Deflectable electrode with variable compression bias along the length of the deflectable electrode

CROSS REFERENCE TO RELATED APPLICATIONS This application is filed under 35 U.S.C. 119(e) under 35 U.S.C. Priority is claimed to US Provisional Patent Application No. 62/955,292, filed Dec. 30.

FIELD OF THE DISCLOSURE The present disclosure is generally adapted and configured to operate with multiple energy modalities, using the multiple energy modalities in simultaneous, independent, or sequential applications to seal and seal tissue. It relates to an end effector that allows cutting. More specifically, the present disclosure operates with surgical instruments that employ combined ultrasound and electrosurgical systems, such as monopolar or bipolar radiofrequency (RF), for example, to combine ultrasound and electrosurgical energy modalities. simultaneously, independently, or sequentially applied to seal and cut tissue. Energy modalities may be applied based on tissue parameters or other algorithms. The end effector may be adapted and configured to couple to a handheld surgical system or a robotic surgical system.

Ultrasonic surgical instruments that employ ultrasonic energy modalities are finding increasingly widespread use in surgery due to the unique performance characteristics of such instruments. Depending on the particular instrument configuration and operating parameters, ultrasonic surgical instruments can provide tissue cutting and hemostasis by coagulation substantially simultaneously, desirably with minimal trauma to the patient. The cutting action is typically accomplished by an end effector, an ultrasonic blade, or an ultrasonic blade tip at the distal end of the instrument that transmits ultrasonic energy to tissue in contact with the end effector. An ultrasonic end effector may comprise, among other components, an ultrasonic blade, a clamp arm, and a pad.

Some surgical instruments utilize ultrasonic energy for both precise cutting and controlled coagulation. Ultrasonic energy cuts and coagulates tissue by vibrating the blade in contact. Ultrasonic blades vibrate at high frequencies (eg, 55,500 times per second) to denature proteins in tissue and form sticky clots. The pressure exerted by the blade surface on the tissue causes the vessel to collapse, allowing the clot to form a hemostatic seal. Accuracy of cutting and coagulation is controlled by the skill of the surgeon and adjustments to power level, blade edge, tissue traction, and blade pressure.

Electrosurgical instruments for applying electrical energy modalities to tissue to treat, seal, cut, and/or destroy tissue are also finding increasingly widespread use in surgery. Electrosurgical instruments typically include instruments having an end effector with one or more electrodes attached to the distal portion thereof. The end effector can be positioned relative to tissue such that an electrical current is introduced into the tissue. Electrosurgical instruments can be configured for bipolar or monopolar operation. During bipolar operation, current is introduced into tissue through a first electrode (eg, active electrode) and returned from tissue through a second electrode (eg, return electrode). During unipolar operation, current is introduced into the tissue by the active electrode of the end effector and returned via a return electrode, eg, a ground pad, separately coupled to the patient's body. Heat generated by current flowing through tissue may form hemostatic seals within and/or between tissues, and thus may be particularly useful for sealing blood vessels, for example. An end effector of an electrosurgical instrument may also include a cutting member movable relative to tissue and the electrode for cutting tissue. Electrosurgical end effectors can be adapted and configured to couple to handheld and robotic instruments.

Electrical energy applied by the 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 can range in frequency from 200 kilohertz (kHz) to 1 megahertz (MHz). During application, the electrosurgical instrument can transmit low frequency RF energy through the tissue, which can cause ionic stirring or friction, ie resistive heating, thereby increasing the temperature of the tissue. A sharp boundary is created between the tissue affected by the procedure and the surrounding tissue, allowing the surgeon to operate with a high level of precision and control without sacrificing adjacent non-target tissue. . The low operating temperature of RF energy is useful for removing, shrinking, or mincing soft tissue while simultaneously sealing blood vessels. RF energy works particularly well on connective tissue because it is composed primarily of collagen and contracts when exposed to heat.

The RF energy can 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 can typically be limited to less than 5 MHz. However, in bipolar RF energy applications, the frequency can be nearly any frequency. Frequencies above 200 kHz can typically be used for monopolar applications to avoid unnecessary stimulation of nerves and muscles resulting from the use of low frequency currents. Lower frequencies may be used for bipolar applications if risk analysis indicates that the likelihood of neuromuscular stimulation has been mitigated to an acceptable level. To minimize problems associated with high frequency leakage currents, frequencies above 5 MHz are generally not used. However, higher frequencies can be used for bipolar applications. 10 mA is generally recognized as the lower threshold for thermal effects on tissue.

Ultrasonic and electrosurgical instruments of the nature described herein can be configured for open surgery, minimally invasive surgery, or non-invasive surgery. Minimally invasive surgery involves the use of cameras and instruments inserted through small incisions to visualize and treat conditions within joints or body cavities. Minimally invasive surgery may be performed entirely within the body or, in some circumstances, may be used with smaller approach incisions. These combined approaches are known, for example, as "arthroscopic-, laparoscopic-, or thoracoscopic-assisted surgery." The surgical instruments described herein can also be used in non-invasive procedures such as, for example, endoscopic surgery. The instruments may be controlled by the surgeon using handheld instruments or robots.

<p>A challenge with utilizing these surgical instruments is the inability to control and customize single or multiple energy modalities depending on the type of tissue being treated. It would be desirable to provide an end effector that overcomes some of the deficiencies of current surgical instruments and improves the quality of tissue treatment, sealing, or cutting, or a combination thereof. The combined energy modality end effector described herein overcomes the above deficiencies and improves the quality of tissue treatment, sealing, or cutting, or a combination thereof.</p>

<p>In one aspect, a device is provided for cutting and coagulating tissue. The apparatus includes a surgical instrument that includes an end effector adapted and configured to deliver multiple energy modalities to tissue at its distal end. Energy modalities may be applied simultaneously, independently, or sequentially. A generator is electrically coupled to the surgical instrument and configured to provide multiple energy modalities to the end effector. In one aspect, the generator supplies electrosurgical energy (e.g., monopolar or bipolar radiofrequency (RF) energy) and ultrasonic energy to the end effector to enable the end effector to interact with tissue. configured to The energy modalities can be supplied to the end effector by a single generator or multiple generators.</p><p>In various aspects, the present disclosure is configured to deliver at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. to provide a surgical instrument that The surgical instrument includes a first activation button for activating energy and a second button for selecting an energy mode for the activation button. A second button is connected to a circuit that defines an energy mode using at least one input parameter. Input parameters can be modified remotely via connection to the generator or software update.</p><p>In one aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, at least one electrode serves as a deflectable support for the opposing ultrasonic blade. At least one electrode traverses the ultrasonic blade and is configured to be deflectable relative to the clamp arm and has functionality for changing mechanical properties of tissue compression under the at least one electrode. At least one electrode includes features to prevent unintentional contact between the electrode and the ultrasonic blade.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the movable clamping jaws comprise at least one non-biased, deflectable electrode for minimizing contact between the ultrasonic blade and the RF electrode. The ultrasonic blade pad includes features for securing the electrodes to the pad. The height of the electrode relative to the clamping jaws is adjusted incrementally as the pad height is worn or cut. Once the clamp jaws are moved away from the ultrasonic blade, the electrodes remain in their new positions.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the at least one bipolar RF electrode is deflectable and biased more distally than proximally. A bipolar RF electrode is deflectable with respect to the clamping jaws. The end effector changes the mechanical properties of the tissue compression portion proximal to the distal end to create a more uniform or different pattern of pressure compared to the pressure pattern of clamping alone. It is configured.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the pad, bipolar RF electrode is deflectable and the end effector provides variable compression/biasing along the length of the deflectable electrode. The end effector is configured to change the mechanical properties of the tissue compression under the electrode based on the amount of closure or tightening of the clamping jaws.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, the pad includes asymmetric segments to provide support for the ultrasonic blade support and the electrodes are movable. The asymmetric segmented pad is configured to cooperatively engage the movable bipolar RF electrode. A segmented ultrasound support pad extends at least partially through the bipolar RF electrode. At least one pad element is significantly higher than the second pad element. A first pad element extends completely through the bipolar RF electrode and a second pad element extends partially through the bipolar RF electrode. The first pad element and the second pad element are made of dissimilar materials.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, variation of physical parameters of the electrodes in combination with the deflectable electrodes is used to vary the energy density delivered to the tissue and the interaction of the tissue. The physical surface of the electrode varies along its length, changing the contact area of the electrode to the tissue and/or the energy density from the electrode to the tissue as the electrode also deflects.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, an ultrasonic transducer control algorithm is provided to reduce the power delivered by the ultrasonic or RF generator when a short of contact between the ultrasonic blade and the electrode is detected, Prevent damage to the ultrasonic blade. The ultrasonic blade control algorithm monitors for electrical shorts or contact of the ultrasonic blade with the electrodes. This detection is used to adjust the power/amplitude level of the ultrasonic transducer when an electrical minimum threshold is exceeded, and damage to the ultrasonic blade, ultrasonic generator, bipolar RF electrode, or bipolar RF generator is detected. Adjust the transducer power/amplitude threshold to a level below the minimum threshold that would cause . The electrical parameter monitored can be tissue impedance (Z) or electrical continuity. The power adjustment may be shutting off the ultrasonic generator, bipolar RF generator of the surgical device, or it may be proportional to either an electrical parameter, pressure, or time or any combination of these parameters. response.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, clamp jaw features or surfaces are provided on the clamp arms to minimize tissue sticking and improve tissue control. The tissue path or clamping area of the clamp arm is configured to align the tissue path with respect to the clamp arm/ultrasound blade to create a predetermined contact location to reduce tissue sticking and charring. including functional parts.</p><p>In another aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In one aspect, a partially conductive clamping arm pad is provided to allow the electrode to wear out to minimize electrical shorting between the ultrasonic blade and the bipolar RF electrode. The clamp arm pad includes a conductive portion and a non-conductive portion that allow the clamp arm pad to function as one of the bipolar RF electrodes while providing an abradable support structure for the ultrasonic blade. also functions as The conductive portion of the clamp arm pad is located around the perimeter of the pad and not directly below the ultrasonic blade contact area. The conductive portion is configured so that it does not degrade or wear out so that any contact with the ultrasonic blade interrupts the conductivity of the rest of the conductive pad.</p><p>In addition to the foregoing, various other method and/or system and/or program product aspects may be described in the text (eg, "claims" and/or detailed description) and/or drawings of the present disclosure. are described and explained in the teachings of</p><p>The foregoing description is a summary and, therefore, may contain simplifications, generalizations, inclusions, and/or omissions of detail. Accordingly, those skilled in the art will appreciate that this Summary of the Invention is illustrative only and is not intended to be limiting in any way. Other aspects, features, and advantages of the apparatus and/or processes and/or other subject matter described herein will become apparent in the teachings described herein.</p><p>In one or more of the various aspects, associated systems include, but are not limited to, circuitry and/or programming to effect aspects of the methods referenced herein. The circuitry and/or programming is essentially any hardware, software, and/or firmware configured to affect aspects of the methods referred to herein, depending on the design choices of the system designer. can be a combination of In addition to the foregoing, various other method and/or system aspects are described and illustrated in the teachings of the present disclosure (eg, claims and/or detailed description) and/or drawings.</p><p>Further, any one or more of the forms, implementations of forms and examples described below can be combined with any one or more of the other forms, implementations of forms and examples described below. It should be understood that it is possible.</p><p>The above "Summary of the Invention" is exemplary only and is not intended to be limiting in any way. In addition to the exemplary aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and detailed description that follows.</p>

The novel features of the described form are set forth with particularity in the appended claims. The forms described, however, both as to organization and method of operation, may best be understood by reference to the following description taken in conjunction with the accompanying drawings.

<figref num="1">FIG. 22 is a perspective view of a clamp arm portion of an end effector for use with a combined ultrasound/RF device, according to at least one aspect of the present disclosure;</figref><figref num="2">2 is an exploded view of the clamp arm shown in FIG. 1, according to at least one aspect of the present disclosure; FIG.</figref><figref num="3">FIG. 3 is a perspective view of a frame, according to at least one aspect of the present disclosure;</figref><figref num="4">FIG. 3 is a perspective view of a frame, according to at least one aspect of the present disclosure;</figref><figref num="5">2 is a perspective view of an electrode, according to at least one aspect of the present disclosure; FIG.</figref><figref num="6">FIG. 20 is a perspective view of a clamp arm pad, according to at least one aspect of the present disclosure;</figref><figref num="7">FIG. 4 is a perspective top view of a large gap pad, according to at least one aspect of the present disclosure;</figref><figref num="8">FIG. 4 is a perspective top view of a small gap pad, according to at least one aspect of the present disclosure;</figref><figref num="9">FIG. 9 is a perspective bottom view of the small gap pad shown in FIG. 8;</figref><figref num="10">FIG. 11 illustrates an effector with a shortened clamp arm for deflectable/cantilever electrode applications, according to various aspects of the present disclosure; FIG. FIG. 19 is a side view of an end effector comprising a shortened clamp arm, an ultrasonic blade, an electrode, and a clamp arm pad in accordance with at least one aspect of the present disclosure;</figref><figref num="11">FIG. 11 illustrates an effector with a shortened clamp arm for deflectable/cantilever electrode applications, according to various aspects of the present disclosure; FIG. FIG. 14 is a top view of an end effector, according to at least one aspect of the present disclosure;</figref><figref num="12">FIG. 11 illustrates an effector with a shortened clamp arm for deflectable/cantilever electrode applications, according to various aspects of the present disclosure; FIG. 1 illustrates a clamp arm comprising clamp jaws, electrodes, and clamp arm pads, according to at least one aspect of the present disclosure;</figref><figref num="13">4 illustrates an end effector clamp arm comprising clamp jaws, electrodes, and clamp arm pads, according to at least one aspect of the present disclosure;</figref><figref num="14">4 illustrates an end effector clamp arm comprising clamp jaws, electrodes, and clamp arm pads, according to at least one aspect of the present disclosure;</figref><figref num="15">4 illustrates an end effector clamp arm comprising clamp jaws, electrodes, and clamp arm pads, according to at least one aspect of the present disclosure;</figref><figref num="16">Fig. 3 shows a worn bottom retainer tooth according to at least one aspect of the present disclosure, the wear allowing the electrode to move toward the clamp jaws due to the pre-formed curve;</figref><figref num="17">4 illustrates an end effector clamp arm comprising clamp jaws, electrodes, and clamp arm pads, according to at least one aspect of the present disclosure;</figref><figref num="18">FIG. 11 shows a retainer wall with a tapered profile that has been worn away, according to at least one aspect of the present disclosure, wherein the wear follows a preformed curve with sufficient elution/outflow from the retainer wall with a tapered profile region; allows the electrode to move towards the clamping jaws.</figref><figref num="19">A clamp arm, an ultrasonic blade, a grid cushion, a flexible electrode disposed above the grid cushion, and a gap between the flexible electrode and the ultrasonic blade, according to at least one aspect of the present disclosure. 1 shows an end effector with a plurality of hard spacers for setting . An open clamp arm and a tissue of non-uniform thickness (T_1a, T_2a, T_3a).</figref><figref num="20">A clamp arm, an ultrasonic blade, a grid cushion, a flexible electrode disposed above the grid cushion, and a gap between the flexible electrode and the ultrasonic blade, according to at least one aspect of the present disclosure. 1 shows an end effector with a plurality of hard spacers for setting . The clamp arms are closed to show that they are squeezing the tissue.</figref><figref num="21">A clamp arm, an ultrasonic blade, a grid cushion, a flexible electrode disposed above the grid cushion, and a gap between the flexible electrode and the ultrasonic blade, according to at least one aspect of the present disclosure. 1 shows an end effector with a plurality of hard spacers for setting . FIG. 21 is an exploded view of the end effector shown in FIGS. 19 to 20; FIG.</figref><figref num="22">FIG. 4 is a cross-sectional view of a conductive polymer clamp arm pad according to at least one aspect of the present disclosure;</figref><figref num="23">FIG. 12 is a perspective view of a clamp arm pad configured to replace conventional electrodes, according to at least one aspect of the present disclosure;</figref><figref num="24">24 illustrates a clamp arm with the clamp arm pad of FIG. 23, according to at least one aspect of the present disclosure;</figref><figref num="25">25 illustrates a clamp arm pad configured as described in FIGS. 23-24, according to at least one aspect of the present disclosure; FIG.</figref><figref num="26">FIG. 22 is a cross-sectional view of a clamping arm with a composite clamping arm pad in contact with tissue, according to at least one aspect of the present disclosure;</figref><figref num="27">4 illustrates a clamp arm comprising a clamp jaw supporting a carrier or stamping attached to the clamp jaw and a clamp arm pad, according to at least one aspect of the present disclosure;</figref><figref num="28">FIG. 28 is a cross-sectional view taken along a cut plane 28-28 in FIG. 27;</figref><figref num="29">FIG. 28 is a cross-sectional view cut along a cut plane 29-29 in FIG. 27;</figref><figref num="30">FIG. 12 is a cross-sectional view of an alternative implementation of a clamp arm comprising clamp jaws, conductive pads, and non-conductive pads, in accordance with at least one aspect of the present disclosure;</figref><figref num="31">FIG. 12 is a cross-sectional view of an alternative implementation of a clamp arm comprising clamp jaws, a carrier or stamping welded to the clamp jaws, a conductive pad, and a non-conductive pad, in accordance with at least one aspect of the present disclosure; .</figref><figref num="32">1 illustrates an insert-molded electrode, according to at least one aspect of the present disclosure;</figref><figref num="33">1 shows an end effector comprising an ultrasonic blade, a clamp arm, and a clamp arm pad comprising a conductive film, according to at least one aspect of the present disclosure;</figref><figref num="34">34 shows the clamp arm shown in FIG. 33;</figref><figref num="35">35 is a cross-sectional view of the clamp arm taken along cut plane 35-35 of FIG. 34; FIG.</figref><figref num="36">1 illustrates a clamp arm with partially conductive clamp arm pads, according to at least one aspect of the present disclosure;</figref><figref num="37">1 illustrates a clamp arm comprising clamp jaws, a support with a hinge-like feature, an electrode, and a clamp arm pad, according to at least one aspect of the present disclosure;</figref><figref num="38">38 is a cross-sectional view of the clamp arm shown in FIG. 37 with no load applied through the clamp arm pad in accordance with at least one aspect of the present disclosure; FIG.</figref><figref num="39">FIG. 38 is a cross-sectional view of the clamp arm shown in FIG. 37 in a loaded condition, in which a force F1 is applied to the electrodes to collapse the support including the hinge-like feature, according to at least one aspect of the present disclosure; ing.</figref><figref num="40">10 shows a clamp arm portion of an end effector, the clamp arm supported by a clamp jaw, a clamp arm pad, a variable longitudinal support element, a bump extension, and a variable longitudinal support element, according to at least one aspect of the present disclosure; and electrodes.</figref><figref num="41A">41 shows the clamp arm shown in FIG. 40 under various loading conditions, according to at least one aspect of the present disclosure; Fig. 3 shows the clamp arm in a new firing condition with no load or evenly distributed load;</figref><figref num="41B">41 shows the clamp arm shown in FIG. 40 under various loading conditions, according to at least one aspect of the present disclosure; Fig. 3 shows the clamp arm under high load conditions with a large force on the distal end and a small force on the proximal end.</figref><figref num="41C">41 shows the clamp arm shown in FIG. 40 under various loading conditions, according to at least one aspect of the present disclosure; Fig. 3 shows a clamp arm under high load with a worn bump extension, high load at the distal end, low load at the proximal end, and moderate load at the center.</figref><figref num="42">A clamp arm, an ultrasonic blade, an electrode, a flexible material fixed to the clamp arm to act as a spring between the electrode and the clamp arm, and the electrode and the clamp arm, according to at least one aspect of the present disclosure. and hard wear-resistant material secured to the proximal ends of the electrodes to set a gap between.</figref><figref num="43">FIG. 4B is a top view of an electrode showing openings for receiving compliant material therethrough;</figref><figref num="44">44 shows a first configuration of the end effector shown in FIGS. 42-43 with a leaf spring element at the distal end of the electrode, according to at least one aspect of the present disclosure; FIG.</figref><figref num="45">44 shows a first configuration of the end effector shown in FIGS. 42-43 with a leaf spring element at the distal end of the electrode, according to at least one aspect of the present disclosure; FIG. FIG. 4B is an enlarged view of the distal end of the electrode showing the leaf spring element;</figref><figref num="46">44 shows a second configuration of the end effector shown in FIGS. 42-43 with a leaf spring element at the distal end of the electrode, according to at least one aspect of the present disclosure; FIG.</figref><figref num="47">44 shows a second configuration of the end effector shown in FIGS. 42-43 with a leaf spring element at the distal end of the electrode, according to at least one aspect of the present disclosure; FIG. FIG. 4 is a cross-sectional view of the tube showing the ultrasonic blades and wires;</figref><figref num="48">44 shows a second configuration of the end effector shown in FIGS. 42-43 with a leaf spring element at the distal end of the electrode, according to at least one aspect of the present disclosure; FIG. FIG. 10 is a cross-sectional view of the clamp arm showing the electrodes and leaf spring elements;</figref><figref num="49">44 shows a third configuration of the end effector shown in FIGS. 42-43 including a compressible material attached to the bottom portion of the distal end of the electrode, according to at least one aspect of the present disclosure; FIG.</figref><figref num="50">1 illustrates a surgical device with a mode selection button switch thereon according to at least one aspect of the present disclosure;</figref><figref num="51A">3 illustrates three options for selecting various modes of operation of a surgical device, according to at least one aspect of the present disclosure; FIG. 10 illustrates a first mode selection option that allows pushing the button switch back and forth to cycle the surgical instrument through various modes; FIG.</figref><figref num="51B">3 illustrates three options for selecting various modes of operation of a surgical device, according to at least one aspect of the present disclosure; Pushing the button switch up or down presents a second mode selection option that cycles the surgical instrument through various modes.</figref><figref num="51C">3 illustrates three options for selecting various modes of operation of a surgical device, according to at least one aspect of the present disclosure; Depressing the button switch back and forth up and down presents a third mode selection option that cycles the surgical instrument through various modes.</figref><figref num="52">1 illustrates a surgical device with a mode selection button switch on its back in accordance with at least one aspect of the present disclosure;</figref><figref num="53A">Fig. 4 shows the first mode selection option, and when the mode button switch is pressed to cycle through the various modes, on the user interface colored lights indicate the selected mode.</figref><figref num="53B">A second mode selection option is shown, the screen (eg liquid crystal display, e-ink) indicating the selected mode when the mode button switch is pressed to cycle through the various modes.</figref><figref num="53C">A third mode selection option is shown and when the mode button switch is pressed to cycle through the various modes, the coded lights indicate the mode selected.</figref><figref num="53D">A fourth mode selection option is shown wherein when an encoded button switch is selected and a mode is selected by pressing the encoded button switch, the encoded button switch is selected. It emits light to indicate the mode.</figref><figref num="54">1 illustrates a surgical device with a trigger actuation mechanism, according to at least one aspect of the present disclosure;</figref><figref num="55">FIG. 12 illustrates an alternative clamp arm comprising metal clamp jaws, electrodes, a plurality of clamp arm pads, and a gap pad, according to at least one aspect of the present disclosure; FIG.</figref><figref num="56">A surgical system comprising a surgical hub paired with a visualization system, a robotic system, and an intelligent instrument, according to at least one aspect of the present disclosure.</figref><figref num="57">1 illustrates an example of a generator, according to at least one aspect of the present disclosure;</figref><figref num="58">FIG. 4 is a diagram of various modules and other components that can be combined to customize a modular energy system, according to at least one aspect of the present disclosure;</figref><figref num="59A">According to at least one aspect of the present disclosure, a first display screen comprising a header module and a display screen that renders a graphical user interface (GUI) for relaying information about modules connected to the header module 1 is an exemplary modular energy system configuration;</figref><figref num="59B">59A is a modular energy system shown in FIG. 59A mounted on a cart, according to at least one aspect of the present disclosure.</figref><figref num="60">1 illustrates a perspective view of an example surgical system having a generator and a surgical instrument operable to treat tissue using ultrasonic energy and bipolar RF energy, according to at least one aspect of the present disclosure; FIG.</figref><figref num="61">61 shows a perspective top view of an end effector of the surgical instrument of FIG. 60, the end effector providing a first electrode and an ultrasonic blade providing a second electrode, according to at least one aspect of the present disclosure; FIG. It has a clamp arm that</figref><figref num="62">62 shows a perspective bottom view of the end effector of FIG. 61, according to at least one aspect of the present disclosure; FIG.</figref><figref num="63">61 shows a partially exploded perspective view of the surgical instrument of FIG. 60, according to at least one aspect of the present disclosure; FIG.</figref><figref num="64">61 shows an enlarged, exploded perspective view of the distal portion of the shaft assembly and the end effector of the surgical instrument of FIG. 60, according to at least one aspect of the present disclosure; FIG .</figref>

