered and the signals generated by the sensors 8406, 8408a, 8408b are provided to analog and/or digital processing circuits of the control circuit.
In one aspect, the first sensor 8406 is a force sensor for measuring a normal force F3 applied to the tissue 8410 by the jaw member 8402. The second sensor 8408a and the third sensor 8408b include one or more elements for applying RF energy to the tissue 8410, measuring tissue impedance, downward force F1, lateral force F2, and temperature, among other parameters. The electrodes 8409a, 8409b are electrically coupled to a power source and apply RF energy to the tissue 8410. In one aspect, the first sensor 8406 and the second and third sensors 8408a, 8408b are strain gauges for measuring force or force per unit area. It should be appreciated that the measurements of the downward force F1, the lateral force F2, and the normal force F3 can be easily converted to pressure by determining the surface area on which the force sensors 8406, 8408a, 8408b act. Additionally, the flexible circuit 8412 may include a temperature sensor embedded in one or more layers of the flexible circuit 8412, as described in detail herein. One or more temperature sensors may be symmetrically or asymmetrically arranged and provide temperature feedback of the tissue 8410 to the control circuitry of the ultrasound drive circuitry and the RF drive circuitry.
FIG. 52 illustrates an aspect of the flexible circuit 8412 shown in FIG. 51 to which the sensors 8406, 8408a, 8408b may be mounted or integrally formed therewith. The flexible circuit 8412 is configured to be fixedly attached to the jaw member 8402. As shown particularly in fig. 52, asymmetric temperature sensors 8414a, 8414b are mounted to the flexible circuit 8412 to enable measurement of the temperature of the tissue 8410 (fig. 51).
Fig. 53 is an alternative system 132000 for controlling the frequency and detecting the impedance of an ultrasonic electromechanical system 132002 in accordance with at least one aspect of the present disclosure. The system 132000 can be incorporated into a generator. The processor 132004 coupled to the memory 132026 programs the programmable counter 132006 to tune to the output frequency f of the ultrasound electromechanical system 132002o. Input frequency is controlled byA crystal oscillator 132008 is generated and input into the fixed counter 132010 to scale the frequency to an appropriate value. The outputs of the fixed counter 132010 and the programmable counter 132006 are applied to a phase/frequency detector 132012. The output of the phase/frequency detector 132012 is applied to an amplifier/active filter circuit 132014 to generate a tuning voltage V applied to a voltage controlled oscillator 13206(VCO)t. VCO 132016 outputs frequency foApplied to the ultrasound transducer portion of the ultrasound electromechanical system 132002, which is modeled as an equivalent circuit as shown herein. The voltage and current signals applied to the ultrasonic transducer are monitored by a voltage sensor 132018 and a current sensor 132020.
The outputs of the voltage sensor 132018 and the current sensor 132020 are applied to another phase/frequency detector 132022 to determine the phase angle between the voltage and current as measured by the voltage sensor 132018 and the current sensor 132020. The output of the phase/frequency detector 132022 is applied to one channel of a high-speed analog-to-digital converter 132024(ADC) and provided through it to the processor 132004. Optionally, the outputs of the voltage sensor 132018 and the current sensor 132020 may be applied to respective channels of the dual-channel ADC 132024 and provided to the processor 132004 for zero crossing, FFT, or other algorithms described herein for determining the phase angle between the voltage and current signals applied to the ultrasound electromechanical system 132002.
Optionally tuning the voltage Vt(the voltage and the output frequency foProportional) may be fed back to the processor 132004 via the ADC 132024. This will provide the output frequency f to the processor 132004oA proportional feedback signal and the feedback can be used to regulate and control the output frequency fo。
Temperature inference
Fig. 54A-54B are illustrations 133000, 133010 of complex impedance spectra of the same ultrasound device with a cold (room temperature) ultrasonic blade and a hot ultrasonic blade, according to at least one aspect of the present disclosure. As used herein, a cold ultrasonic blade refers to an ultrasonic blade at room temperature, while a hot ultrasonic blade refers to an ultrasonic blade after frictional heating in use. FIG. 54A is the same as having a cold ultrasonic blade and a hot ultrasonic bladeResonant frequency f of ultrasonic deviceoImpedance phase angle of function of
Is 133000, and fig. 54B is the resonant frequency f as the same ultrasonic device with a cold ultrasonic blade and a hot ultrasonic bladeoA plot 133010 of the impedance magnitude | Z | of the function of (c). Impedance phase angle
And the impedance magnitude | Z | is at the resonant frequency foEverywhere is at a minimum.
Impedance Z of ultrasonic transducerg(t) may be measured as the drive signal generator voltage Vg(t) and current Ig(t) ratio of drive signals:
as shown in FIG. 54A, when the ultrasonic blade is cold (e.g., at room temperature) and not frictionally heated, the electromechanical resonance frequency f of the ultrasonic deviceoIs about 55,500Hz and the excitation frequency of the ultrasonic transducer is set to 55,500 Hz. Thus, when the ultrasonic transducer is at the electromechanical resonant frequency foPhase angle when the lower part is excited and the ultrasonic blade is cold
At a minimum or about 0Rad, as indicated by the cold blade plot 133002. As shown in FIG. 54B, when the ultrasonic blade is cold and the ultrasonic transducer is at the electromechanical resonant frequency foWhen excited down, the impedance magnitude | Z | is 800 Ω, e.g., the impedance magnitude | Z | is at a minimum impedance and the drive signal amplitude is at a maximum due to the series resonance equivalent circuit of the ultrasound electromechanical system, as depicted in fig. 25.
Referring now back to fig. 54A and 54B, when the ultrasonic transducer is driven to an electromechanical resonant frequency f of 55,500HzoLower generator voltage Vg(t) sum generator current Ig(t) generator voltage V when driven by signalg(t) sum generator current Ig(t) phase angle between signals
At zero, the impedance magnitude, IZ, is at a minimum impedance (e.g., 800 Ω), and the signal amplitude is at a peak or maximum due to the series resonant equivalent circuit of the ultrasound electromechanical system. When the temperature of the ultrasonic blade increases, the electromechanical resonance frequency f of the ultrasonic device due to frictional heat generated in useo' decrease. Because the ultrasonic transducer drives the generator voltage still by the previous (cold blade) electromechanical resonance frequency f of 55,500HzoLower generator voltage Vg(t) sum generator current Ig(t) signal drive, so that the ultrasonic device is not resonant fo' operate to cause the generator voltage Vg(t) sum generator current Ig(t) phase angle between signals
Of (3) is detected. There is also an increase in the impedance magnitude, IZ, and a decrease in the peak magnitude of the drive signal relative to the previous (cold blade) electromechanical resonant frequency of 55,500 Hz. Thus, the damping frequency f can be measured by measuring the damping frequency foGenerator voltage V when changing due to temperature change of ultrasonic bladeg(t) sum generator current Ig(t) phase angle between signals
To infer the temperature of the ultrasonic blade.
As previously mentioned, the electromechanical ultrasound system includes an ultrasound transducer, a waveguide, and an ultrasonic blade. The ultrasonic transducer can be modeled as an equivalent series resonant circuit (see fig. 25) comprising a first branch with a static capacitance and a second "dynamic" branch with series connected inductance, resistance and capacitance defining the electromechanical properties of the resonator. The electromechanical ultrasound system has an initial electromechanical resonant frequency defined by the physical characteristics of the ultrasound transducer, the waveguide, and the ultrasonic blade. The ultrasonic transducer is powered by an alternating voltage at a frequency equal to the electromechanical resonant frequency (e.g., the resonant frequency of the electromechanical ultrasound system)Vg(t) and current Ig(t) signal excitation. When the electromechanical ultrasonic system is excited at a resonant frequency, the voltage Vg(t) and current Ig(t) phase angle between signals
Is zero.
In other words, at resonance, the analog inductive impedance of the electromechanical ultrasound system is equal to the analog capacitive impedance of the electromechanical ultrasound system. When the ultrasonic blade heats up, for example, due to frictional engagement with tissue, the compliance of the ultrasonic blade (modeled as an analog capacitance) causes the resonant frequency of the electro-mechanical ultrasound system to shift. In this example, as the temperature of the ultrasonic blade increases, the resonant frequency of the electromechanical ultrasound system decreases. As a result, the analog inductive impedance of the electromechanical ultrasound system is no longer equal to the analog capacitive impedance of the electromechanical ultrasound system, resulting in a mismatch between the drive frequency and the new resonant frequency of the electromechanical ultrasound system. Thus, with a thermal ultrasonic blade, the electromechanical ultrasound system operates "off-resonance". The mismatch between the drive frequency and the resonant frequency is manifested as a voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
As discussed previously, the generator electronics can easily monitor the voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
Phase angle
Can be determined by fourier analysis, weighted least squares estimation, kalman filtering, space vector based techniques, zero crossing methods, Lissajous figures, three volt methods, cross coil methods, vector voltmeters and vector impedance methods, phase calibration instruments, phase locked loops, and the like. The generator may continuously monitor the phase angle
And adjusting the drive frequency to a phase angle
Becomes zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasound system. Phase angle
And/or the change in generator drive frequency may be used as an indirect or inferred measure of the temperature of the ultrasonic blade.
A variety of techniques can be used to estimate the temperature from the data in these spectra. Most notably, the dynamic relationship between the temperature of the ultrasonic blade and the measured impedance can be modeled using a time-varying nonlinear state space equation set:
within a generator drive frequency range, wherein the range of generator drive frequencies is specific to the device model.
Temperature estimation method
One aspect of estimating or inferring the temperature of the ultrasonic blade may include three steps. First, a state space model of temperature and frequency dependent on time and energy is defined. To model temperature as a function of frequency content, a set of nonlinear state space equations are used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic blade. Second, a kalman filter is applied to improve the accuracy of the temperature estimator and the state space model over time. Again, a state estimator is provided in the feedback loop of the kalman filter to control the power applied to the ultrasonic transducer and thus the ultrasonic blade to adjust the temperature of the ultrasonic blade.
These three steps are described below.
The first step is to define a state space model that depends on temperature and frequency of time and energy. To model temperature as a function of frequency content, a set of nonlinear state space equations are used to model the relationship between the electromechanical resonant frequency and the temperature of the ultrasonic blade. In one aspect, the state space model is defined by:
state space model representation with respect to natural frequency Fn(t)Natural frequency of electromechanical ultrasound system, temperature T (t), energy E (t), and time t
Rate of change and temperature of the ultrasonic blade
The rate of change of (c).
