Deflectable support for an RF energy electrode relative to an opposing ultrasonic blade - Patents.com

Abstract

An end effector is disclosed that includes 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. The clamp arm includes a clamp jaw, a clamp arm pad, and a freely deflecting cantilever electrode. The cantilever electrode is configured to electrically couple to the opposite pole of the electrical generator. Also disclosed are configurations in which the clamp arm includes a peripheral cantilever electrode and a clamp arm pad extending beyond the electrode, a floating cantilever electrode and a resilient clamp arm pad, a coupled cantilever electrode plate and a cap arm pad configured to receive the plate, a laterally deflectable cantilever electrode and a clamp arm pad extending beyond the electrode, and a flexible cantilever electrode and a clamp arm pad extending beyond the electrode.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62 / 955,292, filed December 30, 2019, entitled “COMBINATION ENERGY MODALITY END-EFFECTOR,” the disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THEINVENTION The present disclosure relates generally to an end effector adapted and configured to operate with multiple energy modalities to enable simultaneous, independent or sequential application of the multiple energy modalities to seal and cut tissue. More specifically, the present disclosure relates to an end effector adapted and configured to operate with a surgical instrument using a combined ultrasonic and electrosurgical system, such as monopolar or bipolar radio frequency (RF), to enable simultaneous, independent or sequential application of ultrasonic and electrosurgical energy modalities to seal and cut tissue. The 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. [Background technology]

[0003] Ultrasonic surgical instruments using ultrasonic energy modalities are finding increasingly widespread use in surgical procedures due to the special performance characteristics of such instruments. Depending on the particular instrument configuration and operational parameters, ultrasonic surgical instruments can provide substantially simultaneous cutting of tissue and hemostasis by coagulation, desirably minimizing trauma to the patient. The cutting action is typically accomplished by an end effector, ultrasonic blade, or ultrasonic blade tip, at the distal end of the instrument, which transmits ultrasonic energy to tissue in contact with the end effector. The ultrasonic end effector may include an ultrasonic blade, a clamp arm, and a pad, among other components.

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

[0005] Electrosurgical instruments for applying electrical energy modalities to tissue to treat, seal, cut, and / or destroy the tissue are also finding increasingly widespread use in surgery. Electrosurgical instruments typically include an end effector with one or more electrodes attached to a distal portion. The end effector can be positioned relative to the tissue such that electrical current is introduced into the tissue. Electrosurgical instruments can be configured for bipolar or monopolar operation. During bipolar operation, electrical current is introduced into the tissue through a first electrode (e.g., an active electrode) and returned from the tissue through a second electrode (e.g., a return electrode). During monopolar operation, electrical current is introduced into the tissue by the active electrode of the end effector and returned via a return electrode, such as a ground pad, which is separately coupled to the patient's body. Heat generated by electrical current flowing through the tissue may form a hemostatic seal within and / or between tissues and may thus be particularly useful, for example, for sealing blood vessels. The end effector of the electrosurgical instrument may also include a cutting member movable relative to the tissue and the electrodes to resect the tissue. The electrosurgical end effector may be adapted and configured to couple to handheld and robotic instruments.

[0006] The 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 may range in frequency from 200 kilohertz (kHz) to 1 megahertz (MHz). During application, the electrosurgical instrument may transmit low frequency RF energy through tissue, which may cause ionic agitation or friction, i.e., resistive heating, thereby increasing the temperature of the tissue. Because a sharp boundary is created between the tissue affected by the procedure and the surrounding tissue, the surgeon may 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 simultaneously sealing blood vessels while removing, shrinking, or undermining soft tissue. RF energy works particularly well on connective tissue because it is primarily composed of collagen and shrinks when exposed to heat.

[0007] The RF energy may be in the frequency range described in EN 60601-2-2:2009+A11:2011, Definition 201.3.218-HIGH FREQUENCY. For example, the frequency in monopolar RF applications may typically be limited to less than 5 MHz. However, in bipolar RF energy applications, the frequency may be nearly any frequency. Frequencies above 200 kHz may 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 a risk analysis indicates that the possibility of neuromuscular stimulation has been mitigated to an acceptable level. Frequencies above 5 MHz are not typically used to minimize problems associated with high frequency leakage currents. However, higher frequencies may be used in the case of bipolar applications. It is generally recognized that 10 mA is the lower threshold for thermal effects on tissue.

[0008] Ultrasonic and electrosurgical instruments of the nature described herein can be configured for open, minimally invasive, or non-invasive surgery. Minimally invasive surgery involves the use of cameras and instruments inserted through small incisions to visualize and treat conditions within a joint or body cavity. Minimally invasive surgery can be performed entirely within the body or, in some circumstances, can be used in conjunction with smaller approach incisions. These combined approaches are known, for example, as "arthroscopic, laparoscopic, or thoracoscope-assisted surgery." The surgical instruments described herein can also be used in non-invasive procedures, such as, for example, endoscopic surgery. The instruments can be controlled by the surgeon using handheld instruments or robots. Summary of the Invention [Problem to be solved by the invention]

[0009] A challenge with utilizing these surgical instruments is the inability to control and customize the 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 multi-energy modality end effectors described herein overcome the above deficiencies and improve the quality of tissue treatment, sealing, or cutting, or a combination thereof. [Means for solving the problem]

[0010] In one aspect, an apparatus for cutting and coagulating tissue is provided. The apparatus includes a surgical instrument including an end effector adapted and configured to deliver multiple energy modalities at a distal end thereof to tissue. The energy modalities may be applied simultaneously, independently, or sequentially. A generator is electrically coupled to the surgical instrument and configured to supply the multiple energy modalities to the end effector. In one aspect, the generator is configured to supply electrosurgical energy (e.g., monopolar or bipolar radio frequency (RF) energy) and ultrasonic energy to the end effector to enable the end effector to interact with tissue. The energy modalities may be supplied to the end effector by a single generator or by multiple generators.

[0011] In various aspects, the present disclosure provides a surgical instrument configured to deliver at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. The surgical instrument includes a first activation button for activating the energy and a second button for selecting an energy mode of the activation button. The second button is connected to a circuit that defines the energy mode using at least one input parameter. The input parameter can be modified remotely via connection to the generator or via a software update.

[0012] In one aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, the at least one electrode serves as a deflectable support for an opposing ultrasonic blade. The at least one electrode is configured to cross the ultrasonic blade and be deflectable relative to the clamp arm, and has features for changing mechanical properties of tissue compression under the at least one electrode. The at least one electrode includes features for preventing unintended contact between the electrode and the ultrasonic blade.

[0013] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, the movable clamp jaw includes at least one non-energized, deflectable electrode for minimizing contact between the ultrasonic blade and the RF electrode. The ultrasonic blade pad includes features for securing the electrode to the pad. As the height of the pad wears or is cut, the height of the electrode relative to the clamp jaw is gradually adjusted. Once the clamp jaw is moved away from the ultrasonic blade, the electrode remains in its new position.

[0014] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a moveable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, the at least one bipolar RF electrode is deflectable and biased more distally than proximally. The bipolar RF electrode is deflectable relative to the clamp jaw. The end effector is configured to change mechanical properties of the tissue compression portion proximal to the distal end to create a more uniform or more distinct pressure pattern compared to the pressure pattern of clamping alone.

[0015] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a moveable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, the pad and the bipolar RF electrode are deflectable and the end effector provides variable compression / biasing along a length of the deflectable electrode. The end effector is configured to vary a mechanical property of tissue compression under the electrode based on an amount of closure or tightening of the clamp jaws.

[0016] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, the pad includes asymmetric segments for providing support for the ultrasonic blade support, and the electrode is movable. The asymmetric segmented pad is configured to cooperatively engage the movable bipolar RF electrode. The segmented ultrasonic support pad extends at least partially through the bipolar RF electrode. At least one pad element is significantly taller than a second pad element. The first pad element extends completely through the bipolar RF electrode and the second pad element extends partially through the bipolar RF electrode, the first pad element and the second pad element being made of dissimilar materials.

[0017] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, variation of the physical parameters of the electrode in combination with a deflectable electrode is used to vary the energy density delivered to the tissue and the tissue interaction. The physical surface of the electrode changes 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.

[0018] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, an ultrasonic transducer control algorithm is provided that reduces power delivered by the ultrasonic generator or the RF generator to prevent damage to the ultrasonic blade when a short in contact between the ultrasonic blade and the electrode is detected. The ultrasonic blade control algorithm monitors for electrical shorts or contact of the ultrasonic blade with the electrode. This detection is used to adjust the power / amplitude level of the ultrasonic transducer when a minimum electrical threshold is exceeded, adjusting the transducer power / amplitude threshold to a level below the minimum threshold that would cause damage to the ultrasonic blade, ultrasonic generator, bipolar RF electrode, or bipolar RF generator. The electrical parameter monitored can be tissue impedance (Z) or electrical continuity. The power adjustment can be to shut off the ultrasonic generator, bipolar RF generator of the surgical device, or it can be a proportional response to any of the electrical parameters, pressure, or time, or any combination of these parameters.

[0019] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a moveable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, a clamp jaw feature or surface is provided on the clamp arm to minimize tissue sticking and improve tissue control. The tissue path or clamping region of the clamp arm includes features configured to align the tissue path with the clamp arm / ultrasonic blade and create a predetermined contact location to reduce tissue sticking and charring.

[0020] In another aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a movable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator, and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack driven by the ultrasonic generator. In one aspect, a partially conductive clamp arm pad is provided, allowing the electrode to wear completely to minimize electrical shorts between the ultrasonic blade and the bipolar RF electrode. The clamp arm pad includes a conductive portion and a non-conductive portion, such that the clamp arm pad can function as one of the bipolar RF electrodes while also functioning as an abradable support structure for the ultrasonic blade. The conductive portion of the clamp arm pad is located around the periphery of the pad and is not located directly under the ultrasonic blade contact area. The conductive portion is configured so that it will not degrade or wear away and cause any contact with the ultrasonic blade or interrupt the electrical conductivity of the remainder of the conductive pad.

[0021] In addition to the foregoing, various other method, and / or system, and / or program product aspects are set forth and illustrated in the teachings, such as the text (e.g., claims and / or detailed description) and / or drawings of this disclosure.

[0022] The foregoing description is a summary and thus may include simplifications, generalizations, inclusions, and / or omissions of details. Thus, those skilled in the art will appreciate that this Summary is merely illustrative and is not intended to be limiting in any way. Other aspects, features, and advantages of the devices and / or processes and / or other subject matter described herein will become apparent in the teachings set forth herein.

[0023] In one or more various aspects, the associated systems include, but are not limited to, circuitry and / or programming for effecting aspects of the methods referenced herein. The circuitry and / or programming may essentially be any combination of hardware, software, and / or firmware configured to affect aspects of the methods referenced herein, depending on the design choices of the system designer. In addition to those described above, various other method and / or system aspects are set forth and described in the teachings, such as in the text (e.g., claims and / or detailed description) and / or drawings of this disclosure.

[0024] Additionally, it should be understood that any one or more of the features, embodiment(s), and examples described below may be combined with any one or more of the other features, embodiment(s), and examples described below.

[0025] The above Summary is illustrative only and is not intended to be in any way limiting. 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 the following detailed description. [Brief description of the drawings]

[0026] The novel features of the described embodiments, 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, in which: [Figure 1] FIG. 13 is a perspective view of a clamp arm portion of an end effector for use with a combined ultrasonic / RF device, according to at least one embodiment of the present disclosure. [Diagram 2] FIG. 2 is an exploded view of the clamp arm shown in FIG. 1 in accordance with at least one embodiment of the present disclosure. [Diagram 3] FIG. 1 is a perspective view of a frame according to at least one embodiment of the present disclosure. [Figure 4]FIG. 1 is a perspective view of a frame according to at least one embodiment of the present disclosure. [Diagram 5] FIG. 1 is a perspective view of an electrode according to at least one embodiment of the present disclosure. [Figure 6] FIG. 13 is a perspective view of a clamp arm pad according to at least one embodiment of the present disclosure. [Figure 7] FIG. 2 is a perspective top view of a large gap pad according to at least one embodiment of the present disclosure. [Figure 8] FIG. 2 is a perspective top view of a small gap pad according to at least one embodiment of the present disclosure. [Figure 9] 9 is a perspective bottom view of the small gap pad shown in FIG. 8. [Figure 10] 1 illustrates an effector with a shortened clamp arm for deflectable / cantilever electrode applications, according to various embodiments of the present disclosure. [Figure 11] 1 illustrates an effector with a shortened clamp arm for deflectable / cantilever electrode applications, according to various embodiments of the present disclosure. [Figure 12] 1 illustrates an effector with a shortened clamp arm for deflectable / cantilever electrode applications, according to various embodiments of the present disclosure. [Figure 10A] FIG. 10A shows a clamping arm, according to at least one embodiment of the present disclosure, showing an electrode having a proximal end attached to the clamping arm and a distal end opposite the fixed end that is free to move or deflect. [Figure 10B] FIG. 10B shows an electrode having a proximal end that is proximally attached to a clamp arm and a distal end that is free to move or deflect, opposite the fixed end. [Figure 11A] 11A shows an electrode having a proximal end fixedly attached to the proximal end of a clamp arm and a distal end opposite the fixed end that is free to move or deflect. FIG 11A is an end effector comprising a clamp arm, a peripheral electrode defining an internal opening, and a connection pad isolated from a conductive portion of the peripheral electrode for attaching the peripheral electrode to the proximal end of the clamp arm, according to at least one embodiment of the present disclosure. [Figure 11B] 11A and 11B show an electrode having a proximal end fixedly attached to the proximal end of the clamp arm and a distal end opposite the fixed end that is free to move or deflect, in accordance with at least one embodiment of the present disclosure. [Figure 11C] 11A-11C show an electrode having a proximal end fixedly attached to the proximal end of the clamp arm and a distal end opposite the fixed end that is free to move or deflect, according to at least one embodiment of the present disclosure. FIG. 11C is a side view of an end effector with a clamp arm and an ultrasonic blade, according to at least one embodiment of the present disclosure, and a top view of a peripheral electrode configured to attach to the proximal end of the clamp arm. [Figure 11D] 11A-11D show an electrode having a proximal end fixedly attached to the proximal end of the clamp arm and a distal end opposite the fixed end that is free to move or deflect. FIG. 11C shows a side view of an end effector with a clamp arm and an ultrasonic blade, and a top view of a peripheral electrode configured to attach to the proximal end of the clamp arm, according to at least one embodiment of the present disclosure. [Figure 12A] 12A shows a clamp arm including an electrode having a proximal end fixedly attached to the proximal end of the clamp arm and a distal end opposite the fixed end that is free to move or deflect, in accordance with at least one embodiment of the present disclosure. FIG. 12A shows a clamp arm with a jaw, a clamp arm pad, and an electrode, in accordance with at least one embodiment of the present disclosure. [Figure 12B] 12A and 12B show a clamp arm including an electrode having a proximal end fixedly attached to the proximal end of the clamp arm and a distal end opposite the fixed end that is free to move or deflect, in accordance with at least one embodiment of the present disclosure. [Figure 12C]12A-12C show a clamp arm including an electrode having a proximal end fixedly attached to the proximal end of the clamp arm and a distal end opposite the fixed end that is free to move or deflect, in accordance with at least one embodiment of the present disclosure. [Figure 12D] 12A-12D show a clamp arm including an electrode having a proximal end fixedly attached to the proximal end of the clamp arm and a distal end opposite the fixed end that is free to move or deflect. FIG. 12C shows a clamp arm with a clamp jaw, a clamp arm pad, and a deflectable cantilever electrode, according to at least one embodiment of the present disclosure. [Figure 13A] 13A shows a clamp arm with an electrode and a clamp arm pad in an unloaded, undeflected state, according to at least one embodiment of the present disclosure. [Figure 13B] 13A and 13B show a clamp arm with an electrode and a clamp arm pad in a loaded and deflected state, according to at least one embodiment of the present disclosure. [Figure 14A] 14A shows an electrode configuration having an end-of-life indicator that can be sensed by an electrical generator to facilitate device replacement, according to various aspects of the present disclosure. FIG. 14A shows an end effector comprising a clamp arm and an ultrasonic blade, according to at least one aspect of the present disclosure. [Figure 14B] 14A-C show electrode configurations having end-of-life indicators that can be sensed by an electrical generator to facilitate device replacement, according to various aspects of the present disclosure. FIG. 14B shows the end-of-life indicator tail at the start of a procedure, and FIG. 14C shows the end-of-life indicator tail at the end of a procedure. [Figure 14C] 14A-C show electrode configurations having end-of-life indicators that can be sensed by an electrical generator to facilitate device replacement, according to various aspects of the present disclosure. FIG. 14C shows an end-of-life indicator tail at the end of a procedure. [Figure 15A]15A shows an electrode configuration having an end-of-life indicator that can be sensed by the generator to facilitate device replacement, according to various aspects of the present disclosure. FIG 15A shows an end effector comprising a clamp arm and an ultrasonic blade, according to at least one aspect of the present disclosure. [Figure 15B] FIG 15B shows an electrode configuration having an end of life indicator that can be sensed by a generator to facilitate device replacement, according to various aspects of the retransmission disclosure. FIG 15B shows the end effector of FIG 15A after the clamp arm pads have been worn to near failure. [Figure 16A] 16A shows a configuration in which an electrode can move vertically along its entire length, according to various embodiments of the present disclosure.FIG 16A shows a clamp arm portion of an end effector, according to at least one embodiment of the present disclosure. [Figure 16B] FIG 16B shows a configuration in which the electrode can move vertically along its entire length, according to various embodiments of the present disclosure. FIG 16B shows a wear-resistant clamp arm pad attached to the end of a lubricous clamp arm pad to help reduce wear on the lubricous clamp arm pad. [Figure 17] 1 illustrates a configuration in which an electrode can move vertically along its entire length, according to various aspects of the present disclosure. [Figure 18A] 18A illustrates a configuration in which an electrode can move vertically along its entire length, according to various embodiments of the present disclosure.FIG 18A is a cross-sectional view of an end effector with a clamp arm, according to at least one embodiment of the present disclosure. [Figure 18B] 18A and 18B show a configuration in which the electrode can move vertically along its entire length, according to various embodiments of the present disclosure, and a cross-sectional view of the end effector showing the location of the wear-resistant dowel pins in the clamp arm. [Figure 18C] 18A-18C show cross-sectional views of a wear-resistant dowel pin according to at least one embodiment of the present disclosure, in which an electrode can move vertically along its entire length, according to various embodiments of the present disclosure. [Figure 18D]18A-18D show a configuration in which an electrode can move vertically along its entire length, according to various embodiments of the present disclosure. [Figure 19A] 1 illustrates a portion of an end effector comprising a clamp arm with an electrode having a "center pivot" configuration, according to at least one embodiment of the present disclosure. [Figure 19B] 1 illustrates a portion of an end effector comprising a clamp arm with an electrode having a "center pivot" configuration, according to at least one embodiment of the present disclosure. [Figure 20] 1 illustrates an end effector comprising a clamp arm and an ultrasonic blade, according to at least one embodiment of the present disclosure. [Figure 21] 1 illustrates a spring element formed on an electrode, according to at least one embodiment of the present disclosure. [Figure 22A] 22A shows an embodiment of a clamp arm with a wave spring element supporting an electrode, according to at least one embodiment of the present disclosure. FIG. 22A shows an embodiment of a clamp arm in which a wave spring element is integrally formed with a resilient clamp arm pad to bias the electrode in direction "d". [Figure 22B] 22A shows a clamp arm with a wave spring element supporting an electrode, according to at least one embodiment of the present disclosure. FIG. 22B shows an embodiment of a clamp arm in which a wave spring element is positioned between a resilient clamp arm pad and an electrode to bias the electrode in direction "d". [Figure 22C] 22A-22C show an embodiment of a clamp arm with a wave spring element supporting an electrode, according to at least one embodiment of the present disclosure. FIG. 22C shows an embodiment of a clamp arm in which a wave spring element is also formed integrally with a resilient clamp arm pad to bias the electrode in direction "d". [Figure 23A] 23A-23D illustrate electrode attachment methods according to various embodiments of the present disclosure, in which the electrodes are placed through protrusions in the clamp arm pads and attached to the clamp arm by brackets. [Figure 23B]23A-23C illustrate electrode attachment methods according to various embodiments of the present disclosure: FIG 23B shows that the electrodes are attached to the clamp arm pads by cylindrical springs; [Figure 24A] 24A illustrates an electrode spring element configuration according to various embodiments of the present disclosure.FIG 24A illustrates an end effector with a clamp arm and an ultrasonic blade according to at least one embodiment of the present disclosure. [Figure 24B] 24A and 24B show electrode spring element configurations according to various embodiments of the present disclosure.FIG 24B shows a clamp arm with a diaphragm electrode according to at least one embodiment of the present disclosure. [Figure 24C] 24A-24C show electrode spring element configurations according to various embodiments of the present disclosure, and FIG 24C shows a clamp arm with an integral spring electrode according to at least one embodiment of the present disclosure. [Diagram 25] 1 illustrates an electrode with coined bumps for use with an integral wear pad (not shown) in accordance with at least one embodiment of the present disclosure. [Figure 26] 1 illustrates a spring tested under thermal and tissue fluid conditions, according to at least one embodiment of the present disclosure. [Figure 27] 13 shows electrodes of extended length to prevent electrode binding as the electrodes are deflected up or down, according to at least one embodiment of the present disclosure, and the electrode distance "d1" can be increased. [Figure 28A] 28A shows an end effector configured with one or more resistors embedded within the clamp arm pad to sense the height "h" of the clamp arm pad, according to at least one embodiment of the present disclosure. FIG. 28A shows a new clamp arm pad, according to at least one embodiment of the present disclosure, showing no wear and no resistors, showing the total resistance at full height h1, which is the entire clamp arm pad and cannot cause tissue between the clamp arm and the ultrasonic blade. [Figure 28B]FIG. 28B shows an end effector configured with one or more resistors embedded in the clamp arm pad to sense the height "h" of the clamp arm pad, according to at least one embodiment of the present disclosure. FIG. 28B shows the end effector with no tissue between the clamp arm and the ultrasonic blade, and the clamp arm pad and resistor are worn down to a height of h2, which is less than h1, due to heat generated by friction between the clamp arm, ultrasonic blade, and resistor. [Figure 28C] According to at least one embodiment of the present disclosure, an end effector configured with one or more resistors embedded in the clamp arm pad to sense the height "h" of the clamp arm pad is shown in Figure 28C, in which the electrode is deflected to a height h3 less than h1 due to thick tissue located between the clamp arm and the ultrasonic blade. [Figure 28D] According to at least one embodiment of the present disclosure, an end effector configured with one or more resistors embedded in the clamp arm pad to sense the height "h" of the clamp arm pad is shown in Figure 28D, in which the electrode is deflected to a height h3 less than h1 due to thick tissue located between the clamp arm and the ultrasonic blade. [Figure 29] FIG. 13 is a graphical illustration of an example of resistance level of a resistor in a clamp arm pad versus pad height "h," in accordance with at least one embodiment of the present disclosure. [Figure 30A] According to at least one embodiment of the present disclosure, the resistance levels (R1-R5) are shown as a function of resistor height "h" and, similarly, clamp arm pad height "h" since the resistor is embedded in the clamp arm pad and both elements wear at the same rate. Figure 30A shows an end effector with a new clamp arm pad and resistor installed in the clamp arm. [Figure 30B]According to at least one embodiment of the present disclosure, the resistance levels (R1-R5) are shown as a function of the height "h" of the resistors, as well as the height "h" of the clamp arm pads, since the resistors are embedded in the clamp arm pads and both elements wear at the same rate. Figure 30B shows the condition of the end effector when the clamp arm pads are slightly worn to exhibit the resistance levels. [Diagram 31] FIG. 1 is a graphical illustration of clamp arm pad height "h," as measured by an integrating resistor shown along the vertical axis, as a function of time "t," shown along the horizontal axis, in accordance with at least one embodiment of the present disclosure. [Diagram 32] FIG. 32 illustrates one configuration in which the electrode can pivot near the midpoint of the electrode, according to at least one embodiment of the present disclosure. FIG. 32 is an exploded view of a clamp arm including a central pivoting electrode, according to at least one embodiment of the present disclosure. [Figure 33A] FIG. 33A illustrates a configuration in which the electrode can pivot near the midpoint of the electrode, in accordance with at least one embodiment of the present disclosure. FIG. 33A illustrates a new pad in which the central pivoting electrode is at an angle (e.g., parallel) to the clamp arm jaws in a fully clamped position, in accordance with at least one embodiment of the present disclosure. [Figure 33B] FIG. 33B illustrates a configuration in which the electrodes can pivot near their midpoints, according to at least one embodiment of the present disclosure. FIG. 33B illustrates the change in angle θ between the center pivoting electrodes relative to the clamp arm jaws 1526 to maintain a consistent gap between the ultrasonic blades, according to at least one embodiment of the present disclosure. [Diagram 34] FIG. 13 is a perspective cross-sectional view of a clamp arm with longitudinally aligned slots from a proximal end through which an electrode plate can be advanced without clamp arm pad material, according to at least one embodiment of the present disclosure. [Figure 35A] FIG. 35 is a cross-sectional view of the clamp arm shown in FIG. 34 prior to assembly, in accordance with at least one embodiment of the present disclosure. [Figure 35B]15 shows a clamp arm pad / electrode plate assembly 1556 sliding proximally into a longitudinally aligned slot defined by the clamp jaw, in accordance with at least one embodiment of the present disclosure. [Figure 35C] 15A shows a tab on a proximal end of the clamp arm pad that locks into a proximal recess defined by the proximal end of the clamp jaw that couples the clamp arm pad / electrode plate assembly 1560 with the clamp jaw, according to at least one embodiment of the present disclosure. [Diagram 36] 1 illustrates one embodiment of a continuous spring support located under the electrode rather than a separate spring attachment at one end, in accordance with at least one embodiment of the present disclosure. [Figure 37] FIG. 1 is a perspective view of an end effector including a laterally deflectable electrode forming one pole of an electrosurgical circuit and an ultrasonic blade forming the other pole of the electrosurgical circuit, according to at least one embodiment of the present disclosure. [Figure 38] 1 illustrates a laterally deflectable electrode in an undeflected state (shown in solid lines) and a deflected state (shown in dashed lines), in accordance with at least one embodiment of the present disclosure. [Figure 39] FIG. 1 is a cross-sectional view of an end effector including an electrode as a structural clamping member that forms one pole of an electrosurgical circuit and an ultrasonic blade that forms the other pole of the electrosurgical circuit, according to at least one embodiment of the present disclosure. [Diagram 40] FIG. 1 is a cross-sectional view of an end effector including an electrode as a structural clamping member that forms one pole of an electrosurgical circuit and an ultrasonic blade that forms the other pole of the electrosurgical circuit, according to at least one embodiment of the present disclosure. [Diagram 41] FIG. 1 is a cross-sectional view of an end effector including an electrode as a structural clamping member forming one pole of an electrosurgical circuit and an ultrasonic blade forming the other pole of the electrosurgical circuit in accordance with at least one embodiment of the present disclosure. [Diagram 42] 1 illustrates an electrode in its laterally deflected state (shown in dashed lines) in accordance with at least one embodiment of the present disclosure. [Diagram 43]1 illustrates a clamp arm with a laterally deflectable electrode forming one pole of an electrosurgical circuit according to at least one embodiment of the present disclosure. [Diagram 44] 1 illustrates a clamp arm with a laterally deflectable electrode forming one pole of an electrosurgical circuit according to at least one embodiment of the present disclosure. [Diagram 45] FIG 45 illustrates an end effector comprising a laterally deflectable electrode forming one pole of an electrosurgical circuit and an ultrasonic blade forming the other pole of the electrosurgical circuit, with a distance d between the center of the electrode and its most lateral extension, in accordance with at least one embodiment of the present disclosure. [Diagram 46] FIG 46 illustrates an end effector including a laterally deflectable electrode forming one pole of an electrosurgical circuit and an ultrasonic blade forming the other pole of the electrosurgical circuit, in accordance with at least one embodiment of the present disclosure. FIG 46 illustrates a laterally deflected state of the electrode with a distance d' between the center of the electrode and the most lateral extension of the electrode. [Figure 47] 1 illustrates an end effector comprising a laterally deflectable electrode forming one pole of an electrosurgical circuit and an ultrasonic blade forming the other pole of the electrosurgical circuit, in accordance with at least one embodiment of the present disclosure. [Figure 48] 1 illustrates an end effector comprising a laterally deflectable electrode forming one pole of an electrosurgical circuit and an ultrasonic blade forming the other pole of the electrosurgical circuit, in accordance with at least one embodiment of the present disclosure. [Figure 49] The lateral deflection of the laterally deflectable electrodes is shown by dashed lines in the direction of the arrows. [Figure 50] FIG. 13 is a close-up view of a laterally deflectable electrode, with the lateral deflection indicated by dashed lines. [Figure 51] 1 illustrates an end effector comprising a pair of metal clamping arms coated with a flexible or deformable dielectric material and wire electrodes, in accordance with at least one embodiment of the present disclosure. [Figure 52]1 illustrates an end effector comprising a pair of metal clamping arms coated with a flexible or deformable dielectric material and wire electrodes in accordance with at least one embodiment of the present disclosure. [Figure 53] 1 illustrates an end effector comprising a pair of metal clamping arms coated with a flexible or deformable dielectric material and wire electrodes in accordance with at least one embodiment of the present disclosure. [Figure 54] 1 illustrates an end effector comprising a pair of metal clamping arms coated with a flexible or deformable dielectric material and wire electrodes in accordance with at least one embodiment of the present disclosure. [Figure 55] 1 shows a flexible or deformable dielectric material, which may be the same material (e.g., silicone) or may be a harder or softer material, according to at least one embodiment of the present disclosure. [Figure 56] 13 shows a metal clamp arm implemented as a bipolar electrode by adding an outer electrode, in accordance with at least one embodiment of the present disclosure. [Figure 57] 1 illustrates a bare metal or coated / covered metal clamp arm according to at least one embodiment of the present disclosure. [Figure 58] 1 illustrates a bare metal or coated / covered metal clamp arm according to at least one embodiment of the present disclosure. [Figure 59] FIG. 59 shows an effector with a shorted clamp arm for deflectable / cantilever electrode applications according to various embodiments of the present disclosure. FIG. 59 is a side view of an end effector with a shorted clamp arm, an ultrasonic blade, an electrode, and a clamp arm pad according to at least one embodiment of the present disclosure. [Figure 60] 60 shows an effector with shorted clamping arms for deflectable / cantilever electrode applications according to various embodiments of the present disclosure. FIG. 60 is a top view of an end effector according to at least one embodiment of the present disclosure. [Figure 61]61 shows an effector with a shorted clamp arm for deflectable / cantilever electrode applications according to various embodiments of the present disclosure. FIG. 61 shows a clamp arm with a clamp jaw, an electrode, and a clamp arm pad according to at least one embodiment of the present disclosure. [Figure 62] 1 illustrates an end effector clamp arm comprising a clamp jaw, an electrode, and a clamp arm pad, according to at least one embodiment of the present disclosure. [Figure 63] 1 illustrates an end effector clamp arm comprising a clamp jaw, an electrode, and a clamp arm pad, according to at least one embodiment of the present disclosure. [Figure 64] 1 illustrates an end effector clamp arm comprising a clamp jaw, an electrode, and a clamp arm pad, according to at least one embodiment of the present disclosure. [Figure 65] 13 illustrates a bottom retaining tooth being worn down to allow the electrode to move towards the clamping jaws with a pre-forming curve, in accordance with at least one embodiment of the present disclosure. [Figure 66] 1 illustrates an end effector clamp arm comprising a clamp jaw, an electrode, and a clamp arm pad, according to at least one embodiment of the present disclosure. [Figure 67] 1 illustrates a retainer wall having a tapered profile that is worn away from the retaining wall in the tapered profile area such that a preformed curve allows the electrode to move toward the clamp jaws, in accordance with at least one embodiment of the present disclosure. [Figure 68] According to at least one embodiment of the present disclosure, an end effector including a clamp arm, an ultrasonic blade, a lattice cushion, a flexible electrode disposed above the lattice cushion, and a plurality of hard spacers for setting a gap between the flexible electrode and the ultrasonic blade is shown in Fig. 68. The clamp arm is open and tissue of non-uniform thickness (T1a, T2a, T3a) is disposed on the flexible electrode. [Figure 69]FIG. 69 shows an end effector including a clamp arm, an ultrasonic blade, a lattice cushion, a flexible electrode disposed above the lattice cushion, and a plurality of hard spacers for setting a gap between the flexible electrode and the ultrasonic blade, according to at least one embodiment of the present disclosure, with the clamp arm closed to compress tissue. [Figure 70] FIG 70 shows an end effector including a clamp arm, an ultrasonic blade, a lattice cushion, a flexible electrode disposed above the lattice cushion, and a plurality of hard spacers for setting a gap between the flexible electrode and the ultrasonic blade, according to at least one embodiment of the present disclosure. FIG 70 is an exploded view of the end effector shown in FIG 68-FIG 69. [Figure 71] FIG. 13 is a cross-sectional view of a conductive polymer clamp arm pad according to at least one embodiment of the present disclosure. [Figure 72] FIG. 13 is a perspective view of a clamp arm pad configured to replace a conventional electrode, in accordance with at least one embodiment of the present disclosure. [Figure 73] 73 shows a clamp arm with a clamp arm pad as shown in FIG. 72 in accordance with at least one embodiment of the present disclosure. [Figure 74] 74 shows a clamp arm pad configured as described in FIGS. 72-73 in accordance with at least one embodiment of the present disclosure. [Figure 75] FIG. 13 is a cross-sectional view of a clamp arm with a composite clamp arm pad in contact with tissue, according to at least one embodiment of the present disclosure. [Figure 76] 1 illustrates a clamp arm with a clamp jaw for supporting a carrier or stamping attached to the clamp jaw and a clamp arm pad, according to at least one embodiment of the present disclosure. [Figure 77] A cross-sectional view taken at section 77-77 of Figure 76. [Figure 78] A cross-sectional view taken at section 78-78 of Figure 76. [Figure 79]1 is a cross-sectional view of an alternative implementation of a clamp arm including a clamp jaw, a conductive pad, and a non-conductive pad in accordance with at least one aspect of the present disclosure. [Figure 80] FIG. 13 is a cross-sectional view of an alternative implementation of a clamp arm including a clamp jaw, a carrier or stamping welded to the clamp jaw, a conductive pad, and a non-conductive pad in accordance with at least one aspect of the present disclosure. [Figure 81] 1 illustrates an insert molded electrode according to at least one embodiment of the present disclosure. [Figure 82] 1 illustrates an end effector comprising an ultrasonic blade, a clamp arm, and a clamp arm pad including a conductive film, according to at least one embodiment of the present disclosure. [Figure 83] 83 illustrates the clamp arm shown in FIG. 82. [Figure 84] FIG. 84 is a cross-sectional view of the clamp arm taken along section 84-84 of FIG. [Figure 85] 1 illustrates a clamp arm with a partially conductive clamp arm pad, according to at least one embodiment of the present disclosure. [Figure 86] 1 illustrates a surgical device having a mode selection button switch thereon, in accordance with at least one embodiment of the present disclosure. [Fig. 87A] FIG. 87A illustrates three options for selecting various operational modes of a surgical device according to at least one embodiment of the present disclosure. FIG. 87A illustrates a first mode selection option in which a button switch can be pressed back and forth to cycle through various surgical instruments. [Fig. 87B] 87A-87C show three options for selecting various operating modes of a surgical device according to at least one embodiment of the present disclosure: FIG. 87B shows a second mode selection option in which a button switch is pushed up or down to cycle the surgical instrument through various modes; [Fig. 87C]FIG. 87C illustrates a third mode selection option in which a button switch is pushed back and forth, up and down to cycle the surgical instrument through various modes, according to at least one embodiment of the present disclosure. [Figure 88] 1 illustrates a surgical device with a mode selection button switch on its rear side, in accordance with at least one embodiment of the present disclosure. [Figure 89A] A first mode selection option is shown, and when the mode button switch is pressed to cycle through the various modes, a colored light is displayed on the user interface to indicate the selected mode. [Figure 89B] A second mode selection option is shown, where when the mode button switch is pressed to cycle through the various modes, the screen (eg, LCD, e-ink) indicates the selected mode. [Figure 89C] A third mode selection option is shown whereby when the mode button switch is pressed to cycle through the various modes, coded lights indicate the selected mode. [Fig. 89D] A fourth mode selection option is indicated, where the coded button switch is selected such that when the coded button switch is pressed to select a mode, the coded button switch illuminates to indicate the selected mode. [Figure 90] 1 illustrates a surgical device including a trigger actuation mechanism according to at least one aspect of the present disclosure. [Figure 91] 1 illustrates an alternative clamp arm including a metal clamp jaw, an electrode, a plurality of clamp arm pads, and a gap pad, in accordance with at least one embodiment of the present disclosure. [Figure 92] According to at least one aspect of the present disclosure, a surgical system includes a visualization system, a robotic system, and a surgical hub paired with an intelligent instrument. [Figure 93] 1 illustrates an example of a generator, according to at least one embodiment of the present disclosure. [Figure 94] FIG. 1 illustrates a diagram of various modules and other components that can be combined to customize a modular energy system, according to at least one embodiment of the present disclosure. [Figure 95A] 1 is a first exemplary modular energy system configuration including a header module and a display screen presenting a graphical user interface (GUI) for relaying information regarding modules connected to the header module, in accordance with at least one embodiment of the present disclosure. [Figure 95B] 95B is a modular energy system as shown in FIG. 95A mounted on a cart, according to at least one embodiment of the present disclosure. [Figure 96] 1 shows a perspective view of an exemplary surgical system having a generator and a surgical instrument operable to treat tissue with ultrasonic energy and bipolar RF energy in accordance with at least one embodiment of the present disclosure. [Figure 97] 97 shows a top perspective view of an end effector of the surgical instrument of FIG. 96 having a clamp arm providing a first electrode and an ultrasonic blade providing a second electrode, in accordance with at least one embodiment of the present disclosure. [Figure 98] 98 shows a bottom perspective view of the end effector of FIG. 97 in accordance with at least one embodiment of the present disclosure. [Figure 99] FIG. 97 shows a partially exploded perspective view of the surgical instrument of FIG. 96, in accordance with at least one embodiment of the present disclosure. [Figure 100] 97 shows an enlarged, exploded perspective view of a distal portion of a shaft assembly and an end effector of the surgical instrument of FIG. 96 in accordance with at least one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] The applicant of this application owns the following U.S. provisional patent applications, filed on December 30, 2019, the disclosures of each of which are incorporated herein by reference in their entirety: · U.S. 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."

