Modular battery-powered handheld surgical instrument with selective application of energy based on button displacement, intensity, or local tissue characterization

Abstract

To provide a surgical instrument.SOLUTION: A surgical instrument comprises a controller configured to: control RF energy output to apply RF energy, or control ultrasonic energy output to apply ultrasonic energy, when displacement or intensity of a button is above a first threshold but below a second threshold higher than the first threshold; and control RF energy output to apply RF energy, and control ultrasonic energy output to apply ultrasonic energy, when displacement or intensity of the button is above the second threshold.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED ART) This application claims the benefit of U.S. Provisional Application No. 62 / 279,635, filed January 15, 2016, and U.S. Provisional Application No. 62 / 330,669, filed May 2, 2016, the contents of each of which are incorporated herein by reference in their entirety. [Background technology]

[0002] The present disclosure relates generally to surgical instruments and related surgical techniques, and more particularly to ultrasonic and electrosurgical systems that enable surgeons to perform cutting and coagulation and to adapt and customize such procedures based on the type of tissue being treated.

[0003] Ultrasonic surgical instruments are finding increasingly widespread use in surgical procedures due to the unique performance characteristics of such instruments. Depending on the specific instrument configuration and operating parameters, ultrasonic surgical instruments can simultaneously or nearly simultaneously cut tissue and achieve hemostasis through coagulation, desirably minimizing trauma to the patient. The cutting action is typically accomplished by an end effector or blade tip at the distal end of the instrument, which transmits ultrasonic energy to tissue in contact with the end effector. Ultrasonic instruments of this nature can be configured for open surgical applications, laparoscopic, or endoscopic surgical procedures, including robotic-assisted procedures.

[0004] Some surgical instruments utilize ultrasonic energy for both precise cutting and controlled coagulation. Ultrasonic energy cuts and coagulates by vibrating a blade in contact with tissue. The ultrasonic blade, vibrating at high frequencies (e.g., 55,500 times per second), denatures proteins in the tissue, forming a sticky coagulant. The pressure exerted by the blade surface on the tissue collapses blood vessels, allowing the coagulant to form a hemostatic seal. The precision of cutting and coagulation is controlled by the surgeon's technique and adjustments of power level, blade edge, tissue traction, and blade pressure.

[0005] Electrosurgical instruments for applying electrical energy to tissue to treat and / or destroy the tissue are also finding increasingly widespread use in surgical procedures. Electrosurgical instruments typically include a handpiece, which is an instrument having a distally attached end effector (e.g., one or more electrodes). The end effector can be positioned relative to the tissue so that electrical current is introduced into the tissue. Electrosurgical instruments can be configured for bipolar or monopolar operation. During bipolar operation, electrical current is introduced into the tissue by the active electrode of the end effector and returned from the tissue by the return electrode of the end effector. During monopolar operation, electrical current is introduced into the tissue by the active electrode of the end effector and returned through a return electrode (e.g., a ground pad) separately located on the patient's body. Heat generated by electrical current flowing through the tissue may form a hemostatic seal within and / or between tissues and may therefore be particularly useful, for example, for sealing blood vessels. The end effector of the electrosurgical instrument may also include a cutting member movable relative to the tissue and the electrode for cutting the tissue.

[0006] Electrical energy applied by an electrosurgical instrument may be transmitted to the instrument by a generator in communication with the handpiece. The electrical energy may be in the form of radio frequency ("RF") energy. RF energy is a form of electrical energy that may range in frequency from 200 kilohertz (kHz) to 1 megahertz (MHz). During application, the electrosurgical instrument can transmit low-frequency RF energy through tissue, which can cause ionic agitation or friction, i.e., resistive heating, thereby increasing the temperature of the tissue. Because a sharp boundary is formed between the diseased and surrounding tissue, the surgeon can operate with a high degree of precision and control without sacrificing adjacent non-target tissue. The low operating temperature of RF energy is useful for simultaneously sealing blood vessels while removing, shrinking, or shaping soft tissue. RF energy works particularly well on connective tissue, which is primarily composed of collagen and contracts when exposed to heat.

[0007] The RF energy may be in the frequency range described in EN 60601-2-2:2009+A11:2011, Definition 201.3.218 - HIGH FREQUENCY. For example, frequencies in monopolar RF applications may typically be limited to less than 5 MHz. However, in bipolar RF applications, the frequency may be nearly any frequency. Frequencies above 200 kHz may typically be used in monopolar applications to avoid unnecessary nerve and muscle stimulation resulting from the use of low-frequency currents. Lower frequencies may be used in bipolar applications if a risk analysis indicates that the potential for neuromuscular stimulation has been mitigated to an acceptable level. Frequencies above 5 MHz are typically not used to minimize problems associated with high-frequency leakage currents. However, higher frequencies may be used in bipolar applications. 10 mA is generally recognized as the lower threshold for thermal effects on tissue. Summary of the Invention [Problem to be solved by the invention]

[0008] A challenge when using these medical devices is the lack of sufficient control and customization of the function of the surgical instrument. It would be desirable to provide a surgical instrument that overcomes some of the shortcomings of current instruments. [Means for solving the problem]

[0009] In one aspect, the present disclosure provides a surgical instrument comprising: a shaft assembly including a shaft and an end effector coupled to a distal end of the shaft, the end effector including first and second jaws configured to pivot between a closed position and an open position; a handle assembly coupled to a proximal end of the shaft, the handle assembly including a button configured to be displaced when pressed by a user; a battery assembly coupled to the handle assembly; a sensor configured to measure the displacement or strength of the button; and an RF energy sensor energized by the battery assembly and configured to apply radio frequency (RF) energy to tissue. an ultrasonic energy output energized by a battery assembly and configured to apply ultrasonic energy to tissue; and a controller configured to control the RF energy output to apply RF energy at a low level or control the ultrasonic energy output to apply ultrasonic energy at a low level when the displacement or intensity measured by the sensor exceeds a first threshold but is below a second threshold higher than the first threshold, and to control the RF energy output to apply RF energy at a high level or control the ultrasonic energy output to apply ultrasonic energy at a high level when the displacement or intensity measured by the sensor exceeds the second threshold.

[0010] In another aspect, the present disclosure provides a surgical instrument comprising: a shaft assembly including a shaft and an end effector coupled to a distal end of the shaft, the end effector including first and second jaws configured to pivot between closed and open positions; a handle assembly coupled to a proximal end of the shaft, the handle assembly including a button configured to be displaced when pressed by a user; a battery assembly coupled to the handle assembly; a sensor configured to measure the displacement or strength of the button; and a power supply energized by the battery assembly and configured to apply radio frequency (RF) energy to tissue. an ultrasonic energy output energized by a battery assembly and configured to apply ultrasonic energy to tissue; and a controller configured to control the RF energy output to apply RF energy or control the ultrasonic energy output to apply ultrasonic energy when a displacement or intensity measured by the sensor exceeds a first threshold but is below a second threshold higher than the first threshold, and to control the RF energy output to apply RF energy or control the ultrasonic energy output to apply ultrasonic energy when a displacement or intensity measured by the sensor exceeds the second threshold.

[0011] In another aspect, the present disclosure provides a surgical instrument comprising: a shaft assembly including a shaft and an end effector coupled to a distal end of the shaft, the end effector including a first jaw and a second jaw configured to pivot between a closed position and an open position, the first or second jaw comprising a first sensor configured to measure a tissue property at the first position and a second sensor configured to measure a tissue property at the second position; a handle assembly coupled to a proximal end of the shaft; a battery assembly coupled to the handle assembly; an RF energy output energized by the battery assembly and configured to apply radio frequency (RF) energy to tissue; an ultrasonic energy output energized by the battery assembly and configured to apply ultrasonic energy to tissue; and a controller configured to control the RF energy output to apply RF energy or the ultrasonic energy output to apply ultrasonic energy based at least in part on the tissue properties measured at the first position and the second position.

[0012] In addition to the foregoing, various other method, and / or system, and / or program product aspects are set forth and illustrated in the teachings, such as the text of this disclosure (e.g., the claims and / or detailed description) and / or drawings.

[0013] The foregoing is a summary and, as such, may include simplifications, generalizations, inclusions, and / or omissions of detail; therefore, those skilled in the art will appreciate that this Summary is merely illustrative and is not intended to be in any way limiting. Other aspects, features, and advantages of the devices and / or processes and / or other subject matter described herein will become apparent in the teachings set forth herein.

[0014] In one or more various aspects, the associated systems include, but are not limited to, circuitry and / or programming for effecting aspects of the methods referenced herein, which circuitry and / or programming may essentially be any combination of hardware, software, and / or firmware configured to affect aspects of the methods referenced herein, depending on the design choices of the system designer. In addition to the foregoing, various other method and / or system aspects are set forth and illustrated in the present teachings, such as throughout the text of this disclosure (e.g., in the claims and / or detailed description) and / or in the drawings.

[0015] Furthermore, it should be understood that any one or more of the aspects, embodiment(s) of the aspects, and examples described below can be combined with any one or more of the other aspects, embodiment(s) of the aspects, and examples described below.

[0016] The foregoing Summary is illustrative only and is not intended to be in any way limiting. In addition to the exemplary aspects and features described above, further aspects and features will become apparent by reference to the drawings and the following detailed description. [Brief explanation of the drawings]

[0017] The novel features of the various aspects described herein are set forth with particularity in the appended claims. However, the various aspects, both as to organization and method of operation, may be better understood by reference to the following description taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a diagram of a modular battery-powered handheld ultrasonic surgical instrument according to aspects of the present disclosure. [Figure 2] FIG. 2 is an exploded view of the surgical instrument shown in FIG. 1 according to an embodiment of the present disclosure. [Figure 3] FIG. 2 is an exploded view of a modular shaft assembly of the surgical instrument shown in FIG. 1 according to an embodiment of the present disclosure. [Figure 4]FIG. 2 is a perspective view of an ultrasonic transducer / generator assembly of the surgical instrument shown in FIG. 1 according to an embodiment of the present disclosure. [Figure 5] FIG. 1 is an end view of an ultrasonic transducer / generator assembly according to an embodiment of the present disclosure. [Figure 6] FIG. 1 is a perspective view of an ultrasonic transducer / generator assembly with a top housing portion removed to expose the ultrasonic generator, according to an embodiment of the present disclosure. [Figure 7] FIG. 1 is a cross-sectional view of an ultrasonic transducer / generator assembly according to an embodiment of the present disclosure. [Figure 8] FIG. 1 is an elevational view of an ultrasonic transducer / generator assembly configured to operate at a 31 kHz resonant frequency, according to one embodiment of the present disclosure. [Figure 9] FIG. 1 is an elevational view of an ultrasonic transducer / generator assembly configured to operate at a 55 kHz resonant frequency, according to one embodiment of the present disclosure. [Figure 10A] 1 illustrates a shift assembly for selectively rotating an ultrasonic transmission waveguide relative to an ultrasonic transducer and biasing them toward one another, according to one aspect of the present disclosure. [Figure 10B] 1 illustrates a shift assembly for selectively rotating an ultrasonic transmission waveguide relative to an ultrasonic transducer and biasing them toward one another, according to one aspect of the present disclosure. [Figure 11] FIG. 5 is a schematic diagram of one embodiment of an ultrasonic drive circuit shown in FIG. 4 suitable for driving an ultrasonic transducer, according to one embodiment of the present disclosure. [Figure 12] FIG. 12 is a schematic diagram of a transformer coupled to the ultrasonic drive circuit shown in FIG. 11 according to one embodiment of the present disclosure. [Figure 13] FIG. 13 is a schematic diagram of the transformer shown in FIG. 12 coupled to a test circuit according to one embodiment of the present disclosure. [Figure 14] FIG. 2 is a schematic diagram of a control circuit according to an aspect of the present invention. [Figure 15] FIG. 10 shows a simplified block circuit diagram illustrating different electrical circuits included within a modular ultrasonic surgical instrument according to one aspect of the present disclosure. [Figure 16]1 illustrates a battery assembly for use with a surgical instrument according to one aspect of the present disclosure. [Figure 17] 1 illustrates a disposable battery assembly for use with a surgical instrument according to one aspect of the present disclosure. [Figure 18] 1 illustrates a reusable battery assembly for use with a surgical instrument according to one aspect of the present disclosure. [Figure 19] FIG. 1 is an elevated perspective view of a battery assembly with both halves of a housing shell removed to expose battery cells coupled to multiple circuit boards coupled to multi-lead battery terminals, according to one aspect of the present disclosure. [Figure 20] 1 illustrates a battery test circuit according to an aspect of the present invention. [Figure 21] 1 illustrates an auxiliary power supply circuit for maintaining a minimum output voltage according to one aspect of the present disclosure. [Figure 22] 1 illustrates a switched mode power supply circuit for supplying energy to a surgical instrument according to one aspect of the present disclosure. [Figure 23] 23 illustrates a separate version of the switching regulator shown in FIG. 22 for supplying energy to a surgical instrument, according to one embodiment of the present disclosure. [Figure 24] 1 illustrates a linear power supply circuit for supplying energy to a surgical instrument according to one aspect of the present disclosure. [Figure 25] FIG. 10 is an elevational exploded view of a modular handheld ultrasonic surgical instrument with the left shell half removed from the handle assembly to expose a device identifier communicatively coupled to the multi-lead handle terminal assembly according to one aspect of the present disclosure. [Figure 26] FIG. 26 is a detailed view of the trigger and switch of the ultrasonic surgical instrument shown in FIG. 25 according to one embodiment of the present disclosure. [Figure 27] FIG. 10 is a fragmentary, enlarged perspective view of an end effector from a distal end with the jaw members in an open position, according to one aspect of the present disclosure. [Figure 28] 1 illustrates a modular shaft assembly and end effector portion of a surgical instrument according to one aspect of the present disclosure. [Figure 29]FIG. 10 is a detailed view of an inner tube / spring assembly according to one aspect of the present disclosure. [Figure 30] 1 illustrates a modular battery-powered handheld combination ultrasonic / electrosurgical instrument according to one aspect of the present disclosure. [Figure 31] FIG. 31 is an exploded view of the surgical instrument shown in FIG. 30 according to one embodiment of the present disclosure. [Figure 32] FIG. 1 is a partial perspective view of a modular battery-powered handheld combination ultrasonic / RF surgical instrument according to one embodiment of the present disclosure. [Figure 33] 33 illustrates a nozzle portion of the surgical instrument described with respect to FIGS. 30-32, according to one embodiment of the present disclosure. [Figure 34] FIG. 1 is a schematic diagram of an embodiment of a drive circuit configured for driving radio frequency (RF) current, according to an embodiment of the present disclosure. [Figure 35] FIG. 35 is a schematic diagram of a transformer coupled to the RF drive circuit shown in FIG. 34 according to one embodiment of the present disclosure. [Figure 36] FIG. 1 is a schematic diagram of a circuit including separate power supplies for a high power energy / drive circuit and a low power circuit, according to one aspect of the resent disclosure. [Figure 37] FIG. 32 illustrates a control circuit for the surgical instrument shown in FIGS. 30 and 31 that allows the dual generator system to switch between RF generator and ultrasonic generator energy modalities. [Figure 38] FIG. 1 is a cross-sectional view of an end effector according to one aspect of the present disclosure. [Figure 39] FIG. 1 is a cross-sectional view of an end effector according to one aspect of the present disclosure. [Figure 40] FIG. 10 is a partial longitudinal side cross-sectional view showing the distal jaw portion in a closed state according to one aspect of the present disclosure. [Figure 41] FIG. 10 is a partial longitudinal side cross-sectional view showing the distal jaw portion in an open state according to one aspect of the present disclosure. [Figure 42] FIG. 10 is a partial longitudinal side cross-sectional view showing a jaw member according to one aspect of the present disclosure. [Figure 43]FIG. 10 is a cross-sectional view illustrating the distal jaw portion in an intact state according to one aspect of the present disclosure. [Figure 44] FIG. 10 is a cross-sectional view illustrating a distal jaw portion in a worn state according to one aspect of the present disclosure. [Figure 45] 1 illustrates a modular battery-powered handheld electrosurgical instrument having a distal articulation according to one aspect of the present disclosure. [Figure 46] FIG. 46 is an exploded view of the surgical instrument shown in FIG. 45 according to one embodiment of the present disclosure. [Figure 47] FIG. 47 is a perspective view of the surgical instrument shown in FIGS. 45 and 46, with the display located on the handle assembly, according to one embodiment of the present disclosure. [Figure 48] FIG. 47 is a perspective view of the instrument shown in FIGS. 45 and 46, with the display not located on the handle assembly, according to one embodiment of the present disclosure. [Figure 49] 1 is a motor assembly that can be used with a surgical instrument to drive a knife, according to one aspect of the present disclosure. [Figure 50] FIG. 1 is a diagram of a motor drive circuit according to one aspect of the present disclosure. [Figure 51] 14 illustrates a rotational drive mechanism for driving distal head rotation, articulation, and jaw closure, according to one aspect of the present disclosure. [Figure 52] FIG. 10 is an enlarged left perspective view of an end effector assembly with jaw members shown in an open configuration, according to one aspect of the present disclosure; [Figure 53] FIG. 53 is an enlarged right side view of the end effector assembly of FIG. 52 according to one embodiment of the present disclosure. [Figure 54] 1 illustrates a modular battery-powered handheld electrosurgical instrument having a distal articulation according to one aspect of the present disclosure. [Figure 55] FIG. 55 is an exploded view of the surgical instrument shown in FIG. 54 according to one embodiment of the present disclosure. [Figure 56] FIG. 55 is an enlarged area detail view of the articulation joint shown in FIG. 54, including electrical connections, according to one embodiment of the present disclosure. [Figure 57]FIG. 57 is an enlarged area detail view of the articulation joint shown in FIG. 56, including electrical connections, according to one embodiment of the present disclosure. [Figure 58] FIG. 55 shows a perspective view of the shaft assembly, end effector, and cutting member components of the surgical instrument of FIG. 54 according to one embodiment of the present disclosure. [Figure 59] 1 illustrates an articulation joint in a second stage of articulation according to one embodiment of the present disclosure. [Figure 60] FIG. 60 shows a perspective view of the end effector of the device of FIGS. 54-59 in an open configuration, according to one embodiment of the present disclosure. [Figure 61] FIG. 61 illustrates a cross-sectional end view of the end effector of FIG. 60 in a closed configuration and with the blade in a distal position, according to one embodiment of the present disclosure. [Figure 62] 1 illustrates components of a control circuit for a surgical instrument according to one aspect of the present disclosure. [Figure 63] 62 is a system diagram of a segmented circuit including multiple independently operating circuit segments, according to one embodiment of the present disclosure. FIG. 63 is a diagram of one form of direct digital synthesis circuit. [Figure 64] FIG. 6 shows a diagram of one embodiment of a surgical instrument including a feedback system for use with any one of the surgical instruments described herein with respect to FIGS. 1-61, which may include or implement many of the features described herein. [Figure 65] FIG. 6B illustrates one embodiment of a basic structure of a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit, configured to generate a plurality of waveforms of electrical signal waveforms for use in any of the surgical instruments described herein with respect to FIGS. 1-61 , according to one embodiment of the present disclosure. [Figure 66] FIG. 6B illustrates one embodiment of a direct digital synthesis (DDS) circuit configured to generate multiple waveforms of electrical signal waveforms for use in any of the surgical instruments described herein with respect to FIGS. 1-61 , according to one embodiment of the present disclosure. [Figure 67]1 illustrates one cycle of a discrete-time digital electrical signal waveform (shown superimposed on a discrete-time digital electrical signal waveform for comparison purposes) of an analog waveform according to an embodiment of the present disclosure. [Figure 68A] 6A-6C illustrate circuitry comprising a controller including one or more processors coupled to at least one memory circuit for use in any of the surgical instruments described herein with respect to FIGS. 1-61 , according to one embodiment of the present disclosure. [Figure 68B] 1 illustrates a circuit comprising a finite state machine including combinatorial logic circuitry configured to implement any of the algorithms, processes, or techniques described herein, according to one aspect of the present disclosure. [Figure 68C] 1 illustrates a circuit comprising a finite state machine including sequential logic circuitry configured to implement any of the algorithms, processes, or techniques described herein, according to one aspect of the present disclosure. [Figure 69] FIG. 1 is a circuit diagram of various components of a surgical instrument having motor control capabilities, according to one aspect of the present disclosure. [Figure 70] 1 illustrates a handle assembly with a removable service panel removed to reveal the internal components of the handle assembly, according to one aspect of the present disclosure. [Figure 71] 10 is a graphical representation of determining a wait time based on tissue thickness, according to one aspect of the present disclosure. [Figure 72] 10 is a graph of force versus time for thin, medium, and thick tissue types according to one aspect of the present disclosure. [Figure 73] 10 is a graph of motor current versus time for different tissue types according to one aspect of the present disclosure. [Figure 74] 1 is a graphical depiction of an impedance bathtub according to one aspect of the present disclosure. [Figure 75] 10 is a graph depicting one aspect of the adjustment of the energy switching threshold due to measurement of a secondary tissue parameter, according to one aspect of the present disclosure. [Figure 76]FIG. 10 is a process diagram illustrating selective application of radio frequency or ultrasound treatment energy based on measured tissue properties, according to one aspect of the present disclosure. [Figure 77] 10 is a graph depicting the relationship between trigger button displacement and sensor output according to one aspect of the present disclosure. [Figure 78] 10 is a graph depicting an anomalous relationship between trigger button displacement and sensor output, according to one aspect of the present disclosure. [Figure 79] 10 is a graph depicting an acceptable relationship between trigger button displacement and sensor output, according to one aspect of the present disclosure. [Figure 80] 1 illustrates one embodiment of a left and right segmented flexible circuit according to one aspect of the present disclosure. [Figure 81] FIG. 1 illustrates a cross-sectional view of an embodiment of a flexible circuit having RF electrodes and data sensors embedded therein, according to an embodiment of the present disclosure. [Figure 82] FIG. 10 is a cross-sectional view of an end effector comprising a jaw member, a flexible circuit, and a segmented electrode according to one aspect of the present disclosure. [Figure 83] FIG. 83 is a detailed view of the end effector shown in FIG. 82 according to one embodiment of the present disclosure. [Figure 84A] FIG. 10 is a cross-sectional view of an end effector comprising a rotatable jaw member, a flexible circuit, and an ultrasonic blade positioned perpendicular to the jaw member with no tissue positioned between the jaw member and the ultrasonic blade, according to one aspect of the present disclosure. [Figure 84B] FIG. 84B is a cross-sectional view of the end effector shown in FIG. 84A with tissue positioned between the jaw members and the ultrasonic blade according to one embodiment of the present disclosure. [Figure 85A] FIG. 84C is a cross-sectional view of the end effector shown in FIGS. 84A and 84B with the ultrasonic blade positioned horizontally relative to the jaw members, with no tissue positioned between the jaw members and the ultrasonic blade, according to one embodiment of the present disclosure. [Figure 85B] FIG. 85B is a cross-sectional view of the end effector shown in FIG. 85A with tissue positioned between the jaw members and the ultrasonic blade according to one embodiment of the present disclosure. [Figure 86] 1 illustrates an embodiment of an end effector with an RF data sensor located on a jaw member, according to an embodiment of the present disclosure. [Figure 87] 87 illustrates an embodiment of a flexible circuit as shown in FIG. 86, in which a sensor may be attached to the flexible circuit or may be integrally formed with the flexible circuit, according to one embodiment of the present disclosure. [Figure 88] FIG. 88 is a cross-sectional view of the flexible circuit shown in FIG. 87 according to one embodiment of the present disclosure. [Figure 89] 1 illustrates an embodiment of a segmented flexible circuit configured to be fixedly attached to a jaw member of an end effector, according to an embodiment of the present disclosure. [Figure 90] 1 illustrates an embodiment of a segmented flexible circuit configured to be attached to a jaw member of an end effector, according to an embodiment of the present disclosure. [Figure 91] 1 illustrates an embodiment of an end effector configured to measure tissue gap GT, according to an embodiment of the present disclosure. [Figure 92] 1 illustrates an embodiment of an end effector comprising a segmented flexible circuit according to an embodiment of the present disclosure. [Figure 93] 93 illustrates the end effector shown in FIG. 92 having jaw members that clamp tissue between the jaw members and the ultrasonic blade according to one embodiment of the present disclosure. [Figure 94] 10 shows a graph of energy applied by the right and left sides of the end effector based on locally sensed tissue parameters, according to one aspect of the present disclosure. [Figure 95] FIG. 10 is a cross-sectional view of one aspect of an end effector configured to sense force or pressure applied to tissue located between the jaw members and an ultrasonic blade, according to one aspect of the present disclosure. [Figure 96] FIG. 1 is a schematic diagram of one embodiment of a signal layer of a flexible circuit, according to one embodiment of the present disclosure. [Figure 97] FIG. 97 is a schematic diagram of sensor wiring for the flexible circuit shown in FIG. 96 according to one embodiment of the present disclosure. [Figure 98A]1 is a graphical representation of one embodiment of a medical device surrounding tissue, according to one embodiment of the present disclosure. [Figure 98B] 1 is a graphical representation of one embodiment of a medical device for compressing tissue, according to one embodiment of the present disclosure. [Figure 99A] 1 is a graphical representation of one embodiment of a medical device for compressing tissue, according to one embodiment of the present disclosure. [Figure 99B] 1 also depicts an exemplary force exerted by an embodiment of an end effector of a medical device compressing tissue, according to an embodiment of the present disclosure. [Figure 100] 1 illustrates a logic diagram of an embodiment of a feedback system, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0018] This application is related to the following commonly owned patent applications filed concurrently with this application, the entire contents of each of which are incorporated herein by reference:

[0019] Attorney Docket No. END7911USNP / 160006, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT AND METHODS THEREFOR.

[0020] Attorney Docket No. END7911USNP1 / 160006-1, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH SELECTIVE APPLICATION OF ENERGY BASED ON TISSUE CHARACTERIZATION.

[0021] Attorney Docket No. END7911USNP3 / 160006-3, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH VARIABLE MOTOR CONTROL LIMITS.

[0022] Attorney Docket No. END7911USNP4 / 160006-4, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR CONTROL LIMIT PROFILE.

[0023] Attorney Docket No. END7911USNP5 / 160006-5, filed December 16, 2016, inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR CONTROL LIMITS BASED ON TISSUE CHARACTERIZATION.

[0024] Attorney Docket No. END7911USNP6 / 160006-6, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MULTI-FUNCTION MOTOR VIA SHIFTING GEAR ASSEMBLY.

[0025] Attorney Docket No. END7911USNP7 / 160006-7, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH A PLURALITY OF CONTROL PROGRAMS.

[0026] Attorney Docket No. END7911USNP8 / 160006-8, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH ENERGY CONSERVATION TECHNIQUES.

[0027] Attorney Docket No. END7911USNP9 / 160006-9, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH VOLTAGE SAG RESISTANT BATTERY PACK.

[0028] Attorney Docket No. END7911USNP10 / 160006-10, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MULTISTAGE GENERATOR CIRCUITS.

[0029] Attorney Docket No. END7911USNP11 / 160006-11, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MULTIPLE MAGNETIC POSITION SENSORS.

[0030] Attorney Docket No. END7911USNP12 / 160006-12, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT CONTAINING ELONGATED MULTI-LAYERED SHAFT.

[0031] Attorney Docket No. END7911USNP13 / 160006-13, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH MOTOR DRIVE.

[0032] Attorney Docket No. END7911USNP14 / 160006-14, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH SELF-DIAGNOSING CONTROL SWITCHES FOR REUSABLE HANDLE ASSEMBLY.

[0033] Attorney Docket No. END7911USNP15 / 160006-15, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH REUSABLE ASYMMETRIC HANDLE HOUSING.

[0034] Attorney Docket No. END7911USNP16 / 160006-16, filed December 16, 2016, by inventors Frederick E. Shelton, IV, et al., entitled MODULAR BATTERY POWERED HANDHELD SURGICAL INSTRUMENT WITH CURVED END EFFECTORS HAVING ASYMMETRIC ENGAGEMENT BETWEEN JAW AND BLADE.

[0035] In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like symbols and reference characters generally refer to like elements throughout the several views, unless the content dictates otherwise. The illustrative embodiments described in the Detailed Description, the Drawings, and the Claims are not intended to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the scope of the subject matter presented herein.

[0036] Before describing various aspects of the present disclosure in detail, it should be noted that the various aspects disclosed herein are not limited in their application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. Rather, the disclosed aspects can be positioned with or incorporated into other aspects, variations and modifications thereof, and may be practiced or carried out in various ways. Accordingly, the aspects disclosed herein are exemplary in nature and are not intended to limit their scope or application. Furthermore, unless otherwise noted, the terms and phrases used herein have been chosen for the purpose of describing the aspects for the convenience of the reader and are not intended to limit their scope. Furthermore, it should be understood that any one or more of the disclosed aspects, aspect expressions, and / or examples thereof can be combined, without limitation, with any one or more of the other disclosed aspects, aspect expressions, and / or examples thereof.

[0037] Furthermore, in the following description, terms such as front, back, inside, outside, upper, and lower should be understood as terms of convenience and should not be construed as limiting terms. The terms used herein are not limiting insofar as the devices described herein, or portions thereof, can be attached or used in other orientations. Various aspects will be described in more detail with reference to the drawings.

[0038] In various aspects, the present disclosure is directed to a mixed-energy surgical instrument utilizing both ultrasonic and RF energy modalities, using a modular shaft that achieves existing end effector functionality, such as ultrasonic functionality as disclosed in U.S. Patent No. 9,107,690 (incorporated herein by reference in its entirety), combination device functionality as disclosed in U.S. Patent Nos. 8,696,666 and 8,663,223 (both of which are incorporated herein by reference in their entireties), RF counter-electrode functionality as disclosed in U.S. Patent Nos. 9,028,478 and 9,113,907 (both of which are incorporated herein by reference in their entireties), and RF I-blade offset electrode functionality as disclosed in U.S. Patent Application Publication No. 2013 / 0023868 (incorporated herein by reference in its entirety).