Representing a measurable and observable variable such as the natural frequency F of an electromechanical ultrasound systemn(t)Observability of the temperature of the ultrasonic blade, t (t), the energy applied to the ultrasonic blade, e (t), and the time, t. The temperature t (t) of the ultrasonic blade may be observed as an estimate.
The second step is to apply a kalman filter to improve the temperature estimator and the state space model. FIG. 55 is an illustration of a Kalman filter 133020 for improving a temperature estimator and a state space model based on impedance according to the following equation:
representing the impedance measured across the ultrasound transducer at a plurality of frequencies according to at least one aspect of the present disclosure.
Can adopt a cardThe kalman filter 133020 improves the performance of the temperature estimation and allows for the addition of external sensors, models or previous information to improve the temperature prediction in noisy data. The kalman filter 133020 includes a regulator 133022 and a plant 133024. In a comparative theory, the device 133024 is a combination of a process and an actuator. Device 133024 is said to have a transfer function that indicates the relationship between the input signal and the output signal of the system. The regulator 133022 includes a state estimator 133026 and a controller K133028. The state adjuster 133026 includes a feedback loop 133030. The state adjuster 133026 receives y, the output of the device 133024 as inputs and feeds back a variable u. The state estimator 133026 is an internal feedback system that converges with the true values of the system state. The output of the state estimator 133026 is a full feedback control variable
F including an electromechanical ultrasound systemn(t)Estimation of the temperature of the ultrasonic blade T (t), the energy applied to the ultrasonic blade E (t), the phase angle
And a time t. Inputs to controller K133028 are
And the output u of the controller K133028 is fed back to the state estimator 133026 and t of the device 133024.
Kalman filtering, also known as Linear Quadratic Estimation (LQE), is an algorithm that uses a series of measurements (including statistical noise and other inaccuracies) observed over time and produces estimates of unknown variables by estimating the joint probability distribution of the variables for each time frame and thus computing the maximum likelihood estimate of the actual measurement. The algorithm works in a two-step process. In the prediction step, the kalman filter 133020 generates estimates of the current state variables and their uncertainties. Once the results of the next measurement are observed, which must be corrupted by a certain amount of error, including random noise, these estimates are updated using a weighted average, giving a higher weight, with a higher certainty. The algorithm is recursive and can run in real-time, using only current input measurements and previously computed states and their uncertainty matrices; no additional past information is required.
The kalman filter 133020 uses a kinetic model of the electromechanical ultrasound system, a control input known to the system, and a plurality of time-series measurements (observations) of the natural frequency and phase angle of the signal applied to the ultrasound transducer (e.g., the magnitude and phase of the electrical impedance of the ultrasound transducer) to form an estimate of the amount of change (its state) of the electromechanical ultrasound system to predict the temperature of the ultrasonic blade portion of the electromechanical ultrasound system better than an estimate obtained using only one single measurement. Thus, the kalman filter 133020 is an algorithm that includes sensor and data fusion to provide a maximum likelihood estimate of the temperature of the ultrasonic blade.
The kalman filter 133020 effectively handles the uncertainty due to noisy measurements of the signal applied to the ultrasonic transducer to measure the natural frequency and phase shift data, and also effectively handles the uncertainty due to random external factors. The kalman filter 133020 produces an estimate of the state of the electromechanical ultrasound system with the predicted state of the system and the newly measured average using the weighted average. The weighted values provide a better (i.e., less) estimate of uncertainty and are more "trustworthy" than the unweighted values. The weights may be calculated from the covariance, a measure of the uncertainty of the estimation of the system state prediction. The result of the weighted average is a new state estimate that lies between the predicted state and the measured state and has a better estimate uncertainty than the one alone. This process is repeated at each step, with the new estimate and its covariance telling the prediction used in the following iteration. This recursive nature of the kalman filter 133020 requires only the last "best guess" of the state of the electro-mechanical ultrasound system to compute the new state, rather than the entire history.
The relative certainty of the measurement and current state estimation is an important consideration, and it is common to discuss the response of the filter in terms of the gain K of the kalman filter 133020. The kalman gain, K, is a relative weight given to the measurement and current state estimate, and may be "tuned" to achieve a particular performance. With a high gain K, the kalman filter 133020 applies more weight to the most recent measurements and therefore follows them more responsively. Using a low gain K, the kalman filter 133020 follows the model prediction more closely. In the extreme case, a high gain near one will result in estimated trajectories that are more jerky, while a low gain near zero will smooth out noise but reduce responsiveness.
When performing the actual calculations of the kalman filter 133020 (described below), the state estimates and covariance are encoded as matrices to handle the multiple dimensions involved in a single set of calculations. This allows for representing a linear relationship between different state variables, such as position, velocity and acceleration, in either the transition model or covariance. The use of the kalman filter 133020 does not assume that the error is gaussian. However, in the special case where all errors are gaussian distributed, the kalman filter 133020 produces an accurate conditional probability estimate.
The second step uses the state estimator 133026 in the feedback loop 133032 of the kalman filter 133020 to control the power applied to the ultrasonic transducer and hence to the ultrasonic blade to adjust the temperature of the ultrasonic blade.
Fig. 56 is a graphical representation 133040 of three probability distributions employed by the state estimator 133026 of the kalman filter 133020 shown in fig. 55 for maximizing estimation, in accordance with at least one aspect of the present disclosure. The probability distributions include a previous probability distribution 133042, a predicted (state) probability distribution 133044, and an observed probability distribution 133046. In accordance with at least one aspect of the present disclosure, the three probability distributions 133042, 133044, 1330467 are used for feedback control of the power applied to the ultrasound transducer to adjust the temperature based on the impedance measured across the ultrasound transducer at various frequencies. An estimator for use in feedback control of power applied to an ultrasonic transducer for adjusting temperature based on impedance is defined by the following expression:
which is the impedance measured across the ultrasound transducer at multiple frequencies according to at least one aspect of the present disclosure.
The previous probability distribution 133042 includes a state variance defined by the following expression:
variance of state
For predicting the next state of the system, which is represented as a predictive (state) probability distribution 133044. Observation probability distribution 133046 is the observation variance σmA probability distribution of actual observations of a state of a system for defining a gain, the gain defined by the expression:
feedback control
The power input is reduced to ensure that the temperature (as estimated by the state estimator and kalman filter) is controlled.
In one aspect, the initial proof of concept assumes that there is a static linear relationship between the natural frequency of the electromechanical ultrasound system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasound system (i.e., adjusting the temperature with feedback control), the temperature of the ultrasonic blade tip can be directly controlled. In this example, the temperature of the distal tip of the ultrasonic blade may be controlled to not exceed the melting point of the Teflon pad.
Fig. 57A is a graph 133050 of temperature versus time for an ultrasound device without temperature feedback control. The temperature of the ultrasonic blade (deg.C) is shown along the vertical axis and time (seconds) is shown along the horizontal axis. The test was performed with antelope skin in the jaws of an ultrasonic device. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the chamois clamped between the ultrasonic blade and the clamping arm. Over time, the temperature of the ultrasonic blade (C.) increases due to frictional engagement with the antelope skin. Over time, the temperature profile 133052 of the ultrasonic blade increased until the antelope skin sample was cut after about 19.5 seconds at a temperature of 220 ℃, as indicated at point 133054. Without temperature feedback control, after cutting the antelope skin sample, the temperature of the ultrasonic blade was increased to a temperature of-380 ℃ to-490 ℃ well above the melting point of TEFLON. At point 133056, the temperature of the ultrasonic blade reached a maximum temperature of 490 ℃ until the TEFLON pad completely melted. After the pad completely disappears, the temperature of the ultrasonic blade drops slightly from the peak temperature at point 133056.
FIG. 57B is a graph of temperature versus time for an ultrasound device with temperature feedback control in accordance with at least one aspect of the present invention. The temperature of the ultrasonic blade (deg.C) is shown along the vertical axis and time (seconds) is shown along the horizontal axis. The test was performed with a sample of antelope skin positioned in the jaw of the ultrasound device. One jaw is an ultrasonic blade and the other jaw is a clamp arm with a TEFLON pad. The ultrasonic blade is excited at a resonant frequency while frictionally engaging the chamois clamped between the ultrasonic blade and the clamping arm pad. Over time, the temperature profile 133062 of the ultrasonic blade increased until the antelope skin sample was cut after about 23 seconds at a temperature of 220 ℃, as indicated at point 133064. With temperature feedback control, the temperature of the ultrasonic blade was raised to a maximum temperature of about 380 ℃, as indicated at point 133066, just below the melting point of TEFLON, and then lowered to an average value of about 330 ℃, as generally indicated at region 133068, thereby preventing the TEFLON pad from melting.
Application of intelligent ultrasonic knife technology
When the ultrasonic blade is immersed in a fluid-filled surgical site, the ultrasonic blade cools during activation, making sealing and cutting of tissue in contact therewith less effective. Cooling of the ultrasonic blade may result in longer activation times and/or hemostasis problems because sufficient heat is not delivered to the tissue. To overcome the cooling of the ultrasonic blade, more energy delivery may be required to shorten the transection time and achieve proper hemostasis under these fluid submersion conditions. Using a frequency temperature feedback control system, if the ultrasonic blade is detected to start below a certain temperature or to remain at a certain temperature for a period of time, the output power of the generator may be increased to compensate for the cooling due to the blood/saline/other fluids present in the surgical site.
Thus, the frequency temperature feedback control system described herein may improve the performance of the ultrasonic device, particularly when the ultrasonic blade is partially or fully positioned or immersed in a fluid-filled surgical site. The frequency temperature feedback control system described herein minimizes long activation times and/or potential problems with the performance of an ultrasonic device in a fluid-filled surgical site.
As previously mentioned, the temperature of the ultrasonic blade may be inferred by detecting the impedance of the ultrasonic transducer given by the following expression:
Or equivalently, detecting the voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
Phase angle
The information may also be used to infer the condition of the ultrasonic blade. Phase angle, as discussed in detail herein
As a function of the temperature of the ultrasonic blade. Thus, the phase angle
The information may be used to control the temperature of the ultrasonic blade. This may be accomplished, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade is running too hot, and increasing the power delivered to the ultrasonic blade when the ultrasonic blade is running too cold. 58A-58B are graphical representations of temperature feedback control for current inspectionThe ultrasonic power applied to the ultrasonic transducer is adjusted when a sudden drop in the temperature of the ultrasonic blade is detected.