[0028] The applicant of this application has the following U.S. patent applications filed on even date herewith, each of which is incorporated herein by reference in its entirety: -Attorney Docket No. END9232USNP1 / 190715-1, Title of invention: "USER INTERFACE FOR SURGICAL INSTRUMENT WITH COMBINATION ENERGY MODALITY END-EFFECTOR"; -Attorney Docket No. END9233USNP1 / 190716-1M, Title of invention: "METHOD OF OPERATING A COMBINATION ULTRASONIC / BIPOLAR RF SURGICAL DEVICE WITH A COMBINATION ENERGY MODALITY END-EFFECTOR"; -Attorney Docket No. END9233USNP3 / 190716-3, Title of invention: "NON-BIASED DEFLECTABLE ELECTRODE TO MINIMIZE CONTACT BETWEEN ULTRASONIC BLADE AND ELECTRODE"; Attorney Docket No. END9233USNP4 / 190716-4, Title of invention: "DEFLECTABLE ELECTRODE WITH HIGHER DISTAL BIAS RELATIVE TO PROXIMAL BIAS", Attorney Docket No. END9233USNP5 / 190716-5, Title of invention: "DEFLECTABLE ELECTRODE WITH VARIABLE COMPRESSION BIAS ALONG THE LENGTH OF THE DEFLECTABLE ELECTRODE"; -Attorney Docket No. END9233USNP6 / 190716-6, invention title "ASYMMETRIC SEGMENTED ULTRASONIC SUPPORT PAD FOR COOPERATIVE ENGAGEMENT WITH A MOVABLE RF ELECTRODE", Attorney Docket No. END9233USNP7 / 190716-7, Title of invention: "VARIATION IN ELECTRODE PARAMETERS AND DEFLECTABLE ELECTRODE TO MODIFY ENERGY DENSITY AND TISSUE INTERACTION" -Attorney Docket No. END9233USNP8 / 190716-8, Title of invention: "TECHNIQUES FOR DETECTING ULTRASONIC BLADE TO ELECTRODE CONTACT AND REDUCING POWER TO ULTRASONIC BLADE" Attorney Docket No. END9233USNP9 / 190716-9, Title of Invention: "CLAMP ARM JAW TO MINIMIZE TISSUE STICKING AND IMPROVE TISSUE CONTROL", and -Attorney Docket No. END9233USNP10 / 190716-10, invention name: "PARTIALLY CONDUCTIVE CLAMP ARM PAD TO ENABLE ELECTRODE WEAR THROUGH AND MINIMIZE SHORT CIRCUITING".

[0029] The applicant of this application owns the following U.S. patent applications, filed on May 28, 2020, each of which is incorporated by reference in its entirety herein: - 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 ELECTRODES"; - U.S. Patent Application No. 16 / 885,851, entitled "ELECTROSURGICAL INSTRUMENT WITH ELECTRODES BIASING SUPPORT"; - U.S. Patent Application No. 16 / 885,860, entitled "ELECTROSURGICAL INSTRUMENT WITH FLEXIBLE WIRING ASSEMBLIES"; - U.S. 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"; - U.S. Patent Application No. 16 / 885,873, entitled "ELECTROSURGICAL INSTRUMENTS WITH ELECTRODES HAVING ENERGY FOCUSING FEATURES"; - 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 No. 16 / 885,888, entitled "ELECTROSURGICAL END EFFECTORS WITH THERMALLY INSULATIVE AND THERMALLY CONDUCTIVE PORTIONS"; - U.S. Patent Application No. 16 / 885,893, entitled "ELECTROSURGICAL INSTRUMENT WITH ELECTRODES OPERABLE IN BIPOLAR AND MONOPOLAR 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 No. 16 / 885,931, entitled "SURGICAL SYSTEM COMMUNICATION PATHWAYS"

[0030] Before describing the various forms of the surgical instrument in detail, it should be 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. The exemplary forms may be implemented or incorporated in other forms, variations, and modifications, and may be practiced or carried out in various ways. Moreover, unless otherwise indicated, the terms and phrases used herein have been selected for the purpose of describing the exemplary forms for the convenience of the reader, and not for the purpose of limiting them.

[0031] Additionally, it should be understood that any one or more of the features, embodiment(s), and examples described below may be combined with any one or more of the other features, embodiment(s), and examples described below.

[0032] Various embodiments are directed to improved ultrasonic and / or electrosurgical (RF) instruments configured to provide treatment, dissection, cutting, and / or coagulation of tissue during surgery. In one embodiment, a combination ultrasonic and electrosurgical instrument may be configured for use in open surgery, but also has applications in other types of surgery, such as minimally invasive laparoscopy, orthoscopic, or thoracoscopy, either handheld or robotic assisted surgery, and non-invasive endoscopic procedures, for example. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or in combinations thereof. For example, versatility may be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy), whether simultaneously, independently, sequentially, or in a combination thereof.

[0033] In one aspect, the present disclosure provides an ultrasonic surgical clamping device comprising an ultrasonic blade and a deflectable RF electrode that cooperate to seal, cut, and clamp tissue by cooperation of a clamping mechanism of the device with an RF electrode and an associated ultrasonic blade. The clamping mechanism includes a pivoting clamp arm that cooperates with the ultrasonic blade to grasp tissue therebetween. The clamp arm is preferably provided with a clamp tissue pad (also known as a "clamp arm pad") having a plurality of axially spaced apart grasping teeth, segments, elements, or individual units that facilitate grasping and gripping of tissue during surgery while cooperating with the ultrasonic blade of the end effector to achieve the desired sealing and cutting effect on the tissue.

[0034] In one aspect, the end effectors described herein comprise electrodes. In other aspects, the end effectors described herein comprise alternatives to the electrodes described above, which provide RF energy coupling to tissue that conforms to the shape of the tissue, accommodates pad wear / thinning, minimizes excess heat generation (low coefficient of friction, pressure), minimizes spark generation, minimizes interruptions due to electrical shorts, or a combination thereof. The electrodes are fixed at the proximal end to the clamp jaws and are free to deflect at the distal end. Thus, throughout this disclosure, the electrodes may be referred to as cantilever beam electrodes, or deflectable electrodes.

[0035] In other aspects, the end effectors described herein comprise a clamp arm mechanism configured to apply high pressure between the pad and ultrasonic blade to grasp and seal tissue to maximize the likelihood that the clamp arm electrodes will contact the tissue even in constrained or difficult scenarios, such as thin tissue, tissue under lateral tension, tissue under lifted / vertical tension, especially tissue that is lifted away from the clamp arm.

[0036] In other aspects, the end effectors described herein are configured to balance the surface area / current density match between the electrodes to balance and minimize heat conduction from the tissue interface, for example, to affect the formation and symmetry of denaturation, as well as cycle time, residual heat energy, etc.

[0037] In other aspects, the end effectors described herein are configured to minimize adhesion, tissue sticking (minimize anchor points) and can include small polyimide pads.

[0038] In various aspects, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device. The combined ultrasonic / bipolar RF energy surgical device includes an end effector. The end effector includes a clamp arm and an ultrasonic blade. The clamp arm includes a moveable clamp jaw, a conformable polymer pad, and at least one bipolar RF electrode. The at least one electrode is coupled to a positive pole of an RF generator and the ultrasonic blade is coupled to a negative pole of the RF generator. The ultrasonic blade is acoustically coupled to an ultrasonic transducer stack that is driven by the ultrasonic generator. In various aspects, the end effector includes an electrode biasing mechanism.

[0039] In one general aspect, the present disclosure is directed to a method for using a surgical device including a combination of ultrasonic and advanced bipolar RF energy with a movable RF electrode on at least one jaw of an end effector. The movable RF electrode has a biasing force that varies from a proximal end to a distal end of the movable RF electrode. The movable RF electrode is divided into separate portions such that the movable RF electrodes may be in electrical communication with each other or may be isolated from each other. The movable RF electrode is made of a conductive or partially conductive material. It will be understood that any of the end effectors described in this disclosure may be configured with an electrode biasing mechanism.

[0040] In one aspect, the present disclosure provides a restrictive electrode biasing mechanism to prevent the ultrasonic blade from damaging the electrode. In general, in various aspects, the present disclosure provides an end effector for use with an ultrasonic / RF combined device, the end effector comprising an electrode. In one aspect, the combined ultrasonic / bipolar RF energy surgical device comprises an electrode biasing mechanism. In one aspect, the restrictive electrode biasing mechanism is configured to prevent or minimize the ultrasonic blade from damaging the electrode. The electrode is fixed at a proximal end to the clamp jaws and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0041] In various aspects, the present disclosure provides an electrode cantilever beam that is fixed at only one end with a bias threshold mechanism. In one aspect, the deflectable cantilever electrode is configured for a combined ultrasonic / bipolar RF energy surgical device.

[0042] In one aspect, the combined ultrasonic / RF energy surgical device includes 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 features for changing the mechanical properties of tissue compressed between the electrode and the ultrasonic blade. In another aspect, the electrode 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.

[0043] In various aspects, the electrode comprises a metal spring element attached to the proximal end of the clamp jaw of the end effector. The metal spring element defines an opening through which one or more clamp arm pads (also known as "tissue pads" or "clamp tissue pads") are received. The metal spring element also comprises 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 bonding between the wear pad and the biasing spring, increases the strength of the connection of the electrode to the clamp arm, minimizes unintended release of the clamp arm pads by attaching a polyimide pad to the electrode, and provides a balanced surface area / current density between the electrodes. The electrodes are fixed at the proximal end to the clamp jaw and are 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.

[0044] 1-9 show one embodiment of an end effector with a deflectable / cantilever electrode configured for use with a combined ultrasonic / 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 ultrasonic / RF device according to at least one embodiment of the present disclosure. For brevity and clarity of disclosure, an ultrasonic blade is not shown, which serves as the other clamp arm of the end effector. The end effector is configured such 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, which could result in damage or shorting of the blade. The tissue under treatment is clamped and compressed between the clamp arm 1000 and the ultrasonic blade.

[0045] The clamp arm 1000 includes a frame 1002, an 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 grasp tissue between the clamp arm 1000 and the ultrasonic blade to aid in sealing and cutting the tissue. In other aspects, the small and large non-conductive gap pads may be interchanged. In other aspects, the non-conductive gap pads are simply sized differently, regardless of the relative size difference between the non-conductive gap pads.

[0046] Pivotal movement of the clamp arm 1000 relative to the end effector is provided by providing at least one, and preferably a pair of, lever portions 1012 on the frame 1002 of the clamp arm 1000 at its proximal end 1014. The lever portions 1012 are disposed on opposite sides of the ultrasonic waveguide and the end effector, respectively, and are in operative engagement with a drive portion of a reciprocating actuation member, such that reciprocating movement of the actuation member relative to the outer tubular sheath and ultrasonic waveguide results in pivotal movement of the clamp arm 1000 relative to the end effector about a pivot point 1016. The lever portions 1012 may be disposed within a pair of openings defined by the drive portion, respectively, or may otherwise be suitably mechanically coupled to the drive portion, such that reciprocating movement of the actuation member serves to pivot the clamp arm 1000 through the drive portion and the lever portion 1012.

[0047] FIG. 2 is an exploded view of the clamp arm 1000 shown in FIG. 1 according to at least one embodiment of the present disclosure. In various embodiments, the electrode 1004 is made of a metal spring material attached to a proximal end 1014 of the frame 1002 of the clamp arm 1000 such that the electrode 1004 can deflect. The metal spring electrode 1004 defines an opening 1018 through which elements of the clamp arm pad 1010 are received. The metal spring electrode 1004 defines additional openings 1020, 1021 through which the gap pads 1006, 1008 are received. This establishes a minimum gap between the electrode 1004 and the ultrasonic blade. At least one of the gap pads 1006 is disposed on a distal end 1022 of the electrode 1004. In this manner, the gap pads 1006, 1008 are integral with the electrode 1004. In this configuration, the electrode 1004 prevents tissue from building up around the biasing mechanism, e.g., a cantilevered spring, which could adversely affect the performance of the electrode 1004. This configuration also minimizes bonding between the wearable clamp arm pad 1010 and the biasing spring electrode 1004, increasing the strength of the connection of the electrode 1004 to the clamp arm, and by attaching the gap pads 1006, 1008 to the electrode 1004, minimizes unintentional release of the clamp arm pad 1018, and provides a balanced surface area / current density between the electrodes. The electrode 1004 is attached to the frame 1002 by two prongs 1024. The electrode prongs 1024 are attached to the proximal end 1014 of the frame 1002 as shown in Figures 3 and 4.

[0048] 3 and 4 are perspective views of a frame 1002 according to at least one embodiment of the present disclosure. These views show a connection surface 1026 on the proximal end 1014 of the frame 1002 for attaching the proximal end of the electrode 1004 to the frame 1002. In one embodiment, an electrode protrusion 1024 is welded to the connection surface 1026 of the frame 1002 such that the electrode 1004 behaves in a deflectable manner.

[0049] FIG. 5 is a perspective view of an electrode 1004 according to at least one embodiment of the present disclosure. This view shows the electrode 1004 made of a spring material being biased as indicated by the curvature of the electrode 1004 along its longitudinal length. The openings 1018, 1020, 1021 are for receiving the gap pads 1006, 1008 and the clamp arm pad 1010, respectively. In one embodiment, the electrode 1004 has a thickness "d" of 0.010 inches, where the thickness "d" may be selected, for example, within the range of 0.005 inches to 0.015 inches. Referring also to FIGS. 8 and 9, the opening 1020 is sized and configured to receive the protrusion 1036 defined in the bottom portion of the gap pad 1006.

[0050] FIG. 6 is a perspective view of a clamp arm pad 1010 according to at least one embodiment of the present disclosure. The clamp arm pad 1010 comprises a plurality of clamp arm elements 1032 protruding from a backbone 1030. Throughout this disclosure, the clamp arm elements 1032 are also referred to as "teeth." In one embodiment, the clamp arm pad 1010 defines an aperture 1028 where the gap pad 1006 would be located on the electrode 1004. Referring also to FIGS. 8 and 9, the aperture 1028 defined by the clamp arm pad 1010 is sized and configured to receive a protrusion 1036 defined in a bottom portion of the gap pad 1006. In one embodiment, the material of the clamp arm pad 1010 is softer than the material of the gap pads 1006, 1008. In one embodiment, the clamp arm pad 1010 is made of a non-sticky, lubricious material such as polytetrafluoroethylene (PTFE) or a similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a versatile material that is hydrophobic, non-wettable, dense, and resistant to high temperatures, and has non-stick properties. In contrast, the gap pads 1006, 1008 are made of a polyimide material, and in one embodiment are made of a durable, high-performance polyimide-based plastic, such as that manufactured by DuPont and known under the trade name VESPEL, or other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloys, for example. Unless otherwise noted below, the clamp arm pads and gap pads described herein below are made of the materials described in this paragraph.

[0051] FIG 7 is a perspective top view of a large gap pad 1008 according to at least one embodiment of the present disclosure. The large gap pad 1008 includes a protrusion 1034 sized and configured to fit within an opening 1021 at a proximal end 1014 of an electrode 1004. FIG 8 is a perspective top view of a small gap pad 1006 according to at least one embodiment of the present disclosure. FIG 9 is a perspective bottom view of the small gap pad 1006 shown in FIG 8. As shown in FIGS. 8 and 9, the small gap pad 1006 includes a protrusion 1036 at its bottom that is sized and configured to be received within an opening 1020 defined by the electrode 1004 and an opening 1028 defined by the clamp arm pad 1010. The small gap pad 1006 and the large gap pad 1008 are made of a polyimide material, and in one embodiment are made from 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 when subjected to normal wear and tear.

[0052] In one aspect, the present disclosure also provides additional end effector configurations for combined ultrasonic and bipolar RF energy devices. This portion of the disclosure provides end effector configurations for use with combined ultrasonic and bipolar RF energy devices. In these configurations, the end effector maintains a consistent gap, the RF electrode gap, between the ultrasonic blade, which acts as one pole of the bipolar RF circuit, and the clamp arm, which acts as the opposite pole of the bipolar RF circuit. In conventional end effector configurations, the electrode gap is set by a soft PTFE clamp arm pad that can wear down during surgery. If the clamp arm pad wears completely, the ultrasonic blade can contact the electrode, which can result in blade breakage or an electrical short, both of which are undesirable.

[0053] To overcome these and other limitations, various aspects of the present disclosure incorporate a deflectable RF electrode in combination with a clamp arm pad that includes a non-sticky, lubricated, flexible (e.g., PTFE) pad secured to the clamp arm. The RF electrode includes a wear-resistant, non-conductive pad that contacts the blade to set a gap between the blade and the electrode. The flexible clamp arm pad extends through an opening defined by the electrode and responds to the 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 the electrode. Such a configuration provides a consistent gap between the electrode and ultrasonic blade throughout the life of the device, preventing potential shorts and damage to the ultrasonic blade when the ultrasonic blade contacts the electrode, and allows electrode material to be placed directly opposite the ultrasonic blade to improve sealing performance. The electrode is secured to the clamp jaw at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0054] In one aspect, the present disclosure also provides additional end effector configurations for combined ultrasonic and bipolar RF energy devices. This portion of the disclosure provides end effector configurations for use with combined ultrasonic and bipolar RF energy devices. In these configurations, the end effector maintains a consistent gap between the RF electrode gap and the ultrasonic blade, which acts as one pole of the bipolar RF circuit, and the clamp arm, which acts as the opposite pole of the bipolar RF circuit. In conventional end effector configurations, the electrode gap is set by a soft PTFE clamp arm pad that can wear during surgery. When the clamp arm pad wears, the ultrasonic blade can contact the electrode, resulting in blade breakage or an electrical short, both of which are undesirable.