The applicant of this application owns the following US provisional patent applications filed December 30, 2019, the entire disclosures of each of which are incorporated herein by reference: US provisional patent Application No. 62/955,294, entitled "USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR," U.S. Provisional Patent Application No. 62/955,299, entitled "ELECTROSURGICAL INSTRUMENTS FOR COMBINATION ENERGY DELIVERY," and U.S. Provisional Patent Application No. 62/955,306, entitled "SURGICAL INSTRUMENTS".

The applicant of this application owns the following U.S. patent applications filed on the same date as this application, each of which is hereby incorporated by reference in their entirety: Attorney Docket No. END9232USNP1/190715 -1, Invention title "USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR", Attorney reference number END9233USNP1/190716-1M, Invention title "METHOD OF OPERATING A COMBINATION ULTRASONIC / BIPOLAR RF SURGICAL DEVICE" WITH A COMBINATION ENERGY MODALITY END-EFFECTOR", Agent Reference No. END9233USNP2/190716-2, Invention Title "DEFLECTABLE SUPPORT OF RF ENERGY ELECTRODE WITH RESPECT TO OPPOSING ULTRASONIC BLADE", .Attorney Reference No. END9233USNP3/190716-3, Title of Invention "NON-BIASED DEFLECTABLE ELECTRODE TO MINIMIZE CONTACT BETWEEN ULTRASONIC BLADE AND ELECTRODE", .Agency Reference No. END9233USNP4/190716-4, Title of Invention Name "DEFLECTABLE ELECTRODE WITH HIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS", agent reference number END9233USNP6/190716-6, invention title "ASYMMETRIC SEGMENTED ULTRASONIC SUPPORT PAD FOR COOPERATIVE ENGAGEMENT WITH A MOVABLE RF ELECTRODE", agent arrangement No. END9233USNP7/190716-7, entitled "VARIATION IN ELECTRODE PARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY DENSITY AND TISSUE INTERACTION" .Attorney reference number END9233USNP8/190716-8, title of the invention "TECHNIQUES FOR DETECTING ULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING POWER TO ULTRASONIC BLADE" .Agency reference number END9233USNP9/190716- No. 9, title of invention "CLAMP ARM JAW TO MINIMIZE TISSUE STICKING AND IMPROVE TISSUE CONTROL", and agent reference number END9233USNP10/190716-10, title of invention "PARTIALLY CONDUCTIVE CLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND MINIMIZE SHORT CIRCUITING".

The applicant of this application owns the following U.S. patent applications filed May 28, 2020, each of which is hereby incorporated by reference in their entirety: U.S. Patent Application No. 16 /885,813 entitled "METHOD FOR AN ELECTROSURGICAL PROCEDURE" U.S. Patent Application No. 16/885,820 entitled "ARTICULATABLE SURGICAL INSTRUMENT" U.S. Patent Application No. 16/885,823 entitled "SURGICAL INSTRUMENT" WITH JAW ALIGNMENT FEATURES", U.S. Patent Application No. 16/885,826, entitled "SURGICAL INSTRUMENT WITH ROTATABLE AND ARTICULATABLE SURGICAL END EFFECTOR", U.S. Patent Application No. 16/885,838, entitled "ELECTROSURGICAL INSTRUMENT WITH ASYNCHRONOUS ENERGIZING US Patent Application No. 16/885,851, entitled "ELECTROSURGICAL INSTRUMENT WITH ELECTRODES BIASING SUPPORT", US Patent Application No. 16/885,860, entitled "ELECTROSURGICAL INSTRUMENT WITH FLEXIBLE WIRING ASSEMBLIES", US Patent Application No. 16/885,866, entitled "ELECTROSURGICAL INSTRUMENT WITH VARIABLE CONTROL MECHANISMS"; U.S. Patent Application No. 16/885,870, entitled "ELECTROSURGICAL SYSTEMS WITH INTEGRATED AND EXTERNAL POWER SOURCES"; 885,873, entitled "ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY FOCUSING U.S. Patent Application No. 16/885,879, entitled "ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING VARIABLE ENERGY DENSITIES," U.S. Patent Application No. 16/885,881, entitled "ELECTROSURGICAL INSTRUMENT WITH MONOPOLAR AND BIPOLAR ENERGY CAPABILITIES." U.S. patent application Ser. MODES", U.S. Patent Application No. 16/885,900, entitled "ELECTROSURGICAL INSTRUMENT FOR DELIVERING BLENDED ENERGY MODALITIES TO TISSUE", U.S. Patent Application No. 16/885,917 entitled "CONTROL PROGRAM ADAPTATION BASED ON DEVICE STATUS AND USER INPUT" U.S. Patent Application No. 16/885,923 entitled "CONTROL PROGRAM FOR MODULAR COMBINATION ENERGY DEVICE", and U.S. patent application Ser. No. 16/885,931, entitled "SURGICAL SYSTEM COMMUNICATION PATHWAYS."

Before describing the various forms of surgical instruments in detail, it is noted that the exemplary forms are not limited in application or use to the details of construction and arrangement of parts illustrated in the accompanying drawings and description. Example forms may be practiced or incorporated in other forms, variations, and modifications, and may be practiced or carried out in various ways. Further, unless otherwise indicated, the terms and expressions used herein have been chosen for the convenience of the reader for the purpose of describing example embodiments and not for purposes of limitation.

Further, any one or more of the forms, implementations of forms and examples described below can be combined with any one or more of the other forms, implementations of forms and examples described below. It should be understood that it is possible.

Various aspects are directed to improved ultrasonic and/or electrosurgical (RF) instruments configured to effect tissue treatment, dissection, cutting, and/or coagulation during surgery. In one form, the combined ultrasound and electrosurgical instrument may be configured for use in open surgery, but other types of surgery, such as minimally invasive laparoscopic surgery, either in hand-held or robot-assisted surgery. It also has applications in surgery, orthoscopy, or thoracoscopy, and non-invasive endoscopy, for example. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or in combination. For example, versatility is through the selective use of ultrasound and electrosurgical energy (e.g., monopolar or bipolar RF energy), whether concurrently, independently, sequentially, or in combination. can be achieved.

In one aspect, the present disclosure provides an ultrasonic surgical clamping device comprising an ultrasonic blade and a deflectable RF electrode, wherein the ultrasonic blade and the deflectable RF electrode cooperate to provide a device comprising the RF electrode. The cooperation of the clamping mechanism and associated ultrasonic blades provide tissue sealing, cutting, and clamping. The clamping mechanism includes pivoting clamping arms that cooperate with ultrasonic blades to grasp tissue therebetween. The clamping arm is preferably provided with a clamping tissue pad (also known as a "clamping arm pad"), which comprises a plurality of axially spaced apart gripping teeth, segments, elements or individuals. has a unit of They facilitate grasping and grasping of tissue during surgery while cooperating with the ultrasonic blade of the end effector to achieve the desired sealing and cutting effect on tissue.

In one aspect, an end effector described herein comprises an electrode. In other aspects, the end effectors described herein comprise alternatives to the electrodes described above. It provides RF energy coupling to the tissue that conforms to tissue geometry, adapts to pad wear/thinning, minimizes excessive heat generation (low coefficient of friction, pressure), Minimize generation, minimize interruptions due to electrical shorts, or a combination thereof. The electrodes are fixed at the proximal end to the clamping jaws and free to deflect at the distal end. Accordingly, electrodes may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

In other aspects, the end effectors described herein apply high pressure between the pad and the ultrasonic blade to grasp and seal tissue, e.g., thin tissue, lateral tension Probability of the clamp arm electrode contacting tissue even in constrained or difficult scenarios such as tissue under tension, tissue under lifting/vertical tension, especially tissue lifting away from the clamp arm. a clamp arm mechanism configured to maximize

In other aspects, the end effectors described herein balance the surface area/current density match between the electrodes to balance and minimize heat transfer from the interface with the tissue, e.g. It is designed to affect formation and symmetry, and also influence cycle time, residual heat energy, and the like.

In other aspects, the end effectors described herein are configured to minimize sticking, tissue attachment (minimize anchor points) and may include small polyimide pads.

In various aspects, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device. A combined ultrasound/bipolar RF energy surgical device includes an end effector. The end effector comprises a clamp arm and an ultrasonic blade. The clamp arm comprises movable clamp jaws, a conformable polymer pad, and at least one bipolar RF electrode. At least one electrode is coupled to the positive pole of the RF generator and the ultrasonic blade is coupled to the negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by an ultrasonic generator. In various aspects, the end effector comprises an electrode biasing mechanism.

In one general aspect, the present disclosure is directed to a method for using a surgical device that includes a combination of ultrasound and advanced bipolar RF energy with movable RF electrodes on at least one jaw of an end effector. do. The movable RF electrode has a biasing force that varies from the proximal end to the distal end of the movable RF electrode. The movable RF electrodes are divided into separate portions so that they may be in electrical communication with each other or isolated from each other. The movable RF electrode is made of a conductive or partially conductive material. It will be appreciated that any of the end effectors described in this disclosure may be configured with an electrode biasing mechanism.

In one aspect, the present disclosure provides a restrictive electrode biasing mechanism for preventing ultrasonic blades from damaging the electrodes. In general, in various aspects, the present disclosure provides an end effector for use with a combined ultrasound/RF device, the end effector comprising electrodes. In one aspect, a combined ultrasound/bipolar RF energy surgical device includes an electrode biasing mechanism. In one aspect, the restrictive electrode biasing mechanism is configured to prevent or minimize damage to the electrode by the ultrasonic blade. The electrodes are fixed at the proximal end to the clamping jaws and free to deflect at the distal end. Accordingly, electrodes may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

In various aspects, the present disclosure provides an electrode cantilever beam anchored at only one end with a bias threshold mechanism. In one aspect, the deflectable cantilever electrode is configured for a combined ultrasound/bipolar RF energy surgical device.

In one aspect, a combined ultrasonic/RF energy surgical device comprises an ultrasonic blade, a clamp arm, and at least one electrode across the ultrasonic blade. In one aspect, the electrode is configured to be deflectable relative to the clamp arm and includes a feature for altering mechanical properties of tissue being compressed between the electrode and the ultrasonic blade. Another aspect includes features for preventing inadvertent contact between the electrode and the ultrasonic blade to prevent or minimize damage to the electrode by the ultrasonic blade.

In various aspects, the electrode comprises a metal spring element attached to the proximal end of the clamping jaws of the end effector. The metal spring element defines an opening through which one or more clamping arm pads (also known as "tissue pads" or "clamping tissue pads") are received. The metal spring element also has an integrated minimum gap element. This configuration of the electrode provides a way to prevent tissue build-up around the biasing mechanism, which can affect the performance of the electrode. This configuration also minimizes the coupling between the wear pad and the biasing spring, increases the strength of the connection of the electrode to the clamp arm, and by attaching the polyimide pad to the electrode, the clamp arm pad's intended to minimize undesired release and to harmonize the surface area/current density balance between the electrodes. The electrodes are fixed at the proximal end to the clamping jaws and free to deflect at the distal end. Thus, throughout this disclosure the electrodes are deflectable and may be referred to as cantilever beam electrodes or deflectable electrodes.

1-9 illustrate one embodiment of an end effector comprising deflectable/cantilever electrodes configured for use with a combined ultrasound/bipolar RF energy device, according to at least one embodiment of the present disclosure. FIG. 1 is a perspective view of a clamp arm 1000 portion of an end effector for use with a combined ultrasound/RF device, according to at least one aspect of the present disclosure. For simplicity and clarity of disclosure, the ultrasonic blade serving as the other clamp arm of the end effector is not shown. The end effector is configured so that the ultrasonic blade is one pole of a bipolar RF circuit and the clamp arm 1000 is the opposite pole. A consistent RF electrode gap is maintained between the clamp arm 1000 and the ultrasonic blade to prevent the ultrasonic blade from contacting the electrode and causing blade breakage or shorting. The tissue under treatment is clamped and compressed between the clamp arm 1000 and the ultrasonic blade.

Clamp arm 1000 includes frame 1002 , electrode 1004 , at least one small non-conductive gap pad 1006 , at least one large non-conductive gap pad 1008 , and at least one non-conductive clamp arm pad 1010 . In one aspect, the small gap pad 1006 and the large gap pad 1008 are configured to set a gap between the electrode 1004 and the ultrasonic blade. The clamp arm pad 1010 is configured to grip tissue between the clamp arm 1000 and the ultrasonic blade to aid in sealing and cutting tissue. In other aspects, the large and small non-conductive gap pads may be interchanged. In other aspects, the non-conductive gap pads are each simply differently sized regardless of the relative size difference between the non-conductive gap pads.

Pivoting movement of the clamp arm 1000 relative to the end effector is effected by providing at least one, and preferably a pair, of lever portions 1012 of the frame 1002 of the clamp arm 1000 at its proximal end 1014 . Lever portions 1012 are positioned on opposite sides of the ultrasonic waveguide and end effector, respectively, and are operably engaged with drive portions of the reciprocating actuating member. Reciprocating motion of the actuating member relative to the outer tubular sheath and the ultrasonic waveguide thereby causes the clamp arm 1000 to pivot relative to the end effector about the pivot point 1016 . Lever portions 1012 may each be disposed within a pair of openings defined by the drive portion or may otherwise be suitably mechanically coupled to the drive portion such that the reciprocating motion of the actuating member is controlled by the drive portion. Through the portion and lever portion 1012 serves to pivot the clamp arm 1000 .

FIG. 2 is an exploded view of clamp arm 1000 shown in FIG. 1, according to at least one aspect of the present disclosure. In various embodiments, electrode 1004 is made of a metal spring material attached to proximal end 1014 of frame 1002 of clamp arm 1000 such that electrode 1004 can be deflected. Metal spring electrode 1004 defines an opening 1018 through which an element of clamp arm pad 1010 is received. Metal spring electrode 1004 defines additional openings 1020,1021 through which gap pads 1006,1008 are received. This sets a minimum gap between the electrode 1004 and the ultrasonic blade. At least one of gap pads 1006 is disposed on distal end 1022 of electrode 1004 . Thus, gap pads 1006, 1008 are integrated with electrode 1004. FIG. In this configuration, electrode 1004 prevents tissue from accumulating around the biasing mechanism, such as a cantilevered spring, as this accumulation can adversely affect electrode 1004 performance. This configuration also minimizes coupling between the wearable clamp arm pad 1010 and the biasing spring electrode 1004, increases the strength of the connection of the electrode 1004 to the clamp arm, and connects the gap pads 1006, 1008 to the electrode 1004. The attachment minimizes unintentional release of the clamp arm pads 1018 and provides a balanced surface area/current density balance between the electrodes. Electrode 1004 is attached to frame 1002 by two protrusions 1024 . Electrode protrusions 1024 are attached to proximal end 1014 of frame 1002, as shown in FIGS.