Fig. 58A is a graphical representation of ultrasonic power output 133070 as a function of time in accordance with at least one aspect of the present disclosure. The power output of the ultrasonic generator is shown along the vertical axis and time (seconds) is shown along the horizontal axis. Fig. 58B is a graphical representation of ultrasonic blade temperature 133080 as a function of time in accordance with at least one aspect of the present disclosure. The ultrasonic blade temperature is displayed along the vertical axis and time (seconds) is displayed along the horizontal axis. The temperature of the ultrasonic blade increases with the application of constant power 133072, as shown in fig. 58A. During use, the temperature of the ultrasonic blade suddenly drops. This may be caused by a variety of conditions, however, during use, it may be inferred that the temperature of the ultrasonic blade drops as it is immersed in a fluid-filled surgical site (e.g., blood, saline, water, etc.). At time t0Here, the temperature of the ultrasonic blade falls below the desired minimum temperature 133082, and the frequency temperature feedback control algorithm detects the temperature drop and begins to increase or "ramp up" power, as shown by the power ramp 133074 delivered to the ultrasonic blade, to begin increasing the temperature of the ultrasonic blade above the desired minimum temperature 133082.
Referring to fig. 58A and 58B, the ultrasonic generator outputs a substantially constant power 133072 as long as the temperature of the ultrasonic blade remains above the desired minimum temperature 133082. At t0At this point, the processor or control circuitry in the generator or instrument or both detects that the temperature of the ultrasonic blade has dropped below the desired minimum temperature 133072 and initiates a frequency temperature feedback control algorithm to raise the temperature of the ultrasonic blade above the minimum desired temperature 133082. Thus, the generator power is at a value corresponding to t0T at which a sudden drop in the temperature of the ultrasonic blade is detected1Where it begins to ramp 133074. Under the frequency temperature feedback control algorithm, the power continues to ramp 133074 until the temperature of the ultrasonic blade is above the desired minimum temperature 133082.
Fig. 59 is a logic flow diagram 133090 illustrating a method in accordance with at least one aspect of the present disclosure, depicting a control program or logic configuration for controlling the temperature of the ultrasonic blade. According toThe processor or control circuitry of the method, generator or instrument, or both, executes an aspect of the frequency temperature feedback control algorithm discussed in connection with fig. 58A and 58B to apply 133092 a power level to the ultrasonic transducer to achieve a desired temperature at the ultrasonic blade. The generator monitors 133094 the voltage V applied to the drive ultrasound transducerg(t) and current Ig(t) phase angle between signals
Based on phase angle
The generator infers 133096 the temperature of the ultrasonic blade using the techniques described herein in connection with fig. 54A-56. The generator determines 133098 whether the temperature of the ultrasonic blade is below the desired minimum temperature by comparing the inferred temperature of the ultrasonic blade to a predetermined desired temperature. The generator then adjusts the power level applied to the ultrasound transducer based on the comparison. For example, when the temperature of the ultrasonic blade reaches or is above the desired minimum temperature, the method continues along the NO branch, and when the temperature of the ultrasonic blade is below the desired minimum temperature, the process continues along the YES branch. When the temperature of the ultrasonic blade is below the desired minimum temperature, the generator increases the voltage V, for example, by increasingg(t) and/or the current Ig(t) the signal to increase 133100 the power level to the ultrasonic transducer to increase the temperature of the ultrasonic blade and continue to increase the power level applied to the ultrasonic transducer until the temperature of the ultrasonic blade increases above the minimum desired temperature.
Adaptive advanced tissue treatment pad protection mode
Fig. 60 is a graphical representation 133110 of ultrasonic blade temperature as a function of time during blood vessel firing according to at least one aspect of the present disclosure. A plot 133112 of ultrasonic blade temperature is plotted along the vertical axis as a function of time along the horizontal axis. The frequency temperature feedback control algorithm combines the temperature of the ultrasonic blade feedback control with the jaw sensing capability. The frequency temperature feedback control algorithm provides optimal hemostasis balanced with device durability and is able to intelligently deliver energy for optimal sealing while protecting the clamp arm pads.
As shown in FIG. 60, the optimal temperature 133114 for vessel sealing is labeled as a first target temperature T1And the optimal temperature 133116 for "infinite" clamp arm pad life is labeled as the second target temperature T2. The frequency temperature feedback control algorithm infers the temperature of the ultrasonic blade and maintains the temperature of the ultrasonic blade at a first target temperature threshold T1And a second target temperature threshold T2In the meantime. Thus, the generator power output is driven to achieve an optimal ultrasonic blade temperature for sealing the blood vessel and extending the life of the clamp arm pad.
Initially, the temperature of the ultrasonic blade increases as the blade heats up and eventually exceeds a first target temperature threshold T1. Frequency temperature feedback control algorithm takes over to control the temperature of the blade to T1Until at t 0133118 transection of the blood vessel is completed and the temperature of the ultrasonic blade is reduced to a second target temperature threshold T2The following. A processor or control circuit of the generator or instrument or both detects when the ultrasonic blade contacts the clamp arm pad. Once at t0When the blood vessel crosscutting is finished and detected, the frequency temperature feedback control algorithm is switched to control the temperature of the ultrasonic knife to be the second target threshold value T2To prolong the life of the clamping arm pad. The optimal clamp arm pad life temperature for the TEFLON clamp arm pad is about 325 ℃. In one aspect, the user may be notified of the advanced tissue treatment at the second activation tone.
Fig. 61 is a logic flow diagram 133120 of a method in accordance with at least one aspect of the present disclosure, depicting a control routine or logic configuration for controlling the temperature of the ultrasonic blade between two temperature set points as shown in fig. 60. According to the method, the generator executes an aspect of a frequency temperature feedback control algorithm to, for example, adjust the voltage V applied to the ultrasonic transducerg(t) and/or the current Ig(T) the signal to apply 133122 a first power level to the ultrasound transducer to set the ultrasound blade temperature to a first target T optimized for vessel sealing1. As previously mentioned, the generator monitors 133124 the voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
And based on the phase angle
The generator infers 133126 the temperature of the ultrasonic blade using the techniques described herein in connection with fig. 54A-56. The processor or control circuitry of the generator or instrument or both maintains the temperature of the ultrasonic blade at a first target temperature T according to a frequency temperature feedback control algorithm1Until the crosscut is completed. A frequency temperature feedback control algorithm may be used to detect completion of the vessel transection procedure. A processor or control circuit of the generator or instrument or both determines 133128 when the vessel transection is complete. The method continues along the NO branch when the vessel transection is not complete, and along the YES branch when the vessel transection is complete.
When the vessel transection is not complete, the processor or control circuitry of the generator or instrument or both determines 133130 whether the temperature of the ultrasonic blade is set to a temperature T optimized for vessel sealing and transection1. If the temperature of the ultrasonic blade is set to T1Then the method continues along the YES branch and the processor or control circuit of the generator or instrument or both continues to monitor 133124 the voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
And based on the phase angle
If the temperature of the ultrasonic blade is not set to T1Then the method continues along the NO branch and the processor or control circuitry of the generator or instrument or both continues to apply 133122 the first power level to the ultrasonic transducer.
When the vessel transection is complete, the processor or control circuitry of the generator or instrument or both applies 133132 a second power level to the ultrasonic transducer to set the ultrasonic blade to a position specific to the vesselMaintaining or extending a life-optimized second target temperature T of a clamp arm pad2. The processor or control circuit of the generator or instrument or both determines 133134 whether the temperature of the ultrasonic blade is at the set temperature T2. If the temperature of the ultrasonic blade is set to T2, the method completes 133136 the vessel transection procedure.
Starting temperature of the blade
Knowing the temperature of the ultrasonic blade at the beginning of the transection may enable the generator to deliver the proper amount of power to heat the blade for quick cuts, or to add only the power needed if the blade is already hot. This technique may enable more consistent traverse times and extend the life of the clamping arm pad (e.g., TEFLON clamping arm pad). Knowing the temperature of the ultrasonic blade at the beginning of the transection may enable the generator to deliver the proper amount of power to the ultrasonic transducer to generate the desired amount of ultrasonic blade displacement.
Fig. 62 is a logic flow diagram 133140 depicting a control routine or logic configuration for determining an initial temperature of an ultrasonic blade in accordance with at least one aspect of the present disclosure. To determine the initial temperature of the ultrasonic blade, the resonant frequency of the ultrasonic blade is measured at room temperature or a predetermined ambient temperature at the manufacturing facility. The baseline frequency values are recorded and stored in a look-up table of the generator or the instrument or both. The baseline value is used to generate the transfer function. At the beginning of the ultrasonic transducer activation cycle, the generator measures 133142 the resonant frequency of the ultrasonic blade and compares 133144 the measured resonant frequency to a baseline resonant frequency value and determines a frequency difference (Δ f). Δ f is compared to a look-up table or transfer function of the corrected ultrasonic blade temperature. The resonant frequency of the ultrasonic blade may be determined by sweeping the voltage V applied to the ultrasonic transducerg(t) and current Ig(t) the frequency of the signal. Resonant frequency being voltage Vg(t) and current Ig(t) phase angle between signals
A frequency at zero, as described herein.
Once the resonant frequency of the ultrasonic blade is determined, the processor or control of the generator or instrument or bothThe circuit determines 133146 an initial temperature of the ultrasonic blade based on a difference between the measured resonant frequency and the baseline resonant frequency. The generator is for example by regulating the voltage V before activating the ultrasonic transducerg(t) drive signal or current Ig(t) the drive signal or both to set the power level delivered to the ultrasound transducer to one of the following values.
The processor or control circuit of the generator or instrument or both determines 133148 whether the initial temperature of the ultrasonic blade is low. If the initial temperature of the ultrasonic blade is low, the method continues along the YES branch and the processor or control circuit of the generator or instrument or both applies 133152 a high power level to the ultrasonic transducer to increase the temperature of the ultrasonic blade and complete the 133156 vessel transection procedure.