[0055] To overcome these and other limitations, various aspects of the present disclosure incorporate a deflectable RF electrode in combination with a clamp arm pad that includes a non-sticky, lubricating, flexible (e.g., PTFE) pad secured to the clamp arm. The RF electrode includes a wear-resistant, non-conductive pad that contacts the blade to set the blade-to-electrode gap. The flexible clamp arm pad extends through an opening defined by the electrode and reacts to the 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 the electrode. Such a configuration provides a consistent gap between the electrode and ultrasonic blade throughout the life of the device, preventing potential shorts and ultrasonic blade breakage when the ultrasonic blade contacts the electrode, and allows electrode material to be located directly opposite the ultrasonic blade to improve sealing performance. The electrode is secured to the clamp jaws at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode or a deflectable electrode.

[0056] 10A-13B show configurations in which a deflectable / cantilever electrode is fixed to a clamp arm at a proximal end and can move vertically distal to the attachment point, according to various aspects of the disclosure. In each of the configurations shown and described in connection with FIGs. 10A-13B, the deflectable / cantilever electrode can be attached to the proximal end of the clamp arm by welding, brazing, soldering, or other suitable attachment techniques. Additionally, the clamp arm pads in each of the configurations shown and described herein in connection with FIGs. 10A-13B can be made of a non-sticky, lubricious, flexible material, such as PTFE of tetrafluoroethylene or similar synthetic fluoropolymer. PTFE is hydrophobic, non-wettable, dense, and resistant to high temperatures, making it a versatile material and non-stick properties. Additionally, the gap pads or plugs in each of the configurations shown and described herein in connection with Figures 10A-13B may be made of a polyimide material, and in one embodiment is made of a durable, high performance polyimide-based plastic known under the trade name VESPEL manufactured by DuPont, or other suitable polyimides, polyimide polymer alloys, or polymer alloys such as, for example, PET, PEEK, PEKK.

[0057] 10A-10B, an electrode 1102 is shown having a proximal end 1104 fixedly attached to a proximal end 1104 of a clamp arm 1100 and having a distal end 1106 opposite the fixed end that is free to move or deflect. FIG. 10A shows the clamp arm 1100 and FIG. 10B shows the electrode 1102, according to at least one embodiment of the present disclosure. The electrode 1102 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, with the electrode 1102 being one pole of the RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit. The electrode 1102 is fixed to the clamp jaws at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 1102 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0058] 10A , the clamp arm 1100 comprises an electrode 1102 attached to a proximal end 1104 of the clamp arm 1100. In one aspect, the electrode 1102 is attached to the proximal end 1104 of the clamp arm 1100 by any other suitable means, such as, for example, welding or soldering, such that the electrode 1102 is more vertical at the distal end 1112 of the clamp arm 1100. The clamp arm 1100 comprises a clamp arm pad 1108 and a resilient plug 1110 located at the distal end 1106 of the clamp arm 1100.

[0059] 10B, the electrode 1102 defines a plurality of apertures 1112 for receiving a plurality of protruding elements 1114 (e.g., tines) of the clamp arm pad 1108 therethrough. The electrode 1102 includes a connecting portion 1116 for attaching the electrode 1102 to the proximal end 1104 of the clamp arm 1100. The electrode 1102 includes an elastic plug 1110 at the distal end 1106 of the electrode 1102. In one aspect, the elastic plug 1110 is made of silicone or other suitable material. The electrode 1102 is made of a conductive metal suitable for transmitting RF energy to tissue. The electrode 1102 is one pole of a bipolar RF circuit and the ultrasonic blade is the other pole of the bipolar RF circuit.

[0060] 11A-11D show an electrode having a proximal end fixedly attached to a proximal end of a clamp arm and a distal end opposite the fixed end that is free to move or deflect, according to at least one embodiment of the present disclosure, adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and deflectable under load, the electrode being one pole of an RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit.

[0061] 11A, an end effector 1132 is shown comprising a clamp arm 1120, a peripheral electrode 1122 defining an internal opening 1125, and a connection pad 1124 that is isolated from a conductive portion of the peripheral electrode 1122 and attaches the peripheral electrode 1122 to a proximal end of the clamp arm 1120, according to at least one embodiment of the present disclosure. The figure also shows the connection pad 1124 at the proximal end 1128 that is used to attach the peripheral electrode 1122 to the proximal end 1128 of the clamp arm 1120 (FIG. 11B). The figure also shows a portion of the clamp arm pad 1126 as seen through the opening 1125. The peripheral electrode 1122 is fixed to the clamp arm 1120 at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 1122 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0062] 11B is a top view of a peripheral electrode 1122 and a partial side view of an end effector 1132, according to at least one embodiment of the present disclosure. The peripheral electrode 1122 defines a perimeter and may be referred to herein as a peripheral electrode. Also shown in this view is a gap "x" defined at the distal end 1130 of the ultrasonic blade 1134 and the end effector 1132 and peripheral electrode 1122. The gap "x" is set by the thickness of the connection pad 1124. The end effector 1132 comprises a clamp arm 1120 configured to pivotally open and close to grasp and compress tissue between the clamp arm 1120 and the ultrasonic blade 1134. The peripheral electrode 1122 is fixedly attached to the proximal end 1128 of the clamp arm 1120 and is free to move or deflect at the distal end 1130 of the clamp arm 1120.

[0063] 11C is a side view of an end effector 1154 comprising a clamp arm 1156 and an ultrasonic blade 1159, and a top view of a peripheral electrode 1140 configured to attach to a proximal end 1150 of the clamp arm 1156, according to at least one embodiment of the present disclosure. The peripheral electrode 1140 comprises a conductive portion 1142 and a non-conductive portion 1144 disposed around the periphery of the conductive portion 1142. A space is defined between an outer edge of the conductive portion of the peripheral electrode 1140 and an outer edge of the non-conductive portion of the peripheral electrode 1140. The peripheral electrode 1140 defines an opening 1152 sized and configured to receive a clamp arm pad 1158 therethrough. The peripheral electrode 1140 is fixed to the clamp arm 1156 at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the peripheral electrode 1140 may be referred to as a cantilever beam electrode or a deflectable electrode.

[0064] The peripheral electrode 1140 also includes a connection pad 1146 configured to attach the peripheral electrode 1140 to a proximal end 1150 of a clamp arm 1156. The connection pad 1146 extends from the peripheral electrode. The non-conductive portion 1144 of the peripheral electrode 1140 extends to a distal end 1148 to define a space between a proximal edge of the non-conductive portion 1144 and a distal edge of the conductive portion 1142. The clamp arm 1156 is configured to be pivotally opened and closed about a pivot point 1157 to grasp and compress tissue between the clamp arm 1156 and an ultrasonic blade 1159. The peripheral electrode 1140 is secured to a clamp jaw at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the peripheral electrode 1140 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0065] The clamp arm 1156 includes a clamp arm pad 1158 attached thereto. When the clamp arm 1156 is pivotally closed toward an ultrasonic blade 1159, the clamp arm pad 1158 is received through an aperture 1152 defined by a peripheral electrode 1140. The electrode 1140 is fixedly attached to a proximal end 1150 of the clamp arm 1156 and is free to move or deflect at a distal end 1148 of the clamp arm 1156.

[0066] 11D is a side view of an end effector 1174 comprising a clamp arm 1176 and an ultrasonic blade 1179, and a top view of a peripheral electrode 1160 configured to attach to a proximal end 1170 of the clamp arm 1176, in accordance with at least one embodiment of the present disclosure. The peripheral electrode 1160 comprises a conductive portion 1162 and a non-conductive portion 1164 disposed about the periphery of the conductive portion 1162, except at a distal end 1168 of the peripheral electrode 1160 where the conductive portion 1162 extends the entire distance to an edge 1169 of the non-conductive portion 1164. The peripheral electrode 1160 defines an opening 1172 sized and configured to receive a clamp arm pad 1178 therethrough. The peripheral electrode 1160 also comprises a connection pad 1166 configured to attach the peripheral electrode 1160 to a proximal end 1168 of the clamp arm 1176. The conductive portion 1162 of the electrode 1160 extends to a distal end 1168 where the conductive portion 1162 and the non-conductive portion 1164 overlap an edge 1169 such that no space is defined between the proximal edge of the non-conductive portion 1164 and the distal edge of the conductive portion 1162.

[0067] The end effector 1174 includes a clamp arm 1176 configured to pivotally open and close about a pivot point 1177 to grasp and compress tissue between the clamp arm 1176 and an ultrasonic blade 1179. The clamp arm 1176 includes a clamp arm pad 1178 attached thereto. When the clamp arm 1176 is pivotally closed toward the ultrasonic blade 1179, the clamp arm pad 1178 is received through an aperture 1172 defined by a peripheral electrode 1160. The electrode 1160 is fixedly attached to a proximal end 1170 of the clamp arm 1176 and is free to move or deflect at a distal end 1168 of the clamp arm 1176.

[0068] 12A-12C show a clamp arm 1180 including an electrode 1188 having a proximal end 1194 fixedly attached to the proximal end 1194 of the clamp arm 1180 and having a distal end 1196 opposite the fixed end that is free to move or deflect, according to at least one embodiment of the present disclosure. The electrode 1188 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode being one pole of a bipolar RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit. The electrode 1188 is fixed to the clamp arm 1180 at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 1188 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0069] 12A, a clamp arm 1180 includes a jaw 1182, a clamp arm pad 1184, and an electrode 1188, according to at least one embodiment of the present disclosure. A proximal end 1194 of the electrode 1188 is fixedly attached to a proximal end 1194 of the jaw 1182 to form a connection 1190. A distal end 1196 of the electrode 1188 is free to move or deflect. A plug 1186 is located at the distal end 1196 of the clamp arm 1180 to set a gap between the electrode 1188 and an ultrasonic blade (not shown). The jaw 1182 is pivotally opened and closed to grasp and compress tissue between the clamp arm pad 1184 and the ultrasonic blade (not shown).

[0070] 12B is a cross-sectional view of the clamp arm 1180 from an angle of the distal end 1196 of the clamp arm 1180, according to at least one embodiment of the present disclosure. This view shows the plug 1186 without a backing that defines a gap 1194 between the top 1196 of the plug 1186 and the bottom 1198 of the clamp arm pad 1184. The plug 1186 protrudes below the electrode 1188 and the clamp arm pad 1184, setting the gap between the electrode 1188 and the ultrasonic blade (not shown).

[0071] 12C is a cross-sectional view of a clamp arm pad 1184 with a backing 1197, according to at least one embodiment of the present disclosure. The clamp arm pad 1184 protrudes through the electrode 1188.

[0072] 12D is a clamp arm 1200 including a clamp jaw 1202, a clamp arm pad 1204, and a deflectable cantilever electrode 1208, according to at least one embodiment of the present disclosure. A proximal end 1214 of the deflectable cantilever electrode 1208 is fixedly attached to the proximal end 1204 of the clamp jaw 1202 forming a connection 1210. A distal end 1216 of the deflectable cantilever electrode 1208 is free to move or deflect. A plug 1206 is located at the distal end 1216 of the clamp arm 1200 to set a gap between the deflectable cantilever electrode 1208 and an ultrasonic blade (not shown). The jaw 1202 is pivotally opened and closed to grasp and compress tissue between the clamp arm pad 1204 and the ultrasonic blade (not shown). The deflectable cantilever electrode 1208 is fixed at its proximal end to the clamping jaw 1202 and is free to deflect at its distal end, and thus may be referred to as a cantilever beam electrode, or a deflectable electrode, throughout this disclosure.

[0073] 13A-13B show a clamp arm 1220 comprising an electrode 1228 and a clamp arm pad 1225, according to at least one embodiment of the present disclosure. The electrode 1228 is fixed to the clamp arm 1220 at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode 1228 may be referred to as a cantilever beam electrode, or a deflectable electrode. The clamp arm 1220 also includes a wear pad 1230 configured to set a gap between the electrode 1208 and an ultrasonic blade (not shown). FIG. 13A shows the electrode 1228 in an unloaded, undeflected state, and FIG. 13B shows the electrode 1228 in a loaded, deflected state. The proximal end 1222 of the electrode 1228 is fixedly attached to the proximal end 1224 of the clamp arm 1220. The distal end 1226 of the electrode 1228 opposite the fixed end is free to move or deflect when under load. The electrode 1228 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode 1228 being one pole of a bipolar RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit. The length of the electrode 1228 is selected to accommodate burn-through of the clamp arm pad 1225.

[0074] 14A-15B show an electrode configuration with an end-of-life indicator that can be sensed by an electrical generator to prompt device replacement, according to various embodiments of the regenerative disclosure. Referring initially to FIG. 14A, an end effector 1240 is shown that includes a clamp arm 1242 and an ultrasonic blade 1244, according to at least one embodiment of the present disclosure. The clamp arm 1242 includes an electrode 1246 configured with an end-of-life indicator that can be sensed by an electrical generator to prompt device replacement. A proximal end 1254 of the electrode 1246 is fixedly attached to an anchor point 1250 on the proximal 1254 end of the clamp arm 1242. The clamp arm 1242 is rotatable about a pivot point 1252, allowing the clamp arm 1242 to pivotally open and close to grasp and compress tissue between the electrode 1246 and the ultrasonic blade 1244. The electrode 1246 is fixed to the clamp arm 1242 at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode 1242 may be referred to as a cantilever beam electrode, or a deflectable electrode. The electrode 1246 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, with the electrode 1246 being one pole of a bipolar RF circuit and the ultrasonic blade 1244 being the opposite pole of the bipolar RF circuit.

[0075] An end of life indicator including a tail 1258 made of conductive electrode material is added proximally 1254 to the electrode 1246 anchor point 1250. The tail 1258 deflects towards the ultrasonic blade 1244 as the clamp arm pads and anti-wear pads 1248 show wear and tear during the procedure. When the tail 1258 contacts the ultrasonic blade 1244, it can detect an electrical short within the device, triggering the end of the device's life and informing the surgeon to replace and discard the device. The electrode 1246 is fixed to the clamp jaws at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 1246 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0076] FIG 14B shows the end of life indicator tail 1258 at the start of a procedure and FIG 14C shows the end of life indicator tail 1258 at the end of a procedure. In FIG 14B, the end of life indicator tail 1258 is not in contact with the ultrasonic blade 1244 indicating the device is in good condition. In FIG 14C, the end of life indicator tail 1258 is in contact with the ultrasonic blade 1244 and an electrical short at point 1260 indicates the device is at its end of life and needs to be replaced.

[0077] 15A illustrates an end effector 1270 including a clamp arm 1272 and an ultrasonic blade 1274, according to at least one embodiment of the present disclosure. The clamp arm 1272 includes an electrode 1276 configured with an end-of-life indicator 1278 that can be sensed by an electrical generator to prompt device replacement. The end-of-life indicator 1278 includes a tail 1288 made of conductive electrode material that is attached proximal 1282 to an anchor point 1284 of the electrode 1276. A novel wearable clamp arm pad 1280 is fixedly attached to the clamp arm 1272 and protrudes through an opening provided in the cantilever deflectable electrode 1276 (e.g., as shown and described in FIGS. 1-9). The proximal end 1282 of the electrode 1276 is fixedly attached to an anchor point 1284 on the proximal 1282 end of the clamp arm 1272. The clamp arm 1272 is rotatable about a pivot point 1284, allowing the clamp arm 1272 to pivotally open and close to grasp and compress tissue between the electrode 1276 and the ultrasonic blade 1274. The electrode 1276 is fixed to the clamp arm 1272 at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode 1276 may be referred to as a cantilever beam electrode, or a deflectable electrode. The electrode 1276 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, with the electrode 1276 being one pole of a bipolar RF circuit and the ultrasonic blade 1274 being the opposite pole of the bipolar RF circuit.

[0078] FIG. 15B illustrates the end effector 1270 of FIG. 15A after the clamp arm pad has been worn to near failure. As shown, the end of life indicator 1278 tail 1288 deflects towards the ultrasonic blade 1274 as the clamp arm pad 1280 wears during the procedure, creating electrical contact 1284 between the tail 1288 and the ultrasonic blade 1274. As shown, the components 1290, 1292, 1294, 1296, 1298 of the clamp arm pad 1280 have been significantly worn relative to the clamp arm pad 1280 shown in FIG. 15B. The worn clamp arm pad 1290-1298 causes the tail 1288 to contact 1284 and the ultrasonic blade 1244, creating an electrical short that can be detected by the generator or device and trigger a device end of life notification to the surgeon to replace and dispose of the device. A warning to that effect may be provided to a video display to alert the surgeon or may be provided to a control circuit to trigger other action.

[0079] 16A-16B, 17, and 18A-18D show configurations in which an electrode can move vertically along its length, according to various embodiments of the present disclosure. Referring initially to FIG. 16A, a clamp arm 1300 portion of an end effector is shown, according to at least one embodiment of the present disclosure. The clamp arm 1300 includes a floating electrode 1308 attached to a spring 1310 such that the floating electrode 1308 can be deflected in a direction "d" along its length. The clamp arm 1300 includes a lubricous clamp arm pad 1302 and wear-resistant clamp arm pads 1304, 1306 attached to the lubricous clamp arm pad 1302. The wear-resistant clamp arm pad 1304 is used to set a gap between the floating electrode 1306 and an ultrasonic blade (not shown). For simplicity and clarity of disclosure, the ultrasonic blade portion of the end effector is not shown. As disclosed herein, the lubricious clamp arm pad 1302 is made of a non-stick lubricious material such as, for example, tetrafluoroethylene PTFE or similar synthetic fluoropolymer, and the wear resistant clamp arm pads 1304, 1306 are made of a polyimide material such as, for example, VESPEL, PET, PEEK, or PEKK. The electrode 1306 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode 1306 being one pole of a bipolar RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit.

[0080] 16B, a wear-resistant clamp arm pad 1304 is attached to the end of the lubricous clamp arm pad 1302 to help reduce wear on the lubricous clamp arm pad 1302.

[0081] FIG. 17 illustrates a portion of an end effector 1320 including a clamp arm 1322, according to at least one embodiment of the present disclosure. The clamp arm 1322 includes a floating electrode 1324 attached to a resilient clamp arm pad 1326 such that the floating electrode 1324 can be deflected in a direction "d" along its entire length. The clamp arm 1322 includes a plurality of wear-resistant clamp arm pads 1328 attached to the resilient clamp arm pad 1326. The wear-resistant clamp arm pads 1328 are used to set a gap between the floating electrode 1324 and an ultrasonic blade (not shown). For brevity and clarity of disclosure, the ultrasonic blade portion of the end effector is not shown. The resilient clamp arm pads 1326 function as a spring that allows the floating electrode 1324 to be deflected into the resilient clamp arm pad 1326 and move in the direction "d". The wear-resistant clamp arm pads 1328 set a tissue gap between the floating electrode 1324 and an ultrasonic blade (not shown). As disclosed herein, the lubricious clamp arm pad 1326 is made of a non-stick lubricious material such as, for example, tetrafluoroethylene PTFE or similar synthetic fluoropolymer, and the wear resistant clamp arm pad 1328 is made of a polyimide material such as, for example, VESPEL, PET, PEEK, or PEKK. The electrode 1324 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode 1324 being one pole of a bipolar RF circuit and the ultrasonic 1334 blade being the opposite pole of the bipolar RF circuit.

[0082] 18A is a cross-sectional view of an end effector 1330 comprising a clamp arm 1332, according to at least one embodiment of the present disclosure. The end effector comprises a clamp arm 1332 and an ultrasonic blade 1334. The clamp arm comprises an electrode 1136, a resilient clamp arm pad 1338, and a plurality of wear-resistant dowel pins 1340. The wear-resistant dowel pins 1340 set a tissue gap "G" between the ultrasonic blade 1334 and the electrode 1336.

[0083] 18B is a cross-sectional view of the end effector 1330 showing the position of the wear-resistant dowel pin 1340 within the clamp arm 1332. This view also shows the relative position of the wear-resistant dowel pin 1340 and the resilient clamp arm pad 1336 with respect to the electrode 1336.

[0084] 18C is a cross-sectional view of a wear-resistant dowel pin 1340' according to at least one embodiment of the present disclosure. The dowel pin 1340' includes a barb mechanism 1342 to prevent the wear-resistant dowel pin 1342' from backing out after it is installed in the clamp arm 1332.

[0085] FIG. 18D is a cross-sectional view of a wear-resistant dowel pin 1340″ according to at least one embodiment of the present disclosure. The dowel pin 1340″ includes a piercing feature 1344 to prevent the wear-resistant dowel pin 1342″ from backing out after being installed in the clamp arm 1332.

[0086] 19A shows a portion of an end effector 1350 including a clamp arm 1352 including an electrode 1354 having a "center pivot" configuration, according to at least one embodiment of the present disclosure. The electrode 1354 can rotate about a pivot point 1356 near the midpoint of the electrode 1354. The electrode 1354 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, where the electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0087] 19B shows a portion of an end effector 1360 comprising a clamp arm 1362 with an electrode 1364 having a "center pivot" configuration, according to at least one embodiment of the present disclosure. The electrode 1364 can rotate about a pivot point 1366 near the midpoint of the electrode 1364.

[0088] Figures 20-27 show various design elements for the springs, electrodes, and wear pads that can be incorporated into any of the configurations shown in Figures 10A-19B. The electrodes are adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and are deflectable under load, with the electrodes being one pole of a bipolar RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit.

[0089] 20 shows an end effector 1370 including a clamp arm 1372 and an ultrasonic blade 1374, according to at least one embodiment of the present disclosure. The clamp arm 1372 includes a spring element 1380 formed on an electrode 1376. A wear pad 1378 is attached to the electrode 1376 on the side facing the ultrasonic blade 1374. In another embodiment, the electrode 1376 formed on spring 1380 may further include a strip of metal to form a leaf spring configuration.

[0090] 21 shows a spring element 1382 formed on an electrode 1384, according to at least one embodiment of the present disclosure. The spring element 1382 includes a tab 1386 that is bent at the electrode 1384. A wear pad 1388 is attached to the spring element 1382.

[0091] 22A-22C show a clamp arm 1390 comprising a wave spring element 1392 supporting an electrode 1394, according to at least one embodiment of the present disclosure. The clamp arm 1390 further comprises a resilient wear clamp arm pad 1396. The wave spring element 1392 is positioned such that the electrode 1394 can be deflected in direction "d". In another embodiment, a wear resistant clamp arm pad (not shown) can be added to the clamp arm 1390.

[0092] FIG 22A shows an embodiment of a clamp arm 1390 in which a wave spring element 1392 is integrally formed with a resilient clamp arm pad 1396 to bias the electrode 1392 in direction "d". FIG 22B shows an embodiment of a clamp arm 1398 in which a wave spring element 1392 is positioned between a resilient clamp arm pad 1396 and an electrode 1394 to bias the electrode 1392 in direction "d". FIG 22C shows an embodiment of a clamp arm 1399 in which a wave spring element 1392 is also integrally formed with a resilient clamp arm pad 1396 to bias the electrode 1392 in direction "d".

[0093] 23A-B show methods of attachment of an electrode 1400 according to various embodiments of the present disclosure. In Fig. 23A, the electrode 1400 is placed through a protrusion 1402 in a clamp arm pad 1404 and is attached to the clamp arm by a bracket 1406. In Fig. 23B, the electrode 1400 is attached to the clamp arm pad 1402 by a cylindrical spring 1408.

[0094] 24A-C show electrode spring element configurations according to various embodiments of the present disclosure. FIG. 24A shows an end effector 1410 including a clamp arm 1412 and an ultrasonic blade 1414 according to at least one embodiment of the present disclosure. The clamp arm 1412 includes an electrode 1416 overmolded with an elastomer 1418, thus eliminating the need for a spring. The electrode 1416 is attached to the clamp arm 1412 by a conductive connection 1418. A wear pad 1420 is disposed on the surface of the electrode 1416. The configuration shown in FIG. 24A provides uniform compression along the length of the electrode 1416. Electrical contact is made through the sides. The spring constant increases as it compresses against the elastomer 1418.

[0095] In other aspects, instead of the wear pad 1420 disposed on the surface of the electrode 1416, an overmolded ring or pad can be provided on the ultrasonic blade 1414. In another aspect, the electrode 1416 can be configured to sink into the material displaced by the heated ultrasonic blade 1414.

[0096] FIG. 24B illustrates a clamp arm 1430 with a diaphragm electrode 1432, according to at least one embodiment of the present disclosure. For simplicity and clarity of disclosure, the ultrasonic blade 1414 (FIG. 254A) is not shown in this view. The diaphragm electrode 1432 is attached to the clamp arm 1430 by a rigid conductive connection 1434. A clamp arm pad 1436 is disposed on the diaphragm electrode 1432. The diaphragm electrode 1432 can be made of a thinner metallic conductive material to allow the electrode 1432 to bend or deflect. In one embodiment, the diaphragm electrode 1432 can be made in the form of a ring. The rigid connection 1434 to the clamp arm 1430 ensures an electrical path. The configuration illustrated in FIG. 24B reduces the possibility of the electrode 1432 binding.

[0097] FIG. 24C illustrates a clamp arm 1440 with an integral spring electrode 1442, according to at least one embodiment of the present disclosure. For simplicity and clarity of disclosure, the ultrasonic blade 1414 (FIG. 254A) is not shown in this view. The integral spring electrode 1442 includes a spring-folded end 1444 similar to the shape that forms a staple. The integral spring electrode 1442 is low cost and reduces electrical path transitions. As shown in FIG. 24C, the curved end 1444 of the integral spring electrode 1442 is in electrical communication with the clamp arm 1440 at a connection 1446. A clamp arm pad 1448 is disposed on the integral spring electrode 1442.

[0098] 25 illustrates an electrode 1450 including a coined bump 1452 for use with an integral wear pad (not shown) according to at least one embodiment of the present disclosure. The coined bump 1452 is coated with an electrically insulating material 1454 to prevent shorting to an ultrasonic blade (not shown). The coined bump 1452 allows a larger spring 1456 to deflect the electrode 1450.

[0099] The following is a description of the construction techniques for the electrodes, pads, and springs described herein. In one embodiment, a backing can be placed under the electrode. A 300SST microblank can be used with secondary machining and injection molding to meet tolerances for guiding the electrode up and down. In another embodiment, the clamp arm pads can be made of silicone or plastic. The silicone or plastic clamp arm pad material can be injection molded onto the electrode. A through hole can be formed through the electrode to secure the silicone or plastic material.

[0100] The spring 1460 as shown in FIG. 26 is tested under thermal and tissue fluid conditions according to at least one embodiment of the present disclosure. The length of the spring 1460 can be increased. In one embodiment, the spring 1460 can be a high temperature stainless steel coil spring. In another embodiment, the PTFE clamp arm pad can be broken down into one or more pieces to allow for increased length room for the spring 1460. The PTFE clamp arm pad can be machined. In one embodiment, the clamp arm pad can be modified to remove pad material under the spring.

[0101] Referring to FIG. 27, to prevent coupling when the electrodes 1464 are deflected up or down, according to at least one embodiment of the present disclosure, the electrode distance "d1" can be increased.