[0039] In various aspects, the present disclosure is directed to a modular, battery-powered, handheld ultrasonic surgical instrument comprising a first generator, a second generator, and control circuitry for controlling the energy modality applied by the surgical instrument, the surgical instrument configured to apply at least one energy modality including an ultrasonic energy modality, a radio frequency (RF) energy modality, or a combination of ultrasonic and RF energy modalities.

[0040] In another aspect, the present disclosure is directed to a modular, battery-powered, handheld surgical instrument that can be configured for ultrasonic energy modality, RF modality, or a combination of ultrasonic and RF energy modalities. The mixed-energy surgical instrument utilizes both ultrasonic and RF energy modalities. The mixed-energy surgical instrument can use a modular shaft to achieve end effector functionality. The energy modality can be selectable based on measurements of specific measured tissue and device parameters, such as, for example, electrical impedance, tissue impedance, electric motor current, jaw gap, tissue thickness, tissue compression, tissue type, temperature, or a combination thereof, among other parameters, to determine a suitable energy modality algorithm for using ultrasonic vibrations and / or electrosurgical high-frequency current to perform surgical coagulation / cutting procedures on live tissue based on measured tissue parameters identified by the surgical instrument. Once the tissue parameters are identified, the surgical instrument can be configured to control the treatment energy applied to the tissue in a single or segmented RF electrode configuration or an ultrasonic device through measurements of the specific tissue / device parameters. Tissue treatment algorithms are described in commonly owned US patent application Ser. No. 15 / 177,430, entitled SURGICAL INSTRUMENT WITH USER ADAPTABLE TECHNIQUES, which is incorporated herein by reference in its entirety.

[0041] In another aspect, the present disclosure is directed to a modular, battery-powered, handheld surgical instrument having a motor and a controller, wherein a first limiting threshold is applied to the motor for purposes of attaching the modular assembly, and a second threshold is applied to the motor and is associated with a second assembly process or functionality of the surgical instrument. The surgical instrument may include a motor-driven actuation mechanism that utilizes control of motor speed or torque through measurement of motor current or a parameter related to the motor current, and the motor control is adjusted via a nonlinear threshold to trigger motor adjustments at different magnitudes based on position, inertia, velocity, acceleration, or a combination thereof. The motor-driven actuation of the movement mechanism and motor controller can be used to control the motor speed or torque. Sensors related to physical characteristics of the movement mechanism provide feedback to the motor controller. In one aspect, the sensors are used to adjust pre-defined thresholds that trigger changes in the operation of the motor controller. A motor can be utilized to drive shaft functions such as shaft rotation and jaw closure, and the motor can be switched to also provide for attachment of a torque-limiting waveguide to a transducer. Motor control algorithms can be utilized to generate tactile feedback to the user through the motor drive train for indication of device status and / or limitations of powered actuation. Motor-powered modular advanced energy-based surgical instruments can include a series of control programs or algorithms that operate a series of different shaft modules and transducers. In one aspect, the programs or algorithms reside within the module and are uploaded to the control handle upon installation. Motor-driven modular battery-powered handheld surgical instruments can include a primary rotational drive selectively connectable to at least two independent actuation functions (first, second, both, neither) and can utilize a clutch mechanism located within the distal modular elongated tube.

[0042] In another aspect, the present disclosure is directed to a modular battery-powered handheld surgical instrument comprising an energy storage circuit and a technique for minimizing unused power drain and a wake-up sequence order that differs from the sleep sequence order using sleep mode de-energization of segmented circuits with short circuits. A disposable primary battery pack may be utilized with the battery-powered modular handheld surgical instrument. The disposable primary battery may include a power management circuit to compensate the battery output voltage with additional voltage to offset voltage sags under load and to prevent the battery pack output voltage from dropping below a predetermined level during operation under load. The surgical instrument's circuitry includes radiation-hardened components, and the amplification of the electrical signal may be divided into multiple stages. The ultrasonic transducer housing or RF housing may include the final amplification stage and may include different ratios depending on the energy modality associated with the ultrasonic transducer or RF module.

[0043] In another aspect, the present disclosure is directed to a modular, battery-powered, handheld surgical instrument with multiple magnetic position sensors along the length of the shaft, mated in different configurations to allow multiple sensors to detect the same magnet to determine the three-dimensional position of the shaft's working components from a fixed reference plane while simultaneously diagnosing any errors from external sources. Control and sensing electronics may be integrated into the shaft. Portions of the shaft control electronics may be disposed along the inside of the moving shaft components and separated from other shaft control electronics disposed along the outside of the moving shaft components. The control and sensing electronics may be positioned and designed such that they act as a shaft seal within the device.

[0044] In another aspect, the present disclosure is directed to a modular battery-powered handheld surgical instrument with self-diagnostic control switches within a battery-powered modular reusable handle. The control switches can adjust their thresholds for triggering events as well as indicate external influences on the control or predict time until replacement is required. The reusable handle housing is configured for use with a modular disposable shaft and at least one control and wiring harness. The handle is configured to separate asymmetrically when opened, so that the switch, wiring harness, and / or control electronics can be supportably housed on one side, while the opposite side is removably attached to cover the primary housing.

[0045] FIG. 1 is a diagram of a modular battery-powered handheld ultrasonic surgical instrument 100 according to an embodiment of the present disclosure. FIG. 2 is an exploded view of the surgical instrument 100 shown in FIG. 1 according to an embodiment of the present disclosure. Referring now to FIGS. 1 and 2, the surgical instrument 100 includes a handle assembly 102, an ultrasonic transducer / generator assembly 104, a battery assembly 106, a shaft assembly 110, and an end effector 112. The ultrasonic transducer / generator assembly 104, the battery assembly 106, and the shaft assembly 110 are modular components removably connectable to the handle assembly 102. The handle assembly 102 includes a motor assembly 160. Additionally, some embodiments of the surgical instrument 100 include a battery assembly 106 that includes an ultrasonic generator and motor control circuitry. The battery assembly 106 includes a first stage generator function, with a final stage present as part of the ultrasonic transducer / generator assembly 104 to drive the 55 kHz and 33.1 kHz ultrasonic transducers. The battery assembly 106, common generator components, and different final stage generators for interchangeable use with the segmented circuitry allow the battery assembly 106 to controllably power up portions of the drive circuitry, check circuit stages before powering them, and enable power management modes. Additionally, multi-purpose controls can be provided in the handle assembly 102 with dedicated shaft assembly 110 controls located on the shaft with such functionality. For example, the end effector 112 module can include distal rotation electronics, the shaft assembly 110 can include rotation shaft controls along with an articulation switch, and the handle assembly 102 can include energy activation controls and jaw member 114 trigger 108 controls to clamp and unclamp the end effector 112.

[0046] The ultrasonic transducer / generator assembly 104 includes a housing 148, a display 176, such as a liquid crystal display (LCD), for example, the ultrasonic transducer 130, and an ultrasonic generator 162 (FIG. 4). The shaft assembly 110 includes an outer tube 144, an ultrasonic transmission waveguide 145, and an inner tube (not shown). The end effector 112 includes a jaw member 114 and an ultrasonic blade 116. As described below, the jaw member 114 can be closed using a motor or other mechanism operated by a trigger 108. The ultrasonic blade 116 is the distal end of the ultrasonic transmission waveguide 145. The jaw member 114 is pivotally rotatable to grasp tissue between the jaw member and the ultrasonic blade 116. The jaw members 114 are operably coupled to the trigger 108 such that, when the trigger 108 is squeezed, the jaw members 114 close to grasp tissue, and when the trigger 108 is released, the jaw members 114 open to release the tissue. In a single-stage trigger configuration, the trigger 108 functions to close the jaw members 114 when squeezed and to open the jaw members 114 when released. Once the jaw members 114 are closed, the switch 120 is activated to energize the ultrasonic generator to seal and cut the tissue. In a two-stage trigger configuration, the trigger 108 is squeezed during a first stage to partially close the jaw members 114, and during a second stage, the trigger 108 is squeezed during a second stage to energize the ultrasonic generator to seal and cut the tissue. The jaw members 114a open upon releasing the trigger 108 to release the tissue. It will be appreciated that in other aspects, the ultrasonic transducer 103 can be activated without closing the jaw members 114.

[0047] The battery assembly 106 is electrically connected to the handle assembly 102 by an electrical connector 132. The handle assembly 102 is provided with a switch 120. The ultrasonic blade 116 is activated by energizing the ultrasonic transducer / generator circuit by activating the switch 120. The battery assembly 106, in one embodiment, is a rechargeable, reusable battery pack with regulated output. In some cases, as described below, the battery assembly 106 facilitates user interface functions. The handle assembly 102 is a disposable unit having a bay or dock for attachment to the battery assembly 106, ultrasonic transducer / generator assembly 104, and shaft assembly 110. The handle assembly 102 also houses various indicators, including, for example, a speaker / buzzer and an activation switch. In one embodiment, the battery assembly is a separate component that is inserted into the handle assembly housing through a door or other opening defined by the handle assembly housing.

[0048] The ultrasonic transducer / generator assembly 104 is a reusable unit that produces high frequency mechanical motion at a distal output. The ultrasonic transducer / generator assembly 104 is mechanically coupled to the shaft assembly 110 and the ultrasonic blade 116 and produces motion at the distal output of the ultrasonic blade 116 during operation of the device. In one aspect, the ultrasonic transducer / generator assembly 104 also provides a visual user interface, for example, through red / green / blue (RGB) light-emitting diodes (LEDs), LCD, or other displays. As such, the visual indicator of battery status is not uniquely located on the battery and is therefore separate from the battery.

[0049] According to various aspects of the present disclosure, three components of the surgical instrument 100, e.g., the ultrasonic transducer / generator assembly 104, the battery assembly 106, and the shaft assembly 110, are advantageously quickly disconnectable from one or more of the others. Each of the three components of the surgical instrument 100 is sterile and can be maintained entirely within a sterile field during use. Because the components of the surgical instrument 100 are separable, the surgical instrument 100 can be comprised of one or more portions that are single-use items (e.g., disposable) and other portions that are multi-use items (e.g., sterilizable for use in multiple surgical procedures). Aspects of the components are separate as part of the surgical instrument 100. According to additional aspects of the present disclosure, the handle assembly 102, the battery assembly 106, and the shaft assembly 110 components contribute to an overall weight, and each of the handle assembly 102, the battery assembly 106, and the shaft assembly 110 components is balanced to be the same or substantially the same weight. The handle assembly 102 overhangs the operator's hand for support, allowing the user's hand to more freely operate the controls of the surgical instrument 100 without bearing the weight. This overhang is located very close to the center of gravity. Combined with the triangular assembly configuration, this advantageously provides the surgical instrument 100 with a center of gravity that provides a very natural and comfortable feel for the user operating the device. That is, when held in the user's hand, the surgical instrument 100 has no tendency to tilt forward, backward, or side to side, but remains relatively and dynamically balanced so that the waveguide is held parallel to the ground with little effort from the user. Naturally, the instrument can easily be positioned at a non-parallel angle relative to the ground.

[0050] The rotation knob 118 is operably coupled to the shaft assembly 110. Rotation of the rotation knob 118 ±360° in the direction indicated by arrow 126 rotates the outer tube 144 ±360° in the respective direction of the arrow 128. In one embodiment, the rotation knob 118 may be configured to rotate the jaw member 114, while the ultrasonic blade 116 remains stationary, and a separate shaft rotation knob may be provided to rotate the outer tube 144 ±360°. In various embodiments, the ultrasonic blade 116 does not need to stop at ±360° and can rotate through rotation angles greater than ±360°. The outer tube 144 may have a diameter D1, for example, in the range of 5 mm to 10 mm.

[0051] The ultrasonic blade 116 is coupled to the ultrasonic transducer 130 ( FIG. 2 ) portion of the ultrasonic transducer / generator assembly 104 by an ultrasonic transmission waveguide located within the shaft assembly 110. The ultrasonic blade 116 and ultrasonic transmission waveguide may be formed as a unitary structure from materials suitable for transmitting ultrasonic energy. Examples of such materials include Ti6Al4V (an alloy of titanium containing aluminum and vanadium), aluminum, stainless steel, or other suitable materials. Alternatively, the ultrasonic blade 116 may be separable (and of a different composition) from the ultrasonic transmission waveguide and connected, for example, by a stud, welding, adhesive, quick connect, or other suitable known method. The length of the ultrasonic transmission waveguide may be, for example, an integer number of half wavelengths (nλ / 2). The ultrasonic transmission waveguide may preferably be fabricated from a solid core shaft constructed from a material suitable for efficiently propagating ultrasonic energy, such as the titanium alloys mentioned above (i.e., Ti6Al4V) or any suitable aluminum alloy, or other alloys, or other materials such as sapphire.

[0052] The ultrasonic transducer / generator assembly 104 also includes electronic circuitry for driving the ultrasonic transducer 130. The ultrasonic blade 116 can operate at a preferred vibration frequency range that can be approximately 20 Hz to 120 kHz, with a more preferred vibration frequency range being approximately 30 to 100 kHz. A preferred operating vibration frequency can be, for example, approximately 55.5 kHz. The ultrasonic transducer 130 is energized by actuation of the switch 120.

[0053] It will be understood that the terms "proximal" and "distal" are used herein relative to a clinician grasping the handle assembly 102. Thus, the ultrasonic blade 116 is distal relative to the more proximal handle assembly 102. It will be further understood that for convenience and clarity, spatial terms such as "upper" and "lower" are also used herein relative to a clinician grasping the handle assembly 102. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

[0054] FIG. 3 is an exploded view of a modular shaft assembly 110 of the surgical instrument 100 shown in FIG. 1 , according to an embodiment of the present disclosure. The surgical instrument 100 uses ultrasonic vibrations to perform a surgical procedure on living tissue. The shaft assembly 110 couples to the handle assembly 102 via slots 142 a, 142 b formed thereon and tabs 134 a, 134 b on the shaft assembly 110. The handle assembly 102 includes a male coupling member 136 that is received in a corresponding female coupling member in the shaft assembly 110 at 138. The male coupling member 136 is operably coupled to the trigger 108 such that, when the trigger 108 is squeezed, the male coupling member 136 translates distally to drive a closure tube mechanism 140 that translates an outer tube portion of the shaft assembly 110 to close the jaw member 114. As previously mentioned, when trigger 108 is released, jaw member 114 opens. Male coupling member 136 also couples to an ultrasonic transmission waveguide 145 located within an outer tube 144 of shaft assembly 110 (FIG. 2) and to an ultrasonic transducer 130 received within a nozzle 146 of handle assembly 102 (FIG. 2). Shaft assembly 110 is electrically coupled to handle assembly 102 via electrical contacts 137.

[0055] FIG. 4 is a perspective view of the ultrasonic transducer / generator assembly 104 of the surgical instrument 100 shown in FIG. 1 , according to an embodiment of the present disclosure. FIG. 5 is an end view of the ultrasonic transducer / generator assembly 104, FIG. 6 is a perspective view of the ultrasonic transducer / generator assembly 104 with an upper housing portion removed to expose the ultrasonic generator 162, and FIG. 7 is a cross-sectional view of the ultrasonic transducer / generator assembly 104. Referring now to FIGS. 4-7 , the ultrasonic transducer / generator assembly 104 includes an ultrasonic transducer 130 and an ultrasonic generator 162 for driving the ultrasonic transducer 130 and the housing 148. A first electrical connector 158 couples the ultrasonic generator 162 to the battery assembly 106 ( FIGS. 1 and 2 ), and a second electrical connector 161 couples the ultrasonic generator 162 to the nozzle ( FIG. 3 ). In one embodiment, a display 176 may be provided on one side of the ultrasonic transducer / generator assembly 104 housing 148.

[0056] The ultrasonic generator 162 includes an ultrasonic drive circuit, such as the electrical circuit 177 shown in FIG. 11 , and in some embodiments, a second stage amplifier circuit 178. The electrical circuit 177 is configured to drive the ultrasonic transducer 130 and forms part of the ultrasonic transducer circuit. The electrical circuit 177 includes, among other components, a transformer 166 and a blocking capacitor 168. The transformer 166 is electrically coupled to the piezoelectric elements 150 a, 150 b, 150 c, and 150 d of the ultrasonic transducer 130. The electrical circuit 177 is electrically coupled to a first electrical connector 158 via a first cable 179. The first electrical connector 158 is electrically coupled to the battery assembly 106 ( FIGS. 1 and 2 ). The electrical circuit 177 is electrically coupled to a second electrical connector 160 via a second cable 183. The second electrical connector 160 is electrically coupled to the nozzle 146 ( FIG. 3 ). In one embodiment, the second stage amplifier circuit 178 may be used in a two-stage amplification system.

[0057] The ultrasonic transducer 130, known as a "Langevin stack," generally includes a transduction portion including piezoelectric elements 150a-150d, a first resonator portion or end-bell 164, and a second resonator portion or fore-bell 152 and associated components. The overall structure of these components is a resonator. Other forms of transducers exist and can also be used, such as magnetostrictive transducers. The ultrasonic transducer 130 is preferably an integer number of one-half system wavelengths (nλ / 2, where "n" is any positive integer, e.g., n=1, 2, 3, ...) in length, as described in more detail below. The acoustic assembly includes the end-bell 164, the ultrasonic transducer 130, the fore-bell 152, and the transmission 154.

[0058] The distal end of end-bell 164 is acoustically coupled to the proximal end of piezoelectric element 150a, and the proximal end of fore-bell 152 is acoustically coupled to the distal end of piezoelectric element 150d. Fore-bell 152 and end-bell 164 have lengths determined by many variables, including the thickness of the transduction portion, the density and modulus of elasticity of the materials used to fabricate end-bell 164 and fore-bell 152, and the resonant frequency of ultrasonic transducer 130. Fore-bell 152 may taper inward from its proximal end to its distal end to amplify the amplitude of ultrasonic vibrations in transducer 154, or may have no amplification. A preferred vibration frequency range may be approximately 20 Hz to 120 kHz, with a more preferred vibration frequency range being approximately 30 to 100 kHz. A preferred operating vibration frequency may be approximately 55.5 kHz, for example.

[0059] Ultrasonic transducer 130 includes several piezoelectric elements 150a-150d acoustically coupled or stacked to form a transduction portion. Piezoelectric elements 150a-150d may be fabricated from any suitable material, such as lead zirconate titanate, lead metaniobate, lead titanate, barium titanate, or other piezoelectric ceramic materials. Conductive elements 170a, 170b, 170c, and 170d are interposed between piezoelectric elements 150a-150d to electrically couple electrical circuit 177 to piezoelectric elements 150a-150d. Conductive element 170a, located between piezoelectric elements 150a and 150b, and conductive element 170d, located between piezoelectric element 150d and fore-bell 152, are electrically coupled to positive electrode 174a of electrical circuit 177. Conductive element 170b, located between piezoelectric elements 150b and 150c, and conductive element 170c, located between piezoelectric elements 150c and 150d, are electrically connected to negative electrode 174b of electrical circuit 177. Positive and negative electrodes 174a and 174b are electrically connected to electrical circuit 177 by electrical conductors.

[0060] The ultrasonic transducer 130 converts the electrical drive signal from the electrical circuit 177 into mechanical energy, which produces standing acoustic waves of longitudinal vibratory motion of the ultrasonic transducer 130 and ultrasonic blade 116 (FIGS. 1 and 3) primarily at ultrasonic frequencies. In alternative embodiments, the vibratory motion of the ultrasonic transducer 130 may act in a different direction. For example, the vibratory motion may include a local longitudinal component of a more complex motion of the ultrasonic blade 116. When the acoustic assembly is energized, vibratory motion in the form of a standing wave is generated in the ultrasonic blade 116 through the ultrasonic transducer 130, with a resonance and amplitude determined by various electrical and geometric parameters. The amplitude of the vibratory motion at any point along the acoustic assembly depends on the location along the acoustic assembly where the vibratory motion is measured. Minima or zero-crossings in the vibratory motion standing waves are commonly referred to as wave nodes (i.e., points where the motion is minimal), and local maxima or peaks in the standing waves are commonly referred to as antinodes (i.e., points where the local motion is maximal). The distance between an antinode and its nearest node is one-quarter wavelength (λ / 4).

[0061] The wires carry electrical drive signals from electrical circuit 177 to positive electrode 170a and negative electrode 170b. Piezoelectric elements 150a-150d are energized by electrical signals provided by electrical circuit 177 in response to an actuator, such as switch 120, to generate acoustic standing waves in the acoustic assembly. The electrical signals induce small, repeated displacement disturbances in piezoelectric elements 150a-150d, resulting in large, alternating compression and expansion forces in the material. The small, repeated displacements cause piezoelectric elements 150a-150d to expand and contract continuously along the axis of the voltage gradient, generating longitudinal waves of ultrasonic energy. Ultrasonic energy is transmitted through the acoustic assembly to ultrasonic blade 116 (FIGS. 1 and 3) via transmission components or ultrasonic transmission waveguides through shaft assembly 110 (FIGS. 1-3).

[0062] In order for the acoustic assembly to deliver energy to the ultrasonic blade 116 (FIGS. 1 and 3), the components of the acoustic assembly are acoustically coupled to the ultrasonic blade 116. The coupling stud 156 of the ultrasonic transducer 130 is acoustically coupled to the ultrasonic transmission waveguide 145 by a threaded connection, such as a stud. In one aspect, the ultrasonic transducer 130 may be acoustically coupled to the ultrasonic transmission waveguide 145, as shown in FIGS. 10A and 10B.

[0063] The components of the acoustic assembly are preferably acoustically tuned so that the length of any assembly is an integer number of one-half wavelengths (nλ / 2), where wavelength λ is the preselected or operating longitudinal vibration drive frequency f of the acoustic assembly. d It is also contemplated that the acoustic assembly may incorporate any suitable arrangement of acoustic elements.

[0064] The ultrasonic blade 116 (FIGS. 1 and 3) may have a length that is an integer multiple of one-half system wavelength (nλ / 2). The distal end of the ultrasonic blade 116 may be disposed near an antinode to provide maximum longitudinal excursion of the distal end. When the ultrasonic transducer 130 is energized, the distal end of the ultrasonic blade 116 may be configured to move, for example, in a range of approximately 10-500 microns peak-to-peak, preferably in a range of about 30-150 microns, and in some embodiments, near 100 microns, at a predetermined vibration frequency, for example, 55 kHz.

[0065] FIG. 8 is an elevation view of an ultrasonic transducer / generator assembly 104 configured to operate at a resonant frequency of 31 kHz, according to one embodiment of the present disclosure. FIG. 9 is an elevation view of an ultrasonic transducer / generator assembly 104′ configured to operate at a resonant frequency of 55 kHz, according to one embodiment of the present disclosure. As can be seen, the ultrasonic transducer / generator assemblies 104, 104′ and the housing 148 are the same size to fit into the nozzle 146 of the surgical instrument 100 shown in FIG. 3 . Nevertheless, the individual ultrasonic transducers 130, 130′ vary in size depending on the desired resonant frequency. For example, the ultrasonic transducer 130 shown in FIG. 8 is tuned for a resonant frequency of 31 kHz and is physically larger than the ultrasonic transducer 130′ shown in FIG. 9, which is tuned for a resonant frequency of 55 kHz. The coupling studs 156, 156′ of the ultrasonic transducers 130, 130′ may be acoustically coupled to the ultrasonic transmission waveguide 145 by a threaded connection, such as a stud.

[0066] 10A and 10B illustrate a shift assembly 200 that selectively rotates the ultrasonic transmission waveguide 145 relative to the ultrasonic transducer 130 and biases them toward each other, according to one embodiment of the present disclosure. FIG. 10A illustrates the shift assembly 200 with the ultrasonic transmission waveguide 145 and the ultrasonic transducer 130 in a disengaged configuration, and FIG. 10B illustrates the shift assembly 200 with the ultrasonic transmission waveguide 145 and the ultrasonic transducer 130 in an engaged configuration. Referring now to both FIGS. 10A and 10B , the shift assembly 200 is located within the handle assembly 102 of the surgical instrument 100. One or more sleeves 204 hold the ultrasonic transducer 130 in a fixed position within the housing 148. The distal end of the ultrasonic transducer 130 includes threads 202 that are engaged by a worm gear 206. As the worm gear 206 rotates, the ultrasonic transducer 130 is urged in the direction indicated by arrow 208 to thread the threaded coupling stud 156 into the threaded end of the ultrasonic transmission waveguide 145. The worm gear 206 may be driven by a motor located within the handle assembly 102 of the surgical instrument 100.

[0067] In one aspect, the shift assembly 200 can include the provision of a torque-limiting motor drive of the ultrasonic transmission waveguide 145 via a motor located in the handle assembly 102 that controls the clamping, rotating, and articulating shaft actuation. The shift assembly 200 in the handle assembly 102 applies the appropriate torque to the ultrasonic transmission waveguide 145 to a location with a predetermined minimum torque. For example, the handle assembly 102 can include a transducer torque mechanism that shifts the primary motor that threads the waveguide into the transducer by longitudinally decoupling a primary drive shaft spur gear and engaging a transducer torque gear that rotates the shaft and nozzle.

[0068] FIG. 11 is a schematic diagram of one embodiment of the electrical circuit 177 shown in FIG. 4 suitable for driving an ultrasonic transducer 130, according to one embodiment of the present disclosure. The electrical circuit 177 includes an analog multiplexer 180. The analog multiplexer 180 multiplexes various signals from upstream channels SCL-A / SDA-A, such as ultrasound, battery, and power control circuits. A current sensor 182 is connected in series with the return or ground section of the power supply circuit and measures the current supplied by the power supply. A field effect transistor (FET) temperature sensor 184 provides ambient temperature. A pulse width modulation (PWM) watchdog timer 188 automatically causes a system reset if the main program fails to perform periodic servicing. This is provided to automatically reset the electrical circuit 177 if it hangs or freezes due to a software or hardware failure. It will be understood that the electrical circuit 177 can be configured as an RF driver circuit for driving an ultrasonic transducer 130 or for driving an RF electrode, such as the electrical circuit 702 shown in FIG. 34. 11, electrical circuitry 177 can be used to interchangeably drive both the ultrasonic transducer and the RF electrode. If driven simultaneously, a filter circuit may be provided within the corresponding first stage circuit 5504 to select between the ultrasonic waveform or the RF waveform. Such filtering techniques are described in commonly owned U.S. patent application Ser. No. 15 / 265,293, entitled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, which is incorporated herein by reference in its entirety.

[0069] The drive circuit 186 provides left and right ultrasonic energy outputs. Digital signals representing signal waveforms are provided to the SCL-A / SDA-A inputs of the analog multiplexer 180 from a control circuit, such as the control circuit 210 (FIG. 14). A digital-to-analog converter 190 (DAC) converts the digital input to an analog output to drive a PWM circuit 192 coupled to an oscillator 194. The PWM circuit 192 provides a first signal to a first gate drive circuit 196a coupled to a first transistor output stage 198a to drive the first ultrasonic (left) energy output. The PWM circuit 192 also provides a second signal to a second gate drive circuit 196b coupled to a second transistor output stage 198b to drive the second ultrasonic (right) energy output. A voltage sensor 199 is coupled between the ultrasonic left / right output terminals to measure the output voltage. The driver circuit 186, the first and second driver circuits 196a, 196b, and the first and second transistor output stages 198a, 198b define a first stage amplifier circuit. In operation, the control circuit 210 (FIG. 14) generates a digital waveform 1800 (FIG. 67) using circuitry such as direct digital synthesis (DDS) circuits 1500, 1600 (FIGS. 65 and 66). The DAC 190 accepts the digital waveform 1800 and converts it to an analog waveform, which is accepted and amplified by the first stage amplifier circuit.

[0070] FIG. 12 is a schematic diagram of a transformer 166 coupled to the electrical circuit 177 shown in FIG. 11 according to one embodiment of the present disclosure. The ultrasonic left / right input terminals (primary winding) of the transformer 166 are electrically coupled to the ultrasonic left / right output terminals of the electrical circuit 177. The secondary winding of the transformer 166 is coupled to the positive and negative electrodes 174a, 174b. The positive and negative electrodes 174a, 174b of the transformer 166 are coupled to the positive terminal 170a (stack 1) and negative terminal 170b (stack 2) of the ultrasonic transducer 130 (FIG. 4). In one embodiment, the transformer 166 has a turns ratio n1:n2 of 1:50.

[0071] Figure 13 is a schematic diagram of the transformer 166 shown in Figure 12 coupled to a test circuit 165, according to one embodiment of the present disclosure. The test circuit 165 is coupled to the positive and negative electrodes 174a, 174b. A switch 167 is placed in series with an inductor / capacitor / resistor (LCR) load that simulates the load of an ultrasonic transducer.

[0072] 14 is a schematic diagram of a control circuit 210 according to one embodiment of the present disclosure. The control circuit 210 is located within the housing of the battery assembly 106. The battery assembly 106 is the energy source for various local power sources 215. The control circuit comprises a main processor 214 coupled via an interface master 218 to various downstream circuits, for example, by outputs SCL-A / SDA-A, SCL-B / SDA-B, and SCL-C / SDA-C. In one embodiment, the interface master 218 is 2 The control circuit 212 is connected to the handle assembly 102 via a general-purpose serial interface, such as a USB 3.1 or USB 3.1. C serial interface. The main processor 214 is also configured to drive a switch 224 through a general-purpose input / output (GPIO) 220, a display 226 (e.g., an LCD display), and various indicators 228 through a GPIO 222. A watchdog processor 216 is provided to control the main processor 214. A switch 230 is provided in series with the battery 211 to activate the control circuit 212 upon insertion of the battery assembly 106 into the handle assembly 102 (FIGS. 1-3).