3 and 4 are perspective views of frame 1002, according to at least one aspect of the present disclosure. These figures show the connecting surface 1026 on the proximal end 1014 of the frame 1002 for attaching the proximal end of the electrode 1004 to the frame 1002. FIG. In one aspect, the electrode projections 1024 are welded to the connecting surface 1026 of the frame 1002 such that the electrodes 1004 behave in a deflectable manner.

FIG. 5 is a perspective view of electrode 1004, according to at least one aspect of the present disclosure. This figure shows an electrode 1004 made of a spring material being biased as indicated by the curvature of the electrode 1004 along its longitudinal length. Openings 1018, 1020, 1021 are for receiving gap pads 1006, 1008 and clamp arm pads 1010, respectively. In one aspect, electrode 1004 has a thickness "d" of 0.010 inches, where thickness "d" can be selected, for example, within the range of 0.005 inches to 0.015 inches. Referring also to FIGS. 8 and 9, opening 1020 is sized and configured to receive protrusion 1036 defined in the bottom portion of gap pad 1006 .

FIG. 6 is a perspective view of clamp arm pad 1010, according to at least one aspect of the present disclosure. Clamp arm pad 1010 includes a plurality of clamp arm elements 1032 projecting from backbone 1030 . Throughout this disclosure, clamp arm elements 1032 are also referred to as "teeth." In one aspect, the clamp arm pad 1010 defines an opening 1028 where the gap pad 1006 rests over the electrode 1004 . Referring also to FIGS. 8 and 9, opening 1028 defined by clamp arm pad 1010 is sized and configured to receive protrusion 1036 defined on the bottom portion of gap pad 1006 . In one aspect, the material of the clamp arm pad 1010 is softer than the material of the gap pads 1006,1008. In one aspect, the clamp arm pads 1010 are made of a non-stick, lubricious material such as polytetrafluoroethylene (PTFE) or a similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a hydrophobic, non-wetting, high density, high temperature resistant, versatile material with non-stick properties. In contrast, the gap pads 1006, 1008 are made of a polyimide material, in one aspect, for example, a durable, high-performance polyimide-based plastic manufactured by DuPont and known under the trade name VESPEL, or for example, Made from other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyetheretherketone), PEKK (polyetherketoneketone) polymer alloys. Unless otherwise stated below, the clamp arm pads and gap pads described herein below are made of the materials described in this paragraph.

FIG. 7 is a perspective top view of large gap pad 1008, according to at least one aspect of the present disclosure. Large gap pad 1008 includes protrusion 1034 sized and configured to fit within opening 1021 in proximal end 1014 of electrode 1004 . FIG. 8 is a perspective top view of small gap pad 1006, according to at least one aspect of the present disclosure. 9 is a perspective bottom view of the small gap pad 1006 shown in FIG. 8. FIG. As shown in FIGS. 8 and 9, the small gap pad 1006 includes a protrusion 1036 on the bottom that extends into the opening 1020 defined by the electrode 1004 and the opening 1028 defined by the clamp arm pad 1010. sized and configured to be received in Small gap pad 1006 and large gap pad 1008 are made of a polyimide material, and in one embodiment, a durable, high performance polyimide-based plastic manufactured by DuPont and known under the trade name VESPEL. The durability of the polyimide material ensures that the electrode gap remains relatively constant assuming normal wear and tear.

In one aspect, the present disclosure also provides additional end effector configurations for combined ultrasound and bipolar RF energy devices. This portion of the disclosure provides end effector configurations for use with combined ultrasound and bipolar RF energy devices. In these configurations, the end effector maintains a consistent gap, the RF electrode gap, between the ultrasonic blade acting as one pole of the bipolar RF circuit and the clamp arm acting as the opposite pole of the bipolar RF circuit. . In conventional end effector configurations, the electrode gap is set by soft PTFE clamp arm pads that may wear during surgery. If the clamp arm pad is worn out completely, the ultrasonic blade can contact the electrode, resulting in blade breakage or electrical shorting, both of which are undesirable.

To overcome these and other limitations, various aspects of the present disclosure combine clamp arm pads that include non-stick, lubricious, flexible (e.g., PTFE) pads secured to the clamp arm. , incorporating a deflectable RF electrode. The RF electrode includes a wear-resistant, non-conductive pad that contacts the blade and establishes a gap between the blade and the electrode. A flexible clamp arm pad extends through the opening defined by the electrode and responds to clamping force from the ultrasonic blade. As the flexible clamp arm pad wears, the electrode deflects to maintain a constant gap between the blade and electrode. Such a configuration provides a consistent gap between the electrode and the ultrasonic blade throughout the life of the device, prevents possible short circuits and ultrasonic blade breakage when the ultrasonic blade contacts the electrode, Sealing performance can be improved by allowing the material to be placed directly on the side facing the ultrasonic blade. The electrodes are fixed at the proximal end to the clamping jaws and free to deflect at the distal end. Accordingly, electrodes may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

In one aspect, the present disclosure provides for asymmetric cooperation of clamp arms/electrodes/pads to effect interaction between the ultrasonic blade and RF electrodes. In one aspect, the present disclosure provides a shortened clamp arm. 10-12 illustrate effectors with shortened clamp arms for deflectable/cantilever electrode applications, according to various aspects of the present disclosure. In one aspect, the end effector is configured for asymmetric cooperation of the clamp arm, electrode, and clamp arm pad to provide interaction between the ultrasonic blade and the RF electrode. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

In one aspect, the distal end of the clamp arm is shortened, but the length of the clamp arm pad is kept the same as the original length, so that the distal end of the clamp arm pad is similar to the distal end of the clamp arm. extend beyond. This allows the electrodes to hyperextend, minimizing the possibility of electrically shorting the distal end of the clamp arm. It may also have the advantage of extending the life of the clamp arm pads, as more exposed clamp arm pad material is added for complete wear. This configuration also applies, for example, at distal and intermediate positions, previously referred to herein as wear-resistant clamping arm pads for setting and maintaining the gap between the electrode and the ultrasonic blade. The use of clamp arm pads for gap setting can be eliminated.

FIG. 10 is a side view of an end effector 1680 comprising a shortened clamp arm 1682, an ultrasonic blade 1684, an electrode 1686, and a clamp arm pad 1688, according to at least one aspect of the present disclosure. 11 is a top view of end effector 1680. FIG. As shown in FIGS. 10-11, ultrasonic blade 1684 and electrode 1686 are substantially the same length. Clamp arm 1682 is shortened to allow electrode 1686 to overextend to prevent electrical shorting. In one aspect, gap setting pad 1690 is provided at proximal end 1692 of end effector 1680 .

FIG. 12 shows a clamp arm 1700 comprising clamp jaws 1702, electrodes 1704, and clamp arm pads 1706, according to at least one aspect of the present disclosure. There is an empty space above the clamp arm distal side. Clamp arm 1700 is configured for use with an end effector having an ultrasonic blade, as disclosed in other sections herein. This configuration leaves the distal upper space 1708 of the clamp jaws 1702 empty. The clamp arm pad 1706 (e.g., PTFE) is fully supported underneath, but empty spaces exist in the t-slot area and on the sidewalls to prevent more of the clamp arm pad 1706 from melting down. , allowing the electrode 1704 to be deflected further away from the ultrasonic blade (not shown).

In one aspect, the present disclosure provides an end effector that uses thermal behavior of pads to deflect electrodes. In one aspect, the length of the clamp arm pad can be the same length as the ultrasonic blade, and as the clamp arm pad expands or changes shape due to pressure or heat, the clamp arm pad material (e.g., PTFE) can be used to deflect the electrode out of the path of the ultrasonic blade.

In one aspect, non-energized electrodes and pads are provided. A non-biased but deflectable pad changes position relative to the clamp arm as the pad wears. The non-energized electrodes are configured to minimize contact between the ultrasonic blade and the RF electrodes. The clamp arm pads have features for securing the electrodes to the clamp arm pads. In one aspect, the height of the electrode relative to the clamp arm is gradually adjusted as the height of the clamp arm pad is worn or severed. In another aspect, once the clamp arm is moved away from the ultrasonic blade, the electrode remains in its new position. The electrodes are fixed to the clamp arm at the proximal end and free to deflect at the distal end. Accordingly, electrodes may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

The end effector configurations including the deflectable/cantilevered electrodes described above with respect to FIGS. 1-12 can be combined with biasing electrodes as described below with respect to FIGS. 13-18.

In one aspect, the present disclosure provides an end effector for a combined ultrasound/bipolar RF energy surgical device that uses pressure or clamp jaw compression to adjust electrode height as the clamp arm pads wear. offer. In one aspect, a clamp arm pad follows an electrode that is biased by a clamp arm having an abradable stop. In one aspect, the clamp arm pad includes features for securing the electrode to the pad. As the pad height is worn or cut, the electrode height relative to the clamp arm is gradually adjusted. As the clamp arm moves away from the ultrasonic blade, the electrode remains in its new position.

Achieving adequate clamp arm pad life on combined ultrasound/bipolar RF energy surgical devices maintains a sufficiently small but non-zero gap between the clamp arm pads and electrodes throughout the life of the instrument. to provide the desired ultrasound and bipolar RF tissue effects. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

The existing (seed) electrode is a flat electrode that is horizontal or substantially parallel to the clamp arm in the free state (unloaded). The electrodes are fixed to the clamp arm at the proximal end and free to deflect at the distal end. Accordingly, electrodes may be referred to as cantilever beam electrodes or deflectable/cantilever electrodes throughout this disclosure. When the tissue is clamped, the tissue loads the electrode, causing the electrode to deflect toward the clamp arm.

In one aspect, the electrode "follows" as the pad wears. In this aspect, the electrodes, in the free state (whether formed/curved electrodes or mounted/welded non-parallel to the clamp arm), can be welded, among other fastening techniques. , laser welding, brazing, soldering, stamping, etc., using any suitable fastening technique. A wearable stop feature (on the pad or elsewhere) keeps the electrode away from the clamp arm until the stop feature wears out during use. Once this has worn away, the electrode can be approached to the clamp arm. These features may be tooth or ratchet-shaped, vertically tapered, or otherwise.

In one aspect, the present disclosure provides a deflectable/cantilever electrode that in the free state is biased toward the clamp arm, mounted at an angle, and fabricated with a pre-formed curve. obtain. Any suitable fastening technique is then used, such as welding, laser welding, brazing, soldering, compression, among other fastening techniques.

In one aspect, the present disclosure provides an end effector with a deflectable/cantilever electrode with an abradable stop feature to prevent the electrode from reaching or contacting the clamp arm. As the stop feature wears, the electrode moves toward the clamp arm until it reaches the next stop feature. In one aspect, the stop feature wears at the same time as the clamp arm pad to maintain a proper gap between the clamp arm pad and the electrode. These features can be completely separated from the clamp arm pads. These features can be configured to withstand the clamping load of the clamps, but to be more worn by heat (melting/flowing) or by friction. Possible examples are teeth on one or more clamping arm pads (PTFE, polyimide or others) and tapered profiles on one or more clamping arm pads (PTFE, polyimide or others) is mentioned.

FIG. 13 shows an end effector clamp arm 1710 comprising clamp jaws 1712, electrodes 1714, and clamp arm pads 1716, according to at least one aspect of the present disclosure. Clamp arm 1710 is configured for use with an end effector that includes an ultrasonic blade (not shown), as described throughout this disclosure. Clamp arm 1710 also includes a wear resistant gap pad 1717 for setting a gap between electrode 1714 and the ultrasonic blade. As shown, in the free state, the electrodes 1714 are biased toward a flat or horizontal 1718 orientation with no tilt. Electrodes 1714 are fixed to clamping jaws 1712 at their proximal ends and free to deflect at their distal ends. Accordingly, electrodes 1714 may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

FIG. 14 shows an end effector clamp arm 1720 comprising clamp jaws 1722, electrodes 1724, and clamp arm pads 1726, according to at least one aspect of the present disclosure. Clamp arm 1720 is configured for use with an end effector that includes an ultrasonic blade (not shown), as described throughout this disclosure. Clamp arm 1720 also includes a wear resistant gap pad 1727 for setting a gap between electrode 1724 and the ultrasonic blade. As shown, in the free state, the electrodes 1724 are preformed, configured to bend, or otherwise along line 1728 away from horizontal 1718 orientation. , is biased toward the clamp jaws 1722 . Electrode 1724 is fixed to clamp arm 1720 at its proximal end and free to deflect at its distal end. Accordingly, electrodes 1724 may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure. To prevent biasing electrode 1724 from bending toward clamp jaw 1722 under biasing force, clamp arm 1720 further includes a retainer that prevents biasing electrode 1724 from bending toward clamp jaw 1722 . and maintain the bias electrode 1724 in a substantially flat configuration (eg, parallel, flat, or horizontal) with respect to the ultrasonic blade. Examples of retainers such as retainer teeth 1738 and retainer walls 1760 with tapered profiles are described below with reference to FIGS. 15-18.

FIG. 15 shows an end effector clamp arm 1730 comprising clamp jaws 1732, electrodes 1734, and clamp arm pads 1736, according to at least one aspect of the present disclosure. Clamp arm 1730 is configured for use with an end effector that includes an ultrasonic blade (not shown), as described throughout this disclosure. Clamp arm 1730 also includes a wear resistant gap pad 1737 for setting a gap between electrode 1744 and the ultrasonic blade. In the free state, the electrodes 1734 are configured to be preformed into a curved shape, bent, or otherwise biased toward the clamp jaws 1732 . However, retainer teeth 1738 or similar features are provided on clamp arm pads 1736 to prevent electrodes 1734 from jumping toward clamp jaws 1732 . 16, according to at least one aspect of the present disclosure, as bottom retainer teeth 1738 wear, electrodes 1734 may move toward clamp jaws 1732 according to a preformed curve. Electrode 1734 is fixed to clamp arm 1730 at its proximal end and free to deflect at its distal end. Accordingly, electrodes 1734 may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

FIG. 17 shows an end effector clamp arm 1750 comprising clamp jaws 1752, electrodes 1754, and clamp arm pads 1756, according to at least one aspect of the present disclosure. Clamp arm 1750 is configured for use with an end effector that includes an ultrasonic blade (not shown), as described throughout this disclosure. Clamp arm 1750 also includes a wear resistant gap pad 1757 for setting a gap between electrode 1754 and the ultrasonic blade. In the free state, the electrodes 1754 are preformed with a shape that curves toward the clamping jaws 1752, bent or otherwise configured to be biased 1758. As shown in FIG. However, a retainer wall 1760 with a tapered profile or similar feature is provided on clamp arm pad 1756 to prevent electrode 1754 from jumping toward clamp jaw 1752 .

In FIG. 17, according to at least one aspect of the present disclosure, there is sufficient melting/flow and a pre-formed curve such that as the tapered profile retainer wall 1760 wears away from the tapered profile retainer wall 1760 region. allows electrode 1754 to move toward clamp jaw 1752 . Electrodes 1754 are fixed to clamp jaws 1752 at their proximal ends and free to deflect at their distal ends. Accordingly, electrodes 1754 may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

In one aspect, the present disclosure provides an end effector for a combined ultrasound/bipolar RF energy surgical device that employs a constant pressure distribution biasing mechanism. In one aspect, the end effector includes a resilient compressive support for mounting and insulating the deflectable electrodes. In one aspect, a hollow honeycomb or chambered elastomeric support mounting cushion is used to deflect or bias all or a portion of the electrodes attached thereto toward the ultrasonic blade. can make it possible. This configuration can provide the added benefit of thermally isolating the electrodes from the rest of the metal clamping jaws. It also provides an elastomeric "curtain" around the electrodes to minimize tissue build-up behind the electrodes. In one aspect, the strut-less deflectable geometry for the elastomer cells allows the deflection force to remain constant over a given range of deflection. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

The above configuration prevents the electrodes from bending laterally under compression to prevent short circuits. Additionally, the deflectable electrode is attached to an elastomer, which is secured to a metal clamp arm. The tight height of the spring is limited from driving acceptable compression while maintaining as much of the metal clamp arm as possible. Thermal conduction from the tissue interface is balanced and minimized, affecting formation and symmetry of the modification, cycle time, and residual thermal energy.

The configuration of the end effector with deflectable/cantilever electrodes described above with respect to FIGS. 1-12 includes a flexible electrode disposed above a grid cushion, and It can be combined with a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade.

The configuration of the biasing electrodes as described above with respect to FIGS. 13-18 includes a flexible electrode disposed above the grid cushion and a plurality of hard spacers, as described below with respect to FIGS. 19-21. to set a gap between the flexible electrode and the ultrasonic blade.

Configurations of end effectors comprising the deflectable/cantilever electrodes described above with respect to FIGS. 1-12 in combination with biasing electrodes as described above with respect to FIGS. 13-18 are described below with respect to FIGS. Second, it can be combined with a flexible electrode disposed above the grid cushion and a plurality of hard spacers to set a gap between the flexible electrode and the ultrasonic blade.

19-20 illustrate a clamp arm 1812, an ultrasonic blade 1814, a grid cushion 1816, a flexible electrode 1818 disposed above the grid cushion 1816, and a flexible electrode 1818, according to at least one aspect of the present disclosure. An end effector 1810 is shown comprising a plurality of hard spacers 1820 for setting a gap between a flexible electrode 1818 and an ultrasonic blade 1814. FIG. FIG. 21 is an exploded view of the end effector 1810 shown in FIGS. 19-20. Clamp arm pads 1822 are disposed inside slots 1825 formed in grid cushion 1816 . Lattice cushion 1816 functions as a spring-like element. A hard spacer 1820 is used to set the gap between the flexible electrode 1818 and the ultrasonic blade 1814 .

In FIG. 19, the clamp arm 1812 is open and has a non-uniform thickness (T_1a, T_2a, T_3a) tissue 1824 is disposed over the flexible electrode 1818 . In FIG. 20, clamp arm 1812 is closed, compressing tissue 1824 . The grating cushion 1816 on the clamp arm 1812 is of varying thickness (T_1a, T_2a, T_3a) of tissue 1824 with a consistent thickness (T_1b, T_2b, T_3b) resulting in the organization 1824 of , i.e. achieving a compression where the following relationship holds:

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Additional background disclosure can be found in EP 3378427, International Patent Application Publication No. 2019/006068, which is incorporated herein by reference in its entirety.

In one aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical technique using a zero-gap bipolar RF energy system with means for insuring contact between the biasing electrode and the distal tip. Provide an end effector for your device. In various aspects, the present disclosure provides deflectable electrodes for combined ultrasound/bipolar RF energy surgical devices having a distal biasing force that is greater than the proximal biasing force. In one aspect, the present disclosure provides a combined energy device comprising a bipolar electrode that is deflectable with respect to a clamp arm. Combined energy devices include features that vary the mechanical properties of tissue compression from proximal to distal, creating a more uniform or different pattern of pressure than clamping force alone. . In one aspect, the disclosure provides a non-linear distal distribution mechanism, and in another aspect, the disclosure provides a non-linear distribution of electrical energy density. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

The end effector configurations including deflectable/cantilever electrodes described above with respect to FIGS. 1-12 can be combined with conductive polymer clamping arm pads, as described below with respect to FIGS. 22-36.

The biasing electrode configuration as described above with respect to FIGS. 13-18 can be combined with a conductive polymer clamp arm pad as described below with respect to FIGS. 22-36.

As described above with respect to FIGS. 19-21, a flexible electrode and a plurality of hard spacers disposed above the grid cushion for setting a gap between the flexible electrode and the ultrasonic blade. The configuration can be combined with a conductive polymer clamp arm pad, as described below with respect to Figures 22-36.