[0102] 28A-31 illustrate an end effector 1470 configured with one or more resistors 1480 embedded (integrated) in a clamp arm pad 1478 to sense the height "h" of the clamp arm pad 1478, according to at least one embodiment of the present disclosure. The end effector 1470 comprises a clamp arm 1472, an ultrasonic blade 1474, an electrode 1476, a clamp arm pad 1478, and one or more resistors 1480 embedded in the clamp arm pad 1478. The resistors 1480 melt or wear along with the clamp arm pad 1478 such that the resistance value of the resistor 1480 resembles the height of the clamp arm pad 1478. Thus, the value of the resistor 1480 can be used to estimate the height of the clamp arm pad 1478 in real time, estimate the melting rate of the clamp arm pad 1478, or provide a warning signal or recommendation, or a combination thereof. The warning signal or recommendation can be used by a user or a control circuit to determine next steps. The warning signal is communicated via electrical conductors 1482 to a control circuit coupled to one or more resistors 1480. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode being one pole of a bipolar RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit.

[0103] In FIG. 28A , the clamp arm pad 1478 is new and does not show any wear and the resistor 1480 is in place and at full height h with no tissue between the clamp arm 1472 and the ultrasonic blade 1474. 1 FIG. 28B shows the total resistance at h when there is no tissue between the clamp arm 1472 and the ultrasonic blade 1474 and the clamp arm pad 1478 and resistor 1480 are 2 14 shows the end effector 1470 having worn to a height of h due to heat 1484 generated by friction between the clamp arm 1472 and the ultrasonic blade 1474 and resistor 1480. 1As resistor 1480 wears, the resistance level changes, and may, for example, increase or decrease depending on the actual implementation, and is communicated to a control circuit via an electrical conductor 1482 coupled to resistor 1480. An example of the resistance level R of resistor 1480 versus pad height "h" in clamp arm pad 1478 is shown in FIG. 29, as described below. As shown in FIG. 28B, a warning signal is provided when the melting rate of clamp arm pad 1478 is too rapid and exceeds a predetermined threshold, partially due to a lack of tissue between clamp arm 1472 and ultrasonic blade 1474.

[0104] 28C-28D show that due to the thick tissue 1490 located between the clamp arm 1472 and the ultrasonic blade 1474, the electrode 1476 is 1 Less than h 3 14. The thick tissue 1490 presses down on the electrode 1476 with a force 1488. In this configuration, the clamp arm pad 1478 is still deflected to its full height h 1 or exceeds the warning threshold and the resistance level is also at or above full value.

[0105] FIG. 29 is a graphical illustration 1500 of an example of resistance level R of resistor 1480 in clamp arm pad 1478 versus pad height "h" according to at least one embodiment of the present disclosure. As described in connection with FIGS. 28A-D, the measured resistance levels (R1-R5) shown along the vertical axis vary according to pad height "h" from low to high, as shown along the horizontal axis. As shown in FIG. 29, resistance between levels between R1 and R2 indicates a warning that clamp arm pad 1472 is 50% worn, a resistance level between R2 and R3 indicates a warning signal to replace clamp arm pad 1472 soon, and a resistance level between R3 and R4 indicates a warning signal to shut off energy to ultrasonic blade 1474 or the entire device. As shown in FIG. 29, the resistance level R of resistor 1480 increases as the height "h" of clamp arm pad 1478 decreases. As shown, the curve is exponential. In various other aspects, the electrical circuit may be configured, without limitation, such that the curve is linear and / or the resistance level R of resistor 1480 decreases as the height "h" of clamp arm pad 1478 decreases.

[0106] 30A-30B show the resistance level (R1-R5) as a function of height "h" of resistor 1480, and similarly, height "h" of clamp arm pad 1478, since resistor 1480 is embedded in clamp arm pad 1478 and both elements wear at the same rate. FIG. 30A shows end effector 1470 with new clamp arm pad 1478 and resistor 1480 attached to clamp arm 1472. As shown, ultrasonic blade 1474 is in contact with wear pad 1508 which sets the minimum gap between electrode 1476 and ultrasonic blade 1474. Clamp arm pad 148 is at its full height "h" or at least above the minimum warning threshold and in contact with ultrasonic blade 1474. In this configuration, resistor 1480 is also at a resistance level below minimum warning threshold R1.

[0107] 30B illustrates the condition of the end effector 1470 when the clamp arm pads 1478 are slightly worn and exhibit a resistance level R2, at which the warning signal approaches an indication to immediately replace the clamp arm pads, as shown in graph 1500 of FIG.

[0108] 31 is a graphical illustration 1510 of clamp arm pad 1478 height "h" as measured by an integrating resistor 1480 shown along the vertical axis as a function of time "t" shown along the horizontal axis, in accordance with at least one embodiment of the present disclosure. 1 During the second period t, the warning signal indicates a good condition due to the height "h" of the clamp arm pad 1478 as measured by the integrating resistor 1480. The clamp arm pad 1478 may be high due to either a new pad or a pad that has a very low melt rate because tissue is located between the clamp arm 1472 and the ultrasonic blade 1474. 2 During , the warning signal indicates a bad condition because the jaws are empty with no tissue located between the clamp arm 1472 and the ultrasonic blade 1474. The bad warning signal is issued to unclamp the clamp arm 1472. This condition is indicated by a slope S 1 , S 2 The third period t 3 During this period, if tissue is reintroduced between the clamp arm 1472 and the ultrasonic blade 1474, the warning signal is again generated based on the measured resistance of the integrating resistor 1480 and the slope S 3 Again, the fourth period t 4 During this time, the warning signal indicates a bad condition since the jaws are empty with no tissue located between the clamp arm 1472 and the ultrasonic blade 1474. The issued warning signal indicates to unclamp the clamp arm 1472 or temporarily shut off energy to the ultrasonic blade 1474 or device. This bad condition is detected based on the rate of change of resistance 1478 over time and is indicated by S 4 In the period t 5Now the warning signal again indicates a good condition based on the integrating resistor 1480 measurement.

[0109] 32-33B show a configuration in which the electrode can pivot near the midpoint of the electrode, according to at least one embodiment of the present disclosure. FIG. 32 is an exploded view of a clamp arm 1520 with a central pivot electrode 1522, according to at least one embodiment of the present disclosure. The central pivot electrode 1522 is secured to a non-conductive rocker support 1524 at snap-fit ​​joints labeled A, B, C, and D. The non-conductive rocker support 1524 is pivotally attached to a clamp arm jaw 1526 at a rocker pivot point D'. The central pivot electrode 1522 includes a plurality of non-conductive pads 1528 for setting a gap between the central pivot electrode 1522 and an ultrasonic blade 1532 shown in FIGS. 33A-33B. The central pivot electrode 1522 is coupled to an RF generator via an electrical conductor 1534. The electrode 1522 is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode 1522 being one pole of a bipolar RF circuit and the ultrasonic blade 1532 being the opposite pole of the bipolar RF circuit.

[0110] 33A-B show an end effector 1530 with a clamp arm 1520 and ultrasonic blade 1532 as shown in FIG. 32, according to at least one embodiment of the present disclosure. In FIG. 33A, the pad 1526 is new such that at full clamp, the central pivot electrode 1522 is at a predetermined angle (e.g., parallel) to the clamp arm jaws 1526. As the pad 1528 wears, the angle θ between the central pivot electrode 1522 relative to the clamp arm jaws 1526 changes, as shown in FIG. 33B, and to maintain a consistent gap between the ultrasonic blade 1532.

[0111] In one aspect, the present disclosure provides an interlocking pad feature for enabling a clamp arm pad to secure an electrode to a clamp arm support.

[0112] 34-35C show one embodiment of an interlocking clamp arm pad and electrode plate that acts as both a restraint system and an ultrasonic support. In one embodiment, the clamp arm may include longitudinally aligned slots from the proximal end through which the electrode plate can be advanced without the clamp arm pad material. Once fully inserted, the clamp arm pad material pillars can be inserted from the distal end which deflects the electrode plate until they snap into position. Once interlocked, the back side of the clamp arm pad material component prevents further proximal or distal longitudinal movement of the electrode, and the front side of the clamp arm pad material extending through the electrode opening forms the ultrasonic blade clamp arm support. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode being one pole of a bipolar RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit.

[0113] 34 is a perspective cross-sectional view of a clamp arm 1540 with a slot 1542 aligned longitudinally from a proximal end 1556 through which an electrode plate 1544 may be advanced without clamp arm pad 1546 material, according to at least one embodiment of the present disclosure. The electrode plate 1544 defines an opening 1548 for receiving a protruding element 1550 of the clamp arm pad 1546. The clamp arm pad 1546 is disposed over a clamp jaw 1552 of the clamp arm 1540.

[0114] Figure 35A is a cross-sectional view of the clamp arm 1540 shown in Figure 34 prior to assembly. First, the clamp arm pad 1546 is interconnected to the underside of the electrode plate 1544 by inserting a protruding element 1550 of the clamp arm pad 1546 into an opening 1548 defined by the electrode plate 1544 in the direction indicated by the arrow to form a clamp arm pad / electrode plate assembly 1560. A tab 1554 on a proximal end 1556 of the clamp arm pad 1546 is received or snapped into a proximal recess 1558 on the proximal end of the clamp arm 1540, 1556.

[0115] In FIG. 35B, the clamp arm pad / electrode plate assembly 1560 is slid proximally 1556 into the longitudinally aligned slot 1542 defined by the clamp jaw 1552. In FIG. 35C, a tab 1554 on the proximal end 1556 of the clamp arm pad 1546 is locked into a proximal recess 1558 defined by the proximal end 1556 of the clamp jaw 1552, coupling the clamp arm pad / electrode plate assembly 1560 with the clamp jaw 1552.

[0116] In one aspect, the present disclosure provides a continuous spring support member for a deflectable combo device electrode. FIG. 36 shows one embodiment of a continuous spring support located under the electrode, rather than a separate spring attached to one end of the electrode. In one aspect, the electrode can be attached to the clamp arm support via a wave spring 1570 mechanism along the entire underside of the electrode, as shown in FIG. 36. The wave spring 1570 can be a circumferential concentric ellipse around the electrode, or can be composed of multiple nested deflectable structures. The wave spring 1570 can be made of plastic (non-conductive) or can be electrically insulated from the electrode by a polymer that can also be used for the attachment.

[0117] In another aspect, the present disclosure provides a laterally deflectable electrode to create a blade seating position. Figures 37-50 show a laterally deflectable / split electrode according to various aspects of the present disclosure. In various aspects, the present disclosure provides a deflectable pad that spreads laterally when pressure applied by the ultrasonic blade exceeds a predetermined level, the electrode is separated and prevents direct contact between the electrode and the ultrasonic blade. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load, the electrode being one pole of a bipolar RF circuit and the ultrasonic blade being the opposite pole of the bipolar RF circuit.

[0118] The electrode can be supported to freely deflect vertically and laterally by fixing the proximal end and creating an elastomeric connection between the right and left sections of the electrode which are electrically connected to each other. When the clamp arm pad deflects away from the ultrasonic blade due to interaction of the polyamide pad with the ultrasonic blade, features on the top surface of the underlying clamp arm support have a distal wedge feature that separates the right and left sides at the distal end as the pad deflects more vertically, preventing contact between the blade and the electrode while allowing a zero gap condition.

[0119] The thermal expansion properties of the clamp arm pads can be utilized when heated (10%-20%) to induce lateral expansion. Laterally expanding electrodes can also be created by utilizing the thermal expansion properties of the clamp arm pads due to both heat and compression by the ultrasonic blade. This can in turn induce an increase in the lateral spacing between the electrodes driving them out of the path of the ultrasonic blade.

[0120] FIG 37 is a perspective view of an end effector 1580 including a laterally deflectable electrode 1582 forming one pole of an electrosurgical circuit and an ultrasonic blade 1586 forming the other pole of the electrosurgical circuit in accordance with at least one embodiment of the present disclosure. The end effector 1580 includes a clamp arm 1584 coupled to the laterally deflectable electrode 1582 by any suitable fastener 1583 or fastening technique, such as welding, laser welding, brazing, soldering, compression, among other fastening techniques. The end effector 1580 further includes a clamp arm pad 1588. In FIG 37, the laterally deflectable electrode 1582 is shown in an undeflected state.

[0121] 38 illustrates a laterally deflectable electrode 1582 in an undeflected state (shown in solid lines) and a deflected state 1582′ (shown in dashed lines) in accordance with at least one embodiment of the present disclosure. The laterally deflectable electrode 1582 can be deflected by material clamped between the clamp arm 1584 and the ultrasonic blade 1586 or by the ultrasonic blade 1586 alone.

[0122] 39 is a cross-sectional view of an end effector 1600 including an electrode 1602 as a structural clamping member forming one pole of an electrosurgical circuit, and an ultrasonic blade 1606 forming the other pole of the electrosurgical circuit, in accordance with at least one embodiment of the present disclosure. The electrode 1602 faces inwardly about a clamp arm pad 1604. The electrode 1602 also includes a vertical reinforcing form 1607.

[0123] 40 is a cross-sectional view of an end effector 1608 with an electrode 1610 as a structural clamping member forming one pole of an electrosurgical circuit, and an ultrasonic blade 1612 forming the other pole of the electrosurgical circuit, in accordance with at least one embodiment of the present disclosure. The electrode 1610 faces inwardly about a clamp arm pad 1611. The electrode 1610 also includes a vertical reinforcing form 1613.

[0124] FIG 41 is a cross-sectional view of an end effector 1614 including an electrode 1616 as a structural clamping member forming one pole of an electrosurgical circuit, and an ultrasonic blade 1622 forming the other pole of the electrosurgical circuit, in accordance with at least one embodiment of the present disclosure. The electrode 1616 is coupled to a clamp arm 1618 and coupled to a clamp arm pad 1620 facing inwardly below the clamp arm 1618. The clamp arm 1618 also includes a vertical reinforcing form 1624 for securing the electrode 1616 to the clamp arm 1618. In FIG 41, the electrode 1616 is shown in its undeflected state.

[0125] In FIG. 42, the electrode 1616 is shown in its laterally deflected state 1616′ (shown in dashed lines) in accordance with at least one embodiment of the present disclosure. Thermal expansion of the clamp arm pad 1620 causes the electrode 1616 to deflect or expand laterally and away from the ultrasonic blade 1622 and the clamp arm pad 1620. The lateral expansion of the electrode 1616 spreads or extends significantly into the expanded clamp arm pad 1620′ (shown in dashed lines) as the clamp arm pad material (e.g., PTFE) transitions to a gel-like state at or near 330° C. The deformation is due to a compressive clamp load.

[0126] 43-44 show an example of a clamp arm with a laterally extending electrode, with the original state of the clamp arm shown in solid lime and the extended state shown in dashed lines. FIG. 43 shows a clamp arm 1630 with a laterally deflectable electrode 1632 forming one pole of an electrosurgical circuit according to at least one embodiment of the present disclosure. The clamp arm 1630 is configured for use with an end effector with an ultrasonic blade forming the other pole of an electrosurgical circuit according to at least one embodiment of the present disclosure. The clamp arm 1630 includes a clamp jaw 1636 coupled to the laterally deflectable electrode 1632 by any suitable fastening technique, such as welding, laser welding, brazing, soldering, compression, among other fastening techniques. The clamp arm 1630 further includes a clamp arm pad 1638. The undeflected state is shown in solid lines and the laterally deflected state of the component is shown in dashed lines.

[0127] 44 illustrates a clamp arm 1640 including a laterally deflectable electrode 1642 that forms one pole of an electrosurgical circuit in accordance with at least one embodiment of the present disclosure. The clamp arm 1640 is configured for use with an end effector including an ultrasonic blade that forms the other pole of the electrosurgical circuit in accordance with at least one embodiment of the present disclosure. The clamp arm 1640 includes a clamp jaw 1646 coupled to the laterally deflectable electrode 1642 by any suitable fastening technique, such as welding, laser welding, press pins, among other techniques. The end effector 1640 further includes a clamp arm pad 1648. The undeflected state is shown in solid lines and the laterally deflected state of the component is shown in dashed lines.

[0128] 45-46 illustrate an end effector 1650 including a laterally deflectable electrode 1652 forming one pole of an electrosurgical circuit and an ultrasonic blade 1654 forming the other pole of the electrosurgical circuit in accordance with at least one embodiment of the present disclosure. The end effector 1650 includes a clamp arm 1656 coupled to the laterally deflectable electrode 1652 by any suitable fastening technique, such as welding, laser welding, brazing, soldering, compression, among other fastening techniques. The end effector 1650 further includes a clamp arm pad 1658. The undeflected state of the electrode 1652 is shown in FIG. 45 and has a distance d between the center of the electrode 1652 and the most lateral extension of the electrode 1652. The laterally deflected state of the electrode 1652 is shown in FIG. 46 and has a distance d' between the center of the electrode 1652 and the most lateral extension of the electrode 1652. The lateral deflection of the electrode 1652 is primarily due to lateral thermal expansion and large lateral mechanical deformation. The thermal expansion and mechanical deformation push the electrode 1652 away from the ultrasonic blade 1654, where d'>d. This is especially true when the clamp arm pad 1658 material (e.g., PTFE) reaches a gel-like state at about 330° C. The clamp arm 1654 also includes a vertical reinforcing feature 1655 for securing the electrode 1652 to the clamp arm 1654.

[0129] 47-50 illustrate an end effector 1660 including a laterally deflectable electrode 1662 forming one pole of an electrosurgical circuit and an ultrasonic blade 1664 forming the other pole of the electrosurgical circuit according to at least one embodiment of the present disclosure. The end effector 1660 includes a clamp arm 1666 coupled to the laterally deflectable electrode 1662 by any suitable fastener 1663 or fastening technique, such as welding, laser welding, brazing, soldering, compression, among other fastening techniques. The end effector 1660 further includes a clamp arm pad 1668. The laterally deflectable electrode 1662 includes a notch 1670 defined on a distal end 1672. FIG. 49 illustrates the lateral deflection of the laterally deflectable electrode 1662 in dashed lines in the direction of arrow 1669. FIG. 50 is an enlarged view of the laterally deflectable electrode 1662 with the lateral deflection illustrated in dashed lines.

[0130] 51-58 show an end effector 1671 comprising a pair of metal clamp arms 1673a, 1673b coated with a flexible or deformable dielectric material 1675 and a wire electrode 1674, according to at least one embodiment of the present disclosure. A flexible or deformable dielectric material 1675, such as silicone rubber, shrink tubing, or similar material, is disposed on each of the metal clamp arms 1673a, 1673b. The metal clamp arms 1673a, 1673b may be made of stainless steel, titanium, or a similar metal, or an alloy thereof. A wire electrode 1674 is attached to one of the metal clamp arms 1673a. The wire electrode 1674 may be made of a metal, such as stainless steel, titanium, or a similar metal, or an alloy thereof, and may be coated with a bare metal finish or a thin dielectric material such as PTFE, or may be skived to reveal a very thin bare metal strip.

[0131] 55, the flexible or deformable dielectric material 1675 can be the same material (e.g., silicone) or can be a harder or softer material, such as a hard PTFE tube on one side or the other matched with silicone rubber on the other side, according to at least one embodiment of the present disclosure.

[0132] As shown in FIG. 56, the metal clamp arms 1673a, 1673b can be implemented as bipolar electrodes by adding outer electrodes 1677a, 1677b in accordance with at least one embodiment of the present disclosure.

[0133] As shown in FIGS. 57-58, the metal clamp arms 1673a, 1673b can be bare metal or coated / clad metal, such as, for example, a stainless steel structural member having a PTFE shrink tube 1679 (thin wall) on its inner surface, in accordance with at least one embodiment of the present disclosure.

[0134] Additional background disclosure can be found in U.S. Patent Application Publication Nos. 2016 / 0206367, 2017 / 0164997, and 2015 / 0148834, which are incorporated by reference in their entireties.

[0135] In one aspect, the present disclosure provides asymmetric cooperation of the clamp arm / electrode / pad to provide ultrasonic blade and RF electrode interaction. In one aspect, the present disclosure provides a shortened clamp arm. FIGS. 10-12 show an effector with a shortened clamp arm 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 ultrasonic blade and RF electrode interaction. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0136] In one aspect, the distal end of the clamp arm is shortened, but the length of the clamp arm pad remains the same, so that the distal end of the clamp arm pad extends beyond the distal end of the clamp arm. This allows the electrode to overextend, minimizing the possibility of electrically shorting the distal end of the clamp arm. This may also have the advantage of extending the life of the clamp arm pad, since there is additional exposed clamp arm pad material to wear away completely. This configuration may also eliminate the use of distal and intermediate gap setting clamp arm pads, for example, previously referred to herein as wear resistant clamp arm pads for setting and maintaining the gap between the electrode and the ultrasonic blade.

[0137] FIG. 59 is a side view of an end effector 1680 including a shortened clamp arm 1682, an ultrasonic blade 1684, an electrode 1686, and a clamp arm pad 1688, according to at least one embodiment of the present disclosure. FIG. 60 is a top view of the end effector 1680. As shown in FIGS. 59-60, the ultrasonic blade 1684 and the electrode 1686 are substantially the same length. The clamp arm 1682 is shortened to allow the electrode 1686 to over-advance to prevent electrical shorting. In one embodiment, a gap setting pad 1690 is provided at a proximal end 1692 of the end effector 1680.

[0138] 61 illustrates a clamp arm 1700 comprising a clamp jaw 1702, an electrode 1704, and a clamp arm pad 1706, according to at least one embodiment of the present disclosure. There is clear space above the distal side of the clamp arm. The clamp arm 1700 is configured for use with an end effector comprising an ultrasonic blade, as disclosed in other sections herein. This configuration leaves the space 1708 above the distal side of the clamp jaw 1702 clear. The clamp arm pad 1706 (e.g., PTFE) is fully supported underneath, but clear space exists in the t-slot area and on the sidewalls to allow more of the clamp arm pad 1706 to melt off, allowing the electrode 1704 to deflect further away from the ultrasonic blade (not shown).

[0139] In one aspect, the present disclosure provides an end effector that uses the thermal behavior of the pad to deflect the electrode. 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 thermal expansion properties of the clamp arm pad material (e.g., PTFE) can be utilized to deflect the electrode out of the path of the ultrasonic blade.

[0140] In one aspect, a non-energized electrode and pad are provided. The non-energized but deflectable pad changes position relative to the clamp arm as the pad wears. The non-energized electrode is configured to minimize contact between the ultrasonic blade and the RF electrode. The clamp arm pad includes features to secure the electrode to the clamp arm pad. In one aspect, as the clamp arm pad height wears or breaks, the height of the electrode relative to the clamp arm is gradually adjusted. In another aspect, the electrode remains in its new position once the clamp arm is moved away from the ultrasonic blade. The electrode is fixed to the clamp arm at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0141] End effector configurations including deflectable / cantilever electrodes as described above with respect to Figures 1-61 may be combined with biasing electrodes as described below with respect to Figures 62-67.

[0142] In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device that uses pressure or compression by the clamp jaws to adjust the height of the electrode as the clamp arm pad wears. In one aspect, the clamp arm pad follows the electrode being biased by a clamp arm with a wearable stop. In one aspect, the clamp arm pad includes features to secure the electrode to the pad. As the pad height wears or breaks, the height of the electrode 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.

[0143] Achieving sufficient clamp arm pad life on a combined ultrasonic / bipolar RF energy surgical device requires maintaining a sufficiently small, but non-zero, gap between the clamp arm pad and the electrode throughout the life of the instrument to provide the desired ultrasonic and bipolar RF effects on tissue. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0144] The existing (seed) electrode is a flat electrode that, in its free state (unloaded), is horizontal or substantially parallel to the clamp arm. The electrode is fixed to the clamp arm at its proximal end and is free to deflect at its distal end. Thus, throughout this disclosure, the electrode may be referred to as a cantilever beam electrode, or a deflectable / cantilever electrode. When tissue is clamped, the tissue exerts a load on the electrode, causing it to deflect toward the clamp arm.

[0145] In one aspect, the electrode "follows" the pad as it wears. In this aspect, the electrode, in its free state (whether it is a formed / curved electrode or an electrode attached / welded non-parallel to the clamp arm), is urged toward the clamp arm using any suitable fastening technique, such as welding, laser welding, brazing, soldering, pressing, among other fastening techniques. Wearable stop features (on the pad or elsewhere) keep the electrode away from the clamp arm until the stop feature wears down during use. Once it wears down, the electrode can move closer to the clamp arm. These features can be tooth or ratchet shaped, vertically tapered, or other.

[0146] In one aspect, the present disclosure provides a deflectable / cantilever electrode that, in its free state, is biased towards a clamping arm, is mounted at an angle, and can be made with a preformed curve using any suitable fastening technique, such as welding, laser welding, brazing, soldering, compression, among other fastening techniques.

[0147] In one aspect, the present disclosure provides an end effector with a deflectable / cantilever electrode with a wearable stop feature to prevent the electrode from reaching or contacting the clamp arm. When the stop feature wears, the electrode moves towards the clamp arm until it reaches the next stop feature. In one aspect, the stop feature wears simultaneously with the clamp arm pad to maintain a proper gap between the clamp arm pad and the electrode. These features may be completely separate from the clamp arm pad. These features can be configured to withstand the load of clamping, but more easily wear away by heat (melt / flow) or by friction. Possible examples include teeth on one or more clamp arm pads (PTFE, polyimide, or other) and a tapered profile on one or more clamp arm pads (PTFE, polyimide, or other).

[0148] FIG. 62 illustrates an end effector clamp arm 1710 including a clamp jaw 1712, an electrode 1714, and a clamp arm pad 1716, according to at least one embodiment of the present disclosure. The clamp arm 1710 is configured for use with an end effector including an ultrasonic blade (not shown), as described throughout this disclosure. The clamp arm 1710 also includes a wear-resistant gap pad 1717 for setting a gap between the electrode 1714 and the ultrasonic blade. As shown, in a free state, the electrode 1714 is biased to a flat or horizontal 1718 orientation with no tilt. The electrode 1714 is fixed to the clamp jaw 1712 at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode 1714 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0149] FIG. 63 illustrates an end effector clamp arm 1720 including a clamp jaw 1722, an electrode 1724, and a clamp arm pad 1726, according to at least one embodiment of the present disclosure. The clamp arm 1720 is configured for use with an end effector including an ultrasonic blade (not shown), as described throughout this disclosure. The clamp arm 1720 also includes a wear-resistant gap pad 1727 for setting a gap between the electrode 1724 and the ultrasonic blade. As illustrated, in a free state, the electrode 1724 is preformed, configured to bend, or otherwise biased toward the clamp jaw 1722, away from an orientation of the horizontal 1718 along a line 1728. The electrode 1724 is fixed to the clamp arm 1720 at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, the electrode 1724 may be referred to as a cantilever beam electrode, or a deflectable electrode. To prevent the biasing electrode 1724 from bending toward the clamp jaw 1722 under the biasing force, the clamp arm 1720 further includes a retainer that prevents the biasing electrode 1724 from bending toward the clamp jaw 1722 and maintains the biasing electrode 1724 in a substantially planar configuration (e.g., parallel, flat, or horizontal) relative to the ultrasonic blade. Examples of retainers, such as retainer teeth 1738 and retainer walls 1760 having a tapered profile, are described below with reference to Figures 64-67.

[0150] 64 illustrates an end effector clamp arm 1730 including a clamp jaw 1732, an electrode 1734, and a clamp arm pad 1736, according to at least one embodiment of the present disclosure. The clamp arm 1730 is configured for use with an end effector including an ultrasonic blade (not shown), as described throughout this disclosure. The clamp arm 1730 also includes a wear-resistant gap pad 1737 for setting a gap between the electrode 1744 and the ultrasonic blade. In a free state, the electrode 1734 is configured to be preformed, bent, or otherwise biased into a curved shape toward the clamp jaw 1732. However, a retainer tooth 1738 or similar feature is provided on the clamp arm pad 1736 to prevent the electrode 1734 from jumping toward the clamp jaw 1732. 65, according to at least one embodiment of the present disclosure, when bottom retainer tooth 1738 wears down, electrode 1734 can move toward clamp jaw 1732 according to a preformed curve. Electrode 1734 is fixed to clamp arm 1730 at a proximal end and is free to deflect at a distal end. Thus, throughout this disclosure, electrode 1734 can be referred to as a cantilever beam electrode, or a deflectable electrode.