If the initial temperature of the ultrasonic blade is not low, the method continues along the NO branch and the processor or control circuit of the generator or instrument or both determines 133150 whether the initial temperature of the ultrasonic blade is high. If the initial temperature of the ultrasonic blade is high, the method continues along the YES branch and the processor or control circuit of the generator or instrument or both applies 133154 a low power level to the ultrasonic transducer to reduce the temperature of the ultrasonic blade and complete the 133156 vessel transection procedure. If the initial temperature of the ultrasonic blade is not high, the method continues along the NO branch and the processor or control circuitry of the generator or instrument or both completes 133156 the vessel transection.
Smart blade technology for controlling blade instability
The temperature of the contents within the jaws of the ultrasonic blade and ultrasonic end effector may be determined using the frequency temperature feedback control algorithm described herein. The frequency/temperature relationship of the ultrasonic blade is used to control the instability of the ultrasonic blade at temperature.
As described herein, there is a well-known relationship between frequency and temperature in an ultrasonic blade. Some ultrasonic blades exhibit displacement instability or modal instability in the presence of elevated temperatures. This can employ the known relationship to explain when the ultrasonic blade is approaching instability and then adjust the power level driving the ultrasonic transducer (e.g., by adjusting the applicationDrive voltage V to an ultrasonic transducerg(t) Signal or Current Ig(t) signal, or both) to modulate the temperature of the ultrasonic blade to prevent instability of the ultrasonic blade.
Fig. 63 is a logic flow diagram 133160 of a method in accordance with at least one aspect of the present disclosure that depicts a control program or logic configuration for determining when an ultrasonic blade is approaching instability and then adjusting the power to the ultrasonic transducer to prevent instability of the ultrasonic transducer. Frequency/temperature relationship of an ultrasonic blade exhibiting displacement or modal instability by sweeping the drive voltage V over the temperature of the ultrasonic bladeg(t) Signal or Current Ig(t) the frequency of the signal or both and recording the results for mapping. A function or relationship is developed that can be used/interpreted by a control algorithm executed by the generator. A trigger point may be established using this relationship to inform the generator that the ultrasonic blade is approaching a known blade instability. The generator performs a frequency temperature feedback control algorithm processing function and a closed loop response such that the drive power level is reduced (e.g., by reducing the drive voltage V applied to the ultrasonic transducer)g(t) or the current Ig(t) or both) to modulate the temperature of the ultrasonic blade to or below the trigger point to prevent a given blade from reaching instability.
Advantages include simplifying the ultrasonic blade configuration so that the instability characteristics of the ultrasonic blade need not be designed and can be compensated for using the instability control techniques of the present disclosure. The instability control techniques of the present disclosure also enable new ultrasonic blade geometries and may improve stress distribution in heated ultrasonic blades. In addition, the ultrasonic blade may be configured to reduce the performance of the ultrasonic blade if used with a generator that does not employ this technique.
According to the method depicted by logic flow diagram 133160, a processor or control circuit of the generator or instrument or both monitors 133162 the voltage V applied to the ultrasound transducerg(t) and current Ig(t) phase angle between signals
The processor or control circuit of the generator or instrument or both is based on the voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
The temperature of the ultrasonic blade is inferred 133164. The processor or control circuit of the generator or instrument or both compares 133166 the inferred temperature of the ultrasonic blade to the ultrasonic blade instability trigger point threshold. The processor or control circuit of the generator or instrument or both determines 133168 whether the ultrasonic blade is approaching instability. If not, the method proceeds along the NO branch and the phase angle is monitored 133162
The temperature of the ultrasonic blade is inferred 133164 and the inferred temperature of the ultrasonic blade is compared 133166 to an ultrasonic blade instability trigger point threshold until the ultrasonic blade is near an instability. The method then proceeds along the YES branch, and the processor or control circuit of the generator or instrument or both adjusts 133170 the power level applied to the ultrasonic transducer to adjust the temperature of the ultrasonic blade.
Ultrasonic sealing algorithm with temperature control
An ultrasonic sealing algorithm with ultrasonic blade temperature control may be used to improve hemostasis using the frequency temperature feedback control algorithm described herein to take advantage of the frequency/temperature relationship of the ultrasonic blade.
In one aspect, a frequency temperature feedback control algorithm may be employed to vary the power level applied to the ultrasound transducer based on a measured temperature-dependent resonant frequency (using spectroscopy), as described in various aspects of the present disclosure. In one aspect, the frequency temperature feedback control algorithm may be activated by an energy button on the ultrasonic instrument.
It is known that optimal tissue effects can be achieved by increasing the power level at which the ultrasound transducer is driven early in the sealing cycle (e.g., by increasing the drive voltage V applied to the ultrasound transducer)g(t) or the current Ig(t) or both) to rapidly heat and dehydrate tissue, and then reduce floodingPower level of a dynamic ultrasound transducer (e.g., by reducing the drive voltage V applied to the ultrasound transducerg(t) or the current Ig(t) or both) to slowly allow formation of the final seal. In one aspect, a frequency temperature feedback control algorithm according to the present disclosure sets limits on the temperature threshold achievable when tissue is heated during higher power level phases, and then reduces the power level based on the melting point of the clamping jaw pad (e.g., TEFLON) to control the temperature of the ultrasonic blade to complete the seal. The control algorithm may be implemented by activating an energy button on the instrument for a more responsive/adaptive seal to further reduce the complexity of the hemostasis algorithm.
Fig. 64 is a logic flow diagram 133180 of a method describing a control program or logic configuration for providing ultrasonic sealing with temperature control in accordance with at least one aspect of the present disclosure. According to the control algorithm, the processor or control circuitry of the generator or instrument or both activates 133182 ultrasonic blade sensing using spectroscopy (e.g., a smart blade) and measures 133184 the resonant frequency of the ultrasonic blade (e.g., the resonant frequency of the ultrasonic electromechanical system) to determine the temperature of the ultrasonic blade using a frequency temperature feedback control algorithm (spectroscopy) as described herein. As previously described, the resonant frequency of the ultrasonic electromechanical system is mapped to obtain the temperature of the ultrasonic blade as a function of the resonant frequency of the electromechanical ultrasonic system.
First desired resonance frequency f of the ultrasonic electromechanical systemxCorresponding to the first desired temperature Z of the ultrasonic blade. In one aspect, the first desired ultrasonic blade temperature Z is the optimal temperature for tissue coagulation (e.g., 450℃.). Second desired frequency f of the ultrasonic electromechanical systemYCorresponding to the second desired temperature ZZ ° of the ultrasonic blade. In one aspect, the second desired ultrasonic blade temperature ZZ ° is a temperature of 330 ℃ that is below the melting point of the clamp arm pad, which for TEFLON is about 380 ℃.
The processor or control circuit of the generator or instrument or both converts the measured resonant frequency of the ultrasonic electromechanical system to a first desired frequency fxA comparison 133186 is made. In other words, the method determines whether the temperature of the ultrasonic blade is less than the temperature for optimal tissue coagulation.If the measured resonant frequency of the ultrasonic electromechanical system is less than the first desired frequency fxThen the NO branch is followed and the processor or control circuit of the generator or instrument or both increases 133188 the power level applied to the ultrasonic transducer to increase the temperature of the ultrasonic blade until the measured resonant frequency of the ultrasonic electromechanical system exceeds the first desired frequency fxUntil now. In this case, the tissue coagulation process is complete and the method controls the temperature of the ultrasonic blade to correspond to the second desired frequency fyThe second desired temperature of (a).
The method continues along the YES branch and the processor or control circuit of the generator or instrument or both reduces 133190 the power level applied to the ultrasonic transducer to reduce the temperature of the ultrasonic blade. The processor or control circuit of the generator or instrument or both measures 133192 the resonant frequency of the electromechanical system of the ultrasound and matches the measured resonant frequency with a second desired frequency fYA comparison is made. If the measured resonance frequency is not less than the second desired frequency fYThe processor or control circuit of the generator or instrument or both reduces 133190 the ultrasonic power level until the measured resonant frequency is less than the second desired frequency fYUntil now. The frequency temperature feedback control algorithm maintains the measured resonant frequency of the ultrasonic electromechanical system at the second desired frequency fyThereafter, for example, the temperature of the ultrasonic blade is less than the temperature of the melting point of the clamp arm pad, and the generator then performs an increase in the power level applied to the ultrasonic transducer to increase the temperature of the ultrasonic blade until the tissue-strong procedure is complete 133196.
Fig. 65 is a graphical representation 133200 of ultrasonic transducer current and ultrasonic blade temperature as a function of time in accordance with at least one aspect of the present disclosure. Fig. 65 shows the result of application of the frequency temperature feedback control algorithm described in fig. 64. Diagram 133200 shows the ultrasonic transducer current I as a function of timeg(t) first graph 133202 of ultrasonic blade temperature as a function of time of the second graph 133204. As shown, the transducer Ig(t) held constant until the ultrasonic blade temperature reached 450 °, which is the optimum coagulation temperature. Once the temperature of the ultrasonic knife reachesTo 450 deg., the frequency temperature feedback control algorithm will reduce the transducer current Ig(t) until the temperature of the ultrasonic blade drops below 330 °, which is below the melting point of, for example, a TEFLON pad.
Controlled Thermal Management (CTM) for pad protection
In one aspect, the present disclosure provides a Controlled Thermal Management (CTM) algorithm to adjust temperature with feedback control. The output of the feedback control may be used to prevent burn-through of the ultrasonic end effector clamp arm pad, which is not a desirable effect for ultrasonic surgical instruments. As previously mentioned, pad burn-through is generally caused by the continued application of ultrasonic energy to an ultrasonic blade in contact with the pad after tissue grasped in the end effector has been transected.
The CTM algorithm takes advantage of the fact that: the resonant frequency of an ultrasonic blade, typically made of titanium, varies with temperature. As the temperature increases, the elastic modulus of the ultrasonic blade decreases, as does the natural frequency of the ultrasonic blade. A factor to be considered is that when the distal end of the ultrasonic blade is hot but the waveguide is cold, the frequency difference () achieving the predetermined temperature is different than when both the distal end of the ultrasonic blade and the waveguide are hot.