The configuration of the biasing electrodes as described above with respect to FIGS. 13-18 is combined with flexible electrodes and a plurality of hard spacers disposed over the grid cushions as described above with respect to FIGS. 19-21. , a gap can be set between the flexible electrode and the ultrasonic blade, and can be further combined with a conductive polymer clamping arm pad, as described below with respect to FIGS. 22-36.

The configuration of the biasing electrodes as described above with respect to FIGS. 13-18 is combined with flexible electrodes and a plurality of hard spacers disposed over the grid cushions as described above with respect to FIGS. 19-21. , a gap can be set between the flexible electrode and the ultrasonic blade, and can be further combined with a conductive polymer clamping arm pad, as described below with respect to FIGS. 22-36.

The configuration of the end effector comprising the deflectable/cantilever electrodes described above with respect to FIGS. 1-12 in combination with the biasing electrodes as described above with respect to FIGS. 13-18 is described below with respect to FIGS. , can be combined with a conductive polymer clamp arm pad.

The configuration of the end effector comprising the deflectable/cantilevered electrodes described above with respect to FIGS. 1-12 in combination with the biasing electrodes described above with respect to FIGS. In combination with the electrodes and a plurality of hard spacers, a gap can be set between the flexible electrode and the ultrasonic blade, as described above with respect to Figures 19-21, and also with respect to Figures 22-36. It can be combined with a conductive polymer clamp arm pad as described below.

In various aspects, the present disclosure is a combined ultrasound/bipolar RF energy surgical device comprising an ultrasound pad having a partially or fully conductive portion, wherein the pad is a blade support/wear pad and a bipolar RF electrode. In one aspect, the present disclosure provides a partially conductive clamp arm pad that allows wear of the electrodes and a bipolar RF clamp arm pad in which the clamp arm pad has a conductive portion and a non-conductive portion. and minimizing short circuits in ultrasonic energy combination devices. This allows this clamp arm pad to function as one of the RF electrodes while also functioning as an abradable support structure for the ultrasonic blade. In another aspect, the present disclosure provides a conductive portion around the clamp arm pad, but the conductive portion is not located on the side directly opposite the contact area of the ultrasonic blade. In another aspect, a portion of the conductive clamp arm pad is degradable or abradable to prevent contact from the ultrasonic blade from interrupting the conductivity of the remaining portion of the conductive clamp arm pad. .

In one aspect, the present disclosure provides an end effector for a combined ultrasound/bipolar RF energy surgical device comprising a conductive polymer ultrasound clamping arm pad. In one aspect, the end effector comprises clamp arm pads doped with tin oxide. FIG. 22 is a cross-sectional view of a conductive polymer clamp arm pad 2440, according to at least one aspect of the present disclosure. Conductive polymer clamp arm pads 2440 are made of tin oxide 2442 (SnO₂)including. Doping can be accomplished using a cold spray process. Once doped, the conductive polymer clamp arm pads 2440 behave like conventional ultrasonic tissue, e.g. The function of the clamping arm pad can be realized. The tin oxide doped clamp arm pad 2440 is used to connect one of the two electrodes or poles of the bipolar RF circuit to deliver RF energy to the tissue grasped between the ultrasonic blade and the clamp arm pad 2440. function as one. The tin oxide doped clamp arm pad 2440 is biocompatible, electrically conductive, thermally conductive, and uses the majority of the clamp arm pad 2440 to improve the wear resistance of the clamp arm pad 2440 and is white. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

In one aspect, the present disclosure provides conductive polymer ultrasonic clamp arm pads as an alternative to electrodes. To improve the longevity of ultrasonic clamp arm pads and improve the effectiveness of RF on tissue, the present disclosure provides improved, easier to fabricate, and less costly electrodes to fabricate. do. In one aspect, the present disclosure provides a clamp arm pad that includes a rigid polyimide polymer layer and a conductive layer such that the clamp arm pad accomplishes conventional functions and carries bipolar electricity to carry energy compounded ends. It makes it possible to eliminate the need for a separate electrode in the clamp arm of the effector. In this way, the clamp jaws can be manufactured in a manner similar to ultrasonic-only clamp jaws, and the new clamp arm pad material will replace conventional ultrasonic-only clamp arm pads. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

Advantages include improved ultrasonic performance, including clamp arm pad wear, similar to current ultrasonic-only instruments, as there are no electrode gaps between polymer element "squares". The cost of the improved clamping jaws is similar to current ultrasound-only clamping jaws because separate electrode components are eliminated and multiple small polymer square elements are provided. Additionally, the manufacturing steps required to make the clamping jaws are the same as the manufacturing steps required to make the current ultrasonic-only clamping jaws. Manufacturing the improved clamp jaws requires only replacement of the clamp arm pads and certainly requires the manufacture of additional electrode components added to the clamp jaws, eliminating the assembly step.

FIG. 23 is a perspective view of a clamp arm pad 2450 configured to replace conventional electrodes, according to at least one aspect of the present disclosure. Clamp arm pad 2450 comprises non-conductive layer 2452 and conductive layer 2454 in a sandwich-like configuration. This configuration eliminates the need for spring-loaded electrode plates. Non-conductive layer 2452 can be made of polymers, polyimides, Teflon (PTFE), and similar non-conductive materials. Conductive layer 2454 can be made of a thin conductive polymer, metal foil, or carbon-filled material. The clamp arm pad 2450 can be manufactured such that the non-conductive layer 2452 is the majority of the material that contacts the ultrasonic blade. In one aspect, 75% of the material that contacts the ultrasonic blade is a non-conductive material such as PTFE. In another aspect, 85% of the material in contact with the ultrasonic blade is non-conductive material such as PTFE. In another aspect, 95% of the material that contacts the ultrasonic blade is a non-conductive material such as PTFE. Also, as the clamp arm pad 2450 wears, the conductive layer 2452 still has surface area available for conducting RF electricity through tissue and return electrodes (eg, ultrasonic blades).

FIG. 24 shows a clamp arm 2460 comprising the clamp arm pad 2450 of FIG. 23, according to at least one aspect of the present disclosure. In the illustrated clamp arm 2460, the non-conductive layer 2452 has a large surface area compared to the conductive layer 2454, which appears as a thin layer or foil.

FIG. 25 shows a clamp arm pad configured as described in FIGS. 23-24, according to at least one aspect of the present disclosure. The first clamp arm pad 2470 is new and has teeth 2472 integrally formed therewith. The second clamp arm pad 2476 is new but has no teeth. Third clamp arm pad 2478 is worn and may represent either first clamp arm pad 2470 or second clamp arm pad 2476 .

In one aspect, the present disclosure provides a combined clamping arm pad for a combined ultrasound/bipolar RF energy surgical device. FIG. 26 is a cross-sectional view of clamp arm 2480 with composite clamp arm pad 2482 in contact with tissue 2484, according to at least one aspect of the present disclosure. End effector 2480 includes upper clamp jaw 2486 and adhesive 2488 for fixedly attaching composite clamp arm pad 2482 to upper clamp jaw 2486 . Composite clamp arm pad 2482 includes a thin non-conductive layer 2490 (eg, PTFE) and a thin conductive layer 2492 (eg, thin stainless steel foil). Conductive layer 2492 forms the electrode portion of composite clamp arm pad 2482 . Conductive layer 2492 (eg, thin stainless steel foil) deforms as non-conductive layer 2490 (eg, PTFE) wears. The thickness of conductive layer 2492 allows the electrode portion of composite clamp arm pad 2482 to deform as non-conductive layer 2490 wears away. Advantageously, the conductive layer 2492 conducts some of the heat away from the non-conductive layer 2490, keeping the composite clamp arm pad 2482 cooler. Compound clamp arm pad 2482 is secured to upper clamp jaw 2486 by adhesive 2488, as described above. The adhesive 2488 can be carbon filled to make the adhesive 2488 conductive and connect the electrode portion of the composite clamp arm pad 2482 to the upper clamp jaw 2486 . The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

In one aspect, the clamp arm pad comprises cooperating conductive and insulating portions. In one aspect, the present disclosure provides that while the clamp arm pad also serves as an abradable support structure for the ultrasonic blade, having a conductive portion and a non-conductive portion allows the clamp arm pad to be one of the RF electrodes. A combined ultrasound/bipolar RF energy surgical device is provided that is capable of functioning as one. In another aspect, the conductive portion of the clamp arm pad is located on the perimeter of the pad and not on directly opposite sides of the ultrasonic blade contact area. In another aspect, the conductive portion of the clamp arm pad is degradable or abradable to prevent contact with the ultrasonic blade from disrupting the conductivity of the remaining conductive portion of the clamp arm pad. .

In one aspect, the present disclosure provides a clamp arm pad for use with a combined ultrasound/bipolar RF energy device, a portion of the clamp arm pad comprising a conductive material and another portion non-conductive. Including materials. The electrodes are adapted and configured for use with a combined ultrasound/RF energy device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

In various aspects, the clamp arm pads may be manufactured using various techniques. One technique involves a two-shot process of molding conductive and non-conductive materials in the same compression mold. This process effectively creates a single clamp arm pad with a portion capable of acting as a bipolar RF electrode and another portion acting as an electrical insulator. Another technique involves embedding metal elements into polymer (eg Teflon, PTFE) pads or matrices by supersonic cold spray. Other techniques include 3D printing of multiple materials (eg, Teflon, PTFE, and doped conductive polymers), printing/transfer printing of conductive or functional inks onto clamp arm pads. Another technique is that metals and conductive materials (e.g., graphite/carbon) can be applied to the clamp arm pads using chemical vapor deposition, physical vapor deposition, sputter deposition, vacuum deposition, vacuum metallization, or thermal spraying. including. Another technique comprises conductive/filled clamp arm pad electrodes, which have micro-randomly oriented and positioned particles or macro-oriented structures (e.g., cloth, woven fabric, constrained filaments). Provide continuity through the pads. Other techniques include making the surface of the clamp arm pads conductive, providing electrodes that wear away, 3D printing, hot spraying, cold spraying, coatings/paints/epoxies, among other techniques. , sheet/foil/wire/film wrapping or lamination, vacuum metallization, printing/transfer, etc. In another technique, polymer electrodes are filled with a conductive material.

In one aspect, the end effector clamp arm comprises a fixed polymer electrode. FIG. 27 shows a clamp arm 2500 comprising a clamp jaw 2502 supporting a carrier 2504 or stamping attached to the clamp jaw 2502 and a clamp arm pad 2506 according to at least one aspect of the present disclosure. Clamp arm pads 2506 comprise conductive pads 2508 and non-conductive pads 2510 . Conductive pad 2508 is made of a conductive polymer and serves as one of the electrodes of the bipolar RF circuit. The clamp jaws 2502 and carrier 2504 are made of stainless steel and attached using any suitable fastening technique such as welding, laser welding, brazing, soldering, stamping, among other fastening techniques. can be Conductive pads 2508 may include, for example, polymers such as silicone, fluorosilicone, PTFE, and similar materials. Conductive pads 2508 are made of PTFE, silicone, fluorosilicone filled with silver particles, silver on aluminum, silver on copper, copper, nickel, graphite, carbon (amorphous, short fiber), gold, platinum, and stainless steel. Overmolded onto carrier 2504 using steel, iron, or zinc, or a combination thereof.

28 is a cross-sectional view cut along the cut plane 28-28 in FIG. 27, and FIG. 29 is a cross-sectional view cut along the cut plane 29-29 in FIG. 28-28 and 29-29 show clamp arm 2500 with clamp jaw 2502, support carrier 2504, conductive pad 2508, and non-conductive pad 2510. FIG.

FIG. 30 is a cross-sectional view of an alternative implementation of a clamp arm 2520 comprising clamp jaws 2522, conductive pads 2524, and non-conductive pads 2526, according to at least one aspect of the present disclosure. Conductive pad 2524 is made of a conductive polymer and serves as one of the electrodes in the bipolar RF circuit.

FIG. 31 is an alternative clamp arm 2530 comprising a clamp jaw 2532, a carrier 2534 or stamping welded to the clamp jaw 2532, a conductive pad 2536, and a non-conductive pad 2538, according to at least one aspect of the present disclosure. 1 is a cross-sectional view of one exemplary implementation; FIG. Conductive pad 2536 is made of a conductive polymer and serves as one of the electrodes in the bipolar RF circuit. Conductive pads 2536 are overmolded onto the carrier 2534 or stamping.

In one aspect, the end effector clamp arm includes a film over insert molded metal electrode assembly. In one aspect, the film may be provided on an insert molded metal (eg, stainless steel) electrode assembly. Films can be insert molded onto metals such as stainless steel to form electrode assemblies. The film on the insert-molded electrodes can be etched to form micropores, slots, honeycombs, etc., among other patterns, to conduct RF energy, as well as cut around components. Films can be formed or bonded onto stainless steel electrodes using the IML/FIM (In-Mold Labeling/Film Insert Molding) process described below. The filled film electrodes can be placed in a polymer injection molding tool to mold the polymer to the back of the electrodes and film. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

FIG. 32 shows an insert molded electrode 2540 according to at least one aspect of the present disclosure. The insert molded electrode 2540 comprises a conductive element 2546, a molded polymer pad 2548 and a coating with a film 2542. Features 2550, such as microholes, slots, honeycombs, or similar features, are formed in film 2542 to allow passage of RF energy. A retention feature 2552 is also formed on film 2542 . Sidewalls 2558 of film 2542 extend below the bottom of polymer pad 2548 and may be folded around the bottom of polymer pad 2548 and overmolded with retention posts. Retaining feature 2552 is molded into hole 2554 defined by film 2542 . Although two insert-molded electrodes 2540 are shown with a gap between them, in reality the two insert-molded electrodes 2540 are fitted between the wires 2556 via mold pressure.

Conductive element 2546 can be made from a conductive metal, such as stainless steel or similar conductive metal. Conductive elements 2546 may be approximately 0.010 inches thick, may be selected within the range of 0.005 inches to 0.015 inches thick, and may be formed by tamping or machining. Film 2544 may be approximately 0.001 inch to 0.002 inch thick and may be made of polyimide, polyester, or similar material. Alternatively, the film 2544 can be bonded directly to the conductive elements 2546 for mechanical retention such as posts. An example is DuPont Pyralux HXC Kapton film with an epoxy adhesive backing having a thickness of 0.002 inches.

Advantageously, the non-stick surface prevents tissue from adhering to the insert-molded electrode 2540 . The non-stick surface eliminates shorting between opposing electrodes by setting a gap in the range of 0.002 inch to 0.004 inch along the length of the insert molded electrode 2540 . The non-stick surface minimizes lateral spread of RF energy by covering sidewalls 2558 of insert molded electrode 2540 . The insert molded electrode 2540 also exhibits structural integrity and provides easier, more robust electrical connections than multilayer flexible circuits.

In one aspect, an end effector comprises a conductive clamping arm and pad structure for a combined ultrasound/bipolar RF energy surgical device. In one aspect, the present disclosure provides a clamping arm assembly to, around, or on the clamping arm assembly to serve as a durable "pole" in a combined ultrasound/bipolar RF energy surgical device. A clamp arm assembly comprising a conductive or selectively conductive film, foil, or laminate for application in Additionally, algorithms, software, or logic are provided to manage the conditions under which electrical shorts occur. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of the bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

FIG. 33 shows an end effector 2560 comprising an ultrasonic blade 2562, a clamp arm 2564, and a clamp arm pad 2566 comprising a conductive film 2568, according to at least one aspect of the present disclosure.

FIG. 34 shows clamp arm 2564 shown in FIG. Clamp arm 2564 includes clamp jaws 2570 for supporting clamp arm pad 2566 . A thin conductive film 2568 is disposed over the clamp arm pad 2566 to form an electrode for one of the poles of the bipolar RF circuit.

FIG. 35 is a cross-sectional view of clamp arm 2564 taken along plane 35-35 of FIG. Clamp jaws 2570 may be made of metal such as stainless steel. The clamp arm pads 2566 can be made of non-conductive, flexible materials such as PTFE, silicone, high temperature polymers, or similar materials. Conductive film 2568 or foil can be made of a conductive material such as, for example, titanium, silver, gold, aluminum, zinc, and any alloy thereof including stainless steel.

FIG. 36 shows a clamp arm 2580 with partially conductive clamp arm pads 2582, according to at least one aspect of the present disclosure. A conductive foil 2584 covers a portion of the non-conductive pad 2586 . A non-conductive pad 2588 at the proximal end 2590 sets the gap between the clamp arm pad 2582 and the ultrasonic blade.

Conductive film 2568, foil, or laminate elements include, for example, a single layer of thin conductive material, such as metals (titanium, silver, gold, zinc, aluminum, magnesium, etc.). , iron, etc., and their alloys, or stainless steel), plated metals (e.g., copper plated with nickel and then gold), or metal powders, or polymers heavily filled with fillers etc. Preferably, the elements are biocompatible metal foils such as titanium, silver, gold, zinc, or stainless steel, selected from thicknesses within the range of 0.001 inch to 0.008 inch (0.025 mm to 0.20 mm). is.

A film 2568, foil, or laminate may include a thin polymeric coating, film, or layer covering the thin conductive material described above. This coating, film, or layer has a high electrical resistance, ie, is not a conductor that effectively conducts bipolar RF energy to adjacent tissue. The coating may be perforated to allow energy delivery from the electrodes to the tissue.

The conductive material may be perforated through the entire thickness of the conductive material or contain such through-holes or windows, thereby minimizing the thermal capacitance of this layer (test have shown that long and/or thick foils result in longer time required to cut tissue due to the thermal energy removed from the treatment site. may also allow retention of the foil to other portions or layers These perforations, holes or windows may be patterned throughout the sheet of foil or may be localized to the treatment site. , or may be localized away from the treatment site, eg, only on the side of the clamp arm.

Where thin polymeric coatings, films, or layers are present, they may be perforated so that the conductive film, foil, or laminate communicates directly with tissue to deliver bipolar radiofrequency energy to tissue. Alternatively, they may contain holes or windows through their entire thickness. In the case of coatings, these holes or windows can be formed by selective coating or coating removal.

Ideally, the conductive film 2568, foil, or laminate is in direct contact with the clamp arm structure, which is typically made from stainless steel. The conductive paths obtained thus allow for a simple construction. This is because the path is made up of necessary structural components. That is, it is formed by a support tube or actuator that connects directly to the clamp arm and then by a conductive film, foil, or laminate.

In one aspect, the conductive film 2568, foil, or laminate is a relatively soft, high temperature, low abrasion material made from materials such as PTFE, silicones, polyimides, high temperature thermoplastics, among other materials. Backed by a polymer or elastomer pad. The flexibility of this relatively soft pad is used to obtain a zero or near-zero gap between the jaws and the ultrasonic blade throughout its tissue impinging length when the jaws are fully closed. allows for a wide range of component tolerances. Thus, tissue can be sealed and cut along this length. The flexibility also eliminates or greatly attenuates any audible vibrations of the conductive layer that can occur when the ultrasonic blade is closed against the conductive layer.

The conductive film 2568, foil, or laminate may include a rigid to semi-rigid polymer on its back/back side (ie, the surface facing away from the tissue and toward the clamping arms). The part is made from an injection moldable polymer or polymer alloy and adhered to the film, foil or laminate by film insert molding (FIM) or in-mold labeling (IML).

In tests, thin stainless steel, copper, or aluminum foils are quiet during surgery (no "squeak", no dull squeak). A thin stainless steel, copper, or aluminum foil provides a robust surface against which the ultrasonic blade can act. The foil is robust enough that materials such as silicone rubber, which would otherwise tear and act as a poor pad material, can be used without tearing or cracking easily.

The proximal portion of the clamping surface of the jaws may be free of conductive films, foils, or laminates, but that is because this area of the jaws contacts the blade first and shorts/shorts electrical power in this area. This is because it is more likely to cause a short circuit.