[0151] FIG. 66 illustrates an end effector clamp arm 1750 including a clamp jaw 1752, an electrode 1754, and a clamp arm pad 1756, according to at least one embodiment of the present disclosure. The clamp arm 1750 is configured for use with an end effector including an ultrasonic blade (not shown), as described throughout this disclosure. The clamp arm 1750 also includes a wear-resistant gap pad 1757 for setting a gap between the electrode 1754 and the ultrasonic blade. In a free state, the electrode 1754 is configured to be preformed, bent, or otherwise biased 1758 with a shape that curves toward the clamp jaw 1752. However, a retainer wall 1760 having a tapered profile or similar feature is provided on the clamp arm pad 1756 to prevent the electrode 1754 from jumping toward the clamp jaw 1752.

[0152] 67, according to at least one embodiment of the present disclosure, as the tapered profile retainer wall 1760 wears away, there is sufficient melting / flow away from the tapered profile retainer wall 1760 region, allowing the electrode 1754 to move toward the clamp jaw 1752 due to the preformed curve. The electrode 1754 is fixed to the clamp jaw 1752 at the proximal end and is free to deflect at the distal end. Thus, throughout this disclosure, the electrode 1754 may be referred to as a cantilever beam electrode, or a deflectable electrode.

[0153] In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device that uses a constant pressure distribution biasing mechanism. In one aspect, the end effector includes a resilient compressive support for mounting and insulating a deflectable electrode. In one aspect, a hollow honeycomb or chambered elastomeric support mounting cushion can be used to allow all or a portion of the electrode attached thereto to be deflected or biased toward the ultrasonic blade. This configuration can provide the added benefit of thermally insulating the electrode from the remainder of the metal clamp jaw. It also provides an elastomeric "curtain" around the electrode to minimize tissue build-up behind the electrode. In one aspect, a deflectable geometry without supports for the elastomeric cell allows the deflection force to remain constant over a range of deflections. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0154] The above configuration prevents the electrode from bending laterally under compression, preventing shorting. Additionally, the deflectable electrode is attached to an elastomer, which is fixed to the metal clamp arm. The spring tight height is limited to drive acceptable compression while maintaining as much of the metal clamp arm as possible. Heat conduction from the tissue interface is balanced and minimized, affecting denaturation formation and symmetry, cycle time, and residual heat energy.

[0155] The end effector configuration including the deflectable / cantilever electrode described above with respect to Figures 1-61 can be combined with a flexible electrode positioned on a lattice cushion and multiple hard spacers to set a gap between the flexible electrode and the ultrasonic blade, as described below with respect to Figures 68-70.

[0156] The energizing electrode configuration as described above with respect to Figures 62-67 can be combined with a flexible electrode positioned on a lattice cushion and multiple hard spacers to set a gap between the flexible electrode and the ultrasonic blade, as described below with respect to Figures 68-70.

[0157] The end effector configuration having a deflectable / cantilever electrode as described above with respect to Figures 1-61 in combination with a biasing electrode as described above with respect to Figures 62-97 can be combined with a flexible electrode disposed above a lattice cushion and a number of hard spacers, as described below with respect to Figures 68-70, to establish a gap between the flexible electrode and the ultrasonic blade.

[0158] 68-70 show an end effector 1810 including a clamp arm 1812, an ultrasonic blade 1814, a lattice cushion 1816, a flexible electrode 1818 disposed above the lattice cushion 1816, and a plurality of hard spacers 1820 for setting a gap between the flexible electrode 1818 and the ultrasonic blade 1814, according to at least one embodiment of the present disclosure. FIG. 70 is an exploded view of the end effector 1810 shown in FIGS. 68-69. The clamp arm pad 1822 is disposed inside a slot 1825 formed in the lattice cushion 1816. The lattice cushion 1816 functions as a spring-like element. The hard spacers 1820 are used to set a gap between the flexible electrode 1818 and the ultrasonic blade 1814.

[0159] In FIG. 68, the clamp arm 1812 is open and the non-uniform thickness (T 1a , T 2a , T 3a 69, tissue 1824 of varying thickness (T 1a , T 2a , T 3a) tissue 1824 with consistent thickness (T 1b , T 2b , T 3b ) organization 1824, i.e., compression is achieved such that the following relationships hold:

[0160]

number

[0161] Additional background disclosure can be found in EP 3378427, WO 2019 / 006068, which are incorporated by reference in their entireties.

[0162] In one aspect, the present disclosure provides an end effector for a combined ultrasonic / bipolar RF energy surgical device with a means for insuring contact between the biasing electrode and the distal tip using a zero-gap bipolar RF energy system. In various aspects, the present disclosure provides a deflectable electrode for a combined ultrasonic / bipolar RF energy surgical device with a distal biasing force greater than a proximal biasing force. In one aspect, the present disclosure provides an energy combined device with a bipolar electrode that is deflectable relative to a clamp arm. The energy combined device includes features that change the mechanical properties of tissue compression from proximal to distal, creating a more uniform or more distinct pattern of pressure than clamping force alone. In one aspect, the present disclosure provides a nonlinear distal distribution mechanism, and in another aspect, the present disclosure provides a nonlinear distribution of electrical energy density. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. This electrode is one pole of a bipolar RF circuit and the ultrasound blade is the opposite pole of the bipolar RF circuit.

[0163] The end effector configurations including the deflectable / cantilever electrodes described above with respect to Figures 1-61 can be combined with conductive polymer clamp arm pads as described below with respect to Figures 71-85.

[0164] The biasing electrode configurations as described above with respect to Figures 62-67 can be combined with conductive polymer clamp arm pads as described below with respect to Figures 71-85.

[0165] As described above with respect to Figures 68-70, the configuration of a flexible electrode and multiple hard spacers positioned on a lattice cushion to set a gap between the flexible electrode and the ultrasonic blade can be combined with a conductive polymer clamp arm pad, as described below with respect to Figures 71-85.

[0166] The configuration of the biasing electrodes as described above with respect to Figures 62-67 can be combined with a flexible electrode and multiple rigid spacers disposed on a grid cushion to set a gap between the flexible electrode and the ultrasonic blade as described above with respect to Figures 68-70, and can be combined with a conductive polymer clamp arm pad as described below with respect to Figures 71-85.

[0167] The configuration of the biasing electrodes as described above with respect to Figures 62-67 can be combined with a flexible electrode and multiple rigid spacers disposed on a grid cushion to set a gap between the flexible electrode and the ultrasonic blade as described above with respect to Figures 68-70, and can be combined with a conductive polymer clamp arm pad as described below with respect to Figures 71-85.

[0168] The end effector configurations having deflectable / cantilever electrodes as described above with respect to Figures 1-61 in combination with biasing electrodes as described above with respect to Figures 62-67 can be combined with conductive polymer clamp arm pads as described below with respect to Figures 71-85.

[0169] The end effector configuration with the deflectable / cantilever electrode described above with respect to Figures 1-61 in combination with a biasing electrode as described above with respect to Figures 62-67 can be combined with a flexible electrode disposed above a grid cushion and multiple hard spacers to set a gap between the flexible electrode and the ultrasonic blade as described above with respect to Figures 68-70, and can further be combined with a conductive polymer clamp arm pad as described below with respect to Figures 71-85.

[0170] In various aspects, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device with an ultrasonic pad having a partially or fully conductive portion such that the pad behaves as both 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 electrode wear and minimizes shorting in combined bipolar RF and ultrasonic energy devices where the clamp arm pad has conductive and non-conductive portions. This allows the clamp arm pad to function as one of the RF electrodes while also acting as an abradable support structure for the ultrasonic blade. In another aspect, the present disclosure provides a conductive portion around the periphery of the clamp arm pad, but not 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.

[0171] In one aspect, the present disclosure provides an end effector for an ultrasonic / bipolar RF energy combined surgical device comprising a conductive polymer ultrasonic clamp arm pad. In one aspect, the end effector comprises a clamp arm pad doped with tin oxide. FIG. 71 is a cross-sectional view of a conductive polymer clamp arm pad 2440 according to at least one aspect of the present disclosure. The conductive polymer clamp arm pad 2440 is made of tin oxide 2442 (SnO 2 ) embedded in a polymer material 2444, such as Teflon (PTFE), to make the clamp arm pad 2440 conductive. 2 ). The doping can be accomplished using a cold spray process. Once doped, the conductive polymer clamp arm pad 2440 can function as a conventional ultrasonic tissue clamp arm pad, for example, contacting the ultrasonic blade, absorbing heat from the ultrasonic blade, and assisting in the gripping and clamping of tissue. The tin oxide doped clamp arm pad 2440 functions as one of two electrodes or poles of a bipolar RF circuit to deliver RF energy to tissue gripped between the ultrasonic blade and the clamp arm pad 2440. The tin oxide doped clamp arm pad 2440 is biocompatible, electrically conductive, thermally conductive, can use a large portion of the clamp arm pad 2440 to improve the wear resistance of the clamp arm pad 2440, and is white in color. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0172] In one aspect, the present disclosure provides a conductive polymer ultrasonic clamp arm pad as an alternative to an electrode. To improve the lifespan of the ultrasonic clamp arm pad and improve the effect of RF on tissue, the present disclosure provides an improved electrode that is easier and less costly to fabricate. In one aspect, the present disclosure provides a clamp arm pad that includes a hard polyimide polymer layer and a conductive layer to enable the clamp arm pad to perform traditional functions and to carry bipolar electricity, eliminating the need for a separate electrode in the clamp arm of the combined energy end effector. In this manner, the clamp jaws can be manufactured in a similar manner to ultrasonic-only clamp jaws, and the new clamp arm pad material would replace the traditional ultrasonic-only clamp arm pad. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0173] Advantages include improved ultrasonic performance, including wear on the clamp arm pads, similar to current ultrasonic-only instruments, since there is no electrode gap between the "squares" of the polymer elements. The cost of the improved clamp jaw is similar to current ultrasonic-only clamp jaws, since a separate electrode component is eliminated, providing multiple small polymer square elements. In addition, the manufacturing steps required to create the clamp jaw are the same as those required to create current ultrasonic-only clamp jaws. Manufacturing the improved clamp jaw requires only the replacement of the clamp arm pads, and indeed the manufacture of additional electrode components to be added to the clamp jaw, eliminating the assembly step.

[0174] FIG. 72 is a perspective view of a clamp arm pad 2450 configured to replace a conventional electrode, according to at least one embodiment of the present disclosure. The clamp arm pad 2450 includes a non-conductive layer 2452 and a conductive layer 2454 in a sandwich-like configuration. This configuration eliminates the need for a spring-loaded electrode plate. The non-conductive layer 2452 can be made of polymers, polyimides, Teflon (PTFE), and similar non-conductive materials. The 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 majority of the material in contact with the ultrasonic blade is the non-conductive layer 2452. In one embodiment, 75% of the material in contact with the ultrasonic blade is a non-conductive material, such as PTFE. In another embodiment, 85% of the material in contact with the ultrasonic blade is a non-conductive material, such as PTFE. In another embodiment, 95% of the material in contact with 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 available surface area to conduct RF electricity through the tissue and the return electrode (eg, an ultrasound blade).

[0175] Fig. 73 illustrates a clamp arm 2460 including the clamp arm pad 2450 of Fig. 72, in accordance with at least one embodiment 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.

[0176] 74 shows clamp arm pads configured as described in FIGS. 23-24, according to at least one embodiment of the present disclosure. A first clamp arm pad 2470 is new and has teeth 2472 integrally formed therewith. A second clamp arm pad 2476 is new but does not have teeth. A third clamp arm pad 2478 is worn and may represent either the first clamp arm pad 2470 or the second clamp arm pad 2476.

[0177] In one aspect, the present disclosure provides a composite clamp arm pad for a combined ultrasonic / bipolar RF energy surgical device. FIG. 75 is a cross-sectional view of a clamp arm 2480 with a composite clamp arm pad 2482 in contact with tissue 2484 according to at least one aspect of the present disclosure. The end effector 2480 includes an upper clamp jaw 2486 and an adhesive 2488 for fixedly attaching the composite clamp arm pad 2482 to the upper clamp jaw 2486. The composite clamp arm pad 2482 includes a thin non-conductive layer 2490 (e.g., PTFE) and a thin conductive layer 2492 (e.g., thin stainless steel foil). The conductive layer 2492 forms an electrode portion of the composite clamp arm pad 2482. The conductive layer 2492 (e.g., thin stainless steel foil) deforms as the non-conductive layer 2490 (e.g., PTFE) wears. The thickness of the conductive layer 2492 allows the electrode portion of the combined clamp arm pad 2482 to deform as the 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 combined clamp arm pad 2482 cooler. As described above, the combined clamp arm pad 2482 is secured to the upper clamp jaw 2486 by an adhesive 2488. The adhesive 2488 may be filled with carbon to make the adhesive 2488 conductive and connect the electrode portion of the combined clamp arm pad 2482 to the upper clamp jaw 2486. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0178] In one aspect, the clamp arm pad comprises cooperating conductive and insulating portions. In one aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device having conductive and non-conductive portions that allow the 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 conductive portion of the clamp arm pad is located on the periphery of the pad and is not located on the directly opposite side 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 interrupting the conductivity of the remaining conductive portion of the clamp arm pad.

[0179] In one aspect, the present disclosure provides a clamp arm pad for use with a combined ultrasound / bipolar RF energy device, where a portion of the clamp arm pad comprises a conductive material and another portion comprises a non-conductive material. An electrode is adapted and configured for use with the combined ultrasound / RF energy device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0180] In various embodiments, the clamp arm pads may be manufactured using a variety of techniques. One technique involves a two-shot process where conductive and non-conductive materials are molded in the same compression mold. This process effectively creates a single clamp arm pad with one portion capable of acting as a bipolar RF electrode and another portion acting as an electrical insulator. Another technique involves embedding metal elements into a polymer (e.g., Teflon, PTFE) pad or matrix by supersonic cold spraying. Another technique involves 3D printing of multiple materials (e.g., Teflon, PTFE, and doped conductive polymers), printing / transfer printing of conductive or functional inks onto the clamp arm pads. Another technique involves metals and conductive materials (e.g., graphite / carbon) may be applied to the clamp arm pads using chemical vapor deposition, physical vapor deposition, sputter deposition, vacuum deposition, vacuum metallization, or thermal spraying. Another technique includes conductive / filled clamp arm pad electrodes that provide continuity through the pad with micro-randomly oriented and positioned particles or macro-oriented structures (e.g., cloth, woven fabric, constrained long fibers). Another technique includes making the surface of the clamp arm pad conductive, including providing electrodes that wear away, 3D printing, hot spray, cold spray, coating / paint / epoxy, sheet / foil / wire / film wrapping or lamination, vacuum metallization, printing / transfer, among other techniques. In another technique, a polymer electrode is filled with a conductive material.

[0181] In one embodiment, the end effector clamp arm comprises a fixed polymer electrode. FIG. 76 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 embodiment of the present disclosure. The clamp arm pad 2506 comprises a conductive pad 2508 and a non-conductive pad 2510. The conductive pad 2508 is made of a conductive polymer and serves as one of the electrodes of a bipolar RF circuit. The clamp jaw 2502 and the carrier 2504 are made of stainless steel and may be attached using any suitable fastening technique, such as, for example, welding, laser welding, brazing, soldering, pressing, among other fastening techniques. The conductive pad 2508 may comprise a polymer, such as, for example, silicone, fluorosilicone, PTFE, and similar materials. The conductive pads 2508 are overmolded onto the carrier 2504 using PTFE, silicone, fluorosilicone filled with silver particles, silver on aluminum, silver on copper, copper, nickel, graphite, carbon (amorphous, short fiber), gold, platinum, stainless steel, iron, or zinc, or combinations thereof.

[0182] Fig. 77 is a cross-sectional view taken along section plane 77-77 in Fig. 76, and Fig. 78 is a cross-sectional view taken along section plane 78-78 in Fig. 76. Sections 77-77 and 78-78 show a clamp arm 2500 comprising a clamp jaw 2502, a support carrier 2504, a conductive pad 2508, and a non-conductive pad 2510.

[0183] 79 is a cross-sectional view of an alternative implementation of a clamp arm 2520 including a clamp jaw 2522, a conductive pad 2524, and a non-conductive pad 2526, in accordance with at least one embodiment of the present disclosure. The conductive pad 2524 is made of a conductive polymer and serves as one of the electrodes in a bipolar RF circuit.

[0184] 80 is a cross-sectional view of an alternative implementation of a clamp arm 2530 including 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, in accordance with at least one embodiment of the present disclosure. The conductive pad 2536 is made of a conductive polymer and serves as one of the electrodes in a bipolar RF circuit. The conductive pad 2536 is overmolded onto the carrier 2534 or stamping.

[0185] In one aspect, the end effector clamp arm includes a film on insert molded metal electrode assembly. In one aspect, the film can be provided on an insert molded metal (e.g., stainless steel) electrode assembly. The film can be insert molded onto a metal, such as stainless steel, to form the electrode assembly. The film on the insert molded electrode can be etched to form micro-holes, slots, honeycombs, etc., among other patterns, to conduct RF energy as well as cut around components. The film can be formed or bonded onto the stainless steel electrode using an IML / FIM (in-mold labeling / film insert molding) process described below. The filled film electrode can be placed into a polymer injection molding tool to mold the polymer onto the back of the electrode and film. The electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0186] 81 illustrates an insert molded electrode 2540 according to at least one embodiment 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 micro-holes, slots, honeycomb, or similar features, are formed in the film 2542 to allow for the passage of RF energy. Retention features 2552 are also formed on the film 2542. A sidewall 2558 of the film 2542 extends below the bottom of the polymer pad 2548 and may be folded around the bottom of the polymer pad 2548 or overmolded with a retention post. The retention feature 2552 is molded into a hole 2554 defined by the film 2542. Although the 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.

[0187] The conductive elements 2546 may be made of a conductive metal, such as stainless steel or a similar conductive metal. The conductive elements 2546 may be approximately 0.010 inches thick, may be selected within a range of thicknesses of 0.005 inches to 0.015 inches, and may be formed by tamping or machining. The film 2544 may be approximately 0.001 inches to 0.002 inches thick, and may be made of polyimide, polyester, or similar materials. Alternatively, for mechanical retention such as posts, the film 2544 may be bonded directly to the conductive elements 2546. One example is DuPont's Pyralux HXC Kapton film with an epoxy adhesive backing, having a thickness of 0.002 inches.

[0188] Advantageously, the non-sticky surface prevents tissue from adhering to the insert molded electrode 2540. The non-sticky surface eliminates the occurrence of shorting between opposing electrodes by establishing a gap within the range of 0.002 inches to 0.004 inches along the entire length of the insert molded electrode 2540. The non-sticky surface minimizes the lateral spread of RF energy by covering the sidewalls 2558 of the insert molded electrode 2540. The insert molded electrode 2540 also exhibits structural integrity and provides an easier, more robust electrical connection than multi-layer flexible circuits.

[0189] In one aspect, the end effector comprises a conductive clamp arm and pad structure for a combined ultrasonic / bipolar RF energy surgical device. In one aspect, the present disclosure provides a clamp arm assembly comprising a conductive or selectively conductive thin film, foil, or laminate applied to, around, or on the clamp arm assembly to act as a durable "pole" in a combined ultrasonic / bipolar RF energy surgical device. Additionally, an algorithm, software, or logic is provided to manage the condition of electrical short occurrence. An electrode is adapted and configured for use with a combined ultrasonic / bipolar RF energy surgical device and is deflectable under load. The electrode is one pole of a bipolar RF circuit and the ultrasonic blade is the opposite pole of the bipolar RF circuit.

[0190] FIG. 82 shows an end effector 2560 comprising an ultrasonic blade 2562, a clamp arm 2564, and a clamp arm pad 2566 including a conductive film 2568, in accordance with at least one embodiment of the present disclosure.

[0191] Figure 83 shows the clamp arm 2564 shown in Figure 82. The clamp arm 2564 includes a clamp jaw 2570 for supporting a clamp arm pad 2566. A thin conductive film 2568 is disposed over the clamp arm pad 2566 to form one of the poles of a bipolar RF circuit.

[0192] FIG 84 is a cross-sectional view of the clamp arm 2564 taken along cut plane 84-84 of FIG 83. The clamp jaws 2570 may be made of a metal such as stainless steel. The clamp arm pads 2566 may be made of a non-conductive, flexible material such as PTFE, silicone, high temperature polymers, or similar materials. The conductive film 2568 or foil may be made of a conductive material such as titanium, silver, gold, aluminum, zinc, and any alloys thereof, including stainless steel.

[0193] 85 shows a clamp arm 2580 with a partially conductive clamp arm pad 2582, according to at least one embodiment of the present disclosure. A conductive foil 2584 covers a portion of a 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.

[0194] The conductive film 2568, foil, or laminate element may include, for example, a single layer of a thin conductive material, such as, for example, a metal (such as titanium, silver, gold, zinc, aluminum, magnesium, iron, and the like, and alloys thereof, or stainless steel), a plated metal (such as nickel-then-gold-on-copper), or a polymer highly loaded with a conductive material, such as a metal powder, or a filler. Preferably, the element is a biocompatible metal foil, such as titanium, silver, gold, zinc, or stainless steel, selected from a thickness range of 0.001 inch to 0.008 inch (0.025 mm to 0.20 mm).

[0195] The film 2568, foil, or laminate may include a thin polymer coating, film, or layer that covers the thin conductive material described above. This coating, film, or layer has a high electrical resistance, i.e., is not an effective conductor of bipolar RF energy to adjacent tissue. The coating may be perforated to allow energy delivery from the electrodes to the tissue.

[0196] The conductive material may be perforated or contain holes or windows through the entire thickness of the conductive material, which may minimize the thermal capacitance of this layer (testing has shown that longer and / or thicker foils result in longer times for tissue to be cut due to thermal energy being removed from the treatment site). These perforations, holes, or windows may also allow for retention of the foil to other parts or layers. These perforations, holes, or windows may be patterned throughout the entire sheet of foil, localized at the treatment site, or localized away from the treatment site, e.g., only on the sides of the clamping arms.

[0197] When thin polymeric coatings, films, or layers are present, they may be perforated or may contain holes or windows through their entire thickness such that the conductive film, foil, or laminate is in direct communication with the tissue to deliver bipolar radiofrequency energy to the tissue. In the case of coatings, these holes or windows may be formed by selective coating or coating removal.

[0198] Ideally, the conductive film 2568, foil, or laminate is in direct contact with the clamp arm structure, which is typically manufactured from stainless steel. The resulting conductive path therefore allows for a simple construction since the path is made from the necessary structural components, i.e., by the support tube or actuator that connects directly to the clamp arm, and then by the conductive film, foil, or laminate.

[0199] In one aspect, the conductive film 2568, foil, or laminate is backed by a relatively soft, high temperature, low wear polymer or elastomer pad made from materials such as PTFE, silicone, polyimide, high temperature thermoplastics, among others. The flexibility of this relatively soft pad allows for a wide range of component tolerances to obtain a zero or near zero gap between the jaws and the ultrasonic blade along its entire length of tissue engagement when the jaws are fully closed, thus allowing tissue to be sealed and cut along this length. The flexibility also eliminates or greatly attenuates any audible vibrations of the conductive layer that may occur when the ultrasonic blade is closed against the conductive layer.

[0200] The conductive film 2568, foil, or laminate may include a rigid to semi-rigid polymer on its back / underside (i.e., the surface facing away from the tissue and toward the clamp arm) that is made from an injection moldable polymer or polymer alloy and is adhered to the film, foil, or laminate by film insert molding (FIM) or in-mold labeling (IML).

[0201] In tests, thin stainless steel, copper, or aluminum foil is quiet during surgery (it does not "squeak" or emit a dull squealing sound). It 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 padding material, can be used and will not easily tear or crack.

[0202] The proximal portion of the clamping face of the jaws may not include a conductive film, foil, or laminate since this area of ​​the jaws will be in contact with the blade first, which is more likely to result in electrical short formation / short circuiting of electrical power in this area.

[0203] In one aspect, the present disclosure provides a short circuit mitigation algorithm for activating an output that includes bipolar RF energy.

[0204] If a short circuit occurs after the energy delivered for activation exceeds a threshold amount (thereby indicating that the tissue has thinned but that it likely received an adequate dose of bipolar RF energy to seal and coagulate the tissue), or after the activation time threshold is exceeded (individually again indicating that the tissue has thinned but that it likely was accepted and received an adequate dose), or after both the energy threshold and activation time threshold are exceeded, no short circuit alert is issued to the user.

[0205] The process of making a film on stainless steel insert molded electrode assembly includes etching the film to form openings (micro-holes, slots, or honeycomb) for the passage of RF energy, cutting around the electrode components, forming or adhesively bonding the film onto the stainless steel electrode as needed, placing the attached film and electrode into a polymer injection molding tool, and molding the polymer onto the back of the electrode and film.

[0206] In various aspects, the present disclosure provides combined ultrasonic / bipolar RF energy surgical devices and systems. Various forms are directed to a user interface for a surgical instrument with an ultrasonic and / or electrosurgical (RF) end effector configured to effect treatment, incision, cutting, and / or coagulation of tissue during a surgical procedure. In one form, a user interface for a combined ultrasonic and electrosurgical instrument is provided that may be configured for use in open surgery, but also has applications in other types of procedures, such as minimally invasive laparoscopy, either in handheld or robotic-assisted surgery, and non-invasive endoscopic procedures. Versatility is achieved by selectively applying multiple energy modalities simultaneously, independently, sequentially, or in combinations thereof. For example, versatility may be achieved by selectively using ultrasonic and electrosurgical energy (e.g., monopolar or bipolar RF energy), whether simultaneously, independently, sequentially, or in a combination thereof.

[0207] In one aspect, the present disclosure provides a user interface for a device that includes an ultrasonic blade and a clamp arm with a deflectable RF electrode that cooperates to seal, cut, and clamp tissue by cooperation of a clamp mechanism of the device with an RF electrode and an associated ultrasonic blade. The clamp mechanism includes a pivoting clamp arm that cooperates with the ultrasonic blade to grasp tissue therebetween. The clamp arm is preferably provided with a clamp tissue pad (also known as a "clamp arm pad") having a plurality of axially spaced apart grasping teeth, segments, elements, or individual units that facilitate grasping and gripping of tissue during surgery while cooperating with the ultrasonic blade of the end effector to achieve the desired sealing and cutting effect on the tissue.

[0208] In one aspect, the end effectors described herein comprise electrodes. In other aspects, the end effectors described herein comprise alternatives to the electrodes described above, which provide RF energy coupling to tissue that conforms to the shape of the tissue, accommodates pad wear / thinning, minimizes excess heat generation (low coefficient of friction, pressure), minimizes spark generation, minimizes interruptions due to electrical shorts, or a combination thereof. The electrodes are fixed at the proximal end to the clamp jaws and are free to deflect at the distal end. Thus, throughout this disclosure, the electrodes may be referred to as cantilever beam electrodes, or deflectable electrodes.

[0209] In other aspects, the end effectors described herein comprise a clamp arm mechanism configured to apply high pressure between the pad and ultrasonic blade to grasp and seal tissue to maximize the likelihood of contacting tissue even in constrained or difficult scenarios, such as, for example, thin tissue, tissue under lateral tension, tissue under lifted / vertical tension, especially tissue that is lifted away from the clamp arm.

[0210] In other aspects, the end effectors described herein are configured to balance the surface area / current density match between the electrodes and balance and minimize heat transfer from the tissue interface, affecting, for example, the formation and symmetry of denaturation, as well as affecting cycle time, residual heat energy, etc. In other aspects, the end effectors described herein are configured to minimize adhesion, tissue sticking (minimize anchor points), and can include small polyimide pads.