[0073] In one embodiment, main processor 214 is coupled to electrical circuitry 177 (FIGS. 4 and 11) by output terminals SCL-A / SDA-A. Main processor 214 includes memory for storing tables of digitized drive signals or waveforms that are transmitted to electrical circuitry 177, for example, to drive ultrasonic transducer 130 (FIGS. 4-8). In other embodiments, main processor 214 may generate digital waveforms and transmit them to electrical circuitry 177, or store digital waveforms for later transmission to electrical circuitry 177. Main processor 214 may also provide RF drive by output terminals SCL-B / SDA-B and various sensors (e.g., Hall effect sensors, magnetorheological fluid (MRF) sensors, etc.) by output terminals SCL-C / SDA-C. In one embodiment, main processor 214 is configured to sense the presence of an ultrasonic drive circuit and / or an RF drive circuit to enable appropriate software and user interface functionality.

[0074] In one embodiment, main processor 214 may be, for example, an LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core with on-chip memory of up to 40 MHz, 256 KB of single-cycle flash memory or other non-volatile memory, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse-width modulation (PWM) modules, one or more quadrature encoder input (QED) analogs, and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, among other features readily available from the product datasheet. Other processors may be readily substituted, and therefore the present disclosure should not be limited in this context.

[0075] 15 shows a simplified block circuit diagram illustrating another electrical circuit 300 included within a modular ultrasonic surgical instrument 334, according to one embodiment of the present disclosure. The electrical circuit 300 includes a processor 302, a clock 330, a memory 326, a power source 304 (e.g., a battery), a switch 306, such as a metal-oxide semiconductor field effect transistor (MOSFET) power switch, a drive circuit 308 (PLL), a transformer 310, a signal smoothing circuit 312 (also referred to as a matching circuit, which may be, for example, a tank circuit), a sensing circuit 314, a transducer 130, and a shaft assembly 110 comprising an ultrasonic transmission waveguide (which may be simply referred to herein as a waveguide) terminating in an ultrasonic blade 116.

[0076] One feature of the present disclosure that breaks the dependency on high-voltage (120 VAC) input power (a characteristic of typical ultrasonic cutting devices) is the use of low-voltage switching throughout the wave-forming process and the amplification of the drive signal only immediately prior to the transformer stage. For this reason, in one aspect of the present disclosure, power is derived from just one battery or battery group small enough to fit within the handle assembly 102 (FIGS. 1-3). Current state-of-the-art battery technology provides powerful batteries that are a few centimeters in height and width and a few millimeters in depth. By combining the features of the present disclosure to provide a self-contained and self-powered ultrasonic device, reduced manufacturing costs can be achieved.

[0077] The output of the power supply 304 is provided to and powers the processor 302. The processor 302 receives and outputs signals and functions according to custom logic or according to a computer program executed by the processor 302, as described below. The electrical circuitry 300 can also include memory 326, preferably random access memory (RAM), for storing computer-readable instructions and data.

[0078] The output of the power supply 304 is also directed to a switch 306, whose duty cycle is controlled by the processor 302. By controlling the on-time of the switch 306, the processor 302 can ultimately determine the total amount of power delivered to the converter 316. In one embodiment, the switch 306 is a MOSFET, although other switch and switching configurations are equally applicable. The output of the switch 306 is provided to a drive circuit 308, which may include, for example, a phase-detector phase-locked loop (PLL) and / or a low-pass filter and / or a voltage-controlled oscillator. The output of the switch 306 is sampled by the processor 302 to determine the voltage and current of the output signal (V IN and I IN, respectively). These values are used in a feedback architecture to adjust the pulse-width modulation of the switch 306. For example, the duty cycle of the switch 306 may vary from approximately 20% to approximately 80%, depending on the actual output desired from the switch 306.

[0079] A driver circuit 308 receives the signal from the switch 306 and includes an oscillator circuit that converts the output of the switch 306 into an electrical signal at an ultrasonic frequency, e.g., 55 kHz (VCO). As described above, a smoothed version of this ultrasonic waveform is ultimately fed to the ultrasonic transducer 130, which generates a resonant sine wave along the ultrasonic transmission waveguide 145 (FIG. 2).

[0080] At the output of the driver circuit 308 is a transformer 310 that can step up the low-voltage signal(s) to a higher voltage. It is noted that upstream switching is performed prior to the transformer 310 at a low (e.g., battery-powered) voltage, which has not previously been possible in ultrasonic cutting and cauterization devices. This is at least partially due to the device's advantageous use of low-on-resistance MOSFET switching devices. Low-on-resistance MOSFET switches are advantageous because they generate lower switching losses and less heat than conventional MOSFET devices and can pass higher currents. Therefore, the switching stage (pre-transformer) can be characterized as low-voltage / high-current. To ensure a lower on-resistance of the amplifier MOSFET(s), the MOSFET(s) are operated at, for example, 10 V. In such a case, a separate 10 V DC power supply can be used to supply the MOSFET gates, ensuring that the MOSFETs are fully on and achieving a reasonably low on-resistance. In one aspect of the present disclosure, transformer 310 steps up the battery voltage to a root-mean-square (RMS) of 120 V. Transformers are known in the art and will not be described in detail here.

[0081] In the described circuit configuration, degradation of circuit components can negatively impact the circuit's performance. One factor that directly affects component performance is heat. Known circuits typically monitor switching temperatures (e.g., MOSFET temperature). However, due to technological advances in MOSFET design and corresponding size reductions, MOSFET temperature is no longer an effective indicator of circuit load and heat. For this reason, according to one aspect of the present disclosure, sensing circuit 314 senses the temperature of transformer 310. This temperature sensing is advantageous because transformer 310 operates at or near its maximum temperature during device use. Additional temperature can destroy core materials, such as ferrite, causing permanent damage. The present disclosure can respond to the maximum temperature of transformer 310 by, for example, reducing the drive power in transformer 310, signaling a user, turning off the power supply, pulsing power, or other appropriate response.

[0082] In one aspect of the present disclosure, a processor 302 is communicatively coupled to the end effector 112 and is used to bring a material into physical contact with the ultrasonic blade 116, e.g., the clamping mechanism shown in FIG. 1 . A sensor is provided in the end effector 112 to measure a clamping force value (within a known range), and the processor 302 varies the motion voltage VM based on the received clamping force value. Because a high force value combined with a set motion speed can result in a high blade temperature, a temperature sensor 336 is communicatively coupled to the processor 302, and the processor 302 is operable to receive and interpret a signal indicative of the current temperature of the blade from the temperature sensor 336 and to determine a target frequency of blade movement based on the received temperature. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the trigger 108 to measure the force applied to the trigger 108 by a user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the switch 120 button, such that a displacement magnitude corresponds to the force applied to the switch 120 button by a user.

[0083] According to one aspect of the present disclosure, a PLL portion of the drive circuit 308 coupled to the processor 302 can determine the frequency of waveguide movement and communicate that frequency to the processor 302. The processor 302 stores this frequency value in memory 326 when the device is turned off. By reading the clock 330, the processor 302 can determine the time that has elapsed since the device was shut off and, if the elapsed time is less than a predetermined value, retrieve the last frequency of waveguide movement. The device can then start at the last frequency, which is presumably the optimal frequency for the current load.

[0084] FIG. 16 shows a battery assembly 400 for use with surgical instrument 100 according to one embodiment of the present disclosure. Battery assembly 400 includes a housing 402 sized and configured to contain various energy cells. The energy cells may include rechargeable and non-rechargeable batteries. In one embodiment, battery assembly 400 includes four Li-ion non-rechargeable batteries 404a, 404b, 404c, 404d and two nickel metal hydride (NiMH) rechargeable batteries 406a (a second battery not shown). Housing 402 includes tabs 408a, 408b for removably connecting battery assembly 400 to handle assembly 102 of surgical instrument 100 (FIGS. 1 and 2).

[0085] FIG. 17 illustrates a disposable battery assembly 410 for use with surgical instrument 100 according to one embodiment of the present disclosure. In one embodiment, the disposable battery assembly 410 comprises a primary cell battery pack for use with a battery-powered, high-energy instrument, such as surgical instrument 100 (FIGS. 1 and 2), and includes additional voltage compensating electronics to offset voltage sags from the disposable battery assembly 410 and prevent the output voltage from dropping below a predetermined level during operation under load. The disposable battery assembly 410 comprises a housing 412 sized and configured to contain various energy cells. The energy cells can include rechargeable and non-rechargeable batteries. In one embodiment, the disposable battery assembly 410 includes four primary lithium-ion (Li-ion) non-rechargeable batteries 414a, 414b, 414c, 414d and two secondary NiMH or nickel-cadmium (NiCd) rechargeable batteries 416a, 416b. The housing 412 includes electrical contacts 418 for electrically coupling the disposable battery assembly 410 to the handle assembly 102 of the surgical instrument 100. In the illustrated example, the electrical contacts 418 include four metal contacts. The disposable battery assembly 410 also includes an electrical circuit 419, such as the control circuit 210 (FIG. 14) and / or the electrical circuit 300 (FIG. 15). The electrical circuit 419 is radiation hardened.

[0086] In one aspect, the disposable battery assembly 410 includes batteries 414a-d, electrical circuitry 419, and other components that are resistant to gamma or other radiation sterilization. For example, a switching-mode power supply 460 (FIG. 22) or a linear power supply 470 (FIG. 24) and optional charging circuitry can be incorporated into the housing 412 of the disposable battery assembly 410 to reduce voltage sags on the primary Li-ion batteries 414a-d and allow for the use of secondary NiMH batteries 416a, 416b to reduce voltage sags. This ensures fully charged cells at the beginning of each procedure for easy entry into the sterile field. A dual-type battery assembly including primary Li-ion batteries 414a-d and secondary NiMH batteries 416a-b can be used with dedicated energy cells 416a-b to control electronics from the dedicated energy cells 414a-d, which run generator and motor control circuits. In one aspect, if the associated battery becomes low, the system draws from the battery needed to power the electronics circuitry. In one aspect, the system includes a unidirectional diode system that does not allow current to flow in the opposite direction, e.g., from a battery involved in driving energy and / or motor control circuits to a battery involved in driving electronic circuitry. In an additional aspect, the system can include a gamma-friendly charging circuit and a switch-mode power supply that uses diode and vacuum tube components to minimize sag at a predetermined level. The switch-mode power supply can be eliminated by including a minimum sag voltage that is a division of the NiMH voltage (e.g., three NiMH cells). In another aspect, a modular system can be created in which radiation-hardened components are located within modules, making the modules sterilizable by radiation sterilization. Other non-radiation-hardened components are included in other modular components, and connections are made between the modular components so that the components operate together as if they were located together on the same circuit board. When only two cells of the secondary NiMH batteries 416a-b are desired, a switch-mode power supply based on diodes and vacuum tubes allows for sterilizable electronics within the disposable primary Li-ion batteries 414a-d.

[0087] FIG. 18 shows a reusable battery assembly 420 for use with a surgical instrument 100 according to one embodiment of the present disclosure. The reusable battery assembly 420 includes a housing 422 sized and configured to contain various rechargeable energy cells. The energy cells may include rechargeable batteries. In one embodiment, the reusable battery assembly 420 includes five stacked NiMH rechargeable batteries 424a, 424b, 424c, 424d, and 424e. The housing 422 includes electrical contacts 428 for electrically coupling the reusable battery assembly 420 to the handle assembly 102 of the surgical instrument 100 (FIGS. 1 and 2). In the illustrated example, the electrical contacts 428 include six metal contacts. Reusable battery assembly 420 also includes up to six circuit boards 429a, 429b, 429c, 429d, 429e, 429f, which may include electrical circuitry such as control circuit 210 (FIG. 14) and / or electrical circuitry 300 (FIG. 15). In one aspect, reusable battery assembly 420 includes drive FET transistors and associated circuitry 429a-f within housing 422 for easy replacement, eliminating the need to shut down surgical instrument 100 (FIGS. 1 and 2) to replace reusable battery assembly 420 with energy delivery.

[0088] The reusable battery assembly 420 includes a battery test switch 426 and up to three LED indicators 427a, 427b, and 427c to determine the degradation of the batteries 424a-e within the reusable battery assembly 420. The first LED indicator 427a may indicate a fully charged battery 424a-e that is ready for use. The second LED indicator 427b may indicate that the battery needs to be recharged. The third LED indicator 427c may indicate that the battery is defective and should be discarded. The degradation indicators of the reusable battery assembly 420 allow the user to determine the specific degradation and capacity of the batteries 424a-e before inserting and using them. For example, the state of charge, low voltage, and primary cell voltage of the rechargeable secondary cells are checked by activating the battery test switch 426, which can measure these with no load or with a predefined resistive load applied to the system. The voltages may have at least one, but more preferably three, thresholds for comparing the resulting voltage checks. In the case of the first indicator 427a, the batteries 424a-e indicate whether they are suitable for use. With three levels, the reusable battery assembly 420 can indicate a fully charged, minimally charged, and some marginal but limited charge state. This battery 424a-e health monitor is useful for either the disposable battery assembly 410 (FIG. 17) or the reusable battery assembly 420. In the case of the disposable battery assembly 410, it is a ready / damaged indicator. In the case of the reusable battery assembly 420, in addition to ready / not ready, it can also indicate life remaining, recharge capacity, and even years before failure.

[0089] FIG. 19 is an elevated perspective view of a removable battery assembly 430 with both halves of the housing shell removed to expose battery cells coupled to multiple circuit boards, which are coupled to multi-lead battery terminals, according to one embodiment of the present disclosure. Furthermore, more or less than three circuit boards are possible to provide expanded or limited functionality. As shown in FIG. 19 , multiple circuit boards 432, 434, 436 may be positioned in a stacked architecture, which offers many advantages. For example, due to a smaller layout size, the circuit boards have a smaller footprint within the removable battery assembly 430, thereby enabling a smaller battery. Additionally, this configuration allows for the power boards to be easily isolated from the digital boards to prevent any noise originating from the power boards from harming the digital boards. The stacked configuration also allows for direct connection of features between the boards, thereby reducing the presence of wiring. Furthermore, the circuit boards may be configured as part of a rigid-flex-rigid circuit, allowing the rigid components to be “fanned” into a smaller volumetric area.

[0090] According to aspects of the present disclosure, circuit boards 432, 434, and 436 each provide a specific function. For example, one circuit board 432 can provide components for implementing a battery protection circuit. Similarly, another circuit board 434 can provide components for implementing a battery controller. Another circuit board 436 can provide, for example, high-power buck controller components. Finally, the battery protection circuit can provide a connection path for linking the battery cells 438a-n. By arranging the circuit boards in a stacked configuration and separating the boards by their respective functions, the boards can be strategically placed in a specific order that best addresses their individual noise and heat generation. For example, the circuit board with the high-power buck controller components generates the most heat, so it can be isolated from the other boards and placed in the center of the stack. In this way, heat can be directed away from the outer surface of the device in an effort to prevent the heat from being felt by the physician or device operator. Additionally, the battery board ground can be configured in a star topology, centered on the buck controller board, to reduce noise caused by ground loops.

[0091] The strategically layered circuit board, the low thermal conduction path from the circuit board to the multi-lead battery terminal assembly, and the flex circuit 3516 are features that help prevent heat from reaching the device's exterior surface. The battery cell and back components are thermally connected to a flex circuit within the handle assembly 102 (FIGS. 1 and 2) to direct heat generated by the cell and back components away from the physician's hand. The flex circuit presents a relatively high thermal mass due to its exposed substrate area and the advantageous conductive properties of copper, which redirects, absorbs, and / or dissipates heat over a wider area, thereby slowing down heat concentration and limiting high spot temperatures on the device's exterior surface. Other techniques, including, but not limited to, larger thermal wells, sinks or insulators, metal connector caps, and heavier copper content in the device's flex circuit or handle assembly 102, may be implemented as well.

[0092] Another advantage of the removable battery assembly 430 is realized when Li-ion batteries are used. As previously mentioned, Li-ion batteries should not be charged in a parallel configuration of multiple cells. This is because, as the voltage rises in a particular cell, it begins to accept additional charge more quickly than other lower-voltage cells. Therefore, the cell is monitored so that the charge to that cell can be individually controlled. When a Li-ion battery is formed from a group of cells 438a-n, multiple leads (at least one additional lead for each battery cell beyond the first) extending from the exterior of the device to the batteries 438a-n are required. By having the removable battery assembly 430, the battery cells 438a-n, in one aspect, have their own exposed sets of contacts that can be coupled to corresponding sets of contacts in an external, non-sterile charger when the removable battery assembly 430 is not present in the handle assembly 102 (FIGS. 1 and 2). In another embodiment, the battery cells 438a-n are electrically connected to a battery protection circuit, allowing the battery protection circuit to control and regulate the recharging of the cells 438a-n. The removable battery assembly 430 is provided with circuitry to prevent use of the removable battery assembly 430 beyond its expected lifespan. This term refers not only to the cells, but also to the exterior surfaces, including the battery casing or shell and upper contact assembly. Such circuitry is described in more detail below and includes, for example, a usage count, a recharge count, and an absolute time since manufacture count.

[0093] FIG. 19 also illustrates a multi-lead battery terminal assembly 433, which is an interface that electrically couples components within the removable battery assembly 430 to the electrical interface of the handle assembly 102 (FIGS. 1 and 2). The removable battery assembly 430 can be electrically (and mechanically) coupled to the ultrasonic transducer / generator assembly 104 (FIG. 4) through the handle assembly 102. As described above, the removable battery assembly 430 provides power to the surgical instrument 100 (FIGS. 1 and 2) through the multi-lead battery terminal assembly 433, as well as other functionality described herein. The multi-lead battery terminal assembly 433 includes multiple contact pads 435a-n that can separately electrically connect terminals within the removable battery assembly 430 to other terminals provided by the docking bay of the handle assembly 102. One example of such an electrical connection is coupled to the multiple contact pads 435a-n as power and communication signal paths. In one embodiment of the multi-lead battery terminal assembly 433, 16 different contact pads 435a-n are shown. This number is merely exemplary. In an embodiment, the interior of the battery contact assembly 433 has wells formed on a molded terminal holder that can be filled with potting material to provide a hermetic seal. Contact pads 435a-n are overmolded into the lid and extend through the potting wells to the interior of the battery 430. A flex circuit can then be used to rearrange the arrangement of pins and provide electrical connection to the circuit board. In one embodiment, a 4x4 array is converted to a 2x8 array. In one embodiment of the multi-lead battery contact assembly 433, the plurality of contact pads 435a-n of the multi-lead battery contact assembly 2804 includes a corresponding plurality of internal contact pins 437a-n. Contact pin 437a provides a direct electrical connection to a corresponding one of the contact pads 435a.

[0094] FIG. 20 illustrates a battery test circuit 440 according to one embodiment of the present invention. The battery test circuit 440 includes the battery test switch 426 described in FIG. 18. The battery test switch 426 is a switch that engages an LCR dummy load that simulates the transformer or shaft assembly electronics. As described in FIG. 18, additional indicator circuitry can be coupled to the battery test circuit 440 to provide a suitable indication of the capacity of the batteries in the reusable battery assembly 420. The illustrated battery test circuit 440 may be used with any of the battery assemblies 400, 410, 420, 430 described with respect to FIGS. 16-19, respectively.

[0095] 21 shows an auxiliary power supply circuit 450 for maintaining a minimum output voltage according to one embodiment of the present disclosure. The auxiliary power supply circuit 450 may be included in any of the battery assemblies 400, 410, 420, 430 described with reference to FIGS. 16-19. The auxiliary power supply circuit 450 is configured to maintain a minimum output voltage V O from momentarily dropping under high load conditions. Auxiliary power circuit 450 includes a set of four primary batteries 452a-b, 452c-d (up to n batteries may be used) that are activated when switch 453 is closed upon insertion of battery assembly 400, 410, 420, 430 into handle assembly 102 of surgical instrument 100 (FIGS. 1 and 2). Primary batteries 452a-d may be Li-ion batteries, such as CR123A Li-ion batteries. Under load, primary batteries 452a-d generate an output voltage V O while the secondary rechargeable battery 454 is charged by the charger 455. In one embodiment, the secondary rechargeable battery 454 in a NiMH battery and the charger 455 are suitable NiMH chargers. O When voltage V dips or droops due to high load conditions, X operates the switched mode power supply 456 to supply additional current to the load, thereby increasing the output voltage V O The diode 458 is provided to prevent current from flowing into the output of the switched mode power supply 456. Therefore, the output voltage V bmust overcome the voltage drop across diode 458 (approximately 0.7V) before auxiliary current can flow into the load. Optionally, a battery test switch 459 and test resistor R Test 21, the battery assemblies 400, 410, 420, 430 may be provided with a test circuit 457a including a switch 457b and a resistor 457c, such that when the switch 457b is closed (e.g., via the test button 426), the resistor 457c detects whether the primary batteries 452a-d are at an output voltage V O If not, resistor 457 determines whether secondary battery 454, through the operation of switch-mode power supply 456, is capable of delivering V b , whereby the auxiliary current passing through diode 458 is equal to the output voltage V O Recover.

[0096] 22 illustrates a switched-mode power supply circuit 460 for supplying energy to a surgical instrument 100, according to one embodiment of the present disclosure. The switched-mode power supply circuit 460 may be disposed in any one of the battery assemblies 400, 410, 430 described with respect to FIGS. 16, 17, and 19, respectively. In the illustrated example, the switched-mode power supply circuit 460 includes primary Li cell batteries 429a-d, and a positive (+) output voltage is supplied to an input terminal V of a switching regulator 464. IN It will be appreciated that any suitable number of primary cells may be used. The switched mode power supply circuit 460 includes a remote on / off switch. The input V of the switching regulator 464 IN is also the capacitor C i The output V of the switching regulator 464 is out is the inductor L and the capacitor C O The catch diode D is connected to the output filter represented by V out The feedback signal is fed to the output filter C Oto the FB input of switching regulator 464. L represents the load. In one embodiment, the minimum load is about 200 mA. In one embodiment, the output voltage V OUT is 3.3VDC at 800mA.

[0097] 23 illustrates a separate version of the switching regulator 464 shown in FIG. 22 for supplying energy to the surgical instrument 100, according to one embodiment of the present disclosure. The switching regulator 464 is IN The switching regulator 464 receives an input voltage from the battery assemblies 400, 410, 420, 430 at its terminals. A signal at the on / off input enables or disables operation of the switching regulator 464 by controlling the state of a switch 471. A feedback signal is received from the load at the FB input, divided by a voltage divider circuit 463. The voltage from the voltage divider 463 is applied to the positive input of a fixed gain amplifier 465. The negative input of the fixed gain amplifier 465 is coupled to a bandgap reference diode 469 (e.g., 1.23 V). The amplified output of the fixed gain amplifier 465 is applied to the positive input of a comparator 466. The negative input of the comparator 466 receives the input of a 50 kHz oscillator 467. The output of the comparator 466 is applied to a driver 468 which drives an output transistor 461. The output transistor 461 is connected to a V OUT The terminals supply voltage and current to the load.

[0098] 24 illustrates a linear power supply circuit 470 for supplying energy to a surgical instrument 100, according to one embodiment of the present disclosure. The linear power supply circuit 470 may be disposed in any one of the battery assemblies 400, 410, 420, 430 described with respect to FIGS. 16, 17, 18, and 19, respectively. In the illustrated example, the linear power supply circuit 470 includes primary Li cell batteries 462a-d, and the positive (+) output voltage is supplied by the V IN The output of transistor 472 is coupled to the V terminal of linear power supply circuit 470. OUT The input filter C supplies current and voltage to the load through the terminals. iis provided on the input side, and the output filter C O is provided on the output side. Zener diode D Z applies a regulated voltage to the base of transistor 472. The bias resistor is connected to Zener diode D Z and biases transistor 472.

[0099] FIG. 25 is an elevational exploded view of a modular handheld ultrasonic surgical instrument 480 with the left shell half removed from the handle assembly 482 to expose a device identifier communicatively coupled to the multi-lead handle terminal assembly, according to one embodiment of the present disclosure. In additional embodiments of the present disclosure, an intelligent or smart battery is used to power the modular handheld ultrasonic surgical instrument 480. However, smart batteries are not limited to the modular handheld ultrasonic surgical instrument 480 and, as described, can be used in a variety of devices that may or may not have different power requirements (e.g., current and voltage). The smart battery assembly 486, according to one embodiment of the present disclosure, can advantageously identify the particular device to which it is electrically coupled. This can be done through encrypted or non-encrypted identification methods. For example, the smart battery assembly 486 can have a connection portion, such as connection portion 488. The handle assembly 482 can also be provided with a device identifier communicatively coupled to the multi-lead handle terminal assembly 491 and operable to communicate at least one piece of information regarding the handle assembly 482. This information may relate to the number of times the handle assembly 482 has been used, the number of times the ultrasonic transducer / generator assembly 484 (now disconnected from the handle assembly 482) has been used, the number of times the waveguide shaft assembly 490 (now connected to the handle assembly 482) has been used, the type of waveguide shaft assembly 490 currently connected to the handle assembly 482, the type or identity of the ultrasonic transducer / generator assembly 484 currently connected to the handle assembly 482, and / or many other characteristics. When the smart battery assembly 486 is inserted into the handle assembly 482, a connection portion 488 within the smart battery assembly 486 is in communicative contact with the device identifier of the handle assembly 482. The handle assembly 482 can transmit information to the smart battery assembly 486 (either self-initiated or in response to a request from the smart battery assembly 486) through hardware, software, or a combination thereof. This communicated identifier is received by the connection portion 488 of the smart battery assembly 486.In one aspect, once the smart battery assembly 486 receives the information, the communication portion is operable to control the output of the smart battery assembly 486 to meet the specific power requirements of the device.

[0100] In one aspect, the communications portion includes a processor 493 and a memory 497, which may be separate or a single component. The processor 493, in combination with the memory, may provide intelligent power management for the modular handheld ultrasonic surgical instrument 480. This aspect is particularly advantageous because an ultrasonic device such as the modular handheld ultrasonic surgical instrument 480 has power requirements (frequency, current, and voltage) that may be unique to the modular handheld ultrasonic surgical instrument 480. Indeed, the modular handheld ultrasonic surgical instrument 480 may have a particular power requirement or limitation for one size or type of outer tube 494, and a second, different power requirement for a second type of waveguide having a different size, shape, and / or configuration.

[0101] Thus, a smart battery assembly 486, according to one aspect of the present disclosure, allows the battery assembly to be used across several surgical instruments. Because the smart battery assembly 486 can identify the device to which it is attached and change its output power accordingly, operators of various different surgical instruments utilizing the smart battery assembly 486 do not need to worry about the power source they are installing within the electronics devices they are using. This is particularly advantageous in operating environments where the battery assembly needs to be swapped or replaced with another surgical instrument during a complex surgical procedure.

[0102] In a further aspect of the present disclosure, the smart battery assembly 486 stores a record in memory 497 each time a particular device is used. This record is useful for assessing the end of the device's useful or acceptable lifespan. For example, if a device is used 20 times, it is defined as a "no longer reliable" surgical instrument, and such a battery in the smart battery assembly 486 connected to the device will refuse to power it. Reliability is determined based on many factors. One factor can be wear, which can be estimated in many ways, including the number of times the device has been used or activated. After a certain number of uses, device components may wear out and exceed the tolerances between components. For example, the smart battery assembly 486 can sense the number of button presses received by the handle assembly 482 and determine when the maximum number of button presses has been reached or exceeded. The smart battery assembly 486 can also monitor the impedance of the button mechanism, which can change, for example, if the handle becomes contaminated with salt water.

[0103] This wear can lead to unacceptable failures during a procedure. In some embodiments, the smart battery assembly 486 can recognize which components are combined together in the device and even the number of uses the components have experienced. For example, if the smart battery assembly 486 is a smart battery according to the present disclosure, it can identify the handle assembly 482, the waveguide shaft assembly 490, and the ultrasonic transducer / generator assembly 484 before a user attempts to use the combined device. A memory 497 within the smart battery assembly 486 can record, for example, when the ultrasonic transducer / generator assembly 484 has been operating, and when, how, and for how long. If the ultrasonic transducer / generator assembly 484 has an individual identifier, the smart battery assembly 486 can track the use of the ultrasonic transducer / generator assembly 484 and deny power to the ultrasonic transducer / generator assembly 484 once the handle assembly 482 or the ultrasonic transducer / generator assembly 484 has exceeded its maximum number of uses. The ultrasonic transducer / generator assembly 484, handle assembly 482, waveguide shaft assembly 490, or other components may include a memory chip that records this information as well. In this manner, any number of smart batteries in the smart battery assembly 486 may be used with any number of ultrasonic transducer / generator assemblies 484, staplers, conduit sealers, etc. and still be able to determine the total number of uses, or total hours of use (through the use of a clock), or total number of actuations, etc., or charge or discharge cycles of the ultrasonic transducer / generator assembly 484, staplers, conduit sealers, etc. Smart functionality may also reside external to the battery assembly 486, for example, within the handle assembly 482, ultrasonic transducer / generator assembly 484, and / or shaft assembly 490.

[0104] By counting the uses of the ultrasonic transducer / generator assembly 484 and intelligently terminating the life of the ultrasonic transducer / generator assembly 484, the surgical instrument accurately distinguishes between the completion of actual use of the ultrasonic transducer / generator assembly 484 in a surgical procedure and a momentary loss of operation of the ultrasonic transducer / generator assembly 484 due to, for example, a battery change or a momentary delay in the surgical procedure. Thus, as an alternative to simply counting the number of activations of the ultrasonic transducer / generator assembly 484, a real-time clock (RTC) circuit can be implemented to track the amount of time the ultrasonic transducer / generator assembly 484 has actually been shut down. From the measured length of time, it can be determined whether the shutdown was significant enough to be considered the end of an actual use, or whether the shutdown was too brief to be considered the end of a use. Thus, in some applications, this method may more accurately determine the useful life of the ultrasonic transducer / generator assembly 484 than a simple "trigger-based" algorithm, where, for example, 10 "triggerings" occur during a surgical procedure, whereby 10 triggerings should indicate a counter should be incremented by 1. Generally, this internal clock synchronization type and system will prevent misuse of the device designed to circumvent simple "trigger-based" algorithms, and will also prevent fraudulent logging of complete usage where there was only a simple disconnection of the ultrasonic transducer / generator assembly 484 or smart battery assembly 486 that was legitimately required.