In one aspect, the CTM algorithm calculates the change in frequency of the ultrasonic transducer drive signal that is required to reach some predetermined temperature at the start of activation (when locked) as a function of the resonant frequency of the ultrasonic electromechanical system. An ultrasonic electromechanical system including an ultrasonic transducer coupled to an ultrasonic blade by an ultrasonic waveguide has a predefined resonant frequency that varies with temperature. The resonant frequency of the ultrasonic electromechanical system at lock-up can be used to estimate the change in the ultrasonic transducer drive frequency that is required to achieve a temperature endpoint to account for the initial thermal state of the ultrasonic blade. The resonant frequency of the ultrasonic electromechanical system may vary as a function of the temperature of the ultrasonic transducer or waveguide or blade or a combination of these devices.
Fig. 66 is a graphical representation 133300 of the relationship between the initial resonant frequency (lock frequency) and the frequency change (frequency) required to achieve a temperature of about 340 ℃, according to at least one aspect of the present disclosure. The change in frequency required to reach an ultrasonic blade temperature of about 340 ℃ is shown along the vertical axis and the resonant frequency of the electromechanical ultrasound system when locked is shown along the horizontal axis. Based on the measurement data points 133302, shown as a scatter plot, there is a linear relationship 133304 between the change in frequency required to reach an ultrasonic blade temperature of about 340 ℃ and the resonant frequency at lock-in.
When the resonant frequency is locked, the CTM algorithm uses a linear relationship 133304 between the locking frequency and the frequency required to reach a temperature just below the melting point of the TEFLON pad (about 340 ℃). In accordance with at least one aspect of the present disclosure, once the frequency is within a certain buffer distance from the lower frequency limit, as shown in fig. 67, a feedback control system 133310 including an ultrasound generator 133312 adjusts the current (i) set point applied to the ultrasound transducer of the ultrasound electromechanical system 133314 to prevent the frequency (f) of the ultrasound transducer from dropping below a predetermined threshold. Lowering the current set point may decrease the displacement of the ultrasonic blade, which in turn decreases the temperature of the ultrasonic blade and increases the natural frequency of the ultrasonic blade. This relationship allows the current applied to the ultrasonic transducer to be varied to adjust the natural frequency of the ultrasonic blade and indirectly control the temperature of the ultrasonic blade or ultrasonic electromechanical system 133314. In one aspect, the generator 133312 can be implemented as the ultrasonic generator described with reference to fig. 21, 26, 27A, 27C, and 28A-28B. The feedback control system 133310 may be implemented as a PID controller as described with reference to FIGS. 44-45, for example.
Fig. 68 is a flow chart 133320 of a method or logic configuration for a Controlled Thermal Management (CTM) algorithm for protecting clamp arm pads in an ultrasonic end effector, according to at least one aspect of the present disclosure. The method or logic configuration illustrated by flowchart 133320 may be performed by the ultrasound generator 133312 or control circuitry located in the ultrasonic instrument as described herein, or a combination thereof. As previously described, the generator 133312 may be implemented as the generator described with reference to fig. 21, 26, 27A-27C, and 28A-28B.
In one aspect, the control circuitry in the generator 133312 initially activates the ultrasonic instrument by applying a current to the ultrasonic transducer. The resonant frequency of the ultrasonic electromechanical system is initially locked under initial conditions where the temperature of the ultrasonic blade is cold or near room temperature. When the temperature of the ultrasonic blade increases due to frictional contact with tissue, for example, the control circuit monitors the change in the resonant frequency of the ultrasonic electromechanical system or, and determines 133324 whether a frequency threshold of the predetermined blade temperature has been reached. If the frequency is below the threshold, the method continues along the NO branch and the control circuit continues to look 133325 for a new resonant frequency and monitor the frequency. When the frequency meets or exceeds the frequency threshold, the method continues along the YES branch and a new lower frequency limit (threshold) is calculated 133326, which corresponds to the melting point of the clamp arm pad. In one non-limiting example, the clamping arm pad is made of TEFLON and has a melting point of about 340 ℃.
Once the new lower frequency limit of 133326 is calculated, the control circuit determines 133328 whether the resonant frequency is near the newly calculated lower frequency limit. For example, in the case of TEFLON clamping arm pads, the control circuitry determines 133328 whether the ultrasonic blade temperature is near 350℃, e.g., based on the current resonant frequency. If the current resonant frequency is above the lower frequency limit, the method continues along the NO branch and a normal level of current is applied 133330 to the ultrasound transducer suitable for tissue transection. Alternatively, if the current resonant frequency is at or below the lower frequency limit, the method continues along the YES branch and the resonant frequency is adjusted 133332 by modifying the current applied to the ultrasonic transducer. In one aspect, the control circuit employs a PID controller, as described in connection with FIGS. 44-45, for example. The control circuit adjusts 133332 the frequency in the loop to determine when 133328 the frequency approaches a lower limit until the "seal and cut" surgical procedure is terminated and the ultrasound transducer is deactivated. Since the CTM algorithm shown in logic flow diagram 133320 is only effective at or near the melting point of the clamp arm pad, the CTM algorithm is activated after transecting the tissue.
Burst pressure testing of the samples showed no effect on the burst pressure of the seal when sealing and cutting a blood vessel or other tissue using the CTM method or logic configuration depicted by logic flow diagram 133320. Furthermore, the number of crosscuts is affected based on the test specimen. Furthermore, temperature measurements confirmed that the ultrasonic blade temperature was limited by the CTM algorithm compared to the device without CTM feedback algorithm control, and that the device with 10 firings at maximum power (5 seconds of rest between firings) showed significantly reduced pad wear, while the device without CTM algorithm feedback control did not last more than 2 firings in this abuse test.
Fig. 69 is a graph 133340 of temperature versus time comparing expected temperatures of an ultrasonic blade with a smart ultrasonic blade and a conventional ultrasonic blade in accordance with at least one aspect of the present disclosure. Temperature (degrees celsius) is displayed along the vertical axis and time (seconds) is displayed along the horizontal axis. In the graph, the dotted line is a temperature threshold 133342 that represents the desired temperature of the ultrasonic blade. The solid line is the temperature versus time curve 133344 of the smart ultrasonic blade under control of the CTM algorithm described with reference to fig. 67 and 68. The dotted line is the temperature versus time curve 133346 for a conventional ultrasonic blade that is not under control of the CTM algorithm described with reference to fig. 67 and 68. As shown in the figure. Once the temperature of the smart ultrasonic blade under the control of the CTM algorithm exceeds the desired temperature threshold (-340 ℃), the CTM algorithm controls and adjusts the temperature of the smart ultrasonic blade to match the threshold as closely as possible until the transection procedure is complete and the power of the ultrasonic transducer is deactivated or turned off.
In another aspect, the present disclosure provides a CTM algorithm for a "seal-only" tissue effect for an ultrasound device (such as, for example, ultrasound scissors). Generally, ultrasonic surgical instruments typically seal and cut tissue simultaneously. Because it is not certain when the seal is complete before cutting begins, it is not difficult to manufacture an ultrasonic device configured to be able to only seal without cutting using only ultrasonic techniques. In one aspect, the CTM algorithm may be configured to protect the end effector clamp arm pad by allowing the temperature of the ultrasonic blade to exceed the temperature required to cut (transect) tissue, but not exceed the melting point of the clamp arm pad. In another aspect, the CTM-only sealing algorithm may be tuned to exceed the sealing temperature of the tissue (about 115 ℃ to about 180 ℃ based on the experiment), but not to exceed the cutting (transecting) temperature of the tissue (about 180 ℃ to about 350 ℃). In the latter configuration, the CTM-only sealing algorithm provides a "sealing-only" tissue effect that has been successfully demonstrated. For example, in calculating a linear fit of the frequency change relative to the initial lock frequency, as shown in fig. 66, changing the intercept of the fit adjusts the final steady state temperature of the ultrasonic blade. By adjusting the intercept parameters, the ultrasonic blade can be set to never exceed about 180 ℃, resulting in tissue sealing but not cutting. In one aspect, increasing the clamping force can improve the sealing method without affecting the clamp arm pad burn-through, as the temperature of the blade is controlled by the CTM-only sealing algorithm. As previously described, for example, the CTM-only sealing algorithm may be implemented by the generator and PID controller described with reference to fig. 21, 26, 27A-27C, 28A-28B, and 44-45. Accordingly, the flow chart 133320 shown in fig. 68 may be modified such that the control circuit calculates 133326 a new lower frequency limit (the threshold t corresponds to a "seal only" temperature, such as, for example, about 180 ℃, determines when 133328 frequency is approaching the lower limit, and adjusts 133332 temperature until the "seal only" surgical procedure is terminated and the ultrasound transducer is deactivated.
In another aspect, the present invention provides a cooling thermal monitoring (CTMo) algorithm configured to be able to detect when an atraumatic grip is feasible. The acoustic ultrasonic energy results in an ultrasonic blade temperature of about 230 ℃ to about 300 ℃ to achieve the desired effect of cutting or transecting tissue. Because heat remains within the metal body of the ultrasonic blade for a period of time after the ultrasonic transducer is deactivated, residual heat stored in the ultrasonic blade may cause tissue damage if the ultrasonic end effector is used to grasp tissue before the ultrasonic blade has an opportunity to cool.
In one aspect, the CTMo algorithm calculates the change in the natural frequency of the electromechanical system of the ultrasound from the natural frequency in the hot state to the natural frequency at a temperature that does not damage the tissue being grasped by the end effector. A non-therapeutic signal (about 5mA) is applied to the ultrasound transducer, either directly or for a predetermined period of time after activation of the ultrasound transducer, which contains a frequency bandwidth of, for example, about 48,000Hz to 52,000Hz at which it is desired to find the natural frequency. An FFT algorithm of the ultrasound transducer impedance measured during stimulation of the ultrasound transducer with a non-therapeutic signal or other mathematically valid algorithm that detects the natural frequency of the ultrasound electromechanical system will indicate that the natural frequency of the ultrasonic blade is the frequency at which the impedance magnitude is the smallest. Continuously exciting the ultrasonic transducer in this manner provides continuous feedback of the natural frequency of the ultrasonic blade within the frequency resolution of the FFT or other algorithm used to estimate or measure the natural frequency. When a change in natural frequency corresponding to a temperature feasible for non-invasive grasping is detected, a tone, or LED, or screen display or other form of notification, or a combination thereof, is provided to indicate that the apparatus is capable of non-invasive grasping.