[0211] In various aspects, the present disclosure provides a surgical device configured to deliver at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue. The surgical device includes a first activation button switch for activating the energy and a second button switch for selecting an energy mode of the activation button switch. The second button switch is connected to a circuit that defines the energy mode using at least one input parameter. The input parameter can be modified remotely via connection to the generator or via a software update.

[0212] In one aspect, at least one of the energy modes is a simultaneous blend of RF and ultrasound energy, and the input parameters represent the duty cycle of the RF and ultrasound energies.

[0213] In one embodiment, the second button switch is configurable to select from a list of predefined modes, the number of modes in the list being defined by a second user-defined input parameter.

[0214] In one aspect, the input parameter is any of the following: duty cycle, voltage, frequency, pulse width, or current.

[0215] 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.

[0216] In one aspect, the second button switch is a separate control from the end effector closure trigger.

[0217] In one embodiment, the second button switch is configured to be actuated by a second stage of the closure trigger. A first stage of the closure trigger in the closing direction is to actuate the end effector.

[0218] In one aspect, at least one of the energy modes is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0219] In one aspect, at least one of the energy modes is selected from ultrasound, RF bipolar, RF monopolar, microwave, or IRE and is configured to be applied with a predetermined duty cycle or pulse algorithm.

[0220] In one embodiment, at least one of the energy modes is selected from the sequential application of two or more of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, or IRE.

[0221] In one embodiment, at least one of the energy modes is a simultaneous blend of two or more of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, and IRE.

[0222] In one embodiment, at least one of the energy modes is a simultaneous blend of two or more of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, and IRE, followed by one or more of the aforementioned energy types.

[0223] In one embodiment, at least one of the energy modes is one of the following energy types: ultrasound, RF bipolar, RF monopolar, microwave, and IRE, followed by a simultaneous blend of two or more of the foregoing energy types.

[0224] In one embodiment, at least one of the energy modes is a procedure-specific or tissue-specific pre-defined algorithm.

[0225] In one aspect, at least one of the energy modes is compiled from learned surgical actions or activities.

[0226] In one aspect, the input parameters are at least one of energy type, duty cycle, voltage, frequency, pulse width, current, impedance limits, activation time, or energy blend.

[0227] In one aspect, the second button switch is configurable to select from a list of predefined modes, the number of modes in the list being either predefined or defined by a second input parameter defined by the user.

[0228] In one aspect, the aforementioned energy modes are made available to users through a software update to the generator.

[0229] In one aspect, the aforementioned energy modes are made available to users through a software update to the device.

[0230] In one aspect, the user's preferred selections are made available to multiple generators, either through networking, the cloud, or manual transfer.

[0231] 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.

[0232] As used herein, a button switch may be a manually, mechanically, or electrically operated electromechanical device with one or more sets of electrical contacts that are connected to an external circuit. Each set of electrical contacts may be in one of two states: a "closed" state means that the contacts are in contact and electricity can flow between them, and an "open" state means that the contacts are separated and the switch is not conducting electricity. The mechanism that actuates the transition between these two states (open or closed) may be either an "alternating action" type (flipping the switch results in a continuous "on" or "off") or a "momentary" type (pressing it results in "on" and releasing it results in "off").

[0233] In one aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device that includes on-device mode selection and visual feedback. 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. Thus, the present disclosure provides techniques for assigning different modes to a single physical button switch, which allows for a wider range of mode selection without adding complexity to the housing design (e.g., adding more and more button switches). In one aspect, the housing is in the form of a handle or pistol grip.

[0234] As more specialized modes become available, there is a need to provide the many modes to surgeons using surgical devices without creating complex user interfaces. Surgeons want 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 they can be confident that they know which mode is selected.

[0235] 86 illustrates a surgical device 100 with a mode selection button switch 130 thereon, according to at least one embodiment of the present disclosure. The surgical device 100 includes a housing 102 defining a handle 104 in the form of a pistol grip. The housing 102 includes a trigger 106 that, when squeezed, is received within an interior space defined by the handle 104. The trigger 106 is used to operate a clamp arm 111 portion of an end effector 110. The clamp jaw 112 is pivotally movable about a pivot point 114. The housing 102 is coupled to the end effector 110 via a shaft 108 that is rotatable by a knob 122.

[0236] The end effector 110 comprises a clamp arm 111 and an ultrasonic blade 116. The clamp arm 111 comprises a clamp jaw 112, an electrode 118, and a clamp arm pad 120. In one aspect, the clamp arm pad 120 is made of a non-sticky, lubricious material such as PTFE or a similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a versatile material that is hydrophobic, non-wettable, dense, and resistant to high temperatures, and has non-stick properties. The clamp arm pad 120 is non-conductive. In contrast, the electrode 118 is made of a conductive material for delivering electrical energy, such as, for example, monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrodes 118 may include gap setting pads made of a polyimide material, in one aspect made from, for example, a durable, high performance polyimide-based plastic manufactured by DuPont and known under the trade name VESPEL, or other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyether ketone), PEKK (polyether ketone ketone) polymer alloys, for example. Unless otherwise noted below, the clamp arm pads and gap pads described herein below are made from the materials described in this paragraph.

[0237] The electrode 118 and the ultrasonic blade 116 are coupled to a generator 133. The generator 133 is configured to drive RF, microwave, or IRE energy to the electrode 118. The generator 133 is also configured to drive an ultrasonic transducer acoustically coupled to the ultrasonic blade 116. In one particular implementation, the electrode 118 is one pole of an electrical circuit and the ultrasonic blade 116 is the opposite pole of the electrical circuit. The housing 102 includes a switch 124 for activating the ultrasonic blade 116. The circuitry may be contained in the housing 102 or may reside within the generator 133. The surgical device 100 is coupled to the generator 133 via a cable 131. The cable 131 carries signals for the electrosurgical functions and the ultrasonic transducer.

[0238] In various aspects, the surgical device 100 is configured to deliver at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue located within the end effector 110 between the clamp arm 111 and the ultrasonic blade 116. The housing 102 of the surgical device 100 includes a first activation button switch 126 for activating the energy and a second, "mode" button switch 130 for selecting an energy mode for the activation button switch. The second button switch 130 is connected to a circuit that defines the energy mode using at least one input parameter. The input parameters can be modified remotely via connection to a generator or via a software update. The energy mode is displayed on a user interface 128.

[0239] In one aspect, the surgical instrument 100 provides mode switching via an on-device, directional selector "mode" button switch 130. A user can press the mode button switch 130 to switch through different modes, and a colored light on the user interface 128 indicates the selected mode.

[0240] According to various aspects of the present disclosure, different operating modes can be assigned to the surgical device by pressing a "mode" button switch 130, where each time the mode button switch 130 is pressed or pressed and held, the surgical device 100 switches between modes from the full set of available modes displayed on the user interface 128. Once a mode is selected, the generator 133 provides an appropriate tone representative of the generator, and the surgical device 100 has a lighted indicator on the user interface 128 to show which mode has been selected.

[0241] In the example shown in FIG. 86, the "mode" selection button switch 130 is symmetrically positioned on either side of the housing 102. This allows both right and left handed surgeons to select / switch between a mode without using their non-dominant hand. In this manner, the "mode" selection button switch 130 can switch between many different directions, which allows the surgeon to select from a list of options and navigate more complex selections remotely from the sterile field without having to ask a circulator to make adjustments at the generator 133. In addition to the tone representing the generator 133, a lighted indicator on the user interface 128 of the surgical device 100 gives the surgeon feedback as to which mode has been selected.

[0242] 87A-87C show three options for selecting various operational modes of surgical device 100, according to at least one embodiment of the present disclosure. In addition to the colored light user interface 128 on the housing 102 of surgical device 100, feedback of the mode selection can be heard and / or seen through the interface of generator 133, where generator 133 verbally announces the selected mode and / or shows a description of the selected mode on the screen of generator 133.

[0243] FIG. 87A shows a first mode selection option 132A in which the button switch 130 can be pushed forward 136 or backward 134 to cycle the surgical instrument 100 through various modes.

[0244] FIG. 87B illustrates a second mode selection option 132B in which pressing the button switch 130 upward 140 or downward 138 cycles the surgical instrument 100 through various modes.

[0245] FIG. 87C illustrates a third mode selection option 132C in which pressing the button switch 130 forward 136, backward 134, upward 149, or downward 138 cycles the surgical instrument 100 through various modes.

[0246] FIG. 88 illustrates a surgical device 150 with a mode selection button switch 180 on a rear surface of the device 150, according to at least one embodiment of the present disclosure. The surgical device 150 includes a housing 152 defining a handle 154 in the form of a pistol grip. The housing 152 includes a trigger 156 that, when squeezed, is received within an interior space defined by the handle 154. The trigger 156 is used to operate a clamp arm 161 portion of an end effector 160. The clamp jaw 162 is pivotally movable about a pivot point 164. The housing 152 is coupled to the end effector 160 via a shaft 158 ​​that is rotatable by a knob 172.

[0247] The end effector 160 includes a clamp arm 161 and an ultrasonic blade 166. The clamp arm 161 includes a clamp jaw 162, an electrode 168, and a clamp arm pad 170. In one embodiment, the clamp arm pad 170 is made of a non-sticky lubricious material such as PTFE or a similar synthetic fluoropolymer of tetrafluoroethylene. PTFE is a versatile material that is hydrophobic, non-wettable, dense, and resistant to high temperatures, and has non-stick properties. The clamp arm pad 170 is non-conductive. In contrast, the electrode 168 is made of a conductive material for delivering electrical energy, such as monopolar RF, bipolar RF, microwave, or irreversible electroporation (IRE). The electrodes 168 can include gap setting pads made of a polyimide material, in one aspect made from, for example, a durable, high performance polyimide-based plastic manufactured by DuPont and known under the trade name VESPEL, or other suitable polyimides, polyimide polymer alloys, or PET (polyethylene terephthalate), PEEK (polyether ether ketone), PEKK (polyether ketone ketone) polymer alloys, for example. Unless otherwise noted below, the clamp arm pads and gap pads described herein below are made from the materials described in this paragraph.

[0248] The electrode 168 and ultrasonic blade 166 are coupled to a generator 133. The generator 133 is configured to drive RF, microwave, or IRE energy to the electrode 168. The generator 133 is also configured to drive an ultrasonic transducer acoustically coupled to the ultrasonic blade 166. In one particular implementation, the electrode 168 is one pole of an electrical circuit and the ultrasonic blade 166 is the opposite pole of the electrical circuit. The housing 152 includes a switch 174 for activating the ultrasonic blade 166. The circuitry may be contained within the housing 152 or may reside within the generator 133. The surgical device 150 is coupled to the generator 133 via a cable 181. The cable 181 carries signals for the electrosurgical functions and the ultrasonic transducer.

[0249] In various aspects, the surgical device 100 is configured to deliver at least two energy types (e.g., ultrasound, monopolar RF, bipolar RF, microwave, or irreversible electroporation [IRE]) to tissue located within the end effector 110 between the clamp arm 111 and the ultrasonic blade 116. The housing 102 of the surgical device 100 includes a first activation button switch 126 for activating the energy and a second, "mode" button switch 130 for selecting an energy mode for the activation button switch. The second button switch 130 is connected to a circuit that defines the energy mode using at least one input parameter. The input parameters can be modified remotely via connection to a generator or via a software update. The energy mode is displayed on a user interface 128.

[0250] In one aspect, the surgical instrument 150 provides mode switching via an on-device, directional selector "mode" button switch 180. The user can press the mode button switch 180 to switch through different modes, and a colored light on the user interface 178 indicates the selected mode.

[0251] According to various aspects of the present disclosure, different operating modes can be assigned to the surgical device by pressing a "mode" button switch 180, where each time the mode button switch 180 is pressed or pressed and held, the surgical device 150 switches between modes from the full set of available modes displayed on the user interface 178. Once a mode is selected, the generator 133 provides an appropriate tone representative of the generator, and the surgical device 150 has a lighted indicator on the user interface 178 to show which mode has been selected.

[0252] In the example shown in FIG. 88, the "mode" selection button switch 180 is located on the back of the surgical device 150. The location 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 activation. To change modes, the surgeon must intentionally press the mode button switch 180 using another hand. In addition to the tone representing the generator, a lighted indicator on the user interface 178 of the surgical device 150 provides feedback to the surgeon as to which mode has been selected.

[0253] FIG. 89A shows a first mode selection option, with colored lights indicating the selected mode on the user interface 178 as the mode button switch 180 is pressed to cycle through the various modes.

[0254] FIG. 89B illustrates a second mode selection option, where the screen 182 (eg, LCD, e-ink) indicates the selected mode when the mode button switch 180 is pressed to cycle through the various modes.

[0255] FIG. 89C illustrates a third mode selection option whereby when the mode button switch 180 is pressed to cycle through the various modes, coded lights 184 indicate the selected mode.

[0256] FIG. 89D illustrates a fourth mode selection option in which coded button switch 180 is selected and when coded button switch 186 is pressed to select a mode, the coded button switch illuminates to indicate the selected mode.

[0257] In one aspect, the present disclosure provides a combined ultrasonic / bipolar RF energy surgical device that includes energy activation by trigger closure. As more features are added to advanced energy surgical devices, additional button switches or controls are added to the surgical device. The additional button switches or controls make these advanced energy surgical devices complex and difficult to use. Furthermore, when using advanced energy surgical devices to control bleeding, a user interface that is difficult to use or features that are difficult to access take away critical time and attention during a surgical procedure.

[0258] According to the present disclosure, monopolar RF energy or advanced bipolar RF energy is activated by squeezing the trigger past the first closure click to the second activation click and holding it closed until energy delivery is stopped by a power source within the generator. Energy can also be immediately reapplied as many times as necessary by slightly releasing the trigger and then squeezing it again.

[0259] 90 illustrates a surgical device 190 including a trigger 196 actuation mechanism according to at least one embodiment of the present disclosure. The surgical device 190 includes a housing 192 defining a handle 194 in the form of a pistol grip. The housing 192 includes a trigger 196 that is received within an interior space defined by the handle 194 when the trigger 196 is squeezed. The housing 192 is coupled to an end effector via a shaft 198 that is rotatable by a knob 202. The surgical device 190 is coupled to a generator 206 via a cable 204. The cable 204 carries signals for the electrosurgical functions and the ultrasonic transducer.

[0260] The trigger 196 is configured to operate the clamp arm portion of the end effector and trigger electrosurgical energy, thus eliminating the activation button switch 126, 176 shown in Figures 86 and 88. The trigger 196 closes the jaws to grasp tissue when closed to a first audible and tactile click, and activates electrosurgical energy, such as monopolar, bipolar RF, microwave, or IRE energy, when closed to a second audible and tactile click. The entire sequence is completed by actuating the front button switch which turns off the use of ultrasonic energy.

[0261] The procedure for operating the surgical device 190 is: squeeze the trigger 196 to a first audible and tactile click; identify the target tissue in the jaws; activate RF energy by further squeezing the trigger 196 to a second audible and tactile click, or until a tone is heard indicating the end point; cut the tissue by pressing the ultrasonic front switch 200 until the tissue is divided.

[0262] A modified procedure for operating the surgical instrument 190 for additional functionality: activating and holding RF energy with the trigger 196 while simultaneously actuating the front button switch 200 to activate the ultrasonic transducer. This results in a simultaneous application where electrosurgical and ultrasonic energy modalities are delivered to tissue simultaneously.

[0263] In alternative implementations, the front button switch 200 for activating ultrasonic energy can be switched to different speeds via a mode selector on the surgical device 190 or on the power generator 206.

[0264] The surgical instruments 100, 150, 190 described above in connection with Figures 86-90, including the end effectors described in Figures 1-85, and associated algorithms, may be implemented in the following surgical hub systems, for example, in conjunction with the following generators and modular energy systems:

[0265] FIG. 91 illustrates an alternative clamp arm 2900 including a metal clamp jaw 2904, an electrode 2906, multiple 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 embodiment of the present disclosure. The electrode 2906 is attached to the metal jaw 2906 at a weld location 2908. The electrode 2906 wraps around the metal clamp jaw 2904, allowing the electrode 2906 to deflect. The gap pad 2910 has a top PI layer 2912 and a bottom elastomer layer 2914 for pressure control attached directly to the metal clamp jaw 2904. The clamp arm pad 2920 is attached directly to the metal clamp jaw 2904. Also, the clamp arm pad 2920 is a composite pad having a high pressure central zone 2922 made of PTFE for heat reduction and an outer zone 2924 made of PI for deflection of the electrode 2906 .

[0266] In one aspect, the combined ultrasonic / bipolar RF energy surgical device is configured to operate within a surgical hub system. FIG. 92 is a surgical system 3102 including a surgical hub 3106 paired with a visualization system 3108, a robotic system 3110, and an intelligent instrument 3112, in accordance with at least one aspect of the present disclosure. Referring now to FIG. 92, the hub 3106 is shown in communication with the visualization system 3108, the robotic system 3110, and a handheld intelligent surgical instrument 3112 configured in a manner similar to the surgical instruments 100, 150, 190, as described in FIGS. 86-91. The hub 3106 includes a hub display 3135, an imaging module 3138, a generator module 3140, a communication module 3130, a processor module 3132, and a storage array 3134. In certain embodiments, as shown in FIG. 92, the hub 3106 further includes a smoke evacuation module 3126 and / or a suction / irrigation module 3128.

[0267] During surgery, the application of energy to tissue for sealing and / or cutting is commonly associated with smoke evacuation, aspiration of excess fluids, and / or irrigation of tissue. Fluid, power, and / or data lines from different sources often become entangled during surgery. Valuable time may be lost addressing this issue during surgery. Untangling the lines may require unplugging the lines from their corresponding modules, which may require resetting the modules. The modular enclosure 3136 of the hub provides a unified environment for managing the power, data, and fluid lines, reducing the frequency of such tangling between the lines.

[0268] Aspects of the present disclosure present a surgical hub for use in a surgical procedure 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. The combination generator module includes two or more of an ultrasonic energy generator component, a bipolar RF energy generator component, and a monopolar RF energy generator component 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, at least one smoke evacuation component configured to evacuate smoke, fluid, and / or particulates generated by the application of therapeutic energy to tissue, and a fluid line extending from a remote surgical site to the smoke evacuation component.

[0269] 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 that is slidably received within the hub enclosure. In one aspect, the hub enclosure includes a fluid interface.

[0270] 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 may be used to seal tissue, while an ultrasonic generator may 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 and facilitate interactive communication between various generators. One advantage of the hub's modular enclosure 136 is that it allows for quick removal and / or replacement of various modules.

[0271] Aspects of the present disclosure present a modular surgical enclosure for use in a surgical procedure involving application of energy to tissue, the modular surgical enclosure including a first energy generator module configured to generate a first energy for application to tissue, and a first docking station including a first docking port including first data contacts and first power contacts, the first energy generator module slidably movable into electrical engagement with the power contacts and the data contacts, and the first energy generator module slidably movable out of electrical engagement with the first power contacts and the first data contacts.

[0272] In addition to the above, the modular surgical enclosure also includes a second energy generator module configured to generate a second energy for application to tissue, different from the first energy, and a second docking station including a second docking port including second data contacts and second power contacts, wherein the second energy generator module is slidably movable into electrical engagement with the power contacts and the data contacts, and the second energy generator module is slidably movable out of electrical engagement with the second power contacts and the second data contacts.

[0273] In addition, the modular surgical enclosure also includes a communication bus between the first docking port and the second docking port configured to facilitate communication between the first energy generator module and the second energy generator module.

[0274] In one aspect, the present disclosure provides a generator configured to drive a combined ultrasonic / bipolar RF energy surgical device. FIG. 93 illustrates an example of a generator 3900 according to at least one aspect of the present disclosure. As shown in FIG. 93, the generator 3900 is one form of generator configured to couple to a surgical instrument 100, 150, 190 as described in FIG. 86-FIG. 91 and further configured to execute adaptive ultrasonic and electrosurgical control algorithms within a surgical data network with a modular communication hub as shown in FIG. 92. The generator 3900 is configured to deliver multiple energy modalities to the surgical instrument. The generator 3900 provides RF and ultrasonic signals, either alone or simultaneously, for delivering energy to the surgical instrument. The RF and ultrasonic signals may be provided alone or in combination, and may be provided simultaneously. As described above, at least one generator output can deliver multiple energy modalities (e.g., ultrasound, bipolar or monopolar RF, irreversible and / or reversible electroporation, and / or microwave energy, among others) through a single port, and these signals can be delivered individually or simultaneously to an end effector to treat tissue. The generator 3900 comprises a processor 3902 coupled to a waveform generator 3904. The 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 the processor 3902. Digital information related to the waveforms is provided to the waveform generator 3904, which includes one or more DAC circuits for converting digital inputs to analog outputs. The analog output is provided to an amplifier 3906 for signal conditioning and amplification. The conditioned and amplified output of the amplifier 3906 is coupled to a power transformer 3908. The signal is coupled to a secondary on the patient isolated side across a power transformer 3908. 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. It will be understood that more than two energy modalities may be output, and thus the subscript "n" may be used to indicate that up to n ENERGYn terminals may be provided, where n is a positive integer greater than or equal to 2. It will also be understood that up to "n" return paths (RETURNn) may be provided without departing from the scope of this disclosure.

[0275] A first voltage sense circuit 3912 is coupled across the terminals labeled ENERGY1 and RETURN paths and measures the output voltage therebetween. A second voltage sense circuit 3924 is coupled across the terminals labeled ENERGY2 and RETURN paths and measures the output voltage therebetween. A current sense circuit 3914 is disposed in series with the RETURN section of 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, a separate current sense circuit must be provided in each return section. The outputs of the first voltage sense circuit 3912 and the second voltage sense circuit 3924 are provided to corresponding isolation transformers 3916, 3922, respectively, and the output of the current sense circuit 3914 is provided to another isolation transformer 3918. The outputs of the isolation transformers 3916, 3928, 3922 on the primary side (non-patient isolated side) of the power transformer 3908 are provided to one or more ADC circuits 3926. The digitized output of the ADC circuit 3926 is provided to the processor 3902 for further processing and calculations. Feedback information of the output voltage and output current 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 the processor 3902 and the patient isolation circuitry is provided via an interface circuit 3920. Sensors may also be in electrical communication with the processor 3902 via the interface circuit 3920.

[0276] In one aspect, the impedance may be determined by the processor 3902 by dividing either the output of a first voltage sense circuit 3912 coupled across terminals labeled ENERGY1 / RETURN or the output of a second voltage sense circuit 3924 coupled across terminals labeled ENERGY2 / RETURN by the output of a current sense circuit 3914 placed in series with the RETURN section of the secondary side of the power transformer 3908. The output of the first voltage sense circuit 3912 and the output of the second voltage sense circuit 3924 are provided to separate isolation transformers 3916, 3922, and the output of the current sense circuit 3914 is provided to another isolation transformer 3916. Digitized voltage sense measurements and current sense measurements from the ADC circuit 3926 are provided to the processor 3902 to calculate the impedance. As an example, the first energy modality ENERGY1 may be ultrasound energy and the second energy modality ENERGY2 may be RF energy. Nevertheless, in addition to ultrasonic energy modalities and bipolar or monopolar RF energy modalities, other energy modalities may include irreversible and / or reversible electroporation energy, and / or microwave energy, among others. Also, while the example illustrated in FIG. 93 shows that a single return path RETURN may be provided to two or more energy modalities, in other aspects, multiple return paths RETURNn may be provided to each energy modality ENERGYn. Thus, as described herein, the impedance of the ultrasonic transducer may be measured by dividing the output of the first voltage sense circuit 3912 by the output of the current sense circuit 3914, and the impedance of the tissue may be measured by dividing the output of the second voltage sense circuit 3924 by the output of the current sense circuit 3914.

[0277] As shown in FIG. 93, the 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 provides power to the end effector in the form of one or more energy modalities, such as, for example, ultrasonic, bipolar or monopolar RF, irreversible and / or reversible electroporation energy, and / or microwave energy, among others, depending on the type of tissue treatment being performed. For example, the generator 3900 can deliver high voltage and low current energy to drive an ultrasonic transducer, deliver low voltage and high current energy to drive an RF electrode to seal tissue, or deliver energy with a coagulation waveform for spot coagulation using either monopolar or bipolar RF electrosurgical electrodes. The output waveform from the generator 3900 can be steered, switched, or filtered to provide the frequency to the end effector of the surgical instrument. The ultrasonic transducer connection to the generator 3900 output would preferably be located between the outputs labeled ENERGY1 and RETURN as shown in FIG. 92. In one embodiment, the RF bipolar electrode connection to the generator 3900 output would preferably be located between the outputs labeled ENERGY2 and RETURN. In the case of a monopolar output, the preferred connection would be to connect the active electrode (e.g., a pencil or other probe) to the ENERGY2 output and a suitable return pad to the RETURN output.

[0278] Additional details are disclosed in U.S. Patent Application Publication No. 2017 / 0086914, published March 30, 2017, entitled "TECHNIQUES FOR OPERATING GENERATOR FOR DIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICAL INSTRUMENTS," which is incorporated herein by reference in its entirety.

[0279] In one aspect, the present disclosure provides a modular energy system configured to drive a combined ultrasonic / bipolar RF energy surgical device. FIG. 94 is an illustration 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. FIG. 95A is a first exemplary modular energy system configuration including a header module and a display screen representing a graphical user interface (GUI) for relaying information regarding modules connected to the header module, according to at least one aspect of the present disclosure. FIG. 95B is the modular energy system shown in FIG. 95B mounted on a cart, according to at least one aspect of the present disclosure.

[0280] Now referring to FIGS. 93-95B, due to the amount of equipment required to perform surgical procedures, operating rooms all over the world are a tangled web of cords, equipment, and people. Surgical capital equipment tends to be a major source of this problem since most surgical capital equipment performs a single specialized task. Due to their specialized nature, surgeons may need to utilize multiple different types of equipment in the course of a single surgical procedure, forcing operating rooms to stockpile two or even more pieces of surgical capital equipment, such as energy generators. 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 personnel in the operating room, resulting in a tangle of cords that may require guidance. Another problem faced in modern operating rooms is that each of these specialized pieces of surgical capital equipment must have its own user interface and be controlled independently from other pieces of equipment in the operating room. This complicates the proper control of multiple different devices connected together, and requires users to be trained and memorized on different types of user interfaces (which may further change based on the task or surgical procedure being performed in addition to changing between each of the capital equipment). This cumbersome and complicated process may require even more individuals to be present in the operating room and may create danger if the devices are not properly controlled with each other. Thus, consolidating surgical capital equipment technology into a single system that can flexibly accommodate the surgeon's needs to reduce the footprint of surgical capital equipment in the operating room would simplify the user experience, reduce clutter in the operating room, and prevent the difficulties and dangers associated with simultaneously controlling multiple pieces of capital equipment.Furthermore, making such a system extensible or customizable would allow new technologies to be conveniently incorporated into existing surgical systems, eliminating the need to replace the entire surgical system or for operating room personnel to learn new user interfaces or equipment controls with each new technology.

[0281] The surgical hub can be configured to interchangeably receive a variety of modules that can interface with surgical devices (e.g., surgical instruments or smoke evacuators) or provide a variety of other functions (e.g., communications). In one aspect, the surgical hub can be embodied as a modular energy system 4000, shown in connection with FIGS. 94-95B. The modular energy system 4000 can include a variety of different modules 4001 that are connectable to one another in a stacked configuration. In one aspect, the modules 4001 can be physically and communicatively coupled when stacked or otherwise connected together into a single assembly. Additionally, the modules 4001 can be interchangeably connectable to one another 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, thereby allowing any module 4001 to be connected to another module 4001 in any arrangement (although in some aspects, a particular module type, such as a header module 4002, can be configured to function as the topmost module in a stack, for example). In an alternative aspect, the modular energy system 4000 can include a housing configured to receive and hold the module 4001 as shown in FIG. 92. The modular energy system 4000 can also include a variety of different components or accessories that can be connected to or otherwise associated with the module 4001. In another aspect, the modular energy system 4000 can be embodied as a generator module 3140, 3900 of the surgical hub 3106 (FIGS. 92-93). In yet another aspect, the modular energy system 4000 can be a separate system from the surgical hub 3106. In such an embodiment, the modular energy system 4000 may be communicatively coupleable to the surgical hub 3106 for transmitting and / or receiving data therebetween.