In one aspect, the present disclosure provides a short circuit mitigation algorithm for activating an output containing bipolar RF energy.

After the energy delivered for actuation exceeded a threshold amount (thus thinning the tissue, it was likely that the tissue received an appropriate dose of bipolar RF energy for tissue sealing, coagulation). ), or after the activation time threshold was crossed (individuals, again, indicating that the tissue was thin, but likely accepted and received an adequate dose), or after energy and activation time thresholds If a short occurs after both are exceeded, no short circuit alert will be issued to the user.

The process of making a film on a stainless steel insert-molded electrode assembly consists of etching the film to form openings (microholes, slots, or honeycombs) to pass RF energy and cutting around the electrode components. optionally forming a film or adhesively bonding onto the stainless steel electrode; placing the mounted film and electrode in a polymer injection molding tool; and molding to.

In various aspects, the present disclosure provides an end effector for a combined ultrasound/bipolar RF energy surgical device that includes an electrode support mechanism. In one aspect, the electrode support mechanism is configured to prevent detachment of the electrode from the clamp arm. In one aspect, the electrode is attached to the clamp arm with a continuous adhesive to prevent accidental detachment of the flexible electrode from the clamp arm. In one aspect, the present disclosure provides a flexible electrode adhered to a mechanical support member as described herein. The support member can be a hybrid of metal and plastic with an integral hinge to minimize the possibility of the structural mechanical support member separating from the clamp arm. Delamination can occur between the structural mechanical support member and the electrode member. The electrode member is adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and is deflectable under load. This electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

FIG. 37 shows a clamp arm 1850 comprising a clamp jaw 1852, a support comprising a hinge-like feature 1854, an electrode 1856, and a clamp arm pad 1858, according to at least one aspect of the present disclosure. Clamp arm 1850 is configured for use with an end effector that includes an ultrasonic blade (not shown), as described throughout this disclosure. A hinge-like feature 1854 is disposed around the perimeter of electrode 1856 to prevent delamination. Electrode 1856 is fixed to clamp jaw 1852 at its proximal end and is free to deflect at its distal end. Accordingly, electrodes 1856 may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

38 is a cross-sectional view of the clamp arm 1850 shown in FIG. 37 with no load applied through the clamp arm pad 1858, according to at least one aspect of the present disclosure. FIG. 39 is a cross-sectional view of the clamp arm 1850 shown in FIG. 37 in a loaded condition, in which a force F1 is applied to the electrode 1856 and the hinge-like feature is clamped, according to at least one aspect of the present disclosure. Crumbling supports containing 1854.

In one aspect, the present disclosure provides a support and an electrode attachment member. In one aspect, the electrode is a support structure, mounted in place where it needs to be protected from stress. In another aspect, the mechanical support is easily attached to the surrounding jaws using any suitable fastening technique such as welding, laser welding, brazing, soldering, stamping, among other fastening techniques. can be a metal substrate for attachment to a

In one aspect, the pressure characteristics of the end effector can be varied based on the support. In one aspect, the present disclosure provides variable compression/biasing along the length of the electrodes of a combined ultrasound/bipolar RF energy device. The combined energy device comprises a bipolar RF electrode deflectable with respect to the clamp arm with features that change the mechanical properties of the tissue compression beneath the electrode based on jaw closure or amount of clamping. The electrodes are adapted and configured for use with a combined ultrasound/bipolar RF energy surgical device and are deflectable under load. This electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

Additional background disclosure can be found in US Pat. No. 6,533,784, which is incorporated herein by reference in its entirety.

In one aspect, the variable longitudinal support also functions as an interactive support. Integrated interactive support features are configured to provide compressibility or spring rate of the flexible support structure. The support structure also includes a plastic metal plate to provide an integral interactive support feature that limits maximum deflection of the support structure via plastic bump extensions that interact with underlying jaws along its length. It can be a composite or overmolded part. The integrated interactive support feature also allows adjustment of the spring constant of the electrode either along its length or in proportion to the amount of deflection already induced. It can be a functional part.

FIG. 40 shows a clamp arm 1860 portion of an end effector, comprising clamp jaws 1862, clamp arm pads 1864, variable longitudinal support elements 1866, and bump extensions, according to at least one aspect of the present disclosure. 1867 and electrodes 1868 supported by variable longitudinal support elements 1866 . Clamp arm 1860 is configured for use with an end effector that includes an ultrasonic blade (not shown), as described throughout this disclosure. Variable longitudinal support element 1866 is configured to limit the maximum deflection of electrode 1868 . The variable longitudinal support element 1866 has a variable force (F₁, F₂, F₃, F₄). Bump extension 1867 provides a variable longitudinal spring force (S₁, S₂, S₃, S₄), where S₄&gt;S₃&gt;S₂&gt;S₁&gt;F₄&gt;F₃&gt;F₂&gt;F₁is.

Figures 41A-41C show the clamp arm 1860 shown in Figure 40 under various loading conditions, according to at least one aspect of the present disclosure. FIG. 41A shows clamp arm 1860 in a new fired state with no load or evenly distributed load 1869. FIG. In FIG. 41B, the clamp arm 1860 is shown under high load conditions with a large force 1870 at the distal end and a small force 1874 at the proximal end. As shown, distal bump extension 1867 prevents maximum deflection of electrode 1868 . FIG. 41C shows the clamp arm 1860 under high load with a worn bump extension 1867, high load 1870 at the distal end, low load 1874 at the proximal end, and moderate load 1874 in the middle. There is a load 1872. Bump extension 1867 protects electrode 1868 from maximum deflection.

In one aspect, the present disclosure provides an end effector with integrated proximal/distal springs. Spring mechanisms can be added to both the distal and proximal ends of the electrodes. The spring mechanism can have many possible configurations, including stamped leaf springs, breakaway springs, or flexible materials that act as springs. These springs can be configured and adjusted to the desired pressure profile. Reducing the load on the proximal side may improve the longevity of the clamp arm pads. Alternatively, applying more load distally may provide better tip performance. All of the following configurations include a metal electrode located above the clamp arm, a wear-resistant material on the metal electrode to set the gap between the metal electrode and the ultrasonic blade, and a flexible material on the clamp arm. Including higher materials. The metal electrode is also somehow connected to one pole of the bipolar RF generator and the opposite side of the clamp arm is a titanium ultrasonic blade connected to the other pole of the bipolar RF generator. A titanium ultrasonic blade can vibrate when driven by an ultrasonic transducer.

FIG. 42 illustrates a general configuration of end effector 1880, according to at least one aspect of the present disclosure. FIG. 43 is a top view of electrode 1886 showing opening 1887 for receiving compliant material 1888 therethrough. Here, FIGS. 42 to 43 are referred to. End effector 1880 comprises clamp arm 1882 , ultrasonic blade 1884 , electrode 1886 , flexible material 1888 and hard wear resistant material 1890 . A flexible material 1888 is secured to clamp arm 1882 and acts as a spring between electrode 1886 and clamp arm 1882 . A hard wear resistant material 1890 is secured to the proximal end of electrode 1886 to set a gap between electrode 1886 and clamp arm 1882 .

Figures 44-45 illustrate a first configuration of the end effector 1880 shown in Figures 42-43, according to at least one aspect of the present disclosure. End effector 1880 includes leaf spring element 1892 at distal end 1894 of electrode 1886 . Proximal end 1896 of electrode 1886 is attached to clamp arm 1882 at point 1889 . 45 is an enlarged view of distal end 1894 of electrode 1886 showing leaf spring element 1892. FIG. A leaf spring element 1892 is symmetrically disposed at the distal end of electrode 1886 .

Figures 46-48 illustrate a second configuration of the end effector 1880 shown in Figures 42-43, according to at least one aspect of the present disclosure. End effector 1880 includes leaf spring element 1896 at distal end 1894 of electrode 1886 . Electrode 1886 is attached to the RF generator via wire 1898 provided through tube 1900 . 47 is a cross-sectional view of tube 1900 showing ultrasonic blade 1884 and wire 1898. FIG. 48 is a cross-sectional view of clamp arm 1882 showing electrode 1886 and leaf spring element 1896. FIG.

FIG. 49 shows a third configuration of the end effector 1880 shown in FIGS. 42-43, according to at least one aspect of the present disclosure. The end effector comprises a compressible material 1902 attached to the bottom portion of distal end 1894 of electrode 1886 . Distal end 1894 of clamp arm 1882 defines pocket 1904 for receiving compressible material.

Additional background disclosure can be found in International Patent Application Publication No. 2017/198672, which is incorporated herein by reference in its entirety.

In various aspects, the present disclosure provides a combined ultrasonic/bipolar RF energy surgical device configured to reduce tissue gaps for RF welding while minimizing electrode shorting with ultrasonic blades. Provide an end effector for the device. In one aspect, the end effector components include a DLC or PTFE (Teflon) coating to prevent shorting of the ultrasonic blade to the electrodes while allowing zero gap. In one aspect, an end effector comprising a non-conductive support includes electrodes and electrodes to prevent contact of the opposing electrodes with the ultrasonic blade within a return path defined by the ultrasonic blade and the waveguide. Define the minimum gap between the ultrasonic blade. In one aspect, the first polymer is positioned to interact with the ultrasonic blade to create adequate pressure while minimizing damage to the ultrasonic blade. A second polymer spacer is also provided to avoid damage from the ultrasonic blade and to minimize zero-gap impact with the flexible metal electrode. In another aspect, the proximal end of the flexible metal electrode has a feature that interacts with the jaw support, which is flexible when the jaws are closed beyond a predetermined level. It is designed to induce deflection of metal electrodes.

In various aspects, the present disclosure provides combined ultrasound/bipolar RF energy surgical devices and systems. Various configurations are for surgical instruments with ultrasonic and/or electrosurgical (RF) end effectors configured to treat, dissect, cut, and/or coagulate tissue during surgery. Intended for user interfaces. In one form, a user interface is provided for a combined ultrasound and electrosurgical instrument, which can be configured for use in open surgery, but in either hand-held or robot-assisted surgery. It also has applications in other types of surgery, such as minimally invasive laparoscopy and non-invasive endoscopy. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or in combination. For example, versatility is through the selective use of ultrasound and electrosurgical energy (e.g., monopolar or bipolar RF energy), whether concurrently, independently, sequentially, or in combination. can be achieved.

In one aspect, the present disclosure provides a user interface for a device comprising an ultrasonic blade and a clamp arm comprising a deflectable RF electrode, the ultrasonic blade and the deflectable RF electrode cooperatively providing an RF The cooperation of the clamping mechanism of the device with the electrodes and the associated ultrasonic blade provides tissue sealing, cutting and clamping. The clamping mechanism includes pivoting clamping arms that cooperate with ultrasonic blades to grasp tissue therebetween. The clamping arm is preferably provided with a clamping tissue pad (also known as a "clamping arm pad"), which comprises a plurality of axially spaced apart gripping teeth, segments, elements or individuals. has a unit of They facilitate grasping and grasping of tissue during surgery while cooperating with the ultrasonic blade of the end effector to achieve the desired sealing and cutting effect on tissue.

In one aspect, an end effector described herein comprises an electrode. In other aspects, the end effectors described herein comprise alternatives to the electrodes described above. This provides RF energy coupling to the tissue that conforms to the shape of the tissue, adapts to pad wear/thinning, minimizes excessive heat generation (low coefficient of friction, pressure), and reduces sparks. Minimize generation, minimize interruptions due to electrical shorts, or a combination thereof. The electrodes are fixed at the proximal end to the clamping jaws and free to deflect at the distal end. Accordingly, electrodes may be referred to as cantilever beam electrodes or deflectable electrodes throughout this disclosure.

In other aspects, the end effectors described herein apply high pressure between the pad and the ultrasonic blade to grasp and seal tissue, e.g., thin tissue, lateral tension Maximizes the likelihood of contacting tissue in constrained or difficult scenarios such as tissue under tension, lifting/vertical tension, especially lifting away from the clamp arm a clamp arm mechanism configured to

In other aspects, the end effectors described herein balance the surface area/current density match between the electrodes to balance and minimize heat transfer from the interface with the tissue, e.g. It is designed to affect formation and symmetry, and also influence cycle time, residual heat energy, and the like. In other aspects, the end effectors described herein are configured to minimize sticking, tissue attachment (minimize anchor points) and may include small polyimide pads.

In various aspects, the present disclosure is configured to deliver at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. to provide a surgical device that The surgical device includes a first activation button switch for activating energy and a second button switch for selecting an energy mode of the activation button switch. A second button switch is connected to a circuit that defines an energy mode using at least one input parameter. Input parameters can be modified remotely via connection to the generator or software update.

In one aspect, at least one of the energy modes is a simultaneous blend of RF energy and ultrasonic energy, and the input parameter represents the duty cycle of RF energy and ultrasonic energy.

In one aspect, the second button switch is configurable to select from a predetermined list of modes, the number of modes in the list being defined by a second user-defined input parameter.

In one aspect, the input parameter is either duty cycle, voltage, frequency, pulse width, or current.

In one aspect, the device also includes a visual indicator of the selected energy mode within the portion of the device within the surgical field.

In one aspect, the second button switch is a separate control from the end effector closure trigger.

In one aspect, the second button switch is configured to be actuated in the second phase of the closing trigger. The first step of the closure trigger in the closing direction is to actuate the end effector.

In one aspect, at least one of the energy modes is selected from ultrasound, RF dipole, RF monopolar, microwave, or IRE.

In one aspect, at least one of the energy modes is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE and configured to be applied with a predetermined duty cycle or pulse algorithm.

In one aspect, at least one of the energy modes is selected from sequential application of two or more of the following energy types: ultrasonic, RF dipole, RF monopolar, microwave, or IRE.

In one aspect, at least one of the energy modes is a simultaneous blend of two or more of the following energy types: ultrasonic, RF dipole, RF monopolar, microwave, and IRE.

In one aspect, at least one of the energy modes is a simultaneous blend of two or more of the following energy types: ultrasonic, RF dipole, RF monopolar, microwave, and IRE, followed by and one or more of

In one aspect, at least one of the energy modes is one of the following energy types: ultrasonic, RF dipole, RF monopolar, microwave, and IRE, followed by two of the aforementioned energy types. Simultaneous blending of the above.

In one aspect, at least one of the energy modes is a surgery-specific or tissue-specific predetermined algorithm.

In one aspect, at least one of the energy modes is compiled from a learned surgical act or activity.

In one aspect, the input parameter is at least one of energy type, duty cycle, voltage, frequency, pulse width, current, impedance limit, activation time, or energy blend.

In one aspect, the second button switch is configurable to select from a predetermined list of modes, the number of modes in the list being predefined or defined by a second input. either defined by parameters.

In one aspect, the aforementioned energy modes are made available to users through software updates to the generator.

In one aspect, the aforementioned energy modes are made available to the user through a software update to the device.

In one aspect, the user's preferred selection is made available to multiple generators either through networking, the cloud, or manual transfer.

In one aspect, the device also includes a visual indicator of the selected energy mode within the portion of the device within the surgical field.

As used herein, a button switch is a manually, mechanically or electrically operated electromechanical device with one or more sets of electrical contacts that connect to an external circuit. could be. Each set of electrical contacts can be in one of two states: the "closed" state means the contacts are in contact and electricity can flow between them; state means that the contacts are separated and the switch is not conducting electricity. Mechanisms that actuate the transition between these two states (open or closed) can be of the "alternating action" type (continuously "on" or "off" when the switch is flipped) or "momentary". type ("on" when pressed, "off" when released).

In one aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device including mode selection and visual feedback on the device. As surgical devices evolve and become more capable, the number of specialized modes in which they can operate increases. Adding additional button switches on the device to accommodate these new additional modes complicates the user interface and makes the device more difficult to use. Accordingly, the present disclosure provides techniques for assigning different modes to a single physical button switch without adding complexity to the housing design (e.g., adding more and more button switches). , allowing the selection of modes from a wider range. In one aspect, the housing is in the form of a handle or pistol grip.

As more specialized modes become available, there is a need to provide more modes to the surgeon using the surgical device without creating a complicated user interface. Surgeons would like to be able to control mode selection from the sterile field rather than relying on circulating nurses at the generator site. Surgeons want real-time feedback so that they can be confident that they know which mode has been selected.

FIG. 50 shows device 100 with mode selection button switch 130 on surgical device 100, according to at least one aspect of the present disclosure. Surgical device 100 comprises a housing 102 defining a handle 104 in the form of a pistol grip. The housing 102 includes a trigger 106 that is received within the interior space defined by the handle 104 when the trigger 106 is squeezed. Trigger 106 is used to operate clamp arm 111 portion of end effector 110 . Clamp jaw 112 is pivotally movable about pivot point 114 . Housing 102 is coupled to end effector 110 via shaft 108 rotatable by knob 122 .

End effector 110 comprises clamp arm 111 and ultrasonic blade 116 . Clamp arm 111 comprises clamp jaw 112 , electrode 118 and clamp arm pad 120 . In one aspect, the clamp arm pads 120 are made of a non-stick, lubricious material such as PTFE or similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a hydrophobic, non-wetting, high density, high temperature resistant, versatile material with non-stick properties. Clamp arm pads 120 are non-conductive. In contrast, electrodes 118 are made of conductive materials for delivering electrical energy, eg, monopolar RF, bipolar RF, microwaves, or irreversible electroporation (IRE). The electrodes 118 can comprise gap setting pads made of a polyimide material, in one aspect, for example, a durable high performance polyimide-based plastic manufactured by DuPont and known under the trade name VESPEL, or For example, made from other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyetherketone), PEKK (polyetherketoneketone) polymer alloys. Unless otherwise stated below, the clamp arm pads and gap pads described herein below are made of the materials described in this paragraph.

Electrode 118 and ultrasonic blade 116 are coupled to generator 133 . Generator 133 is configured to drive RF, microwave, or IRE energy to electrode 118 . Generator 133 is also configured to drive an ultrasonic transducer that is acoustically coupled to ultrasonic blade 116 . In one particular implementation, electrode 118 is one pole of the electrical circuit and ultrasonic blade 116 is the opposite pole of the electrical circuit. Housing 102 includes switch 124 for activating ultrasonic blade 116 . The circuitry may be housed in housing 102 or may reside within generator 133 . Surgical device 100 is coupled to generator 133 via cable 131 . Cable 131 carries signals for the electrosurgical function and the ultrasound transducer.

In various embodiments, surgical device 100 applies at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF) to tissue located within end effector 110 between clamp arm 111 and ultrasonic blade 116. , microwaves, or irreversible electroporation [IRE]). Housing 102 of surgical device 100 includes a first activation button switch 126 for activating energy and a second, "mode" button switch 130 for selecting an energy mode for said activation button switch. include. A second button switch 130 is connected to circuitry that defines an energy mode using at least one input parameter. Input parameters can be modified remotely via connection to the generator or software update. Energy modes are displayed on user interface 128 .

In one aspect, surgical instrument 100 provides mode switching via a direction selector "mode" button switch 130 on the device. The user can switch between different modes by pressing the mode button switch 130, and colored lights on the user interface 128 indicate the selected mode.

According to various aspects of the present disclosure, different operating modes can be assigned to the surgical device by pressing the "mode" button switch 130, but each time the mode button switch 130 is pressed, or remains pressed, the Each time it is held, surgical device 100 cycles through the available modes displayed on user interface 128 . Once a mode is selected, generator 133 provides an appropriate tone representative of the generator and surgical device 100 displays a lighted indicator on user interface 128 to indicate which mode has been selected. have.