[0105] While the ultrasonic transducer / generator assembly 484 of the surgical instrument 480 is reusable, in one aspect, it can be configured for a finite number of uses due to the harsh conditions the surgical instrument 480 is exposed to during cleaning and sterilization. More specifically, the battery pack is configured to be sterilized. Regardless of the material used for the exterior surface, there is a limited expected lifespan for the actual material used. This lifespan is determined by various characteristics, which may include, for example, the amount of time the pack has actually been sterilized, the time since the pack was manufactured, and the number of times the pack has been recharged, to name just a few. Additionally, the battery cells themselves have a limited lifespan. The software of the present disclosure incorporates an inventive algorithm that verifies the number of uses of the ultrasonic transducer / generator assembly 484 and smart battery assembly 486 and disables the device when this number of uses is met or exceeded. An analysis of the battery pack exterior for each possible sterilization method can be performed. A maximum number of permitted sterilizations can be defined based on the most severe sterilization procedure, and this number can be stored in the memory of the smart battery assembly 486. If the charger is non-sterile and the smart battery assembly 486 is expected to be used after charging, the charge count may be defined as equal to the number of sterilizations a particular pack will encounter.

[0106] In one aspect, hardware within a battery pack can minimize or eliminate safety concerns due to continuous drain from battery cells after the pack has been disabled by software. There may be situations where the battery's internal hardware is unable to disable the battery under certain low-voltage conditions. In such situations, in one aspect, a charger can be used to "shut down" the battery. Due to the fact that the battery microcontroller is off while the battery is in its charger, a non-volatile system management bus (SMB)-based electrically erasable programmable read-only memory (EEPROM) can be used to exchange information between the battery microcontroller and the charger. Thus, a series of EEPROMs can be used to store information that can be written and read even when the battery microcontroller is off, which is very useful when attempting to exchange information with a charger or other peripheral device. The EEPROM in this example can be configured to include sufficient memory registers to store at least (a) a usage count limit (battery usage count) at which the battery should be disabled, (b) the number of procedures the battery has undergone (battery usage count), and / or (c) the number of charges the battery has undergone (charge count), to name just a few. Some of the information stored in the EEPROM, such as the usage count register and charge count register, is stored in a write-protected portion of the EEPROM to prevent users from changing the information. In one aspect, the usage and counters are stored with corresponding bit-reversed small registers to detect data corruption.

[0107] Any residual voltage in the SMBus lines can damage the microcontroller and corrupt the SMBus signals, therefore, a relay is provided between the external SMBus lines and the battery microcontroller board to ensure that the SMBus lines of the battery controller 703 do not carry voltage while the microcontroller is off.

[0108] During charging of the smart battery assembly 486, for example, when using a constant current / constant voltage charging scheme, an "end of charge" state of the battery in the smart battery assembly 486 is determined when the current draw into the battery falls below a given threshold in a tapered manner. To accurately detect this "end of charge" state, the battery microcontroller and back board are powered down and turned off while the battery is charging to reduce any current drain that may be caused by the board and that may interfere with tapered current detection. Additionally, the microcontroller and back board are powered down during charging to prevent any resulting corruption of SMBus signals.

[0109] With regard to the charger, in one aspect, the smart battery assembly 486 is prevented from being inserted into the charger in any way other than the correct insertion position. Accordingly, the exterior of the smart battery assembly 486 is provided with features to hold the charger. The cup for securely holding the smart battery assembly 486 in the charger is configured with a tapered shape that matches the contours to prevent accidental insertion of the smart battery assembly 486 in any way other than the correct (intended) way. It is further contemplated that the presence of the smart battery assembly 486 may be detectable by the charger itself. For example, the charger may be configured to detect the presence of SMBus transmissions from the battery protection circuit as well as resistors located in the protection board. In such a case, the charger may control the voltage exposed at the charger pins until the smart battery assembly 486 is properly seated or in place in the charger. This is because exposed voltage at the charger pins presents a hazard and risk of an electrical short across the pins causing the charger to inadvertently begin charging.

[0110] In some embodiments, the smart battery assembly 486 can communicate to the user through audio and / or visual feedback. For example, the smart battery assembly 486 can cause an LED to light up in a pre-set manner. In such cases, a microcontroller within the ultrasonic transducer / generator assembly 484 controls the LED, but the microcontroller receives instructions to be executed directly from the smart battery assembly 486.

[0111] In yet a further aspect of the present disclosure, the microcontroller within the ultrasonic transducer / generator assembly 484 goes into sleep mode when not in use for a predetermined period of time. Advantageously, when in sleep mode, the microcontroller's clock speed is reduced, significantly reducing current drain. Some current continues to be consumed as the processor continues pinging and waits to sense input. Advantageously, when the microcontroller is in this power-saving sleep mode, the microcontroller and battery controller can directly control the LEDs. For example, a decoder circuit can be built into the ultrasonic transducer / generator assembly 484 and connected to the communication lines, so that the LEDs can be independently controlled by the processor 493 while the ultrasonic transducer / generator assembly 484 microcontroller is "off" or in "sleep mode." This is a power-saving feature that eliminates the need to wake up the microcontroller within the ultrasonic transducer / generator assembly 484. Power is conserved by turning off the generator while still allowing active control of the user interface indicators.

[0112] Another aspect is to slow down one or more of the microcontrollers to conserve power when not in use. For example, the clock frequency of both microcontrollers can be reduced to save power. To maintain synchronous operation, the microcontrollers coordinate both near-simultaneous changes to their respective clock frequencies, and a reduction when full speed operation is required, followed by a subsequent increase in frequency. For example, upon entering idle mode, the clock frequency is reduced, and upon exiting idle mode, the frequency is increased.

[0113] In additional embodiments, the smart battery assembly 486 can determine the amount of available power remaining in its cells and is programmed to operate an attached surgical instrument only if it determines that there is enough power remaining to predictably operate the device throughout the anticipated procedure. For example, the smart battery assembly 486 remains in an inoperative state if there is not enough power in the cells to operate the surgical instrument for 20 seconds. According to one embodiment, the smart battery assembly 486 determines the amount of power remaining in the cells at the end of its most recent preceding function, e.g., a surgical cut. In this embodiment, the smart battery assembly 486 thus prevents subsequent functions from being performed if it determines that the cells are low on power during that procedure, for example. Alternatively, if the smart battery assembly 486 determines during a procedure that there is enough power for a subsequent procedure and falls below that threshold, it does not interrupt the procedure in progress but instead terminates it, preventing additional procedures from occurring thereafter.

[0114] The following describes the advantages of maximizing the use of devices equipped with the smart battery assembly 486 of the present disclosure. In this example, different sets of devices have different ultrasonic transmission waveguides. By definition, each waveguide may have its own maximum allowable power limit, and exceeding that power limit will overstress the waveguide and ultimately cause it to fracture. One waveguide from a set of waveguides will inherently have the smallest maximum power allowable range. Because prior art batteries lack intelligent battery power management, the output of a prior art battery must be limited by the minimum maximum allowable power input for the smallest / thinnest / most fragile waveguide of the set intended for use with the device / battery. This is true even though a larger, thicker waveguide may later be attached to the handle, which, by definition, allows for greater force to be applied. This limit also holds true for the maximum battery power. For example, if a single battery is designed to be used with multiple devices, its maximum output power will be limited to the lowest maximum power rating of any of the devices with which it is used. Such a configuration may prevent one or more devices or device configurations from maximizing battery usage because the battery is unaware of the specific limitations of a particular device.

[0115] In one aspect, the smart battery assembly 486 can be used to intelligently circumvent the limitations of ultrasound devices described above. The smart battery assembly 486 can generate one output for one device or a specific device configuration, and the same smart battery assembly 486 can later generate a different output for a second device or device configuration. This universal smart battery surgical system is well-suited for modern operating rooms where space and time are at a premium. By powering many different devices with a smart battery pack, nurses can easily manage the storage, retrieval, and inventory of these packs. Advantageously, in one aspect, smart batteries according to the present disclosure can use one type of charging station, thus increasing ease and efficiency of use and reducing the cost of operating room charging equipment.

[0116] Additionally, other surgical instruments, such as electric staplers, may have different power requirements than the modular handheld ultrasonic surgical instrument 480. According to various aspects of the present disclosure, the smart battery assembly 486 can be used with any one of a series of surgical instruments and can be tailored to tailor its power output to the specific device in which it is installed. In one aspect, this power tailoring is accomplished by controlling the duty cycle of a switch-mode power supply, such as a buck-boost, boost, or other configuration, that is integral to or otherwise coupled with the smart battery assembly 486. In other aspects, the smart battery assembly 486 can dynamically change its power output during device operation. For example, in conduit sealing devices, power management provides improved tissue sealing. In these devices, a large, constant current value is required. As tissue is sealed, its impedance changes, requiring dynamic adjustment of the total power output. Aspects of the present disclosure provide a variable maximum current limit for the smart battery assembly 486. The current limit can vary from application (or device) to application (or device) based on the requirements of the application or device.

[0117] FIG. 26 is a detailed view of the trigger 483 portion and switch of the ultrasonic surgical instrument 480 shown in FIG. 25 , according to one embodiment of the present disclosure. The trigger 483 is operably coupled to a jaw member 495 of an end effector 492. An ultrasonic blade 496 is energized by an ultrasonic transducer / generator assembly 484 upon activation of an activation switch 485. Continuing to refer to FIGS. 25 and 26 , the trigger 483 and activation switch 485 are shown as components of the handle assembly 482. The trigger 483 activates the end effector 492, which has a cooperative relationship with the ultrasonic blade 496 of the waveguide shaft assembly 490, enabling various contacts between the end effector jaw member 495 and the ultrasonic blade 496 and tissue and / or other material. The jaw member 495 of the end effector 492 is typically a pivoting jaw that acts to grasp or clamp on tissue disposed between the jaw and the ultrasonic blade 496. In one aspect, audible feedback is provided within the trigger that clicks when the trigger is fully depressed. The noise can be generated by a thin metal part that snaps as the trigger closes. This feature adds an audible component to user feedback that notifies the user that the jaws are fully compressed against the waveguide and that sufficient clamping pressure has been applied to achieve a conduit seal. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the trigger 483 to measure the force applied to the trigger 483 by the user. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the switch 485 button, such that a displacement magnitude corresponds to the force applied to the switch 485 button by the user.

[0118] When depressed, the activation switch 485 places the modular handheld ultrasonic surgical instrument 480 in an ultrasonic operating mode, causing ultrasonic movement in the waveguide shaft assembly 490. In one aspect, depression of the activation switch 485 closes electrical contacts within the switch, thereby completing a circuit between the smart battery assembly 486 and the ultrasonic transducer / generator assembly 484 and applying power to the ultrasonic transducer, as previously described. In another aspect, depression of the activation switch 485 closes electrical contacts to the smart battery assembly 486. It should be understood that the description of closing electrical contacts within a circuit herein is merely an exemplary, general description of switch operation. Many alternative embodiments exist that may include open contacts or processor-controlled power delivery that receives information from the switch and directs a corresponding circuit response based on that information.

[0119] FIG. 27 is a fragmentary, enlarged perspective view of an end effector 492 from its distal end with a jaw member 495 in an open position, according to one embodiment of the present disclosure. Referring to FIG. 27 , a perspective, partial view of the distal end 498 of a waveguide shaft assembly 490 is shown. The waveguide shaft assembly 490 includes an outer tube 494 that surrounds a portion of the waveguide. An ultrasonic blade 496 portion of the waveguide 499 protrudes from the distal end 498 of the outer tube 494. It is the ultrasonic blade 496 portion that contacts tissue and transmits its ultrasonic energy to the tissue during a medical procedure. The waveguide shaft assembly 490 also includes a jaw member 495 coupled to the outer tube 494 and an inner tube (not visible in this view). The jaw member 495, together with the inner and outer tubes of the waveguide 499 and the ultrasonic blade 496 portion, may be referred to as the end effector 492. As described below, the outer tube 494 and the inner tube (not shown) slide longitudinally relative to one another. Relative movement between the outer tube 494 and the inner tube (not shown) causes the jaw members 495 to pivot on a pivot point, thereby opening and closing the jaw members 495. When closed, the jaw members 495 apply a clamping force to tissue located between the jaw members 495 and the ultrasonic blade 496, ensuring positive and efficient blade-to-tissue contact.

[0120] 28 illustrates a modular shaft assembly 110 and end effector 112 portion of a surgical instrument 100 according to one embodiment of the present disclosure. The shaft assembly 110 includes an outer tube 144, an inner tube 147, and an ultrasonic transmission waveguide 145. The shaft assembly 110 is removably attached to the handle 102. The inner tube 147 is slidably received within the outer tube 144. The ultrasonic transmission waveguide 145 is positioned within the inner tube 147. The jaw member 114 of the end effector 112 is pivotally coupled to the outer tube 144 at a pivot point 151. The jaw member 114 is also coupled to the inner tube 147 by a pin 153, which allows the inner tube 147 to slide within a slot 155 to open and close the jaw member. In the illustrated configuration, the inner tube 147 is in its distal position and the jaw member 114 is open. To close the jaw members 114, the inner tube 147 is retracted in a proximal direction 157, and to open the jaw members, it is advanced in a distal direction 159. The proximal end of the shaft assembly 110 includes a jaw member tube (e.g., inner tube) / spring assembly 141. A spring 139 is provided to apply a constant force control mechanism for use with different shaft assemblies, a motor closure to control constant force closure, a two bar mechanism to drive the closure system, a cam lobe to push / pull the closure system, a drive screw design to drive the closure or a wave spring design to control constant force.

[0121] 29 is a detailed view of inner tube / spring assembly 141. Closure mechanism 149 is operatively coupled to trigger 108 (FIGS. 1-3). Thus, when trigger 108 is squeezed, inner tube 143 retracts in proximal direction 157 to close jaw member 114. Thus, when trigger 108 is released, inner tube 143 advances in distal direction 159 to open jaw member 114.

[0122] For a more detailed description of combined ultrasonic / electrosurgical instruments, reference is made to US Pat. No. 9,107,690, which is incorporated herein by reference.

[0123] FIG. 30 illustrates a modular, battery-powered, handheld combination ultrasonic / electrosurgical instrument 500 according to one embodiment of the present disclosure. FIG. 31 illustrates an exploded view of the surgical instrument 500 shown in FIG. 30 according to one embodiment of the present disclosure. Referring now to FIGS. 30 and 31 , the surgical instrument 500 includes a handle assembly 502, an ultrasonic transducer / RF generator assembly 504, a battery assembly 506, a shaft assembly 510, and an end effector 512. The ultrasonic transducer / RF generator assembly 504, the battery assembly 506, and the shaft assembly 510 are modular components removably connectable to the handle assembly 502. The handle assembly 502 also includes a motor assembly 560. The surgical instrument 500 is configured to perform a surgical coagulation / cutting procedure on living tissue using both ultrasonic vibrations and electrosurgical high-frequency current, and to perform a surgical coagulation procedure on living tissue using high-frequency current. The ultrasonic vibrations and high-frequency (e.g., RF) current can be applied independently or in combination according to an algorithm or user-input control.

[0124] The ultrasonic transducer / RF generator assembly 504 includes a housing 548, a display 576, such as an LCD display, for example, the ultrasonic transducer 530, an electrical circuit 177 (electrical circuit 300 of FIGS. 4, 10, and / or 14), and an electrical circuit 702 (FIG. 34) configured to drive the RF electrodes and form part of the RF generator circuit. The shaft assembly 510 includes an outer tube 544, an ultrasonic transmission waveguide 545, and an inner tube (not shown). The end effector 512 includes a jaw member 514 and an ultrasonic blade 516. The jaw member 514 includes an electrode 515 coupled to the RF generator circuit. The ultrasonic blade 516 is the distal end of the ultrasonic transmission waveguide 545. The jaw member 514 is pivotally rotatable to grasp tissue between the jaw member 514 and the ultrasonic blade 516. The jaw member 514 is operably coupled to a trigger 508. The trigger 508 functions to close the jaw members 514 when the trigger 508 is squeezed and to open the jaw members 514 when the trigger 508 is released to release the tissue. In a single-stage trigger configuration, the trigger 508 is squeezed to close the jaw members 514, and once the jaw members 514 are closed, a first switch 521a of the switch section 520 is activated to energize the RF generator to seal the tissue. After sealing the tissue, a second switch 521b of the switch section 520 is activated to energize the ultrasonic generator to cut the tissue. In various embodiments, the trigger 508 may be a two-stage or multi-stage trigger. In a two-stage trigger configuration, the trigger 508 is squeezed during a first stage to partially close the jaw members 514, and during a second stage, the trigger 508 is squeezed during a second stage to energize the RF generator circuit to seal the tissue. After sealing the tissue, one of the switches 521a, 521b can be activated to energize the ultrasonic generator to cut the tissue. After the tissue is cut, the jaw members 514 are opened by releasing the trigger 508, releasing the tissue. In another embodiment, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the trigger 508 to measure the force applied to the trigger 508 by the user. In another embodiment, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the switch 520 button, such that the displacement magnitude corresponds to the force applied to the switch 520 button by the user.

[0125] The battery assembly 506 is electrically connected to the handle assembly 502 by an electrical connector 532. The handle assembly 502 is provided with a switch section 520. A first switch 520a and a second switch 520b are provided within the switch section 520. The RF generator is activated by activating the first switch 520a, and the ultrasonic blade 516 is activated by activating the second switch 520b. Thus, the first switch 520a energizes the RF circuit to drive high frequency current through the tissue to form a seal, and the second switch 520b energizes the ultrasonic transducer 530 to vibrate the ultrasonic blade 516 and cut the tissue.

[0126] A rotation knob 518 is operably coupled to the shaft assembly 510. Rotation of the rotation knob 518 ±360° in the direction indicated by arrow 526 rotates the outer tube 544 ±360° in the respective direction of the arrow 528. In one embodiment, a separate rotation knob 522 can be configured to rotate the jaw member 514, while the ultrasonic blade 516 remains stationary and the rotation knob 518 rotates the outer tube 144 ±360°. The outer tube 144 can have a diameter D1 in the range of 5 mm to 10 mm, for example.

[0127] FIG. 32 is a partial perspective view of a modular, battery-powered, handheld, combination ultrasonic / RF surgical instrument 600 according to one embodiment of the present disclosure. The surgical instrument 600 is configured to perform a surgical coagulation / cutting procedure on living tissue using both ultrasonic vibrations and radio frequency current, and to perform a surgical coagulation procedure on living tissue using radio frequency current. The ultrasonic vibrations and radio frequency (e.g., RF) current can be applied independently or in combination according to an algorithm or user input control. The surgical instrument 600 includes a handle assembly 602, an ultrasonic transducer / RF generator assembly 604, a battery assembly 606, a shaft assembly (not shown), and an end effector (not shown). The ultrasonic transducer / RF generator assembly 604, the battery assembly 606, and the shaft assembly are modular components removably connectable to the handle assembly 602. A trigger 608 is operably coupled to the handle assembly 602. As previously described, the trigger operates the end effector.

[0128] The ultrasonic transducer / RF generator assembly 604 includes a housing 648 and a display 676, such as an LCD display. The display 676 provides a visual display of surgical procedure parameters such as tissue thickness, seal status, cut status, tissue thickness, tissue impedance, running algorithm, battery capacity, and applied energy (either ultrasonic vibrations or RF current), among other parameters. The ultrasonic transducer / RF generator assembly 604 also includes two visual feedback indicators 678, 679 to indicate the energy modality currently being applied in the surgical procedure. For example, one indicator 678 indicates when RF energy is being used, and another indicator 679 indicates when ultrasonic energy is being used. It will be appreciated that when both energy modalities RF and ultrasonic are being applied, both indicators will indicate this state. The surgical instrument 600 also includes an ultrasonic transducer, an ultrasonic generator circuit and / or electrical circuit, a shaft assembly, and an end effector including jaw members and an ultrasonic blade, the modular components being similar to those described with respect to Figures 30 and 31, and this description will not be repeated here for the sake of brevity and clarity of disclosure.

[0129] The battery assembly 606 is electrically connected to the handle assembly 602 by an electrical connector. The handle assembly 602 is provided with a switch unit 620. A first switch 620a and a second switch 620b are provided within the switch unit 620. The ultrasonic blade is activated by activating the first switch 620a, and the RF generator is activated by activating the second switch 620b. In another embodiment, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the trigger 608 to measure the force applied to the trigger 608 by a user. In another embodiment, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the switch 620 button, such that a displacement magnitude corresponds to the force applied to the switch 620 button by a user.

[0130] A rotation knob 618 is operably coupled to the shaft assembly. Rotation of the rotation knob 618 ±360° rotates the outer tube ±360° in each direction, as described herein with respect to FIGS. 30 and 31 . In one aspect, a separate rotation knob can be configured to rotate the jaw members, while the ultrasonic blade remains stationary and the rotation knob 618 rotates the outer tube ±360°. A button 673 is used to couple and hold the shaft assembly to the handle assembly 602. Another slide switch 675 is used to lock in and release the ultrasonic transducer / RF generator assembly 604.

[0131] In one aspect, the surgical instrument 500, 600 includes battery-powered advanced energy (ultrasonic vibrations + radio frequency current) with drive amplification split into multiple stages. Different stages of amplification may reside within different modular components of the surgical instrument 500, 600, such as the handle assembly 502, 602, the ultrasonic transducer / RF generator assembly 504, 604, the battery assembly 506, 606, the shaft assembly 510, and / or the end effector 112. In one aspect, the ultrasonic transducer / RF generator assembly 504, 604 may include amplification stages within the ultrasonic transducer and / or RF electronics within the housing 548, 648, and different gains based on the energy modality associated with a particular energy mode. The final stage, as previously described, is the I 2The RF signal may be controlled via signals from the electronic system of the surgical instrument 100 located within the handle assembly 502, 602 and / or the battery assembly 506, 606 through a bus structure such as GND. A final stage switch system may be used to apply power to the transformer and blocking capacitor to shape the RF waveform. Measurements of RF power, such as voltage and current, are fed back to the electronic system via the bus. The handle assembly 502, 602 and / or the battery assembly 506, 606 may contain most of the primary amplifier circuitry, including any electrical isolation components, motor control, and waveform generator. Two different ultrasonic transducers (e.g., the ultrasonic transducers 130, 130' shown in FIGS. 8 and 9) and the RF converter utilize a precondition generator signal to perform final conditioning and power the different frequency converters with RF signals of the desired frequency range and amplification. This minimizes the weight, size, and cost of electronics present only in the transducers themselves. It also allows the primary processor board, due to its size, to occupy the area of the handle with the most useful space where the transducers are least likely to be present. Also, the electronics can be split so that high wear, high duty cycle elements only need to be connectively attached to the primary electronics making the system more practical and repairable since it is designed for high repeated use before disposal.

[0132] The surgical instruments 500, 600 described with respect to Figures 30-32 are configured to perform a surgical coagulation / cutting procedure on living tissue using radio frequency electrical current, and to perform a surgical coagulation procedure on living tissue using radio frequency electrical current. Accordingly, additional structural and functional components for performing this additional functionality are described below with respect to Figures 33-44.

[0133] The structural and functional aspects of the battery assembly 506, 606 are similar to those of the battery assembly 106 of the surgical instrument 100 described with reference to Figures 1, 2, and 16-24, including the battery circuitry described with reference to Figures 20-24. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such battery assembly 106 are incorporated herein by reference and will not be repeated here. Similarly, unless otherwise noted, the structural and functional aspects of the shaft assembly 510 are similar to those of the shaft assembly 110 of the surgical instrument 100 described with reference to Figures 1-3. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such shaft assembly 110 are incorporated herein by reference and will not be repeated here. Furthermore, the structural and functional aspects of the ultrasonic transducer 530 generator circuitry are similar to those of the ultrasonic transducer 130 generator circuitry of the surgical instrument 100 described with reference to Figures 1, 2, and 4-15. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such ultrasonic transducer 130 are incorporated herein by reference and will not be repeated here. Additionally, surgical instruments 500, 600 include the circuitry described with respect to Figures 12-15, including, for example, the control circuit 210 described with respect to Figure 14 and the electrical circuitry 300 described with respect to Figure 15. Accordingly, for the sake of brevity and clarity of disclosure, the circuit descriptions described with respect to Figures 12-15 are incorporated herein by reference and will not be repeated here.

[0134] Referring now to FIG. 33, a nozzle 700 portion of the surgical instrument 500, 600 described with respect to FIGS. 30-32 is shown, according to one embodiment of the present disclosure. The nozzle 700 includes an electrical circuit 702 configured to drive high frequency RF current to an electrode located within the end effector, as described below with respect to FIGS. 38-44. The electrical circuit 702 is coupled to a primary winding of a transformer 704. The positive side of the secondary winding of the transformer 704 is coupled to first and second blocking capacitors 706, 708 connected in series. The load side of the second blocking capacitor 708 is coupled to a positive RF(+) terminal that is coupled to the positive side of the end effector electrode. The negative side of the secondary winding of the transformer 704 is coupled to a negative RF(-) terminal, otherwise referred to as ground. It will be understood that the RF(-) or ground terminal of the RF energy circuit is coupled to an outer tube 744 formed of a conductive metal. Thus, in use, radio frequency current is conducted from the end effector electrode RF(+) through the tissue and back through the negative electrode RF(-).

[0135] 30 and 31 , in one aspect, an outer tube 744 is operably coupled to the jaw member 514 of the end effector 512 such that advancement of the outer tube 744 in a distal direction 722 opens the jaw member 514 and retraction of the outer tube 744 in a proximal direction 724 closes the jaw member 514. Although not shown in FIG. 33 , the outer tube 744 is operably coupled to a trigger 508 that is used to open and close the jaw member 514 portion of the end effector 512. Examples of actuation mechanisms for use with the ultrasonic surgical instruments described herein are disclosed in U.S. Publication Nos. 2006 / 0079879 and 2015 / 0164532, each of which is incorporated herein by reference.

[0136] 30, 31, and 33, in one embodiment, inner tube 714 is slidably disposed within outer tube 744. Inner tube 714 is operatively coupled to jaw member 514 to rotate jaw member 514 while maintaining ultrasonic blade 516 stationary. In the embodiment shown in FIGS. 30 and 31, inner tube 714 is rotated by rotation knob 522. In the embodiment shown in FIG. 33, motor 719 is provided within handle assembly 502 and can optionally engage gear 721 on the proximal end of outer tube 744 through idler gear 725.

[0137] 30, 31, and 33, in one aspect, an electrically insulating (e.g., rubber, plastic) inner tube 716 is slidably disposed within the inner tube 714. A flex circuit 728 may be disposed within the electrically insulating inner tube 716 to electrically couple energy and sensor circuitry to the end effector 512. For example, the jaw member 514 may include electrodes coupled to conductors within the flex circuit 728. In other aspects, the end effector 512, jaw member 514, or ultrasonic blade 516 may include various sensors or other electrical elements that may be interconnected to electrical circuits and components within, for example, the shaft assembly 510, the handle assembly 502, the ultrasonic transducer / RF generator assembly 504, and / or the battery assembly 506.

[0138] Still referring to FIGS. 30, 31, and 33, in one aspect, the ultrasonic transmission waveguide 545 (shown only in FIG. 32 and not in FIG. 33 for clarity) is disposed within the electrically insulating inner tube 716. In one aspect, the positive electrode RF(+) of the electrical circuit 702 is electrically coupled to the ultrasonic transmission waveguide 545, and the negative electrode RF(-) of the electrical circuit 702 is electrically coupled to an electrode disposed on the jaw member 514, which is electrically coupled to the outer tube 744. In operation, after tissue is grasped between the ultrasonic blade 516 and the jaw member 514, the control circuitry of the surgical instrument 500 can execute various algorithms to seal and cut the tissue. Ultrasonic vibrations and radio frequency energy may be applied to the tissue according to monitored tissue conditions, such as tissue impedance, friction, etc. In some circumstances, radio frequency current is applied to the tissue through the ultrasonic blade 516 and returned to the outer tube 744 return path. Tissue impedance is monitored, and once a tissue seal is formed, as can be determined by the tissue impedance, the ultrasonic blade 516 is mechanically energized to induce vibrational energy into the tissue to cut it. In other embodiments, ultrasonic vibration and radio frequency may be applied by pulsing these energy modalities, applying the energy modalities alternately or simultaneously. In some unique situations, the algorithm can detect when the tissue impedance is too low to deliver energy to the tissue. In response, the algorithm mechanically energizes the ultrasonic blade 516 to apply vibrational energy to the tissue until such time as the impedance rises above a threshold suitable for application of radio frequency current. When this threshold is reached, the algorithm switches the energy delivery mode to radio frequency current to seal the tissue.

[0139] FIG. 34 is a schematic diagram of an embodiment of an electrical circuit 702 configured to drive radio frequency (RF) current, according to one embodiment of the present disclosure. The electrical circuit 702 includes an analog multiplexer 580. The analog multiplexer 580 multiplexes various signals from upstream channels SCL-A / SDA-A, such as RF, battery, and power control circuits. A current sensor 582 is coupled in series with the return or ground leg of the power supply circuit to measure the current provided by the power supply. A field-effect transistor (FET) temperature sensor 584 provides ambient temperature. A pulse-width modulation (PWM) watchdog timer 588 automatically causes a system reset if the main program fails to perform periodic servicing. This is provided to automatically reset the electrical circuit 702 if it hangs or freezes due to a software or hardware failure. It will be understood that the electrical circuit 702 can be configured to drive an RF electrode or an ultrasonic transducer 130, for example, as described with respect to FIG. 11 . Thus, referring back now to FIG. 34, electrical circuitry 702 can be used to alternately drive both ultrasound and RF electrodes.