[0282] The modular energy system 4000 can be assembled from a variety of different modules 4001, some examples of which are shown in FIG. 94. Each of the different types of modules 4001 can provide different functions, thereby allowing the modular energy system 4000 to be assembled in different configurations to customize the functionality and capabilities of the modular energy system 4000 by customizing the modules 4001 included in each modular energy system 4000. The modules 4001 of the modular energy system 4000 can include, for example, a header module 4002 (which may include a display screen 4006), an energy module 4004, a technology module 4040, and a visualization module 4042. In the embodiment shown, the header module 4002 is configured to function as the top or top module in the modular energy system stack and therefore may lack a connector along its top surface. In another embodiment, the header module 4002 can be configured to be positioned at the bottom or be the bottom module in the modular energy system stack and therefore may lack a connector along its bottom surface. In yet another aspect, the header module 4002 can be configured to be positioned in an intermediate position within the modular energy system stack and therefore can include connectors along both its bottom and top surfaces. The header module 4002 can be configured to control system-wide settings of each module 4001 and their connected components through physical controls 4011 on the header module 4002 and / or through a graphical user interface (GUI) 4008 displayed on the display screen 4006. Such settings could include activation of the modular energy system 4000, alarm volume settings, foot switch settings, settings icons, user interface appearance or configuration, surgeon profile logged into the modular energy system 4000, and / or type of surgical procedure being performed.The header module 4002 may also be configured to provide communication, processing, and / or power for the modules 4001 connected to the header module 4002. The energy module 4004, which may also be referred to as a generator module 3140, 3900 (FIGS. 92-93), may be configured to generate one or more energy modalities for driving an electrosurgical and / or ultrasonic surgical instrument connected to the energy module 4004, such as those described above in connection with the generator 3900 shown in FIG. 93. The technology module 4040 may be configured to provide additional or extended control algorithms (e.g., electrosurgical or ultrasonic control algorithms for controlling the energy output of the energy module 4004). The visualization module 4042 may be configured to interface with a visualization device (i.e., a scope), thus providing enhanced visualization capabilities.

[0283] The modular energy system 4000 may further include various accessories 4029 connectable to the module 4001 to control the functionality of the module 4001 or otherwise configured to function in conjunction with the modular energy system 4000. The accessories 4029 may include, for example, a single pedal footswitch 4032, a dual pedal footswitch 4034, and a cart 4030 for supporting the modular energy system 4000 thereon. The footswitches 4032, 4034 may be configured, for example, to control the activation or functionality of a particular energy modality output by the energy module 4004.

[0284] 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 (e.g., dual electrosurgical and ultrasonic energy generators) and software-driven algorithms for customized effects on tissue. Still further, the surgical system architecture reduces the capital equipment footprint by combining multiple technologies critical to surgery into a single system.

[0285] The various modular components that may be utilized in connection with the modular energy system 4000 may include a monopolar energy generator, a bipolar energy generator, a dual electrosurgical / ultrasonic energy generator, a display screen, and various other modules and / or components, some of which have also been previously described in connection with FIGS. 1-91.

[0286] 95A , the header module 4002, in some aspects, may 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 may 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, the header module 4002 may lack a display screen 4006, or the display screen 4006 may be removably connected to the housing 4010 of the header module 4002. In such aspects, the header module 4002 may be communicatively coupleable to an external system configured to display information generated by the modules 4001 of the modular energy system 4000. For example, in a robotic surgical application, the modular energy system 4000 may be communicatively coupled to a robotic cart or robotic control console configured to display information generated by the modular energy system 4000 to an operator of the robotic surgical system. As another example, the modular energy system 4000 may be communicatively coupled to a mobile display carried by or attached to a surgical staff member to enable viewing of information via the mobile display. In yet another example, the modular energy system 4000 may be communicatively coupled to a surgical hub 4100 or to another computer system that may include a display 4104. In aspects utilizing a user interface that is separate or otherwise distinct from the modular energy system 4000, the user interface may be wirelessly connectable to the entire modular energy system 4000, or to one or more of the modules 4001 therein, such that the user interface may display information from the connected module 4001.

[0287] 95A, the energy module 4004 can include a port assembly 4012 that includes a number of different ports that are configured to deliver different energy modalities to corresponding surgical instruments that are connectable to the respective ports. In the particular embodiment shown in FIGS. 94-95B, the port assembly 4012 includes a bipolar port 4014, a first monopolar port 4016a, a second monopolar port 4018b, a neutral port 4018 (to which a monopolar return pad is connectable), and a combined energy port 4020. However, this particular combination of ports is provided for illustrative purposes only, and alternative combinations of ports and / or energy modalities may be possible for the port assembly 4012.

[0288] As discussed above, the modular energy system 4000 can be assembled into different configurations. Additionally, different configurations of the modular energy system 4000 may also be available for different surgical types and / or different tasks. For example, FIGS. 95A and 95B show a first exemplary configuration of the modular energy system 4000 including a header module 4002 (including a display screen 4006) and an energy module 4004 connected together. Such a configuration may be suitable for laparoscopic and open surgery, for example.

[0289] 96-100 illustrate an exemplary surgical system 10 having ultrasonic and electrosurgical capabilities, including any one of the end effectors, surgical instruments, and generators described herein. FIG. 96 illustrates the surgical system 10 including a generator 12 and a surgical instrument 14. The surgical instrument 14 is operably coupled to the generator 12 via a power cable 16. The generator 12 is operable to power the surgical instrument 14 to deliver ultrasonic energy for cutting tissue and electrosurgical bipolar RF energy (i.e., therapeutic levels of RF energy) for sealing tissue. In one aspect, the generator 12 is configured to power the surgical instrument 14 to deliver ultrasonic energy and electrosurgical bipolar RF energy simultaneously or independently.

[0290] The surgical instrument 14 of this example includes a handle assembly 18, a shaft assembly 20 extending distally from the handle assembly 18, and an end effector 22 disposed at the distal end of the shaft assembly 20. The handle assembly 18 includes a body 24 including a pistol grip 26 and energy control buttons 28, 30 configured to be operated by a surgeon. A trigger 32 is coupled to a lower portion of the body 24. The trigger 32 is pivotable toward and away from the pistol grip 26 to selectively actuate the end effector 22, as described in more detail below. In other suitable variations of the surgical instrument 14, the handle assembly 18 may include, for example, a scissor grip configuration. An ultrasonic transducer 34 is housed within and supported by the body 24. In other configurations, the ultrasonic transducer 34 may be provided outside the body 24.

[0291] As shown in FIGS. 97 and 98, the end effector 22 includes an ultrasonic blade 36 and a clamp arm 38 configured to selectively pivot toward and away from the ultrasonic blade 36 to clamp tissue therebetween. The ultrasonic blade 36 is acoustically coupled to an ultrasonic transducer 34 configured to drive (i.e., vibrate) the ultrasonic blade 36 at ultrasonic frequencies to cut and / or seal tissue positioned in contact with the ultrasonic blade 36. The clamp arm 38 is operatively coupled to the trigger 32 such that the clamp arm 38 is configured to pivot toward the ultrasonic blade 36 to a closed position in response to pivoting of the trigger 32 toward the pistol grip 26. Additionally, the clamp arm 38 is configured to pivot away from the ultrasonic blade 36 to an open position in response to pivoting of the trigger 32 away from the pistol grip 26 (see, e.g., FIGS. 96-98). Given the teachings provided herein, it will be apparent to one of ordinary skill in the art that a variety of suitable ways in which clamp arm 38 may be coupled to trigger 32. In some variations, one or more resilient members may be incorporated to bias clamp arm 38 and / or trigger 32 toward the open position.

[0292] The clamp pad 40 is secured to and extends distally along the clamp side of the clamp arm 38 facing the ultrasonic blade 36. The clamp pad 40 is configured to engage and clamp tissue against a corresponding tissue treatment portion of the ultrasonic blade 36 when the 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. In addition, 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. The electrodes 42, 44 are configured to apply electrosurgical bipolar RF energy provided by the generator 12 to tissue electrically coupled to the electrodes 42, 44. The clamp arm electrode 42 functions as the active electrode while the blade electrode 44 may function as the return electrode, or vice versa. The surgical instrument 14 may be configured to apply electrosurgical bipolar RF energy through the electrodes 42, 44 while vibrating the ultrasonic blade 36 at ultrasonic frequencies, before vibrating the ultrasonic blade 36 at ultrasonic frequencies, and / or after vibrating the ultrasonic blade 36 at ultrasonic frequencies.

[0293] As shown in FIGS. 96-100, 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 an ultrasonic waveguide 50 supported within the inner tube 48. As best seen in FIGS. 97-100, a clamp arm 38 is coupled to the distal ends of the inner tube 48 and the outer tube 46, respectively. Specifically, the clamp arm 38 includes a pair of proximally extending clevis arms 52 that receive a distal end 54 of the inner tube 48 therebetween and are pivotally coupled to the distal end 54 of the inner tube 48 by a pivot pin 56 received through a through hole formed in the clevis arms 52 and the distal end 54 of the inner tube 48. A first finger 58 and a second clevis finger 58 depend downwardly from the clevis arms 52 and are pivotally coupled to a distal end 60 of the 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 the distal end 60 of the outer tube 46 .

[0294] In this embodiment, the inner tube 48 is fixed longitudinally relative to the handle assembly 18, and the outer tube 46 is configured to translate relative to the inner tube 48 and the handle assembly 18 along the longitudinal axis of the shaft assembly 20. As the outer tube 46 translates distally, the clamp arm 38 pivots about the pivot pin 56 toward its open position. As the outer tube 46 translates proximally, the clamp arm 38 pivots in the opposite direction toward its closed position. The proximal end of the outer tube 46 is operatively coupled to the trigger 32, e.g., via a linkage assembly, such that actuation of the trigger 32 causes translation of the outer tube 46 relative to the inner tube 48, thereby opening and closing the clamp arm 38. In other suitable configurations not shown herein, the outer tube 46 may be fixed longitudinally, and the inner tube 48 may be configured to translate to move the clamp arm 38 between its open and closed positions.

[0295] The shaft assembly 20 and the end effector 22 are configured to rotate together about a longitudinal axis relative to the handle assembly 18. A retaining pin 66, shown in FIG. 99, extends laterally through a proximal portion of each of the outer tube 46, the inner tube 48, and the waveguide 50, thereby rotatably coupling these components relative to one another. In this embodiment, a rotation knob 68 is provided at a proximal end portion of the shaft assembly 20 to facilitate rotation of the shaft assembly 20 and the end effector 22 relative to the handle assembly 18. The rotation knob 68 is rotatably secured to the shaft assembly 20 by the retaining pin 66, which extends through a proximal collar of the rotation knob 68. It will be appreciated that in other suitable configurations, the rotation knob 68 may be omitted or replaced with an alternative rotational actuation structure.

[0296] The ultrasonic waveguide 50 is acoustically coupled at its proximal end to the ultrasonic transducer 34 and at its distal end to the ultrasonic blade 36, for example by a threaded connection, as shown in FIG. 100. The ultrasonic blade 36 shown is integrally formed with the waveguide 50, with the blade 36 extending distally directly from the distal end of the waveguide 50. In this manner, the waveguide 50 acoustically couples the ultrasonic transducer 34 to the ultrasonic blade 36 and functions to transmit ultrasonic mechanical vibrations from the transducer 34 to the blade 36. Thus, the ultrasonic transducer 34, the waveguide 50, and the ultrasonic blade 36 collectively define an acoustic assembly. In use, the ultrasonic blade 36 may be 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 cutting and / or sealing the tissue. For example, the blade 36 may cut tissue clamped between the clamp arm 38 and a first treatment side of the blade 36, or alternatively, the blade 36 may cut tissue located in contact with a second treatment side disposed on the opposite side of the blade 36, for example, during a "back cut" movement. In some variations, the waveguide 50 may amplify the ultrasonic vibrations delivered to the blade 36. Additionally, the waveguide 50 may include various mechanisms operable to control the gain of the vibrations and / or mechanisms suitable for tuning the waveguide 50 to a selected resonant frequency. Additional mechanisms of the ultrasonic blade 36 and the waveguide 50 are described in more detail below.

[0297] The waveguide 50 is supported within the inner tube 48 by a number of nodal support elements 70 located along the length of the waveguide 50, as shown in FIGS. 99-100. Specifically, the nodal 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. The nodal support elements 70 may provide structural support for the waveguide 50, but may also provide acoustic isolation between the waveguide 50 and the inner tube 48 and outer tube 46 of the shaft assembly 20. In an alternative embodiment, the nodal support elements 70 may include O-rings. The waveguide 50 is supported at its distal-most acoustic node by a nodal support element in the form of an overmolded member 72 shown in FIG. The waveguide 50 is longitudinally and rotatably fixed within the shaft assembly 20 by a retaining pin 66 that passes through a lateral through-hole 74 formed in a proximally located acoustic node of the waveguide 50, such as the most proximal acoustic node.

[0298] In this embodiment, the distal tip 76 of the ultrasonic blade 36 is located at a position corresponding to an antinode associated with the resonant ultrasonic vibrations transmitted through the waveguide 50. Such a configuration allows the acoustic assembly of the instrument 14 to be tuned to a preferred resonant frequency f when the ultrasonic blade 36 is not loaded with tissue. o When the ultrasonic transducer 34 is energized by the generator 12 to transmit mechanical vibrations to the blade 36 via the waveguide 50, the distal tip 76 of the blade 36 vibrates at a predetermined vibration frequency f, for example, about 50 kHz, in a peak-to-peak range of about 20-120 micrometers, for example, in a range of about 20-50 micrometers. o When the ultrasonic blade 36 is positioned in contact with tissue, the ultrasonic vibrations of the blade 36 can simultaneously cut the tissue and provide a coagulation effect with minimal thermal diffusion by denaturing proteins within adjacent tissue cells. EXAMPLES

[0299] Examples of various aspects of the end effectors and surgical instruments of the present disclosure are provided below. Aspects of the end effector or surgical instrument may include any one or more, and any combination, of the embodiments described below.

[0300] 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to the opposite pole of the electrical generator, and a clamp arm pad fixed to the clamp jaw and having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode and in contact with tissue.

[0301] Example 2. The end effector of example 1, further comprising at least one gap pad for securing the cantilever electrode and establishing a gap between the ultrasonic blade and the cantilever electrode.

[0302] Example 3. The end effector of any one of Examples 1-2, wherein the gap pad is located at a proximal end of the cantilever electrode.

[0303] Example 4. An end effector described in any one of Examples 1 to 3, wherein the gap pad is made of a material having a hardness greater than the hardness of the clamp arm pad such that the gap pad has a longer wear life than the clamp arm pad.

[0304] Example 5. The end effector of any one of Examples 1-4, wherein the clamp arm pad is made of a polymer material and the gap pad is made of a polyimide material.

[0305] Example 6. An end effector according to any one of Examples 1 to 5, wherein the gap pad is made of a non-compliant material and the clamp arm pad is made of a compliant material.

[0306] Example 7. The end effector of any one of Examples 1 to 6, wherein the clamp arm pad is made of a polymer material and the gap pad is made of a polyimide material.

[0307] Example 8. An end effector described in any one of Examples 1 to 7, wherein the cantilever electrode comprises a gap pad at a proximal end of the cantilever electrode, a gap pad at a distal end of the cantilever electrode, and a gap pad located between the proximal end and the distal end.

[0308] Example 9. An end effector described in any one of Examples 1 to 8, wherein the clamp arm pad comprises a base portion fixedly attached to the clamp jaw and a plurality of teeth extending from the base in a direction toward the cantilever electrode.

[0309] Example 10. An end effector according to any one of Examples 1 to 9, wherein the cantilever electrode defines a plurality of apertures.

[0310] Example 11. An end effector described in any one of Examples 1 to 10, further comprising at least one gap pad for securing the cantilever electrode to set a gap between the ultrasonic blade and the cantilever electrode, the clamp arm pad comprising a base portion fixedly attached to the clamp jaw and a plurality of tines extending from the base in a direction toward the cantilever electrode, and the cantilever electrode defining a plurality of openings sized and configured to receive the at least one gap pad and the plurality of tines therethrough.

[0311] Example 12. An end effector described in any one of Examples 1 to 11, wherein the cantilever electrode defines a proximal opening defining an open end for slidably receiving one of the gap pads.

[0312] Example 13. An end effector described in any one of Examples 1 to 12, further comprising a gap pad located at the distal end of the cantilever electrode and a gap pad located between the distal and proximal ends of the cantilever electrode, the proximal gap pad being larger in size than the distal and inner gap pads.

[0313] Example 14. An end effector described in any one of Examples 1 to 14, wherein the proximal end of the cantilever electrode is welded, brazed, or soldered to the proximal end of the clamp jaw.

[0314] Example 15. A surgical instrument comprising a housing, an ultrasonic transducer, and an end effector as defined by any of Examples 1-14. An ultrasonic blade is acoustically coupled to the ultrasonic transducer and electrically coupled to one pole of an electrical generator. An electrode is electrically coupled to the opposite pole of the electrical generator.

[0315] Example 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 the clamp arm comprises a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point; and a cantilever electrode having a proximal end secured to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to the opposite pole of the electrical generator, the cantilever electrode comprising a resilient plug at a distal end and a clamp arm pad secured to the clamp jaw and having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0316] Example 17 The end effector of example 16, wherein the elastic plug is made of silicone.

[0317] Example 18: An end effector described in any one of Examples 16 to 17, further comprising at least one gap pad for fixing the cantilever electrode and setting a gap between the ultrasonic blade and the cantilever electrode.

[0318] Example 19. An end effector described in any one of Examples 18, wherein the gap pad is located at the proximal end of the cantilever electrode.

[0319] Example 20. An end effector described in any one of Examples 19, wherein the gap pad is made of a material having a hardness greater than the hardness of the clamp arm pad such that the gap pad has a longer wear life than the clamp arm pad.

[0320] Example 21. An end effector described in any one of Examples 20, wherein the clamp arm pad is made of a polymer material and the gap pad is made of a polyimide material.

[0321] Example 22. An end effector described in any one of Examples 18 to 21, wherein the gap pad is made of a non-compliant material and the clamp arm pad is made of a compliant material.

[0322] Example 23. An end effector described in any one of Examples 22, wherein the clamp arm pad is made of a polymer material and the gap pad is made of a polyimide material.

[0323] Example 24. An end effector described in any one of Examples 18 to 23, wherein the cantilever electrode comprises a gap pad at a proximal end of the cantilever electrode, a gap pad at a distal end of the cantilever electrode, and a gap pad located between the proximal and distal ends.

[0324] Example 25. An end effector described in any one of Examples 16 to 24, wherein the clamp arm pad has a base portion fixedly attached to the clamp jaw and a plurality of teeth extending from the base in a direction toward the cantilever electrode.

[0325] Example 26. An end effector described in any one of Examples 16 to 25, wherein the cantilever electrode defines a plurality of openings.

[0326] Example 27. An end effector described in any one of Examples 26, further comprising at least one gap pad for securing the cantilever electrode and setting a gap between the ultrasonic blade and the cantilever electrode, the clamp arm pad comprising a base portion fixedly attached to the clamp jaw and a plurality of tines extending from the base in a direction toward the cantilever electrode, and the cantilever electrode defining a plurality of openings sized and configured to receive the at least one gap pad and the plurality of tines therethrough.

[0327] Example 28. An end effector described in any one of Examples 27, wherein the cantilever electrode defines a proximal opening defining an open end for slidably receiving one of the gap pads.

[0328] Example 29. An end effector described in any one of Examples 28, further comprising a gap pad located at the distal end of the cantilever electrode and a gap pad located between the distal and proximal ends of the cantilever electrode, the proximal gap pad being larger in size than the distal and inner gap pads.

[0329] Example 30. An end effector described in any one of Examples 16 to 29, wherein the proximal end of the cantilever electrode is welded, brazed, or soldered to the proximal end of the clamp jaw.

[0330] Example 31. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a peripheral cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the peripheral cantilever electrode being configured to electrically couple to an opposite pole of an electrical generator, the peripheral cantilever electrode defining an internal opening, and a clamp arm pad fixed to the clamp jaw and having at least a portion disposed between the clamp jaw and the peripheral cantilever electrode and another portion extending beyond the surface of the peripheral cantilever electrode through the internal opening to contact tissue.

[0331] Example 32. An end effector as described in Example 31, wherein the cantilever electrode is isolated from the peripheral cantilever electrode and further comprises a connection pad for attaching the peripheral cantilever electrode to the proximal end of the clamp arm.

[0332] Example 33. An end effector described in any one of Examples 31 to 32, wherein the connection pad sets a gap "x" defined between the peripheral cantilever electrode and the ultrasonic blade.

[0333] Example 34. An end effector described in any one of Examples 31 to 33, wherein the cantilever electrode further comprises a connection pad extending from the peripheral cantilever electrode for attaching the peripheral cantilever electrode to the proximal end of the clamp arm.

[0334] Example 35. An end effector described in any one of Examples 31 to 34, wherein the peripheral cantilever electrode has a non-conductive portion for defining a space between the outside of the conductive portion of the peripheral cantilever electrode and the outer edge of the peripheral cantilever electrode.

[0335] Example 36. An end effector described in any one of Examples 35, wherein the peripheral cantilever electrode has a conductive portion extending the entire distance to the distal edge of the non-conductive portion.

[0336] Example 37. 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, the clamp arm comprising: a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point; a cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to an opposite pole of the electrical generator, the cantilever electrode comprising an end of life indicator that can be sensed by the electrical generator to facilitate replacement of the cantilever electrode; and a clamp arm pad fixed to the clamp jaw and having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0337] Example 38. An end effector as described in Example 37, wherein the end of life indicator includes a tail made of conductive cantilever electrode material added to the proximal end of the cantilever electrode anchor point.

[0338] Example 39. An end effector described in any one of Examples 38, wherein the tail is configured to deflect toward the ultrasonic blade when the clamp arm pad and the wear-resistant pad exhibit wear and tear usage.

[0339] Example 40. An end effector described in any one of Examples 39, wherein contact of the tail with the ultrasonic blade creates an electrical short circuit that can be detected to trigger an end notification.

[0340] Example 41. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a floating electrode configured to deflect along its entire length, the floating electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the floating electrode configured to electrically couple to the opposite pole of the electrical generator, and a resilient clamp arm pad secured to the clamp jaw and having at least a portion disposed between the clamp jaw and the electrode and another portion extending beyond the surface of the electrode to contact tissue.

[0341] Example 42. The end effector of example 41, wherein the floating electrode is attached to a spring.

[0342] Example 43. An end effector described in any one of Examples 41 to 42, wherein the clamp arm has a plurality of wear-resistant clamp arm pads attached to a resilient clamp arm pad.

[0343] Example 44. An end effector described in any one of Examples 41 to 43, wherein the elastic clamp arm pad acts as a spring so that the floating electrode can deflect into the elastic clamp arm pad and move in a direction toward the clamp jaw.

[0344] Example 45. An end effector described in any one of Examples 41 to 44, further comprising a wear-resistant clamp arm pad for setting a tissue gap between the floating electrode and the ultrasonic blade.

[0345] Example 46. An end effector described in any one of Examples 41 to 45, further comprising a plurality of wear-resistant dowel pins sized and configured to set a tissue gap between the ultrasonic blade and the floating electrode.

[0346] Example 47. An end effector described in any one of Examples 46, comprising a barb mechanism for preventing the wear-resistant dowel pin from retracting out after it is installed in the clamp arm.

[0347] Example 48. An end effector described in any one of Examples 46, comprising a piercing mechanism for preventing the wear-resistant dowel pin from retracting out after it is installed in the clamp arm.

[0348] Example 49. An end effector comprising: a clamp arm; and an ultrasonic blade configured to acoustically couple to an ultrasonic transducer and electrically couple to an opposite pole of an electrical generator, wherein the clamp arm comprises a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point; a cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to one pole of the electrical generator, the cantilever electrode comprising a central pivot configuration to allow the cantilever electrode to rotate about a central pivot point; and a clamp arm pad fixed to the clamp jaw and comprising at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the clamp jaw to contact tissue.

[0349] Example 50. An end effector as described in Example 49, wherein the cantilever electrode is formed on the spring element.

[0350] Example 51. An end effector described in any one of Examples 50, wherein the spring may further include a strip of metal to form a leaf spring configuration.

[0351] Example 52. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode being configured to electrically couple to the opposite pole of the electrical generator, a clamp arm pad fixed to the clamp jaw and having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue, and a spring disposed between the cantilever electrode and the clamp jaw.

[0352] Example 53. The end effector of Example 52, wherein the cantilever electrode comprises a wear pad attached to the side of the cantilever electrode facing the ultrasonic blade.

[0353] Example 54. An end effector described in any one of Examples 52 to 53, wherein the clamp arm further comprises a wave spring element for supporting the cantilever electrode.

[0354] Example 55. An end effector described in any one of Examples 54, wherein a wave spring element is integrally formed with the clamp arm pad to deflect the cantilever electrode in a direction toward the clamp jaw.

[0355] Example 56. An end effector described in any one of Examples 54, wherein a wave spring element is positioned between the clamp arm pad and the cantilever electrode to bias the cantilever electrode in a direction toward the clamp jaw.

[0356] Example 57. An end effector described in any one of Examples 54, wherein a wave spring element is integrally formed with the clamp arm pad to deflect the cantilever electrode in a direction toward the clamp jaw.

[0357] Example 58. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end of which is pivotally movable about a pivot point, a cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to the opposite pole of the electrical generator, the cantilever electrode being overmolded with an elastomer, and a clamp arm pad fixed to the clamp jaw, the cantilever electrode having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0358] Example 59. The end effector of example 58, wherein the cantilever electrode is overmolded with an elastomer to provide uniform compression along the length of the cantilever electrode.

[0359] Example 60. An end effector described in any one of Examples 58 to 59, wherein the cantilever electrode has an electrical contact on its lateral portion.

[0360] Example 61. An end effector described in any one of Examples 58 to 60, wherein the spring constant increases as the elastomer-overmolded cantilever electrode compresses against the elastomer.

[0361] Example 62. An end effector described in any one of Examples 58 to 61, further comprising a ring or pad overmolded onto the ultrasonic blade.

[0362] Example 63. An end effector described in any one of Examples 58 to 62, wherein the cantilever electrode comprises a diaphragm attached to the clamp jaw by a rigid conductive connection.

[0363] Example 64. An end effector described in any one of Examples 63, wherein the clamp arm pad is disposed on the diaphragm cantilever electrode.

[0364] Example 65. An end effector described in any one of Examples 63, wherein the diaphragm cantilever electrode may be formed of a thin metal conductor material to bend or deflect the cantilever electrode.

[0365] Example 66. An end effector described in any one of Examples 63, wherein the diaphragm cantilever electrode is fabricated in the form of a ring.

[0366] Example 67. An end effector described in any one of Examples 58 to 66, wherein a cantilever electrode overmolded with an elastomer is folded into a spring and has an end in electrical contact with the clamp jaw.

[0367] Example 68. 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, the clamp arm comprising: a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point; a cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode being configured to electrically couple to the opposite pole of the electrical generator; a clamp arm pad fixed to the clamp jaw and having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue; and one or more resistors embedded in the clamp arm pad for sensing a height "h" of the clamp arm pad.

[0368] Example 69: An end effector as described in Example 68, wherein one or more resistors are configured to melt or wear along with the clamp arm pad such that the resistance value of the one or more resistors is similar to the height of the clamp arm pad.