In another aspect, the present disclosure provides a CTM algorithm configured to enable toning for sealing and end of cut or transection. Providing "tissue sealing" and "end of cut" notifications is a challenge for conventional ultrasonic devices because temperature measurements cannot be easily mounted directly to the ultrasonic blade and the blade does not explicitly detect the clamp arm pad using the sensor. The CTM algorithm may indicate the temperature status of the ultrasonic blade and may be used to indicate "end of cut" or "tissue seal", or both, as these are temperature-based events.
In one aspect, a CTM algorithm according to the present disclosure detects an "end of cut" state and activates a notification. Tissue is typically cut with high probability at about 210 ℃ to about 320 ℃. The CTM algorithm may activate a tone at 320 ℃ (or similar temperature) to indicate that further activation on the tissue is ineffective because the tissue may be cut and the ultrasonic blade is now traveling against the clamp arm pad, which is acceptable when the CTM algorithm is activated because it controls the temperature of the ultrasonic blade. In one aspect, the CTM algorithm is programmed to control or adjust the power of the ultrasonic transducer to maintain the temperature of the ultrasonic blade at about 320 ℃ when the temperature estimate of the ultrasonic blade has reached 320 ℃. The start tone now provides an indication that the tissue has been cut. The CTM algorithm is based on the variation of frequency with temperature. After determining the initial state temperature (based on the initial frequency), the CTM algorithm may calculate a frequency change corresponding to a temperature indicating when tissue was cut. For example, if the starting frequency is 51,000Hz, the CTM algorithm will calculate the frequency change required to achieve 320 deg.C, which may be-112 Hz. It will then begin control to maintain the frequency set point (e.g., 50,888Hz) to adjust the temperature of the ultrasonic blade. Similarly, the frequency change may be calculated based on an initial frequency indicating when the ultrasonic blade is at a temperature indicating that tissue is likely to be cut. At this point, the CTM algorithm does not have to control power, but just initiate a tone to indicate the state of the tissue, or the CTM algorithm may control the frequency at this point to maintain the temperature (if needed). Either way, "end of cut" is indicated.
In one aspect, a CTM algorithm according to the present disclosure detects a "tissue seal" state and activates a notification. Similar to the end-of-cut test, the tissue is sealed between about 105 ℃ and about 200 ℃. The change in frequency from the initial frequency required to indicate that the temperature of the ultrasonic blade has reached 200 c (which indicates a seal only condition) can be calculated at the time the ultrasonic transducer begins to activate. The CTM algorithm may activate the tone at this point, and if the surgeon wishes to achieve a seal-only state, the surgeon may stop the activation or achieve a seal-only state. The surgeon may stop activating the ultrasound transducer and from this point automatically start a particular sealing-only algorithm, or the surgeon may continue to activate the ultrasound transducer to obtain a tissue cutting state.
Situation awareness
Referring now to fig. 70, a timeline 5200 depicting situational awareness of a hub (e.g., surgical hub 106 or 206) is shown. The time axis 5200 is illustrative of a surgical procedure and background information that the surgical hub 106, 206 may derive from data received from the data source at each step in the surgical procedure. The time axis 5200 depicts typical steps that nurses, surgeons, and other medical personnel will take during a segmented resection procedure, starting from the establishment of an operating room and ending with the transfer of the patient to a post-operative recovery room.
The situation aware surgical hub 106, 206 receives data from data sources throughout the course of a surgical procedure, including data generated each time a medical professional utilizes a modular device paired with the surgical hub 106, 206. The surgical hub 106, 206 may receive this data from the paired modular devices and other data sources, and continually derive inferences about the ongoing procedure (i.e., background information) as new data is received, such as which step of the procedure is performed at any given time. The situational awareness system of the surgical hub 106, 206 can, for example, record data related to the procedure used to generate the report, verify that the medical personnel are taking steps, provide data or prompts that may be related to particular procedure steps (e.g., via a display screen), adjust the modular device based on context (e.g., activate a monitor, adjust a field of view (FOV) of a medical imaging device, or change an energy level of an ultrasonic surgical instrument or RF electrosurgical instrument), and take any other such actions described above.
As a first step 5202 in the exemplary procedure, the hospital staff retrieves the patient's EMR from the hospital's EMR database. Based on the selected patient data in the EMR, the surgical hub 106, 206 determines that the procedure to be performed is a chest procedure.
In a second step 5204, the staff scans the incoming medical supply for the procedure. The surgical hub 106, 206 cross-references the scanned supplies with a list of supplies used in various types of protocols and confirms that the supplied mix corresponds to a chest protocol. In addition, the surgical hub 106, 206 is also able to determine that the procedure is not a wedge procedure (because the incoming supplies lack some of the supplies required for the chest wedge procedure, or otherwise do not correspond to the chest wedge procedure).
In a third step 5206, medical personnel scan the patient belt via a scanner communicatively coupled to the surgical hub hubs 106, 206. The surgical hub 106, 206 may then confirm the identity of the patient based on the scanned data.
Fourth, the medical staff opens the ancillary equipment 5208. The ancillary equipment utilized may vary depending on the type of surgical procedure and the technique to be used by the surgeon, but in this exemplary case they include smoke ejectors, insufflators, and medical imaging devices. When activated, the auxiliary device as a modular device may be automatically paired with a surgical hub 106, 206 located in a specific vicinity of the modular device as part of its initialization process. The surgical hub 106, 206 may then derive contextual information about the surgical procedure by detecting the type of modular device with which it is paired during the pre-operative or initialization phase. In this particular example, the surgical hub 106, 206 determines that the surgical procedure is a VATS procedure based on this particular combination of paired modular devices. Based on the combination of data from the patient's EMR, the list of medical supplies used in the procedure, and the type of modular device connected to the hub, the surgical hub 106, 206 can generally infer the specific procedure that the surgical team will perform. Once the surgical hub 106, 206 knows what specific procedure is being performed, the surgical hub 106, 206 may retrieve the steps of the procedure from memory or cloud and then cross-reference the data it subsequently receives from the connected data sources (e.g., modular devices and patient monitoring devices) to infer what steps of the surgical procedure are being performed by the surgical team.
In a fifth step 5210, the staff member attaches EKG electrodes and other patient monitoring devices to the patient. EKG electrodes and other patient monitoring devices can be paired with the surgical hubs 106, 206. When the surgical hub 106, 206 begins to receive data from the patient monitoring device, the surgical hub 106, 206 thus confirms that the patient is in the operating room.
Sixth step 5212, the medical personnel induce anesthesia in the patient. The surgical hub 106, 206 may infer that the patient is under anesthesia based on data from the modular device and/or the patient monitoring device, including, for example, EKG data, blood pressure data, ventilator data, or a combination thereof. Upon completion of the sixth step 5212, the pre-operative portion of the lung segmentation resection procedure is completed and the surgical portion begins.
In a seventh step 5214, the patient's lungs being operated on are collapsed (while ventilation is switched to the contralateral lungs). For example, the surgical hub 106, 206 may infer from the ventilator data that the patient's lungs have collapsed. The surgical hub 106, 206 may infer that the surgical portion of the procedure has begun because it may compare the detection of the patient's lung collapse to the expected steps of the procedure (which may have been previously visited or retrieved) to determine that collapsing the lungs is the surgical step in that particular procedure.
In an eighth step 5216, a medical imaging device (e.g., an endoscope) is inserted and video from the medical imaging device is initiated. The surgical hub 106, 206 receives medical imaging device data (i.e., video or image data) through its connection to the medical imaging device. After receiving the medical imaging device data, the surgical hub 106, 206 may determine that a laparoscopic portion of the surgical procedure has begun. In addition, the surgical hub 106, 206 may determine that the particular procedure being performed is a segmental resection, rather than a leaf resection (note that the wedge procedure has been excluded based on the data received by the surgical hub 106, 206 at the second step 5204 of the procedure). Data from the medical imaging device 124 (fig. 2) may be used to determine contextual information relating to the type of procedure being performed in a number of different ways, including by determining the angle of visualization orientation of the medical imaging device relative to the patient anatomy, monitoring the number of medical imaging devices utilized (i.e., activated and paired with the surgical hub 106, 206), and monitoring the type of visualization devices utilized. For example, one technique for performing a VATS lobectomy places the camera in the lower anterior corner of the patient's chest above the septum, while one technique for performing a VATS segmental resection places the camera in an anterior intercostal location relative to the segmental cleft. For example, using pattern recognition or machine learning techniques, the situational awareness system may be trained to recognize the positioning of the medical imaging device from a visualization of the patient's anatomy. As another example, one technique for performing VATS leaf resection utilizes a single medical imaging device, while another technique for performing VATS segmental resection utilizes multiple cameras. As another example, one technique for performing a VATS segmental resection utilizes an infrared light source (which may be communicatively coupled to a surgical hub as part of a visualization system) to visualize segmental fissures that are not used in a VATS leaf resection. By tracking any or all of this data from the medical imaging device, the surgical hub 106, 206 can thus determine the specific type of surgical procedure being performed and/or the technique being used for a particular type of surgical procedure.
Ninth step 5218, the surgical team begins the dissection step of the procedure. The surgical hub 106, 206 may infer that the surgeon is dissecting to mobilize the patient's lungs because it receives data from the RF generator or ultrasound generator indicating that the energy instrument is being fired. The surgical hub 106, 206 may intersect the received data with the retrieved steps of the surgical procedure to determine that the energy instrument fired at that point in the procedure (i.e., after completion of the previously discussed procedure steps) corresponds to an anatomical step. In some cases, the energy instrument may be an energy tool mounted to a robotic arm of a robotic surgical system.
In a tenth step 5220, the surgical team continues with the ligation step of the procedure. The surgical hub 106, 206 may infer that the surgeon is ligating arteries and veins because it receives data from the surgical stapling and severing instrument indicating that the instrument is being fired. Similar to the previous steps, the surgical hub 106, 206 may deduce the inference by cross-referencing the receipt of data from the surgical stapling and severing instrument with the retrieval steps in the procedure. In some cases, the surgical instrument may be a surgical tool mounted to a robotic arm of a robotic surgical system.
An eleventh step 5222, a segmental resection portion of the procedure is performed. The surgical hub 106, 206 may infer that the surgeon is transecting soft tissue based on data from the surgical stapling and severing instrument, including data from its cartridge. The cartridge data may correspond to, for example, the size or type of staples fired by the instrument. Since different types of staples are used for different types of tissue, the cartridge data can indicate the type of tissue being stapled and/or transected. In this case, the type of staple fired is for soft tissue (or other similar tissue type), which allows the surgical hub 106, 206 to infer that a segmental resection portion of the procedure is in progress.