[0140] A driver circuit 586 provides left and right RF energy outputs. Digital signals representing signal waveforms are provided to the SCL-A / SDA-A inputs of the analog multiplexer 580 from a control circuit, such as the control circuit 210 (FIG. 14). A digital-to-analog converter 590 (DAC) converts the digital input to an analog output to drive a PWM circuit 592 coupled to an oscillator 594. The PWM circuit 592 provides a first signal to a first gate driver circuit 596a coupled to a first transistor output stage 598a to drive the first RF+ (left) energy output. The PWM circuit 592 also provides a second signal to a second gate driver circuit 596b coupled to a second transistor output stage 598b to drive the second RF- (right) energy output. A voltage sensor 599 is coupled between the RF-Left / RF-Output terminals to measure the output voltage. The driver circuit 586, first and second driver circuits 596a, 596b, and first and second transistor output stages 598a, 598b define a first stage amplifier circuit. In operation, the control circuit 210 (FIG. 14) generates a digital waveform 1800 (FIG. 67) using circuitry such as direct digital synthesis (DDS) circuits 1500, 1600 (FIGS. 65 and 66). The DAC 590 accepts the digital waveform 1800 and converts it to an analog waveform, which is accepted and amplified by the first stage amplifier circuit.

[0141] FIG. 35 is a schematic diagram of a transformer 704 coupled to the electrical circuit 702 shown in FIG. 34 according to one embodiment of the present disclosure. The RF Left / RF Input terminal (primary winding) of the transformer 704 is electrically coupled to the RF Left / RF Output terminal of the electrical circuit 702. One side of the secondary winding is coupled in series with first and second blocking capacitors 706, 708. The second blocking capacitor is coupled to the RF+ 574a terminal. The other side of the secondary winding is coupled to the RF- 574b terminal. As previously mentioned, the RF+ 574a output is coupled to the ultrasonic blade 516 (FIG. 30), and the RF- 574b ground terminal is coupled to the outer tube 544 (FIG. 30). In one embodiment, the transformer 166 has a turns ratio n1:n2 of 1:50.

[0142] FIG. 36 is a schematic diagram of a circuit 710 including separate power supplies for the high-power energy / drive circuitry and the low-power circuitry, according to one embodiment of the present disclosure. The power supply 712 includes a primary battery pack including first and second primary batteries 715, 717 (e.g., Li-ion batteries) that are connected to the circuit 710 by a switch 718 when the power supply 712 is inserted into the battery assembly, and a secondary battery pack including a secondary battery 720 that is connected to the circuit by a switch 723. The secondary battery 720 is a voltage-sink-proof battery with components that are resistant to gamma or other radiation sterilization. For example, a switch-mode power supply 727 and optional charging circuitry within the battery assembly can be incorporated to enable the secondary battery 720 to reduce voltage sags in the primary batteries 715, 717. This ensures fully charged cells at the beginning of surgery for easy introduction into the sterile field. The primary batteries 715, 717 can be used to directly power the motor control circuitry 726 and the energy circuitry 732. The power supply / battery pack 712 may comprise a dual-type battery assembly including a primary Li-ion battery 715, 717 and a secondary NiMH battery 720, with a dedicated energy cell 720 controlling the handle electronics circuitry 730 from a dedicated energy cell 715, 717 for running the motor control circuitry 726 and the energy circuitry 732. In this case, when the primary battery 715, 717 involved in powering the energy circuitry 732 and / or the motor control circuitry 726 becomes low, the circuitry 710 draws from the secondary battery 720 involved in powering the handle electronics circuitry 730. In various aspects, the circuitry 710 may include a one-way diode that does not allow current to flow in the opposite direction (e.g., from the battery involved in powering the energy and / or motor control circuitry to the battery involved in powering the electronics circuitry).

[0143] Additionally, a gamma-friendly charging circuit can be provided that includes a switched-mode power supply 727 that uses diode and vacuum tube components to minimize voltage sag at a predetermined level. The inclusion of a minimum sag voltage that is a division of the NiMH voltage (3 NiMH cells) allows the elimination of the switched-mode power supply 727. Furthermore, a modular system can be provided in which radiation-hardened components are located within a module, making the module sterilizable by radiation sterilization. Other non-radiation-hardened components can be included with other modular components and connections made between modular components, allowing the components to operate together as if they were located together on the same circuit board. When only two NiMH cells are desired, a switched-mode power supply 727 based on diodes and vacuum tubes allows for sterilizable electronics within a disposable primary battery pack.

[0144] 37, there is shown a control circuit 800 for operating a battery 801 powered RF generator circuit 802 for use with the surgical instrument 500 shown in Figures 30 and 31, according to one embodiment of the present disclosure. The surgical instrument 500 is configured to perform a surgical coagulation / cutting procedure on living tissue using both ultrasonic vibrations and radio frequency current, and to perform a surgical coagulation procedure on living tissue using radio frequency current.

[0145] FIG. 37 illustrates a control circuit 800 for the surgical instrument 500 shown in FIGS. 30 and 31 that enables the dual generator system to switch between the RF generator circuit 802 and the ultrasonic generator circuit 820 (similar to the electrical circuit 177 shown in FIGS. 11 and 12) energy modalities. In one embodiment, a current threshold in the RF signal is detected. When tissue impedance is low, high frequency current through the tissue is high when RF energy is used as the tissue treatment source. According to one embodiment, a visual indicator 812 or light located on the surgical instrument 500 may be configured to be in an ON state during this high current period. When the current falls below the threshold, the visual indicator 812 is in an OFF state. Thus, the phototransistor 814 can be configured to detect the transition from an ON state to an OFF state and release the RF energy, as shown in the control circuit 800 shown in FIG. 37. Thus, when the energy button is released and the energy switch 826 is opened, the control circuit 800 is reset, and both the RF and ultrasonic generator circuits 802, 820 are held in an OFF state.

[0146] 30-33 and 37, in one aspect, a method of managing an RF generator circuit 802 and an ultrasonic generator circuit 820 is provided. As previously described, the RF generator circuit 802 and / or the ultrasonic generator circuit 820 may be located within the handle assembly 502, the ultrasonic transducer / RF generator assembly 504, the battery assembly 506, the shaft assembly 510, and / or the nozzle 700. The control circuit 800 is held in a reset state when the energy switch 826 is off (e.g., open). Thus, when the energy switch 826 is opened, the control circuit 800 is reset and both the RF and ultrasonic generator circuits 802, 820 are turned off. When the energy switch 826 is pressed and engaged (e.g., closed), RF energy is delivered to the tissue and the visual indicator 812 operated by the current sensing step-up transformer 804 is illuminated while tissue impedance is low. The light from the visual indicator 812 provides a logic signal to maintain the ultrasonic generator circuit 820 in an off state. Once the tissue impedance increases above a threshold and the radio frequency current through the tissue decreases below the threshold, the visual indicator 812 turns off and the light transitions to the off state. This transition generates a logic signal that turns off the relay 808, thereby turning off the RF generator circuit 802 and turning on the ultrasonic generator circuit 820 to complete the coagulation and cutting cycle.

[0147] 30-33 and 37 , in one aspect, the dual generator circuit 802, 820 configuration uses, for one modality, an on-board RF generator circuit 802 powered by a battery 801 and a second on-board ultrasonic generator circuit 820 that may be on-board within the handle assembly 502, battery assembly 506, shaft assembly 510, nozzle 700, and / or ultrasonic transducer / RF generator assembly 504. The ultrasonic generator circuit 820 is also operated by the battery 801. In various aspects, the RF generator circuit 802 and the ultrasonic generator circuit 820 may be integral or separable components of the handle assembly 502. According to various aspects, having the dual RF / ultrasonic generator circuits 802, 820 as part of the handle assembly 502 may eliminate the need for complex wiring within the surgical instrument 500. The RF / ultrasonic generator circuits 802, 820 may be configured to provide the full capabilities of existing generators while simultaneously utilizing the capabilities of a cordless generator system.

[0148] Either type of system can have separate controls for the modalities that do not communicate with each other. The surgeon activates RF and ultrasound separately and at will. Another approach is to provide a fully integrated communication scheme that shares buttons, tissue status, instrument actuation parameters (e.g., jaw closure, force, etc.), and algorithms for managing tissue manipulation. Various combinations of this integration can be implemented to provide the appropriate level of functionality and performance.

[0149] In one embodiment, the control circuit 800 includes an RF generator circuit 802 powered by a battery 801, with the battery serving as an energy source. As shown, the RF generator circuit 802 is coupled to two conductive surfaces, referred to herein as electrodes 806a and 806b, and configured to drive the electrodes 806a and 806b with RF energy (e.g., radio frequency current). A first winding 810a of a step-up transformer 804 is connected in series with one pole of the bipolar RF generator circuit 802 and a return electrode 806b. In one embodiment, the first winding 810a and the return electrode 806b are connected to the negative pole of the bipolar RF generator circuit 802. The other pole of the bipolar RF generator circuit 802 is connected to the active electrode 806a through a switch contact 809 of a relay 808, or to any suitable electromagnet switching device including an armature moved by an electromagnet 836 to operate the switch contact 809. When the electromagnet 836 is energized, the switch contact 809 is closed, and when the electromagnet 836 is de-energized, the switch contact 809 is open. When the switch contact is closed, RF current flows through conductive tissue (not shown) located between the electrodes 806 a, 806 b. It will be appreciated that in one embodiment, the active electrode 806 a is connected to the positive pole of the bipolar RF generator circuit 802.

[0150] Visual indicator circuit 805 includes a step-up transformer 804, a series resistor R2, and a visual indicator 812. Visual indicator 812 may be adapted for use with surgical instrument 500 as well as other electrosurgical systems and tools such as those described herein. A first winding 810a of step-up transformer 804 is connected in series with return electrode 806b, and a second winding 810b of step-up transformer 804 is connected in series with resistor R2 and visual indicator 812, which may comprise, for example, an NE-2 type neon bulb.

[0151] In operation, when the switch contact 809 of the relay 808 is open, the active electrode 806 a is disconnected from the positive terminal of the bipolar RF generator circuit 802, and no current flows through the tissue, the return electrode 806 b, and the first winding 810 a of the step-up transformer 804. Thus, the visual indicator 812 is not energized and does not illuminate. When the switch contact 809 of the relay 808 is closed, the active electrode 806 a is connected to the positive terminal of the bipolar RF generator circuit 802, and current flows through the tissue, the return electrode 806 b, and the first winding 810 a of the step-up transformer 804 to operate on the tissue, e.g., to cut and cauterize the tissue.

[0152] A first current flows through the first winding 810a as a function of the impedance of the tissue located between the active and return electrodes 806a, 806b, generating a first voltage across the first winding 810a of the step-up transformer 804. A second, boosted voltage is induced across the second winding 810b of the step-up transformer 804. The secondary voltage appears across resistor R2 and energizes a visual indicator 812, which illuminates a neon bulb, when the current through the tissue is greater than a predetermined threshold. It will be understood that the circuit and component values are exemplary and not limiting. When the switch contact 809 of the relay 808 closes, current flows through the tissue and the visual indicator 812 turns on.

[0153] Referring now to the energy switch 826 portion of the control circuit 800, when the energy switch 826 is in the open position, a logic high is applied to the input of the first inverter 828 and a logic low is applied to one of the two inputs of the AND gate 832. Thus, the output of the AND gate 832 is low, and the transistor 834 is turned off, preventing current from flowing through the winding of the electromagnet 836. With the electromagnet 836 in a de-energized state, the switch contacts 809 of the relay 808 remain open, preventing current from flowing through the electrodes 806a, 806b. The logic low output of the first inverter 828 is also applied to the second inverter 830, causing its output to go high and resetting the flip-flop 818 (e.g., a D-type flip-flop). At this time, the Q output goes low, turning off the ultrasonic generator circuit 820 and

[0154]

number

[0155] When a user presses the energy switch 826 on the instrument handle to apply energy to tissue between the electrodes 806a, 806b, the energy switch 826 closes and applies a logic low to the input of a first inverter 828, which applies a logic high to the other input of the AND gate 832, causing the output of the AND gate 832 to go high and turn on a transistor 834. In the on state, the transistor 834 conducts and sinks current through a winding of the electromagnet 836, energizing the electromagnet 836 and closing the switch contact 809 of the relay 808. As described above, when the switch contact 809 is closed, current can flow through the electrodes 806a, 806b and the first winding 810a of the step-up transformer 804 when tissue is located between the electrodes 806a, 806b.

[0156] As mentioned above, the magnitude of the current flowing through electrodes 806a, 806b depends on the impedance of the tissue located between electrodes 806a, 806b. Initially, the tissue impedance is low and the magnitude of the current through the tissue and first winding 810a is high. Therefore, the voltage applied to second winding 810b is high enough to turn on visual indicator 812. Light emitted by visual indicator 812 turns on phototransistor 814, which drives the input of inverter 816 low, causing the output of inverter 816 to go high. A high input applied to CLK of flip-flop 818 drives Q or

[0157]

number

[0158]

number

[0159] As the tissue between electrodes 806a, 806b dries due to heat generated by the current flowing through the tissue, the impedance of the tissue increases and the current therethrough decreases. As the current through first winding 810a decreases, the voltage across second winding 810b also decreases, and when the voltage drops below the minimum threshold required to operate visual indicator 812, visual indicator 812 and phototransistor 814 turn off. When phototransistor 814 turns off, a logic high is applied to the input of inverter 816 and a logic low is applied to the CLK input of flip-flop 818 to clock a logic high to the Q output and a logic low to the CLK input of flip-flop 818 to clock a logic high to the Q output.

[0160]

number

[0161]

number

[0162] While the switch contacts 809 of the relay 808 are open, no current flows through the electrodes 806a, 806b, the tissue, and the first winding 810a of the step-up transformer 804. Therefore, no voltage is developed across the second winding 810b, and no current flows through the visual indicator 812.

[0163] The user holds the energy switch 826 on the instrument handle and turns on the Q and Q of the flip-flop 818 while keeping the energy switch 826 closed.

[0164]

number

[0165]

number

[0166] 38 is a cross-sectional view of an end effector 900 according to one embodiment of the present disclosure. The end effector 900 includes an ultrasonic blade 902 and a jaw member 904. The jaw member 904 has a channel-shaped groove 906 along its axial direction, into which a portion of the end effector 900 engages. The channel-shaped groove 906 has a wide channel shape with a wide opening at a portion perpendicular to the axis of the jaw member 904. The jaw member 904 is made of a conductive material, and an insulating member 910 is provided in an area where the ultrasonic blade 902 contacts a bottom surface portion 912 of the channel along the axial direction.

[0167] The ultrasonic blade 902 has a partially truncated diamond shape in a cross section perpendicular to the axial direction. The cross section of the ultrasonic blade 902 is truncated in a direction perpendicular to the long diagonal of the diamond shape, as shown in Figure 38. The ultrasonic blade 902 having the truncated diamond-shaped portion in cross section has a trapezoidal portion 914 that fits within the channel-shaped groove 906 of the jaw member 904. The portion of the diamond shape that is not truncated in cross section is an isosceles triangular portion 916 of the ultrasonic blade 902.

[0168] When the trigger of the handle assembly is closed, the ultrasonic blade 902 and the jaw member 904 mate with each other. When they are mated, the bottom surface portion 912 of the channel-shaped groove 906 abuts the top surface portion 918 of the trapezoidal portion 914 of the ultrasonic blade 902, and the two inner wall portions 920 of the channel-shaped groove 906 abut the inclined surface portions 922 of the trapezoidal portion 914.

[0169] Furthermore, although the apex portion 924 of the isosceles triangular portion 916 of the ultrasonic blade 902 is rounded, the apex portion 924 has a slightly sharp angle.

[0170] When the surgical instrument is used as a spatula ultrasonic treatment tool, the ultrasonic blade 902 acts as an ultrasonic vibration treatment portion, and the apex portion 924 and its surrounding portion (shown in dashed lines) particularly act as a scalpel knife on the tissue to be treated.

[0171] Furthermore, when the surgical instrument is used as a spatula high frequency treatment tool, the apex portion 924 and its surrounding portion (shown in dashed lines) act as an electric scalpel knife on the tissue to be treated.

[0172] In one aspect, the bottom surface portion 912, the inner wall portion 920, the top surface portion 918, and the inclined surface portion 922 act as working surfaces for ultrasonic vibrations.

[0173] Additionally, in one aspect, the inner wall portion 920 and the inclined surface portion 922 act as working surfaces for bipolar high frequency current.

[0174] In one aspect, the surgical instrument can be used as a spatula treatment tool with simultaneous output of ultrasound and high-frequency current, where the ultrasonic blade 902 acts as an ultrasonic vibration treatment portion, and the apex portion 924 and its surrounding portion (shown in dashed lines) act specifically as an electric scalpel knife on the tissue to be treated.

[0175] Furthermore, when the surgical instrument provides simultaneous ultrasonic and high frequency current output, the bottom surface portion 912 and top surface portion 918 act as active surfaces for ultrasonic vibrations, and the inner wall portion 920 and inclined surface portion 922 act as active surfaces for bipolar high frequency current.

[0176] Therefore, the configuration of the treatment portion shown in Figure 37 provides excellent operability not only when the surgical instrument is used as an ultrasonic treatment instrument or a high-frequency treatment instrument, but also when the surgical instrument is used as an ultrasonic treatment instrument or a high-frequency current treatment instrument, and further when the surgical instrument is used during the simultaneous output of ultrasonic waves and high frequencies.

[0177] If the surgical instrument implements high frequency current output or simultaneous high frequency current and ultrasound output, monopolar output may be enabled instead of bipolar output as the high frequency output.

[0178] 39 is a cross-sectional view of an end effector 930 according to one embodiment of the present disclosure. A jaw member 932 is made of a conductive material, and an insulating member 934 is disposed axially on a channel-shaped bottom portion 936.

[0179] The ultrasonic blade 938 has a partially truncated diamond shape in a cross section perpendicular to the axial direction. The cross section of the ultrasonic blade 938 has a diamond shape with a portion of the diamond shape truncated in a direction perpendicular to the diagonal, as shown in Figure 39. The ultrasonic blade 938 with the truncated diamond-shaped portion in cross section has a trapezoidal portion 940 that fits within a channel-shaped groove 942 in the jaw member 932. The portion of the diamond shape that is not truncated in cross section is an isosceles triangular portion 944 of the end effector 900.

[0180] When the trigger of the handle assembly is closed, the ultrasonic blade 938 and the jaw member 906 mate with one another. When they mate, the bottom surface portion 936 of the channel-shaped groove 942 abuts the top surface portion 946 of the trapezoidal portion 940 of the ultrasonic blade 938, and the two inner wall portions 954 of the channel-shaped groove 932 abut the angled surface portions 948 of the trapezoidal portion 940.

[0181] Furthermore, the apex 950 of the isosceles triangular portion 944 of the ultrasonic blade 938 is rounded, but the apex 952 on the inside of the hook shape has a slightly acute angle. The angle θ of the apex 952 is preferably 45° to 100°. 45° is the strength limit of the ultrasonic blade 938. In this way, the tip portion 952 of the ultrasonic blade 938 forms a protruding portion with a predetermined angle on the inside of the hook-shaped portion, i.e., on the edge portion.

[0182] The hook-shaped treatment portion is often used for incision. The apex portion 952 of the end effector 930 becomes the working portion during incision. The apex portion 952 has a slightly acute angle θ, so the apex portion 952 is effective for incision treatment.

[0183] The ultrasonic blade 938 and jaw member 932 shown in Figure 39 perform the same operations as the ultrasonic blade 938 and jaw member 932 shown in Figure 38 when ultrasonic waves are output, when high frequency waves are output, and when ultrasonic waves and high frequency waves are output simultaneously, except for the operations described above when cutting.

[0184] 40 to 43, an end effector 1000 is shown operably connected to an insertion sheath 1001 formed by an outer sheath 1002 and an inner sheath 1004. The end effector 1000 includes an ultrasonic blade 1006 and a jaw member 1014. In the outer sheath 1002, the outside of a conductive metal pipe is covered with an insulating resin tube. The inner sheath 1004 is a conductive metal pipe. The inner sheath 1004 can move in the front-to-rear axial direction relative to the outer sheath 1002.

[0185] The ultrasonic blade 1006 is made of a conductive material with high acoustic efficiency and biocompatibility, for example, a titanium alloy such as Ti-6AI-4V alloy. An insulating and elastic rubber lining 1008 is provided externally on the ultrasonic blade 1006 at the node position of the ultrasonic vibration. The rubber lining 1008 is disposed in a compressed state between the inner sheath 1004 and the ultrasonic blade 1006. The ultrasonic blade 1006 is held to the inner sheath 1004 by the rubber lining 1008. A gap is maintained between the inner sheath 1004 and the ultrasonic blade 1006.

[0186] The abutment portion 1010 is formed by a part of the ultrasonic blade 1012 facing the jaw member 1014 at the distal end portion of the ultrasonic blade 1006. Here, the ultrasonic blade 1012 has an octagonal cross section perpendicular to the axial direction of the ultrasonic blade 1006. The abutment surface 1016 is formed by one surface of the abutment portion 1010 facing the jaw member 1014. A pair of electrode surfaces 1018 are formed by surfaces provided on both sides of the abutment surface 1016.

[0187] The jaw member 1014 is formed by a main body member 1020, an electrode member 1022, a pad member 1024, and a restricting member 1026 as a restricting portion.

[0188] The body member 1020 is made of a rigid, electrically conductive material. A proximal end portion of the body member 1020 defines a pivot connection portion 1028. The pivot connection portion 1028 is pivotally connected to a distal end portion of the outer sheath 1002 via a pivot connection shaft 1030. The pivot connection shaft 1030 extends in an axial direction and a width direction perpendicular to the opening and closing directions. The body member 1020 can rotate in the opening and closing directions relative to the outer sheath 1002 about the pivot connection shaft 1030. The distal end portion of the inner sheath 1004 is pivotally connected to the pivot connection portion 1028 of the body member 1020 at a position distal to and on the opening side of the pivot connection shaft 1030. When the movable handle is rotated relative to the fixed handle in the handle unit, the inner sheath 1004 moves back and forth relative to the outer sheath 1002, and the body member 1020 is driven by the inner sheath 1004 to rotate about the pivot connection shaft 1030 in an opening and closing direction relative to the outer sheath 1002. In one embodiment, a distal portion of the body member 1020 forms a pair of pivot bearings 1032. The pair of pivot bearings 1032 are in the form of flat plates that extend axially and perpendicular to the width direction, and are disposed spaced apart from each other in the width direction.

[0189] The electrode member 1022 is made of a hard, conductive material. A portion of the electrode member 1022 provided on the opening side constitutes a pivot support portion 1034. An insertion hole 1036 is formed in the width direction through the pivot support portion 1034. A pivot support shaft 1038 is inserted through the insertion hole 1036 and extends in the width direction. The pivot support portion 1034 is disposed between a pair of pivot bearings 1032 of the main body member 1020 and is pivotally supported by the pair of pivot bearings 1032 via the pivot support shaft 1038. The electrode member 1022 can oscillate around the pivot support shaft 1038 relative to the main body member 1020. Furthermore, a portion of the electrode member 1022 provided on the closing side constitutes an electrode portion 1040. The electrode portion 1040 extends in the axial direction and protrudes on both sides in the width direction. A concave groove 1042 that is open toward the closing direction extends axially in a portion of the electrode portion 1040 provided on the closing direction side. Teeth are provided in the axial direction in a portion of the groove 1042 provided on the closing direction side, thereby forming a tooth portion 1044. The side surfaces defining the groove 1042 constitute a pair of electrode receiving surfaces 1046 that are inclined from the closing direction toward both sides in the width direction. A concave mating receptacle 1048 that is open toward the closing direction extends axially in the bottom portion that defines the groove 1042. An embedding hole 1050 is formed through the pivot support portion 1034 of the electrode member 1022 in the opening / closing direction perpendicular to the insertion hole 1036. The embedding hole 1050 opens into the mating receptacle 1048.

[0190] The pad member 1024 is softer than the ultrasonic blade 1006 and is made of a biocompatible insulating material such as polytetrafluoroethylene. The pad member 1024 is fitted with a mating receptacle 1048 of the electrode member 1022. A portion of the pad member 1024 on the closing direction side protrudes from the electrode member 1022 in the closing direction, thus forming an abutment receptacle 1052. In a cross section perpendicular to the axial direction, the abutment receptacle 1052 has a concave shape corresponding to the protruding shape of the abutment portion 1010 of the ultrasonic blade 1012. When the jaw member 1014 is closed against the ultrasonic blade 1012, the abutment portion 1010 of the ultrasonic blade 1012 abuts on and engages with the abutment receptacle 1052 of the pad member 1024. The pair of electrode surfaces 1018 of the ultrasonic blade 1012 are arranged parallel to the pair of electrode receiving surfaces 1046 of the electrode portion 1040 , and a gap is maintained between the electrode portion 1040 and the ultrasonic blade 1012 .

[0191] The restricting member 1026 is harder than the ultrasonic blade 1006 and is made of a high-strength insulating material such as ceramic. The restricting pad member 1024 is pin-shaped. The restricting pad member 1024 is inserted into an embedding hole 1050 in the pivot support portion 1034 of the electrode member 1022, protrudes toward the mating receptacle 1048 of the electrode portion 1040, and is embedded in an abutting receptacle 1052 of the pad member 1024 within the mating receptacle 1048. The closing direction end of the restricting member 1026 constitutes a restricting end 1054. The restricting end 1054 does not protrude from the abutting receptacle 1052 in the closing direction, but is housed within the abutting receptacle 1052. An insertion hole 1036 is also formed through the restricting member 1026 , and a pivot support shaft 1038 is inserted through the insertion hole 1036 in the prefabricated member 1026 .

[0192] Here, the inner sheath 1004, the body member 1020, and the electrode member 1022 are electrically connected to one another and form a first electrical pathway 1056 used in radiofrequency surgical procedures. The electrode portion 1040 of the electrode member 1022 functions as one side of a bipolar electrode used in radiofrequency surgical procedures. In one embodiment, the ultrasonic blade 1006 forms a second electrical pathway 1058 used in radiofrequency procedures. The ultrasonic blade 1012 provided at the distal end portion of the ultrasonic blade 1006 functions as the other side of the bipolar electrode used in radiofrequency procedures. As described above, the ultrasonic blade 1006 is held to the inner sheath 1004 by the insulating rubber lining 1008, maintaining a gap between the inner sheath 1004 and the ultrasonic blade 1006. This prevents short circuits between the inner sheath 1004 and the ultrasonic blade 1006. When the jaw members 1014 are closed against the ultrasonic blade 1012, the abutment portion 1010 of the ultrasonic blade 1012 abuts and engages with the abutment receptacles 1052 of the pad member 1024. Therefore, the pair of electrode surfaces 1018 of the ultrasonic blade 1012 are arranged parallel to the pair of electrode receiving surfaces 1046 of the electrode portion 1040, and a gap is maintained between the electrode portion 1040 and the ultrasonic blade 1012. This prevents a short circuit between the electrode portion 1040 and the ultrasonic blade 1012.

[0193] 44 , the pad member 1024 is softer than the ultrasonic blade 1006. Therefore, when the jaw member 1014 closes against the ultrasonic blade 1012 and the ultrasonic blade 1012 vibrates ultrasonically, the abutment receptacle 1052 is worn by the ultrasonic blade 1012, and the abutment portion 1010 of the ultrasonic blade 1012 abuts and engages with the abutment receptacle 1052 of the pad member 1024. As the abutment receptacle 1052 wears, the gap between the electrode portion 1040 and the ultrasonic blade 1012 gradually decreases when the abutment portion 1010 is frictionally engaged with the abutment receptacle 1052. When the abutment receptacle 1052 wears beyond a predetermined amount, the restricting end 1054 of the restricting member 1026 is exposed from the abutment receptacle 1052 in the closing direction. When the restricting end 1054 is exposed from the abutment receptacle 1052 in the closing direction, when the jaw members 1014 are closed around the ultrasonic blade 1012, the restricting end 1054 contacts the ultrasonic blade 1012 before the electrode portion 1040 contacts the ultrasonic blade 1012. As a result, contact between the ultrasonic blade 1012 and the electrode portion 1040 is restricted. Here, the electrode portion 1040 and the ultrasonic blade 1012 are rigid. Therefore, when the ultrasonically vibrated ultrasonic blade 1012 contacts the electrode portion 1040, the ultrasonic blade 1012 quickly and repeatedly moves toward and away from the electrode portion 1040. When a high-frequency voltage is applied between the electrode portion 1040 and the ultrasonic blade 1012, a spark occurs between the ultrasonic blade 1012 and the electrode portion 1040. In one aspect, contact between the ultrasonic blade 1012 and the electrode portion 1040 is restricted by the restricting end 1054 of the restricting member 1026, thereby preventing sparks. The restricting member 1026 is made of an insulating material and is electrically insulated from the electrode member 1022. Therefore, when the ultrasonically vibrated ultrasonic blade 1012 comes into contact with the restricting end 1054 of the restricting member 1026, no sparks are generated between the restricting end 1054 and the ultrasonic blade 1012, even if the ultrasonic blade 1012 quickly and repeatedly moves into and out of contact with the restricting end 1054. This prevents sparks from occurring between the ultrasonic blade 1012 and the jaw member 1014.

[0194] The restricting member 1026 is made of a high-strength material that is harder than the ultrasonic blade 1006. Therefore, when the restricting end 1054 contacts the ultrasonically vibrated ultrasonic blade 1012, the restricting member 1026 does not wear down, but the ultrasonic blade 1006 cracks. In one embodiment of the surgical treatment system, when the abutment receptacle 1052 wears beyond a predetermined amount, the restricting end 1054 contacts the ultrasonic blade 1012, intentionally cracking the ultrasonic blade 1006. Detecting this cracking indicates the end of the life of the surgical treatment tool. Therefore, the contact position between the ultrasonic blade 1012 and the restricting end 1054 is set to a stress concentration area on the ultrasonic blade 1012, ensuring that the ultrasonic blade 1006 cracks when the restricting end 1054 contacts the ultrasonic blade 1012. In the linear ultrasonic blade 1006, stress is concentrated at the node position of the ultrasonic vibration, and the stress concentration area is located at the proximal end portion of the ultrasonic blade 1012.