In the example shown in FIG. 50, the "mode" selection button switches 130 are symmetrically positioned on opposite sides of the housing 102. In the example shown in FIG. This allows both right-handed and left-handed surgeons to select/switch between modes without using their non-dominant hand. In this embodiment, the 'mode' select button switch 130 can toggle in many different directions, allowing the surgeon, at the generator 133 location, without having to ask a patrol to make adjustments. It is possible to select from a list of options and navigate through more complex choices remotely from the sterile field. In addition to the tones representing generator 133, illuminated indicators on user interface 128 of surgical device 100 provide feedback to the surgeon as to which mode is selected.

51A-51C illustrate three options for selecting various modes of operation of surgical device 100, according to at least one aspect of the present disclosure. In addition to the colored light user interface 128 on the housing 102 of the surgical device 100, the mode selection feedback can be heard and/or viewed through the generator 133 interface, where: The generator 133 verbalizes the selected mode and/or shows a description of the selected mode on the screen of the generator 133 .

FIG. 51A shows a first mode selection option 132A in which button switch 130 can be pushed forward 136 or backward 134 to sequentially switch surgical instrument 100 between different modes.

FIG. 51B shows a second mode selection option 132B in which button switch 130 is pushed up 140 or down 138 to sequentially switch surgical instrument 100 between different modes.

FIG. 51C shows a third mode selection option 132C in which button switch 130 is pushed forward 136, backward 134, upward 149, or downward 138 to sequentially switch surgical instrument 100 between different modes.

FIG. 52 shows device 150 with mode selection button switch 180 on the back of surgical device 150, according to at least one aspect of the present disclosure. Surgical device 150 includes a housing 152 that defines a handle 154 in the form of a pistol grip. Housing 152 includes a trigger 156 that is received within an interior space defined by handle 154 when the trigger 156 is squeezed. Trigger 156 is used to operate the clamp arm 161 portion of end effector 160 . Clamp jaw 162 is pivotally movable about pivot point 164 . Housing 152 is coupled to end effector 160 via shaft 158 rotatable by knob 172 .

End effector 160 comprises clamp arm 161 and ultrasonic blade 166 . Clamp arm 161 includes clamp jaw 162 , electrode 168 and clamp arm pad 170 . In one aspect, the clamp arm pads 170 are made of a non-stick lubricious material such as PTFE or similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a hydrophobic, non-wetting, high density, high temperature resistant, versatile material with non-stick properties. Clamp arm pads 170 are non-conductive. In contrast, electrode 168 is made of a conductive material for delivering electrical energy, eg, monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrodes 168 can comprise gap setting pads made of a polyimide material, in one aspect, for example, a durable high performance polyimide-based plastic manufactured by DuPont and known under the trade name VESPEL, or For example, made from other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyetheretherketone), PEKK (polyetherketoneketone) polymer alloys. Unless otherwise stated below, the clamp arm pads and gap pads described herein below are made of the materials described in this paragraph.

Electrode 168 and ultrasonic blade 166 are coupled to generator 133 . Generator 133 is configured to drive RF, microwave, or IRE energy to electrode 168 . Generator 133 is also configured to drive an ultrasonic transducer that is acoustically coupled to ultrasonic blade 166 . In one particular implementation, the electrode 168 is one pole of the electrical circuit and the ultrasonic blade 166 is the opposite pole of the electrical circuit. Housing 152 includes switch 174 for activating ultrasonic blade 166 . The circuitry may be contained within housing 152 or may reside within generator 133 . Surgical device 150 is coupled to generator 133 via cable 181 . Cable 181 carries signals for the electrosurgical function and the ultrasound transducer.

In various embodiments, surgical device 100 applies at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF) to tissue located within end effector 110 between clamp arm 111 and ultrasonic blade 116. , microwaves, or irreversible electroporation [IRE]). Housing 102 of surgical device 100 includes a first activation button switch 126 for activating energy and a second, "mode" button switch 130 for selecting an energy mode for said activation button switch. include. A second button switch 130 is connected to circuitry that defines an energy mode using at least one input parameter. Input parameters can be modified remotely via connection to the generator or software update. Energy modes are displayed on user interface 128 .

In one aspect, surgical instrument 150 provides mode switching via a direction selector "mode" button switch 180 on the device. A user can switch between different modes by pressing the mode button switch 180, and colored lights on the user interface 178 indicate the selected mode.

According to various aspects of the present disclosure, different operating modes can be assigned to the surgical device by pressing the "mode" button switch 180, but each time the mode button switch 180 is pressed, or remains pressed, the Each time it is held, surgical device 150 cycles through the available modes displayed on user interface 178 . Once a mode is selected, generator 133 provides an appropriate tone representative of the generator and surgical device 150 displays a lighted indicator on user interface 178 to indicate which mode has been selected. have.

In the example shown in FIG. 52, the "mode" selection button switch 180 is located on the back of the surgical device 150. In the example shown in FIG. The position of the "mode" selection button switch 180 is out of reach of the surgeon's hand holding the surgical device 150, so another hand is required to change modes. This is intended to prevent inadvertent actuation. To change modes, the surgeon must use another hand to deliberately press the mode button switch 180 . In addition to the tones representing the generator, illuminated indicators on the user interface 178 of the surgical device 150 give feedback to the surgeon as to which mode is selected.

FIG. 53A shows a first mode selection option, showing the colored light mode selected on the user interface 178 when the mode button switch 180 is pressed to cycle through the various modes.

FIG. 53B shows a second mode selection option, showing the mode selected by screen 182 (eg, liquid crystal display, e-ink) when mode button switch 180 is pressed to cycle through the various modes. be.

FIG. 53C shows a third mode selection option, in which encoded lights 184 indicate the mode selected when the mode button switch 180 is pressed to cycle through the various modes.

FIG. 53D shows a fourth mode selection option wherein when encoded button switch 180 is selected and encoded button switch 186 is pressed to select a mode, the encoded button A fourth mode selection option is shown where the switch lights up to indicate the selected mode.

In one aspect, the present disclosure provides a combined ultrasound/bipolar RF energy surgical device including energy activation by trigger closure. As more functionality is added to advanced energy surgical devices, additional button switches or controls are added to the surgical device. Additional button switches or controls make these advanced energy surgical devices complex and difficult to use. Furthermore, when controlling bleeding using advanced energy surgical devices, a difficult-to-use user interface, or a difficult-to-access function, can be very time- and steals attention.

In accordance with the present disclosure, monopolar RF energy or advanced bipolar RF energy is activated by pulling the trigger past a first closure click to a second actuation click and holding it closed to release energy. The activated state continues until energy delivery is stopped by the power supply within the generator. Energy can also be reapplied immediately by slightly releasing and then re-squeezing the trigger as many times as needed.

FIG. 54 shows a surgical device 190 with a trigger 196 actuation mechanism, according to at least one aspect of the present disclosure. Surgical device 190 includes a housing 192 that defines a handle 194 in the form of a pistol grip. Housing 192 includes a trigger 196 that is received within an interior space defined by handle 194 when the trigger 196 is squeezed. Housing 192 is coupled to the end effector via shaft 198 rotatable by knob 202 . Surgical device 190 is coupled to generator 206 via cable 204 . Cable 204 carries signals for the electrosurgical function and the ultrasound transducer.

The trigger 196 is configured to operate the clamp arm portion of the end effector and trigger electrosurgical energy, thus eliminating the activation button switches 126, 176 shown in FIGS. Trigger 196 closes the jaws to grasp tissue when closed to a first audible and tactile click, and further closes to a second audible and tactile click to trigger monopolar, bipolar RF, microwave, or Activate electrosurgical energy, such as IRE energy. The entire sequence is completed by activating the front button switch which turns off the use of ultrasonic energy.

Procedure for operating surgical device 190: Squeeze trigger 196 to first audible and tactile click, identify target tissue in jaws, to second audible and tactile click, tone indicating end point. Activate the RF energy by further squeezing the trigger 196 until you hear , cut the tissue by pressing the ultrasonic front switch 200 until the tissue is divided.

Modified procedure for operating surgical instrument 190 for additional functionality: trigger 196 is used to activate and hold RF energy while simultaneously activating front button switch 200 to activate ultrasonic transducer. start up. This results in a simultaneous application in which electrosurgical and ultrasonic energy modalities are simultaneously delivered to the tissue.

In alternative implementations, the front button switch 200 for activating the ultrasonic energy may be switched to different speeds via a mode selector on the surgical device 190 or on the power generator 206.

The surgical instruments 100, 150, 190 and associated algorithms described above with respect to FIGS. 50-54, including the end effector of FIGS. in conjunction with the following surgical hub systems:

FIG. 55 shows an alternative clamp arm comprising metal clamp jaws, electrodes, multiple clamp arm pads, and a gap pad, according to at least one aspect of the present disclosure. FIG. 55 shows an alternative comprising a metal clamp jaw 2904, an electrode 2906, a plurality of clamp arm pads 2920 extending through holes in the electrode 2906, a gap pad 2930, and a gap pad 2910, according to at least one aspect of the present disclosure. Target clamp arm 2900 is shown. Electrode 2906 is attached to metal jaw 2906 at weld location 2908 . The electrode 2906 wraps around the metal clamp jaw 2904 and the electrode 2906 can be deflected. Gap pad 2910 has a top PI layer 2912 and a bottom elastomer layer 2914 for pressure control attached directly to metal clamping jaws 2904 . Clamp arm pads 2920 attach directly to metal clamp jaws 2904 . The clamp arm pad 2920 is also a composite pad with a high pressure central zone 2922 made of PTFE for heat reduction and an outer zone 2924 made of PI for deflection of the electrodes 2906.

In one aspect, a combined ultrasound/bipolar RF energy surgical device is configured to operate within a surgical hub system. FIG. 56 is a surgical system 3102 comprising a surgical hub 3106 paired with a visualization system 3108, a robotic system 3110, and an intelligent instrument 3112, according to at least one aspect of the present disclosure. Referring now to Figure 56, hub 3106 is configured in a manner similar to visualization system 3108, robotic system 3110, and surgical instruments 100, 150, 190 as described in Figures 50-55. Shown in communication with handheld intelligent surgical instrument 3112 . Hub 3106 includes hub display 3135 , imaging module 3138 , generator module 3140 , communication module 3130 , processor module 3132 and storage array 3134 . In certain aspects, the hub 3106 further includes a smoke evacuation module 3126 and/or an aspiration/irrigation module 3128, as shown in FIG.

During a surgical procedure, the application of energy to tissue for sealing and/or cutting is commonly associated with evacuating smoke, aspirating excess fluid, and/or irrigating the tissue. Fluid lines, power lines and/or data lines from different sources often become tangled during a surgical procedure. Valuable time may be lost in addressing this issue during surgery. Untangling the lines may require uncoupling the lines from their corresponding modules, which may require the modules to be reset. The hub's modular enclosure 3136 provides a unified environment for managing power, data, and fluid lines, reducing the frequency of tangling between such lines.

Aspects of the present disclosure present a surgical hub for use in surgical procedures involving the application of energy to tissue at a surgical site. The surgical hub includes a hub enclosure and a combination generator module slidably receivable within a docking station of the hub enclosure. The docking station includes data contacts and power contacts. A combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a unipolar RF energy generator component housed within a single unit. In one aspect, the combination generator module also includes a smoke evacuation component, at least one energy delivery cable for connecting the combination generator module to a surgical instrument, smoke generated by application of therapeutic energy to tissue, At least one smoke evacuation component configured to evacuate fluids and/or particulates, and a fluid line extending from the remote surgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluid line extends from a remote surgical site to an aspiration and irrigation module slidably received within the hub enclosure. . In one aspect, the hub enclosure includes a fluidic interface.

Certain surgical procedures may require the application of more than one energy type to tissue. One energy type may be more beneficial for cutting tissue, while another different energy type may be more beneficial for sealing tissue. For example, a bipolar generator can be used to seal tissue, while an ultrasonic generator can be used to cut the sealed tissue. Aspects of the present disclosure present a solution in which the hub's modular enclosure 136 is configured to house various generators and facilitate interactive communication therebetween. One advantage of the hub modular enclosure 136 is that it allows for quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosure for use in surgical procedures involving the application of energy to tissue. The modular surgical enclosure includes a first energy generator module configured to generate a first energy for application to tissue, a first data contact and a first power contact. a first docking station having a docking port, wherein the first energy generator module is slidably moveable into electrical engagement with the power contacts and the data contacts; The instrument module is slidably moveable out of electrical engagement with the first power contacts and the first data contacts.

Further to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy for application to the tissue, different from the first energy; a second docking station having a second docking port including data contacts and second power contacts, wherein the second energy generator module slides into electrical engagement with the power contacts and the data contacts; Moveably moveable, and the second energy generator module is slidably moveable out of electrical engagement with the second power contacts and the second data contacts.

Additionally, the modular surgical enclosure also includes a first docking port and a second docking port configured to facilitate communication between the first energy generator module and the second energy generator module. including the communication bus to and from the docking port of the

In one aspect, the present disclosure provides a generator configured to drive a combined ultrasound/bipolar RF energy surgical device. FIG. 57 shows an example generator 3900, according to at least one aspect of the disclosure. As shown in FIG. 57, generator 3900 is one form of generator configured to couple to surgical instruments 100, 150, 190 as described in FIGS. further configured to execute adaptive ultrasound and electrosurgical control algorithms within a surgical data network comprising a modular communication hub as shown in FIG. Generator 3900 is configured to deliver multiple energy modalities to a surgical instrument. Generator 3900 either singly or simultaneously provides RF and ultrasound signals for delivering energy to the surgical instrument. RF and ultrasound signals may be provided alone or in combination, and may be provided simultaneously. As described above, at least one generator output can transmit multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and/or reversible electroporation, and/or micro-energy, among others) through a single port. wave energy), and these signals can be delivered to the end effector individually or simultaneously to treat tissue. Generator 3900 comprises processor 3902 coupled to waveform generator 3904 . Processor 3902 and waveform generator 3904 are configured to generate various signal waveforms based on information stored in a memory (not shown for clarity of disclosure) coupled to processor 3902. there is Digital information associated with the waveform is provided to waveform generator 3904, which includes one or more DAC circuits for converting digital input to analog output. The analog output is provided to amplifier 3906 for signal conditioning and amplification. The conditioned and amplified output of amplifier 3906 is coupled to power transformer 3908 . signal to power transformer 390 8 and connected to the secondary on the patient isolation side. A first signal of a first energy modality is provided to the surgical instrument between terminals labeled ENERGY1 and RETURN. A second signal of a second energy modality is coupled across capacitor 3910 and provided to the surgical instrument between terminals labeled ENERGY2 and RETURN. More than two energy modalities may be output, so the subscript 'n' can be used to denote that up to n ENERGYn terminals can be provided, where n is 2 or more. It will be understood to be a positive integer. It will also be appreciated that up to 'n' return paths (RETURNn) may be provided without departing from the scope of the present disclosure.

A first voltage sensing circuit 3912 is coupled across terminals labeled ENERGY1 and RETURN paths to measure the output voltage therebetween. A second voltage sensing circuit 3924 is coupled across terminals labeled ENERGY2 and RETURN paths to measure the output voltage therebetween. A current sensing circuit 3914 is arranged in series with the RETURN leg on the secondary side of the power transformer 3908 as shown to measure the output current of either energy modality. If different return paths are provided for each energy modality, separate current sensing circuitry must be provided for each return leg. The outputs of the first voltage sensing circuit 3912 and the second voltage sensing circuit 3924 are provided to respective isolation transformers 3916, 3922, and the output of the current sensing circuit 3914 is provided to another isolation transformer 3918. . The outputs of isolation transformers 3916 , 3928 , 3922 on the primary side (non-patient isolated side) of power transformer 3908 are provided to one or more ADC circuits 3926 . The digitized output of ADC circuitry 3926 is provided to processor 3902 for further processing and calculations. Output voltage and output current feedback information can be used to calculate output impedance, among other parameters, to adjust the output voltage and current provided to the surgical instrument. Input/output communication between processor 3902 and patient isolation circuitry is provided through interface circuitry 3920 . Sensors may also be in electrical communication with processor 3902 via interface circuit 3920 .

In one aspect, the impedance is the output of the first voltage sensing circuit 3912 coupled across the terminals labeled ENERGY1/RETURN or the output of the second voltage sensing circuit 3924 coupled across the terminals labeled ENERGY2/RETURN. Either of the outputs may be determined by processor 3902 by dividing by the output of current sensing circuit 3914 placed in series with the RETURN leg on the secondary side of power transformer 3908 . The output of the first voltage sensing circuit 3912 and the output of the second voltage sensing circuit 3924 are provided to separate isolation transformers 3916, 3922 and the output of the current sensing circuit 3914 is provided to another isolation transformer 3916. be. Digitized voltage sensing and current sensing measurements from ADC circuitry 3926 are provided to processor 3902 to calculate impedance. As an example, the first energy modality ENERGY1 may be ultrasonic energy and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to ultrasound energy modalities and bipolar or unipolar RF energy modalities, other energy modalities include, among others, irreversible electroporation energy and/or reversible electroporation energy and/or micro wave energy and the like. Also, while the example illustrated in FIG. 57 shows that a single return path RETURN may be provided for more than one energy modality, in other embodiments multiple return paths RETURNn may be provided for each May be provided for the energy modality ENERGYn. Thus, as described herein, the impedance of an ultrasound transducer may be measured by dividing the output of the first voltage sensing circuit 3912 by the output of the current sensing circuit 3914, resulting in tissue impedance may be measured by dividing the output of the second voltage sensing circuit 3924 by the output of the current sensing circuit 3914

As shown in FIG. 57, a generator 3900 with at least one output port can include a power transformer 3908 with a single output and with multiple taps. The power transformer 3908 converts power to, for example, ultrasound, bipolar RF or monopolar RF, irreversible electroporation energy and/or reversible electroporation energy, among others, depending on the type of tissue treatment being performed. ration energy and/or in the form of one or more energy modalities such as microwave energy to the end effector. For example, the generator 3900 delivers high voltage, low current energy to drive an ultrasound transducer, low voltage, high current energy to drive an RF electrode to seal tissue, Alternatively, energy with a coagulation waveform can be delivered for spot coagulation using either monopolar RF electrosurgical electrodes or bipolar RF electrosurgical electrodes. The output waveform from generator 3900 can be induced, switched or filtered to provide frequencies to the end effector of the surgical instrument. The connection to the output of the ultrasonic transducer generator 3900 will preferably be located between the outputs labeled ENERGY1 and RETURN shown in FIG. In one embodiment, the connection to the output of the RF bipolar electrode generator 3900 will preferably be located between the outputs labeled ENERGY2 and RETURN. For a unipolar output, the preferred connections would be to connect the active electrode (eg pencil or other probe) to the ENERGY2 output and connect a suitable return pad to the RETURN output.

Additional details can be found in U.S. Patent Application Publication No. 2017/0086914, published March 30, 2017, entitled TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS, which is incorporated herein by reference in its entirety. disclosed in No.

In one aspect, the present disclosure provides a modular energy system configured to drive a combined ultrasound/bipolar RF energy surgical device. FIG. 58 is a diagram of various modules and other components that can be combined to customize a modular energy system, according to at least one aspect of the disclosure. FIG. 59A includes a header module and a display screen representing a graphical user interface (GUI) for relaying information about modules connected to the header module, according to at least one aspect of the present disclosure; 1 is a first exemplary modular energy system configuration; FIG. 59B is the modular energy system shown in FIG. 59A mounted on a cart, according to at least one aspect of the present disclosure.