In a twelfth step 5224, a node dissection step is performed. The surgical hub 106, 206 may infer that the surgical team is dissecting a node and performing a leak test based on data received from the generator indicating that the RF or ultrasonic instrument is being fired. For this particular procedure, the RF or ultrasound instruments used after transecting soft tissue correspond to a node dissection step that allows the surgical hub 106, 206 to make such inferences. It should be noted that the surgeon periodically switches back and forth between the surgical stapling/severing instrument and the surgical energy (i.e., RF or ultrasonic) instrument according to specific steps in the procedure, as different instruments are better suited to the particular task. Thus, the particular sequence in which the stapling/severing instrument and the surgical energy instrument are used may indicate the steps of the procedure being performed by the surgeon. Further, in some cases, robotic implements may be used for one or more steps in a surgical procedure, and/or hand-held surgical instruments may be used for one or more steps in a surgical procedure. The surgeon(s) may alternate and/or may use the device simultaneously, for example, between a robotic tool and a hand-held surgical instrument. Upon completion of the twelfth step 5224, the incision is closed and the post-operative portion of the procedure begins.
A thirteenth step 5226, reverse the patient's anesthesia. For example, the surgical hub 106, 206 may infer that the patient is waking up from anesthesia based on, for example, ventilator data (i.e., the patient's breathing rate begins to increase).
Finally, a fourteenth step 5228 is for the medical personnel to remove various patient monitoring devices from the patient. Thus, when the hub loses EKG, BP, and other data from the patient monitoring device, the surgical hub 106, 206 may infer that the patient is being transferred to a recovery room. As can be seen from the description of the exemplary procedure, the surgical hub 106, 206 may determine or infer from data received from various data sources communicatively coupled to the surgical hub 106, 206 when each step of a given surgical procedure occurs.
Situational awareness is further described in U.S. provisional patent application serial No. 62/611,341 entitled interactive surgical platform (INTERACTIVE SURGICAL PLATFORM), filed on 28.12.2017, which is incorporated herein by reference in its entirety. In certain instances, operation of the robotic surgical system (including the various robotic surgical systems disclosed herein) may be controlled by the hub 106, 206 based on its situational awareness and/or feedback from its devices and/or based on information from the cloud 102.
While several forms have been illustrated and described, it is not the intention of the applicants to restrict or limit the scope of the appended claims to such detail. Numerous modifications, changes, variations, substitutions, combinations, and equivalents of these forms can be made without departing from the scope of the present disclosure, and will occur to those skilled in the art. Further, the structure of each element associated with the described forms may alternatively be described as a means for providing the function performed by the element. In addition, where materials for certain components are disclosed, other materials may also be used. It is, therefore, to be understood that the foregoing detailed description and appended claims are intended to cover all such modifications, combinations and variations as fall within the scope of the disclosed forms of the invention. It is intended that the following claims cover all such modifications, changes, variations, substitutions, modifications, and equivalents.
The foregoing detailed description has set forth various forms of the devices and/or methods via the use of block diagrams, flowcharts, and/or examples. Insofar as such block diagrams, flowcharts, and/or examples contain one or more functions and/or operations, it will be understood by those within the art that each function and/or operation within such block diagrams, flowcharts, or examples can be implemented, individually and/or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. Those skilled in the art will recognize that some aspects of the forms disclosed herein, in whole or in part, can be equivalently implemented in integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or as virtually any combination thereof, and that designing the electronic circuitry and/or writing the code for the software and or hardware would be well within the skill of one of skill in the art in light of this disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein are capable of being distributed as one or more program products in a variety of forms, and that an exemplary form of the subject matter described herein applies regardless of the particular type of signal bearing media used to actually carry out the distribution.
The instructions for programming logic to perform the various disclosed aspects may be stored within a memory within the system, such as a Dynamic Random Access Memory (DRAM), cache, flash memory, or other memory. Further, the instructions may be distributed via a network or through other computer readable media. Thus, a machine-readable medium may include a mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), but is not limited to, floppy diskettes, optical disks, read-only memories (CD-ROMs), magneto-optical disks, read-only memories (ROMs), Random Access Memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memory, or a tangible, machine-readable storage device for use in transmitting information over the internet via electrical, optical, acoustical or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Thus, a non-transitory computer-readable medium includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).
As used in any aspect herein, the term "control circuitry" can refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor that includes one or more separate instruction processing cores, processing units, processors, microcontrollers, microcontroller units, controllers, Digital Signal Processors (DSPs), Programmable Logic Devices (PLDs), Programmable Logic Arrays (PLAs), Field Programmable Gate Arrays (FPGAs)), state machine circuitry, firmware that stores instructions executed by programmable circuitry, and any combination thereof. The control circuitry may be implemented collectively or individually as circuitry that forms part of a larger system, e.g., an Integrated Circuit (IC), an Application Specific Integrated Circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electronic circuitry having at least one discrete circuit, electronic circuitry having at least one integrated circuit, electronic circuitry having at least one application specific integrated circuit, electronic circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially implements the methods and/or apparatus described herein, or a microprocessor configured by a computer program that at least partially implements the methods and/or apparatus described herein), electronic circuitry forming a memory device (e.g., in the form of random access memory), and/or electronic circuitry forming a communication device (e.g., a modem, a communication switch, or an optoelectronic device). Those skilled in the art will recognize that the subject matter described herein may be implemented in an analog or digital fashion, or some combination thereof.
As used in any aspect herein, the term "logic" may refer to an application, software, firmware, and/or circuitry configured to be capable of performing any of the foregoing operations. The software may be embodied as a software package, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or instruction sets and/or data that are hard-coded (e.g., nonvolatile) in a storage device.
As used in any aspect herein, the terms "component," "system," "module," and the like can refer to a computer-related entity, either hardware, a combination of hardware and software, or software in execution.
An "algorithm," as used in any aspect herein, is a self-consistent sequence of steps leading to a desired result, wherein "step" refers to the manipulation of physical quantities and/or logical states which may (but are not necessarily) take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. And are used to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or conditions.
The network may comprise a packet switched network. The communication devices may be capable of communicating with each other using the selected packet switched network communication protocol. One exemplary communication protocol may include an ethernet communication protocol that may allow communication using the transmission control protocol/internet protocol (TCP/IP). The ethernet protocol may conform to or be compatible with the ethernet standard entitled "IEEE 802.3 standard" promulgated by the Institute of Electrical and Electronics Engineers (IEEE) at 12 months 2008 and/or higher versions of this standard. Alternatively or additionally, the communication devices may be capable of communicating with each other using an x.25 communication protocol. The x.25 communication protocol may conform to or conform to standards promulgated by the international telecommunication union, telecommunication standardization sector (ITU-T). Alternatively or additionally, the communication devices may be capable of communicating with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or conform to standards promulgated by the international committee for telephone and telephone negotiations (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be capable of communicating with each other using an Asynchronous Transfer Mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard entitled "ATM-MPLS network interworking 2.0" promulgated by the ATM forum at 8 months 2001 and/or higher versions of that standard. Of course, different and/or later-developed connection-oriented network communication protocols are also contemplated herein.
Unless specifically stated otherwise as apparent from the above discussion, it is appreciated that throughout the above disclosure, discussions utilizing terms such as "processing," "computing," "calculating," "determining," "displaying" or the like, refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.
One or more components may be referred to herein as "configured to be able," "configurable to be able," "operable," "adapted/adaptable," "able," "conformable/conformable," or the like. Those skilled in the art will recognize that "configured to be able to" may generally encompass components in an active state and/or components in an inactive state and/or components in a standby state unless the context indicates otherwise.
The terms "proximal" and "distal" are used herein with respect to a clinician manipulating a handle portion of a surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located away from the clinician. It will be further appreciated that for simplicity and clarity, spatial terms such as "vertical," "horizontal," "up," and "down" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.
Those skilled in the art will recognize that, in general, terms used herein, and especially in the appended claims (e.g., bodies of the appended claims) are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claims. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to claims containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations.
In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Further, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such a construction is intended to have a meaning that one of ordinary skill in the art would understand the convention (e.g., "a system having at least one of A, B and C" would include, but not be limited to, systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended to have a meaning that one of skill in the art would understand the convention (e.g., "a system having at least one of A, B or C" would include but not be limited to systems having a alone, B alone, C, A and B together alone, a and C together, B and C together, and/or A, B and C together, etc.). It will also be understood by those within the art that, in general, disjunctive words and/or phrases having two or more alternative terms, whether appearing in the detailed description, claims, or drawings, should be understood to encompass the possibility of including one of the terms, either of the terms, or both terms, unless the context indicates otherwise. For example, the phrase "a or B" will generally be understood to include the possibility of "a" or "B" or "a and B".
Those skilled in the art will appreciate from the appended claims that the operations recited therein may generally be performed in any order. In addition, while the various operational flow diagrams are presented in an order(s), it should be appreciated that the various operations may be performed in an order other than that shown, or may be performed concurrently. Examples of such alternative orderings may include overlapping, interleaved, interrupted, reordered, incremental, preliminary, complementary, simultaneous, reverse, or other altered orderings, unless context dictates otherwise. Furthermore, unless the context dictates otherwise, terms like "responsive," "related," or other past adjectives are generally not intended to exclude such variations.
It is worthy to note that any reference to "an aspect," "an example" means that a particular feature, structure, or characteristic described in connection with the aspect is included in at least one aspect. Thus, the appearances of the phrases "in one aspect," "in an example" in various places throughout this specification are not necessarily all referring to the same aspect. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more aspects.
Any patent applications, patents, non-patent publications or other published materials mentioned in this specification and/or listed in any application data sheet are herein incorporated by reference, to the extent that the incorporated materials are not inconsistent herewith. Thus, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
In summary, a number of benefits resulting from employing the concepts described herein have been described. The foregoing detailed description of one or more forms has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Modifications or variations are possible in light of the above teachings. The form or forms selected and described are to be illustrative of the principles and practical applications to thereby enable one of ordinary skill in the art to utilize the form or forms and various modifications as are suited to the particular use contemplated. The claims as filed herewith are intended to define the full scope.