[0195] For a more detailed description of combined ultrasonic / electrosurgical instruments, reference is made to US Pat. No. 8,696,666 and US Pat. No. 8,663,223, each of which is incorporated herein by reference.

[0196] FIG. 45 illustrates a modular battery-powered handheld electrosurgical instrument 1100 with distal articulation according to one embodiment of the present disclosure. The surgical instrument 1100 includes a handle assembly 1102, a knife drive assembly 1104, a battery assembly 1106, a shaft assembly 1110, and an end effector 1112. The end effector 1112 includes a pair of opposing jaw members 1114a, 1114b secured to a distal end thereof. The end effector 1112 is configured to articulate and rotate. FIG. 46 is an exploded view of the surgical instrument 1100 shown in FIG. 45 according to one embodiment of the present disclosure. The end effector 1112 for use with the surgical instrument 1100 for sealing and cutting tissue includes a pair of opposing jaw members 1114a, 1114b that are movable relative to one another and grasp tissue therebetween. The jaw members 1114a, 1114b include a jaw housing adapted to connect to a source of electrosurgical energy (RF source) and conductive surfaces 1116a, 1116b, e.g., electrodes, so that the conductive surfaces can conduct electrosurgical energy through tissue held therebetween to effect a tissue seal. One of the conductive surfaces 1116b includes a channel defined therein and extending along its length that communicates with a drive rod 1145 connected to a motor disposed within the knife drive assembly 1104. A knife is configured to translate and reciprocate along the channel to cut tissue grasped between the jaw members 1114a, 1114b.

[0197] Figure 47 is a perspective view of the surgical instrument 1100 shown in Figures 45 and 46 with a display located on the handle assembly 1102, according to one embodiment of the present disclosure. The handle assembly 1102 of the surgical instrument shown in Figures 45-47 includes a motor assembly 1160 and a display assembly. The display assembly includes a display 1176, such as, for example, an LCD display, removably connectable to the housing 1148 portion of the handle assembly 1102. The display 1176 provides a visual display of surgical procedure parameters such as tissue thickness, seal status, cut status, tissue thickness, tissue impedance, running algorithm, battery capacity, among other parameters.

[0198] FIG. 48 is a perspective view of the instrument shown in FIGS. 45 and 46 without a display located on the handle assembly 1102, according to one embodiment of the present disclosure. The handle assembly 1102 of the surgical instrument 1150 shown in FIG. 48 includes a different display assembly 1154 on a separate housing 1156. Referring now to FIGS. 45-48, the surgical instruments 1100, 1150 are configured to perform surgical coagulation / cutting procedures on living tissue using radio frequency (RF) current and a knife, and to perform surgical coagulation procedures on living tissue using radio frequency current. The radio frequency (RF) current can be applied independently or in combination with an algorithm or user input control. The display assembly, battery assembly 1106, and shaft assembly 1110 are modular components removably connectable to the handle assembly 1102. The motor 1140 is located within the handle assembly 1102. The RF generator circuitry and motor drive circuitry described herein, for example, with respect to FIGS. 34-37 and 50, are located within the housing 1148.

[0199] The shaft assembly 1110 includes an outer tube 1144, a knife drive rod 1145, and an inner tube (not shown). The shaft assembly 1110 includes an articulation joint 1130 and a distal rotation section 1134. The end effector 1112 includes opposed jaw members 1114a, 1114b and a motor-driven knife. The jaw members 1114a, 1114b include conductive surfaces 1116a, 1116b coupled to an RF generator circuit for delivering radio frequency current to tissue grasped between the opposing jaw members 1114a, 1114b. The jaw members 1114a, 1114b are pivotally rotatable about a pivot pin 1136 to grasp tissue between the jaw members 1114a, 1114b. The jaw members 1114a, 1114b are operably coupled to a trigger 1108 such that squeezing the trigger 1108 causes the jaw members 1114a, 1114b to close and grasp tissue, and releasing the trigger 1108 causes the jaw members 1114a, 1114b to open and release the tissue.

[0200] The jaw members 1114a, 1114b are operably coupled to a trigger 1108 such that squeezing the trigger 1108 closes the jaw members 1114a, 1114b to grasp tissue, and releasing the trigger 1108 opens the jaw members 1114a, 1114b to release the tissue. In a single-stage trigger configuration, squeezing the trigger 1108 closes the jaw members 1114a, 1114b, and once the jaw members 1114a, 1114b are closed, a first switch 1121a of the switch portion 1121 is activated to energize the RF generator and seal the tissue. After the tissue is sealed, a second switch 1121b of the switch portion 1120 is activated to advance the knife and cut the tissue. In various embodiments, the trigger 1108 may be a two-stage or multi-stage trigger. In a two-stage trigger configuration, the trigger 1108 is squeezed during the first stage to partially close the jaw members 1114a, 1114b, and during the second stage, the trigger 1108 is squeezed partially to energize the RF generator circuit and seal the tissue. After sealing the tissue, one of the first and second switches 1121a, 1121b is activated to advance the knife to cut the tissue. After cutting the tissue, the trigger 1108 is released to open the jaw members 1114a, 1114b and release the tissue. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to the trigger 1108 to measure the force applied to the trigger 1108 by the user. In another aspect, a force sensor such as a strain gauge or pressure sensor may be coupled to the first and second switch 1121a, 1121b buttons of the switch unit 1120, whereby the displacement magnitude corresponds to the force that may be applied by a user to the first and second switch 1121a, 1121b buttons of the switch unit 1120.

[0201] The battery assembly 1106 is electrically connected to the handle assembly 1102 by an electrical connector 1132. The handle assembly 1102 is provided with a switch section 1120. A first switch 1121a and a second switch 1121b are provided within the switch section 1120. The RF generator is energized by activating the first switch 1121a, and the knife is activated by energizing the motor 1140 by activating the second switch 1121b. Thus, the first switch 1121a energizes the RF circuit to drive high frequency current through the tissue to form a seal, and the second switch 1121b energizes the motor to drive the knife to cut the tissue. The structural and functional aspects of the battery assembly 1106 are similar to those of the battery assembly 106 for the surgical instrument 100 described with reference to FIGS. 1, 2, and 16-24. Therefore, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such battery assemblies 106 are incorporated herein by reference and will not be repeated here.

[0202] A rotation knob 1118 is operably coupled to the shaft assembly 1110. Rotation of the rotation knob 1118 ±360° in the direction indicated by arrow 1126 rotates the outer tube 1144 ±360° in the direction of the respective arrow 1119. In one aspect, another rotation knob 1122 may be configured to rotate the end effector 1112 ±360° in the direction indicated by arrow 1128, independent of rotation of the outer tube 1144. The end effector 1112 may be articulated by first and second control switches 1124a, 1124b, whereby actuation of the first control switch 1124a articulates the end effector 1112 about the pivot 1138 in the direction indicated by arrow 1132a, and actuation of the second control switch 1124b articulates the end effector 1112 about the pivot 1138 in the direction indicated by arrow 1132b. Furthermore, the outer tube 1144 may have a diameter D3 in the range of, for example, 5 mm to 10 mm.

[0203] FIG. 49 illustrates a motor assembly 1160 that may be used with the surgical instruments 1100, 1150 to drive the knife, according to one embodiment of the present disclosure. The motor assembly 1160 includes a motor 1162, a planetary gear 1164, a shaft 1166, and a drive gear 1168. The gears may be operably coupled to drive the knife bar 1145 (FIG. 46). In one embodiment, the drive gear 1168 or shaft 1166 is operably coupled to a rotational drive mechanism 1170 described with respect to FIG. 50 to drive distal head rotation, articulation, and jaw closure.

[0204] FIG. 50 is a diagram of a motor drive circuit 1165 according to one embodiment of the present disclosure. The motor drive circuit 1165 is suitable for driving a motor M that may be used in the surgical instruments 1100, 1150 described herein. The motor M is driven by an H-bridge including four switches S1-S4. The switches S1-S4 are typically solid-state switches, such as MOSFET switches. To rotate the motor M in one direction, two switches S1, S4 are turned on and the other two switches S3, S1 are turned off. To reverse the direction of the motor M, the state of the switches S1-S4 is reversed, thereby turning the switches S1, S4 off and turning the other two switches S3, S1 on. A current sensing circuit is disposed within the motor drive circuit 1165 to measure the motor current i 1a , i 2a , i 1b , i 2b can be sensed.

[0205] 51 shows a rotational drive mechanism 1170 for driving distal head rotation, articulation, and jaw closure, according to one aspect of the present disclosure. The rotational drive mechanism 1170 has a primary rotational drive shaft 1172 operably coupled to a motor assembly 1160. The primary rotational drive shaft 1172 is selectively coupleable to at least two independent actuation mechanisms (first, second, both, or neither) by a clutch mechanism located within the outer tube 1144 of the shaft assembly 1110. The primary rotational drive shaft 1172 is coupled to an independent clutch that allows shaft functions to be independently coupled to the rotational drive shaft 1172. For example, an articulation clutch 1174 engages to articulate the shaft assembly 1110 about an articulation axis 1175 of the articulation joint 1130. A distal head rotation clutch 1178 is engaged to rotate the distal rotation portion 1134, and a jaw closing clutch 1179 is engaged to close the jaw members 1114a, 1114b of the end effector 1112. The knife is advanced and retracted by a knife drive rod 1145. All or any combination of the rotation mechanisms may be engaged at any time, or none may be engaged.

[0206] In one aspect, a micro-electric clutch arrangement enables rotation of the distal rotary portion 1134 and articulation of the articulation portion 1130 about the pivot 1138 and articulation axis 1175. In one aspect, a ferrofluid clutch couples the clutch to the primary rotary drive shaft 1172 via a fluid pump. The clutch ferrofluid is activated by electrical coils 1181, 1183, 1185 encapsulated around the knife drive rod 1145. The other ends of the coils 1181, 1183, 1185 are connected to three separate control circuits to independently activate the clutches 1174, 1178, 1179. In operation, when the coils 1181, 1183, 1185 are not energized, the clutches 1174, 1178, 1179 are disengaged and there is no articulation, rotation, or jaw movement.

[0207] When the articulation clutch 1174 is engaged by energizing coil 1181, and the distal head rotation clutch 1178 and jaw closing clutch 1179 are disengaged by de-energizing coils 1183, 1185, the gear 1180 is mechanically coupled to the primary rotary drive shaft 1172 to articulate the articulation joint 1130. In the orientation shown, when the primary rotary drive shaft 1172 rotates clockwise, the gear 1180 rotates clockwise and the shaft articulates to the right about the articulation axis 1175, and when the primary rotary drive shaft 1172 rotates counterclockwise, the gear 1180 rotates counterclockwise and the shaft articulates to the left about the articulation axis 1175. It will be understood that left and right articulation is dependent on the orientation of the surgical instruments 1100, 1150.

[0208] When the articulation clutch 1174 and the jaw closure clutch 1179 are disengaged by de-energizing the coils 1181, 1185, and the distal head rotation clutch 1178 is engaged by energizing the coil 1183, the primary rotary drive shaft 1172 rotates the distal rotor 1134 in the same rotational direction. When the coil 1183 is energized, the distal head rotation clutch 1178 engages the primary rotary drive shaft 1172 with the distal rotor 1134. Thus, the distal rotor 1134 rotates with the primary rotary drive shaft 1172.

[0209] When the articulation clutch 1174 and distal head rotation clutch 1178 are disengaged by de-energizing coils 1181, 1183, and the jaw closing clutch 1179 is engaged by energizing coil 1185, the jaw members 1114a, 1114b can open and close depending on the rotation of the primary rotary drive shaft 1172. When the coil 1185 is energized, the jaw closing clutch 1179 engages a captive internally threaded drive member 1186, which rotates in place in the direction of the primary rotary drive shaft 1172. The captive internally threaded drive member 1186 includes external threads that mesh with an externally threaded drive member 1188, which includes an internally threaded surface. When the primary rotary drive shaft 1172 rotates clockwise, the externally threaded drive member 1188, which meshes with the captive internally threaded drive member 1186, is driven in a proximal direction 1187 to close the jaw members 1114a, 1114b. As the primary rotary drive shaft 1172 rotates counterclockwise, an externally threaded drive member 1188 that is threadedly engaged with the captured internally threaded drive member 1186 is driven in a distal direction 1189 to open the jaw members 1114a, 1114b.

[0210] FIG. 52 is an enlarged left perspective view of an end effector assembly having jaw members shown in an open configuration, according to one embodiment of the present disclosure. FIG. 53 is an enlarged right side view of the end effector assembly of FIG. 52, according to one embodiment of the present disclosure. Referring now to FIGS. 52 and 53, an enlarged view of the end effector 1112 is shown in an open position for approximating tissue. The jaw members 1114, 1114b are generally symmetrical and cooperate to allow easy rotation about pivot pin 1136 to effect sealing and dividing tissue. As a result, and unless otherwise noted, only jaw member 1114a and its associated operating features will be described in detail herein, although it will be understood that many of these features apply to the other jaw member 1114b as well.

[0211] The jaw member 1114a also includes a jaw housing 1115a, an insulating substrate or insulator 1117a, and a conductive surface 1116a. The insulator 1117a is configured to securely engage the conductive sealing surface 1116a. This may be achieved by forging, overmolding, overmolding a forged conductive sealing plate, and / or overmolding a metal injection molded sealing plate. These manufacturing techniques produce an electrode having a conductive surface 1116a surrounded by the insulator 1117a.

[0212] As described above, the jaw member 1114a includes similar elements, including a jaw housing 1115b, an insulator 1117b, and a conductive surface 1116b sized to securely engage the insulator 1117b. When assembled, the conductive surface 1116b and the insulator 1117b form a defined, longitudinally oriented knife channel 1113 for reciprocating movement of a knife blade 1123. The knife channel 1113 facilitates reciprocating longitudinal movement of the knife blade 1123 along a predetermined cutting plane to effectively and precisely separate tissue along the formed tissue seal. Although not shown, the jaw member 1114a may also include a knife channel that cooperates with the knife channel 1113 to facilitate translation of the knife through tissue.

[0213] The jaw members 1114a, 1114b are electrically isolated from one another to effectively transfer electrosurgical energy through tissue to form a tissue seal. The conductive surfaces 1116a, 1116b are also isolated from the remaining working components of the end effector 1112 and outer tube 1144. Multiple stop members can be used to adjust the gap distance between the conductive surfaces 1116a, 1116b to ensure an accurate, consistent, and reliable tissue seal.

[0214] The structural and functional aspects of the battery assembly 1106 are similar to those of the battery assembly 106 of the surgical instrument 100 described with reference to Figures 1, 2, and 16-24, including the battery circuitry described with reference to Figures 20-24. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such battery assembly 106 are incorporated herein by reference and will not be repeated here. Furthermore, the structural and functional aspects of the RF generator circuitry are similar to those of the RF generator circuitry described for the surgical instruments 500, 600 described with reference to Figures 34-37. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such RF generator circuitry are incorporated herein by reference and will not be repeated here. Furthermore, the surgical instrument 1100 includes the battery and control circuitry described with reference to Figures 12-15, including, for example, the control circuit 210 described with reference to Figure 14 and the electrical circuitry 300 described with reference to Figure 15. Therefore, for the sake of brevity and clarity of disclosure, the circuit descriptions set forth with respect to FIGS. 12-15 are incorporated herein by reference and will not be repeated here.

[0215] For a more detailed description of an electrosurgical instrument having a cutting mechanism and an articulation joint operable to deflect the end effector away from the longitudinal axis of the shaft, reference is made to U.S. Pat. Nos. 9,028,478 and 9,113,907, each of which is incorporated herein by reference.

[0216] FIG. 54 illustrates a modular battery-powered handheld electrosurgical instrument 1200 with distal articulation according to one embodiment of the present disclosure. The surgical instrument 1200 includes a handle assembly 1202, a knife drive assembly 1204, a battery assembly 1206, a shaft assembly 1210, and an end effector 1212. The end effector 1212 includes a pair of opposing jaw members 1214a, 1214b secured to a distal end thereof. The end effector 1212 is configured to articulate and rotate. FIG. 55 illustrates an exploded view of the surgical instrument 1200 shown in FIG. 54 according to one embodiment of the present disclosure. The end effector 1212 for use with the surgical instrument 1200 for sealing and cutting tissue includes a pair of opposing jaw members 1214a, 1214b that are movable relative to one another and grasp tissue therebetween. Either jaw member 1214a, 1214b may include a jaw housing adapted to connect to an electrosurgical energy source (RF source) and a conductive surface 1216a, 1216b, e.g., an electrode, such that the conductive surface can conduct electrosurgical energy through tissue held therebetween to effect a tissue seal. Jaw members 1214a, 1214b and conductive surfaces 1216a, 1216b include a channel defined therein and extending along their length that communicates with a knife drive rod 1245 connected to knife drive assembly 1204. Knife 1274 (FIGS. 60-61) is configured to translate and reciprocate along the channel to cut tissue grasped between jaw members 1214a, 1214b. The knife has an I-beam configuration whereby jaw members 1214a, 1214b converge toward each other as knife 1274 advances through the channel. In one aspect, the conductive surfaces 1216a, 1216b are offset relative to one another. The knife 1274 includes a sharpened distal end.

[0217] The handle assembly 1202 of the surgical instrument shown in FIGS. 54-55 includes a motor assembly 1260 and a knife drive assembly 1204. In one aspect, a display assembly may be provided on the housing 1248. The display assembly may include a display, such as an LCD display, removably connectable to the housing 1248 portion of the handle assembly 1202. The LCD display provides a visual display of surgical procedure parameters such as tissue thickness, seal status, cut status, tissue thickness, tissue impedance, running algorithms, and battery capacity, among other parameters. Referring now to FIGS. 54-55, the surgical instrument 1200 is configured to perform a surgical coagulation / cutting procedure on living tissue using radio frequency (RF) current and a knife 1274 (FIGS. 60-61). The radio frequency (RF) current may be applied independently or in combination with an algorithm or user input control. The knife drive assembly 1204, battery assembly 1206, and shaft assembly 1210 are modular components removably connectable to the handle assembly 1202. The motor assembly 1240 may be located within the handle assembly 1202. The RF generator and motor drive circuitry are described with respect to Figures 34-37 and 50 and are located, for example, within a housing 1248. The housing 1248 includes a removable cover plate 1248 for accessing the circuitry and mechanisms located within the housing 1276. The knife drive assembly 1204 is operably coupled to the handle assembly 1202 and the switch portion 1220 and includes gears and linkages for activating and driving the knife 1274. More particularly, the knife 1274 has an I-beam configuration.

[0218] The shaft assembly 1210 includes an outer tube 1244, a knife drive rod 1245, and an inner tube (not shown). The shaft assembly 1210 includes an articulation joint 1230. The end effector 1212 includes a pair of jaw members 1214a, 1214b and a knife 1274 configured to reciprocate with a channel formed in the jaw members 1214a, 1214b. In one embodiment, the knife 1274 may be driven by a motor. The jaw members 1214a, 1214b include conductive surfaces 1216a, 1216b coupled to an RF generator circuit for delivering radio frequency current to tissue grasped between the jaw members 1214a, 1214b. The jaw members 1214a, 1214b are pivotally rotatable about a pivot pin 1235 to grasp tissue between the jaw members 1214a, 1214b. Jaw members 1214a, 1214b are operably coupled to trigger 1208 such that squeezing trigger 1208 causes one or both of jaw members 1214a, 1214b to close and grasp tissue, and releasing trigger 1208 causes jaw members 1214a, 1214b to open and release tissue. In the illustrative example, one jaw member 1214a is movable relative to the other jaw member 1214b. In other aspects, both jaw members 1214a, 1214b may be movable relative to one another. In another aspect, a force sensor, such as a strain gauge or pressure sensor, can be coupled to trigger 1208 to measure the force applied to trigger 1208 by a user. In another aspect, a force sensor such as a strain gauge or pressure sensor may be coupled to the first and second switch 1221a, 1221b buttons of the switch section 1220, whereby the displacement magnitude corresponds to the force that may be applied by a user to the first and second switch 1221a, 1221b buttons of the switch section 1220.

[0219] The jaw member 1214a is operably coupled to the trigger 1208 such that when the trigger 1208 is squeezed, the jaw member 1214a closes to grasp tissue, and when the trigger 1208 is released, the jaw member 1214a opens to release the tissue. In a single-stage trigger configuration, the trigger 1208 is squeezed to close the jaw member 1214a, and once the jaw member 1214a is closed, a first switch 1221a of the switch portion 1220 is activated to energize the RF generator and seal the tissue. After the tissue is sealed, a second switch 1221b of the switch portion 1220 is activated to advance the knife and cut the tissue. In various embodiments, the trigger 1208 may be a two-stage or multi-stage trigger. In a two-stage trigger configuration, trigger 1208 is squeezed during the first stage to partially close jaw members 1214a, and during the second stage, trigger 1208 is squeezed partially to energize the RF generator circuit and seal the tissue. After the tissue is sealed, one of switches 1221a, 1221b is activated to advance the knife to cut the tissue. After the tissue is cut, trigger 1208 is released to open jaw members 1214a and release the tissue.

[0220] The shaft assembly 1210 includes an articulation joint 1230 operable to deflect the end effector 1212 away from a longitudinal axis "A" of the shaft assembly 1210. Dials 1232a, 1232b are operable to pivot the articulation joint 1230 at the distal end of the elongate shaft assembly 1210 to various articulation orientations relative to the longitudinal axis AA. More specifically, the articulation dials 1232a, 1232b are operatively coupled to a plurality of cables or tendons that are in operative communication with the articulation joint 1230 of the shaft assembly 1210, as described in more detail below. One articulation dial 1232a can be rotated in the direction of arrow "C0" to induce pivoting movement in a first plane, e.g., a vertical plane, as indicated by arrow "C1." Similarly, the other articulation dial 1232b can be rotated in the direction of arrow "D0" to induce pivoting movement in a second plane, e.g., the horizontal plane, as indicated by arrow "D1". Rotation of the articulation dials 1232a, 1232b in the direction of either arrow "C0" or "D0" causes the tendons to pivot or articulate the shaft assembly 1210 about the articulation joint 1230.

[0221] The battery assembly 1206 is electrically connected to the handle assembly 1202 by an electrical connector 1231. The handle assembly 1202 is provided with a switch portion 1220. A first switch 1221a and a second switch 1221b are provided within the switch portion 1220. The RF generator is energized by actuating the first switch 1221a, and the knife 1274 can be activated by energizing the motor assembly 1240 by actuating the second switch 1221b. Thus, the first switch 1221a energizes the RF circuit to drive high frequency current through tissue to form a seal, and the second switch 1221b energizes the motor to drive the knife 1274 to cut the tissue. In other embodiments, the knife 1274 may be manually fired using a two-stage trigger 1208 configuration. The structural and functional aspects of the battery assembly 1206 are similar to those of the battery assembly 106 for the surgical instrument 100 described with respect to Figures 1, 2 and 16-24. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such battery assembly 106 are incorporated herein by reference and will not be repeated here.

[0222] A rotation knob 1218 is operably coupled to the shaft assembly 1210. Rotation of the rotation knob 1218 ±360° in the direction indicated by arrow 1226 rotates the outer tube 1244 ±360° in the respective direction of arrow 1228. The end effector 1212 may be articulated by a control button such that actuation of the control button articulates the end effector 1212 in one direction indicated by arrows C1 and D1. Further, the outer tube 1244 may have a diameter D3 in the range of, for example, 5 mm to 10 mm.

[0223] FIG. 56 is an enlarged area detail view of the articulation joint shown in FIG. 54 , including electrical connections, according to one embodiment of the present disclosure. FIG. 57 is an enlarged area detail view of the articulation joint shown in FIG. 56 , including electrical connections, according to one embodiment of the present disclosure. Referring now to FIGS. 56-57 , there is shown an articulation joint 1230 operably disposed on or coupled to the shaft assembly 1210 between the proximal and distal ends 1222, respectively. In the embodiment shown in FIGS. 56-57 , the articulation joint 1230 is defined by a plurality of articulation links 1233 (links 1233). The links 1233 are configured to articulate the shaft assembly 1210 laterally across the longitudinal axis “AA” in either a horizontal or vertical plane. See FIG. 54 . For illustrative purposes, the shaft assembly 1210 is shown articulated across the horizontal plane.

[0224] The links 1233 collectively define a central annulus 1238 therethrough that is configured to receive a drive mechanism, e.g., a drive rod, therethrough. As can be appreciated, the configuration of the central annulus 1238 provides adequate clearance for the drive rod to pass through. The central annulus 1238 defines an axis "BB" therethrough that is parallel to the longitudinal axis "AA" when the shaft assembly 1210 is in the non-articulating configuration. See FIG. 54.

[0225] 56-57 , the links 1233 are operably coupled to the articulation dials 1232 a, 1232 b via tendons 1234. For illustrative purposes, four tendons 1234 are shown. The tendons 1234 may be constructed of stainless steel wire or other material suitable for transmitting tension to the distal-most link of the links 1233. Regardless of the construction material, the tendons 1234 exhibit a spring rate that is amplified over their length, and thus the tendons 1234 may tend to stretch when an external load is applied to the elongate shaft assembly 1210. This tendency to stretch may be associated with an unintended change in orientation of the distal end 1222 of the elongate shaft assembly 1210, for example, without a corresponding movement of the articulation dials 1232 a, 1232 b initiated by the surgeon.

[0226] The tendons 1234 are operably coupled to the articulation dials 1232a, 1232b, which are configured to actuate, e.g., "pull," the tendons 1234 when the articulation dials 1232a, 1232b are rotated. The plurality of tendons 1234 are operably coupled to the links 1233 via one or more suitable coupling methods. More specifically, the links 1233 include a corresponding plurality of first openings or bores 1236a defined therein (four bores 1236a are shown in the representative illustration), which are radially disposed along the link 1233 and centrally aligned along a common axis. See FIG. 56 . A bore of the plurality of bores 1236a is configured to receive the tendons 1234. A distal end of the tendon 1234 is operably coupled to the distal-most link of the links 1233 via a suitable method, for example, one or more of the coupling methods described above.

[0227] 56-57, link 1233 includes a second plurality of bores 1236b (four bores 1236b are shown in the representative view, as best seen in FIG. 56). The bores 1236b are configured to receive corresponding conductive leads of the plurality of conductive leads 1237 (four conductive leads 1237 are shown in the representative view). The conductive leads 1237 are configured to transition between a first state and a second state within the second plurality of bores 1236b. To facilitate the transition of the conductive leads 1237, the bores 1236b include a diameter that is larger than the diameter of the conductive leads 1237 when the conductive leads 1237 are in the first state.

[0228] The surgical instrument 1220 includes an electrical circuit configured to selectively induce a voltage and a current in the plurality of conductive leads 1237, thereby transitioning the conductive leads 1237 from a first state to a second state. To this end, a generator G provides a voltage potential Eo of an appropriate ratio. A voltage is induced in the conductive leads 1237, causing a current to flow through the conductive leads. The current flowing through the conductive leads 1237 transitions the conductive leads 1237 from the first state (FIG. 56) to a second state (FIG. 57). In the second state, the conductive leads 1237 provide an interference fit between the conductive leads 1237 and the corresponding bores 1236b, as best seen in FIG. 57.

[0229] Figure 58 shows a perspective view of the components of the shaft assembly 1210, end effector 1212, and cutting member 1254 of the surgical instrument 1200 of Figure 54, according to one embodiment of the present disclosure. Figure 59 shows the articulation section at a second stage of articulation, according to one embodiment of the present disclosure. Referring now to Figures 58-59, one articulation band 1256a is slidably disposed in a recess on one side of the separator 1261, while a second articulation band 1256b (Figure 59) is slidably disposed in a recess on the opposite side of the separator 1261. The cutting member driver tube is longitudinally movable to longitudinally drive the driver block 1258, thereby longitudinally moving the cutting member 1254. The lateral recesses include longitudinally extending grooves configured to reduce the contact surface area with the articulation bands 1256a, 1256b, thereby reducing friction between the separator 1261 and the articulation bands 1256a, 1256b. The separator 1261 may also be formed of a low-friction material and / or may include a surface treatment to reduce friction. The articulation bands 1256a, 1256b extend longitudinally through the articulation joint 1230 and along the length of the shaft assembly 1210. The distal end 1252 of one articulation band 1256a is secured to one side of the proximal portion 1250 of the end effector 1212 at an anchor point. The distal end 1262 of the second articulation band 1256b is secured to the opposite side of the proximal portion 1250 of the end effector 1212 at an anchor point. The rotary articulation knob is operable to selectively advance one articulation band 1256a distally while simultaneously retracting the second articulation band 1256b proximally, and vice versa. It should be understood that this opposing translation flexes the articulation joint 1230, thereby articulating the end effector 1212. In particular, the end effector 1212 deflects toward the articulation bands 1256a, 1256b being retracted proximally and deflects away from the articulation bands 1256a, 1256b being advanced distally.

[0230] 58-59, several of the above-mentioned components are shown interacting to bend the articulation joint 1230 and articulate the end effector 1212. In FIG. 58, the articulation joint 1230 is in a straight configuration. One of the articulation dials 1232a, 1232b (FIGS. 54-55) is then rotated to translate a lead screw proximally and advance another lead screw distally. The proximal translation of one lead screw pulls the articulation band 1256b proximally, which begins to bend the articulation joint 1230 as shown in FIG. 59. This bending of the articulation joint 1230 pulls the other articulation band 1256a distally. Distal advancement of the lead screw in response to rotation of the articulation dials 1232a, 1232b allows the articulation band 1256a and drive member to advance distally. In some other versions, distal advancement of the lead screw actively drives the drive member and articulation band 1256a distally. As the user continues to rotate one of the articulation dials 1232a, 1232b, the above interaction continues in the same manner, resulting in further bending of the articulation joint 1230, as shown in FIGURE 59. It should be understood that rotating the articulation dials 1232a, 1232b in the opposite direction will correct the articulation joint 1230, and further rotation in the opposite direction will cause the articulation joint 1230 to flex in the opposite direction.