[0369] Example 70. A surgical instrument comprising a housing and an end effector as defined by any of Examples 16 to 69. The ultrasonic blade is acoustically coupled to the ultrasonic transducer and electrically coupled to one pole of the electrical generator. The electrode is electrically coupled to the opposite pole of the electrical generator.

[0370] Example 71. 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 a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a cantilever electrode plate defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode plate being configured to electrically couple to the opposite pole of an electrical generator, a cantilever electrode plate, and a clamp arm pad comprising a longitudinally aligned slot configured to receive the cantilever electrode plate, wherein the coupled cantilever electrode plate and clamp arm pad function as both a restraint system and an ultrasonic support.

[0371] Example 72. An end effector as described in Example 71, having longitudinally aligned slots extending from a proximal end, through which a cantilever electrode plate can be advanced without clamp arm pad material.

[0372] Example 73. An end effector described in any one of Examples 71 to 72, further comprising a tab at the proximal end of the clamp arm pad.

[0373] Example 74. An end effector described in any one of Examples 73, further comprising a proximal recess at the proximal end of the clamp jaw, the proximal recess being configured to receive a tab therein to snap-fit ​​and lock the clamp arm pad to the clamp jaw.

[0374] Example 75. An end effector described in any one of Examples 71 to 74, wherein the clamp arm pad has a plurality of protrusions sized and configured to be received through openings defined in the cantilever electrode plate.

[0375] Example 76. A surgical instrument comprising a housing and an end effector as defined by any of Examples 71-75. The ultrasonic blade is acoustically coupled to the ultrasonic transducer and electrically coupled to one pole of the electrical generator. The electrode is electrically coupled to the opposite pole of the electrical generator.

[0376] Example 77. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a laterally deflectable cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode being configured to electrically couple to the opposite pole of the electrical generator, and a clamp arm pad secured to the clamp jaw, the clamp jaw having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0377] Example 78. An end effector as described in Example 77, wherein the cantilever electrode has a proximal end fixed to the proximal end of the clamp jaw and a distal end that is free to deflect vertically and laterally by creating an elastomeric connection between right and left portions of the cantilever electrode that are fixed at the proximal end and electrically connected to each other.

[0378] Example 79. An end effector described in any one of Examples 77 to 78, wherein the laterally deflectable cantilever electrode is configured to expand due to thermal expansion of the clamp arm pad due to heat and deformation due to a compressive clamp load.

[0379] Example 80. An end effector described in any one of Examples 77 to 79, wherein the laterally deflectable cantilever electrode has a notch defined at its distal end.

[0380] Example 81. An end effector described in any one of Examples 77 to 80, wherein the laterally deflectable cantilever electrode has a vertical reinforcement form for fixing the deflectable cantilever electrode to the clamping jaw.

[0381] Example 82. An end effector described in any one of Examples 77 to 81, wherein the laterally deflectable cantilever electrode is a structural clamping member and faces inwardly around the clamp arm pad.

[0382] Example 83. An end effector described in any one of Examples 77 to 82, wherein the laterally expandable cantilever electrode extends toward the expanded clamp arm pad when the clamp arm pad material transitions to a gel-like state at or near 330°C.

[0383] Example 84. A surgical instrument comprising a housing and an end effector as defined by any of Examples 77-83. The ultrasonic blade is acoustically coupled to the ultrasonic transducer and electrically coupled to one pole of the electrical generator. The electrode is electrically coupled to the opposite pole of the electrical generator.

[0384] Example 85. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a lattice cushion defining a longitudinal slot, the lattice cushion functioning as a spring-like element, a flexible cantilever electrode disposed on the lattice cushion defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to the opposite pole of the electrical generator, and a clamp arm pad disposed inside the longitudinal slot defined by the lattice cushion, secured to the clamp jaw, the clamp arm pad having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0385] Example 86. An end effector as described in Example 85, further comprising a plurality of hard spacers disposed on the flexible cantilever electrode to set a gap between the flexible cantilever electrode and the ultrasonic blade.

[0386] Example 87. An end effector described in any one of Examples 85 to 86, wherein in the closed position of the clamp arm, the lattice cushion applies consistent tissue compression across variable thickness tissues T1a, T2a, and T3a.

[0387] Example 88. Consistent tissue compression across variable thickness tissues T1a, T2a, T3a

number

[0388] Example 88. A surgical instrument comprising a housing and an end effector as defined by any of Examples 85 to 88. The ultrasonic blade is acoustically coupled to the ultrasonic transducer and electrically coupled to one pole of the electrical generator. The electrode is electrically coupled to the opposite pole of the electrical generator.

[0389] Example 89. 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 a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a clamp arm pad secured to the clamp jaw, and a cantilever electrode having a proximal end secured to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to the opposite pole of the electrical generator.

[0390] Example 90. An end effector as described in Example 90, further comprising at least one gap pad that secures the cantilever electrode to set a gap between the ultrasonic blade and the cantilever electrode.

[0391] Example 91. An end effector as described in Example 90, wherein a gap pad is located at a proximal end of the cantilever electrode, the gap pad is made of a material having a hardness greater than the hardness of the clamp arm pad, thereby causing the gap pad to have a longer wear life than the clamp arm pad, the clamp arm pad is made of a polymer material, and the gap pad is made of a polyimide material.

[0392] Example 92. An end effector described in any one of Examples 90 to 91, wherein the gap pad is made of a non-compliant material and the clamp arm pad is made of a compliant material.

[0393] Example 93. An end effector described in any one of Examples 90 to 92, wherein the cantilever electrode comprises a gap pad at a proximal end of the cantilever electrode, a gap pad at a distal end of the cantilever electrode, and a gap pad located between the proximal end and the distal end.

[0394] Example 94. An end effector described in any one of Examples 89 to 93, wherein the clamp arm pad comprises a base portion fixedly attached to the clamp jaw and a plurality of teeth extending from the base in a direction toward the cantilever electrode.

[0395] Example 95. An end effector described in any one of Examples 89 to 94, wherein the cantilever electrode defines a plurality of openings.

[0396] Example 96. An end effector described in any one of Examples 89 to 95, wherein the cantilever electrode is provided with an end-of-life indicator that can be sensed by an electrical generator to facilitate replacement of the cantilever electrode, the end-of-life indicator including a tail made of conductive electrode material added to the proximal end of the cantilever electrode anchor point, the tail configured to deflect toward the ultrasonic blade when the clamp arm pads and wear-resistant pads indicate wear and tear use, and contact of the tail with the ultrasonic blade creates an electrical short that can be detected to trigger an end-of-life notification.

[0397] Example 97. An end effector described in any one of Examples 89 to 96, comprising a central pivot configuration for enabling the cantilever electrode to rotate around a central pivot point.

[0398] Example 98. An end effector described in any one of Examples 89 to 97, wherein the cantilever electrode is formed on a spring element, and the spring may further include a strip of metal to form a leaf spring configuration.

[0399] Example 99. An end effector described in any one of Examples 89 to 98, further comprising a spring disposed between the cantilever electrode and the clamp jaw.

[0400] Example 100. The end effector of example 98, wherein the cantilever electrode comprises a wear pad attached to the side of the cantilever electrode facing the ultrasonic blade.

[0401] Example 101. An end effector described in any one of Examples 89 to 100, wherein the clamp arm further comprises a wave spring element for supporting the cantilever electrode, the wave spring element being integrally formed with the clamp arm pad to deflect the cantilever electrode in a direction toward the clamp jaw, the wave spring element being positioned between the clamp arm pad and the cantilever electrode to deflect the cantilever electrode in a direction toward the clamp jaw, and the wave spring element being integrally formed with the clamp arm pad to deflect the cantilever electrode in a direction toward the clamp jaw.

[0402] Example 102. An end effector described in any one of Examples 89 to 101, wherein the cantilever electrode is overmolded with an elastomer to provide uniform compression along the length of the cantilever electrode, and the clamp arm pad has at least a portion secured to the clamp jaw and positioned between the clamp jaw and the cantilever electrode, and another portion extending beyond the surface of the cantilever electrode and contacting tissue.

[0403] Example 103. An end effector as described in Example 102, wherein the cantilever electrode has electrical contacts on its lateral portions.

[0404] Example 104. An end effector described in any one of Examples 102 to 103, wherein the spring constant increases as the cantilever electrode overmolded with an elastomer compresses against the elastomer.

[0405] Example 105. An end effector described in any one of Examples 102 to 104, wherein the ultrasonic blade has an overmolded ring or pad.

[0406] Example 106. An end effector described in any one of examples 102 to 105, wherein the cantilever electrode comprises a diaphragm attached to the clamp jaw by a rigid conductive connection, and a clamp arm pad is disposed on the diaphragm, the diaphragm may be formed from a thin metal conductor material to bend or deflect the cantilever electrode.

[0407] Example 107. An end effector described in any one of Examples 102 to 106, wherein the cantilever electrode is overmolded with an elastomer, folded into a spring, and has an end in electrical contact with the clamp jaw.

[0408] Example 108. An end effector described in any one of Examples 89 to 107, wherein the clamp arm pad has one or more resistors embedded within the clamp arm pad to sense the height "h" of the clamp arm pad.

[0409] Example 109: An end effector as described in Example 108, wherein the one or more resistors are configured to melt or wear along with the clamp arm pad such that the resistance value of the one or more resistors is similar to the height of the clamp arm pad.

[0410] Example 110. An end effector described in any one of Examples 89 to 109, wherein the cantilever electrode has an elastic plug at a distal end, and the clamp arm pad has at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0411] Example 111. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a peripheral cantilever electrode having a proximal end fixed to the proximal end of the clamp jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the peripheral cantilever electrode being configured to electrically couple to the opposite pole of the electrical generator, the peripheral cantilever electrode defining an internal opening, and a clamp arm pad fixed to the clamp jaw and having at least a portion disposed between the clamp jaw and the peripheral cantilever electrode and another portion extending beyond the surface of the peripheral cantilever electrode through the internal opening to contact tissue.

[0412] Example 112. An end effector as described in Example 111, further comprising a connection pad isolated from the peripheral cantilever electrode for attaching the peripheral cantilever electrode to the proximal end of the clamp arm.

[0413] Example 113. An end effector described in any one of Examples 111 to 112, wherein the connection pad sets a gap "x" defined between the peripheral cantilever electrode and the ultrasonic blade.

[0414] Example 114. An end effector described in any one of Examples 111 to 113, wherein the peripheral cantilever electrode further comprises a connection pad extending from the peripheral cantilever electrode for attaching the peripheral cantilever electrode to the proximal end of the clamp arm.

[0415] Example 115. An end effector described in any one of Examples 111 to 114, wherein the peripheral cantilever electrode has a non-conductive portion for defining a space between the outside of the conductive portion of the peripheral cantilever electrode and the outer edge of the peripheral cantilever electrode.

[0416] Example 116. An end effector comprising a clamp arm and an ultrasonic blade configured to couple to an ultrasonic transducer and one pole of an electrical generator, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a floating cantilever electrode configured to deflect along its entire length and defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the floating cantilever electrode configured to couple to the opposite pole of the electrical generator, and a resilient clamp arm pad secured to the clamp jaw and having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0417] Example 117. The end effector of example 116, wherein the floating cantilever electrode is attached to a spring.

[0418] Example 118. An end effector as described in Example 117, wherein the clamp arm comprises a plurality of wear-resistant clamp arm pads attached to a resilient clamp arm pad.

[0419] Example 119. An end effector described in any one of Examples 116 to 118, wherein an elastic clamp arm pad acts as a spring so that the floating cantilever electrode can be deflected into the elastic clamp arm pad and move in a direction toward the clamp jaw.

[0420] Example 120. An end effector described in any one of Examples 116 to 119, further comprising a wear-resistant clamp arm pad for setting a tissue gap between the floating cantilever electrode and the ultrasonic blade.

[0421] Example 121. An end effector described in any one of Examples 116 to 120, further comprising a plurality of wear-resistant dowel pins sized and configured to set a tissue gap between the ultrasonic blade and the floating cantilever electrode, the dowel pins comprising a barb mechanism for preventing the wear-resistant dowel pins from retracting out after they are installed in the clamp arm, and the dowel pins comprising a piercing feature for preventing the wear-resistant dowel pins from retracting out after they are installed in the clamp arm.

[0422] Example 121. 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 a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, an associated cantilever electrode plate defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the associated cantilever electrode plate being configured to electrically couple to the opposite pole of an electrical generator, and a clamp arm pad including a longitudinally aligned slot configured to receive the associated cantilever electrode plate, wherein the associated cantilever electrode plate and the clamp arm pad are configured to restrain and support the ultrasonic blade.

[0423] Example 122. An end effector as described in Example 121, having longitudinally aligned slots extending from a proximal end through which an associated cantilever electrode plate can be advanced without clamp arm pad material.

[0424] Example 123. An end effector described in any of Examples 121 to 122, further comprising a tab at a proximal end of the clamp arm pad and a proximal recess at a proximal end of the clamp jaw, the proximal recess being configured to receive the tab therein to snap-fit ​​and lock the clamp arm pad to the clamp jaw.

[0425] Example 124. An end effector described in any one of Examples 121 to 123, wherein the clamp arm pad has a plurality of protrusions sized and configured to be received through openings defined in the connected electrode plate.

[0426] Example 125. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a laterally deflectable cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the laterally deflectable cantilever electrode being configured to electrically couple to the opposite pole of the electrical generator, and a clamp arm pad secured to the clamp jaw and having at least a portion disposed between the clamp jaw and the laterally deflectable cantilever electrode and another portion extending beyond the surface of the laterally deflectable cantilever electrode to contact tissue.

[0427] Example 126. An end effector as described in Example 125, wherein the laterally deflectable cantilever electrode has a proximal end fixed to the proximal end of the clamp jaw and a distal end that is free to deflect vertically and laterally by fixing the proximal end and creating an elastomeric connection between right and left portions of the laterally deflectable cantilever electrode that are electrically connected to each other.

[0428] Example 127. An end effector described in any one of Examples 125 to 126, wherein the laterally deflectable cantilever electrode is configured to expand due to thermal expansion of the clamp arm pad due to heat and deformation due to a compressive clamp load.

[0429] Example 128. An end effector described in any one of Examples 125 to 127, wherein the laterally deflectable cantilever electrode has a notch defined at its distal end.

[0430] Example 129. An end effector described in any one of Examples 125 to 128, wherein the laterally deflectable cantilever electrode has a vertical reinforcement form for fixing the deflectable cantilever electrode to the clamping jaw.

[0431] Example 130. 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, the clamp arm comprising a clamp jaw having a proximal end and a distal end, the proximal end being pivotally movable about a pivot point, a lattice cushion defining a longitudinal slot, the lattice cushion functioning as a spring-like element, a flexible cantilever electrode disposed on the lattice cushion defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to electrically couple to the opposite pole of the electrical generator, and a clamp arm pad disposed inside the longitudinal slot defined by the lattice cushion and secured to the clamp jaw, the clamp arm pad having at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode to contact tissue.

[0432] Example 131. An end effector as described in Example 130, further comprising a plurality of hard spacers disposed on the flexible cantilever electrode to set a gap between the flexible cantilever electrode and the ultrasonic blade.

[0433] Example 132. In the closed position of the clamp arms, the lattice cushion applies consistent tissue compression across the variable thickness tissues T1a, T2a, T3a, and consistent tissue compression across the variable thickness tissues T1a, T2a, T3a is

number

[0434] Example 133. A surgical instrument comprising a housing and an end effector defined by any one of examples 1 to 132.

[0435] While several embodiments have been shown and described, it is not the intention of the applicant to restrict or limit the scope of the appended claims to such details. Numerous modifications, variations, changes, substitutions, combinations, and equivalents of these embodiments can be implemented and will occur to those skilled in the art without departing from the scope of the present disclosure. Moreover, the structure of each element associated with the described embodiments can be alternatively described as a means for providing the function performed by that element. Also, although materials are disclosed with respect to specific components, other materials may be used. It is therefore to be understood that the above description and the appended claims are intended to cover all such modifications, combinations, and variations as falling within the scope of the disclosed embodiments. The appended claims are intended to cover all such modifications, variations, changes, substitutions, modifications, and equivalents.

[0436] The above detailed description has described various aspects of the apparatus and / or process using block diagrams, flow diagrams, and / or examples. To the extent that such block diagrams, flow diagrams, and / or examples include one or more functions and / or operations, it should be understood by one skilled in the art that each function and / or operation included in such block diagrams, flow diagrams, and / or examples can be implemented individually and / or collectively by a variety of hardware, software, firmware, or virtually any combination thereof. It should be understood by one skilled in the art that all or a portion of some aspects of the embodiments disclosed herein can be equivalently implemented on an integrated circuit as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more processors (e.g., as one or more programs running on one or more microprocessors), as firmware, or virtually any combination thereof, and that designing circuitry and / or writing software and / or firmware code is within the skill of one skilled in the art in view of the present disclosure. In addition, those skilled in the art will appreciate that the mechanisms of the subject matter described herein may be distributed as one or more program products in a variety of forms, and that the particular form of the subject matter described herein applies regardless of the particular type of signal-bearing medium used to actually effect the distribution.

[0437] The instructions used to program the logic to implement the various disclosed aspects may be stored in a 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. Machine-readable media may therefore include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer), including but not limited to floppy diskettes, optical disks, compact disks, read-only memories (CD-ROMs), as well as magneto-optical disks, read-only memories (ROMs), random access memories (RAMs), erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), magnetic or optical cards, flash memories, or tangible machine-readable storage used to transmit information over the Internet via electrical, optical, acoustical, or other forms of propagated signals (e.g., carrier waves, infrared signals, digital signals, etc.). Non-transitory computer-readable media may therefore include any type of tangible machine-readable media suitable for storing or transmitting electronic instructions or information in a form readable by a machine (e.g., a computer).

[0438] The term "control circuitry" as used in any aspect of the present specification can refer to, for example, hardwired circuitry, programmable circuitry (e.g., a computer processor including one or more individual instruction processing cores, a processing unit, a processor, a microcontroller, a microcontroller unit, a controller, a digital signal processor (DSP), a programmable logic device (PLD), a programmable logic array (PLA), or a field programmable gate array (FPGA)), a state machine circuit, firmware that stores instructions executed by the programmable circuit, and any combination thereof. The control circuitry, collectively or individually, can be embodied as circuits that form part of a larger system, such as, for example, an integrated circuit (IC), an application specific integrated circuit (ASIC), a system on a chip (SoC), a desktop computer, a laptop computer, a tablet computer, a server, a smartphone, etc. Thus, as used herein, "control circuitry" includes, but is not limited to, electrical circuitry having at least one discrete electrical circuit, electrical circuitry having at least one integrated circuit, electrical circuitry having at least one application specific integrated circuit, electrical circuitry forming a general purpose computing device configured by a computer program (e.g., a general purpose computer configured by a computer program that at least partially executes the processes and / or devices described herein, or a microprocessor configured by a computer program that at least partially executes the processes and / or devices described herein), electrical circuitry forming a memory device (e.g., a form of random access memory) and / or electrical circuitry forming a communications device (e.g., a modem, a communications switch, or an optical-electrical facility). Those skilled in the art will recognize that the subject matter described herein may be implemented in analog or digital form, or some combination thereof.

[0439] As used in any aspect of this specification, the term "logic" may refer to an application, software, firmware, and / or circuitry configured to perform any of the operations described above. Software may be embodied as a software package, code, instructions, instruction sets, and / or data recorded on a non-transitory computer-readable storage medium. Firmware may be embodied as code, instructions or instruction sets, and / or hard-coded (e.g., non-volatile) data in a memory device.

[0440] As used in any aspect of this specification, the terms "component," "system," "module," etc. may refer to a computer-related entity that is either hardware, a combination of hardware and software, software, or software in execution.

[0441] As used in any aspect of this specification, an "algorithm" refers to a self-consistent sequence of steps leading to a desired result, and the "steps" refer to manipulations of physical quantities and / or logical states, which may, but need not, take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It is common practice to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. These and similar terms may be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities and / or states.

[0442] The network may include a packet-switched network. The communication devices may communicate with each other using a selected packet-switched network communication protocol. One exemplary communication protocol may include an Ethernet communication protocol that may e...

Claims

1. A clamp arm; an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of the electrical generator; An end effector comprising: The clamp arm is a clamp jaw having a proximal end and a distal end, the proximal end being pivotally moveable about a pivot point; a clamp arm pad secured to the clamp jaw; and a cantilever electrode having a proximal end fixed to the proximal end of the clamping jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to be electrically coupled to opposite poles of the electrical generator; the clamp arm pad includes one or more resistors embedded therein for sensing height of the clamp arm pad; End effector.

2. The end effector of claim 1 , further comprising at least one gap pad secured to the cantilever electrode to establish a gap between the ultrasonic blade and the cantilever electrode.

3. 3. The end effector of claim 2, wherein the gap pad is located at the proximal end of the cantilever electrode, the gap pad is made of a material having a hardness greater than a hardness of the clamp arm pad such that the gap pad has a longer wear life than the clamp arm pad, the clamp arm pad is made of a polymer material, and the gap pad is made of a polyimide material.

4. The end effector of claim 2 , wherein the gap pad is made of a non-compliant material and the clamp arm pad is made of a compliant material.

5. 3. The end effector of claim 2, wherein the at least one gap pad includes a gap pad at the proximal end of the cantilever electrode, a gap pad at the distal end of the cantilever electrode, and a gap pad located between the proximal and distal ends of the cantilever electrode.

6. The end effector of claim 1 , wherein the clamp arm pad comprises a base portion fixedly attached to the clamp jaw and a plurality of teeth extending from the base portion in a direction toward the cantilever electrode.

7. The end effector of claim 1 , wherein the cantilever electrode defines a plurality of apertures.

8. 2. The end effector of claim 1, wherein the cantilever electrode comprises an end of life indicator that can be sensed by the electrical generator to facilitate replacement of the cantilever electrode, the end of life indicator including a tail made of conductive electrode material added to the proximal end of the cantilever electrode's anchor point, the tail configured to deflect towards the ultrasonic blade when the clamp arm pads and wear resistant pads indicate wear and tear usage, and contact of the tail with the ultrasonic blade creates an electrical short that can be detected to trigger an end of life notification.

9. The end effector of claim 1 , wherein the cantilever electrode comprises a central pivot arrangement to allow the cantilever electrode to rotate about a central pivot point.

10. The end effector of claim 1 , wherein the cantilever electrode is formed on a spring element.

11. The end effector of claim 1 , further comprising a spring disposed between the cantilever electrode and the clamping jaw.

12. The end effector of claim 10 , wherein the cantilever electrode comprises a wear pad attached to a side of the cantilever electrode facing the ultrasonic blade.

13. 2. The end effector of claim 1, wherein the clamp arm further comprises a wave spring element for supporting the cantilever electrode, the wave spring element being integrally formed with the clamp arm pad to bias the cantilever electrode in a direction toward the clamp jaw or positioned between the clamp arm pad and the cantilever electrode to bias the cantilever electrode in a direction toward the clamp jaw.

14. 2. The end effector of claim 1, wherein the cantilever electrode is overmolded with an elastomer to provide uniform compression along a length of the cantilever electrode, and the clamp arm pad secured to the clamp jaw has at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode and contacting tissue.

15. The end effector of claim 14 , wherein the cantilever electrode includes electrical contacts on lateral portions thereof.

16. The end effector of claim 14 , wherein a spring constant increases as the elastomer overmolded cantilever electrode compresses against the elastomer.

17. The end effector of claim 14 , wherein the ultrasonic blade comprises an overmolded ring or pad.

18. The end effector of claim 14 , wherein the cantilever electrode comprises a diaphragm attached to the clamp jaw by a rigid conductive connection, the clamp arm pad being disposed on the diaphragm.

19. The end effector of claim 14, wherein the cantilever electrode overmolded with the elastomer is spring-folded and has an end in electrical contact with the clamp jaw.

20. 2. The end effector of claim 1, wherein the one or more resistors are configured to melt or wear along with the clamp arm pad such that a resistance value of the one or more resistors is similar to the height of the clamp arm pad.

21. 2. The end effector of claim 1, wherein the cantilever electrode comprises a resilient plug at the distal end of the cantilever electrode, and the clamp arm pad comprises at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode and contacting tissue.

22. A clamp arm, an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of the electrical generator; An end effector comprising: The clamp arm is a clamp jaw having a proximal end and a distal end, the proximal end being pivotally moveable about a pivot point; a clamp arm pad secured to the clamp jaw; and a cantilever electrode having a proximal end fixed to the proximal end of the clamping jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to be electrically coupled to opposite poles of the electrical generator; the cantilever electrode is overmolded with an elastomer to provide uniform compression along the length of the cantilever electrode, and the clamp arm pad secured to the clamp jaw has at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode and in contact with tissue. End effector.

23. A clamp arm, an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of the electrical generator; An end effector comprising: The clamp arm is a clamp jaw having a proximal end and a distal end, the proximal end being pivotally moveable about a pivot point; a clamp arm pad secured to the clamp jaw; and a cantilever electrode having a proximal end fixed to the proximal end of the clamping jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to be electrically coupled to opposite poles of the electrical generator; the cantilever electrode comprises a resilient plug at the distal end of the cantilever electrode, and the clamp arm pad comprises at least a portion disposed between the clamp jaw and the cantilever electrode and another portion extending beyond the surface of the cantilever electrode and in contact with tissue; End effector.

24. A clamp arm, an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of the electrical generator; An end effector comprising: The clamp arm is a clamp jaw having a proximal end and a distal end, the proximal end being pivotally moveable about a pivot point; a clamp arm pad secured to said clamp jaw; a cantilever electrode having a proximal end fixed to the proximal end of the clamping jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to be electrically coupled to opposite poles of the electrical generator; and at least one gap pad secured to the cantilever electrode to establish a gap between the ultrasonic blade and the cantilever electrode; the gap pad is located at the proximal end of the cantilever electrode, the gap pad is made of a material having a hardness greater than a hardness of the clamp arm pad, such that the gap pad has a longer wear life than the clamp arm pad, the clamp arm pad is made of a polymer material, and the gap pad is made of a polyimide material. End effector.

25. A clamp arm, an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of the electrical generator; An end effector comprising: The clamp arm is a clamp jaw having a proximal end and a distal end, the proximal end being pivotally moveable about a pivot point; a clamp arm pad secured to the clamp jaw; and a cantilever electrode having a proximal end fixed to the proximal end of the clamping jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to be electrically coupled to opposite poles of the electrical generator; the cantilever electrode comprises an end of life indicator that can be sensed by the electrical generator to facilitate replacement of the cantilever electrode, the end of life indicator including a tail made of conductive electrode material added to the proximal end of the cantilever electrode, the tail configured to deflect towards the ultrasonic blade when the clamp arm pad indicates wear and tear usage, and contact of the tail with the ultrasonic blade creates an electrical short that can be detected to trigger an end of life notification; End effector.

26. A clamp arm, an ultrasonic blade configured to acoustically couple to the ultrasonic transducer and electrically couple to one pole of the electrical generator; An end effector comprising: The clamp arm is a clamp jaw having a proximal end and a distal end, the proximal end being pivotally moveable about a pivot point; a clamp arm pad secured to said clamp jaw; a cantilever electrode having a proximal end fixed to the proximal end of the clamping jaw and a freely deflecting distal end, the cantilever electrode defining a surface configured to contact tissue and apply electrical energy to the contacted tissue, the cantilever electrode configured to be electrically coupled to opposite poles of the electrical generator; and a wave spring element for supporting the cantilever electrode; the wave spring element is integrally formed with the clamp arm pad to bias the cantilever electrode toward the clamp jaw, a portion of the wave spring element being located between the clamp arm pad and the cantilever electrode. End effector.

27. The end effector of claim 10, wherein the spring element comprises a strip of metal forming a leaf spring configuration.

28. An end effector as described in claim 18, wherein the diaphragm is formed from a thin metallic conductive material to bend or deflect the cantilever electrode.

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