Various aspects of the subject matter described herein are set forth in the following numbered examples:
example 1: a method of determining a temperature of an ultrasonic blade, the method comprising: determining, by a control circuit coupled to a memory, an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade through 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; and inferring, by a control circuit, a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
Example 2: the method of embodiment 1, wherein determining, by the control circuit, the actual resonant frequency of the ultrasound electromechanical system comprises: determining, by the control circuit, a voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
Example 3: the method of embodiment 2, further comprising generating, by the control circuit, a temperature estimator of the inferred temperature of the ultrasonic blade as a function of the resonant frequency of the ultrasonic electromechanical system and a state space model based on a set of non-linear state space formulas.
Example 4: the method of embodiment 3, wherein the state space model is defined by:
example 5: the method of embodiment 4, further comprising applying, by the control circuit, a Kalman filter to improve the temperature estimator and state space model.
Example 6: the method of embodiment 5, further comprising: applying, by the control circuit, a state estimator in a feedback loop of the Kalman filter; controlling, by the control circuit, power applied to the ultrasonic transducer; and adjusting the temperature of the ultrasonic blade by the control circuit.
Example 7: the method of embodiment 6 wherein the state variance of the state estimator of the Kalman filter is defined by:
The gain K of the kalman filter is defined by:
example 8: the method of embodiment 1, wherein the control circuit and the memory are located at a surgical hub in communication with the ultrasound electromechanical system.
Example 9: a generator for determining a temperature of an ultrasonic blade, the generator comprising: a control circuit coupled to the memory, the control circuit configured to be capable of: determining an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade through 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; and inferring a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
Example 10: the apparatus of embodiment 9, wherein to determine the actual resonant frequency of the ultrasound electromechanical system, the control circuit is further configured to: determining a voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
Example 11: the generator of embodiment 10 wherein the control circuit is further configured to generate a state space model and a temperature estimator 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.
Example 12: the generator of embodiment 11, wherein the state space model is defined by:
example 13: the generator of embodiment 12 wherein the control circuit is further configured to enable application of a kalman filter to improve the temperature estimator and state space model.
Example 14: the generator of embodiment 13, wherein the control circuit is further configured to be capable of: applying a state estimator in a feedback loop of the Kalman filter; controlling power applied to the ultrasonic transducer; and adjusting the temperature of the ultrasonic blade.
Example 15: the generator of embodiment 14 wherein the state variance of the state estimator of the kalman filter is defined by:
The gain K of the kalman filter is defined by:
example 16: the generator of embodiment 9, wherein the control circuit and the memory are located at a surgical hub in communication with the generator.
Example 17: an ultrasonic apparatus for determining a temperature of an ultrasonic blade, the ultrasonic apparatus comprising: a control circuit coupled to the memory, the control circuit configured to be capable of: determining an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade through 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; and inferring a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
Example 18: the ultrasound apparatus of embodiment 17, wherein to determine an actual resonant frequency of the ultrasound electromechanical system, the control circuit is further configured to be capable of: determining a voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
Example 19: the ultrasound apparatus of embodiment 18, wherein the control circuit is further configured to generate a state space model and a temperature estimator 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.
Example 20: the ultrasound apparatus of embodiment 19 wherein the state space model is defined by:
example 21: the ultrasound device of embodiment 20 wherein the control circuitry is further configured to enable application of a kalman filter to improve the temperature estimator and state space model.
Example 22: the ultrasound apparatus of embodiment 21, wherein the control circuitry is further configured to be capable of: applying a state estimator in a feedback loop of the Kalman filter; controlling power applied to the ultrasonic transducer; and adjusting the temperature of the ultrasonic blade.
Example 23: the ultrasound device of embodiment 22 wherein the state variance of the state estimator of the kalman filter is defined by:
The gain K of the kalman filter is defined by:
example 24: the ultrasonic instrument of embodiment 17, wherein the control circuit and the memory are located at a surgical hub in communication with the ultrasonic instrument.
Claims (24)
1. A method of determining a temperature of an ultrasonic blade, the method comprising:
determining, by a control circuit coupled to a memory, an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade through 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; and
inferring, by the control circuit, a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
2. The method of claim 1, wherein determining, by the control circuit, an actual resonant frequency of the ultrasound electromechanical system comprises:
determining, by the control circuit, a voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
3. The method of claim 2, further comprising generating, by the control circuit, a temperature estimator of the inferred temperature of the ultrasonic blade as a function of the resonant frequency of the ultrasonic electromechanical system and a state space model based on a set of non-linear state space formulas.
4. The method of claim 3, wherein the state space model is defined by:
5. the method of claim 4, further comprising applying, by the control circuit, a Kalman filter to improve the temperature estimator and state space model.
6. The method of claim 5, further comprising:
applying, by the control circuit, a state estimator in a feedback loop of the Kalman filter;
controlling, by the control circuit, power applied to the ultrasonic transducer; and
adjusting, by the control circuit, a temperature of the ultrasonic blade.
7. The method of claim 6, wherein the state variance of the state estimator of the Kalman filter is defined by:
The gain K of the kalman filter is defined by:
8. the method of claim 1, wherein the control circuit and the memory are located at a surgical hub in communication with the ultrasound electromechanical system.
9. A generator for determining a temperature of an ultrasonic blade, the generator comprising:
a control circuit coupled to a memory, the control circuit configured to be capable of:
determining an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade through 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; and
inferring a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
10. The generator of claim 9, wherein to determine an actual resonant frequency of the ultrasound electromechanical system, the control circuit is further configured to be capable of:
determining the ultrasonic transduction applied toVoltage V of the deviceg(t) and current Ig(t) phase angle between signals
11. The generator of claim 10, wherein the control circuit is further configured to generate a state space model and a temperature estimator 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 non-linear state space formulas.
12. The generator of claim 11, wherein the state space model is defined by:
13. the generator of claim 12, wherein the control circuit is further configured to enable application of a kalman filter to improve the temperature estimator and state space model.
14. The generator of claim 13, wherein the control circuit is further configured to be capable of:
applying a state estimator in a feedback loop of the Kalman filter;
controlling power applied to the ultrasonic transducer; and
adjusting the temperature of the ultrasonic blade.
15. The generator of claim 14, wherein the state variance of the state estimator of the kalman filter is defined by:
The gain K of the kalman filter is defined by:
16. the generator of claim 9, wherein the control circuit and the memory are located at a surgical hub in communication with the generator.
17. An ultrasonic apparatus for determining a temperature of an ultrasonic blade, the ultrasonic apparatus comprising:
a control circuit coupled to a memory, the control circuit configured to be capable of:
determining an actual resonant frequency of an ultrasonic electromechanical system, the ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade through 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; and
inferring a temperature of the ultrasonic blade based on a difference between the actual resonant frequency and the reference resonant frequency.
18. The ultrasound device of claim 17, wherein, to determine an actual resonant frequency of the ultrasound electromechanical system, the control circuit is further configured to be capable of:
determining a voltage V applied to the ultrasonic transducerg(t) and current Ig(t) phase angle between signals
19. The ultrasound apparatus of claim 18, wherein the control circuit is further configured to generate a state space model and a temperature estimator 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 non-linear state space formulas.
20. The ultrasound apparatus of claim 19, wherein the state space model is defined by:
21. the ultrasound device of claim 20, wherein the control circuitry is further configured to enable application of a kalman filter to improve the temperature estimator and state space model.
22. The ultrasound apparatus of claim 21, wherein the control circuitry is further configured to enable:
applying a state estimator in a feedback loop of the Kalman filter;
controlling power applied to the ultrasonic transducer; and
adjusting the temperature of the ultrasonic blade.
23. The ultrasound device of claim 22, wherein the state variance of the state estimator of the kalman filter is defined by:
The gain K of the kalman filter is defined by:
24. the ultrasonic instrument of claim 17, wherein the control circuit and the memory are located at a surgical hub in communication with the ultrasonic instrument.
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| US201862640415P | 2018-03-08 | 2018-03-08 | |
| US62/640,415 | 2018-03-08 | ||
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| US201862650887P | 2018-03-30 | 2018-03-30 | |
| US201862650898P | 2018-03-30 | 2018-03-30 | |
| US201862650877P | 2018-03-30 | 2018-03-30 | |
| US201862650882P | 2018-03-30 | 2018-03-30 | |
| US62/650,887 | 2018-03-30 | ||
| US62/650,882 | 2018-03-30 | ||
| US62/650,898 | 2018-03-30 | ||
| US62/650,877 | 2018-03-30 | ||
| US201862692748P | 2018-06-30 | 2018-06-30 | |
| US201862692768P | 2018-06-30 | 2018-06-30 | |
| US201862692747P | 2018-06-30 | 2018-06-30 | |
| US62/692,747 | 2018-06-30 | ||
| US62/692,748 | 2018-06-30 | ||
| US62/692,768 | 2018-06-30 | ||
| US201862721995P | 2018-08-23 | 2018-08-23 | |
| US201862721996P | 2018-08-23 | 2018-08-23 | |
| US201862721999P | 2018-08-23 | 2018-08-23 | |
| US201862721994P | 2018-08-23 | 2018-08-23 | |
| US201862721998P | 2018-08-23 | 2018-08-23 | |
| US62/721,995 | 2018-08-23 | ||
| US62/721,996 | 2018-08-23 | ||
| US62/721,998 | 2018-08-23 | ||
| US62/721,999 | 2018-08-23 | ||
| US62/721,994 | 2018-08-23 | ||
| US16/115,205 US11571234B2 (en) | 2017-12-28 | 2018-08-28 | Temperature control of ultrasonic end effector and control system therefor |
| US16/115,205 | 2018-08-28 | ||
| PCT/US2019/020142 WO2019134006A1 (en) | 2017-12-28 | 2019-02-28 | Temperature control of ultrasonic end effector and control system therefor |
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| CN111542281A true CN111542281A (en) | 2020-08-14 |
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| CN201980006872.XA Pending CN111542281A (en) | 2018-03-08 | 2019-02-28 | Temperature control of ultrasonic end effector and control system therefor |
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| JP (1) | JP7350746B2 (en) |
| CN (1) | CN111542281A (en) |
| MX (1) | MX2020006820A (en) |
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| JP2021508524A (en) | 2021-03-11 |
| MX2020006820A (en) | 2020-09-03 |
| JP7350746B2 (en) | 2023-09-26 |
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