[0231] FIG. 60 shows a perspective view of the end effector 1212 of the device of FIGS. 54-59 in an open configuration, according to one embodiment of the present disclosure. The end effector 1212 in this example includes a pair of jaw members 1214a, 1214b. In this example, one jaw member 1214b is fixed relative to the shaft assembly, while the other jaw member 1214a pivots toward and away from the other jaw member 1214b relative to the shaft assembly. In some versions, an actuator, such as a rod or cable, may extend through a sheath and be joined to one jaw member 1214a at a pivot coupling, such that longitudinal movement of the actuator rod / cable, etc., through the shaft assembly provides pivoting of the jaw member 1214a relative to the shaft assembly and relative to the second jaw member 1214b. Of course, the jaw members 1214a, 1214b may instead have any other suitable type of movement and may be actuated in any other suitable manner. By way of example only, the jaw members 1214a, 1214b can be actuated, and thus closed, by longitudinal translation of the firing beam 1266, thereby, in some versions, simply eliminating the actuator rod / cable, etc. The upper side of one jaw member 1214a includes a plurality of tooth serrations 1272. It should be understood that the underside of the other jaw member 1214b can include complementary serrations 1277 nested with the serrations 1272 to enhance the grip of tissue captured between the jaw members 1214a, 1214b of the end effector 1212, without necessarily tearing the tissue.

[0232] FIG. 61 shows a cross-sectional end view of the end effector 1212 of FIG. 60 in a closed configuration and with the blade 1274 in a distal position, according to one embodiment of the present disclosure. Referring now to FIGS. 60-61 , one jaw member 1214a defines a longitudinally extending elongated slot 1268, while the other jaw member 1214b also defines a longitudinally extending elongated slot 1270. In addition, the underside of one jaw member 1214a presents an electrically conductive surface 1216a, while the upper side of the other jaw member 1214b presents another electrically conductive surface 1216b. The electrically conductive surfaces 1216a, 1216b are in communication with a power source 1278 and a controller 1280 via one or more electrical conductors (not shown) extending along the length of the shaft assembly. The power source 1278 is operable to deliver RF energy with a first polarity to the first conductive surface 1216b and with a second (opposite) polarity to the second conductive surface 1216a, causing RF current to flow between the conductive surfaces 1216a, 1216b and thereby through tissue captured between the jaw members 1214a, 1214b. In some versions, the fired beam 1266 functions as an electrical conductor that cooperates with the conductive surfaces 1216a, 1216b (e.g., as a ground return) to deliver bipolar RF energy captured between the jaw members 1214a, 1214b. The power source 1278 may be external to the surgical instrument 1200 or may be integral with the surgical instrument 1200 (e.g., in the handle assembly 1202), as described in one or more references cited herein or otherwise. The controller 1280 regulates the delivery of power from the power source 1278 to the conductive surfaces 1216a, 1216b. The controller 1280 may also be external to the surgical instrument 1200 or may be integral with the surgical instrument 1200 (e.g., in the handle assembly 1202, etc.), as described in one or more references cited herein or otherwise. It should also be understood that the conductive surfaces 1216a, 1216b may be provided in a variety of alternative locations, configurations and relationships.

[0233] 60-61 , the surgical instrument 1200 of this example includes a firing beam 1266 that is longitudinally movable along a portion of the length of the end effector 1212. The firing beam 1266 is coaxially positioned within the shaft assembly 1210, extends along the length of the shaft assembly 1210, and translates longitudinally within the shaft assembly 1210 (including the articulation joint 1230 in this example), although it should be understood that the firing beam 1266 and the shaft assembly 1210 may have any other suitable relationship. The firing beam 1266 includes a knife 1274 having a sharpened distal end, an upper flange 1281, and a lower flange 1282. As best seen in FIG. 61 , knife 1274 extends through slots 1268, 1270 in jaw members 1214a, 1214b, with upper flange 1281 located above jaw member 1214a in recess 1284 and lower flange 1282 located below jaw member 1214b in recess 1286. The configuration of knife 1274 and flanges 1281, 1282 provides an “I-beam” shaped cross section at the distal end of firing beam 1266. In this embodiment, flanges 1281, 1282 extend longitudinally along only a small portion of the length of firing beam 1266, although it should be understood that flanges 1281, 1282 may extend longitudinally along any suitable length of firing beam 1266. Additionally, although the flanges 1281, 1282 are positioned along the outside of the jaw members 1214a, 1214b, the flanges 1281, 1282 may alternatively be disposed in corresponding slots formed in the jaw members 1214a, 1214b. For example, the jaw members 1214a, 1214b may define a "T" shaped slot, with a portion of the knife 1274 disposed in one vertical portion of the "T" shaped slot and the flanges 1281, 1282 disposed in a horizontal portion of the "T" shaped slot. Various other suitable configurations and relationships will be apparent to those skilled in the art in view of the teachings herein.By way of example only, the end effector 1212 may include one or more positive temperature coefficient (PTC) thermistor bodies 1288, 1290 (e.g., PTC polymers, etc.) located adjacent to the conductive surfaces 1216a, 1216b and / or elsewhere.

[0234] The structural and functional aspects of the battery assembly 1206 are similar to those of the battery assembly 106 of the surgical instrument 100 described with reference to Figures 1, 2, and 16-24, including the battery circuitry described with reference to Figures 20-24. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such battery assembly 106 are incorporated herein by reference and will not be repeated here. Furthermore, the structural and functional aspects of the RF generator circuitry are similar to those of the RF generator circuitry described for the surgical instruments 500, 600 described with reference to Figures 34-37. Accordingly, for the sake of brevity and clarity of disclosure, the structural and functional aspects of such RF generator circuitry are incorporated herein by reference and will not be repeated here. Furthermore, the surgical instrument 1200 includes the battery and control circuitry described with reference to Figures 12-15, including, for example, the control circuit 210 described with reference to Figure 14 and the electrical circuitry 300 described with reference to Figure 15. Therefore, for the sake of brevity and clarity of disclosure, the circuit descriptions set forth with respect to FIGS. 12-15 are incorporated herein by reference and will not be repeated here.

[0235] For a more detailed description of an electrosurgical instrument having a cutting mechanism and an articulation joint operable to deflect the end effector away from the longitudinal axis of the shaft, see U.S. Publication No. 2013 / 0023868, which is incorporated herein by reference.

[0236] It should also be understood that any of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein can be modified to include a motor or other electrically powered device to drive components that would otherwise be moved manually. Various examples of such modifications are described in U.S. Publication Nos. 2012 / 0116379 and 2016 / 0256184, each of which is incorporated herein by reference. In view of the teachings herein, various other suitable ways in which a motor or other electrically powered device may be incorporated into any of the instruments herein will be apparent to those skilled in the art.

[0237] It should also be understood that the circuits described with respect to Figures 11-15, 20-24, 34-37, and 50 may be configured to operate alone or in combination with any of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein.

[0238] 62-70 illustrate various circuits configured to operate with any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described with respect to FIGS. 1-61. Referring now to FIG. 62, components of a control circuit 1300 of a surgical instrument are shown, according to one embodiment of the present disclosure. The control circuit 1300 includes a processor 1302 coupled to a volatile memory 1304, one or more sensors 1306, a non-volatile memory 1308, and a battery 1310. In one embodiment, the surgical instrument can include a handle housing that houses the control circuit 1300 and includes a general-purpose control for implementing a power conservation mode. In some embodiments, the processor 1302 can be the primary processor of a surgical instrument that includes one or more secondary processors. In some embodiments, the processor 1302 can be stored within the battery 1310. The processor 1302 is configured to control various operations and functions of the surgical instrument by executing machine-executable instructions, such as a control program or other software modules. For example, execution of an energy modality control program by the processor 1302 enables a surgeon using the surgical instrument to select a particular type of energy to be applied to patient tissue. The surgical instrument may include an energy modality actuator located on the handle of the surgical instrument. The actuator may be a slider, a toggle switch, a segmented momentary contact switch, or some other type of actuator. Actuation of the energy modality actuator causes the processor 1302 to activate an energy modality corresponding to the selected type of energy. This type of energy may be ultrasonic, RF, or a combination of ultrasonic and RF energy. In various embodiments, the processor 1302 is generally electrically coupled to multiple circuit segments of the surgical instrument and activates or deactivates the circuit segments according to an energization and de-energization sequence, as shown in FIG. 63 .

[0239] Volatile memory 1304, such as random access memory (RAM), temporarily stores selected control programs or other software modules while the processor 1302 is operational, for example, when the processor 1302 executes the control programs or software modules. The one or more sensors 1306 may include a force sensor, a temperature sensor, a current sensor, or a motion sensor. In some embodiments, the one or more sensors 1306 may be located on the shaft, the end effector, the battery, or the handle, or any combination or subcombination thereof. The one or more sensors 1306 transmit data related to the operation of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described with respect to FIGS. 1-61 , such as the presence of tissue grasped by the jaws of the end effector or the force applied by the motor. In one embodiment, the one or more sensors 1306 may include an accelerometer that verifies the functionality or operation of circuit segments based on safety checks and power-on self-tests (POSTs). Machine-executable instructions, such as control programs or other software modules, are stored in nonvolatile memory 1308. For example, nonvolatile memory 1308 stores a Basic Input / Output System (BIOS) program. Nonvolatile memory 1308 may be read-only memory, erasable programmable ROM (EPROM), EEPROM, flash memory, or some other type of nonvolatile memory device. Various examples of control programs are described in U.S. Publication No. 2015 / 0272578, which is incorporated herein by reference in its entirety. The battery 1310 powers the surgical instrument by providing a source voltage that generates an electric current. The battery 1310 may include a motor control circuit segment 1428, shown in FIG. 63 .

[0240] In one aspect, the processor 1302 may be any single-core or multi-core processor, such as those known under the trade name ARM Cortex manufactured by Texas Instruments. In one aspect, the processor 1302 may be implemented as a safety processor, including two microcontroller-based families, such as the TMS570 and RM4x, also known under the trade name Hercules ARM Cortex R4 manufactured by Texas Instruments. Nevertheless, other suitable replacements for the microcontroller and safety processor may be used without limitation. In one aspect, the safety processor may be specifically configured for IEC 61508 and ISO 26262 safety-critical applications, among others, to provide advanced integrated safety features while offering scalable performance, connectivity, and memory options.

[0241] In particular aspects, processor 1302 may be, for example, an LM 4F230H5QR available from Texas Instruments. In at least one example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F processor core with on-chip memory of up to 40 MHz, 256 KB of single-cycle flash memory or other non-volatile memory, a prefetch buffer to improve performance above 40 MHz, 32 KB of single-cycle serial random access memory (SRAM), internal read-only memory (ROM) loaded with StellarisWare® software, 2 KB of electrically erasable programmable read-only memory (EEPROM), one or more pulse-width modulation (PWM) modules, one or more quadrature encoder inputs (QED analog), and one or more 12-bit analog-to-digital converters (ADCs) with 12 analog input channels, among other features readily available from the product datasheet. Other processors may be readily substituted, and thus the present disclosure should not be limited in this context.

[0242] 63 is a system diagram 1400 of a segmented circuit 1401 including multiple independently operating circuit segments 1402, 1414, 1416, 1420, 1424, 1428, 1434, and 1440 according to one embodiment of the present disclosure. Each of the multiple circuit segments of the segmented circuit 1401 includes one or more circuits and one or more sets of machine-executable instructions stored in one or more memory devices. The one or more circuits of the circuit segments are coupled for electrical communication through one or more wired or wireless connection media. The multiple circuit segments are configured to transition between three modes, including a sleep mode, a standby mode, and an operational mode.

[0243] In one aspect, the circuit segments 1402, 1414, 1416, 1420, 1424, 1428, 1434, and 1440 first start in standby mode, transition to sleep mode, and transition to operational mode. However, in other aspects, the circuit segments can transition from any one of the three modes to any other of the three modes. For example, the circuit segments can transition directly from standby mode to operational mode. Individual circuit segments can be placed in specific states by the voltage control circuit 1408 based on execution of machine-executable instructions by the processor 1302. These states include an unpowered state, a low-energy state, and a powered state. The unpowered state corresponds to sleep mode, the low-energy state corresponds to standby mode, and the powered state corresponds to operational mode. The transition to the low-energy state can be achieved, for example, through the use of a potentiometer.

[0244] In one aspect, the plurality of circuit segments 1402, 1414, 1416, 1420, 1424, 1428, 1434, 1440 can transition from a sleep mode or standby mode to an operational mode according to a power-on sequence. The plurality of circuit segments can also transition from an operational mode to a standby mode or sleep mode according to a de-power-on sequence. The power-on sequence and the de-power-on sequence can be different. Some aspects include powering only a subset of the plurality of circuit segments. Some aspects include powering only a subset of the plurality of circuit segments.

[0245] 63, the segmented circuit 1401 comprises a plurality of circuit segments, including a transition circuit segment 1402, a processor circuit segment 1414, a handle circuit segment 1416, a communication circuit segment 1420, a display circuit segment 1424, a motor control circuit segment 1428, an energy processing circuit segment 1434, and a shaft circuit segment 1440. The transition circuit segment comprises a wake-up circuit 1404, a boost current circuit 1406, a voltage control circuit 1408, a safety controller 1410, and a POST controller 1412. The transition circuit segment 1402 is configured to implement de-energization and energization sequences, safety detection protocols, and POST.

[0246] In some embodiments, the wake-up circuit 1404 includes an accelerometer button sensor 1405. In embodiments, the transition circuit segment 1402 is configured to be in a powered state, while other circuit segments of the plurality of circuit segments of the segmented circuit 1401 are configured to be in a low energy state, a non-powered state, or a powered state. The accelerometer button sensor 1405 can monitor the movement or acceleration of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to FIGS. 1-61 . For example, the movement can be a change in orientation or rotation of the surgical instrument. The surgical instrument can be moved in any direction relative to three-dimensional Euclidean space, for example, by a user of the surgical instrument. When the accelerometer button sensor 1405 senses movement or acceleration, it sends a signal to the voltage control circuit 1408, which applies voltage to the processor circuit segments 1414, transitioning the processor 1302 and the volatile memory 1304 to a powered state. In aspects, the processor 1302 and the volatile memory 1304 are in a powered state before the voltage control circuit 1409 applies voltage to the processor 1302 and the volatile memory 1304. In an operational mode, the processor 1302 can initiate a power-on or power-off sequence. In various aspects, the accelerometer button sensor 1405 also sends a signal to the processor 1302, causing the processor 1302 to initiate a power-on or power-off sequence. In some aspects, the processor 1302 initiates a power-on sequence when most of the individual circuit segments are in a low-energy or power-off state. In another aspect, the processor 1302 initiates the de-energization sequence when a majority of the individual circuit segments are in an energized state.

[0247] Additionally or alternatively, the accelerometer button sensor 1405 can sense external movement within a predetermined vicinity of the surgical instrument. For example, the accelerometer button sensor 1405 can allow a user to sense any of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to FIGS. 1-61 by moving the user's hand within a predetermined vicinity. When the accelerometer button sensor 1405 senses this external movement, it can send a signal to the voltage control circuit 1408 and to the processor 1302, as described above. After receiving the signal, the processor 1302 can initiate an energization or de-energization sequence to transition one or more circuit segments among the three modes. In an embodiment, the signal sent to the voltage control circuit 1408 is sent to verify that the processor 1302 is in an operational mode. In some embodiments, the accelerometer button sensor 1405 can sense when the surgical instrument is dropped and send a signal to the processor 1302 based on the detected drop. For example, the signal can indicate an error in the operation of an individual circuit segment. One or more sensors 1306 can sense damage or malfunction of the affected individual circuit segment. Based on the detected damage or malfunction, the POST controller 1412 can perform a POST of the corresponding individual circuit segment.

[0248] The energization or de-energization sequence may be defined based on the accelerometer button sensor 1405. For example, the accelerometer button sensor 1405 can sense a particular motion or sequence of motions indicating 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 1405 can transmit a signal to the processor 1302 when the processor 1302 is in an energized state, the signal including an indication of one or more circuit segments of the plurality of circuit segments. Based on this signal, the processor 1302 determines an energization sequence including the selected one or more circuit segments. Additionally or alternatively, a user of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to FIGS. 1-61 can select a number of circuit segments and their order to define an energization or de-energization sequence based on interaction with a graphical user interface (GUI) of the surgical instrument.

[0249] In various aspects, the accelerometer button sensor 1405 can signal the voltage control circuit 1408 and send a signal to the processor 1302 only upon detecting movement of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to FIGS. 1-61 or external movement within a predetermined vicinity above a predetermined threshold. For example, a signal can be sent only if movement is sensed for five seconds or more, or if the surgical instrument is moved 13 centimeters or more (five inches or more). In other aspects, the accelerometer button sensor 1405 can signal the voltage control circuit 1408 and send a signal to the processor 1302 only when the accelerometer button sensor 1405 detects oscillatory movement of the surgical instrument. The predetermined threshold reduces inadvertent transitions of circuit segments of the surgical instrument. As previously described, the transitions can include transitions to an operating mode following a power-on sequence, a low energy mode following a power-off sequence, or a sleep mode following a power-off sequence. In some embodiments, the surgical instrument includes an actuator that can be actuated by a user of the surgical instrument. This actuation is sensed by an accelerometer button sensor 1405. The actuator may be a slider, a toggle switch, or a momentary contact switch. Based on the sensed actuation, the accelerometer button sensor 1405 can send a signal to the voltage control circuit 1408 and send a signal to the processor 1302.

[0250] The boost current circuit 1406 is coupled to the battery 1310. The boost current circuit 1406 is a current amplifier, such as a relay or transistor, configured to amplify the magnitude of the current in each circuit segment. The initial magnitude of the current corresponds to the power supply voltage provided by the battery 1310 to the segmented circuit 1401. Suitable relays include solenoids. Suitable transistors include field effect transistors (FETs), MOSFETs, and bipolar junction transistors (BJTs). The boost current circuit 1406 can amplify the magnitude of the current corresponding to each circuit segment or circuit requiring more current draw in any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, and 1200 described with reference to FIGS. 1-61 . For example, an increase in current to the motor control circuit segment 1428 can be provided when the motor of the surgical instrument requires more input power. An increase in current provided to each circuit segment can cause a corresponding decrease in current in another circuit segment or circuit segment. Additionally or alternatively, the increase in current may correspond to a voltage provided by an additional voltage source operating in conjunction with the battery 1310 .

[0251] The voltage control circuit 1408 is coupled to the battery 1310. The voltage control circuit 1408 is configured to provide or remove voltage to the multiple circuit segments. The voltage control circuit 1408 is also configured to increase or decrease the voltage provided to the multiple circuit segments of the segmented circuit 1401. In various embodiments, the voltage control circuit 1408 includes a combinational logic circuit, such as a multiplexer (MUX), that selects inputs, multiple electronic switches, and multiple voltage converters. The electronic switches of the multiple electronic switches may be configured to switch between an open configuration and a closed configuration to connect or disconnect individual circuit segments to the battery 1310. The multiple electronic switches may be solid-state devices, such as transistors, or other types of switches, such as wireless switches, ultrasonic switches, accelerometers, and inertial sensors, among others. The combinational logic circuit is configured to select individual electronic switches to switch to an open configuration to allow application of voltage to the corresponding circuit segment. The combinational logic circuit is also configured to select individual electronic switches to switch to a closed configuration to allow removal of voltage from the corresponding circuit segment. By selecting multiple individual electronic switches, the combinational logic circuit can implement a de-energized or energized sequence. Multiple voltage converters can provide boosted or bucked voltages to multiple circuit segments. The voltage control circuit 1408 may also include a microprocessor and memory device, as shown in FIG. 62.

[0252] The safety controller 1410 is configured to perform safety checks on the circuit segments. In some embodiments, the safety controller 1410 performs safety checks on one or more individual circuit segments when the circuit segments are in an operational mode. The safety checks may be performed to determine whether there are any errors or defects in the function or operation of the circuit segments. The safety controller 1410 may monitor one or more parameters of the circuit segments. The safety controller 1410 can verify the identity and operation of the circuit segments by comparing one or more parameters to predetermined parameters. For example, when an RF energy modality is selected, the safety controller 1410 can verify that the shaft articulation parameters match the predetermined articulation parameters and verify the operation of the RF energy modality of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, and 1200 described with reference to FIGS. 1-61 . In some embodiments, the safety controller 1410 may monitor, via the sensors 1306, a predetermined relationship between one or more characteristics of the surgical instrument to detect a fault. A fault may occur when one or more characteristics do not conform to the predetermined relationship. When the safety controller 1410 determines that a fault exists, an error exists, or the operation of some of the circuit segments has not been verified, the safety controller 1410 prevents or disables operation of the particular circuit segment where the fault, error, or verification failure occurred.

[0253] The POST controller 1412 performs a POST to verify the proper operation of the multiple circuit segments. In some embodiments, the POST is performed on each of the multiple circuit segments before the voltage control circuit 1408 applies voltage to the individual circuit segment, transitioning it from a standby or sleep mode to an operational mode. If an individual circuit segment does not pass the POST, the particular circuit segment does not transition from a standby or sleep mode to an operational mode. The POST of the handle circuit segment 1416 may include, for example, testing whether the handle control sensor 1418 senses actuation of a handle control of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described with reference to FIGS. 1-61 . In some embodiments, the POST controller 1412 may send a signal to the accelerometer button sensor 1405 to verify the operation of the individual circuit segments as part of the POST. For example, after receiving a signal, the accelerometer button sensor 1405 can prompt the user of the surgical instrument to move the surgical instrument to multiple verification positions to confirm the operation of the surgical instrument. The accelerometer button sensor 1405 can also monitor the output of a circuit segment or the circuitry of a circuit segment as part of POST. For example, the accelerometer button sensor 1405 can sense incremental motor pulses generated by the motor 1432 to verify operation. A motor controller in the motor control circuit 1430 can be used to control the motor 1432 to generate the incremental motor pulses.

[0254] In various embodiments, any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described with respect to FIGS. 1-61 may include an additional accelerometer button sensor that may be used. The POST controller 1412 may also execute a control program stored in the memory device of the voltage control circuit 1408. The control program may cause the POST controller 1412 to send a signal requesting matching encryption parameters from multiple circuit segments. Failure to receive matching encryption parameters from an individual circuit segment indicates to the POST controller 1412 that the corresponding circuit segment is damaged or malfunctioning. In some embodiments, if the POST controller 1412 determines based on the POST that the processor 1302 is damaged or malfunctioning, the POST controller 1412 may send a signal to one or more secondary processors to cause the one or more secondary processors to perform critical functions that the processor 1302 cannot perform. In some aspects, if the POST controller 1412 determines based on POST that one or more circuit segments are not operating properly, the POST controller 1412 can initiate a reduced performance mode for the circuit segments that are operating properly while locking out the circuit segments that failed POST or are not operating properly. The locked-out circuit segments can function similarly to circuit segments in standby or sleep mode.

[0255] The processor circuit segment 1414 includes the processor 1302 and volatile memory 1304 described with reference to FIG. 62. The processor 1302 is configured to initiate an energization or de-energization sequence. To initiate an energization sequence, the processor 1302 sends an energization signal to the voltage control circuit 1408, causing the voltage control circuit 1408 to apply voltage to the circuit segments or a subset of the circuit segments according to the energization sequence. To initiate a de-energization sequence, the processor 1302 sends an un-energization signal to the voltage control circuit 1408, causing the voltage control circuit 1408 to remove voltage from the circuit segments or a subset of the circuit segments according to the de-energization sequence.

[0256] The handle circuit segment 1416 includes a handle control sensor 1418. The handle control sensor 1418 can sense actuation of one or more handle controls of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to FIGS. 1-61 . In various embodiments, the one or more handle controls include a clamp control, a release button, an articulation switch, an energy activation button, and / or any other suitable handle control. A user can activate the energy activation button to select RF energy mode, ultrasonic energy mode, or a combination of RF energy mode and ultrasonic energy mode. The handle control sensor 1418 can also facilitate attachment of the modular handle to the surgical instrument. For example, the handle control sensor 1418 can sense 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 1426 can provide a graphical representation of the sensed attachment. In some aspects, the handle control sensor 1418 senses actuation of one or more handle controls. Based on the sensed actuation, the processor 1302 can initiate either an energization sequence or a de-energization sequence.

[0257] The communication circuit segment 1420 includes a communication circuit 1422. The communication circuit 1422 includes a communication interface for facilitating signal communication between individual circuit segments of the plurality of circuit segments. In some embodiments, the communication circuit 1422 provides a path for the modular components of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to FIGS. 1-61 to communicate electrically. For example, the modular shaft and modular transducer, when attached together to the handle of the surgical instrument, can upload a control program to the handle via the communication circuit 1422.

[0258] The display circuit segment 1424 includes an LCD display 1426. The LCD display 1426 can include a liquid crystal display screen, an LED indicator, or the like. In some embodiments, the LCD display 1426 is an organic light-emitting diode (OLED) screen. The display 226 can be located on, embedded in, or remotely located with any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to FIGS. 1-61 . For example, the display 226 can be located on the handle of the surgical instrument. The display 226 is configured to provide sensory feedback to the user. In various embodiments, the LCD display 1426 further includes a backlight. In some embodiments, the surgical instrument can also include an audible feedback device, such as a speaker or buzzer, and a tactile feedback device, such as a haptic actuator.

[0259] The motor control circuit segment 1428 includes a motor control circuit 1430 coupled to a motor 1432. The motor 1432 is coupled to the processor 1302 by a driver and a transistor, such as a FET. In various embodiments, the motor control circuit 1430 includes a motor current sensor in signal communication with the processor 1302 and provides a signal indicative of a measurement of the motor's current draw to the processor 1302. The processor transmits the signal to the display 226. The display 226 receives the signal and displays the measurement of the motor's current draw. The processor 1302 can use the signal to, for example, monitor that the motor's current draw is within acceptable limits, compare the current draw to one or more parameters of multiple circuit segments, and determine one or more parameters of the patient treatment site. In various embodiments, the motor control circuit 1430 includes a motor controller that controls the operation of the motor. For example, the motor control circuit 1430 controls various motor parameters by adjusting the speed, torque, and acceleration of the motor 1432, for example. This adjustment is made based on the current through the motor 1432 as measured by the motor current sensor.

[0260] In various embodiments, the motor control circuitry 1430 includes a force sensor that measures the force and torque generated by the motor 1432. The motor 1432 is configured to actuate a mechanism of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, and 1200 described herein with reference to FIGS. 1-61 . For example, the motor 1432 is configured to control the actuation of a shaft of the surgical instrument to achieve clamping, rotation, and articulation functionality. For example, the motor 1432 can actuate the shaft to achieve clamping motion with the jaws of the surgical instrument. The motor controller can determine whether the material clamped by the jaws is tissue or metal. The motor controller may also determine the extent to which the jaws clamp the material. For example, the motor controller can determine the degree to which the jaws are open or closed based on a derivative of a sensed motor current or motor voltage. In some embodiments, the motor 1432 is configured to actuate a transducer to apply torque to a handle or to control articulation of the surgical instrument. The motor current sensor can interact with the motor controller to set a motor current limit. If the current meets a predefined threshold limit, the motor controller initiates a corresponding change in motor control behavior. For example, exceeding the motor current limit causes the motor controller to reduce the motor's current draw.

[0261] The energy treatment circuit segment 1434 includes an RF amplifier and safety circuit 1436 and an ultrasonic signal generator circuit 1438 and implements the energy module functionality of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described with respect to Figures 1-61. In various aspects, the RF amplifier and safety circuit 1436 is configured to control the RF modality of the surgical instrument by generating RF signals. The ultrasonic signal generator circuit 1438 is configured to control the ultrasonic energy modality by generating ultrasonic signals. The RF amplifier and safety circuit 1436 and the ultrasonic signal generator circuit 1438 can operate together to control the combined RF and ultrasonic energy modalities.

[0262] The shaft circuit segment 1440 includes a shaft module controller 1442, a module control actuator 1444, one or more end effector sensors 1446, and a non-volatile memory 1448. The shaft module controller 1442 is configured to control multiple shaft modules containing control programs executed by the processor 1302. The multiple shaft modules implement shaft modalities such as ultrasonic, combined ultrasonic and RF, RF I-blade, and RF opposable jaw. The shaft module controller 1442 can select a shaft modality by selecting a corresponding shaft module for execution by the processor 1302. The module control actuator 1444 is configured to actuate the shaft according to the selected shaft modality. 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 1446 located on the end effector can include a force sensor, a temperature sensor, a current sensor, or a motion sensor. The one or more end effector sensors 1446 transmit data regarding one or more movements of the end effector based on the energy modality implemented by the end effector. In various embodiments, the energy model includes an ultrasonic energy modality, an RF energy modality, or a combination of an ultrasonic energy modality and an RF energy modality. The nonvolatile memory 1448 stores a shaft control program. The control program includes one or more parameters, routines, or programs specific to the shaft. In various embodiments, the nonvolatile memory 1448 may be a ROM, EPROM, EEPROM, or flash memory. The nonvolatile memory 1448 stores a shaft module corresponding to a selected shaft of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, and 1200 described herein with reference to FIGS. 1-61 .The shaft module may be changed or upgraded in non-volatile memory 1448 by shaft module controller 1442 depending on the surgical instrument shaft used during operation.