57-59B, due to the amount of equipment required to perform surgical procedures, operating rooms around the world have become a tangled web of cords, equipment, and people. there is Surgical capital equipment tends to be the primary source of this problem because most surgical capital equipment performs a single specialized task. Due to their specialized nature, operating rooms require surgical capital equipment, such as energy generators, to utilize multiple different types of equipment during the course of a single surgical procedure. You may be forced to stockpile 2 pieces or even more pieces. Each piece of these surgical capital equipment must be individually plugged into a power source and may be connected to one or more other devices that are passed between operating room personnel. Yes, it can tangle the cord and require guidance. Another problem faced in modern operating rooms is that each of these specialized surgical capital equipment has its own user interface and is controlled independently of other pieces of equipment in the operating room. It is a must. This complicates the proper control of multiple different devices by connecting them together, requiring users to be trained and memorized in different types of user interfaces (these user interfaces may further change based on the task or surgery being performed, in addition to changing between each piece of capital equipment). This cumbersome and complicated process can require the presence of even more individuals in the operating room and can create hazards if multiple devices are not properly controlled from each other. be. Therefore, by consolidating surgical capital equipment technology into a single system that can flexibly meet the needs of the surgeon, reducing the surgical capital equipment footprint in the operating room, the user experience is simplified and the surgical Room clutter is reduced and the difficulties and hazards associated with controlling multiple pieces of capital equipment simultaneously are avoided It will happen. Further, by making such systems scalable or customizable, new technology can be conveniently incorporated into existing surgical systems, eliminating the need to replace entire surgical systems, or eliminating the need to replace entire surgical systems or personnel will not have to learn new user interfaces or equipment controls with each new technology.

The surgical hub interchangeably designates various modules that can interface with surgical devices (e.g., surgical instruments or smoke evacuators) or provide various other functions (e.g., communications). It can be configured to accept In one aspect, the surgical hub can be embodied as a modular energy system 4000, shown in connection with FIGS. 58-59B. A modular energy system 4000 can include a variety of different modules 4001 that are connectable together in a stacked configuration. In one aspect, modules 4001 may be physically and communicatively coupled when stacked or otherwise connected together into a single assembly. Further, modules 4001 may be interchangeably connectable to each other in different combinations or arrangements. In one aspect, each of the modules 4001 can include a consistent or universal array of connectors disposed along their upper and lower surfaces such that any module 4001 can to be connected to another module 4001 in an arrangement (although in some aspects certain module types, such as the header module 4002, serve, for example, as the topmost positioned module in a stack). can be configured as follows). In alternative aspects, the modular energy system 4000 can include a housing configured to receive and hold the modules 4001 as shown in FIG. Modular energy system 4000 can also include a variety of different components or accessories that can be connected to or otherwise associated with module 4001 . In another aspect, the modular energy system 4000 can be embodied as generator modules 3140, 3900 of the surgical hub 3106 (FIGS. 56-57). In yet another aspect, the modular energy system 4000 is a separate system from the surgical hub 3106. can be a system. In such aspects, modular energy system 4000 may be communicatively coupleable to surgical hub 3106 for transmitting and/or receiving data therebetween.

A modular energy system 4000 can be assembled from a variety of different modules 4001, some examples of which are shown in FIG. Each of the different types of modules 4001 can provide different functions, thereby assembling the modular energy system 4000 into different configurations by customizing the modules 4001 included in each modular energy system 4000, The functionality and capabilities of the modular energy system 4000 can be customized. Modules 4001 of modular energy system 4000 may include, for example, header module 4002 (which may include display screen 4006), energy module 4004, technology module 4040, and visualization module 4042. In the aspect shown, header module 4002 is configured to function as a top or top module in a modular energy system stack, and thus may lack connectors along its top surface. In another aspect, the header module 4002 can be configured to be positioned at the bottom in a modular energy system stack, or to be the bottom module, so that the connectors along its bottom surface are may be absent. In yet another aspect, the header module 4002 may be configured to be positioned at an intermediate position within a modular energy system stack, and thus may include connectors along both its bottom and top surfaces. Header module 4002 provides system-wide settings for each module 4001 and the components connected to them through physical controls 4011 on header module 4002 and/or a graphical user interface displayed on display screen 4006 ( GUI) 4008. One such setup is the launch of the Modular Energy System 4000. movement, alarm volume setting, footswitch setting, setting icon, user interface appearance or configuration, surgeon profile logged into the Modular Energy System 4000, and/or the type of surgical procedure being performed. be. Header module 4002 may also be configured to provide communication, processing, and/or power for modules 4001 connected to header module 4002 . Energy module 4004, which may also be referred to as generator modules 3140, 3900 (FIGS. 56-57), is an electrosurgical and electrosurgical power module 4004 connected to energy module 4004 as described above with respect to generator 3900 shown in FIG. /or may be configured to generate one or more energy modalities for driving an ultrasonic surgical instrument. Technology module 4040 may be configured to provide additional or enhanced control algorithms (eg, electrosurgical or ultrasonic control algorithms for controlling the energy output of energy module 4004). A visualization module 4042 can be configured to interface with a visualization device (ie, a scope), thus providing enhanced visualization capabilities. may be configured to generate a security. Technology module 4040 may be configured to provide additional or enhanced control algorithms (eg, electrosurgical or ultrasonic control algorithms for controlling the energy output of energy module 4004). A visualization module 4042 can be configured to interface with a visualization device (ie, a scope), thus providing enhanced visualization capabilities. may be configured to generate a security. Technology module 4040 may be configured to provide additional or enhanced control algorithms (eg, electrosurgical or ultrasonic control algorithms for controlling the energy output of energy module 4004). A visualization module 4042 can be configured to interface with a visualization device (ie, a scope), thus providing enhanced visualization capabilities.

The modular energy system 4000 can be connected to the module 4001 to control the functionality of the module 4001 or otherwise configured to work in conjunction with the modular energy system 4000. Various Further accessories 4029 can be included. Accessories 4029 may include, for example, a single-pedal footswitch 4032, a dual-pedal footswitch 4034, and a cart 4030 for mounting and supporting the modular energy system 4000 thereon. Foot switches 4032 , 4034 may be configured to control the activation or function of specific energy modalities output by energy module 4004 , for example.

By utilizing modular components, the illustrated modular energy system 4000 provides a surgical platform that grows with technology availability and is customizable to the needs of the facility and/or surgeon. Additionally, the modular energy system 4000 supports multiple devices (eg, dual electrosurgical and ultrasonic energy generators) and supports software-driven algorithms for customized effects on tissue. Still further, the surgical system architecture reduces the capital equipment footprint by combining multiple techniques critical to surgery into a single system.

Various modular components available in conjunction with the Modular Energy System 4000 include monopolar energy generators, bipolar energy generators, dual electrosurgical/ultrasonic energy generators, display screens, as well as various others. modules and/or other components, some of which have also been previously described in connection with Figures 1-55.

Referring now to FIG. 59A, the header module 4002 can, in some aspects, include a display screen 4006 that displays a GUI 4008 for relaying information regarding the modules 4001 connected to the header module 4002. In some aspects, the GUI 4008 of the display screen 4006 can provide a unified control point for all of the modules 4001 that make up a particular configuration of the modular energy system 4000. In alternative aspects, header module 4002 may lack display screen 4006 or display screen 4006 may be removably connected to housing 4010 of header module 4002 . In such aspects, header module 4002 may be communicatively coupleable to an external system configured to display information generated by modules 4001 of modular energy system 4000 . For example, in a robotic surgical application, the modular energy system 4000 may be communicatively coupleable to a robotic cart or robotic control console, where the robotic cart or robotic control console is responsible for information generated by the modular energy system 4000. to an operator of the robotic surgical system. As another example, modular energy system 4000 may be communicatively coupleable to a mobile display that is carried by or attached to a surgical staff member to view information through the mobile display. is possible. In yet another example, modular energy system 4000 may be communicatively coupleable to surgical hub 4100 or to another computer system that may include display 4104 . A user interface that is separate from or otherwise distinguished from the Modular Energy System 4000.

Still referring to FIG. 59A, the energy module 4004 can include a port assembly 4012 that includes a number of different ports that connect different energy modalities to respective corresponding surgical instruments. configured to deliver to 58-59B, the port assembly 4012 includes a bipolar port 4014, a first unipolar port 4016a, a second unipolar port 4018b, and a neutral port 4018 (unipolar return). a port to which a pad can be connected) and a combined energy port 4020. However, this particular combination of ports is provided for illustrative purposes only, and alternate combinations of ports and/or energy modalities may be possible for port assembly 4012.

As noted above, the modular energy system 4000 can be assembled into different configurations. Further, different configurations of modular energy system 4000 may also be available for different surgical types and/or different tasks. For example, FIGS. 59A and 59B show a first exemplary configuration of a modular energy system 4000 including a header module 4002 (including a display screen 4006) and an energy module 4004 connected together. Such configurations may be suitable for laparoscopic and open surgery, for example.

60-64 illustrate an exemplary surgical system 10 with ultrasonic and electrosurgical capabilities including any one of the end effectors, surgical instruments, and generators described herein. show. FIG. 60 shows surgical system 10 including generator 12 and surgical instrument 14 . Surgical instrument 14 is operatively connected to generator 12 via power cable 16 . The generator 12 is operable to power the surgical instrument 14 to produce ultrasonic energy for cutting tissue and bipolar electrosurgical RF energy for sealing tissue (i.e., therapeutic level of RF energy). In one aspect, the generator 12 is configured to power the surgical instrument 14 to deliver ultrasonic energy and electrosurgical bipolar RF energy either simultaneously or independently.

Surgical instrument 14 of the present example includes handle assembly 18 , shaft assembly 20 extending distally from handle assembly 18 , and end effector 22 disposed at the distal end of shaft assembly 20 . Handle assembly 18 includes a body 24 that includes a pistol grip 26 and energy control buttons 28, 30 configured to be operated by a surgeon. A trigger 32 is connected to the lower portion of body 24 . Trigger 32 is pivotable toward and away from pistol grip 26 to selectively actuate end effector 22, as described in more detail below. In other suitable variations of surgical instrument 14, handle assembly 18 may include, for example, a scissor grip configuration. An ultrasonic transducer 34 is housed within and supported by body 24 . In other configurations, ultrasonic transducer 34 may be provided external to body 24 .

As shown in FIGS. 61 and 62, the end effector 22 includes an ultrasonic blade 36 and a clamp arm 38 that selectively moves toward and away from the ultrasonic blade 36. It is configured to pivot to clamp tissue with the ultrasonic blade 36 . The ultrasonic blade 36 is acoustically coupled to the ultrasonic transducer 34, which drives (i.e. vibrates) the ultrasonic blade 36 at ultrasonic frequencies into contact with the ultrasonic blade 36. configured to cut and/or seal tissue positioned on the A clamp arm 38 is operably coupled to the trigger 32 such that the clamp arm 38 pivots toward the ultrasonic blade 36 to the closed position in response to pivoting of the trigger 32 toward the pistol grip 26. is configured as Additionally, clamp arm 38 is configured to pivot away from ultrasonic blade 36 to an open position in response to pivoting trigger 32 away from pistol grip 26 (e.g., FIG. 60). ~see Figure 62). Various suitable ways in which the clamp arm 38 may be coupled with the trigger 32 will be apparent to those skilled in the art in view of the teachings provided herein. In some variations, one or more resilient members may be incorporated to bias clamp arm 38 and/or trigger 32 toward the open position.

A clamp pad 40 is secured to the clamp side of clamp arm 38 facing ultrasonic blade 36 and extends distally along the clamp side. Clamp pad 40 is configured to engage a corresponding tissue treatment portion of ultrasonic blade 36 and clamp tissue against that portion when clamp arm 38 is actuated to its closed position. At least the clamp side of the clamp arm 38 is provided with a first electrode 42 , referred to herein as the clamp arm electrode 42 . Additionally, at least the clamp side of the ultrasonic blade 36 is provided with a second electrode 44 , referred to herein as the blade electrode 44 . Electrodes 42 , 44 are configured to apply electrosurgical bipolar RF energy provided by generator 12 to tissue electrically coupled with electrodes 42 , 44 . The clamp arm electrode 42 may function as the active electrode while the blade electrode 44 functions as the return electrode, or vice versa. The surgical instrument 14 may vibrate the ultrasonic blade 36 at the ultrasonic frequency, before vibrating the ultrasonic blade 36 at the ultrasonic frequency, and/or after vibrating the ultrasonic blade 36 at the ultrasonic frequency. , to apply electrosurgical bipolar RF energy through the electrodes 42,44.

As shown in FIGS. 60-64, the shaft assembly 20 extends along a longitudinal axis and includes an outer tube 46, an inner tube 48 received within the outer tube 46, and a tube within the inner tube 48. and a supported ultrasonic waveguide 50 . As best seen in FIGS. 61-64, clamp arms 38 are coupled to the distal ends of inner tube 48 and outer tube 46, respectively. Specifically, clamp arm 38 includes a pair of proximally extending clevis arms 52 that receive therebetween a distal end 54 of inner tube 48 and a clevis arm. It is pivotally connected to distal end 54 of inner tube 48 by arm 52 and pivot pin 56 received through a through hole formed in distal end 54 of inner tube 48 . A first finger 58 and a second clevis finger 58 depend downwardly from clevis arm 52 and are pivotally connected to distal end 60 of outer tube 46 . Specifically, each clevis finger 58 includes a projection 62 that is rotatably received within a corresponding opening 64 formed in a sidewall of distal end 60 of outer tube 46 .

In this embodiment, inner tube 48 is longitudinally fixed relative to handle assembly 18 and outer tube 46 translates relative to inner tube 48 and handle assembly 18 along the longitudinal axis of shaft assembly 20 . is configured as As outer tube 46 translates distally, clamp arm 38 pivots about pivot pin 56 toward its open position. As outer tube 46 translates proximally, clamp arm 38 pivots in the opposite direction toward its closed position. The proximal end of outer tube 46 is operably coupled to trigger 32 , eg, via a linkage assembly, such that actuation of trigger 32 causes translation of outer tube 46 relative to inner tube 48 , thereby clamping arm 38 . is opened and closed. In other suitable configurations not shown here, the outer tube 46 may be longitudinally fixed and the inner tube 48 translates to move the clamp arm 38 between its open and closed positions. may be configured to be moved by

Shaft assembly 20 and end effector 22 are configured to rotate together about the longitudinal axis relative to handle assembly 18 . Retaining pins 66, shown in FIG. 63, extend laterally through proximal portions of each of outer tube 46, inner tube 48, and waveguide 50, thereby rotating these components relative to each other. connect as possible. In the present example, a rotation knob 68 is provided at the proximal end portion of shaft assembly 20 to facilitate rotation of shaft assembly 20 and end effector 22 relative to handle assembly 18 . Rotation knob 68 is rotatably secured to shaft assembly 20 by retaining pin 66 extending through a proximal collar of rotation knob 68 . It will be appreciated that in other suitable configurations, the rotary knob 68 may be omitted or replaced with an alternative rotary actuation structure.

The ultrasonic waveguide 50 is acoustically coupled at its proximal end to the ultrasonic transducer 34 and at its distal end acoustically to the ultrasonic blade 36, for example by a threaded connection, as shown in FIG. Combined. The illustrated ultrasonic blade 36 is formed integrally with the waveguide 50 , with the blade 36 extending directly distally from the distal end of the waveguide 50 . In this manner, waveguide 50 acoustically couples ultrasonic transducer 34 with ultrasonic blade 36 and functions to transmit ultrasonic mechanical vibrations from transducer 34 to blade 36 . Accordingly, the ultrasonic transducer 34, waveguide 50, and ultrasonic blade 36 collectively define an acoustic assembly. In use, the ultrasonic blade 36 is placed in direct contact with tissue, with or without the auxiliary clamping force provided by the clamp arm 38, to impart ultrasonic vibrational energy to the tissue, thereby Tissue may be cut and/or sealed. For example, the blade 36 may cut tissue clamped between the clamp arm 38 and the first treatment side of the blade 36, or the blade 36 may, for example, be positioned during a "backward cutting" movement. Tissue located in contact with a second treatment side disposed opposite 36 may be cut. In some variations, waveguide 50 may amplify the ultrasonic vibrations delivered to blade 36 . Further, waveguide 50 may include various mechanisms operable to control the gain of oscillation and/or suitable mechanisms for tuning waveguide 50 to a selected resonant frequency. Further features of ultrasonic blade 36 and waveguide 50 are described in greater detail below.

Waveguide 50 is supported within inner tube 48 by a plurality of nodal support elements 70 positioned along the length of waveguide 50, as shown in FIGS. Specifically, the node support elements 70 are positioned longitudinally along the waveguide 50 at locations corresponding to acoustic nodes defined by resonant ultrasonic vibrations transmitted through the waveguide 50. . Node support elements 70 may provide structural support for waveguide 50, but also provide acoustic isolation between waveguide 50 and inner tube 48 and outer tube 46 of shaft assembly 20. obtain. Alternatively, the node support element 70 may include an O-ring. Waveguide 50 is supported at its most distal acoustic node by a node support element in the form of overmolded member 72 shown in FIG. The waveguide 50 is secured to the shaft assembly by a retaining pin 66 passing through a transverse through hole 74 formed in an acoustic node located proximally of the waveguide 50, such as the proximal-most acoustic node. It is longitudinally rotatably fixed within 20 .

In this embodiment, distal tip 76 of ultrasonic blade 36 is positioned to correspond to an antinode associated with resonant ultrasonic vibrations transmitted through waveguide 50 . With this configuration, when the ultrasonic blade 36 is not filled with tissue, the acoustic assembly of the instrument 14 is tuned to the preferred resonant frequency f_ocan be synchronized. When the ultrasonic transducer 34 is energized by the generator 12 to transmit mechanical vibrations through the waveguide 50 to the blades 36, the distal tips 76 of the blades 36 have a peak-to-peak amplitude of about 20-120 microns. In the range, for example in some cases about 20-50 micrometers, a predetermined vibration frequency f_ovibrate in the longitudinal direction. When the ultrasonic blade 36 is positioned in contact with tissue, the ultrasonic vibrations of the blade 36 simultaneously cut the tissue and denature proteins within adjacent tissue cells, thereby minimizing heat diffusion. It can provide an accompanying coagulating effect.