[0263] FIG. 64 shows a diagram of one embodiment of a surgical instrument 1500 including a feedback system for use with any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to FIGS. 1-61 , which may include or implement many of the features described herein. For example, in one embodiment, the surgical instrument 1500 may be similar to or representative of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200. The surgical instrument 1500 may include a generator 1502. The surgical instrument 1500 may also include an end effector 1506 that may be activated when a clinician operates a trigger 1510. In various embodiments, the end effector 1506 may include an ultrasonic blade for delivering ultrasonic vibrations to perform a surgical coagulation / cutting procedure on living tissue. In other aspects, the end effector 1506 may include either a conductive element coupled to a source of electrosurgical radio frequency current energy to perform surgical coagulation or cauterization procedures on living tissue, and a mechanical knife or ultrasonic blade with a sharpened end to perform cutting procedures on living tissue. When the trigger 1510 is actuated, the force sensor 1512 may generate a signal indicative of the amount of force applied to the trigger 1510. In addition to, or instead of, the force sensor 1512, the surgical instrument 1500 may include a position sensor 1513 that may generate a signal indicative of the position of the trigger 1510 (e.g., how far the trigger is depressed or otherwise actuated). In one aspect, the position sensor 1513 may be a sensor positioned with the outer tubular sheath or a reciprocating tubular actuating member located within the outer tubular sheath. 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 can be used for proximity switching, positioning, velocity detection, and current sensing applications. In one aspect, the Hall Effect sensor acts as an analog converter and returns a voltage directly, and with a known magnetic field, the distance from the Hall plate can be determined.

[0264] The control circuit 1508 can receive signals from the sensors 1512 and / or 1513. The control circuit 1508 can include any suitable analog or digital circuit components. The control circuit 1508 can also communicate with the generator 1502 and / or the transducer 1504 to modulate the power delivered to the end effector 1506 and / or the generator level or ultrasonic blade amplitude of the end effector 1506 based on the force applied by the trigger 1510, and / or the position of the trigger 1510 and / or the position of the outer tubular sheath 56 relative to the reciprocating tubular actuating member 58 located within the outer tubular sheath 56 (e.g., as measured by a combination of a Hall Effect sensor and a magnet). For example, the more force applied to the trigger 1510, the more power and / or higher ultrasonic blade amplitude can be delivered to the end effector 1506. According to various embodiments, the force sensor 1512 can be replaced by a multi-position switch.

[0265] According to various embodiments, the end effector 1506 can include a clamp or clamping mechanism, such as those described above with respect to FIGS. 1-5. When the trigger 1510 is first actuated, the clamping mechanism can close, clamping tissue between the clamp arm and the end effector 1506. As the force applied to the trigger increases (e.g., as sensed by the force sensor 1512), the control circuit 1508 can increase the power delivered to the end effector 1506 by the transducer 1504 and / or the generator level or ultrasonic blade amplitude produced at the end effector 1506. In one embodiment, the trigger position sensed by the position sensor 1513, or the clamp or clamp arm position sensed by the position sensor 1513 (e.g., using a Hall Effect sensor), can be used by the control circuit 1508 to set the power and / or amplitude of the end effector 1506. For example, as the trigger is moved further toward the fully actuated position or the clamp or clamp arm is moved further toward the ultrasonic blade (or end effector 1506), the power and / or amplitude of the end effector 1506 can be increased.

[0266] According to various embodiments, the surgical instrument 1500 can also include one or more feedback devices to indicate the amount of power delivered to the end effector 1506. For example, the speaker 1514 can emit a signal indicative of the end effector power. According to various embodiments, the speaker 1514 can emit a series of pulsed tones, the frequency of which indicates the power. In addition to, or instead of, the speaker 1514, the surgical instrument 1500 can include a visual display 1516. The visual display 1516 can indicate the end effector power according to any suitable method. For example, the visual display 1516 can include a series of LEDs, with the end effector power being indicated by the number of illuminated LEDs. The speaker 1514 and / or the visual display 1516 can be driven by the control circuit 1508. According to various embodiments, the surgical instrument 1500 can include a ratchet device (not shown) connected to the trigger 1510. As more force is applied to the trigger 1510, the ratchet device can produce an audible sound, providing an indirect indication of end effector power. The surgical instrument 1500 can include other features that can enhance safety. For example, the control circuit 1508 can be configured to prevent power from being delivered to the end effector 1506 above a predetermined threshold. The control circuit 1508 can also provide a delay between the time a change in end effector power is indicated (e.g., by the speaker 1514 or visual display 1516) and the time the change in end effector power is delivered. In this way, the clinician can have ample warning that the level of ultrasonic power delivered to the end effector 1506 is about to change.

[0267] In one aspect, the ultrasonic or radio frequency current generator of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, and 1200 described with respect to FIGS. 1-61 may be configured to digitally generate an electrical signal waveform using a predetermined number of phase points stored in a lookup table to digitize the waveform. The phase points may be stored in a table defined in memory, a field programmable gate array (FPGA), or any suitable non-volatile memory. FIG. 65 shows one aspect of a basic architecture for a digital synthesis circuit, such as a direct digital synthesis (DDS) circuit 1600, configured to generate multiple waveforms for the electrical signal waveform. The generator software and digital control may instruct the FPGA to scan addresses in the lookup table 1604, sequentially providing changing digital input values to a DAC circuit 1608 that feeds the power amplifier. The addresses may be scanned according to the desired frequency. Use of such lookup tables 1604 allows for the generation of various types of waveforms that can be delivered into tissue, or into a transducer, an RF electrode, multiple transducers simultaneously, multiple RF electrodes simultaneously, or a combination of RF and ultrasonic instruments. Additionally, multiple lookup tables 1604 representing multiple waveforms can be created, stored, and applied to tissue from the generator.

[0268] The waveform signal may be configured to control at least one of the output current, output voltage, or output power of an ultrasonic transducer and / or RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). Where a surgical instrument includes an ultrasonic component, the waveform signal may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Accordingly, the generator may be configured to provide a waveform signal to at least one surgical instrument, the signal responsive to at least one waveform of a plurality of waveforms in a table. The waveform signals provided to the two surgical instruments may include two or more waveforms. The table may include information related to the plurality of waveforms, and the table may be stored within the generator. In one aspect or embodiment, the table may be a direct digital synthesis table and may be stored within the generator's FPGA. The table may be addressed, in any way, as is convenient for categorizing the waveforms. According to one aspect, the table, which may be a direct digital synthesis table, is addressed according to the frequency of the waveform signal. Additionally, information relating to multiple waveforms may be stored as digital information in a table.

[0269] The analog electrical signal waveform may be configured to control at least one of the output current, output voltage, or output power of an ultrasonic transducer and / or RF electrode, or a plurality thereof (e.g., two or more ultrasonic transducers and / or two or more RF electrodes). Where a surgical instrument includes an ultrasonic component, the analog electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of at least one surgical instrument. Accordingly, the generator circuit may be configured to provide an analog electrical signal waveform to at least one surgical instrument, where the analog electrical signal waveform corresponds to at least one waveform of a plurality of waveforms stored in the lookup table 1604. The analog electrical signal waveforms provided to the two surgical instruments may include two or more waveforms. The lookup table 1604 may include information related to a plurality of waveforms, and the lookup table 1604 may be stored either in the generator circuit or in the surgical instrument. In one aspect or embodiment, the lookup table 1604 may be a direct digital synthesis table and may be stored within the generator circuit or FPGA of the surgical instrument. The lookup table 1604 may be addressed by any convenient method for categorizing waveforms. According to one aspect, the lookup table 1604, which may be a direct digital synthesis table, is addressed according to the frequency of the desired analog electrical signal waveform. Furthermore, information related to multiple waveforms may be stored in the lookup table 1604 as digital information.

[0270] With the widespread use of digital technology in instrumentation and communication systems, a digitally controlled method for generating multiple frequencies from a reference frequency has been developed and is referred to as direct digital synthesis. The basic architecture is shown in Figure 65. In this simplified block diagram, a DDS circuit is coupled to a processor, controller, or logic circuit of a generator circuit and to memory circuitry located in the generator circuit of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to Figures 1-61. The DDS circuit 1600 includes an address counter 1602, a look-up table 1604, a register 1606, a DAC circuit 1608, and a filter 1612. A stable clock f c is received by an address counter 1602, and a register 1606 drives a programmable read-only memory (PROM) that stores one or more integer numbers of cycles of a sine wave (or any other waveform) in a look-up table 1604. As the address counter 1602 steps through the memory locations, the values stored in the look-up table 1604 are written to a register 1606 that is coupled to a DAC circuit 1608. The corresponding digital amplitude of the signal at the memory location of the look-up table 1604 drives the DAC circuit 1608, which in turn generates an analog output signal 1610. The spectral purity of the analog output signal 1610 is primarily determined by the DAC circuit 1608. Phase noise is essentially a function of the phase of a reference clock f c A first analog output signal 1610 output from the DAC circuit 1608 is filtered by a filter 1612, and a second analog output signal 1614 output by the filter 1612 is provided to an amplifier having an output coupled to the output of the generator. The second analog output signal has a frequency f out It has.

[0271] Because the DDS circuit 1600 is a sampled data system, it must consider sampling-related issues such as quantization noise, aliasing, and filtering. For example, while higher-order harmonics of a phase-locked-loop (PLL)-based synthesizer output can be filtered, higher-order harmonics of the DAC circuit 1608 output frequency fold back into the Nyquist bandwidth, making them unfilterable. The lookup table 1604 contains signal data for an integer number of cycles. The final output frequency f out is the reference clock frequency f c or by reprogramming the PROM.

[0272] The DDS circuit 1600 may include multiple lookup tables 1604, each storing a waveform represented by a predetermined number of samples, which define a predetermined waveform shape. Thus, multiple waveforms with unique shapes can be stored in the multiple lookup tables 1604 to provide different tissue treatments based on instrument settings or tissue feedback. Example waveforms include a high crest factor RF electrical signal waveform for superficial tissue coagulation, a low crest factor RF electrical signal waveform for deeper tissue penetration, and an electrical signal waveform that promotes effective modified coagulation. In one aspect, the DDS circuit 1600 can create multiple waveform lookup tables 1604 and switch between different waveforms stored in separate lookup tables 1604 during a tissue treatment procedure (e.g., “on the fly” or in substantial real-time based on user or sensor input) based on the desired tissue effect and / or tissue feedback. Thus, switching between waveforms can be based on, for example, tissue impedance and other factors. In other aspects, the lookup table 1604 can store electrical signal waveforms (i.e., trapezoidal or square waves) configured to maximize the power per cycle delivered into tissue. In other aspects, the lookup table 1604 can store waveforms that synchronize the RF and ultrasonic drive signals while delivering them for maximum power delivery by any one of the multifunction surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to Figures 1-61. In still other aspects, the lookup table 1604 can store electrical signal waveforms to drive ultrasonic and RF therapeutic and / or sub-therapeutic energies simultaneously while maintaining ultrasonic frequency lock. Custom waveforms specific to different instruments and their tissue effects may be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (e.g., EEPROM) of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to Figures 1-61, and may be retrieved upon connection of a multi-function surgical instrument to the generator circuit.An example of an exponentially decaying sinusoidal waveform, as used in many high crest factor "coagulation" waveforms, is shown in Figure 67.

[0273] A more flexible and efficient implementation of DDS circuit 1600 uses a digital circuit called a Numerically Controlled Oscillator (NCO). A block diagram of a more flexible and efficient digital synthesis circuit, such as DDS circuit 1700, is shown in FIG. 66. In this simplified block diagram, DDS circuit 1700 is coupled to a processor, controller, or logic circuit of a generator and to memory circuitry located in the generator or any of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to FIGS. 1-61. DDS circuit 1700 includes a load register 1702, a parallel delta phase register 1704, a summer circuit 1716, a phase register 1708, a look-up table 1710 (phase-to-amplitude converter), a DAC circuit 1712, and a filter 1714. The adder circuit 1716 and the phase register 1708a form part of the phase accumulator 1706. The clock signal f c is applied to the phase register 1708 and the DAC circuit 1712. The load resistor 1702 is connected to the reference clock frequency f c The output of the load register 1702, along with the tuning word M, is provided to a parallel delta phase register 1704.

[0274] The DDS circuit 1700 operates at a clock frequency f c , a phase accumulator 1706, and a look-up table 1710 (e.g., a phase-to-amplitude converter). The capacity of the phase accumulator 1706 is cThe phase accumulator 1706 is updated once every clock cycle. Once the phase accumulator 1706 is updated, the digital number M stored in the parallel delta phase register 1704 is added to the number in the phase register 1708 by an adder circuit 1716. Assume the number in the parallel delta phase register 1704 is 00...01 and that the initial contents of the phase accumulator 1706 are 00...00. The phase accumulator 1706 is updated with 00...01 every clock cycle. If the phase accumulator 1706 is 32-bits wide, it will take 232 clock cycles (over 4 billion) for the phase accumulator 1706 to return to 00...00, and the cycle will repeat.

[0275] The truncated output 1718 of the phase accumulator 1706 is provided to a phase-to-amplitude converter lookup table 1710, the output of which is coupled to a DAC circuit 1712. The truncated output 1718 of the phase accumulator 1706 serves as an address to a sine (or cosine) lookup table. Addresses in the lookup table correspond to phase points from 0° to 360° of the sine wave. The lookup table 1710 contains the corresponding digital amplitude information for one complete cosine wave cycle. The lookup table 1710 thus maps the phase information from the phase accumulator 1706 to a digital amplitude word, which in turn drives the DAC circuit 1712. The output of the DAC circuit is a first analog signal 1720, which is also filtered by a filter 1714. The output of the filter 1714 is a second analog signal 1722, which is provided to a power amplifier coupled to the output of the generator circuit.

[0276] In one embodiment, the electrical signal waveform may be digitized into 1024 (210) phase points, although the waveform that may be digitized may be any suitable number of 2n phase points ranging from 256 (28) to 281, 474, 976, 710, 656 (248), where n is a positive integer as shown in Table 1. The electrical signal waveform may be represented as An(θn), where the normalized amplitude An at point n is represented by the phase angle θn and is referred to as the phase point at point n. The number of distinct phase points n determines the tuning resolution of DDS circuit 1700 (similarly, DDS circuit 1600 shown in FIG. 65).

[0277] [Table 1]

[0278] The generator circuit algorithm and digital control circuit scans addresses in a lookup table 1710, sequentially providing changing digital input values to a DAC circuit 1712 that feeds a filter 1714 and a power amplifier. The addresses may be scanned according to a desired frequency. Using the lookup table, various types of waveforms can be generated that can be converted to an analog output signal by the DAC circuit 1712, filtered by the filter 1714, amplified by a power amplifier coupled to the generator circuit output, and applied to tissue in the form of ultrasonic vibrations that supply power to the tissue in the form of RF energy or energy to an ultrasound transducer and deliver energy to the tissue in the form of heat. The amplifier output can be applied to, for example, a single RF electrode, multiple RF electrodes simultaneously, a single ultrasound transducer, multiple ultrasound transducers simultaneously, or a combination of RF and ultrasound transducers. Additionally, multiple waveform tables can be created, stored, and applied to tissue from the generator circuit.

[0279] Referring back to Figure 65, if n=32 and M=1, the phase accumulator 1706 steps through 232 possible outputs before it overflows and restarts. The corresponding output wave frequency is equal to the input clock frequency divided by 232. If M=2, then the phase register 1708 "rolls over" twice while remaining fast, and the output frequency doubles. This can be generalized as follows:

[0280] For a phase accumulator 1706 configured to accumulate n bits (n is typically in the range of 24 to 32 in most DDS systems, but as mentioned above, n may be selected from a wide range of choices), 2 n There are ≈ 1000 possible phase points. The digital word M in the delta phase register represents the amount the phase accumulator increments per clock cycle. If fc is the clock frequency, then the frequency of the output sine wave is equal to:

[0281]

number

[0282] Equation 1 is known as the DDS "tuning equation." The frequency resolution of the system is:

[0283]

number

[0284] The electrical signal waveform may be characterized by a current, voltage, or power at a predetermined frequency. Furthermore, if any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to Figures 1-61 includes an ultrasonic component, the electrical signal waveform may be configured to drive at least two vibration modes of an ultrasonic transducer of the at least one surgical instrument. Thus, the generator circuit may be configured to provide an electrical signal waveform to the at least one surgical instrument, the electrical signal waveform characterized by a predetermined waveform stored in lookup table 1710 (or lookup table 1604 of Figure 65). Note that the electrical signal waveform may be a combination of two or more waveforms. Lookup table 1710 may contain information related to multiple waveforms. In one aspect or embodiment, lookup table 1710 may be generated by DDS circuit 1700 and may also be referred to as a direct digital synthesis table. The DDS operates by first storing a large, repetitive waveform in on-board memory. A cycle of the waveform (sine, triangle, square, or any) can be represented by a predetermined number of phase points and stored in memory, as shown in Table 1. Once the waveform is stored in memory, it can be generated at highly accurate frequencies. The direct digital synthesis table can be stored in non-volatile memory of the generator circuitry and / or implemented with FPGA circuitry within the generator circuitry. The lookup table 1710 can be addressed by any suitable technique that is convenient for categorizing waveforms. According to one embodiment, the lookup table 1710 is addressed according to the frequency of the electrical signal waveform. Additionally, information related to multiple waveforms can be stored as digital information in memory or as part of the lookup table 1710.

[0285] In one aspect, the generator circuit may be configured to provide electrical signal waveforms to at least two surgical instruments simultaneously. The generator circuit may also be configured to provide electrical signal waveforms (which may be characterized by two or more waveforms) to two surgical instruments simultaneously via a single output channel of the generator circuit. For example, in one aspect, the electrical signal waveform includes a first electrical signal (e.g., an ultrasonic drive signal) that drives an ultrasonic transducer, a second RF drive signal, and / or a combination thereof. Furthermore, the electrical signal waveform may include multiple ultrasonic drive signals, multiple RF drive signals, and / or a combination of multiple ultrasonic and RF drive signals.

[0286] Further, a method of operating a generator circuit according to the present disclosure includes generating an electrical signal waveform and providing the generated electrical signal waveform to any one of surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to Figures 1-61, where generating the electrical signal waveform includes receiving information related to the electrical signal waveform from a memory. The generated electrical signal waveform includes at least one waveform. Further, providing the generated electrical signal waveform to at least one surgical instrument includes providing the electrical signal waveform to at least two surgical instruments simultaneously.

[0287] The generator circuit described herein may enable the generation of various types of direct digital synthesis tables. Examples of waveforms of RF / electrosurgical signals generated by the generator circuit suitable for treating various tissues include RF signals with high crest factors (which may be used for superficial coagulation in RF mode), RF signals with low crest factors (which may be used for deeper tissue penetration), and waveforms that promote efficient modified coagulation. The generator circuit may also generate multiple waveforms using the direct digital synthesis lookup table 1710 and, during operation, switch between specific waveforms based on the desired tissue effect. Switching may be based on tissue impedance and / or other factors.

[0288] In addition to traditional sine / cosine waveforms, the generator circuit may be configured to generate waveform(s) (i.e., trapezoidal or square waves) that maximize power to tissue per cycle. If the generator circuit includes a circuit topology that allows for simultaneous driving of RF and ultrasonic signals, the generator circuit can provide waveform(s) that are synchronized to maximize power delivered to the load and maintain ultrasonic frequency lock when simultaneously driving RF and ultrasonic signals. Furthermore, instrument-specific custom waveform shapes and their tissue effects can be stored in non-volatile memory (NVM) or instrument EEPROM and retrieved upon connection of any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to Figures 1-61 to the generator circuit.

[0289] The DDS circuit 1700 may include multiple lookup tables 1604, where the lookup tables 1710 store waveforms represented by a predetermined number of phase points (sometimes called samples), which define a predetermined waveform shape. Thus, multiple waveforms with unique shapes can be stored in the multiple lookup tables 1710 to provide different tissue treatments based on instrument settings or tissue feedback. Examples of waveforms include RF electrical signal waveforms with high crest factors for superficial tissue coagulation, RF electrical signal waveforms with low crest factors for deeper tissue penetration, and electrical signal waveforms that promote effective modified coagulation. In one aspect, the DDS circuit 1700 can create multiple waveform lookup tables 1710 and, during a tissue treatment procedure (e.g., "on the fly" or in virtual real-time based on user or sensor input), switch between different waveforms stored in different lookup tables 1710 based on the desired tissue effect and / or tissue feedback. Thus, switching between waveforms can be based on tissue impedance and other factors, for example. In other aspects, the lookup table 1710 can store an electrical signal waveform (i.e., a trapezoidal wave or a square wave) configured to maximize the power delivered into tissue per cycle. In other aspects, the lookup table 1710 can store waveforms synchronized to maximize power delivery by any one of the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with respect to FIGS. 1-61 when delivering RF and ultrasonic drive signals. In still other aspects, the lookup table 1710 can store electrical signal waveforms to drive ultrasonic and RF therapeutic and / or sub-therapeutic energies simultaneously while maintaining ultrasonic frequency lock. In general, the output waveforms may be in the form of sine waves, cosine waves, pulse waves, square waves, etc. Nevertheless, more complex custom waveforms specific to different instruments and their tissue effects can be stored in the non-volatile memory of the generator circuit or in the non-volatile memory (e.g., EEPROM) of the surgical instrument and can be retrieved upon connection of the surgical instrument to the generator circuit.An example of a custom waveform is an exponentially decaying sinusoidal waveform as used in many high crest factor "coagulation" waveforms, as shown in FIG.

[0290] 67 shows one cycle of a discrete-time digital electrical signal waveform 1800 according to one embodiment of the present disclosure, where an analog waveform 1804 (shown superimposed on the discrete-time digital electrical signal waveform 1800 for comparison purposes) is used. The horizontal axis represents time (t) and the vertical axis represents digital phase points. The digital electrical signal waveform 1800 is, for example, a digital discrete-time version of the desired analog waveform 1804. The digital electrical signal waveform 1800 is a digital discrete-time version of the desired analog waveform 1804. The digital electrical signal waveform 1800 is shown as a waveform of a clock cycle T over one cycle or period T0. clk The digital electrical signal waveform 1800 is generated by storing amplitude phase points 1802 representing the amplitude of every cycle T0. The digital electrical signal waveform 1800 is generated over one period T0 by any suitable digital processing circuit. The amplitude phase points are digital words stored in a memory circuit. In the example shown in Figures 65 and 66, the digital words are 6-bit words capable of storing amplitude phase points with 26 or 64 bits of resolution. It will be understood that the examples shown in Figures 65 and 66 are for illustrative purposes and that in actual implementations the resolution may be higher. The digital amplitude phase points 1802 over one cycle T0 are stored in memory, for example, as a string of string words in lookup tables 1604, 1710, as described with respect to Figures 65 and 66. To generate an analog version of the analog waveform 1804, the amplitude phase points 1802 are stored in memory as a string of string words in lookup tables 1604, 1710, as described with respect to Figures 65 and 66. clkThe amplitude and phase points 1802 of the digital electrical signal waveform 1800 are read sequentially from 0 to T0 each time cycle and converted by the DAC circuit 1608, 1712, similarly described with respect to Figures 65 and 66. Additional cycles can be generated by repeatedly reading the amplitude and phase points 1802 of the digital electrical signal waveform 1800 from 0 to T0 for as many cycles or periods as may be desired. A smoothed analog version of the analog waveform 1804 is achieved by filtering the output of the DAC circuit 1608, 1712 with a filter 1612, 1714 (Figures 65 and 66). The filtered analog output signal 1614, 1722 (Figures 65 and 66) is applied to the input of the power amplifier.

[0291] 68A, the circuit 1900 can comprise a controller including one or more processors 1902 (e.g., microprocessors, microcontrollers) coupled to at least one memory circuit 1904. The at least one memory circuit 1904 stores machine-executable instructions that, when executed by the processor 1902, cause the processor 1902 to execute machine instructions that implement any of the algorithms, processes, or techniques described herein.

[0292] The processor 1902 may be any one of a number of single or multi-core processors known in the art. The memory circuit 1904 may include volatile and non-volatile storage media. In one aspect, as shown in FIG. 68A, the processor 1902 may include an instruction processing unit 1906 and an arithmetic unit 1908. The instruction processing unit may be configured to receive instructions from one of the memory circuits 1904.

[0293] In one aspect, the circuit 1910 can comprise a finite state machine including combinational logic 1912 configured to implement any of the algorithms, processes, or techniques described herein, as shown in FIG. 68B. In one aspect, the circuit 1920 can comprise a finite state machine including sequential logic, as shown in FIG. 68C. The sequential logic 1920 can include, for example, the combinational logic 1912 and at least one memory circuit 1914. The at least one memory circuit 1914 can store the current state of the finite state machine, as shown in FIG. 68C. The sequential logic 1920 or the combinational logic 1912 can be configured to implement any of the algorithms, processes, or techniques described herein. In certain examples, the sequential logic 1920 can be synchronous or asynchronous.

[0294] In other aspects, a circuit may include a combination of a processor 1902 and a finite state machine to implement any of the algorithms, processes, or techniques described herein. In other aspects, a finite state machine may include a combination of combinational logic 1910 and sequential logic 1920.

[0295] 69 is a schematic diagram of a circuit 1925 of various components of a surgical instrument having motor control capabilities, according to one embodiment of the present disclosure. In various embodiments, the surgical instruments 100, 480, 500, 600, 1100, 1150, 1200 described herein with reference to FIGS. 1-68C can include a drive mechanism 1930 configured to drive shafts and / or gear components to perform various operations associated with the surgical instrument 100, 480, 500, 600, 1100, 1150, 1200. In one embodiment, the drive mechanism 1930, 160 includes a rotational drive train 1932 configured to rotate the end effector 112, 512, 1000, 1112, 1212, for example, about a longitudinal axis relative to the handle housing, as described with reference to FIGS. 1, 20, 40, 41, 45, 54. The drive mechanism 1930 further includes a closure drive train 1934 configured to close the jaw members to grasp tissue with the end effector. Additionally, the drive mechanism 1930 includes a firing drive train 1936 configured to fi...

Claims

1. 1. A surgical instrument comprising: A shaft assembly including a shaft and an end effector coupled to a distal end of the shaft, the end effector including a first jaw and a second jaw configured to pivot between a closed position and an open position, the first or second jaw comprising: a first sensor configured to measure a tissue property at a first location; a second sensor configured to measure the tissue property at a second location; and a handle assembly coupled to a proximal end of the shaft; a battery assembly coupled to the handle assembly; an RF energy output energized by the battery assembly and configured to apply radio frequency (RF) energy to tissue; an ultrasonic energy output energized by the battery assembly and configured to apply ultrasonic energy to the tissue; a controller configured to control the RF energy output to apply RF energy or the ultrasonic energy output to apply ultrasonic energy based at least in part on the tissue properties measured at the first location and the second location; the first and second sensors are vertical pressure sensors; The controller: High energy is applied at a position where the sensor output is high, and The surgical instrument is further configured to apply low energy at low sensor output locations.

2. A surgical instrument, A shaft assembly including a shaft and an end effector coupled to a distal end of the shaft, the end effector including a first jaw and a second jaw configured to pivot between a closed position and an open position, the first or second jaw comprising: a first sensor configured to measure a tissue property at a first location; a second sensor configured to measure the tissue property at a second location; and a handle assembly coupled to a proximal end of the shaft; a battery assembly coupled to the handle assembly; an RF energy output energized by the battery assembly and configured to apply radio frequency (RF) energy to tissue; an ultrasonic energy output energized by the battery assembly and configured to apply ultrasonic energy to the tissue; a controller configured to control the RF energy output to apply RF energy or the ultrasonic energy output to apply ultrasonic energy based at least in part on the tissue properties measured at the first location and the second location; the first and second sensors are configured to sense the presence or absence of tissue at the first location and the second location; The controller: establishing a first impedance threshold below which RF energy is switched to ultrasound energy when tissue is present at both the first location and the second location; and further configured to set a second impedance threshold below which RF energy is switched to ultrasound energy when tissue is present at only one of the first location and the second location; A surgical instrument wherein the first and second impedance thresholds are different.

3. A surgical instrument, A shaft assembly including a shaft and an end effector coupled to a distal end of the shaft, the end effector including a first jaw and a second jaw configured to pivot between a closed position and an open position, the first or second jaw comprising: a first sensor configured to measure a tissue property at a first location; a second sensor configured to measure the tissue property at a second location; and a handle assembly coupled to a proximal end of the shaft; a battery assembly coupled to the handle assembly; an RF energy output energized by the battery assembly and configured to apply radio frequency (RF) energy to tissue; an ultrasonic energy output energized by the battery assembly and configured to apply ultrasonic energy to the tissue; a controller configured to control the RF energy output to apply RF energy or the ultrasonic energy output to apply ultrasonic energy based at least in part on the tissue properties measured at the first location and the second location; the first and second sensors are configured to sense the presence or absence of tissue at the first location and the second location; The controller: establishing a first force threshold used to control the application of energy when tissue is present at both the first location and the second location; and further configured to set a second force threshold used to control application of energy when tissue is present at only one of the first location and the second location; A surgical instrument wherein the first and second force thresholds are different.

4. A surgical instrument, A shaft assembly including a shaft and an end effector coupled to a distal end of the shaft, the end effector including a first jaw and a second jaw configured to pivot between a closed position and an open position, the first or second jaw comprising: a first sensor configured to measure a tissue property at a first location; a second sensor configured to measure the tissue property at a second location; and a handle assembly coupled to a proximal end of the shaft; a battery assembly coupled to the handle assembly; an RF energy output energized by the battery assembly and configured to apply radio frequency (RF) energy to tissue; an ultrasonic energy output energized by the battery assembly and configured to apply ultrasonic energy to the tissue; a controller configured to control the RF energy output to apply RF energy or the ultrasonic energy output to apply ultrasonic energy based at least in part on the tissue properties measured at the first location and the second location; the first and second sensors are configured to sense the presence or absence of tissue at the first location and the second location; The controller: applying energy to the tissue; and The surgical instrument is further configured to avoid applying energy to locations where no tissue is present.

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