<p>Examples of various aspects of end effectors and surgical instruments of the present disclosure are provided below. Aspects of the end effector or surgical instrument can include any one or more of the examples described below, and any combination thereof.</p><p>Example 1. An end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator, comprising: , the clamping arm is a cantilever electrode configured to electrically couple to the clamping jaws, the plurality of variable longitudinal support elements, and the opposite poles of the electrical generator, the cantilever electrode being clamped at the proximal end. Fixed to the jaws and configured to be free to deflect at the distal end, the cantilevered electrode is supported by a variable longitudinal support element, the variable longitudinal support element providing a variable longitudinal support element to the cantilevered electrode from the proximal end to the distal end. An end effector comprising a cantilever electrode that applies a force.</p><p>Example 2. The end effector of Example 1, wherein the variable longitudinal support element limits the maximum deflection of the cantilever electrode.</p><p>Example 3. The end effector of any one of Examples 1-2, wherein the variable longitudinal support element comprises a plurality of springs with variable force (F).</p><p>Example 4. The end effector of Example 3, wherein the cantilever electrode further comprises a bump extension located on the cantilever electrode between the cantilever electrode and the clamp jaw.</p><p>Example 5. According to Example 4, a bump extension located on the cantilever electrode between the cantilever electrode and the clamping jaw limits the maximum deflection of the variable longitudinal support element with a variable longitudinal spring force (S). End effector as described.</p><p>Example 6. The end effector of Example 5, wherein the variable longitudinal spring force (S) is less than the variable force (F).</p><p>Example 7. The end effector of any one of Examples 1-6, wherein the clamp arm further comprises a clamp arm pad.</p><p>Example 8. An end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator, comprising: , the clamp arm supports the clamp jaw, the segmented electrode configured to electrically couple to the opposite pole of the electric generator, and the cantilever electrode, and as a spring between the cantilever electrode and the clamp jaw. An end effector comprising a flexible material operatively secured to a clamping jaw.</p><p>Example 9. The end effector of Example 8, wherein the clamp arm further comprises a hard wear resistant material secured to the cantilever electrode to set a gap between the cantilever electrode and the ultrasonic blade.</p><p>Example 10. According to Example 9, wherein the cantilever electrode comprises a hard wear resistant material secured to the proximal end of the cantilever electrode and a hard wear resistant material secured to the distal end of the cantilever electrode. end effector.</p><p>Example 11. The end effector of any one of Examples 8-10, wherein the cantilever electrode defines an opening for receiving the compliant material therethrough.</p><p>Example 12. An end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator, comprising: , the clamping arm comprises a clamping jaw, a cantilever electrode configured to electrically couple to opposite poles of the electrical generator, and a leaf spring element disposed at the distal end of the cantilever electrode. .</p><p>Example 13. The end effector of Example 12, wherein the proximal end of the cantilever electrode is fixedly attached to the clamp jaw.</p><p>Example 14. Any one of Examples 12-13, further comprising a hard wear-resistant pad disposed on the proximal end of the cantilever electrode to set a gap between the cantilever electrode and the clamp arm. The end effector described in 1.</p><p>Example 15. The end effector of any one of Examples 12-14, wherein the leaf spring defines a symmetry element on the lateral side of the distal end of the cantilever electrode.</p><p>Example 16. An end effector comprising a clamp arm and an ultrasonic blade, the clamp arm comprising a clamp jaw, a cantilever electrode, and a compressible material attached to the distal end of the cantilever electrode. end effector.</p><p>Example 17. The end effector of Example 16, wherein the compressible material attached to the distal end of the cantilever electrode is disposed between the cantilever electrode and the clamping jaws.</p><p>Example 18. The end effector of Example 16, wherein the distal ends of the clamping jaws define pockets for receiving the compressible material.</p><p>Example 19. A housing, ultrasonic transducer, and end effector configured to acoustically couple to a clamp arm and ultrasonic transducer and electrically couple to one pole of an electrical generator an end effector comprising an ultrasonic blade with a clamping arm electrically coupled to opposite poles of the clamping jaws, a plurality of variable longitudinal support elements, and an electrical generator a cantilevered electrode, the cantilevered electrode being fixed at the proximal end to the clamping jaws and free to deflect at the distal end, the cantilevered electrode being supported by a variable longitudinal support element; A surgical instrument, wherein the directional support element applies a variable force to the cantilevered electrode from a proximal end to a distal end.</p><p>Example 20. The surgical instrument of Example 19, wherein said variable longitudinal support element limits the maximum deflection of said cantilever electrode.</p><p>Example 21. The surgical instrument of any one of Examples 19-20, wherein the variable longitudinal support element comprises a plurality of springs with variable force (F).</p><p>Example22.An embodiment wherein the cantilever electrode further comprises a bump extension located on the cantilever electrode between the cantilever electrode and the clamp jaw.21Surgical instruments described in.</p><p>Example 23. According to Example 22, a bump extension located on the cantilever electrode between the cantilever electrode and the clamping jaw limits the maximum deflection of the variable longitudinal support element with a variable longitudinal spring force (S). A surgical instrument as described.</p><p>Example 24. The surgical instrument of Example 22, wherein the variable longitudinal spring force (S) is less than the variable force (F).</p><p>Example 25. The surgical instrument of any one of Examples 19-24, wherein the clamp arm further comprises a clamp arm pad.</p><p>Example 26. A housing, ultrasonic transducer, and end effector configured to acoustically couple to the clamp arm and ultrasonic transducer and electrically couple to one pole of an electrical generator an end effector comprising an ultrasonic blade with a clamping arm comprising a clamping jaw and a cantilever electrode electrically coupled to opposite poles of an electrical generator; equipment.</p><p>Example 27. The surgical instrument of Example 26, further comprising a compliant material secured to the clamping jaws to support the cantilevered electrode and act as a spring between the cantilevered electrode and the clamping jaws.</p><p>Example 28. The surgical instrument of Example 27, wherein the clamp arm further comprises a hard wear resistant material secured to the cantilever electrode for setting a gap between the cantilever electrode and the ultrasonic blade.</p><p>Example 29. According to Example 28, wherein the cantilever electrode comprises a hard wear resistant material secured to the proximal end of the cantilever electrode and a hard wear resistant material secured to the distal end of the cantilever electrode. surgical instruments.</p><p>Example 30. The surgical instrument of any one of Examples 27-29, wherein the cantilevered electrode defines an opening for receiving the compliant material therethrough.</p><p>Example 31. The surgical instrument of any one of Examples 26-30, further comprising a leaf spring element disposed at the distal end of the cantilever electrode.</p><p>Example 32. The surgical instrument of Example 31, wherein the proximal end of the cantilever electrode is fixedly attached to the clamp jaw.</p><p>Example 33. Any one of Examples 31-32, further comprising a hard wear-resistant pad disposed on the proximal end of the cantilever electrode to set a gap between the cantilever electrode and the clamp arm. The surgical instrument according to 1.</p><p>Example 34. The surgical instrument of any one of Examples 31-33, wherein the leaf spring defines a symmetrical element on the lateral side of the distal end of the cantilever electrode.</p><p>Example 35. The surgical instrument of any one of Examples 26-34, further comprising a compressible material attached to the distal end of the cantilever electrode.</p><p>Example 36. The surgical instrument of Example 35, wherein the compressible material attached to the distal end of the cantilever electrode is disposed between the cantilever electrode and the clamp jaws.</p><p>Example 37. The surgical instrument of Example 36, wherein the distal ends of the clamp jaws define pockets for receiving the compressible material.</p><p>Although several forms have been shown and described, it is not the applicant's intention to limit or limit the scope of the appended claims to such details. Many modifications, variations, alterations, permutations, combinations and equivalents of these forms can be implemented and will occur to those skilled in the art without departing from the scope of this disclosure. Further, the structure of each element associated with the described form can be alternatively described as a means for providing the function performed by that element. Also, although materials are disclosed for particular components, other materials may be used. Accordingly, the above description and appended claims are intended to cover all such modifications, combinations, and variations as included within the scope of the disclosed forms. Please understand. The appended claims are intended to cover all such modifications, variations, alterations, substitutions, modifications and equivalents.</p><p>The foregoing detailed description has described various aspects of apparatus and/or processes using block diagrams, flow diagrams and/or examples. To the extent such block diagrams, flow diagrams and/or examples include one or more functions and/or operations, a person of ordinary skill in the art will recognize each function included in such block diagrams, flow diagrams and/or examples. and/or operations may be implemented individually and/or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. One skilled in the art will appreciate that all or part of some aspects of the forms disclosed herein can be implemented as one or more computer programs running on one or more computers (e.g., one or more as one or more programs running on a computer system), as one or more programs running on one or more processors (for example, as one or more programs running on one or more microprocessors), Designing a circuit and/or writing code for software and/or firmware, which can be equivalently implemented on an integrated circuit as firmware, or substantially any combination thereof, requires the use of the present disclosure. It is understood to be within the skill of one of ordinary skill in the art. Additionally, those skilled in the art will appreciate that the subject matter described herein may be distributed as one or more program products in a variety of forms, and may be implemented as a specific implementation of the subject matter described herein. It should be understood that the forms apply regardless of the particular type of signal-bearing medium used to actually carry out the distribution.</p><p>Instructions used to program logic to implement various disclosed aspects may be stored in system memory such as dynamic random access memory (DRAM), cache, flash memory or other storage. Additionally, the instructions may be distributed over a network or by other computer-readable media. Thus, a machine-readable medium can include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including floppy diskettes, optical discs, compact discs, read-only memories (CDs), -ROM), as well as magneto-optical disks, read-only memory (ROM), random-access memory (RAM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), magnetic or optical cards, Any tangible, machine-readable material used to transmit information over the Internet via flash memory or electrical, optical, acoustic, or other form of propagated signal (e.g., carrier wave, infrared signal, digital signal, etc.) Not limited to storage. Non-transitory computer-readable media thus includes any type of tangible machine-readable medium suitable for storing or transmitting electronic instructions or information in a form readable by a machine (eg, a computer).</p><p>As used in any aspect herein, the term "control circuitry" includes, for example, hardwired circuitry, programmable circuitry (e.g., computer processors including one or more individual instruction processing cores, processing units, processor , microcontroller, microcontroller unit, controller, digital signal processor (DSP), programmable logic device (PLD), programmable logic array (PLA), or field programmable gate array (field programmable gates It can refer to arrays, FPGAs)), state machine circuits, firmware that stores instructions to be executed by programmable circuits, and any combination thereof. Control circuits, collectively or individually, can be found in, for example, integrated circuits (ICs), application-specific integrated circuits (ASICs), system-on-chips (SoCs), desktop computers, laptop computers, tablet computers, servers, smartphones, etc. , may be embodied as circuits forming part of a larger system. Thus, as used herein, "control circuit" refers to an electrical circuit having at least one discrete electrical circuit, an electrical circuit having at least one integrated circuit, an electrical circuit having at least one application-specific integrated circuit, an electrical circuit having at least one A circuit, a general-purpose computing device configured with a computer program (e.g., a general-purpose computer configured with a computer program that executes, at least in part, a process and/or apparatus described herein, or a process described herein) and/or a microprocessor configured by a computer program that at least partially executes the device); , communication switches, or optical-to-electrical equipment). Those skilled in the art will appreciate that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.</p><p>As used in any aspect herein, the term "logic" may refer to applications, software, firmware, and/or circuitry configured to perform any of the operations described above. Software may be embodied as software packages, code, instructions, instruction sets, and/or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or sets of instructions in a memory device, and/or hard-coded (eg, non-volatile) data.</p><p>As used in any aspect of this specification, the terms "component," "system," "module," etc. refer to hardware, a combination of hardware and software, software, or software in execution. can refer to a computer-related entity that is</p><p>As used in any aspect herein, "algorithm" refers to a self-consistent sequence of steps leading to a desired result; , comparison, and manipulation of physical quantities and/or logical states, which may take the form of electrical or magnetic signals capable of being otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and/or states.</p><p>The network may include packet switched networks. The communication devices can communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include the Ethernet communication protocol, which may use Transmission Control Protocol/Internet Protocol (TCP/IP) to enable communication. The Ethernet protocol shall comply with or be compatible with the Ethernet standard entitled "IEEE802.3 Standard" published December 2008 by the Institute of Electrical and Electronics Engineers (IEEE) and/or later versions of this standard. possible. Alternatively or additionally, the communication devices can communicate with each other using the X.25 communication protocol. The X.25 communication protocol is the International Telecommunication Union-Telecommunication Standardization It may conform to or be compatible with standards promulgated by the Sector (ITU-T). Alternatively or additionally, the communication devices can communicate with each other using a frame relay communication protocol. The frame relay communication protocol may conform to or be compatible with standards promulgated by the Consultative Committee for International Telegraph and Telephone (CCITT) and/or the American National Standards Institute (ANSI). Alternatively or additionally, the transceivers may be able to communicate with each other using an asynchronous transfer mode (ATM) communication protocol. The ATM communication protocol may conform to or be compatible with the ATM standard published in August 2001 by the ATM Forum under the title "ATM-MPLS Network Interworking 2.0" and/or later versions of this standard. Of course, different and/or later developed connection-oriented network communication protocols are equally contemplated herein.</p><p>Unless expressly specified otherwise, the terms "processing," "computing," and "calculating" are used throughout the foregoing disclosure as is apparent from the foregoing disclosure. , "determining," "displaying," and the like refer to data represented as physical (electronic) quantities in the registers and memory of a computer system. the actions and processing of a computer system or similar electronic computing device that manipulates and converts such information into other data that are similarly represented as physical quantities in a memory or register or other such information storage, transmission, or display device It should be understood what you are referring to.</p><p>As used herein, one or more components are "configured to", "configurable to", "operable/operating as ( "operable/operative to", "adapted/adaptable", "able to", "conformable/conformed to" etc. can be mentioned. Those skilled in the art will understand that "configured to" generally refers to active components and/or inactive components and/or standby components, unless the context requires otherwise. will be understood to include</p><p>The terms "proximal" and "distal" are used herein with reference to the clinician manipulating the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician and the term "distal" refers to the portion located farther from the clinician. It will be further appreciated that for convenience and clarity, spatial terms such as "vertical," "horizontal," "above," and "below" may be used herein with respect to the drawings. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and/or absolute.</p><p>Those skilled in the art will appreciate that the terms used herein generally, and particularly in the appended claims (e.g., in the appended claim text), are generally intended as "open" terms. (e.g., the term "including" is to be interpreted as "including but not limited to"; the term "having" is to be interpreted as "including but not limited to"); shall be construed as "having at least" and the term "includes" shall be construed as "includes but is not limited to" should be done, etc.). Further, where a particular number is intended in an introduced claim recitation, such intent is expressly recited in the claim; and in the absence of such a statement, such intent does not exist. will be understood by those skilled in the art. For example, as an aid to understanding, the following appended claims may read "at least one (at The introductory phrases "at least one" and "one or more" may be included to introduce claim recitations. However, the use of such phrases when introducing a claim recitation by the indefinite article "a" or "an" may be used to refer to "one or more" or "at least one" even within the same claim. and the indefinite article "a" or "an", any particular claim containing such an introduced claim recitation shall be subject to claims containing only one such recitation. should not be construed as being implied to be limiting (e.g., "a" and/or "an" are generally taken to mean "at least one" or "one or more"). should be interpreted). the same holds true where the definite article is used to introduce claim recitations.</p><p>In addition, even where a specific number is specified in an introduced claim statement, such statement should typically be construed to mean at least the stated number. but will be recognized by those skilled in the art (e.g., where there is a statement simply "two statements" without other modifiers, generally there are at least two statements, or two or three means one or more entries). Further, where notations like "at least one of A, B and C, etc." are used, such syntax is generally intended in the sense that a person skilled in the art would understand the notation (e.g. , "a system having at least one of A, B and C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, B and C and/or all of A and B and C, etc.). Where notations like "at least one of A, B or C, etc." are used, such syntax is generally intended in the sense that a person skilled in the art would understand the notation (e.g., "A , B, or C" includes, but is not limited to, A only, B only, C only, both A and B, both A and C, both B and C and/or systems with all of A and B and C, etc.). Moreover, typically any disjunctive word and/or phrase representing two or more alternative terms, whether within the specification, unless the context requires otherwise, It should be understood that the possibility of including one of those terms, either of those terms, or both of those terms is intended, whether in the claims or in the drawings. One of ordinary skill in the art will recognize that there is. For example, the phrase "A or B" will typically be understood to include the possibilities of "A" or "B" or "A and B."</p><p>With regard to the appended claims, those skilled in the art will understand that the operations recited herein can generally be performed in any order. Also, while the flow diagrams of various acts are shown in sequence, it should be understood that the various acts may be performed in an order other than that shown, or may be performed simultaneously. be. Examples of such alternative orderings include overlapping, interleaving, interrupting, reordering, incremental, preliminary, additional, simultaneous, reverse or other different orderings, unless the context requires otherwise. may contain. Further, terms such as "responding to", "relating to", or other past tense adjectives generally exclude such variations unless the context dictates otherwise. not intended.</p><p>Any reference to "an embodiment", "an embodiment", "exemplary", "an example", etc., means that at least one embodiment includes the particular feature, structure or property described in connection with that embodiment. The implications deserve special mention. Thus, the appearances of the phrases "in one aspect," "in an aspect," "in an example," and "in an example" in various places throughout this specification are not necessarily all referring to the same aspect. Moreover, the particular features, structures or properties may be combined in any suitable manner in one or more aspects.</p><p>Any patent applications, patents, non-patent publications, or other disclosure material referenced herein and/or listed in any application data sheet is, to the extent the material incorporated herein, is not inconsistent with this specification. , incorporated herein by reference. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting statements incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated herein by reference but that conflicts with the current definitions, opinions, or other disclosure content set forth herein, is deemed and to the extent not inconsistent with the current disclosure.</p><p>In summary, a number of benefits have been described that result from using the concepts described herein. The foregoing description of one or more forms has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to be limited to the precise forms disclosed. Modifications or variations are possible in light of the above teachings. One or more of the embodiments is intended to illustrate principles and practical applications, thereby enabling a person skilled in the art to utilize the various forms, with various modifications, as appropriate for the particular application envisioned. are selected and described in order to It is intended that the claims presented herewith define the overall scope.</p><p>Embodiments (1) An end comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator. an effector, wherein the clamp arm is a cantilever electrode configured to electrically couple to clamp jaws, a plurality of variable longitudinal support elements, and opposite poles of the electrical generator, the cantilever electrode is fixed at a proximal end to the clamping jaws and free to deflect at a distal end, the cantilever electrode being supported by the variable longitudinal support element, the variable longitudinal support element being attached to the cantilever electrode. An end effector comprising a cantilevered electrode that applies a variable force from a proximal end to said distal end.</p><p>(2) The end effector of embodiment 1, wherein the variable longitudinal support element limits maximum deflection of the cantilever electrode.</p><p>(3) The end effector of claim 1, wherein said variable longitudinal support element comprises a plurality of springs with variable force (F).</p><p>(4) The end effector of embodiment 3, wherein the cantilever electrode further comprises a bump extension located on the cantilever electrode between the cantilever electrode and the clamp jaw.</p><p>(5) the bump extension located on the cantilever electrode between the cantilever electrode and the clamping jaw limits the maximum deflection of the variable longitudinal support element with a variable longitudinal spring force (S); 5. An end effector according to embodiment 4.</p><p>(6) An end effector according to embodiment 5, wherein said variable longitudinal spring force (S) is less than said variable force (F).</p><p>(7) The end effector of embodiment 1, wherein the clamp arm further comprises a clamp arm pad.</p><p>(8) an end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator, wherein The clamp arm supports a clamp jaw, a cantilever electrode configured to electrically couple to opposite poles of the electrical generator, and the cantilever electrode and between the cantilever electrode and the clamp jaw. a flexible material affixed to said clamping jaws to act as a spring for the end effector.</p><p>(9) The end of embodiment 8, wherein the clamp arm further comprises a hard wear resistant material secured to the cantilever electrode to set a gap between the cantilever electrode and the ultrasonic blade. effector.</p><p>(10) Embodiment 9, wherein the cantilever electrode comprises a hard wear resistant material secured to a proximal end of the cantilever electrode and a hard wear resistant material secured to a distal end of the cantilever electrode. End effector as described.</p><p>(11) The end effector of embodiment 8, wherein the cantilever electrode defines an aperture for receiving the compliant material therethrough.</p><p>(12) An end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator, wherein The clamp arm comprises clamp jaws, a cantilever electrode configured to electrically couple to opposite poles of the electrical generator, and a leaf spring element disposed at a distal end of the cantilever electrode. , end effector.</p><p>(13) The end effector of embodiment 12, wherein the proximal end of the cantilever electrode is fixedly attached to the clamp jaw.</p><p>(14) The end effector of claim 12, further comprising a hard wear-resistant pad disposed on the proximal end of the cantilever electrode for setting a gap between the electrode and the clamp arm. .</p><p>15. The end effector of claim 12, wherein the leaf spring defines a symmetry element on the lateral side of the distal end of the cantilever electrode.</p><p>(16) An end effector comprising a clamp arm and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to one pole of an electrical generator, wherein An end effector, wherein the clamp arm comprises clamp jaws, a cantilever electrode configured to couple to opposite poles of the electrical generator, and a compressible material attached to a distal end of the cantilever electrode. .</p><p>Clause 17. The end effector of clause 16, wherein the compressible material attached to the distal end of the cantilever electrode is disposed between the cantilever electrode and the clamping jaws.</p><p>(18) The end effector of embodiment 17, wherein distal ends of the clamp jaws define pockets for receiving the compressible material.</p>